Source: http://www.google.es/patents/US20050192557?hl=es&ie=ISO-8859-1
Timestamp: 2015-07-28 17:45:43
Document Index: 629211685

Matched Legal Cases: ['art 140', 'Application No. 10', 'Application No. 10', 'Application No. 10', 'Application No. 10', 'Application No. 09', 'Application No. 09', 'Application No. 09', 'Application No. 10', 'Application No. 09', 'Application No. 09']

Patente US20050192557 - Integrated delivery device for continuous glucose sensor - Google PatentesB�squeda Im�genes Maps Play YouTube Noticias Gmail Drive M�s »Iniciar sesi�n B�squeda avanzada de patentesPatentesAbstract of the Disclosure Systems and methods for integrating a continuous glucose sensor, including a receiver, a medicament delivery device, and optionally a single point glucose monitor are provided. Manual integrations provide for a physical association between the devices wherein a user (for example,...http://www.google.es/patents/US20050192557?utm_source=gb-gplus-sharePatente US20050192557 - Integrated delivery device for continuous glucose sensor B�squeda avanzada de patentes N�mero de publicaci�nUS20050192557 A1Tipo de publicaci�nSolicitud N�mero de solicitudUS 10/789,359 Fecha de publicaci�n1 Sep 2005 Fecha de presentaci�n26 Feb 2004 Fecha de prioridad26 Feb 2004Tambi�n publicado comoEP1718350A1, EP1718350A4, EP1718350B1, EP2223710A1, EP2226086A1, US7591801, US7976492, US8460231, US8721585, US8882741, US8920401, US8926585, US9050413, US20090299276, US20110270158, US20120186581, US20120190953, US20120191063, US20120215201, US20120220979, US20120238852, US20120296311, WO2005082436A1, WO2005082436A9 N�mero de publicaci�n10789359, 789359, US 2005/0192557 A1, US 2005/192557 A1, US 20050192557 A1, US 20050192557A1, US 2005192557 A1, US 2005192557A1, US-A1-20050192557, US-A1-2005192557, US2005/0192557A1, US2005/192557A1, US20050192557 A1, US20050192557A1, US2005192557 A1, US2005192557A1 InventoresJames Brauker, Mark Tapsak, Sean Saint, Apurv Kamath, Paul Neale, Peter Simpson, Michael Mensinger, Dubravka Markovic Cesionario originalDexcomExportar citaBiBTeX, EndNote, RefMan Citada por (170), Clasificaciones (17), Eventos legales (6) Enlaces externos: USPTO, Cesi�n de USPTO, EspacenetIntegrated delivery device for continuous glucose sensor
US 20050192557 A1 Resumen
Im�genes(11) Reclamaciones(36)
determining a host’s metabolic response to the medicament delivery;
calculating medicament therapy responsive to the host’s metabolic response to the medicament delivery.
8. The method according to claim 7, wherein the host’s metabolic response is calculated using a pattern recognition algorithm.
9. The method according to claim 7, wherein the step of determining a host’s metabolic response to medicament delivery is repeated when additional medicament delivery data is received by the receiver.
10. The method according to claim 9, wherein the host’s metabolic response iteratively determined for a time period exceeding one week.
12. The method according to claim 11, wherein the individual’s metabolic patterns associated with medicament delivery are calculated using a pattern recognition algorithm.
13. The method according to claim 11, wherein the step of determining the individual’s metabolic patterns to medicament delivery is repeated when the receiver receives additional medicament delivery data.
14. The method according to claim 13, wherein the individual’s metabolic patterns are iteratively determined for a time period exceeding one week.
34. The integrated system according to claim 33, wherein the receiver comprises a microprocessor, and wherein the microprocessor comprises programming to determine a host’s metabolic response to the medicament delivery by evaluating the sensor data points substantially corresponding to delivery and release of the medicament delivery for the first time period.
35. The integrated system according to claim 34, wherein the microprocessor calculates medicament therapy for a second time period responsive to sensor data and the host’s metabolic response to the medicament delivery.
36. The integrated system according to claim 34, wherein the microprocessor comprises programming to estimate glucose values responsive to glucose sensor data and host’s metabolic response.
The present invention relates generally to systems and methods monitoring glucose in a host. More particularly, the present invention relates to an integrated medicament delivery device and continuous glucose sensor.
Diabetes mellitus is a disorder in which the pancreas cannot create sufficient insulin (Type I or insulin dependent) and/or in which insulin is not effective (Type 2 or non–insulin dependent). In the diabetic state, the victim suffers from high blood sugar, which may cause an array of physiological derangements (for example, kidney failure, skin ulcers, or bleeding into the vitreous of the eye) associated with the deterioration of small blood vessels. A hypoglycemic reaction (low blood sugar) may be induced by an inadvertent overdose of insulin, or after a normal dose of insulin or glucose-lowering agent accompanied by extraordinary exercise or insufficient food intake.
In a first embodiment, a method for treating diabetes with an integrated glucose sensor and medicament delivery device is provided, including: receiving in a receiver a data stream from a glucose sensor, including one or more sensor data points; calculating medicament therapy responsive to the one or more sensor data points; validating the calculated therapy based on at least one of data input into the receiver and data obtained from an integrated single point glucose monitor; and outputting validated information reflective of the therapy recommendations.
In a second embodiment, a method for treating diabetes in a host with an integrated glucose sensor and medicament delivery device is provided, including: receiving in a receiver medicament delivery data responsive to medicament delivery from a medicament delivery device; receiving in a receiver a data stream from a glucose sensor, including one or more sensor data points for a time period before and after the medicament delivery; determining a host’s metabolic response to the medicament delivery; receiving a subsequent data stream from the glucose sensor including one or more sensor data points; and calculating medicament therapy responsive to the host’s metabolic response to the medicament delivery.
In an aspect of the second embodiment, the host’s metabolic response is calculated using a pattern recognition algorithm.
In an aspect of the second embodiment, the step of determining a host’s metabolic response to medicament delivery is repeated when the receiver receives additional medicament delivery data.
In an aspect of the second embodiment, the host’s metabolic response iteratively determined for a time period exceeding one week.
In an aspect of the third embodiment, the individual’s metabolic patterns associated with medicament delivery are calculated using a pattern recognition algorithm.
In an aspect of the third embodiment, the step of determining the individual’s metabolic patterns to medicament delivery is repeated when the receiver receives additional medicament delivery data.
In an aspect of the third embodiment, the individual’s metabolic patterns are iteratively determined for a time period exceeding one week.
In an aspect of the fourth embodiment, the the receiver includes a microprocessor, and wherein the microprocessor includes programming to determine a host’s metabolic response to the medicament delivery by evaluating the sensor data points substantially corresponding to delivery and release of the medicament delivery for the first time period.
In an aspect of the fourth embodiment, the microprocessor calculates medicament therapy for a second time period responsive to sensor data and the host’s metabolic response to the medicament delivery.
In an aspect of the fourth embodiment, the microprocessor includes programming to estimate glucose values responsive to glucose sensor data and host’s metabolic response.
Fig. 1 is a block diagram of an integrated system of the preferred embodiments, including a continuous glucose sensor, a receiver for processing and displaying sensor data, a medicament delivery device, and an optional single point glucose-monitoring device.
The term “continuous glucose sensor,” as used herein, is a broad term and are used in its ordinary sense, including, but not limited to, a device that continuously or continually measures glucose concentration, for example, at time intervals ranging from fractions of a second up to, for example, 1, 2, or 5 minutes, or longer. It should be understood that continual or continuous glucose sensors can continually measure glucose concentration without requiring user initiation and/or interaction for each measurement, such as described with reference to U.S. Patent 6,001,067, for example.
The term “sensing region,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, the region of a monitoring device responsible for the detection of a particular glucose. In one embodiment, the sensing region generally comprises a non-conductive body, a working electrode (anode), a reference electrode and a counter electrode (cathode) passing through and secured within the body forming an electrochemically reactive surface at one location on the body and an electronic connection at another location on the body, and a sensing membrane affixed to the body and covering the electrochemically reactive surface. The counter electrode typically has a greater electrochemically reactive surface area than the working electrode. During general operation of the sensor a biological sample (for example, blood or interstitial fluid) or a portion thereof contacts (for example, directly or after passage through one or more domains of the sensing membrane) an enzyme (for example, glucose oxidase); the reaction of the biological sample (or portion thereof) results in the formation of reaction products that allow a determination of the glucose level in the biological sample.
The term “electrochemically reactive surface,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, the surface of an electrode where an electrochemical reaction takes place. In the case of the working electrode, the hydrogen peroxide produced by the enzyme catalyzed reaction of the glucose being detected reacts creating a measurable electronic current (for example, detection of glucose utilizing glucose oxidase produces H2O2 as a by product, H2O2 reacts with the surface of the working electrode producing two protons (2H+), two electrons (2e-) and one molecule of oxygen (O2) which produces the electronic current being detected). In the case of the counter electrode, a reducible species (for example, O2) is reduced at the electrode surface in order to balance the current being generated by the working electrode.
The term “microprocessor,” as used herein, is a broad term and is used in its ordinary sense, including, without limitation, a computer system or processor designed to perform arithmetic and logic operations using logic circuitry that responds to and processes the basic instructions that drive a computer.
The term “electronic circuitry,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, the components (for example, hardware and/or software) of a device configured to process data. In the case of an analyte sensor, the data includes biological information obtained by a sensor regarding the concentration of the analyte in a biological fluid. U.S. Patent Nos. 4,757,022, 5,497,772 and 4,787,398, which are hereby incorporated by reference in their entirety, describe suitable electronic circuits that can be utilized with devices of certain embodiments.
The term “potentiostat,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, an electrical system that controls the potential between the working and reference electrodes of a three-electrode cell at a preset value. The potentiostat forces whatever current is necessary to flow between the working and counter electrodes to keep the desired potential, as long as the needed cell voltage and current do not exceed the compliance limits of the potentiostat.
The term “algorithmically smoothed,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, modification of a set of data to make it smoother and more continuous and remove or diminish outlying points, for example, by performing a moving average of the raw data stream.
The terms “recursive filter” and “auto-regressive algorithm,” as used herein, are broad terms and are used in their ordinary sense, including, but not limited to, an equation in which previous averages are part of the next filtered output. More particularly, the generation of a series of observations whereby the value of each observation is partly dependent on the values of those that have immediately preceded it. One example is a regression structure in which lagged response values assume the role of the independent variables.
The terms “velocity” and “rate of change,” as used herein, are broad terms and are used in their ordinary sense, including, but not limited to, time rate of change; the amount of change divided by the time required for the change. In one embodiment, these terms refer to the rate of increase or decrease in an analyte for a certain time period.
The term “acceleration” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, the rate of change of velocity with respect to time. This term is broad enough to include deceleration.
The term “clinical risk,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, an identified danger or potential risk to the health of a patient based on a measured or estimated analyte concentration, its rate of change, and/or its acceleration.
The term “clinically acceptable,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, an analyte concentration, rate of change, and/or acceleration associated with that measured analyte that is considered to be safe for a patient.
The term “time period,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, an amount of time including a single point in time and a path (for example, range of time) that extends from a first point in time to a second point in time.
The term “measured analyte values,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, an analyte value or set of analyte values for a time period for which analyte data has been measured by an analyte sensor. The term is broad enough to include data from the analyte sensor before or after data processing in the sensor and/or receiver (for example, data smoothing, calibration, or the like).
The term “alarm,” as used herein, is a broad term and is used in its ordinary sense, including, but not limited to, audible, visual, or tactile signal that are triggered in response to detection of clinical risk to a patient. In one embodiment, hyperglycemic and hypoglycemic alarms are triggered when present or future clinical danger is assessed based on continuous analyte data.
The body 20 is preferably formed from epoxy molded around the sensor electronics, however the body may be formed from a variety of materials, including metals, ceramics, plastics, or composites thereof. Co-pending U.S. Patent Application 10/646,333, entitled, “Optimized Sensor Geometry for an Implantable Glucose Sensor” discloses suitable configurations suitable for the body 20, and is incorporated by reference in its entirety.
Glucose + O 2 -> Gluconate + H 2 O 2 The change in H2O2 can be monitored to determine glucose concentration because for each glucose molecule metabolized, there is a proportional change in the product H2O2. Oxidation of H2O2 by the working electrode is balanced by reduction of ambient oxygen, enzyme generated H2O2, or other reducible species at the counter electrode. The H2O2 produced from the glucose oxidase reaction further reacts at the surface of working electrode and produces two protons (2H+), two electrons (2e-), and one oxygen molecule (O2).
In one embodiment, a potentiostat (Fig. 3) is employed to monitor the electrochemical reaction at the electroactive surface(s). The potentiostat applies a constant potential to the working and reference electrodes to determine a current value. The current that is produced at the working electrode (and flows through the circuitry to the counter electrode) is substantially proportional to the amount of H2O2 that diffuses to the working electrode. Accordingly, a raw signal can be produced that is representative of the concentration of glucose in the user’s body, and therefore can be utilized to estimate a meaningful glucose value.
In some embodiments, the sensing membrane includes an enzyme, for example, glucose oxidase, and covers the electrolyte phase. In one embodiment, the sensing membrane generally includes a resistance domain most distal from the electrochemically reactive surfaces, an enzyme domain less distal from the electrochemically reactive surfaces than the resistance domain, and an electrolyte domain adjacent to the electrochemically reactive surfaces. However, it is understood that a sensing membrane modified for other devices, for example, by including fewer or additional domains, is within the scope of the preferred embodiments. Co-pending U.S. Patent Appl. No. 09/916,711, entitled, “SENSOR HEAD FOR USE WITH IMPLANTABLE DEVICES,“ which is incorporated herein by reference in its entirety, describes membranes that can be used in some embodiments of the sensing membrane. It is noted that in some embodiments, the sensing membrane may additionally include an interference domain that blocks some interfering species; such as described in the above-cited co-pending patent application. Co-pending U.S. Patent Application 10/695,636, entitled, “SILICONE COMPOSITION FOR BIOCOMPATIBLE MEMBRANE” also describes membranes that may be used for the sensing membrane of the preferred embodiments, and is incorporated herein by reference in its entirety.
Preferably, the biointerface membrane supports tissue ingrowth, serves to interfere with the formation of a barrier cell layer, and protects the sensitive regions of the device from host inflammatory response. In one embodiment, the biointerface membrane generally includes a cell disruptive domain most distal from the electrochemically reactive surfaces and a cell impermeable domain less distal from the electrochemically reactive surfaces than the cell disruptive domain. The cell disruptive domain is preferably designed to support tissue ingrowth, disrupt contractile forces typically found in a foreign body response, encourage vascularity within the membrane, and disrupt the formation of a barrier cell layer. The cell impermeable domain is preferably resistant to cellular attachment, impermeable to cells, and composed of a biostable material. Copending U.S. Patent Application 09/916,386, entitled, “MEMBRANE FOR USE WITH IMPLANTABLE DEVICES,” U.S. Patent Application 10/647,065, entitled, “POROUS MEMBRANES FOR USE WITH IMPLANTABLE DEVICES,” and U.S. Provisional Patent Application 60/544,722, filed February 12, 2004 entitled, “BIOINTERFACE WITH INTEGRATED MACRO- AND MICRO-ARCHITECTURE,” describe biointerface membranes that may be used in conjunction with the preferred embodiments, and are incorporated herein by reference in their entirety. It is noted that the preferred embodiments may be used with a short term (for example, 1 to 7 day sensor), in which case a biointerface membrane may not be required. It is noted that the biointerface membranes described herein provide a continuous glucose sensor that has a useable life of greater than about one week, greater than about one month, greater than about three months, or greater than about one year, herein after referred to as “long-term.”
Fig. 3 is a block diagram that illustrates the electronics associated with a continuous glucose sensor 12 in one embodiment. In this embodiment, a potentiostat 24 is shown, which is operably connected to electrodes (Fig. 2) to obtain a current value, and includes a resistor (not shown) that translates the current into voltage. An A/D converter 26 digitizes the analog signal into “counts” for processing. Accordingly, the resulting raw data stream in counts is directly related to the current measured by the potentiostat 24.
A microprocessor 28 is the central control unit that houses ROM 30 and RAM 32, and controls the processing of the sensor electronics. It is noted that certain alternative embodiments can utilize a computer system other than a microprocessor to process data as described herein. In some alternative embodiments, an application-specific integrated circuit (ASIC) can be used for some or all the sensor’s central processing as is appreciated by one skilled in the art. The ROM 30 provides semi-permanent storage of data, for example, storing data such as sensor identifier (ID) and programming to process data streams (for example, programming for data smoothing and/or replacement of signal artifacts such as described in copending U.S. Patent Application entitled, “SYSTEMS AND METHODS FOR REPLACING SIGNAL ARTIFACTS IN A GLUCOSE SENSOR DATA STREAM,” filed August 22, 2003). The RAM 32 can be used for the system’s cache memory, for example for temporarily storing recent sensor data. In some alternative embodiments, memory storage components comparable to ROM 30 and RAM 32 may be used instead of or in addition to the preferred hardware, such as dynamic RAM, static-RAM, non-static RAM, EEPROM, rewritable ROMs, flash memory, or the like.
The preferred embodiments provide an integrated system, which includes a receiver 14 that receives and processes the raw data stream from the continuous glucose sensor 12. The receiver may perform all or some of the following operations: a calibration, converting sensor data, updating the calibration, evaluating received reference and sensor data, evaluating the calibration for the analyte sensor, validating received reference and sensor data, displaying a meaningful glucose value to a user, calculating therapy recommendations, validating recommended therapy, adaptive programming for learning individual metabolic patterns, and prediction of glucose values, for example. Some complementary systems and methods associated with the receiver are described in more detail with reference to co-pending U.S. Patent Application 10/633,367, entitled, “SYSTEM AND METHODS FOR PROCESSING ANALYTE SENSOR DATA,” which is incorporated herein by reference in its entirety. Figs. 9 to 11 describe some processes that may be programmed into the receiver. Additionally, the receiver 14 of the preferred embodiments works together with the other components of the system (for example, the medicament delivery device 16 and the single point glucose monitor 18) to provide enhanced functionality, convenience, and safety, such as described in more detail herein. Figs. 4 to 7 are illustrates of a few exemplary integrated systems of the preferred embodiments, each of which include the receiver, such as described in more detail herein.
In some embodiments, the receiver 14 is integrally formed with at least one of the medicament delivery device 16, and single point glucose monitor 18. In some embodiments, the receiver 14, medicament delivery device 16 and/or single point glucose monitor 18 are detachably connected, so that one or more of the components can be individually detached and attached at the user’s convenience. In some embodiments, the receiver 14, medicament delivery device 16, and/or single point glucose monitor 18 are separate from, detachably connectable to, or integral with each other; and one or more of the components are operably connected through a wired or wireless connection, allowing data transfer and thus integration between the components. In some embodiments, one or more of the components are operably linked as described above, while another one or more components (for example, the syringe or patch) are provided as a physical part of the system for convenience to the user and as a reminder to enter data for manual integration of the component with the system. Some exemplary embodiments are described with reference to Figs. 4 to 7, however suffice it to say that each of the components of the integrated system may be manually, semi-automatically, or automatically integrated with each other, and each component may be in physical and/or data communication with another component, which may include wireless connection, wired connection (for example, via cables or electrical contacts), or the like.
Referring now to the integration between the syringe and the receiver, it is noted that the receiver can be programmed with information about the time, amount, and types of medicament that may be administered with the syringe, for example. In some embodiments during set-up of the system, the patient and/or doctor manually enters information about the amounts and types of medicament available via the syringe of the integrated system. In some alternative embodiments, manufacturer-provided data can be downloaded to the receiver so that the patient and/or doctor can select appropriate information from menus on the screen, for example, to provide easy and accurate data entry. Thus, by knowing the available medicaments, the receiver may be programmed to customize the patient’s therapy recommendations considering available types and amounts of medicaments in combination with concentration, rate-of-change, and/or acceleration of the patient’s glucose. While not wishing to be bound by theory, it is believed that by storing available medicament therapies, the receiver is able to customize medicament calculations and recommend appropriate therapy based glucose on trend information and the preferred types and the amounts of medicament available to the patient.
Subsequently in some embodiments, once the patient has administered a medicament (including via the syringe and or by other means), the amount, type, and/or time of medicament administration are input into the receiver by the patient. Similarly, the receiver may be programmed with standard medicaments and dosages for easy selection by the patient (for example, menus on the user interface). This information can be used by the receiver to increase the intelligence of the algorithms used in determining the glucose trends and patterns that may be useful in predicting and analyzing present, past, and future glucose trends, and in providing therapy recommendations, which will be described in more detail below. Additionally, by continuously monitoring the glucose concentration over time, the receiver provides valuable information about how a patient responds to a particular medicament, which information may be used by a doctor, patient, or by the algorithms within the receiver, to determine patterns and provide more personalized therapy recommendations. In other words, in some embodiments, the receiver includes programming that learns the patterns (for example, an individual’s metabolic response to certain medicament deliveries and patient behavior) and to determine an optimum time, amount, and type of medicament to delivery in a variety of conditions (e.g., glucose concentration, rate-of-change, and acceleration). While not wishing to be bound by theory, it is believed that by continuously monitoring an individual’s response to various medicaments, the patient’s glucose levels can be more proactively treated, keeping the diabetic patient within safe glucose ranges substantially all the time.
In some embodiments, the receiver includes programming to predict glucose trends, such as described in co-pending U.S. provisional patent application 60/528382, entitled, “SIGNAL PROCESSING FOR CONTINUOUS ANALYTE SENSORS”, which is incorporated herein by reference in its entirety. In some embodiments, the predictive algorithms consider the amount, type, and time of medicament delivery in predicting glucose values. For example, a predictive algorithm that predicts a glucose value or trend for the upcoming 15 to 20 minutes uses a mathematical algorithm (for example, regression, smoothing, or the like) such as described in the above-cited provisional patent application 60/528382 to project a glucose value. However outside influences, including medicament delivery may cause this projection to be inaccurate. Therefore, some embodiments provide programming in the receiver that uses the medicament delivery information received from the delivery device 14, in addition to other mathematical equations, to more accurately predict glucose values in the future.
The integration of the patches 58 with the receiver 14 includes similar functionality and provides similar advantages as described with reference to other manual integrations including manual medicament delivery devices (for example, syringe and inhaler). However, a unique advantage may be seen in the integration of a continuous glucose sensor with a glucagon-type patch. Namely, a continuous glucose sensor, such as described in the preferred embodiments, provides more than single point glucose readings. In fact, because the continuous glucose sensor 12 knows the concentration, rate-of-change, acceleration, the amount of insulin administered (in some embodiments), and/or individual patterns associated with a patient’s glucose trends (learned over time as described in more detail elsewhere herein), the use of the glucagon patch can be iteratively optimized (inputting its usage into the receiver and monitoring the individual’s metabolic response) to proactively preempt hypoglycemic events and maintain a more controlled range of glucose values. This may be particularly advantageous for nighttime hypoglycemia by enabling the diabetic patient (and his/her caretakers) to improve overall nighttime diabetic health. While not wishing to be bound by theory, the integration of the continuous glucose sensor and transdermal glucagon-type patch can provide diabetic patients with a long-term solution to reduce or avoid hypoglycemic events.
In another alternative embodiment, a cell transplantation device, such as described in U.S. Patents 6,015,572, 5,964,745, and 6,083,523, which are incorporated herein by reference in their entirety, is manually integrated with the continuous sensor of the preferred embodiments. In this alternative embodiment, a patient would be implanted with beta islet cells, which provide insulin secretion responsive to glucose levels in the body. The receiver associated with the implantable glucose sensor can be programmed with information about the cell transplantation (for example, time, amount, type, etc). In this way, the long-term continuous glucose sensor may be used to monitor the body’s response to the beta islet cells. This may be particularly advantageous when a patient has been using the continuous glucose sensor for some amount of time prior to the cell transplantation, and the change in the individual’s metabolic patterns associated with the transplantation of the cells can be monitored and quantified. Because of the long-term continuous nature of the glucose sensor of the preferred embodiments, the long-term continuous effects of the cell transplantation can be consistently and reliably monitored. This integration may be advantageous to monitor any person’s response to cell transplantation before and/or after the implantation of the cells, which may be helpful in providing data to justify the implantation of islet cells in the treatment of diabetes.
Subsequently, the pen 60 includes programming to send information regarding the amount, type, and time of medicament delivery to the receiver 14 for processing. The receiver 14 can use this information received from the pen 60, in combination with the continuous glucose data obtained from the sensor, to monitor and determine the patient’s glucose patterns to measure their response to each medicament delivery. Knowing the patient’s individual response to each type and amount of medicament delivery may be useful in adjusting or optimizing the patient’s therapy. It is noted that individual metabolic profiles (for example, insulin sensitivity) are variable from patient to patient. While not wishing to be bound by theory, it is believed that once the receiver has learned (for example, monitored and determined) the individual’s metabolic patterns, including glucose trends and associated medicament deliveries, the receiver can be programmed to adjust and optimize the therapy recommendations for the patient’s individual physiology to maintain their glucose levels within a desired target range. In alternative embodiments, the pen 60 may be manually integrated with the receiver.
In some alternative embodiments, the semi-automated integration provides programming that requires at least one of the receiver 14, single point glucose monitor 18, and medicament delivery device 16 to be validated or confirmed by another of the components to provide a fail safe accuracy check; in these embodiments, the validation includes algorithms programmed into any one or more of the components. In some alternative embodiments, the semi-automated integration provides programming that requires at least one of the receiver 14 and medicament delivery device 16 to be validated or confirmed by an a human (for example, confirm the amount and/or type of medicament). In these embodiments, validation provides a means by which the receiver can be used adjunctively, when the patient or doctor would like to have more control over the patient’s therapy decisions, for example. See Figs. 9 to 11 for processes that may be implemented herein.
In some embodiments of the automated integrated system 10, a fail-safe mode is provided, wherein the system is programmed with conditions whereby when anomalies or potentially clinically risky situations arise, for example when a reference glucose value (for example, from an SMBG) indicates a discrepancy from the continuous sensor that could cause risk to the patient if incorrect therapy is administered. Another example of a situation that may benefit from a validation includes when a glucose values are showing a trend in a first direction that shows a possibility of “turn around,” namely, the patient may be able to reverse the trend with a particular behavior within a few minutes to an hour, for example. In such situations, the automated system may be programmed to revert to a semi-automated system requiring user validation or other user interaction to validate the therapy in view of the situation.
Figs. 4 to 7 are perspective views of integrated receivers including a single point glucose monitor. It is noted that the integrated single point glucose monitor may be integral with, detachably connected to, and/or operably connected (wired or wireless) to the receiver 14 and medicament delivery device 16. The single point glucose monitor 18 integrates rapid and accurate measurement of the amount of glucose in a biological fluid and its associated processing with the calibration, validation, other processes associated with the continuous receiver 14, such as described in more detail with reference to co-pending U.S. provisional patent application, 60/523,840, entitled “INTEGRATED RECEIVER FOR CONTINUOUS ANALYTE SENSOR,” which is incorporated herein by reference in its entirety.
The microprocessor 82 is the central control unit that provides the processing for the receiver, such as storing data, analyzing continuous glucose sensor data stream, analyzing single point glucose values, accuracy checking, checking clinical acceptability, calibrating sensor data, downloading data, recommending therapy instructions, calculating medicament delivery amount, type and time, learning individual metabolic patterns, and controlling the user interface by providing prompts, messages, warnings and alarms, or the like. The ROM 84 is operably connected to the microprocessor 82 and provides semi-permanent storage of data, storing data such as receiver ID and programming to process data streams (for example, programming for performing calibration and other algorithms described elsewhere herein). RAM 88 is used for the system’s cache memory and is helpful in data processing. For example, the RAM 88 stores information from the continuous glucose sensor, delivery device, and/or single point glucose monitor for later recall by the user or a doctor; a user or doctor can transcribe the stored information at a later time to determine compliance with the medical regimen or evaluation of glucose response to medication administration (for example, this can be accomplished by downloading the information through the pc com port 90). In addition, the RAM 88 may also store updated program instructions and/or patient specific information. Figs. 9 and 10 describe more detail about programming that is preferably processed by the microprocessor 82. In some alternative embodiments, memory storage components comparable to ROM and RAM can be used instead of or in addition to the preferred hardware, such as SRAM, EEPROM, dynamic RAM, non-static RAM, rewritable ROMs, flash memory, or the like.
In some embodiments, the microprocessor 82 monitors the continuous glucose sensor data stream to determine a preferable time for medicament delivery, including type, amount, and time. In some embodiments, the microprocessor is programmed to detect impending clinical risk and may request data input, a reference glucose value from the single point glucose monitor, or the like, in order to confirm a therapy recommendation. In some embodiments, the microprocessor is programmed to process continuous glucose data and medicament therapies to adaptive adjust to an individual’s metabolic patterns. In some embodiments, the microprocessor is programmed to project glucose trends based on data from the integrated system (for example, medicament delivery information, user input, or the like). In some embodiments, the microprocessor is programmed to calibrate the continuous glucose sensor based on the integrated single point glucose monitor. Numerous other programming may be incorporated into the microprocessor, as is appreciated by one skilled in the art, as is described in cited patents and patent applications here, and as is described with reference to flowcharts of Figs. 9 to 11.
It is noted that one advantage of integrated system of the preferred embodiments can be seen in the time stamp of the sensor glucose data, medicament delivery data, and reference glucose data. Namely, typical implementations of the continuous glucose sensor 12, wherein the medicament delivery 16 and/or single point glucose monitor 18 is not integral with the receiver 14, the reference glucose data or medicament delivery data can be obtained at a time that is different from the time that the data is input into the receiver 14. Thus, the user may not accurately input the “time stamp” of the delivery or (for example, the time or obtaining reference glucose value or administering the medicament) at the time of reference data input into the receiver. Therefore, the accuracy of the calibration of the continuous sensor, prediction of glucose values, therapy recommendations, and other processing is subject to human error (for example, due to inconsistencies in entering the actual time of the single point glucose test). In contrast, the preferred embodiments of the integrated system advantageously do no suffer from this potential inaccuracy when the time stamp is automatically and accurately obtained at the time of the event. Additionally, the processes of obtaining reference data and administering the medicament may be simplified and made convenient using the integrated receiver because of fewer loose parts (for example, cable, test strips, etc.) and less required manual data entry.
A PC communication (com) port 90 may be provided to enable communication with systems, for example, a serial communications port, allows for communicating with another computer system (for example, PC, PDA, server, or the like). In one exemplary embodiment, the receiver is able to download historical data to a physician’s PC for retrospective analysis by the physician. The PC communication port 90 can also be used to interface with other medical devices, for example pacemakers, implanted analyte sensor patches, infusion devices, telemetry devices, or the like.
In some embodiments, prompts or messages about the medicament delivery device can be displayed on the user interface to inform or confirm to the user type, amount, and time of medicament delivery. In some embodiments, the user interface provides historical data and analytes pattern information about the medicament delivery, and the patient’s metabolic response to that delivery, which may be useful to a patient or doctor in determining the level of effect of various medicaments.
At block 132, a sensor data receiving module, also referred to as the sensor data module, receives sensor data (e.g., a data stream), including one or more time-spaced sensor data points, from a sensor via the receiver, which may be in wired or wireless communication with the sensor. The sensor data point(s) may be raw or smoothed, such as described in co-pending U.S. Patent Application 10/648,849, entitled “SYSTEMS AND METHODS FOR REPLACING SIGNAL ARTIFACTS IN A GLUCOSE SENSOR DATA STREAM,” which is incorporated herein by reference in its entirety.
In some embodiments, when the integrated system 10 is in fully automated mode, the validation module is triggered when a potential risk is evaluated. For example, when a clinically risky discrepancy is evaluated, when the acceleration of the glucose value is changing or is low (indicative of a significant change in glucose trend), when it is near a normal meal, exercise or sleep time, when a medicament delivery is expected based on an individual’s dosing patterns, and/or a variety of other such situations, wherein outside influences (meal time, exercise, regular medicament delivery, or the like) may deem consideration in the therapy instructions. These conditions for triggering the validation module may be pre-programmed and/or may be learned over time, for example, as the processor module monitors and patterns an individual’s behavior patterns.
Fig. 10 is a flow chart 140 that illustrates the process of providing adaptive metabolic control using an integrated system in one embodiment. In this embodiment, the integrated system is programmed to learn the patterns of the individual’s metabolisms, including metabolic response to medicament delivery.
At block 146, the processor module, which may be programmed into the receiver 14 and/or the delivery device 16 is programmed to monitor the sensor data from the sensor data module 142 and medicament delivery from the medicament delivery module 144 to determine an individual’s metabolic profile, including their response to various times, amounts, and/or types of medicaments. The processor module uses any pattern recognition-type algorithm as is appreciated by one skilled in the art to quantify the individual’s metabolic profile.
At block 148, a medicament calculation module, which is a part of a processor module, calculates the recommended medicament based on the sensor glucose data, medicament delivery data, and/or individual’s metabolic profile. In some embodiments, the recommended therapy is validated such as described with reference to Fig. 9 above. In some embodiments, the recommended therapy is manually, semi-automatically, or automatically delivered to the patient.
At block 150, the process of monitoring and evaluation a patient’s metabolic profile is repeated with new medicament delivery data, wherein the processor monitors the sensor data with the associated medicament delivery data to determine the individual’s metabolic response in order to adaptively adjust, if necessary, to newly determined metabolic profile or patterns. This process may be continuous throughout the life of the integrated system, may be initiated based on conditions met by the continuous glucose sensor, may be triggered by a patient or doctor, or may be provided during a start-up or learning phase.
While not wishing to be bound by theory, it is believed that by adaptively adjusting the medicament delivery based on an individual’s metabolic profile, including response to medicaments, improved long-term patient care and overall health can be achieved.
At block 158, the processor module evaluates medicament delivery data with substantially time corresponding glucose sensor data to determine individual metabolic patterns associated with medicament delivery. “Substantially time corresponding data” refers to that time period during which the medicament is delivered and its period of release in the host.
In yet another exemplary implementation of the preferred embodiments, a medicament delivery device is provided that includes reservoirs of both fast acting insulin and slow acting insulin. The medicament delivery device is integrated with the receiver as described elsewhere herein, however in this implementation, the receiver determines an amount of fast acting insulin and an amount of slow acting insulin, wherein the medicament delivery device is configured to mix slow- and fast- acting insulin in the amounts provided. In this way, the receiver and medicament delivery device can work together in a feedback loop to iteratively optimize amounts of slow and fast acting insulin for a variety of situations (for example, based on glucose level, rate of change, acceleration, and behavioral factors such as diet, exercise, time of day, etc.) adapted to the individual patient’s metabolic profile.
Methods and devices that can be suitable for use in conjunction with aspects of the preferred embodiments are disclosed in copending applications including U.S. Application No. 10/695,636 filed October 28, 2003 and entitled, “SILICONE COMPOSITION FOR BIOCOMPATIBLE MEMBRANE”; U.S. Patent Application No. 10/648,849 entitled, “SYSTEMS AND METHODS FOR REPLACING SIGNAL ARTIFACTS IN A GLUCOSE SENSOR DATA STREAM,” filed August 22, 2003; U.S. Patent Application No. 10/646,333 entitled, “OPTIMIZED SENSOR GEOMETRY FOR AN IMPLANTABLE GLUCOSE SENSOR,” filed August 22, 2003; U.S. Patent Application No. 10/647,065 entitled, “POROUS MEMBRANES FOR USE WITH IMPLANTABLE DEVICES,” filed August 22, 2003; U.S. Patent Application Nos. 10/633,367, 10/632,537, 10/633,404, and 10/633,329, each entitled, “SYSTEM AND METHODS FOR PROCESSING ANALYTE SENSOR DATA,” filed August 1, 2003; U.S. Patent Application No. 09/916,386 filed July 27, 2001 and entitled “MEMBRANE FOR USE WITH IMPLANTABLE DEVICES”; U.S. Patent Application No. 09/916,711 filed July 27, 2001 and entitled “SENSING REGION FOR USE WITH IMPLANTABLE DEVICE”; U.S. Patent Application No. 09/447,227 filed November 22, 1999 and entitled “DEVICE AND METHOD FOR DETERMINING ANALYTE LEVELS”; U.S. Patent Application No. 10/153,356 filed May 22, 2002 and entitled “TECHNIQUES TO IMPROVE POLYURETHANE MEMBRANES FOR IMPLANTABLE GLUCOSE SENSORS”; U.S. Appl. No. 09/489,588 filed January 21, 2000 and entitled “DEVICE AND METHOD FOR DETERMINING ANALYTE LEVELS”; U.S. Patent Application No. 09/636,369 filed August 11, 2000 and entitled “SYSTEMS AND METHODS FOR REMOTE MONITORING AND MODULATION OF MEDICAL DEVICES”; and U.S. Patent Application No. 09/916,858 filed July 27, 2001 and entitled “DEVICE AND METHOD FOR DETERMINING ANALYTE LEVELS,” as well as issued patents including U.S. 6,001,067 issued December 14, 1999 and entitled “DEVICE AND METHOD FOR DETERMINING ANALYTE LEVELS”; U.S. 4,994,167 issued February 19, 1991 and entitled “BIOLOGICAL FLUID MEASURING DEVICE”; and U.S. 4,757,022 filed July 12, 1988 and entitled “BIOLOGICAL FLUID MEASURING DEVICE.” All of the above patents and patent applications are incorporated in their entirety herein by reference.
Citada por Patente citante Fecha de presentaci�n Fecha de publicaci�n Solicitante T�tuloUS707430721 Jul 200411 Jul 2006Dexcom, Inc.Electrode systems for electrochemical sensorsUS710877821 Jul 200419 Sep 2006Dexcom, Inc.Electrochemical sensors including electrode systems with increased oxygen generationUS729908227 Oct 200420 Nov 2007Abbott Diabetes Care, Inc.Method of calibrating an analyte-measurement device, and associated methods, devices and systemsUS7344500 *27 Jul 200418 Mar 2008Medtronic Minimed, Inc.Sensing system with auxiliary displayUS73645929 Feb 200529 Abr 2008Dexcom, Inc.Biointerface membrane with macro-and micro-architectureUS737976521 Jul 200427 May 2008Dexcom, Inc.Oxygen enhancing membrane systems for implantable devicesUS7519408 *17 Nov 200414 Abr 2009Dexcom, Inc.Integrated receiver for continuous analyte sensorUS772253614 Jul 200425 May 2010Abbott Diabetes Care Inc.Glucose measuring device integrated into a holster for a personal area network deviceUS7727148 *30 Oct 20071 Jun 2010Medtronic Minimed, Inc.Sensing system with auxiliary displayUS7774145 *18 Ene 200610 Ago 2010Dexcom, Inc.Transcutaneous analyte sensorUS778792319 Oct 200431 Ago 2010Becton, Dickinson And CompanyFiber optic device for sensing analytes and method of making sameUS78605447 Mar 200728 Dic 2010Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS78698536 Ago 201011 Ene 2011Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS78856996 Ago 20108 Feb 2011Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS79209069 Mar 20065 Abr 2011Dexcom, Inc.System and methods for processing analyte sensor data for sensor calibrationUS792727419 Abr 2011Dexcom, Inc.Integrated receiver for continuous analyte sensorUS7972296 *10 Oct 20085 Jul 2011Optiscan Biomedical CorporationFluid component analysis system and method for glucose monitoring and controlUS797649212 Jul 2011Dexcom, Inc.Integrated delivery device for continuous glucose sensorUS805073116 Nov 20051 Nov 2011Dexcom, Inc.Techniques to improve polyurethane membranes for implantable glucose sensorsUS805301815 Ene 20108 Nov 2011Dexcom, Inc.Techniques to improve polyurethane membranes for implantable glucose sensorsUS8114023 *1 Nov 200614 Feb 2012Legacy Emanuel Hospital & Health CenterAnalyte sensing and response systemUS8133178 *22 Feb 200613 Mar 2012Dexcom, Inc.Analyte sensorUS816090017 Abr 2012Abbott Diabetes Care Inc.Analyte monitoring and management device and method to analyze the frequency of user interaction with the deviceUS816282930 Mar 200924 Abr 2012Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS81756739 Nov 20098 May 2012Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS817771621 Dic 200915 May 2012Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS82110163 Jul 2012Abbott Diabetes Care Inc.Method and system for providing analyte monitoringUS821613720 Jul 200910 Jul 2012Abbott Diabetes Care Inc.Method and system for providing analyte monitoringUS822134624 Abr 200917 Jul 2012Arkray, Inc.Blood sugar level control systemUS822441310 Oct 200817 Jul 2012Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS822655518 Mar 200924 Jul 2012Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS822655728 Dic 200924 Jul 2012Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS822655827 Sep 201024 Jul 2012Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS822689124 Jul 2012Abbott Diabetes Care Inc.Analyte monitoring devices and methods thereforUS823153230 Abr 200731 Jul 2012Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS823589621 Dic 20097 Ago 2012Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS825503117 Mar 200928 Ago 2012Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS82603929 Jun 20084 Sep 2012Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS82657269 Nov 200911 Sep 2012Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS827302213 Feb 200925 Sep 2012Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS82754399 Nov 200925 Sep 2012Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS828255029 Jul 20089 Oct 2012Dexcom, Inc.Integrated receiver for continuous analyte sensorUS8285378 *27 Sep 20049 Oct 2012Cardiac Pacemakers, IncSystem and method for determining patient-specific implantable medical device programming parametersUS83065989 Nov 20096 Nov 2012Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS834633618 Mar 20091 Ene 2013Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS835382921 Dic 200915 Ene 2013Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS835709121 Dic 200922 Ene 2013Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS836661430 Mar 20095 Feb 2013Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS83700773 Oct 20115 Feb 2013Hygieia, Inc.System for optimizing a patient's insulin dosage regimenUS837200521 Dic 200912 Feb 2013Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS838027311 Abr 200919 Feb 2013Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS839194517 Mar 20095 Mar 2013Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS84091317 Mar 20072 Abr 2013Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS844459515 Jun 200721 May 2013Animas CorporationMethods to pair a medical device and at least a remote controller for such medical deviceUS844952315 Jun 200728 May 2013Animas CorporationMethod of operating a medical device and at least a remote controller for such medical deviceUS84579013 Abr 20094 Jun 2013Hygieia, Inc.System for optimizing a patient's insulin dosage regimenUS846023111 Jun 2013Dexcom, Inc.Integrated delivery device for continuous glucose sensorUS847302131 Jul 200925 Jun 2013Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS85454373 May 20121 Oct 2013Arkray, Inc.Blood sugar level control systemUS856003726 Mar 201015 Oct 2013Dexcom, Inc.System and methods for processing analyte sensor data for sensor calibrationUS8562558 *5 Jun 200822 Oct 2013Dexcom, Inc.Integrated medicament delivery device for use with continuous analyte sensorUS85798167 Ene 201012 Nov 2013Dexcom, Inc.System and methods for processing analyte sensor data for sensor calibrationUS857985331 Oct 200612 Nov 2013Abbott Diabetes Care Inc.Infusion devices and methodsUS859757523 Jul 20123 Dic 2013Abbott Diabetes Care Inc.Analyte monitoring devices and methods thereforUS86006823 Abr 20093 Dic 2013Hygieia, Inc.Apparatus for optimizing a patient's insulin dosage regimenUS861707121 Jun 200731 Dic 2013Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS862290621 Dic 20097 Ene 2014Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS863671114 Jun 201128 Ene 2014Legacy Emanuel Hospital & Health CenterStabilized glucagon solutions and uses thereforUS864161921 Dic 20094 Feb 2014Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS86498413 Abr 200711 Feb 2014Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS866062717 Mar 200925 Feb 2014Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS866353830 Jun 20114 Mar 2014Picolife Technologies, LlcMethod of making a membrane for use with a flow control system for a micropumpUS866646916 Nov 20074 Mar 2014Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS867081530 Abr 200711 Mar 2014Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS8715177 *20 Feb 20076 May 2014Ip Holdings, Inc.Intelligent drug delivery applianceUS872158530 Mar 201213 May 2014Dex Com, Inc.Integrated delivery device for continuous glucose sensorUS873433930 Nov 200427 May 2014Ip Holdings, Inc.Electronic skin patch for real time monitoring of cardiac activity and personal health managementUS873434630 Abr 200727 May 2014Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS873434817 Mar 200927 May 2014Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS87381093 Mar 200927 May 2014Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS87445453 Mar 20093 Jun 2014Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS875526923 Dic 200917 Jun 2014Medtronic Minimed, Inc.Ranking and switching of wireless channels in a body area network of medical devicesUS87712291 Dic 20118 Jul 2014Picolife Technologies, LlcCartridge system for delivery of medicamentUS877488724 Mar 20078 Jul 2014Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS87903079 Feb 201229 Jul 2014Picolife Technologies, LlcDrug delivery device and methods thereforUS880716930 Jun 201119 Ago 2014Picolife Technologies, LlcFlow control system for a micropumpUS8808228 *5 Jun 200819 Ago 2014Dexcom, Inc.Integrated medicament delivery device for use with continuous analyte sensorUS88405528 Dic 200923 Sep 2014Dexcom, Inc.Membrane for use with implantable devicesUS884055326 Feb 200923 Sep 2014Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS886524928 Sep 201221 Oct 2014Dexcom, Inc.Techniques to improve polyurethane membranes for implantable glucose sensorsUS888013718 Abr 20034 Nov 2014Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS888274130 Abr 201211 Nov 2014Dexcom, Inc.Integrated delivery device for continuous glucose sensorUS892038112 Abr 201330 Dic 2014Medtronic Minimed, Inc.Infusion set with improved bore configurationUS892040130 Abr 201230 Dic 2014Dexcom, Inc.Integrated delivery device for continuous glucose sensorUS892658530 Mar 20126 Ene 2015Dexcom, Inc.Integrated delivery device for continuous glucose sensorUS8932216 *7 Ago 200613 Ene 2015Abbott Diabetes Care Inc.Method and system for providing data management in integrated analyte monitoring and infusion systemUS8932250 *15 Jun 200713 Ene 2015Animas CorporationSystems and methods to pair a medical device and a remote controller for such medical deviceUS896819830 Ene 20123 Mar 2015Dexcom, Inc.Analyte sensorUS898620830 Sep 200824 Mar 2015Abbott Diabetes Care Inc.Analyte sensor sensitivity attenuation mitigationUS899246411 Nov 200931 Mar 2015Hygieia, Inc.Apparatus and system for diabetes managementUS899333131 Ago 201031 Mar 2015Abbott Diabetes Care Inc.Analyte monitoring system and methods for managing power and noiseUS901133129 Dic 200421 Abr 2015Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS90147737 Mar 200721 Abr 2015Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS902297317 Dic 20085 May 2015New World Pharmaceuticals, LlcIntegrated intra-dermal delivery, diagnostic and communication systemUS903392418 Ene 201319 May 2015Medtronic Minimed, Inc.Systems for fluid reservoir retentionUS90399752 Dic 201326 May 2015Abbott Diabetes Care Inc.Analyte monitoring devices and methods thereforUS90429532 Mar 200726 May 2015Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS904419910 Mar 20052 Jun 2015Dexcom, Inc.Transcutaneous analyte sensorUS904998230 Mar 20119 Jun 2015Animas CorporationMethods to pair a medical device and at least a remote controller for such medical deviceUS905004121 May 20129 Jun 2015Abbott Diabetes Care Inc.Method and apparatus for detecting false hypoglycemic conditionsUS905041330 Abr 20129 Jun 2015Dexcom, Inc.Integrated delivery device for continuous glucose sensorUS905590114 Sep 201216 Jun 2015Dexcom, Inc.Transcutaneous analyte sensorUS906071913 Dic 201323 Jun 2015Abbott Diabetes Care Inc.Method and apparatus for providing data processing and control in a medical communication systemUS906074219 Mar 201023 Jun 2015Dexcom, Inc.Transcutaneous analyte sensorUS906410730 Sep 201323 Jun 2015Abbott Diabetes Care Inc.Infusion devices and methodsUS90666943 Abr 200730 Jun 2015Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS906669512 Abr 200730 Jun 2015Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS906669727 Oct 201130 Jun 2015Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS906670917 Mar 201430 Jun 2015Abbott Diabetes Care Inc.Method and device for early signal attenuation detection using blood glucose measurementsUS906953630 Oct 201230 Jun 2015Abbott Diabetes Care Inc.Electronic devices having integrated reset systems and methods thereofUS907247721 Jun 20077 Jul 2015Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS907860717 Jun 201314 Jul 2015Abbott Diabetes Care Inc.Analyte monitoring device and methods of useUS907860813 Jul 201214 Jul 2015Dexcom, Inc.System and methods for processing analyte sensor data for sensor calibrationUS907862631 Mar 201114 Jul 2015Dexcom, Inc.Transcutaneous analyte sensorUS908845231 Ene 201321 Jul 2015Abbott Diabetes Care Inc.Method and system for providing data communication in continuous glucose monitoring and management systemUS20050033132 *14 May 200410 Feb 2005Shults Mark C.Analyte measuring deviceUS20070100222 *4 Dic 20063 May 2007Metronic Minimed, Inc.Analyte sensing apparatus for hospital useUS20070168145 *26 Jul 200619 Jul 2007Uwe BeyerCalibration of Sensors or Measuring SystemsUS20070254381 *27 Abr 20061 Nov 2007Searete Llc, A Limited Liability Corporation Of The State Of DelawareMonitoring and/or treating syringe mechanismUS20080262469 *5 Jun 200823 Oct 2008Dexcom. Inc.Integrated medicament delivery device for use with continuous analyte sensorUS20080306435 *5 Jun 200811 Dic 2008Dexcom, Inc.Integrated medicament delivery device for use with continuous analyte sensorUS20080312584 *15 Jun 200718 Dic 2008Animas CorporationSystems and methods to pair a medical device and a remote controller for such medical deviceUS20090054745 *7 Ago 200626 Feb 2009Abbott Diabetes Care, Inc.Method and System for Providing Data Management in Integrated Analyte Monitoring and Infusion SystemUS20100057057 *4 Mar 2010Abbott Diabetes Care, Inc.Closed Loop Control And Signal Attenuation DetectionUS20100185175 *22 Jul 2010Deka Products Limited PartnershipSystems and methods for fluid deliveryUS20110237918 *29 Sep 2011Robin WagnerMethods and systems for providing therapeutic guidelines to a person having diabetesUS20130274576 *16 Abr 201217 Oct 2013PicoLife TechnologiesMedication delivery device with multi-reservoir cartridge system and related methods of useUS20130274577 *11 May 201217 Oct 2013PicoLife TechnologiesMedication Delivery Device and Related Methods of UseUS20140206972 *26 Mar 201424 Jul 2014Abbott Diabetes Care Inc.Analyte Monitoring System and MethodsUS20140247109 *13 Mar 20134 Sep 2014Pjc Investments, LlcCondition status-based device system and operationEP1942801A2 *31 Oct 200616 Jul 2008Abbott Diabetes Care, Inc.Analyte monitoring device and methods of useEP2046413A2 *16 Jul 200715 Abr 2009Regents of the University of ColoradoMedical systems and methods of useEP2152350A1 *5 Jun 200817 Feb 2010Dexcom, Inc.Integrated medicament delivery device for use with continuous analyte sensorEP2407093A122 Feb 200618 Ene 2012DexCom, Inc.Analyte sensorEP2407094A122 Feb 200618 Ene 2012DexCom, Inc.Analyte sensorEP2407095A122 Feb 200618 Ene 2012DexCom, Inc.Analyte sensorEP2499969A120 Jun 200619 Sep 2012DexCom, Inc.Analyte sensorEP2532305A1 *8 Jun 201212 Dic 2012Dexcom, Inc.Transcutaneous analyte sensorEP2561807A110 Mar 200627 Feb 2013DexCom, Inc.System and methods for processing analyte sensor data for sensor calibrationEP2829224A222 Feb 200628 Ene 2015DexCom, Inc.Analyte sensorWO2005011520A221 Jul 200410 Feb 2005Dexcom IncOxygen enhancing membrane systems for implantable devicesWO2008031106A2 *10 Sep 200713 Mar 2008Abbott Diabetes Care IncMethod and system for providing an integrated analyte sensor insertion device and data processing unitWO2008069931A1 *27 Nov 200712 Jun 2008Medtronic Minimed IncAnalyte sensing apparatus for hospital useWO2008080237A1 *1 Nov 200710 Jul 2008Hoffmann La RocheDevice for automated delivery of a liquid medicamentWO2008154312A1 *5 Jun 200818 Dic 2008Dexcom IncIntegrated medicament delivery device for use with continuous analyte sensorWO2009029662A1 *27 Ago 20085 Mar 2009Abbott Diabetes Care IncAnalyte monitoring device and methods of useWO2009055736A1 *24 Oct 200830 Abr 2009Dexcom IncSystems and methods for processing sensor dataWO2011003035A21 Jul 20106 Ene 2011Dexcom, Inc.Analyte sensorWO2011119832A1 *24 Mar 201129 Sep 2011University Of Virginia Patent FoundationMethod, system, and computer program product for improving the accuracy of glucose sensors using insulin delivery observation in diabetesWO2013022775A13 Ago 201214 Feb 2013Dexcom, Inc.Systems and methods for detecting glucose level data patternsWO2013138369A112 Mar 201319 Sep 2013Dexcom, Inc.Systems and methods for processing analyte sensor dataWO2013152090A23 Abr 201310 Oct 2013Dexcom, Inc.Transcutaneous analyte sensors, applicators therefor, and associated methodsWO2013158430A1 *10 Abr 201324 Oct 2013PicoLife TechnologiesMedication delivery device and related methods of useWO2013158431A1 *10 Abr 201324 Oct 2013PicoLife TechnologiesMedication delivery device with multi-reservoir cartridge system and related methods of useWO2013184566A23 Jun 201312 Dic 2013Dexcom, Inc.Systems and methods for processing analyte data and generating reportsWO2014011488A23 Jul 201316 Ene 2014Dexcom, Inc.Systems and methods for leveraging smartphone features in continuous glucose monitoringWO2014011740A1 *10 Jul 201316 Ene 2014Becton Dickinson France S.A.S.Integrated injection system and communication deviceWO2014052080A116 Sep 20133 Abr 2014Dexcom, Inc.Zwitterion surface modifications for continuous sensorsWO2014123998A2 *5 Feb 201414 Ago 2014Deka Products Limited ParnershipDevices, methods and systems for wireless control of medical devicesWO2014158405A212 Feb 20142 Oct 2014Dexcom, Inc.Systems and methods for processing and transmitting sensor data* Citada por examinadorClasificaciones Clasificaci�n de EE.UU.604/503 Clasificaci�n internacionalA61B5/00, A61M1/00, A61M31/00 Clasificaci�n cooperativaA61M5/1723, G06F19/3406, A61B5/0002, G06F19/3468, A61M5/31525, A61B5/14532, A61B5/1486, A61B5/4839, A61B2560/0443 Clasificaci�n europeaA61B5/145G, A61B5/48J2, A61B5/00B, A61M5/315DEventos legales FechaC�digoEventoDescripci�n6 Jul 2004ASAssignmentOwner name: DEXCOM, INC., CALIFORNIAFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:BRAUKER, JAMES H.;TAPSAK, MARK A.;SAINT, SEAN T.;AND OTHERS;REEL/FRAME:014821/0149;SIGNING DATES FROM 20040617 TO 2004062916 Feb 2010CCCertificate of correction21 Sep 2010CCCertificate of correction10 Ene 2012RRRequest for reexamination filedEffective date: 201111115 Mar 2013B1Reexamination certificate first reexaminationFree format text: CLAIMS 1-4, 6-10, 12-15, 17, 18, 22-24 AND 31-33 ARE CANCELLED.CLAIM 11 IS DETERMINED TO BE PATENTABLE AS AMENDED.CLAIMS 19-21, DEPENDENT ON AN AMENDED CLAIM, ARE DETERMINED TO BE PATENTABLE.NEW CLAIMS 38-43 ARE ADDED AND DETERMINED TO BE PATENTABLE.CLAIMS 5, 16, 25-30 AND 34-37 WERE NOT REEXAMINED.22 Mar 2013FPAYFee paymentYear of fee payment: 4GirarImagen originalP�gina principal de Google - Sitemap - Descargas masivas de USPTO - Pol�tica de privacidad - Condiciones de servicio - Acerca de Google Patentes - Enviar sugerenciasDatos proporcionados por IFI CLAIMS Patent Services