Patent Grant
8808230
This document relates to an infusion pump system, such as a portable infusion pump system for dispensing insulin or another medication.
Pump devices are commonly used to deliver one or more fluids to a targeted individual. For example, a medical infusion pump device may be used to deliver a medicine to a patient as part of a medical treatment. The medicine that is delivered by the infusion pump device can depend on the condition of the patient and the desired treatment plan. For example, infusion pump devices have been used to deliver insulin to the vasculature of diabetes patients so as to regulate blood-glucose levels.
Some traditional infusion pump devices may include an occlusion detection system for purposes of determining when the medicine dispensation is inadvertently interrupted or interfered. If the medicine dispensation path to the user is occluded, the user may receive no dosage or a lower dosage of the medicine. Some occlusion detections systems for infusion pumps can be configured as a “dry side” detector in which a sensor is positioned along a component of the drive system to detect a malfunction or change in pressure. Other occlusion detection systems for infusion pumps can be configured as a “wet side” detector in which characteristics of the fluid flow path are monitored. In some circumstances, the occlusion detection systems may be sensitive to environmental conditions (e.g., ambient temperature, pressure, or the like) in a manner that could cause false indications of a flow path occlusion.
Some embodiments of an infusion pump system include an occlusion detection system to detect when an occlusion exists in the fluid path between the medicine reservoir and the infusion site located, for example, on the user's skin. Such an occlusion may occur, for example, when the fluid flow line (e.g., a cannula, infusion set tubing, or the like) is kinked. The occlusion detection system can be configured to account for changes in environmental conditions, such as ambient temperature, pressure, or the like, so that the occlusion detection system provides reliable feedback to a user as to the occluded or non-occluded state of the medicine flow path. As such, the occlusion sensor can be used to indicate when the fluid is flowing or not flowing, thereby permitting the infusion pump system to communicate an alarm to the user if an occlusion exists.
Particular embodiments described herein include an occlusion sensor system for detecting an occlusion in a flow path from an insulin infusion pump system. The occlusion sensor system may include a fluid channel that at least partially defines an insulin flow path between an insulin reservoir and an output port. The system may also include a flexible membrane in fluid communication with the fluid channel so that fluid pressure in the fluid channel acts upon the flexible membrane. The system may further include an air cavity positioned adjacent to the flexible membrane and generally opposite the fluid channel. The system may include a light transmissive member adjacent to the air cavity. The light transmissive member may be arranged opposite the flexible membrane such that fluid pressure in the fluid channel above a threshold value causes the flexible membrane to deform into the air cavity and toward the light transmissive member. The system may also include a primary light emitter configured to align with the light transmissive member and emit light into the light transmissive member. The system may further include a light sensor configured to align with the light transmissive member and receive light from the primary light emitter that passes through the light transmissive member. The system may include a reference light emitter configured to emit light that is received by the light sensor, wherein the reference light emitter is spaced apart from the primary light emitter.
Some embodiment described herein may include occlusion sensor system for an infusion pump system including a reusable controller device that is removably attachable to a disposable single-use pump device that defines a space to receive medicine therein. The occlusion sensor system may include a primary light emitter, a reference light emitter, and a light sensor arranged in the reusable controller device. The primary light emitter, the reference light emitter, and the light sensor may be in electrical communication with control circuitry housed inside the reusable controller device. The system may also include a light transmissive member arranged in the disposable single-use pump device. The light transmissive member may be aligned with the primary light emitter and the light sensor when the reusable controller device is removably attached to a disposable single-use pump device. The light sensor may be positioned relative to the light transmissive member so as to receive light from the primary light emitter that passes through the light transmissive member in response to activation of the primary light emitter. Also, in response to activation of the reference light emitter, the light sensor may receive light emitted from the reference light emitter without passing through the light transmissive member.
Particular embodiments described herein may include an occlusion sensor system for detecting an occlusion in a flow path from an insulin infusion pump system. The occlusion sensor system may include a primary light emitter configured to emit light toward an insulin flow path. The system may also include a light sensor configured to receive at least a portion of the light from the primary light emitter after the light is emitted toward the insulin flow path. The light sensor may output an electrical signal in response to receiving light. The system may further include a reference light emitter configured to emit light that is received by the light sensor. The reference light emitter may be separate from the primary light emitter. The system may further include control circuitry electrically connected to the primary light emitter, the reference light emitter, and the light sensor. The control circuitry may compare a first value indicative of light detected at the light sensor from the primary light emitter to a second value indicative of light detected at the light sensor from the reference light emitter. In response to the comparison of the first value to the second value being outside of a threshold range, the control circuitry may generate an occlusion alarm for output via a user interface.
Some embodiments include a method for detecting an occlusion in a flow path from an infusion pump system. The method may include activating a reference light emitter to direct light toward a light sensor housed in an infusion pump system. The light sensor may generate an electrical signal in response to receiving light from the reference light emitter. The method may also include determining a first value indicative of light detected at the light sensor from the reference light emitter. The method may further include activating a primary light emitter to direct toward a medicine flow path for the infusion pump system. The light sensor may receive a least a portion of the light emitted from the primary light emitter. The method may include determining a second value indicative of light detected at the light sensor from the primary light emitter. The method may also include determining if an occlusion exists in the medicine flow path based at least in part on a comparison of the second value to the first value.
Some or all of the embodiments described herein may provide one or more of the following advantages. First, the infusion pump system may include an occlusion detection system configured to reliably detects occlusions in the medicine flow path even when the infusion pump system is exposed to significant changes in environments conditions. For example, the occlusion detection system can be configured to self-calibrate and thereby account for changes in ambient temperature so that the occlusion detection system provides reliable feedback even when the infusion pump system is carried in low-temperature conditions. As such, the occlusion detection system can provide notice to the user if he or she is receiving no dosage or a lower dosage of the medicine due to an occlusion in the medicine flow path.
Second, particular embodiments of the occlusion detection system may employ at least two different light emitters for each light sensor. For example, the occlusion detection system may include a primary light emitter that emits a light for communication toward the medicine flow path and is received at a light detector (e.g., after internal reflection of the light). In addition, the occlusion detection system may include a reference light emitter that emits a light for communication along a different path toward the light detector. As such, a comparison of the detected light signal from the reference light emitter and the detected light signal from the primary light emitter can be employed to calibrate the occlusion detection system to account for changes in environmental conditions.
Third, some embodiments of the infusion pump system may include a reusable controller device that houses the electronic components of the occlusion detection system even though the electronic components of the occlusion sensor system are used to detect characteristics the medicine flow path passing through a removable pump device. As such, sensor signals of the occlusion detection system can be readily communicated to control circuitry of the reusable controller device to determine if an occlusion exists. If so, the user interface of the controller device can be used to promptly alert the user of the problem.
Fourth, some embodiments of the infusion pump system may be configured to be portable, wearable, and (in some circumstances) concealable. For example, a user can conveniently wear the infusion pump system on the user's skin under clothing or can carry the pump device in the user's pocket (or other portable location) while receiving the medicine dispensed from the pump device.
The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.
Like reference symbols in the various drawings indicate like elements.
Referring to
In some embodiments, the controller device 200 communicates with the pump device 100 to control the operation of the drive system. When the controller device 200, the pump device 100 (including the cap device 130), and the fluid cartridge 120 are assembled together, the user can (in some embodiments) conveniently wear the infusion pump system 10 on the user's skin under clothing, in a pouch clipped at the waist (e.g., similar to a cell phone pouch), or in the user's pocket while receiving the fluid dispensed from the pump device 100. Optionally, the controller device 200 may be configured as a reusable component that provides electronics and a user interface to control the operation of the pump device 100. In such circumstances, the pump device 100 can be a disposable component that is disposed of after a single use. For example, as described in more detail below in connection with
Briefly, in use, the pump device 100 is configured to removably attach to the controller device 200 in a manner that provides a secure fitting, an overall compact size, and a reliable electrical connection that is resistant to water migration. For example, as described in more detail below in connection with
Referring again to
In some embodiments, the pump device 100 can include one or more structures that interfere with the removal of the medicine cartridge 120 after the medicine cartridge 120 is inserted into the cavity 116. For example, the pump housing structure 110 can include one or more retainer wings (not shown in
Still referring to
As shown in
Still referring to
Accordingly, when the controller device 200 is connected to the pump device 100, the user can be provided with the opportunity to readily monitor the infusion pump operation by simply viewing the user interface 220 of the controller device 200 connected to the pump device 100. Such monitoring capabilities may provide comfort to a user who may have urgent questions about the current operation of the pump device 100. Also, in these embodiments, there may be no need for the user to carry and operate a separate module to monitor the operation of the pump device 100, thereby simplifying the monitoring process and reducing the number of devices that must be carried by the user. If a need arises in which the user desires to monitor the operation of the pump device 100 or to adjust the settings of the pump system 10 (e.g., to request a bolus amount of medicine), the user can readily operate the user interface 220 of the controller device 200, which is removably attached to the pump device 100, without the requirement of locating and operating a separate monitoring module.
Referring now to
Referring to
In some embodiments, the infusion pump system 10 can be pocket-sized so that the pump device 100 and controller device 200 can be worn in the user's pocket or in another portion of the user's clothing. In some circumstances, the user may desire to wear the pump system 10 in a more discrete manner. Accordingly, the user can pass the tube 147 from the pocket, under the user's clothing, and to the infusion site where the adhesive patch can be positioned. As such, the pump system 10 can be used to deliver medicine to the tissues or vasculature of the user in a portable, concealable, and discrete manner.
In some embodiments, the infusion pump system 10 can be configured to adhere to the user's skin directly at the location in which the skin is penetrated for medicine infusion. For example, a rear surface 102 (
Referring now to
The controller device 200, however, may be reused with subsequent new pump devices 100′ and new medicine cartridges 120′. As such, the control circuitry, the user interface components, the rechargeable battery pack 245, and other components that may have relatively higher manufacturing costs can be reused over a longer period of time. For example, in some embodiments, the controller device 200 can be designed to have an expected operational life of about 1 year to about 7 years, about 2 years to about 6 years, or about 3 years to about 5 years—depending on a number of factors including the usage conditions for the individual user. Accordingly, the user can be permitted to reuse the controller device 200 (which can include complex or valuable electronics, and a rechargeable battery pack) while disposing of the relatively low-cost pump device 100 after each use. Such a pump system 10 can provide enhanced user safety as a new pump device 100′ (and drive system therein) is employed with each new medicine cartridge 120′.
Referring to
The new pump device 100′ can be removably attached to the controller device 200 to assemble into the infusion pump system 10 for delivery of medicine to the user. As previously described, the guided motion in the longitudinal direction 219 provides the user with a convenient “one-movement” process to attach the pump device 100′ and the controller device 200. For example, the user can readily slide the pump device 100′ and the controller device 200 toward one another in a single movement (e.g., in the longitudinal direction 219) that causes both a physical connection and an electrical connection. Thus, the infusion pump system 10 can permit users to readily join the pump device 100′ and the controller device 200 without compound or otherwise difficult hand movements—a feature that can be particularly beneficial to child users or to elderly users.
Referring now to
Furthermore, the control circuitry 240 may include one or more dedicated memory devices 242 that store executable software instructions for a processor 243 communicatively coupled to the control circuitry 240. The control circuitry 240 may include other components, such as sensors, that are electrically connected to the main processor board 242. For example, at least a portion of the occlusion detection system 250 can be electrically connected to the main processor board 242 via a flexible circuit substrate or one or more wires, as described in more detail below in connection with
Still referring to
In some optional embodiments, the controller circuitry 240 can include a cable connector (e.g., a USB connection port or another data cable port) that is accessible on an external portion of the controller housing 210. As such, a cable can be connected to the controller circuitry 240 to upload data or program settings to the controller circuitry or to download data from the controller circuitry. For example, historical data of medicine delivery can be downloaded from the controller circuitry 240 (via the cable connector) to a computer system of a physician or a user for purposes of analysis and program adjustments. Optionally, the data cable can also provide recharging power.
Referring now to
In this embodiment, the pump device 100 houses the drive system 300 and the power source 310. For example, the power source 310 may comprise an alkaline battery cell, such as a 1.5 Volt “AAA” alkaline battery cell, which is contained in a dedicated space of the pump housing structure 110. The power source 310 may be capable of transmitting electrical energy to the controller device 200 when the pump device 100 is attached to the controller device 200, via connectors 118 and 218 as described above. For example, the power source 310 may be used to charge the rechargeable battery pack 245 when the pump device 100 is attached to the controller device 200. In some embodiments, the power source 310 is used to provide energy to the drive system 300 of the pump device 100, and also to electronic components of the controller device 200. In particular embodiments, the power source 310 may provide the energy to power all aspects of the infusion pump system 10. In some alternative embodiments, the rechargeable battery 245 housed in the controller 200 may provide the energy to power all aspects of the infusion pump system 10. In other embodiments, the rechargeable battery 245 and the power source 310 may each be responsible for powering particular aspects of the infusion pump system 10. In further embodiments, the rechargeable battery 245 may provide the energy to supplement the energy provided by the power source 310 to power aspects of the infusion pump system.
Still referring to
Referring now to
Referring to
The fluid channel 260 arranged in the cap device 130 may include a secondary channel 262 that extends to a flexible member 265. In this embodiment, one side of the flexible membrane 265 is exposed to the fluid channel 260 (via the secondary channel 262) while the opposite side of the flexible membrane 265 is adjacent to an air cavity 267 (also shown in
Referring to
The sensor circuit 252 can be arranged so that the cap device 130 is aligned with the light emitters 253, 255 and the light sensor 258 when the pump device 100 is attached to the controller device 200. It should be understood that the pump housing 110 and the controller housing 210 have been removed from
The sensor circuit 252 can be connected to the control circuitry 240 of the controller device 200 (
The light collector 256 can be made of any reflective material, preferably polished aluminum, and is designed to collect light from both the reference light emitter 255 and the primary light emitter 253. For example, apertures are advantageously constructed in the light collector 256 to allow light to reach the light sensor 258 from specific directions corresponding to light originating from the reference light emitter 255 and from the primary light emitter 253 (described below in connection with
In some embodiments, the reference light emitter 255 can provide a reference light reading at the sensor 258, which can be advantageously compared to a light reading from the primary light emitter 253 for purposes of determining when a reduced light reading from the main emitter 253 is caused by a buildup of fluid pressure in the fluid channel 260 (e.g., from an occlusion in the infusion set tubing 147) or is caused by some other reason not related to the presence of an occlusion (e.g., environmental conditions such as ambient temperature). For example, in some embodiments, the amount of light emitted from the primary emitter 253 begins to degrade or otherwise changes with fluctuations in ambient temperature and ambient light condition. If the control circuitry was configured to rely upon the light sensor readings detected by the light sensor 258 from the primary emitter 253 alone, such reductions in the amount of the light readings from the primary light emitter 253 would possibly induce false occlusion warnings (e.g., occlusion alerts where in fact the suboptimal temperatures are responsible for the reduced light readings and no occlusion is present in the infusion set tubing 147). In this embodiment, each of the primary emitter 253 and the reference light emitter 255 are substantially equally affected by the fluctuations in ambient temperature and ambient light condition. Accordingly, a comparison of the amount of the light received from the primary light emitter 253 with the amount of the light received from the reference light emitter 255 (rather than an absolute light measurement from the primary light emitter 253 alone) can be employed to substantially reduce or eliminate the number of false occlusion warnings.
Referring to
In the depicted embodiment, the sensor circuit 252 is arranged to at least partially extend to the barrel channel 211 (
Still referring to
Referring now to
Referring now to
As shown in
Referring to
In other words, the amount of light emitted by the reference emitter 255 and received by the light sensor 258 does not fluctuate according to fluid pressure but may fluctuate according to other environmental factors, such as ambient temperature (and it should be understood that primary light emitter 253 is similarly affected by these same environmental factors). This configuration can be employed to aid in the detection of an occlusion that accounts for changes in environmental factors affecting the primary light emitter 253. For example, when the pump device 10 is operating in regions having lower ambient temperatures, both the reference light emitter 255 and the primary light emitter 253 will have reduced light outputs. In those circumstances, the occlusion detection system 250 can use the reduction in the amount of light from the reference light emitter 255 to account for the reduction in the amount of light from the primary light emitter 253. In other circumstances in which the light sensor 258 receives a reduced light signal only from the primary light emitter 253 while the light sensor 258 receive a normal light signal from the reference light emitter 255, then there is a greater likelihood of the presence of an occlusion and the user may be warned accordingly.
Referring to
For example, as shown in
Referring still to
Referring to
The interface where the light transmissive member 254 meets the flexible membrane 265 (
Furthermore, in a preferred embodiment, processes 1500 or 1600 may be performed initially to establish baseline light values used in subsequent executions of processes 1500 or 1600. For example, when the pump device 100 and control device 200 are removably attached or when a user cancels an occlusion alarm (e.g., displayed on displayed device 220), processes 1500 or 1600 may be performed to establish baseline values of light emitted by both the wide-angle reference light emitter 255 and the primary light emitter 253. These baseline values can be stored in one or more memory devices (e.g., on the circuit board 242) by the control circuitry 240 and can be used to determine the presence or absence of an occlusion. For example, if the value corresponding to the light emitted by the primary light emitter 253 is substantially less than the primary light emitter baseline value, an occlusion may exist if the value corresponding to the light emitted by the wide-angle reference light emitter 255 is substantially similar to the wide-angle reference light emitter baseline value. It should be understood that the processes 1500 and 1600 are illustrative of a preferred embodiment. As such, steps described may be performed in orders other than the one described herein.
Referring now to
Still referring to
Still referring to
Referring now to
In a step shown by box 1604, the control circuitry 240 detects a signal corresponding to the light emitted by the reference light emitter 255 and received by the light sensor 258. For example, light transmitted from the reference light emitter 255 may reflect off of the interior surface of the light collector 256 and interact with the light sensor 258. As described in more detail above, the light sensor 258 can generate an electrical signal corresponding to the received light. Because the control circuitry 240 is in electrical communication with the light sensor 258, the control circuitry 240 detects the signal corresponding to the light emitted by the wide-angle reference light emitter 255 when the control circuitry 240 receives the electrical signal from the light sensor 258. In a preferred embodiment, each of the detected signals corresponding to light emitted by the reference light emitter 255 is a floating point value within the range of [0-1] and is stored on one more dedicated memory devices included in the control circuitry 240.
In a decision shown by step 1606, the control circuitry 240 determines whether a minimum number of light samples transmitted by the wide-angle light emitter 255 has been received. For example, in a preferred embodiment, the control circuitry 240 determines whether sixteen iterations of activating the reference emitter 255 and detecting the corresponding sixteen electrical signals from the light sensor 258 have been completed. If the minimum number of light samples has not been received, than the control circuitry 240 may instruct the reference light emitter 255 to activate again, repeating the steps included in the first iterative step shown by box 1605. In this embodiment, the sixteen iterations can be consecutive performed in a period of 0.5 seconds or less.
Once the minimum number of light samples has been received (e.g., sixteen in this embodiment), the control circuitry 240 may perform operation 1612 to determine an average detected value of the reference light emitter samples received. For example, in a preferred embodiment, because the control circuitry 240 receives sixteen light samples from the reference light emitter 255, the sixteen light samples are added together and the total divided by sixteen to determine the average detected value of the wide-angle reference samples received. In a preferred embodiment, the determined average value corresponding to light transmitted by the reference light emitter 255 is a floating point value within the range of [0-1] and is stored on one or more dedicated memory devices included in the control circuitry 240.
In a second iterative step shown by box 1620, the control circuitry 240 activates the primary light emitter 253 as shown in a step 1614. For example, because the control circuitry 240 is in electrical communication with the primary light emitter 253, the control circuitry 240 can generate an electrical signal that when received by the primary light emitter 253 activates the primary light emitter 253 to emit light. In addition, the absence of the electrical signal may instruct the primary light emitter 253 to deactivate.
In a step 1616, the control circuitry 240 can detect a signal corresponding to the light emitted by the primary light emitter 253 and received at the light sensor 258. For example, the light transmitted from the primary light emitter 253 that passes through the light transmissive member 254, may be reflected by the interface between the light transmissive member 254 and the air cavity 267 toward the light sensor 258. As described in more detail above, the light sensor 258 can generate an electrical signal corresponding to the received light. Because the control circuitry 240 is in electrical communication with the light sensor 258, the control circuitry 240 detects the signal corresponding to the light emitted by the primary light emitter 253 when the control circuitry 240 receives the electrical signal from the light sensor 258. In a preferred embodiment, each of the detected signals corresponding to the light emitted by the primary light emitter 253 is a floating point value within the range of [0-1] and is stored on one more dedicated memory devices included in the control circuitry 240.
Still referring to
Once the minimum number of light samples has been received, in a step shown by box 1622, the control circuitry 240 determines an average detected value of the primary light emitter samples received. For example, in a preferred embodiment, because the control circuitry 240 receives 16 light samples from the primary light emitter 253, the 16 light samples are added together and the total divided by 16 to determine the average detected value of the primary light emitter samples received. In a preferred embodiment, the determined average value corresponding to light transmitted by the primary light emitter 253 is a floating point value within the range of [0-1] and is stored on one or more dedicated memory devices included in the control circuitry 240.
The process 1600 for to determining whether the medicine flow path is in an occluded or non-occluded state may include an operation that compares the detected value of the light emitted by the primary light emitter 253 with the detected value of the light emitted by the reference light emitter 253. For example, in this embodiment, the step 1624 indicates that the control circuitry 240 compares the average detected value of the light emitted by the primary light emitter 253 (determined by the step shown by box 1622) with the average detected value of the light emitted by the wide-angle reference light emitter 253 (determined by the step shown by box 1612). In one example of this comparison function, the average detected value of the light emitted by the primary light emitter 253 is divided by the average detected value of the light emitted by the wide-angle reference light emitter 255. Also, in particular embodiments, the resulting comparison value is a floating point value within the range of [0-1] and is stored on one more dedicated memory devices included in the control circuitry 240.
In an optional step shown by dashed box 1626, the control circuitry 240 normalized the comparison value determined in the step shown by box 1624. For example, in a preferred embodiment, the floating point comparison value in the range of [0-1] is multiplied by 100, normalizing the comparison value to an integer value in the range of [0-100].
The process 1600 may use the comparison value as an indicator of whether the medicine flow path is in an occluded or non-occluded state. For example, in this embodiment, the process 1600 includes a step 1628 in which the control circuitry 240 determines if the comparison value (e.g., either of the values determined by the step shown by box 1624 or the normalized comparison value determined in the step shown by box 1626) is outside a threshold range (e.g., less than or equal to a minimum threshold value, or greater than or equal to a maximum threshold value, or the like).
In particular embodiments, this step 1628 may employ a baseline value, which can be initially calculated when the pump device 100 is initially primed to force medicine through the infusion set tubing 147 (e.g., when there are no blockages or kinks and the medicine is visibly moved out of the tubing 147). In some cases, the baseline value can be calculated by the control circuitry 240 as a value corresponding to an initial amount of detected light from the primary light emitter 253 during or immediately before the priming operation divided by a value corresponding to a initial amount of light emitted by the reference light emitter 255 during or immediately before the priming operation).
In this embodiment of step 1628, the normalized comparison value (e.g., from step 1626) is divided by this previously determined baseline value. In a preferred embodiment, if this comparison is less than or equal to a minimum threshold value (such as 40% in this embodiment), then the comparison is outside the threshold range. In other words, for this particular embodiment, the comparison value is outside the threshold range when:
(MD/RD)/(MB/RB) is less than or equal to 40%, where
Optionally, in some embodiments, the control circuitry 240 stores a set of the most recently calculated comparison values from step 1628. This set of recent comparison values from step 1628 can be employed by the occlusion detection software of the control circuitry 240 to determine if there is a trend that is indicative of an ongoing occlusion in the medicine flow path. For example, if a plurality of consecutive values from the comparison step 1628 are all less than or equal to the minimum threshold value (such as 40% in this embodiment), occlusion detection software of the control circuitry 240 may determine that an occlusion exists and a user alert should be output. In this particular embodiment, the control circuitry 240 stores at least five of the most recent comparison values from the step 1628. In such embodiments, when the most recent five comparison values from the step 1628 are outside the threshold range, then the control circuitry 240 will generate an occlusion alarm in a step shown by box 1630. Alternatively, the control circuitry 240 may not necessarily store a plurality of the most recently calculated comparison values from step 1628, but instead may generate the occlusion alarm in step 1630 after any one instance of the comparison value from step 1628 are outside the threshold range.
The process 1600 can be performed immediately prior to each drive cycle of the pump device 100. In such circumstances, the process may proceed to step 1632 in which the pump drive cycle is initiate if the comparison value from step 1628 is not outside the threshold range (or, in a preferred embodiment, if one of the five most recent comparison values is not outside the threshold range). For example, if the comparison step 1628 reveals that (MD/RD)/(MB/RB) is greater than 40%, this result is an indication that there is no meaningful occlusion in the medicine flow path and the control circuitry 240 may then initiate the pump drive cycle 1632. When the control circuitry 240 initiates the pump drive cycle in step 1632 (e.g., in accordance with a previously determined basal dosage schedule or a requested bolus dosage), the pump drive system 300 is activated to dispense the dose of medicine through the infusion tubing 147 into the infusion set 146 and cannula 149. After the pump drive cycle 1632 is activated, the control circuitry may then standby 1634 prior to the next pump drive cycle (e.g., in accordance with a previously determined basal dosage schedule or a requested bolus dosage) before executing process 1600 again.
A number of embodiments of the invention have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the invention. Accordingly, other embodiments are within the scope of the following claims.
| Number | Name | Date | Kind |
|---|---|---|---|
| 5225763 | Krohn et al. | Jul 1993 | A |
| 5858001 | Tsals et al. | Jan 1999 | A |
| 6436072 | Kullas et al. | Aug 2002 | B1 |
| 6524280 | Hansen et al. | Feb 2003 | B2 |
| 6533183 | Aasmul et al. | Mar 2003 | B2 |
| 6537251 | Klitmose | Mar 2003 | B2 |
| 6540672 | Simonsen et al. | Apr 2003 | B1 |
| 6544229 | Danby et al. | Apr 2003 | B1 |
| 6547764 | Larsen et al. | Apr 2003 | B2 |
| 6551276 | Mann et al. | Apr 2003 | B1 |
| 6554798 | Mann et al. | Apr 2003 | B1 |
| 6554800 | Nezhadian et al. | Apr 2003 | B1 |
| 6558320 | Causey, III et al. | May 2003 | B1 |
| 6558351 | Steil et al. | May 2003 | B1 |
| 6562001 | Lebel et al. | May 2003 | B2 |
| 6562011 | Buch-Rasmussen et al. | May 2003 | B1 |
| 6564105 | Starkweather et al. | May 2003 | B2 |
| 6569126 | Poulsen et al. | May 2003 | B1 |
| 6571128 | Lebel et al. | May 2003 | B2 |
| 6577899 | Lebel et al. | Jun 2003 | B2 |
| 6582404 | Klitgaard et al. | Jun 2003 | B1 |
| 6585644 | Lebel et al. | Jul 2003 | B2 |
| 6585699 | Ljunggreen et al. | Jul 2003 | B2 |
| 6589229 | Connelly et al. | Jul 2003 | B1 |
| 6605067 | Larsen | Aug 2003 | B1 |
| 6613019 | Munk | Sep 2003 | B2 |
| 6641533 | Causey, III et al. | Nov 2003 | B2 |
| 6648821 | Lebel et al. | Nov 2003 | B2 |
| 6650951 | Jones et al. | Nov 2003 | B1 |
| 6656158 | Mahoney et al. | Dec 2003 | B2 |
| 6656159 | Flaherty | Dec 2003 | B2 |
| 6659948 | Lebel et al. | Dec 2003 | B2 |
| 6659978 | Kasuga et al. | Dec 2003 | B1 |
| 6659980 | Moberg et al. | Dec 2003 | B2 |
| 6663602 | Møller | Dec 2003 | B2 |
| 6668196 | Villegas et al. | Dec 2003 | B1 |
| 6669669 | Flaherty et al. | Dec 2003 | B2 |
| 6687546 | Lebel et al. | Feb 2004 | B2 |
| 6690192 | Wing | Feb 2004 | B1 |
| 6691043 | Ribeiro, Jr. | Feb 2004 | B2 |
| 6692457 | Flaherty | Feb 2004 | B2 |
| 6692472 | Hansen et al. | Feb 2004 | B2 |
| 6694191 | Starkweather et al. | Feb 2004 | B2 |
| 6699218 | Flaherty et al. | Mar 2004 | B2 |
| 6702779 | Connelly et al. | Mar 2004 | B2 |
| 6715516 | Ohms et al. | Apr 2004 | B2 |
| 6716198 | Larsen | Apr 2004 | B2 |
| 6723072 | Flaherty et al. | Apr 2004 | B2 |
| 6733446 | Lebel et al. | May 2004 | B2 |
| 6736796 | Shekalim | May 2004 | B2 |
| 6740059 | Flaherty | May 2004 | B2 |
| 6740072 | Starkweather et al. | May 2004 | B2 |
| 6740075 | Lebel et al. | May 2004 | B2 |
| 6744350 | Blomquist | Jun 2004 | B2 |
| 6749587 | Flaherty | Jun 2004 | B2 |
| 6752787 | Causey, III et al. | Jun 2004 | B1 |
| 6758810 | Lebel et al. | Jul 2004 | B2 |
| 6768425 | Flaherty et al. | Jul 2004 | B2 |
| 6780156 | Haueter et al. | Aug 2004 | B2 |
| 6786246 | Ohms et al. | Sep 2004 | B2 |
| 6786890 | Preuthun et al. | Sep 2004 | B2 |
| 6796970 | Klitmose et al. | Sep 2004 | B1 |
| 6799149 | Hartlaub | Sep 2004 | B2 |
| 6809653 | Mann et al. | Oct 2004 | B1 |
| 6810290 | Lebel et al. | Oct 2004 | B2 |
| 6811533 | Lebel et al. | Nov 2004 | B2 |
| 6811534 | Bowman, IV et al. | Nov 2004 | B2 |
| 6813519 | Lebel et al. | Nov 2004 | B2 |
| 6827702 | Lebel et al. | Dec 2004 | B2 |
| 6830558 | Flaherty et al. | Dec 2004 | B2 |
| 6852104 | Blomquist | Feb 2005 | B2 |
| 6854620 | Ramey | Feb 2005 | B2 |
| 6854653 | Eilersen | Feb 2005 | B2 |
| 6855129 | Jensen et al. | Feb 2005 | B2 |
| 6872200 | Mann et al. | Mar 2005 | B2 |
| 6873268 | Lebel et al. | Mar 2005 | B2 |
| 6878132 | Kipfer | Apr 2005 | B2 |
| 6893415 | Madsen et al. | May 2005 | B2 |
| 6899695 | Herrera | May 2005 | B2 |
| 6899699 | Enggaard | May 2005 | B2 |
| 6922590 | Whitehurst | Jul 2005 | B1 |
| 6936006 | Sabra | Aug 2005 | B2 |
| 6936029 | Mann et al. | Aug 2005 | B2 |
| 6945961 | Miller et al. | Sep 2005 | B2 |
| 6948918 | Hansen | Sep 2005 | B2 |
| 6950708 | Bowman IV et al. | Sep 2005 | B2 |
| 6960192 | Flaherty et al. | Nov 2005 | B1 |
| 6979326 | Mann et al. | Dec 2005 | B2 |
| 6997911 | Klitmose | Feb 2006 | B2 |
| 6997920 | Mann et al. | Feb 2006 | B2 |
| 7005078 | Van Lintel et al. | Feb 2006 | B2 |
| 7008399 | Larsen et al. | Mar 2006 | B2 |
| 7014625 | Bengtsson | Mar 2006 | B2 |
| 7018360 | Flaherty et al. | Mar 2006 | B2 |
| 7025743 | Mann et al. | Apr 2006 | B2 |
| 7029455 | Flaherty | Apr 2006 | B2 |
| 7054836 | Christensen et al. | May 2006 | B2 |
| 7104972 | Moller et al. | Sep 2006 | B2 |
| 7128727 | Flaherty et al. | Oct 2006 | B2 |
| 7133329 | Skyggebjerg et al. | Nov 2006 | B2 |
| 7232423 | Mernoe | Jun 2007 | B2 |
| 7789859 | Estes et al. | Sep 2010 | B2 |
| 20010041869 | Causey, III et al. | Nov 2001 | A1 |
| 20010056262 | Cabiri | Dec 2001 | A1 |
| 20020004651 | Ljunggreen et al. | Jan 2002 | A1 |
| 20020007154 | Hansen et al. | Jan 2002 | A1 |
| 20020040208 | Flaherty et al. | Apr 2002 | A1 |
| 20020091358 | Klitmose | Jul 2002 | A1 |
| 20020126036 | Flaherty et al. | Sep 2002 | A1 |
| 20030055380 | Flaherty | Mar 2003 | A1 |
| 20030065308 | Lebel et al. | Apr 2003 | A1 |
| 20030088238 | Poulsen | May 2003 | A1 |
| 20030167035 | Flaherty et al. | Sep 2003 | A1 |
| 20030198558 | Nason et al. | Oct 2003 | A1 |
| 20030199825 | Flaherty | Oct 2003 | A1 |
| 20030216683 | Shekalim | Nov 2003 | A1 |
| 20040010207 | Flaherty et al. | Jan 2004 | A1 |
| 20040019325 | Shekalim | Jan 2004 | A1 |
| 20040064088 | Gorman et al. | Apr 2004 | A1 |
| 20040064096 | Flaherty et al. | Apr 2004 | A1 |
| 20040078028 | Flaherty et al. | Apr 2004 | A1 |
| 20040087894 | Flaherty | May 2004 | A1 |
| 20040092865 | Flaherty et al. | May 2004 | A1 |
| 20040092878 | Flaherty | May 2004 | A1 |
| 20040116866 | Gorman et al. | Jun 2004 | A1 |
| 20040127844 | Flaherty | Jul 2004 | A1 |
| 20040153032 | Garribotto et al. | Aug 2004 | A1 |
| 20040171983 | Sparks et al. | Sep 2004 | A1 |
| 20040176727 | Shekalim | Sep 2004 | A1 |
| 20040204673 | Flaherty | Oct 2004 | A1 |
| 20040220551 | Flaherty et al. | Nov 2004 | A1 |
| 20040235446 | Flaherty et al. | Nov 2004 | A1 |
| 20040260233 | Garibotto et al. | Dec 2004 | A1 |
| 20050021005 | Flaherty et al. | Jan 2005 | A1 |
| 20050022274 | Campbell et al. | Jan 2005 | A1 |
| 20050065760 | Murtfeldt et al. | Mar 2005 | A1 |
| 20050090808 | Malave et al. | Apr 2005 | A1 |
| 20050090851 | Devlin | Apr 2005 | A1 |
| 20050095063 | Fathallah | May 2005 | A1 |
| 20050160858 | Mernoe | Jul 2005 | A1 |
| 20050171512 | Flaherty | Aug 2005 | A1 |
| 20050182366 | Vogt et al. | Aug 2005 | A1 |
| 20050192561 | Mernoe | Sep 2005 | A1 |
| 20050203461 | Flaherty et al. | Sep 2005 | A1 |
| 20050215982 | Malave et al. | Sep 2005 | A1 |
| 20050222645 | Malave et al. | Oct 2005 | A1 |
| 20050234404 | Vilks et al. | Oct 2005 | A1 |
| 20050238507 | DiIanni et al. | Oct 2005 | A1 |
| 20050245878 | Mernoe et al. | Nov 2005 | A1 |
| 20050251097 | Mernoe | Nov 2005 | A1 |
| 20050267402 | Stewart et al. | Dec 2005 | A1 |
| 20050273059 | Mernoe et al. | Dec 2005 | A1 |
| 20060041229 | Garibotto et al. | Feb 2006 | A1 |
| 20060069382 | Pedersen | Mar 2006 | A1 |
| 20060074381 | Malave et al. | Apr 2006 | A1 |
| 20060095014 | Ethelfeld | May 2006 | A1 |
| 20060135913 | Ethelfeld | Jun 2006 | A1 |
| 20060142698 | Ethelfeld | Jun 2006 | A1 |
| 20060151545 | Imhof et al. | Jul 2006 | A1 |
| 20060178633 | Garibotto et al. | Aug 2006 | A1 |
| 20060184119 | Remde et al. | Aug 2006 | A1 |
| 20060200073 | Radmer et al. | Sep 2006 | A1 |
| 20060206054 | Shekalim | Sep 2006 | A1 |
| 20060247581 | Pedersen et al. | Nov 2006 | A1 |
| 20070073228 | Mernoe et al. | Mar 2007 | A1 |
| 20070073236 | Mernoe et al. | Mar 2007 | A1 |
| 20070088271 | Richards | Apr 2007 | A1 |
| 20070106218 | Yodfat et al. | May 2007 | A1 |
| 20070124002 | Estes et al. | May 2007 | A1 |
| 20070156092 | Estes et al. | Jul 2007 | A1 |
| 20070167905 | Estes et al. | Jul 2007 | A1 |
| 20070167912 | Causey et al. | Jul 2007 | A1 |
| 20070239116 | Follman et al. | Oct 2007 | A1 |
| 20080051716 | Stutz | Feb 2008 | A1 |
| 20080097381 | Moberg et al. | Apr 2008 | A1 |
| 20080208627 | Skyggebjerg | Aug 2008 | A1 |
| 20080294094 | Mhatre et al. | Nov 2008 | A1 |
| 20080319383 | Byland et al. | Dec 2008 | A1 |
| 20090118667 | Haueter et al. | May 2009 | A1 |
| Number | Date | Country |
|---|---|---|
| 2543545 | May 2005 | CA |
| 196 27 619 | Jan 1998 | DE |
| 102 36 669 | Feb 2004 | DE |
| 0 062 974 | Oct 1982 | EP |
| 0 496 141 | Jul 1992 | EP |
| 0 612 004 | Aug 1994 | EP |
| 0 580 723 | Oct 1995 | EP |
| 0 275 213 | Jul 1998 | EP |
| 1 045 146 | Oct 2000 | EP |
| 1 136 698 | Sep 2001 | EP |
| 1 177 802 | Feb 2002 | EP |
| 0 721 358 | May 2002 | EP |
| 1 495 775 | Jan 2005 | EP |
| 1 527 792 | May 2005 | EP |
| 1 754 498 | Feb 2007 | EP |
| 1 818 664 | Aug 2007 | EP |
| 2 585 252 | Jan 1987 | FR |
| 747 701 | Apr 1956 | GB |
| 2 218 831 | Nov 1989 | GB |
| WO 9015928 | Dec 1990 | WO |
| WO 9721457 | Jun 1997 | WO |
| WO 9804301 | Feb 1998 | WO |
| WO 9811927 | Mar 1998 | WO |
| WO 9857683 | Dec 1998 | WO |
| WO 9921596 | May 1999 | WO |
| WO 9939118 | Aug 1999 | WO |
| WO 9948546 | Sep 1999 | WO |
| WO 0172360 | Oct 2001 | WO |
| WO 0191822 | Dec 2001 | WO |
| WO 0191833 | Dec 2001 | WO |
| WO 0240083 | May 2002 | WO |
| WO 02057627 | Jul 2002 | WO |
| WO 02068015 | Sep 2002 | WO |
| WO 02084336 | Oct 2002 | WO |
| WO 02100469 | Dec 2002 | WO |
| WO 03026726 | Apr 2003 | WO |
| WO 03074121 | Sep 2003 | WO |
| WO 03103763 | Dec 2003 | WO |
| WO 2004056412 | Jul 2004 | WO |
| WO 2004110526 | Dec 2004 | WO |
| WO 2005002652 | Jan 2005 | WO |
| WO 2005039673 | May 2005 | WO |
| WO 2005072794 | Aug 2005 | WO |
| WO 2005072795 | Aug 2005 | WO |
| WO 2006067217 | Jun 2006 | WO |
| WO 2006097453 | Sep 2006 | WO |
| WO 2006105792 | Oct 2006 | WO |
| WO 2006105793 | Oct 2006 | WO |
| WO 2006105794 | Oct 2006 | WO |
| WO 2007141786 | Dec 2007 | WO |
| Entry |
|---|
| Authorized Officer Jacques Voinot, International Search Report and Written Opinion for Application No. PCT/US2012/053912, dated Nov. 26, 2012, 10 pages. |
| Accu-Chek Spirit, “Pump Therapy Made for You,” Roche, 2006, 6 pages. |
| Collins and Lee, “Microfluidic flow transducer based on the measurement of electrical admittance,” Lab Chip, 2004, 4:7-10. |
| Debiotech News Release, “Debiotech reveals its new miniaturized Disposable Insulin Nanopump™ for Diabetes therapy,” available at http://www.debiotech.com/news/nw—159.html Apr. 24, 2006, 3 pages. |
| International Preliminary Report on Patentability, PCT/US2008064244, mailed Dec. 3, 2009, (9 pages). |
| International Search Report & Written Opinion, PCT/US2008064244, mailed Sep. 16, 2008, (18 pages). |
| Medtronic News Release, “Medtronic Receives FDA Approval for World's First Insulin Pump with Real-time Continuous Glucose Monitoring,” Apr. 13, 2006, 3 pages. |
| OmniPod Insulin Management System-Investor Relations- Press Release, Feb. 1, 2005, http://investors.insulet.com/phoenix.zhtml?c=2093368&p=irol-newsArticle&ID=988708&highlight= 1 page. |
| OmniPod Quick Start Guide, 2007, 2 pages. |
| Patent Abstracts of Japan, vol. 1999, No. 04, and JP 11 010036 , Apr. 30, 1999 and Jan. 19, 1999, Toray Ind. Inc. |
| The Medtronic Diabetes Connection, 2006, 6 pages. |
| Xilas Temp Touch, “The latest in high-tech and convenient devices,” DOCNews, vol. 2, No. 7, Jul. 1, 2005, http://docnews.diabetesjournals.ord/cgi/content/full/2/7/13, 3 pages. |
| International Preliminary Report on Patentability in International Application No. PCT/US2012/053912, mailed Mar. 20, 2014, 7 pages. |
| Number | Date | Country | |
|---|---|---|---|
| 20130060194 A1 | Mar 2013 | US |
