Analyte sensor ports

The present disclosure provides a contamination resistant sensor port which includes one or more sealing members positioned so as to limit and/or prevent internal contamination of the sensor port with fluids and/or particles present in the environment outside the sensor port.

BACKGROUND OF THE INVENTION

Analyte sensors are commonly used to monitor the level of an analyte in a body fluid. For example, diabetics use analyte sensors, e.g., in the form of analytical test strips, to monitor body glucose levels. Commonly, an analyte sensor is contacted with a bodily fluid and inserted into an analyte meter or other device capable of determining one or more analyte levels based on signals provided by the analyte sensor. The analyte sensor can be received by the analyte meter or other device either before or after a sample of body fluid is applied to the analyte sensor. The sensor receiving area of the device, commonly referred to as a “sensor port,” provides an opening in the device for insertion of the analyte sensor. Consequently, the sensor port also provides an opening from the outside environment to the interior of the device. This exposure to the outside environment via the sensor port creates the potential for contaminating materials to enter the device's interior. As such contamination may affect internal components and/or interfere with the analysis results, there is interest in developing sensor ports which limit the potential for contamination.

SUMMARY OF THE INVENTION

The present disclosure provides a contamination resistant sensor port which includes one or more sealing members positioned so as to limit and/or prevent internal contamination of the sensor port with fluids and/or particles present in the environment outside the sensor port.

In a first aspect, the present disclosure provides a sensor port, which includes a housing, wherein the housing includes a body and a protruding member. The protruding member defines an entry slot configured to receive an analyte sensor. The sensor port according to the first aspect also includes a first sealing member positioned on the protruding member and circumscribing the protruding member, wherein the first sealing member is configured to form a seal between the sensor port and an electrical device.

In one embodiment of the sensor port according to the first aspect, the body defines a first opening and a second opening. The sensor port includes a second sealing member positioned on the body of the housing such that a seal is formed over the first opening. The sensor port also includes a third sealing member positioned on the body of the housing such that a seal is formed over the second opening. In one such embodiment, the second and third sealing members each include an adhesive backing which provides for attachment to the body of the housing. In one embodiment, where the second and third sealing members each include an adhesive backing which provides for attachment to the body of the housing, the second and third sealing members each include polyimide film tape.

In one embodiment of the sensor port according to the first aspect, the protruding member includes a channel which circumscribes the protruding member, wherein the first sealing member is positioned in the channel. In one such embodiment, the channel defines an oval.

In one embodiment of the sensor port according to the first aspect, the electrical device is an analyte meter. In one such embodiment, the analyte meter is a glucose meter. In one embodiment, where the analyte meter is a glucose meter, the analyte sensor is a glucose test strip.

In one embodiment of the sensor port according to the first aspect, the first sealing member is a compliant gasket material. In one such embodiment, the compliant gasket material includes an elastomeric material. In one embodiment, where the first sealing member is a compliant gasket material, the compliant gasket material is an o-ring.

In one embodiment of the sensor port according to the first aspect, the entry slot includes an internal beveled face.

In one embodiment of the sensor port according to the first aspect, the housing includes an injection molded plastic.

In one embodiment of the sensor port according to the first aspect, the housing includes a top portion and a bottom portion which are joined to form the sensor port.

In one embodiment of the sensor port according to the first aspect, the sensor port is integrated in and operably connected to an electrical device. In one such embodiment, the electrical device is an analyte meter. In one embodiment, the analyte meter is a glucose meter.

In another embodiment of the sensor port according to the first aspect, where the sensor port is integrated in and operably connected to an electrical device, the electrical device is an integrated continuous glucose monitor receiver.

In another embodiment of the sensor port according to the first aspect, where the sensor port is integrated in and operably connected to an electrical device, the electrical device is a medication delivery device. In one such embodiment, the medication delivery device is a pump. In one embodiment, the medication delivered by the medication delivery device is insulin.

In one embodiment of the sensor port according to the first aspect, the first sealing member provides a substantially fluid-tight seal between the sensor port and the electrical device.

In a second aspect, the present disclosure provides a medication delivery device, wherein the medication delivery device includes a sensor port. The sensor port includes a housing and a first sealing member. The housing includes a body and a protruding member, the protruding member defining an entry slot configured to receive an analyte sensor. The first sealing member is positioned on the protruding member and circumscribes the protruding member. The first sealing member forms a seal between the sensor port and the medication delivery device.

In one embodiment of the medication delivery device according to the second aspect, the body defines a first opening and a second opening. The sensor port includes a second sealing member positioned on the body of the housing such that a seal is formed over the first opening. The sensor port also includes a third sealing member positioned on the body of the housing such that a seal is formed over the second opening. In one such embodiment, the second and third sealing members each include an adhesive backing which provides for attachment to the body of the housing. In one embodiment, where the second and third sealing members each include an adhesive backing which provides for attachment to the body of the housing, the second and third sealing members each include polyimide film tape.

In one embodiment of the medication delivery device according to the second aspect, the protruding member includes a channel which circumscribes the protruding member, wherein the first sealing member is positioned in the channel. In one such embodiment, the channel defines an oval.

In one embodiment of the medication delivery device according to the second aspect, the analyte sensor is a glucose test strip.

In one embodiment of the medication delivery device according to the second aspect, the first sealing member is a compliant gasket material. In one such embodiment, the compliant gasket material comprises an elastomeric material. In one embodiment, where the first sealing member is a compliant gasket material, the compliant gasket material is an o-ring.

In one embodiment of the medication delivery device according to the second aspect, the entry slot includes an internal beveled face.

In one embodiment of the medication delivery device according to the second aspect, the housing includes an injection molded plastic.

In one embodiment of the medication delivery device according to the second aspect, the housing includes a top portion and a bottom portion which are joined to form the sensor port.

In one embodiment of the medication delivery device according to the second aspect, the medication delivery device is a pump. In one embodiment, the medication delivered by the medication delivery device is insulin.

In one embodiment of the medication delivery device according to the second aspect, the first sealing member provides a substantially fluid-tight seal between the sensor port and the medication delivery device.

These and other objects, features and advantages of the present disclosure will become more fully apparent from the following detailed description of the embodiments, the appended claims and the accompanying drawings.

Before the present invention is further described, it is to be understood that this invention is not limited to particular embodiments described, as such may vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.

DETAILED DESCRIPTION OF THE INVENTION

As summarized above, the present disclosure is directed to a splash-proof sensor port which includes one or more sealing members positioned so as to prevent internal contamination of the sensor port with fluids and/or particles present in the environment outside the sensor port. In some embodiments, the sensor port may be included in, e.g., integrated with, an analyte meter or monitoring system, e.g., an in vitro analyte meter or an in vivo analyte monitoring system. Analyte meters and analyte monitoring systems suitable for use with the disclosed sensor ports include, for example, those available from Abbott Diabetes Care Inc. (Alameda, Calif.). Analyte meters may be electrochemical or optical meters, and may be configured to determine the level of one or more analytes, where analytes of interest include, but are not limited to, glucose, blood β-ketone, ketone bodies, lactate, acetyl choline, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA, fructosamine, glucose, glutamine, growth hormones, hormones, ketones, lactate, peroxide, prostate-specific antigen, prothrombin, RNA, thyroid stimulating hormone, and troponin, in sample of body fluid. Analyte meters may also be configured to determine the concentration of drugs, such as, for example, antibiotics (e.g., gentamicin, vancomycin, and the like), digitoxin, digoxin, drugs of abuse, theophylline, and warfarin, may also be determined and the like, in a sample of body fluid.

Integration with Analyte Meters and/or Analyte Monitoring Systems

In certain embodiments, sensor ports according to the present disclosure are integrated with analyte meters and/or analyte monitoring systems. For example, a sensor port according to the present disclosure may be integrated with a FreeStyle® blood glucose monitoring meter or a Precision® brand blood monitoring meter capable of monitoring glucose and ketones, or other such analytes. In addition, the disclosed sensor ports may find use in meters designed for use in a hospital or similar clinic environment where a single meter may be used for a plurality of patients. Such systems include, but are not limited to, Precision PCx® meters, FreeStyle Connect™ meters and Precision Xceed Pro™ meters manufactured by Abbott Diabetes Care Inc. (Alameda, Calif.).

In certain embodiments, the sensor ports may be integrated with a continuous analyte monitoring system. For example, a continuous glucose monitoring system may include a component that receives analyte data from a transcutaneously positioned or wholly implanted glucose sensor, and which component may be configured to communicate analyte results to the user, e.g., audibly by way of a display, or visually. The continuous monitoring system receiver may include a conventional blood glucose meter and therefore a port for accepting a glucose sensor, e.g., a glucose test strip. The conventional meter and test strip may be used to calibrate the continuous system, e.g., using one point calibration or other calibration protocol. For example, see U.S. Pat. No. 6,175,752, the disclosure of which is incorporated by reference herein.

Integration with Medication Delivery Devices and/or Systems

In some embodiments, the sensor ports disclosed herein may be included in, e.g., integrated with, a medication delivery system, e.g., an insulin pump module, such as an insulin pump or controller module thereof. Additional information regarding medication delivery devices and/or systems, such as, for example, integrated systems, is provided in U.S. Patent Application Publication No. US2006/0224141, published on Oct. 5, 2006, entitled “Method and System for Providing Integrated Medication Infusion and Analyte Monitoring System”, and U.S. Patent Application Publication No. US2004/0254434, published on Dec. 16, 2004, entitled “Glucose Measuring Module and Insulin Pump Combination,” the disclosure of each of which is incorporated by reference herein. Medication delivery devices which may be provided with an analyte meter which in turn includes a sensor port as described herein include, e.g., a needle, syringe, pump, catheter, inhaler, transdermal patch, or combination thereof. In some embodiments, the medication delivery device or system may be in the form of a drug delivery injection pen such as a pen-type injection device incorporated within the housing of an analyte meter. Additional information is provided in U.S. Pat. Nos. 5,536,249 and 5,925,021, the disclosure of each of which is incorporated by reference herein.

The medication delivery system may be used for injecting a dose of medication, such as insulin, into a patient based on a prescribed medication dosage, and may be automatically updated with dosage information received from an analyte meter. In another embodiment, the medication dosage of the medication delivery system may include manual entry of dosage changes made through, for example, an optional input unit coupled to the housing of an analyte meter. Medication dosage information associated with the medication delivery system may be displayed on an optional display unit disposed on a housing of an analyte meter.

Integration with Entry Slot Protectors

In some embodiments, the sensor ports described herein can be configured to work with (e.g., engage with or operate in connection with) additional mechanisms and/or devices designed to limit and/or prevent contamination of the internal areas of the sensor ports themselves or the internal areas of the electrical devices into which the sensor ports can be integrated. For example, mechanisms, devices and methods of protecting sensor port openings are described in U.S. Patent Application Publication No. US2008/0234559, and U.S. Patent Application Publication No. US2008/0119709, the disclosure of each of which is incorporated by reference herein. Sensor ports according to the present disclosure can also be configured to be replaceable and/or disposable, and/or configured so as to limit and/or prevent contamination of an electrical device in which the sensor port is integrated. Additional description is provided, for example, in U.S. application Ser. No. 12/495,662, filed Jun. 30, 2009, entitled “Strip Connectors for Measurement Devices;” the disclosure of which is incorporated by reference herein.

Exemplary Sensor Ports

Exemplary sensor ports are now described with reference to the Figures.FIGS. 1A-1Cshow a sensor port100, which includes a housing101, wherein the housing101includes a body102and a protruding member103which protrudes from body102. Protruding member103defines an entry slot104which is configured to receive an analyte sensor (not shown). Protruding member103includes a sealing member105positioned on protruding member103and circumscribing protruding member103. In other words, sealing member105extends around the outside edge of protruding member103, e.g., as shown inFIGS. 1A-1C. In the embodiments depicted in the Figures, sealing member105is illustrated as defining an elliptical shape around the outside edge of protruding member103. However, a variety of configurations are possible for the protruding member103and consequently for the sealing member105which circumscribes protruding member103, e.g., circular, oval, or polygonal configurations.

Entry slot104provides access to an internal region of body102and is configured to receive an analyte sensor, e.g., an analyte test strip (not shown). In some embodiments, entry slot104includes an internal beveled face111, e.g., as shown inFIG. 4BandFIG. 8. The angle of the beveled face relative to the plane of insertion122can vary. For example, in some embodiments, the angle of the beveled face relative to the plane of insertion122is about 25° to about 45°, e.g., about 30° to about 40°. In one specific embodiment, the angle of the beveled face relative to the plane of insertion122is about 35°. Inclusion of such a beveled face in entry slot104can limit and/or prevent ingress of one or more external contaminants through entry slot104and into the internal area of sensor port100. For example, the presence of internal beveled face111may limit and/or prevent splashed fluid material from reaching beyond the beveled portion of beveled face111, e.g., via deflection of the splashed fluid material away from entry slot104. It should be noted that entry slot104may be any suitable shape. The shape may depend at least in part on the shape of the sensor which the sensor port and/or the electrical device is designed to accept.

Sealing member105is configured to form a seal between the sensor port100and an electrical device (not shown) into which the sensor port is integrated or to which the sensor port is attached, e.g., an analyte meter or a medication delivery device. Sealing member105may be made of any suitable material. Examples of suitable materials include, but are not limited to, elastomeric materials, e.g., rubber, or other compliant material. In certain embodiments, the material may be a thermoplastic elastomer (TPE), thermoplastic urethane (TPU), polycarbonate (PC), acrylonitrile butadiene-styrene (ABS) or a combination of two or more of these. In some embodiments, sealing member105takes the form of a compliant gasket material, e.g., an o-ring made of a suitable material. In some embodiments, sealing member105provides a seal between the sensor port100and an electrical device into which the sensor port100is integrated or to which the sensor port100is attached, wherein the seal is a fluid tight seal. For example, the seal may be one which prevents fluid, e.g., water or blood, intrusion between sensor port100and an electrical device into which the sensor port100is integrated or to which the sensor port100is attached. Sealing member105may provide a seal between sensor port100and an electrical device, wherein the seal is one or more of the following: splash-proof, water-resistant, water repellant and water proof. Thus, in some embodiments, the sealing member105resists or does not allow the passage of water, blood, or another liquid between the sensor port100and an electrical device. Put another way, sealing member105may prevent or at least partially inhibit the ingress of water, blood, or another liquid. In some embodiments, the sealing member105reduces by at least about 50%, e.g., at least about 60%, at least about 70%, at least about 80%, at least about 90%, or at least about 99%, the amount of a fluid and/or liquid which would otherwise penetrate, during normal use, between the sensor port100and an electrical device into which the sensor port100is integrated or to which the sensor port100is attached.

The housing101can be formed from a variety of suitable materials. For example, a plastic material, e.g., an injection molded plastic material may be utilized. In some embodiments, the material is at least substantially rigid and of a sufficient hardness such that it will not deform under conditions of normal use, e.g., under normal analytical testing conditions. In one specific embodiment, a hot water moldable polyphthalamide (PPA) glass fiber material (available from RTP Company, Winona, Minn.) is utilized as the housing material.

In some embodiments, e.g., as shown inFIGS. 2-5Band7A-8, protruding member103includes a channel106which circumscribes the protruding member. In other words, channel106extends around the outside edge of protruding member103, e.g., as shown inFIG. 2. In the embodiment depicted inFIG. 2, channel106is illustrated as defining an elliptical shape around the outside edge of protruding member103. However, a variety of configurations are possible for the protruding member103, and consequently for the channel106which circumscribes protruding member103, e.g., circular, oval, or polygonal configurations. The channel itself can also take on a variety of configurations, e.g., a half-circle, half-oval or polygonal configuration. The channel106provides a location for the deposition and/or positioning of sealing member105discussed previously with reference toFIGS. 1A-1C. As such, in some embodiments, the channel106is configured based on the shape and size of sealing member105or vice versa. Sealing member105is configured to form a seal between the sensor port100and an electrical device (not shown) into which the sensor port is integrated or to which the sensor port is attached, e.g., an analyte meter or a medication delivery device. As such, it may be desirable for sealing member105to fit relatively tightly into channel106such that the seal between the sensor port100and the electrical device is not compromised.

In some embodiments, e.g., as shown inFIGS. 3A-5B, the body102of sensor port100defines a first opening109and a second opening110. Openings109and110can take a variety of shapes depending on the particular application of the sensor port. In some embodiments, openings109and110provide access to an internal region of the sensor port where one or more internal components may be disposed, e.g., one or more electrical contacts/traces. This access allows for proper placement and/or adjustment of, e.g., the one or more electrical contacts/traces during production of the sensor port100. The electrical contacts/traces provide a physical and/or electrical interface to an appropriately configured analyte sensor, e.g., an analytical test strip.

In order to limit and/or prevent contamination of the internal region of sensor port100, e.g., via the ingress of particles and/or fluids through opening109and/or110, in some embodiments, a sealing member107is positioned on the body102of the housing101such that a seal is formed over the first opening109. Another sealing member108is positioned on the body102of the housing101such that a seal is formed over the second opening110. See, e.g.,FIGS. 3A-3Cand6A-7B. In operation, sealing members107and108can limit and/or prevent ingress of one or more fluids, particles, or other contaminants through openings109and110. Sealing members107and108may provide a seal, wherein the seal is one or more of the following: splash-proof, water-resistant, water-repellant and water-proof. Thus, in some embodiments, sealing members107and108resist or do not allow the passage of water, blood, or another liquid through openings109and110respectively. Put another way, sealing members107and108may prevent or at least partially inhibit the ingress of water, blood, or another liquid through openings109and110respectively. In some embodiments, the sealing members107and108reduce by at least about 50%, e.g., at least about 60%, at least about 70%, at least about 80%, at least about 90%, or at least about 99%, the amount of a fluid and/or liquid which would otherwise penetrate, during normal use, through openings109and110respectively. In other embodiments, e.g., as shown inFIGS. 1A-1CandFIG. 2, body102lacks any openings to the environment external to body102other than that provided by entry slot104and is thus sealed without the use of additional sealing members on body102.

A variety of suitable materials may be used for sealing members107and108, provided they are capable of limiting and/or preventing ingress of one or more fluids, particles, or other contaminants through openings109and110. For example, suitable materials include, but are not limited to, one or more natural or synthetic polymers. In some embodiments, it may be desirable to use a material which includes a pre-applied adhesive, e.g., a silicone adhesive, in order to facilitate attachment of the sealing member to the body102of sensor port100. Alternatively, a suitable adhesive can be applied separately. In one embodiment, a suitable material for use as sealing member107and/or108is polyimide film tape, such as that available from 3M Corporation (St. Paul, Minn.).

In some embodiments, as shown, for example, inFIGS. 4A-5B, a housing101of a sensor port100includes a top portion112and a bottom portion113which are joined to form sensor port100. Top portion112and bottom portion113can be joined, for example, by inserting optional connection stilts114on top portion112through optional connection stilt insertion holes115on bottom portion113.

As illustrated inFIGS. 4A,4B,5A,5B,7A and7B, an exemplary embodiment of a sensor port100according to the present disclosure is described with respect to a specific electrical contact/lead configuration. It should be noted, however, that a variety of such configurations are known in the art, as evidenced by the patents, patent applications, and patent application publications incorporated by reference herein. The sensor ports according to the present disclosure may be readily configured to accommodate a variety of such configurations. For example, in one embodiment, a sensor port according to the present disclosure can be configured as a “Smart Sensor Port” as described in U.S. patent application Ser. No. 12/431,672, filed Apr. 28, 2009, and entitled “Smart Sensor Ports and Methods of Using Same,” the disclosure of which is incorporated by reference herein.

FIGS. 4A and 4Bshow three electrical contacts/leads (116,117and118) incorporated into top portion112of housing101. In one embodiment, electrical contact116is configured to contact a working electrode lead of an analyte sensor (not shown) when the analyte sensor is inserted into entry slot104of an assembled sensor port100.

Electrical contacts/leads117and118are optional electrical contacts/leads which can be configured such that upon insertion of an analyte sensor (not shown) optional electrical contacts/leads117and118contact an optional insertion monitor (not shown) positioned on the analyte sensor as described, for example, in U.S. Pat. No. 6,616,819, the disclosure of which is incorporated by reference herein; and/or a turn-on/selection monitor as described, for example, in U.S. application Ser. No. 12/431,672, filed Apr. 28, 2009, and entitled “Smart Sensor Ports and Methods of Using Same,” the disclosure of which is incorporated by reference herein. Additional description of insertion monitors and configurations suitable for use as turn-on/selection monitors is provided, for example, in U.S. Patent Application Publication No. US2006/0091006; U.S. Patent Application Publication No. US2008/0267823; U.S. Patent Application Publication No. US2009/0011449; U.S. Patent Application Publication No. US2008/0066305; U.S. Patent Application Publication No. US2008/0060196; U.S. Pat. No. 6,592,745; U.S. Pat. No. 6,143,164; U.S. Pat. No. 6,071,391; U.S. Pat. No. 6,503,381; and U.S. Pat. No. 6,893,545; the disclosures of each of which are incorporated by reference herein.

FIGS. 5A and 5Bshow three electrical contacts/leads (119,120, and121) incorporated into bottom portion113of housing101. In one embodiment, electrical contact119is configured to contact a reference/counter electrode lead of an analyte sensor (not shown) when the analyte sensor is inserted into entry slot104of an assembled sensor port100. As used herein, the term “reference/counter electrode” refers to an electrode that functions as a reference electrode, a counter electrode, or both a reference and a counter electrode.

Electrode contacts/leads120and121are optional electrical contacts/leads which can be configured such that upon insertion of an analyte sensor (not shown) optional electrical contacts/leads120and121contact optional fill indicator electrode leads (not shown) of an analyte sensor (not shown), e.g., as described in U.S. Pat. No. 6,616,819, the disclosure of which is incorporated by reference herein.

FIGS. 6A,6B,7A and7B show exemplary embodiments of sealing member107and sealing member108. In the depicted embodiments, first and second sealing members107and108are shaped and sized such that they completely cover and seal first opening109and second opening110respectively. Although particular configurations are shown in the Figures, it should be noted that sealing members107and108can have a variety of suitable configurations and/or shapes depending on the particular configuration of one or more of housing101, body102and openings109and110. For example, as shown inFIG. 7B, in one embodiment, sealing member108has an irregular shape which allows it to completely cover and seal second opening110while simultaneously leaving uncovered the area of body102where the connection stilts114and the connection stilt insertion holes115are positioned. In some embodiments, body102of housing101is configured to include depressed regions which facilitate proper positioning of sealing members107and108over openings109and110. Exemplary depressed regions are shown inFIGS. 4A and 5Awhere they are indicated as bounded by edge123.