WO2009026394A1

WO2009026394A1 - Body fluid sampling systems

Info

Publication number: WO2009026394A1
Application number: PCT/US2008/073765
Authority: WO
Inventors: Lawson Fisher; George Lewis; Brian Patrick Costello; Stephen Schooley; Basel Bahhour; Vanvisa Attaset; Matthew Richard Mcalonis; Robert Todd Frederick; Lynn Robert Sipe; Yuen Mei Lee; Nigel Harrison; Douglas Ivan Jennings; Haim Cezana; Michael Higgins; Matthew Schumann; Robert Bartetzko; Ganapati Mauze; Travis Marsot; Paul Lum
Original assignee: Pelikan Technologies, Inc.
Priority date: 2007-08-20
Filing date: 2008-08-20
Publication date: 2009-02-26

Abstract

An analyte measuring apparatus is provided that has a housing, a plurality of penetrating members and a plurality of analyte sensors each associated with an analyte sensor pocket and with a penetrating member A plurality of connector pins are coupled to the plurality of analyte sensors and configured to be coupled to contacts of an analyte sensing device that includes analyte read electronics

Description

BODY FLUID SAMPLING SYSTEMS

BACKGROUND

Field of the Invention

This invention relates generally to body fluid sampling and detecting systems, and more particularly to body fluid sampling and detecting systems with improved analyte sensor contacts

Description of the Related Art

Lancing devices are known in the medical health-care products industry for piercing the skin to produce blood for analysis Biochemical analysis of blood samples is a diagnostic tool for determining clinical information Many poιnt-of- care tests are performed using whole blood, the most common being monitoring diabetic blood glucose level Other uses for this method include the analysis of oxygen and coagulation based on Prothrombin time measurement Typically, a drop of blood for this type of analysis is obtained by making a small incision in the fingertip, creating a small wound, which generates a small blood droplet on the surface of the skin

Early methods of lancing included piercing or slicing the skin with a needle or razor Current methods utilize lancing devices that contain a multitude of spring, cam and mass actuators to drive the lancet Success rate generally encompasses the probability of producing a blood sample with one lancing action, which is sufficient in volume to perform the desired analytical test The blood may appear spontaneously at the surface of the skin, or may be "milked" from the wound Milking generally involves pressing the side of the digit, or in proximity of the wound to express the blood to the surface The blood droplet produced by the lancing action must reach the surface of the skin to be viable for testing For a one-step lance and blood sample acquisition method, spontaneous blood droplet formation is requisite Then it is possible to interface the test strip with the lancing process for metabolite testing

Many diabetic patients (insulin dependent) are required to self-test for blood glucose levels five to six times daily Reducing the number of steps required for testing would increase compliance with testing regimes A one-step testing procedure where test strips are integrated with lancing and sample generation would achieve a simplified testing regimen Improved compliance is directly correlated with long-term management of the complications arising from diabetes including retinopathies, neuropathies, renal failure and peripheral vascular degeneration resulting from large variations in glucose levels in the blood Tight control of plasma glucose through frequent testing is therefore mandatory for disease management

Another problem frequently encountered by patients who must use lancing equipment to obtain and analyze blood samples is the amount of manual dexterity and hand-eye coordination required to properly operate the lancing and sample testing equipment due to retinopathies and neuropathies particularly, severe in elderly diabetic patients For those patients, operating existing lancet and sample testing equipment can be a challenge Once a blood droplet is created, that droplet must then be guided into a receiving channel of a small test strip or the like If the sample placement on the strip is unsuccessful, repetition of the entire procedure including re-lancing the skin to obtain a new blood droplet is necessary

With current systems, there is a connector inside a glucose meter A test strip is then introduced into the glucose meter

There is a need for connecting sequential analyte sensors to glucose read electronics where there are multiple sample chambers that each has an analyte sensor

SUMMARY

Accordingly, an object of the present invention is to provide an analyte measuring apparatus that provides for connecting sequential analyte sensors to glucose read electronics where there are multiple sample chambers that each have an analyte sensor

These and other objects of the present invention are provide in an analyte measuring apparatus that has a housing, a plurality of penetrating members and a plurality of analyte sensors each associated with an analyte sensor pocket and with a penetrating member. A plurality of connector pins are coupled to the plurality of analyte sensors and configured to be coupled to contacts of an analyte sensing device that includes analyte read electronics.

In another embodiment of the present invention, an analyte measuring apparatus has a housing with a shutter door, a plurality of penetrating members and a plurality of analyte sensors each in an analyte sensor pocket and each associated with a penetrating member. The analyte sensors are configured to be coupled to contacts of an analyte sensing device that has analyte read electronics. The connector is configured to be inserted into an analyte sensor pocket.

In another embodiment of the present invention, an analyte measuring apparatus has a housing with a shutter door, a plurality of penetrating members and a plurality analyte sensors each in an analyte sensor pocket and each associated with a penetrating member. The analyte sensors are configured to be coupled to contacts of an analyte sensing device that has analyte read electronics. The connector is configured to be inserted into an analyte sensor pocket. Each connector has a first connector that makes connection with the housing, and a second connection coupled to an analyte sensor.

In another embodiment of the present invention, an analyte measuring apparatus has a housing with a shutter door, a plurality of penetrating members and a plurality analyte sensors each in an analyte sensor pocket and each associated with a penetrating member. At least one seal maintains each of a penetrating member in a selected environment. One or more blades are provided to cut at least a portion of the seal prior to a penetrating member advancing to a tissue site.

BRIEF DESCRIPTION OF THE DRAWINGS

Figures 1-12 illustrate multiple pins that are in a triangular relationship.

Figures 13 through 17 illustrated an embodiment of the present invention where the connector is disconnected from the pivoting mechanism and put on a cam track.

Figures 18-21 illustrate an embodiment of the present invention with a new analyte sensor design.

Figure 22 illustrates an embodiment of the analyte sensor with a carbon pad.

Figure 23 illustrates analyte sensor pocket dimensions at a midline of the carbon pads.

Figure 24 illustrates heat-seal flash dimensions of an analyte sensor of the present invention with carbon pads.

Figure 25 illustrates an embodiment of the present invention of the dimensions after folding a foil seal into the analyte sensor pocket.

Figure 26 illustrates a sensor-to-analyte sensor pocket alignment.

Figure 27 illustrates one embodiment of a connector and analyte sensor with dimensions.

Figure 28 illustrates the alignment of the connector to the analyte sensor pocket opening and the carbon pads.

Figure 29 is a perspective view of the connector operation with the shutter of the present invention.

Figures 30 and 31 illustrate embodiments of connectors with a flex cable.

Figure 32 through 39 illustrate embodiments of a formed connector that are used in the fluid detecting system of the present invention.

Figures 40-45 illustrate embodiments of the present invention that include blade elements to cut the foil/seal prior to the penetrating member advancing to the tissue site.

Figure 46 illustrates an embodiment of the present invention where the size and pitch of the electrode contact pads on the analyte sensor strip are increased by linking one electrode from each analyte sensor onto a common electrode for all of the analyte sensors in the disposable.

Figure 47 illustrates an embodiment of the present invention where each analyte sensor has its own set of three contacts.

Figures 48-51 illustrate an embodiment of the present invention molded plastic packaging structures are used in packaging the analyte sensors where the electrical contacts are co-molded and positioned in a manner to establish contact with the electrical pads of the analyte sensors.

Figures 52 to 57 illustrates embodiments of the present invention where interfaces are created between analyte sensor conductors to flex circuit conductors.

DETAILED DESCRIPTION

The present invention provides a body fluid detecting system. The system includes a housing with a door, a disposable that is positionable and replaceable to and from the housing, a plurality of tissue penetrating members, a plurality of sample chambers that are in the disposable, analyte sensors and electrical contacts couple to the analyte sensors. Each sample chamber is associated with a tissue penetrating member. Analyte read electronics are coupled to the analyte sensors to provide a reading on the measured analyte, such as glucose. Electrical contacts are used for the coupling.

A tissue penetrating driver is configured to be coupled to each penetrating member, which can be by way of a gripper. Upon action of a lancing event, the gripper is coupled to the penetrating member and a penetrating member driver. The penetrating member is advanced to the tissue site, creates a wound, and a body fluid sample, such as blood, enters a sample chamber. Each sample chamber has an analyte detecting member, or analyte sensor, that measures the amount of analyte in the blood or fluid sample.

The analyte sensors may be designed for use with a variety of different sensing techniques. Analyte sensors can be in a well, or merely be placed on a support. In one embodiment, analyte sensors include chemistries that are utilized to measure and detect glucose, and other analytes. In another embodiment, analyte detecting members are utilized to detect and measure the amount of different analytes in a body fluid or sample. In one embodiment, the analyte detected is glucose.

A plurality of sterility enclosures can be provided that at least cover tips of the penetrating members. One or more seals are provided to maintain each penetrating member in a sterile condition.. Each analyte sensor needs to be maintained in a dry state and is sealed or covered. A cover sheet can be provided that is a flexible polymer sheet. It should be understood of course that the sheet may be made of a variety of materials useful for coupling an analyte detecting member. This allows the analyte sensor to be sterilized separately from each penetrating member and assembled together at a later time. This process may be used on certain analyte sensors that may be damaged if exposed to the sterilization process. Of course, some embodiments may also have the analyte sensor coupled to the penetrating members during sterilization. The cover sheet may also form part of the seal to maintain a sterile environment about portions of the penetrating member.

The sterility enclosure is removed from their associated penetrating members prior to launch of the penetrating member. The enclosure may be peeled away. . During launch, the sterility barrier can be breached by a device other than a penetrating member or can be breached by a penetrating member itself. Each analyte sensor is positioned to receive fluid from a wound created by the penetrating member

In one embodiment, a punch is used to push down on the seal covering the port associated with a penetrating member. This breaks the seal and also pushes it downward, allowing the penetrating member to exit without contacting the seal. In other embodiments, the seal protrudes outward and is broken off by the downward motion of the punch. Seals may be made from a variety of materials such as but not limited to metallic foil, aluminum foil, paper, polymeric material, or laminates combining any of the above. The seals may also be made of a fracturable material. The seals may be made of a material that can easily be broken when a device applies a force thereto. The seals alone or in combination with other barriers may be used to create a sterile environment about at least the tip of the penetrating member prior to lancing or actuation.

In various embodiments, the present invention provides methods and devices for connecting the analyte sensor to the analyte read electronics of the system.

In one embodiment of the present invention, illustrated in Figures 1-12, the width of the connector can be reduced if the connectors, pins, are placed at the corners of a triangle rather than on a line. In this embodiment, multiple pins 10, e.g., three, are in a triangular relationship. However, is this embodiment, the connector is not a connector that wipes across the analyte sensor. In this embodiment, a spring loaded pin is utilized. In this embodiment, a leaf spring 12 is used to provide the force behind the spring loaded pins 10. One advantage of this design is that the pins 10 can be positioned closer together, resulting in a smaller connector.

By way of illustration, and without limitation, the pins 10 can have a diameter of about 0.5 mm on a 1.0 mm equilateral triangle enabling leads 14 down to about 1.7 mm. Only a short length of the pins 10 is exposed and the leaf springs 12 can be about 0.8 mm wide. The leaf spring 12 contacts the door or shutter 16, there can be a rolling flexible pcb connection, a pivoting mechanism and a sliding mechanism.

Figure 4 illustrates an inside view with three recesses that can be 0.9 mm wide, are enough to allow heat staking at the top to retain conductors 14. It is also deep enough to prevent contacts for shorting on the foil of the housing.

Figure 5 illustrates an outside view showing three holes 18 and recesses to mount the pins 10 and provide access for the contacts. This region is wider to allow for improved strength and to prevent the recesses 18 from breaking out.

Figure 6 shows one contact omitted for clarity. Figures 6 and 7 show the leaf spring contacts 12, mid contact in bending and side contact in torsion and bending.

Figure 8 illustrates a pin 10.

Figures 9 through 12 illustrates an embodiment of coil springs of the present invention, with exemplary dimensions.

In one embodiment, illustrated in Figures 13-17 a analyte measuring apparatus 100 is provided that includes a shutter 110, housing door and connector 112 is provided and the connector 112 is inserted into an analyte sensor pocket 114. The connector 112 is disconnected from the pivoting mechanism, put on a cam track 116 and added to the shutter 110, the door, to drive the connector 112 into the analyte sensor pocket 114. As the shutter opens 110, the shutter 110 forces the connector 112 into the analyte sensor pocket 114. As the shutter 110 closes, the connector 112 is pulled out of the analyte sensor housing 114. This enables the force applied to the connector 112 to be increased by varying an incline plane of the cam track 116 surface Because the connector 112 now moves in a track 116, and by varying the width of the track 116, the compliance of the connector 112 can now align with the analyte sensor pocket 114 This provides horizontal compliance of the connector 112 with the analyte sensor pocket 114

Figures 18-21 illustrate an embodiment of the present invention with a another analyte sensor design 118 Figure 22 illustrates an embodiment of the analyte sensor with a carbon pad 120 Figure 23 illustrates analyte sensor pocket dimensions at a midline of the carbon pads 120 Figure 24 illustrates heat-seal flash dimensions of an analyte sensor of the present invention with carbon pads 120 Figure 25 illustrates an embodiment of the present invention of the dimensions after folding a foil seal into the analyte sensor pocket 114 Figure 26 illustrates a sensor-to-analyte sensor pocket 114 alignment Figure 27 illustrates one embodiment of a connector 112 and analyte sensor with dimensions Figure 28 illustrates the alignment of the connector 112 to the analyte sensor pocket 114 opening and the carbon pads 120 Figure 29 is a perspective view of the connector operation with the shutter 110 of the present invention

Referring to the Figures 30-32, in various embodiments, the present invention provides methods and devices for connecting the analyte sensor to the analyte read electronics of a analyte read system configured to be coupled to the analyte measurement apparatus 200 With the present invention, a connector 210 is provided that makes two connections One connection is with the housing 212 The second connection is with the analyte sensor 214 This connects the system circuitry with the analyte read electronics system of the sensor circuitry

With the present invention, friction is reduced, and or eliminated, by including a piece of flex cable 216 between the pivot connector and a contact point of the system housing The flex cable 216 eliminates the friction With the flex cable 216, motion compliance is in the flex cable 216, and the flex cable 216 can be mounted on the system housing 212 An off the shelf connector 210 can be on a door of the housing 212

In this embodiment, the connector 210 is mounted off the shelf on the door The flex cable 216 is added to the connector 210 and is mounted on the housing 212 The benefits are, there is compliance of motion that comes from the flex cable 216 and not a rubbing motion, there is no friction loads to deal with which alleviates power requirements of a carriage drive and there is less of a bad connection, or connector manning, due to increased friction loads over time

Referring to Figures 33 through 37, and the table in Figure 38, a connector 210 is a formed connector based on a profile connector The profile connector 210 gives close spacing of the connectors themselves In this embodiment, instead of bending the wire, the shape of the wire is cut as a profile The profile has the desired curvature to give the a desired wiping connection that wipes across the surface of a carbon pad of the analyte sensor The metal of the connector 210 is not bent but is instead rotated, such as 90 degrees The features of the wires are then cut as a profile rather then bent as form The shape of the wire connectors 210 is changed to control the amount of wipe across the analyte sensor A plastic shield 218 can be placed on the outside of the connectors to shield them from electrical shorting a foil of the disposable In this embodiment, an ability is provided to use 0 15 mm thick contact, and to thicken walls to a mm of about 0 31 mm

Figures 38 and 39 illustrate a wiping distance across the sensor by the connector 210

In one embodiment of the present invention, illustrated in Figures 40-45, blade elements 310 are provided cut the foil/seal, prior to the penetrating member advancing to the tissue site By way of illustration, and without limitation, the foil web 312 left by the punch defines an opening that can be for purposes of an example, and without limiting the scope of the present invention, be about 2 396 plus or minus 0 050 mm wide Increasing the opening width to 2 860 plus or minus 0 080 mm, the pocket width with flashing, would require an excessive force The addition of the blades cuts the foil 312 and converts the web into a flag 314 Figures 40-42 illustrate an embodiment that creates foil flags 314 on the side In the embodiment illustrates in Figures 43-45, the blades are configured to create foil flags 314 on the top as well as on the sides

In another embodiment of the present invention, illustrated in Figure 46, the size and pitch of the electrode contact pads 316 on the analyte sensor strip are increased by linking one electrode from each analyte sensor onto a common electrode 318 for all of the analyte sensors in the disposable The common electrode 318 can be contacted at a separate convenient location, leaving only two remaining electrode pads 316 per analyte sensor to fit into the available analyte sensor space

In another embodiment of the present invention, illustrated in Figure 47, the analyte sensor pads 316 are connected to a meter 320 During the molding process of the disposable, wire, such as copper, is preformed and deposited in a mold Part of the wire is a connector pad at the bottom and front end of the disposable In this embodiment, each analyte sensor has its own set of three contacts This is a simpler approach for the meter 320 An advantage of this embodiment is that is solves a connector problem and is a simple, cost effective manner In one embodiment with bottom front connector pads, a jack connector is placed in the bottom of an analyte sensor chamber, the analyte sensor is placed in the analyte sensor chamber and the jack connector is crimped underneath This moves the analyte sensor into place with the molded wire This provides for a regular pick and place of the analyte sensor, followed by a connecting step through a hole molded in the bottom of the disposable This adds stability because it partially fixes the analyte sensor in the pocket

In another embodiment, illustrated in Figures 48-51 , molded plastic packaging structures 322 and foil seals 323 are used in packaging the analyte sensors while protecting them from moisture ingress from the ambient During use, it is necessary to open these packaging structures 322 by stripping the foil and providing access to the connector pads on the analyte sensor In this embodiment, these connector contacts 324 are on external surface of the package 322 This can be achieved by insert molding, or co-molding, metal electrical conduits as integral parts of the packaging structure The electrical contacts 324 can be co-molded and positioned in a manner as to establish contact with the electrical pads of the analyte sensors, at one end of the conduits upon insertion of the analyte sensors into the packaging structures, and making the other end of the conduit available for connection to other devices external to the packaging structure. This embodiment also provides a method of using the external electrical contact 324 to read the analyte sensor signal during use with these same electrical contacts 324 to establish proper location of the analyte sensors within the packaging structure 322 by monitoring electrical signals. These electrical signals are produced when proper contacts between the analyte sensor pads and the inner end of the conduit are achieved during loading of the analyte sensors into the packaging structure 322.

In another embodiment of the present invention, illustrated in Figures 52 to 57, interfaces 326 are created between analyte sensor conductors to flex circuit conductors 328 with minimal costs, space and an avoidance of multiple mechanical and or thermal coefficient effects.

Expected variations or differences in the results are contemplated in accordance with the objects and practices of the present invention. It is intended, therefore, that the invention be defined by the scope of the claims which follow and that such claims be interpreted as broadly as is reasonable.

Claims

I An analyte measuring apparatus, comprising a housing, a plurality of penetrating members, a plurality analyte sensors each associated with an analyte sensor pocket and with a penetrating member, and a plurality of connector pins coupled to the plurality of analyte sensors and configured to be coupled to contacts of an analyte sensing device that includes analyte read electronics

2 The device of claim 1 , wherein contacts of the analyte sensing device are configured to be introduced into the housing of the analyte measuring apparatus

3 The device of claim 1 , wherein each of a connector pin is placed at corners of a triangle structure coupled to the housing

4 The device of claim 3, wherein three connector pins are in a triangular relationship

5 The device of claim 4, wherein spring loaded pins are provided to provide a force

6 The device of claim 5, further comprising leaf springs configured to provide force behind the spring loaded pins

7 The device of claim 1 , further comprising a shutter at the housing

8 The device of claim 6, wherein the leaf springs contact the door

9 The device of claim 1 , wherein at least one of a rolling flexible pcb connection, a pivoting mechanism and a sliding mechanism is provided

10 The device of claim 1 , further comprising three recesses associated with each of an analyte sensor pocket

I 1 The device of claim 10, wherein the three recesses are sized to provide for heat staking at a top to retain the contacts associated with the analyte sensors

12 The device of claim 10, wherein the three recesses are sufficiently deep to prevent the connector pins from shorting on a foil of the housing

13 The device of claim 1 , further comprising a plurality of holes and recesses to mount the connector pins and provide access for the contacts

14 An analyte measuring apparatus, comprising a housing with a shutter door, a plurality of penetrating members, and a plurality analyte sensors each in an analyte sensor pocket and each associated with a penetrating member, the analyte sensors configured to be coupled to contacts of an analyte sensing device that has analyte read electronics, wherein the connector is configured to be inserted into an analyte sensor pocket

15 The apparatus of claim 14, wherein each connector is coupled to a pivoting mechanism of the apparatus, is disconnectable from a pivoting mechanism and added to the shutter

16 The apparatus of claim 15, wherein each connector is placed on a cam track and added to the shutter to drive the connector into an analyte sensor pocket

17 The apparatus of claim 14, wherein when the shutter opens, the shutter forces the connector into the analyte sensor pocket

18 The apparatus of claim 17, wherein as the shutter closes the connector is pulled out of the analyte sensor pocket

19 The apparatus of claim 18, wherein a force applied to the connector is increased by varying an incline plane of the cam track surface

20 The apparatus of claim 19, wherein each connector moves in a track and compliance of the connector provided for alignment with the analyte sensor pocket

21 The apparatus of claim 20, wherein the alignment provides horizontal compliance of the connector with the analyte sensor pocket

22 The apparatus of claim 14, further comprising a plurality of carbon pads each associated with an analyte sensor

23 The apparatus of claim 24 wherein each of an analyte sensor pocket has dimensions at a midline of a carbon pad

24 An analyte measuring apparatus, comprising a housing with a shutter door, a plurality of penetrating members, and a plurality analyte sensors each in an analyte sensor pocket and each associated with a penetrating member, the analyte sensors configured to be coupled to contacts of an analyte sensing device that has analyte read electronics, wherein the connector is configured to be inserted into an analyte sensor pocket, each of a connector having a first connector that makes connection with the housing, and a second connection coupled to an analyte sensor

25 The apparatus of claim 24, wherein the first and second connectors connect circuitry of the apparatus with the analyte read electronics of the device

26 The apparatus of claim 24, further comprising a flex cable between a pivot connector and a contact point of the apparatus

27 The apparatus of claim 26, wherein the flex cable reduces friction

28 The apparatus of claim 26, wherein the connector is mounted off a shelf on the shutter

29 The apparatus of claim 28, wherein the flex cable is added to the connector and is mounted on the housing

30 The apparatus of claim 24, further comprising a plurality of carbon pads, each of a pad associated with an analyte sensor

31 The apparatus of claim 30, wherein each connector has a curvature configured to provide a desired wiping across a surface of a carbon pad

32. The apparatus of claim 30, wherein metal of the connector rotated and not bent.

33. The apparatus of claim 32, wherein a shape of the connector is changed to control an amount of wipe across an analyte sensor.

34. The apparatus of claim 24, further comprising: a shield placed on an outside of the connector to shield the connector them from electrical shorting a foil associated with the analyte sensor.

35. An analyte measuring apparatus, comprising: a housing with a shutter door; a plurality of penetrating members; a plurality analyte sensors each in an analyte sensor pocket and each associated with a penetrating member; at least one seal that maintains each of a penetrating member in a selected environment; one or more blades configured to cut at least a portion of the seal prior to a penetrating member advancing to a tissue site.

36. The apparatus of claim 35, further comprising a punch.

37. The apparatus of claim 36, wherein the punch penetrates at least a portion of the seal and creates a seal web.

38. The apparatus of claim 37, wherein the blade is configured to cut the seal and converts the web into a flag.

39. The apparatus of claim 38.where the blade is configured to create foil flags on a top as well as on sides.

40. The apparatus of claim 35, further comprising: electrode contact pads associated with each of an analyte sensor.

41. The apparatus of claim 40, wherein at least one electrode contact pad of analyte sensor is linked to electrode contact pads of other analyte sensors to form a common electrode that can be contacted at a separate location.

42 The apparatus of claim 41 , wherein only two remaining electrode pads per analyte sensor fit into each analyte sensor pocket

43 The apparatus of claim 41 , wherein analyte sensor pads are connected to a meter

44 The apparatus of claim 35, wherein each analyte sensor has its own set of three contacts

45 The apparatus of claim 44, wherein a jack connector is placed in a bottom of an analyte sensor pocket and the associated analyte sensor is placed in the analyte sensor pocket with the jack connector crimped underneath

46 The apparatus of claim 35, molded packaging structures or seals are used in packaging the analyte sensors

47 The apparatus of claim 46, wherein during use packaging structures or seals are opened by removing at least a portion of the packaging structure or seal and providing access to connector pads on an analyte sensor

48 The apparatus of claim 47, where at least a portion of analyte sensor connector contacts are on an external surface of the packaging structure or seal

49 The apparatus of claim 47, wherein metal electrical conduits are provided that are integral parts of the packaging structure or seal

50 The apparatus of claim 49, wherein the electrical contacts are external and co-molded and positioned to establish contact with electrical pads of the analyte sensors upon insertion of the analyte sensors into the packaging structure or seal

51 The apparatus of claim 50, wherein the external electrical contacts read analyte sensor signals during use and can establish proper location of the analyte sensors within the packaging structure or seal by monitoring electrical signals

52 The apparatus of claim 35, wherein interfaces are created between analyte sensor conductors to flex circuit conductor

53. The apparatus of claim 35, wherein the analyte sensors are configured to be coupled to contacts of an analyte sensing device that has analyte read electronics, wherein the connector is configured to be inserted into an analyte sensor pocket.