Patent Application
20230277759
This disclosure relates to medical agent administration. More specifically, this disclosure relates to medical agent administration sets and other components which may aid in supporting administration of agent to a patient.
In accordance with an example embodiment of the present disclosure an example medical agent administration device may comprise a main body including a central region and a peripheral region. The peripheral region may have a plurality of petal members extending outwardly from the central region. The device may further comprise at least one coupling on a first face of the central region. The device may further comprise at least one sharp bearing body on an opposing face of the central region. Each of the at least one sharp bearing body may be in fluid communication with a respective one of the at least one coupling.
In some embodiments, the central region may be raised with respect to the peripheral region. In some embodiments, each of the at least one coupling may be a fitting. In some embodiments, the at least one coupling may include connector receivers each having a ramped face and a ledge face. In some embodiments, the at least one coupling may include at least one guide. In some embodiments, each of the at least one coupling may include a luer fitting. In some embodiments, the main body and coupling may be configured for injection molding with no side action. In some embodiments, the opposing face of the central region may include at least one rocker member. In some embodiments, the at least one sharp bearing body may be constructed of etched silicon. In some embodiments, each of the at least one sharp bearing body may be coupled to a respective one of an at least one stage projection on the opposing face in an injection molding operation. In some embodiments, each of the at least one sharp bearing body may be coupled to a respective one of an at least one stage projection on the opposing face via adhesive. In some embodiments, the device may further comprise a septum sealing a passage in fluid communication with the at least one sharp bearing body. In some embodiments, the opposing face of the central region may be at least partially covered with an adhesive bearing member. In some embodiments, the device may further comprise an adhesive bearing member. In some embodiments, each of the at least one sharp bearing body may include at least one microneedle. In some embodiments, each of the at least one sharp bearing body may include an array of microneedles. In some embodiments, a first of the at least one sharp bearing body may include at least one first microneedle having a first height. A second of the at least one sharp bearing body may include at least one second microneedle having a second height different from the first height. In some embodiments, the first height may be selected to place the at least one first microneedle in a shallow delivery destination and the second height may be selected to place the at least one second microneedle in a deeper delivery destination when the device is in use. In some embodiments, the shallow delivery destination may be an intradermal delivery destination. In some embodiments, the deeper delivery destination may be a subcutaneous delivery destination. In some embodiments, each of the at least one sharp bearing body may be in fluid communication with the respective one of the at least one coupling only.
In accordance with another example embodiment of the present disclosure and example medical agent administration device may comprise a main body including a central region and a peripheral region. The peripheral region may have a plurality of petal members extending outwardly from the central region. The device may further comprise a body coupled to the main body including at least one coupling on a first face of the central region and at least one sharp bearing body on an opposing face of the central region. Each of the at least one sharp bearing body may be in fluid communication with a respective one of the at least one coupling.
In some embodiments, the body may be coupled to a ridge included in a portion of the main body. In some embodiments, the body may include a plurality of tabs which couple into slits in the main body. In some embodiments, the central region may be raised with respect to the peripheral region. In some embodiments, each of the at least one coupling may be a fitting. In some embodiments, each of the at least one coupling may be a tubing receiver into which a fluid line leading to a fitting is coupled. In some embodiments, the at least one coupling may include connector receivers each having a ramped face and a ledge face. In some embodiments, the at least one coupling may include at least one guide. In some embodiments, each of the at least one coupling may include a luer fitting. In some embodiments, the main body and body may be injection molded. In some embodiments, the opposing face of the body may include at least one rocker member. In some embodiments, the at least one sharp bearing body may be constructed of etched silicon. In some embodiments, each of the at least one sharp bearing body may be coupled to a respective one of an at least one stage projection on the opposing face in an injection molding operation. In some embodiments, each of the at least one sharp bearing body may be coupled to a respective one of an at least one stage projection on the opposing face via adhesive. In some embodiments, the device may further comprise a septum sealing a passage in fluid communication with the at least one sharp bearing body. In some embodiments, the opposing face of the body may be at least partially covered with an adhesive bearing member. In some embodiments, the device may further comprise an adhesive bearing member. In some embodiments, each of the at least one sharp bearing body may include at least one microneedle. In some embodiments, each of the at least one sharp bearing body may include an array of microneedles. In some embodiments, a first of the at least one sharp bearing body may include at least one first microneedle having a first height. A second of the at least one sharp bearing body may include at least one second microneedle having a second height different from the first height. In some embodiments, the first height may be selected to place the at least one first microneedle in a shallow delivery destination and the second height may be selected to place the at least one second microneedle in a deeper delivery destination when the device is in use. In some embodiments, the shallow delivery destination may be an intradermal delivery destination. In some embodiments, the deeper delivery destination may be a subcutaneous delivery destination. In some embodiments, each of the at least one sharp bearing body may be in fluid communication with the respective one of the at least one coupling only.
In accordance with another example embodiments of the present disclosure an exemplary medical agent administration device may comprise a main body including a central region and a peripheral region. The peripheral region may have a plurality of petal members extending outwardly from the central region. The device may further comprise at least one coupling on a first face of the central region. The device may further comprise at least one sharp bearing body on an opposing face of the central region. Each of the at least one sharp bearing body may be in fluid communication with a respective one of the at least one coupling. The at least one sharp bearing body may be coupled to a stage projection on the opposing face.
In accordance with another example embodiment of the present disclosure an analyte sensor device may comprise a main body including a central region and a peripheral region. The peripheral region may include a plurality of petal members extending outwardly from the central region. The device may further comprise at least one sharp bearing body on a first face of the central region. Each of the at least one sharp bearing body may include at least one electrode. The device may include at least one first electrode and at least one second electrode associated with analyte sensing chemistry.
In some embodiments, the central region may be raised with respect to the peripheral region. In some embodiments, each of the at least one electrode may communicate with a conductive trace extending to an opposing side of the central region. In some embodiments, the device may include a first sharp bearing body including the at least one first electrode and a second sharp bearing body separate from the first sharp bearing body including the at least one second electrode. In some embodiments, an opposing face of the central region opposite the first face may include at least one coupling member for coupling the device to a transmitter. In some embodiments, each of the at least one sharp bearing body may be coupled to a stage projection on the first face of the central region. In some embodiments, each of the at least one sharp bearing body may be coupled to the stage projection in an injection molding operation. In some embodiments, the first face of the central region may include at least one stage projection. The at least one first and second electrodes each may be coupled to one of the at least one stage projection. In some embodiments, the at least one first and second electrodes may each be coupled to one of the at least one stage projection during an injection molding operation. In some embodiments, the main body may be injection molded. In some embodiments, the first face of the central region may include at least one rocker member. In some embodiments, the at least one sharp bearing body may be constructed of etched silicon. In some embodiments, the first face of the central region may be at least partially covered with an adhesive bearing member. In some embodiments, the device may further comprise an adhesive bearing member. In some embodiments, each of the at least one first electrode and each of the at least one second electrode may be micropenetrators. In some embodiments, each of the at least one first electrode and each of the at least one second electrode may be included on micropenetrators which are at least partially covered in an insulative material. In some embodiments, a first of the at least one second electrode may be configured to penetrate a first depth into a biological barrier and a second of the at least one second electrode may be configured to penetrate a second depth into the biological barrier. In some embodiments, first depth may be selected to be a shallow depth the second depth may be selected to be a subcutaneous depth. In some embodiments, the shallow depth may be an intradermal depth. In some embodiments, the device may further comprise at least one transmitter. In some embodiments, the at least one transmitter may be disposed on a second face of the central region opposite the first. In some embodiments, the analyte sensor device may be a glucose sensor.
In accordance with another example embodiment of the present disclosure an access assembly device for a biological barrier may comprise a main body including a central region and a peripheral region. The peripheral region may have a plurality of petal members. The device may further comprise a coupling on a first face of the central region. The device may further comprise at least one access member on an opposing face of the central region. The at least one access member may have a delivery lumen. The device may further comprise at least one analyte sensor having electrodes on the opposing face of the central region.
In some embodiments, the coupling may be a fitting such as a luer lock fitting. In some embodiments, the coupling may include at least one guide and at least one connector receiver. Each of the at least one connector receiver may have a ramped face and a ledge face. In some embodiments, the device further may comprise a septum sealing a passage in fluid communication with the at least one access member. In some embodiments, the device may further comprise at least one transmitter. In some embodiments, the opposing face of the central region may include at least one stage projection. The access members and the electrodes each may be coupled to one of the at least one stage projection. In some embodiments, the opposing face of the central region may include at least one rocker member. In some embodiments, the opposing face of the central region may include at least one stage projection. The at least one access member and the electrodes each may be coupled to one of the at least one stage projection and one of the at least one stage projections may form one of the at least one rocker member. In some embodiments, the analyte sensor may be a glucose sensor. In some embodiments, the at least one access member may include an array of microneedles extending from a sharp bearing body. In some embodiments, the electrodes may include micropenetrators extending from sharp bearing bodies. In some embodiments, the at least one access member may be constructed of etched silicon. In some embodiments, the at least one access member may include at least one first access member configured for shallow delivery and at least one second access member configured for subcutaneous delivery. In some embodiments, the at least one first access member may be configured for intradermal delivery. In some embodiments, the electrodes comprise a first set of electrodes configured to sense analyte levels at a shallow location in the biological barrier and a second set of electrodes configured to sense analyte levels at a subcutaneous location in the biological barrier. In some embodiments, the shallow location may be an intradermal location.
In accordance with still another example embodiment of the present disclosure an example access assembly device for a biological barrier may comprise a main body including a central region and a peripheral region. The peripheral region may have a plurality of petal members extending outwardly from the central region. The device may further comprise at least one coupling on a first face of the central region. The device may further comprise at least one first sharp bearing body on an opposing face of the central region. Each of the at least one first sharp bearing body may be in fluid communication with a respective one of the at least one coupling. The device may further comprise at least one second sharp bearing body on the opposing face of the central region. Each of the at least one second sharp bearing body may include at least one electrode. The device may include at least one first electrode and at least one second electrode which is associated with analyte sensing chemistry.
In certain embodiments of any of the devices described above, the main body may be configured to transition from a storage state to a deployed state. At least two portions of the main body may spreadingly displace as the main body transitions from the storage state to the deployed state. In certain embodiments of any of the devices described above, the main body may be configured to transition from a storage state to a deployed state. At least two adhesive bearing portions of the main body may spreadingly displace as the main body transitions from the storage state to the deployed state. Om certain embodiments of any of the devices described above, the main body may be configured to transition from a storage state to a deployed state. The central region may be configured to translate toward a biological barrier to which the device has been applied as the main body transitions from the storage state to the deployed state.
In accordance with another example embodiment of the present disclosure a medical agent administration system may comprise an infusion device. The infusion device may include a delivery assembly including at least one sensor and at least one pumping arrangement. The system may further comprise a set in fluid communication with the delivery device. The set may include at least one intradermal access member. The system may further comprise a controller configured to govern operation of the at least one pumping arrangement. The controller may be in data communication with the at least one sensor and configured to analyze data from the at least one sensor. The controller may be configured to determine a change in depth of the at least one access member has occurred based on the data from the at least one sensor.
In some embodiments, the system may further comprise at least one analyte monitor. In some embodiments, the system may further comprise a glucose monitor. In some embodiments, the controller may be in communication with at least one smart device and the infusion device. In some embodiments, the delivery assembly may be split between a first portion of the infusion device and a second portion of the infusion device removably coupled to the first portion. In some embodiments, the second portion may be a cassette assembly. In some embodiments, the cassette assembly may include at least one flow path and at least one valve component which are overlaid by at least one membrane. In some embodiments, the at least one sensor may include a pressure sensor configured to monitor volumes of fluid delivered from the infusion device to the set. In some embodiments, the controller may be configured to analyze the data from the at least one sensor to determine if a pressure decay rate is in breach of a predefined criteria. In some embodiments, the controller may be configured to analyze the data from the at least one sensor to determine if a pressure decay rate is in excess of a predefined threshold and configured to generate an alert for display on a user interface of the system when the pressure decay rate exceeds the threshold. In some embodiments, the controller may be configured to analyze the data from the at least one sensor to determine if a pressure decay rate is in below a predefined threshold and configured to generate an alert for display on a user interface of the system when the pressure decay rate is below the threshold. In some embodiments, the at least one sensor may include an acoustic volume sensor comprising a variable volume chamber and the data from the at least one sensor may be indicative of a volume of fluid in the variable volume chamber. In some embodiments, the controller may be configured to analyze the data from the at least one sensor to determine if change in volume of the variable volume chamber over time is in breach of predefined criteria. In some embodiments, the controller may be configured to analyze the data from the at least one sensor to determine if rate of change in volume of the variable volume chamber is in excess of a predefined threshold and configured to generate an alert for display on a user interface of the system when the rate exceeds the threshold. In some embodiments, the controller may be configured to analyze the data from the at least one sensor to determine if rate of change in volume of the variable volume chamber is below a predefined threshold and configured to generate an alert for display on a user interface of the system when the rate is below the threshold. In some embodiments, the at least one intradermal access member may include a microneedle. In some embodiments, the at least one intradermal access member may include an array of microneedles on a sharp bearing body coupled to a stage projection on a face of the set. In some embodiments, the face of the set may include at least one rocker member. In some embodiments, the set may include a main body having a central region and a peripheral region including a plurality of petal members. In some embodiments, the main body may be configured to transition from a storage state to a deployed state. At least two adhesive bearing portions of the main body may spreadingly displace as the main body transitions from the storage state to the deployed state. The central region may be configured to translate toward a biological barrier to which the set is applied as the main body transitions from the storage state to the deployed state. In some embodiments, the at least one sensor may be configured to generate a data signal which varies in relation to a delivery impedance from the at least one access member.
In accordance with another example embodiment of the present disclosure an example medical agent administration system may comprise an infusion device. The infusion device may include a delivery assembly including at least one sensor and at least one pumping arrangement. The system may further comprise a set in fluid communication with the delivery device. The set may include at least one shallow access member and at least one subcutaneous access member. The system may further comprise a controller configured to govern operation of the at least one pumping arrangement. The controller may be in data communication with the at least one sensor and configured to compare data from the at least one sensor related to fluid deliveries to the shallow access member and the at least one subcutaneous access member and determine a change in depth of one or more of the shallow access member and at least one subcutaneous access member has occurred based on the data from the at least one sensor.
In some embodiments, the at least one shallow access member and at least one subcutaneous access member may be microneedles. In some embodiments, the at least one shallow access member and at least one subcutaneous access member may each include an array of microneedles on a sharp bearing body coupled to a stage projection on a face of the set. In some embodiments, the face of the set may include at least one rocker member. In some embodiments, the set may include a main body having a central region and a peripheral region including a plurality of petal members. In some embodiments, the main body may be configured to transition from a storage state to a deployed state. At least two adhesive bearing portions of the main body may spreadingly displace as the main body transitions from the storage state to the deployed state. The central region may be configured to translate toward a biological barrier to which the set is applied as the main body transitions from the storage state to the deployed state. In some embodiments, the system may further comprise at least one analyte monitor. In some embodiments, the system may further comprise a glucose monitor. In some embodiments, the controller may be in communication with at least one smart device and the infusion device. In some embodiments, the delivery assembly may be split between a first portion of the infusion device and a second portion of the infusion device removably coupled to the first portion. In some embodiments, the second portion may be a cassette assembly. In some embodiments, the cassette assembly may include at least one flow path and at least one valve component which are overlaid by at least one membrane. In some embodiments, the at least one sensor may be configured to generate a data signal which varies in relation to a delivery impedance from the at least one access member. In some embodiments, the controller may be configured to determine the at least one subcutaneous access member has displaced to an intradermal depth when the delivery impedance related to the at least one subcutaneous access member indicated by the at least one data increases. In some embodiments, the controller may be configured to determine the at least one subcutaneous access member has displaced to an intradermal depth when the delivery impedance related to the at least one subcutaneous access member indicated by the at least one sensor increases to within a range of historical data related to the at least one intradermal access member. In some embodiments, the controller may be configured to generate an alarm when the delivery impedance related to the at least one subcutaneous access member indicated by the at least one sensor increases to within a range of historical data related to the at least one intradermal access member and the delivery impedance related to the at least one intradermal access member indicated by the at least one sensor decreases.
In accordance with another example embodiment of the present disclosure, a medical agent administration system may comprise an infusion device with a delivery assembly. The delivery assembly may include at least one pumping arrangement. The system may further comprise a set in fluid communication with the delivery device. The set may include at least one access member, a shallow analyte sensor, and a deep analyte sensor. The system may further comprise a controller configured to govern operation of the at least one pumping arrangement to selectively deliver fluid from the infusion device to the at least one access member. The controller may be in data communication with the shallow and deep analyte sensors. The controller may be configured to compare data from the shallow and deep analyte sensors and generate a notification when a relationship between data from the shallow and deep analyte sensors breaches a predefined criteria.
In some embodiments, the at least one shallow analyte sensor and at least one subcutaneous analyte sensor may include micropenetrators. In some embodiments, a face of the set may include at least one stage projection and the shallow and deep analyte sensors may be each coupled to one of the at least one stage projection. In some embodiments, the face of the set may include at least one rocker member. In some embodiments, the set may include a main body having a central region and a peripheral region including a plurality of petal members. In some embodiments, the main body may be configured to transition from a storage state to a deployed state. At least two adhesive bearing portions of the main body may spreadingly displace as the main body transitions from the storage state to the deployed state. The central region may be configured to translate toward a biological barrier to which the set is applied as the main body transitions from the storage state to the deployed state. In some embodiments, the shallow analyte sensor may be an intradermal analyte sensor and the deep analyte sensor may be a subcutaneous analyte sensor. In some embodiments, the shallow analyte sensor and deep analyte sensor may be glucose sensors. In some embodiments, the controller may be in communication with at least one smart device and the infusion device. In some embodiments, the delivery assembly may be split between a first portion of the infusion device and a second portion of the infusion device which may be removably coupled to the first portion. In some embodiments, the second portion may be a cassette assembly. In some embodiments, the cassette assembly may include at least one flow path and at least one valve component which are overlaid by at least one membrane. In some embodiments, the predefined criteria may be a time lag between changes in analyte level measured by the shallow analyte sensor and deep analyte sensor. In some embodiments, the predefined criteria may be determined from historical data collected from the shallow analyte sensor and deep analyte sensor. In some embodiments, the controller may be further configured to analyze data from the shallow and deep analyte sensors and generate a notification when data from either of the analyte sensors indicates the respective analyte sensor has displaced from its intended position.
In accordance with another example embodiment of the present disclosure, a medical agent administration system may comprise an infusion device with a delivery assembly. The delivery assembly may include at least one pumping arrangement. The system may further comprise a set in fluid communication with the delivery device. The set may include at least one shallow access member, at least one deep access member, and at least one an analyte monitor. The system may further comprise a controller configured to govern operation of the at least one pumping arrangement to selectively deliver fluid from the infusion device to each of the access members. The system may further comprise at least one sensor configured to generate a signal which varies in relation to a delivery impedance from the access members. The controller may be configured to analyze data from the sensor and the at least one analyte monitor and generate a notification when data from the at least one analyte monitor and data from the sensor respectively indicate at least one of the at least one analyte sensor and at least one of the access members has displaced from their intended positions.
In some embodiments, the at least one shallow access member and at least one deep access member may be microneedles. In some embodiments, the at least one shallow access member and at least one deep access member may each include an array of microneedles on a sharp bearing body coupled to a stage projection on a face of the set. In some embodiments, the face of the set may include at least one rocker member. In some embodiments, the set may include a main body having a central region and a peripheral region including a plurality of petal members. In some embodiments, the main body may be configured to transition from a storage state to a deployed state. At least two adhesive bearing portions of the main body may spreadingly displace as the main body transitions from the storage state to the deployed state. The central region may be configured to translate toward a biological barrier to which the set is applied as the main body transitions from the storage state to the deployed state. In some embodiments, the at least one shallow access member may be an intradermal access member and the at least one deep access member may be a subcutaneous access member. In some embodiments, the at least one analyte monitor may include a micropenetrator. In some embodiments, the controller may be in communication with at least one smart device and the infusion device. In some embodiments, the delivery assembly may be split between a first portion of the infusion device and a second portion of the infusion device removably coupled to the first portion. In some embodiments, the second portion may be a cassette assembly. In some embodiments, the cassette assembly may include at least one flow path and at least one valve component which are overlaid by at least one membrane. In some embodiments, the set may include a coupling configured to couple with a fluid transfer connector at a terminal end of a fluid line extending from the infusion device. In some embodiments, the set may include conductive traces extending from the at least one analyte monitor. The fluid transfer connector may include contacts configured to seat against the conductive traces when the fluid transfer connector is engaged with the coupling. In some embodiments, an electrical communication path may extend from the contacts and along the length of the fluid line.
In accordance with another example embodiment of the present disclosure an analyte sensing system may comprise an analyte sensor assembly including a shallow analyte sensor and a deep analyte sensor. The system may further comprise a controller in data communication with the shallow analyte sensor and the deep analyte sensor. The controller may be configured to compare data received from the shallow analyte sensor and the deep analyte sensor and generate a notification in the event that data from the analyte sensors deviate from an expected relationship by more than a threshold.
In some embodiments, the controller may be configured to initialize the expected relationship to a predefined anticipated relationship. In some embodiments, the controller may be configured to adjust the expected relationship based on data received from the shallow analyte sensor and the deep analyte sensor. In some embodiments, the controller is configured to set the expected relationship based at least in part on historical data received from the shallow analyte sensor and the deep analyte sensor. In some embodiments, the shallow analyte sensor may be an intradermal analyte sensor and the deep analyte sensor may be a subcutaneous analyte sensor. In some embodiments, the shallow analyte sensor and the deep analyte sensor may each include at least one micropenetrator. In some embodiments, the expected relationship may define a delay between changes in analyte levels sensed by the shallow analyte sensor and those sensed by the deep analyte sensor. In some embodiments, the analyte sensing assembly may include a coupling for a connector in hardwired communication with the controller. In some embodiments, the analyte sensing assembly may be configured to couple to a transmitter for wirelessly communicating data to the controller. In some embodiments, the analyte sensing assembly may include a face with at least one stage projection. The shallow and deep analyte sensors may each be disposed on the at least one stage projection. In some embodiments, the face may include a rocker member. In some embodiments, the analyte sensing assembly may include a main body having a central region and a peripheral region including a plurality of petal members. In some embodiments, the main body may be configured to transition from a storage state to a deployed state. At least two adhesive bearing portions of the main body may spreadingly displace as the main body transitions from the storage state to the deployed state. The central region may be configured to translate toward a biological barrier to which the analyte sensing assembly is applied as the main body transitions from the storage state to the deployed state.
These and other aspects will become more apparent from the following detailed description of the various embodiments of the present disclosure with reference to the drawings wherein:
In various embodiments, a set may be used in conjunction with an infusion device, system, and related method. In various embodiments, example sets may be configured to be inserted into a layer of a user's skin and be fluidly connected to a fluid source. In various embodiments, example sets may be fluidly connected to a length of tubing and/or to an infusion device. Infusion devices include any infusion pump and may include, but are not limited to, the various infusion devices described in U.S. patent application Ser. No. 13/788,260, filed Mar. 7, 2013 and entitled Infusion Pump Assembly, now U.S. Publication No. US-2014-0107579, published Apr. 17, 2014 (Attorney Docket No. K40); U.S. Pat. No. 8,491,570, issued Jul. 23, 2013 and entitled Infusion Pump Assembly (Attorney Docket No. G75); U.S. Pat. No. 8,414,522, issued Apr. 9, 2013 and entitled Fluid Delivery Systems and Methods (Attorney Docket No. E70); U.S. Pat. No. 8,262,616, issued Sep. 11, 2012 and entitled Infusion Pump Assembly (Attorney Docket No. F51); and U.S. Pat. No. 7,306,578, issued Dec. 11, 2007 and entitled Loading Mechanism for Infusion Pump (Attorney Docket No. C54); all of which are hereby incorporated herein by reference in their entireties. Any connectors which couple a fluid line from a pump to an infusion set described in the above referenced applications may be used with the sets described herein or any of the connectors described in U.S. patent application Ser. No. 16/797,624, filed Feb. 21, 2020 and entitled Infusion Set and Inserter Assembly Systems and Methods, now U.S. Publication No. US-2020-0289748, published Sep. 17, 2020 (Attorney Docket No. 00101.00307.AA159) also incorporated by reference herein in its entirety. Microneedles described herein may include, but are not limited to, the various microneedles described in U.S. Pat. No. 11,154,698, issued Oct. 26, 2021, and entitled Microneedle Systems and Apparatus (Attorney Docket No. G34) or U.S. Pat. No. 5,983,136, issued Nov. 9, 1999, and entitled System for Delivery of Drugs by Transport (Attorney Docket No. B60).
Various embodiments are described and shown herein. Each embodiment of each element of each device may be used in any other device embodiment.
Referring now to
For delivery of certain agents, it may be desirable that the set 12 include at least one access member 16 appropriate for shallow delivery. Due to the high degree of vascularization of dermal region, for example, absorption of agent may occur more rapidly than if the same agent where to be administered into a subcutaneous destination. This may, for example, allow an injection of an agent such as insulin to be faster acting. Thus, such shallow delivery may facilitate tighter control of analyte levels of interest. Shallow delivery may also result in less variability in rates of absorption between patients or between different infusion sites on the same patient. Additionally, certain agents such as insulin may come in different varieties. For example, insulin types may include rapid, short, intermediate, and long acting insulin which differ, e.g., in how quickly and how long they will act to reduce blood glucose levels. Due to the faster absorption in the intradermal region, it may be possible to deliver types of agent with slower onset of action and observe onset times closer to comparable with the onset time of a more rapid onset agent administered subcutaneously. Shallow injection may also increase patient compliance and quality of life. This may be especially true for certain patient populations such as those with juvenile diabetes. Application of set 12 with access member(s) 16 for delivery into a shallow delivery destination may be painless as the access member(s) 16 may be too short to reach nerve endings which are located deeper in the anatomy. Additionally, certain types of access member(s) 16 may be better tolerated by patients. Silicon microneedles, for instance, may not have these same allergy concerns as access member(s) 16 formed from materials including nickel (e.g. stainless steel).
The set 12 may fluidically communicate with an infusion device 18. The infusion device 18 may include a controller 20 which may govern operation of a delivery assembly 24 (e.g. pumping components, valves, sensors monitoring pumping components or configured to provide data related to aspect of fluid delivery from the infusion device, etc.) to output desired volumes of fluid from a reservoir 22 associated with the infusion device 18. Multiple controllers 20 may be included in certain embodiments and at least one of the controller 20 may be disposed outside of the infusion device 18. An example delivery assembly 24 is depicted and described in relation to
The infusion device 18 (e.g. an outlet of cassette assembly 25) may be fluidically coupled to the set 12 via a connector 26 (see, e.g.,
The infusion device 18 may deliver any desired fluid to the delivery destination via the set 12. In various examples, the infusion device 18 may deliver at least one medical agent. Agents supplied may include drugs which are generally supplied as a continuous or substantially continuous infusion though other drugs may also be used. This may include small molecules, biologicals, recombinantly produced pharmaceuticals, and analogs thereof. In various examples, the infusion device 18 may deliver an agent which affects the cardiovascular system or blood vessels. For example, an infusion device 18 may deliver a vasodilator. In certain examples, a drug for the treatment of pulmonary arterial hypertension such as Treprostinil may be delivered. In some examples, an infusion device 18 may deliver a peptide such as a regulatory hormone. In some examples, the agent may be a drug for the treatment of diabetes or a drug which acts to alter blood glucose levels. In certain examples, the infusion device 18 may deliver insulin. In certain embodiments, an infusion device 18 may deliver glucagon. Chemotherapy drugs may also be delivered via the set 12. In some embodiments, multiple agents may be delivered by one or more infusion devices 18 of the system 10. For example, any of the agents described above may be delivered. Any of the agents delivered may be delivered with one or more excipient which may or may not have help to increase absorption. Using insulin as an example, niacinamide may, for example, be delivered. Where references to insulin, glucagon, blood glucose, diabetes, etc. are described herein, their use is merely exemplary and it shall be understood, that use for other medical conditions or with other drugs or other analytes is contemplated.
In various embodiments, the system 10 may also include one or more analyte sensors 30. The analyte sensor(s) 30 may generate data related to a level of an analyte of interest in a patient. The analyte sensor(s) 30 may include an amperometric sensor which generates an electric current which is in proportion to the level of an analyte of interest in the patient. The analyte sensor(s) 30 may include one or more electrode arrangement and may be covered, coated, or otherwise associated with an enzyme specific the analyte of interest to facilitate such sensing. Any chemistry known for a desired analyte may be used. The enzyme may in some examples be an oxidoreductase from enzyme commission group EC 1.1. The enzyme may be categorized in enzyme group EC 1.1.3 in some embodiments. In certain examples, glucose oxidase may be used, though any suitable sensor chemistry for the analyte of interest may be used. Some examples may include an exclusion membrane which blocks, for example, large molecules, molecules above a certain molecular weight (e.g. if glucose is the analyte of interest), or interfering substances may separate the enzyme from the rest of the patient anatomy. Additionally, certain embodiments may include a membrane which may increase biocompatibility. In certain implementations, an analyte sensor 30 may be a blood glucose monitor. Other analytes may be monitored as well. The analyte sensor(s) 30 may monitor fluid in a subcutaneous space in some examples.
In alternative examples, the analyte sensor(s) 30 may monitor patient fluid at least at a shallow location. The analyte sensor(s) 30 may, for example, monitor fluid in a portion of the skin between the stratum corneum and subcutaneous tissue. Shallow sensing locations may include an epidermal or dermal target location or may, for example, target a junctional area between the epidermis and dermis or dermis and subcutis. The sensing location may be an intradermal location in some examples. The analyte sensor(s) 30 may be any of those described herein for example in relation to
The analyte sensor(s) 30 may include or be associated with a transmitter 32. The transmitter 32 may be included within a housing for an analyte sensor 30 or may alternatively be a separate component which may, for example, dock with the sensor 30 and transmit data collected by the analyte sensor 30. The transmitter 32 may be a wireless transmitter such as a radio frequency based transmitter 32. For example, the transmitter 32 may be a near field communication transmitter 32 or may be a Bluetooth transmitter 32. In some embodiments, multiple types of transmitters may be included in a transmitter 32 (e.g. NFC and Bluetooth). Analyte sensor(s) 30 and/or transmitters 32 may include a power source (e.g. coin cell battery) and may include a memory for storing sensor data. Analyte sensor(s) 30 may transmit sensor data via a transmitter 32 upon interrogation by another component of the system 10 or may transmit sensor data based upon a predefined schedule. For example, a transmitter may transmit sensor data after some preset number of minutes (e.g. 1-5 minutes) has elapsed since last transmission. Where transmission is based on a predefined schedule, data may also be transmitted upon interrogation by another component of the system 10. The data transmitted may be data from individual sensor readings or may be numerically processed data from an analyte sensor 30 (e.g. average of sensor readings over some period of time). Individual sensor readings may be taken at a given time or each individual sensor reading may be rendered from integrated sensor signal over some period of time. Any of the analyte sensors 30 described herein may forego a transmitter 32 and instead have (or establish when data transfer is desired) a wired or other physical connection to another component of the system 10. In embodiments where a transmitter 32 is included, wired connection may still be possible to access data from the sensor 30 if desired.
In certain examples, the transmitter 32 may also transmit alarms in the event that data from an analyte sensor 30 warrants alerting a user of the system 10. These alarms may be transmitted by the transmitter 32 independent of any predefined schedule and/or without the need for any interrogation by another component of the system 10. In some embodiments, sensor data may be transmitted by a first type of transmitter (e.g. NFC) included in the transmitter 32 and alarms may be transmitted by a second type of transmitter (e.g. Bluetooth) in the transmitter 32.
Sensor data may be transferred to the infusion device 18, a first interface 34 of the system 10, a second interface 36 of the system 10 (third, fourth, fifth, etc. interfaces may also be included in some examples), a database 40 in the cloud 38, or some combination thereof. Additionally, data may be transmitted to one or more of the above and that component may then pass the data to other components of the system 10. In certain examples, the first interface 34 may be a reader for the analyte sensor(s) 30. The reader may be a dedicated reader or may be a smart device such as a smart phone in some embodiments. The second interface 36 may be a smart device. In some examples, the first interface 34 may be a smart phone and the second interface may be a smart watch, tablet, or second smart phone (e.g. that of a parent, guardian, caregiver, etc.). Any of the infusion device 18, first or second interface 34, 36, or cloud 38 may generate and transmit an alarm to other components of the system 10 should data received meet certain predefined criteria.
The infusion device 18 may receive data from the transmitter 32 (directly or indirectly) and the controller 20 of the infusion device 18 may analyze this data to inform administration of agent from the infusion device 18. Delivery of agent may thus be closed loop in certain examples. Delivery of agent in other examples may be open loop, but data from the analyte sensor(s) 30 may, for example, be used to inform generation of alerts by the controller 20.
The controller 20 of the infusion device 18 may initiate or halt delivery of agent in the event that the analyte level or analyte level trend is determined to be in breach of a threshold or outside of a predefined range. The controller 20 may also adjust delivery of agent in the event that certain criteria are met. For example, the controller may increase or decrease an infusion rate in the event that data from the analyte sensor(s) 30 indicate analyte levels are changing in correspondence with a predefined trend. In some embodiments where the agent serves to decrease analyte levels, if analyte levels are decreasing, the delivery rate may be lowered or delivery may be halted. If analyte levels are increasing, the delivery rate may be increased by the controller 20. The opposite may be true in scenarios where the agent serves to increase the analyte level. In certain embodiments, the infusion device 18 may pump fluid to the set 12 at a basal rate and may occasionally provide a bolus to the patient. Depending on the rate of change in the analyte level, the basal delivery rate may be adjusted by the controller 20 or the controller 20 may orchestrate administration of a bolus (or the basal rate may be adjusted in addition to the administration of a bolus). Where multiple agents are delivered (e.g. to different sets 12, see, e.g.
Referring now to
In alternative embodiments, each of the sets 12, 42 may be combined into a single assembly with flow paths and access members 16 associated with each respective connector interface for the connectors 26, 44. Each set of flow paths and access members 16 may be isolated fluidically from other sets of flow paths and access members 16 within the single assembly. Thus one agent may be delivered via the first connector's 26 coupling to the set 12 and a second agent may be delivered via the second connector's 44 coupling to the set 12. The agents would remain out of fluid communication with one another in the delivery assembly.
Referring now to
The indwelling portion(s) 31 of the analyte sensor may be microneedles in certain examples. In some embodiments, the indwelling portion(s) 31 may be microneedles with no flow lumen 68 or bore. Such indwelling portions 31 may be referred to as micropenetrators. Micropenetrators may be constructed of etched silicon and may in some embodiments act as electrodes of the analyte sensor(s) 30. The silicon used may be doped to optimize conductivity for use of the micropenetrators as electrodes. In other embodiments, micropenetrators may be coated at least partially with an insulative material and one or more conductive electrode may be included on the surface of the insulative material. Known analyte sensor arrangements may also be incorporated into a set 14 in alternative embodiments.
The access assembly 46 may be in fluid communication with an infusion device 18 via tubing and a connector 26 (see, e.g.,
A transmitter 32 may also be included in the access assembly 46. Alternatively the transmitter 32 may dock with the access assembly 46 and transmit data received from any analyte sensor(s) 30. Systems 10 including an access assembly 46 may also include one or more individual analyte sensor(s) 30 or set 12, 42 which is/are distinct from the access assembly 46. In other embodiments, data from the sensor(s) 30 may be transferred via a wired connection. The connector 26, may for example, include a contacts and be associated with a wire leading to the infusion device 18. Example embodiments of access assemblies 46 are shown and described in relation to
Referring now to
Such sets 12 may be used to dispense an agent into a target delivery destination of a patient via one or more access member 16. In the example embodiment, a plurality of access members 16 are included in the set 12, though other embodiments may only include a single access member 16. The exemplary plurality of access members 16 may be arranged in a one or two dimensional array and extend from a body 50 to which a connector 26 communicating with an infusion device 18 may be coupled. Where multiple access members 16 are included, the access members 16 may be arranged in one or more rows and/or columns. Though three access members 16 arranged in a single row are depicted in
Referring now also to
The points or tips of microneedles described herein may be solid and the flow lumens 68 through the microneedles may be offset from the points or tips (in
With reference to
For example, as shown in
An appropriate silicon etching technique (or mold in embodiments using polymeric microneedles) may be used to create steeper side walls of the channel 70. This may help inhibit the skin from bending into and occluding the channel 70. Etching techniques that could be used include, by way of non-limiting example, chemical etching techniques (e.g., acid). Suitable etching techniques may include ion based etching techniques (e.g. reactive ion etching). The etching process could be a wet etching process or a dry etching process. In some non-limiting embodiments, the channel 70 may be within a range of 50-60 microns wide from side to side. In some non-limiting embodiments, the flow lumen 68 may have a diameter of 50-60 microns. The channel 70 may have a width equal to the diameter or widest portion of the flow lumen 68 or the channel 70 may have a width which is less than or greater than the width of the flow lumen 68. In certain examples, the width of the channel 70 may be about 5-10 percent of the height of the microneedle.
To avoid leakage of the fluid from the channel 70, it may be desirable to ensure that the channel 70 terminates at least a certain distance beneath the surface of the skin yet also reaches the targeted skin layer (e.g., the lamina lucida junction) when the microneedle is inserted into the skin. In some embodiments the channel 70 extends from the flow lumen 68 to within at most 50 microns (e.g. 50-200 microns) of the base 62 of the microneedle. In some embodiments, the end of the channel 70 most proximal the base 62 of the microneedle may be at least below the stratum corneum (and perhaps one or more of the stratum lucidum, stratum granulosum, stratum spinosum, and stratum basale) when the microneedle is inserted into the skin. In some embodiments, the end of the channel 70 most proximal the base 62 may be disposed below the epidermis (e.g. in the basement membrane) or within the epidermis.
The channel 70 need not be straight or shaped in the manner shown in and described with reference to
The depth of the channel 70 may be about 25 microns or more (e.g. 25-50 microns) in certain examples. The depth of the channel 70 may be or be less than 5 percent the height of the microneedle. While the depth of the channel 70 may be constant along the length of the channel 70, the depth of the channel 70 need not be constant along the length of the channel 70. Likewise, the width of the channel 70 need not be constant along the length of the channel 70 (see, e.g.,
Referring now also to
Referring now to
Still referring to
Additionally or in the alternative, a microneedle may include a depression 78. The depression 78 may include first and second opposing vertices 80, 82. In some embodiments the depression 78 may be (though need not necessarily be) a rounded depression or a concave depression, as shown in
In certain examples, and referring now to
In yet another embodiment, and referring now to
In still other embodiments and referring now to
In embodiments of microneedles which are obelisk shaped, the microneedles may include at least one side port 94 which may serve as an outlet for that microneedle. Such side port(s) 94 may be difficult to block off with tissue which that may become compressed during insertion of the microneedle into a patient. In the example embodiment, a lumen 68 may extend through the base 62′ of the microneedle and have a terminal end which is more proximal the end region 90 than the base 62′. The lumen 68 may be of relatively constant cross-section. The taper of the sidewalls 64′ may be such that the terminal end of the lumen 68 is wider than portions of the cross-section of the corresponding region of the microneedle. Thus, the lumen 68 may form openings in the sidewalls 64′ which may serve as the side ports 94. In various examples, the lumen 68 may be centrally disposed yielding symmetrical side ports 94. In alternative embodiments, the lumen 68 need not be centrally disposed and the side ports 94 may not be symmetrical.
Microneedles and features thereof may be manufactured in one or more of, though are not limited to, a molding process, etching process, ablative process (e.g. laser ablation), or a material additive process (e.g. 3D printed). In various embodiments, it may be desirable that microneedles be constructed of a biocompatible, non-ductile, high Young's modulus material with an indentation hardness sufficient to allow penetration into skin without breakage.
Sets 12 including microneedles such as any of those described herein may be painless or nearly pain free is apply to a patient. This may make such sets user preferable over other types of infusion sets. This may be particularly true of certain patient populations such as patients with juvenile diabetes. Additionally, such sets 12 may be less complicated to apply. A set 12 including microneedles may be ready or substantially ready (e.g. an adhesive backing may need to be removed) for application when removed from a package. Thus, no inserter used to assisting in puncturing the skin and placing an infusion set may be needed. Sets 12 including microneedles may facilitate easy site changes without the need for a user to carry additional, relatively bulky components such as an inserter. Moreover, as an inserter (which may typically be a single use disposable) may be omitted, patient financial burden associated with frequent site changes may be mitigated. This may help increase patient compliance with prescribed site change schedules or may allow for site changes to performed more frequently (e.g. daily).
Referring again to
In various examples, transition of the set 12 from the storage state to the delivery state may be accomplished via bending, pivoting, or deformation of one or more regions of the main body 52. In certain examples, the main body 20 may be or include a bi-stable element which may have a first stable state which corresponds to the storage state and a second stable state which corresponds to the delivery state. The main body 52 may for example substantially or partially invert (e.g. convex to concave) in shape or have one or more invertible regions which at least partially invert when the set 12 is transitioned from the storage state to the delivery state. The transition may be affected via application of force throughout the entire transition. Alternatively, the transition may only require application of force throughout a portion of the transition. For example, in some embodiments a triggering force may be applied to initiate the transition and the transition may subsequently complete in the absence of any external application of force. For example, after application of the triggering force, the transition may be characterized by a snap-through buckling via which the main body 52 rapidly shifts into the delivery state.
The main body 52 may be at least partially covered with adhesive 54 over a first face 56 of the main body 52. The adhesive 54 may serve to couple the main body 52 to a skin surface at an infusion site on a patient. Thus, the first face 56 may be a skin adjacent face or proximal (proximal and distal defined in relation to a patient) face of the main body 52. The main body 52 may be adhered to the skin when the main body 52 is in the storage state and then may be transitioned to the delivery state. As the transition occurs, at least two adhesive bearing portions of the main body 52 may be displaced with respect to one another so as to stretch or spread a surface anchored to the main body 52 via the adhesive 54. As these portions may be adhered to the skin surface, the skin may be stretched as the adhesive bearing portions are displaced with respect to one another. This may be desirable as the skin may be rendered taught facilitating piercing of the skin by the access members 16 as the main body 52 transitions to the delivery state. In certain examples, the adhesive 54 bearing portions may be disposed, for example, in opposition to one another. The displacement of the two adhesive 54 bearing portions may increase the distance between or spread apart the two adhesive 54 bearing portions. In other embodiments, the distance between the two adhesive 54 bearing portions may not increase or may even decrease while still causing stretching of the skin surface. This may for example occur if the transition causes a flat patch of skin to be pulled around a curve or contour of the main body 52 (see, e.g.,
Transition of the main body 52 to the delivery state may also result in a proximal displacement or lowering of any access member(s) 16 toward and into the skin. In embodiments described herein, the access member(s) 16 may be covered prior to use.
Referring now to
The main body 52 of the set 12 may have a round (e.g. circular) foot print and may include a central region 100 and a peripheral region 102. The central region 100 may be a raised region of the main body 52 and the peripheral region 102 may be a substantially flat region of the main body 52 which surrounds the central region 100. The thickness of the main body 52 may be substantially uniform over the entirety of the main body 52. The main body 52 may be formed as a thin sheet or disc of material which may be thermoformed to create the raised central region 100 and flat peripheral region 102.
Alternatively, the main body 52 may be injection molded and the raised central region 100 and flat peripheral region 102 may be formed in the molding operation. In various embodiments where sets 12 are or may be injection molded, the main body 52 may be injection molded so as to be in the storage state or in the delivery state. The main body 52 may transition more easily into the state in which it was molded from the opposite state. Thus, to lower the effort needed to transition a set 12 from a storage state to a delivery state, it may be desirable to mold the main body 52 of the set 12 in its delivery state configuration. During assembly of a set 12, the main body 52 may be brought into its storage state configuration and remain in that configuration until use.
The central region 100 may be domed and the domed shape may establish a receptacle 104 on the proximal side of the main body 52 within which the body 50 may be disposed. The body 50 may be coupled within the receptacle 104 via adhesive or in another suitable manner. The central region 100 may also include a series of fenestrations 106 which may form a fenestrated ring in the central region 100. In the example, the fenestrations 106 are evenly spaced from one another and arranged in a circle which is generally coaxial with the center of the central region 100. In alternative embodiments, fenestrations 106 may be irregularly spaced or omitted. Additionally, in some embodiments, the fenestrations 106 may instead be replaced with thinned regions or a ring where the material of the main body 100 is thinned.
The main body 52 may include a number of slots 108. The slots 108 may extend from a peripheral edge 110 of the main body 52 toward a center or midpoint of the main body 52. In the example embodiment, the slots 108 extend in a radial direction. The slots 108 may extend through the entirety of the peripheral region 102. In some embodiments, and as shown, the slots 108 may additionally extend though at least a portion of the central region 100 as well. The fenestrations 106 in the central region 100 may be disposed radially inward of the terminus 112 of each of the slots 108. The main body 52 may thus include a central region 100 which is circumscribed by a number of petal members 114 which are spaced apart via the slots 108.
Referring now to
Referring now to
The main body 52 may be a bi-stable element or include at least one bi-stable region which may be stable in both the storage state and the delivery state. When an axial load is applied on the central region 100 and the main body 52 is in the storage state, the main body 52 may deform into an unstable state. The main body 52 may then exhibit a snap through buckling action which rapidly shifts the main body 52 into the stable delivery state similar to that shown in
Two opposing points 116A, B disposed at the peripheral edge 110 of the proximal surface 56 are shown in
Due to the elasticity of the skin 14, the skin 14 may exert a restoring force against the proximal surface 56 of the main body 52 as it attempts to revert to an unstretched state. The main body 52 may resist this restoring force and retain its bowl shape. The body 50, however, may be compressed between the skin 14 and the main body 52. This may aid in ensuring the access member(s) 16 puncture the skin 14 and enter fluid communication with a target delivery destination in the patient.
As mentioned above, in certain examples, some petal members 114 may not include adhesive 54 regions or may have a proximal surface 56 which is at least partially covered in adhesive 54 that is less aggressive than adhesive 54 of on other petal members 114. In embodiments where some petal members 114 are devoid of adhesive 54, this may help to limit stretching of the skin 14. Likewise, petal members 114 with less aggressive adhesive 52 may release the patches of skin 14 to which they are affixed if force needed to stretch the skin 14 exceeds a threshold. The petal members 114 themselves may also be constructed such that at least one of the petal members 114 includes a relief region (e.g. a thin or narrow region). For example, if force needed to stretch the skin 14 is above a threshold, one of more of the petal members 114 may bend or buckle at the relief region to relieve some of the tension on the skin 14.
This may be desirable as it may help to mitigate potential discomfort during wear of a set 12 due to excessive tensioning of the skin 14. Additionally, this may be helpful in certain patient populations as skin characteristics vary significantly with age, hydration state, lifestyle (sun exposure, nutrition), etc. It may be desirable that slacker or looser skin be stretched to a greater degree than highly elastic skin. Thus, instead of providing a variety of sets 12 with different adhesives 54 targeted at specified patient populations, a set 12 may be made in a more universal manner.
With reference to
Referring now to
In some embodiments, and as also shown in
In other embodiments, and referring primarily to
In some examples, and referring now primarily to
As shown exemplarily in
In still other embodiments, the width of one or more of the slots 126 may vary over the length of that slot 126. A number of embodiments including variable width slots 126 are depicted in
Still referring to
In some embodiments and as shown in one example in
Referring now to
With reference to
Additionally or in the alternative, the peripheral region 102 may not be a substantially flat annular shape. The peripheral region 102 may be defined by curved petal members 114 that continue in a downward direction such that their peripheral edge 110 is spaced from the plane of the base 122 of the supporting structure 120 (e.g. about the same or less than the distance from the base 122 to the periphery 124 of the top surface 118). The peripheral edge 110 may be disposed along a plane which is more distal to the periphery 124 of the top surface 118 than the base 122. As depicted in
As best shown in
Referring now primarily to
Still referring to
Still referring to
Still referring to
Referring now primarily to
In various embodiments, certain regions of the main body 52 of the set 12 may remain static or may not invert. Thus, a main body 52 may include inverting regions and resilient regions. Though described as resilient regions, it is to be understood that some bending or deformation may still occur as pressure is applied. These regions may, however, appear generally similar or extend/project in the general same direction in both the storage and delivery state. As shown, the peripheral region 102 and top surface 118 may invert, but a portion of the central region 100 may resist deformation to this degree. The supporting structures 120 shown in other embodiments described herein (see, e.g.,
In some embodiments, as shown in
Still referring to
A sharp bearing body 74 may be coupled to any of a body 50 during a molding operation in certain examples. Where the sharp bearing body 74 is joined to a body 50 during molding, some material may be molded up the sidewalls 162 of the sharp bearing body 74 and over onto the face of the sharp bearing body 74 from which the access member(s) 16 project to capture the sharp bearing body 74. In alternative embodiments, the sidewalls 162 of the sharp bearing body 74 may be chamfered or at an angle which is not perpendicular to the face of the sharp bearing body 74 from which the access member(s) 16 extend. The footprint or cross-section of the sharp bearing body 74 may increase in area as distance from the sharp bearing face of the sharp bearing body 74 increases. Where the access member(s) 16 is/are silicon microneedles, a number of sets of access members 16 may typically be formed on a large wafer and sharp bearing bodies 74 including the desired number of access member(s) 16 may be diced out of the wafer. To form the chamfered sidewalls 162, the dicing saw may have angled faces such that dicing process creates the desired chamfer or angle on the sidewalls 162. In certain embodiments, sidewalls 162 which are between 30-60° (e.g. 45°) may be used. Where chamfered sidewalls 162 are present, material may be molded up only a portion of the sidewall 162 to couple the sharp bearing body 74 to a body 50. This may allow for a sharp bearing body 74 to be captured in a body 50 without material being molded over onto the sharp bearing face of the sharp bearing body 74 (though this could optionally be done). Thus no molded material may act as a stand-off on the sharp bearing face blocking the full height of any access member(s) 16 from penetrating into the skin 14 (see, e.g.
Referring now also to
Referring now to
Still referring got
The body 50 may include a plurality of stage projections 156. A stage projection 156 to which a sharp bearing body 74 may be coupled may be associated with each of the conduit receivers 150 included on the body 50 (or alternatively couplings 98 on the body 50). Though two stage projections 156 and conduit receivers 150 are shown, a greater number may be included in alternative examples.
The stage projections 156 may, for example, be any of those described herein such as those shown in
A first agent may be administered through access member(s) 16 coupled to a first of the stage projections 156 and different agent(s) may be administered through access member(s) 16 coupled to other stage projections 156. For example, agents with counteracting effects may be administered. A first regulatory hormone and a second regulatory hormone that counters the first regulatory hormone could be administered. In some examples, insulin and glucagon may be delivered. Alternatively, the same agent may be administered through the access member(s) 16 coupled to each of the stage projections 156. Alternatively, different types of the same agent may be administered through access member(s) 16 coupled to each of the stage projections 156.
The access member(s) 16 coupled to each of the stage projections 156 may be identical or substantially identical. In certain examples, one stage projection 156 may have a greater or lesser number of access member(s) 16 coupled thereto than another of the access member(s) 16. In certain examples, the access member(s) 16 coupled to one of the stage projections 156 may be longer or shorter than the access member(s) 16 coupled to another of the stage projections 156. Stage projections 156 with access member(s) 16 of any number of heights may be included. Using insulin as an example, insulin may be delivered through shorter access member(s) 16 (e.g. to an intradermal destination) if a fast response is needed or desired and may be delivered through longer access member(s) 16 (e.g. to subcutaneous destination) in other scenarios. Routing of agent to longer or shorter access member(s) 16 (or access member(s) 16 of different heights at the same time) may be governed by the controller 20 of an infusion device 18. The access member(s) 16 selected for delivery could be determined by the controller 20 based at least in part on how quickly it is desired for the delivered agent to act.
Where a plurality of stage projections 156 are provided, the stage projections 156 may be arranged in a row on the body 50. The stage projections 156 may each have the same orientation as shown in
Referring now to
In some embodiments, portions of the set 12 may also deform or adjust in response to the rocking of the body 50 in order to accommodate the rocking of the body 50. The tilting of the body 50 may cause the access member(s) 16 to displace in a non-straight path. For example the access member(s) 16 may rotate or swing along an arcuate path during at least a portion of the transition of a set 12 to the delivery state. In example embodiments, the tilting may occur automatically as a consequence of the transition of a set 12 to a delivery state. No linkages or interactions with guide elements may be needed in order to achieve the tilting. Example bodies 50 may tilt together as a single unit due to the presence of the one or more rocker member 166. Such tilting of a body 50 may lower the pressure at which injection may begin to occur and/or increase delivery flow rate in certain set 12 embodiments. Additionally, the inclusion of one or more rocker member 166 may impact characteristics of bleb formation during delivery. Tilting may also help to facilitate delivery where access member(s) 16 are initially advanced into skin 14 at an angle substantially perpendicular to the skin 14.
Still referring to
When sets 12 including at least one rocker member 166 are transitioned to a delivery state, the rocker member(s) 166 may come into contact with the user and impede further displacement of the portion of the body 50 including the rocker member(s) 166. The opposing side may be free of any rocker members 166 and the body 50 may tilt or rock to accommodate continued displacement of the opposing side toward the user. In certain examples, the access member(s) 16 (e.g. microneedles) may tilt 3-5° (e.g. 4°) with respect to their initial orientation. In other examples, the access member(s) 16 may tilt lesser or greater amounts. Height of a rocker member 166 may alter the point at which the access member(s) 16 begin to rotate or swing during the transition of the set 12 to the delivery state. Rocker members 166 even with the height of a stage projection 156 may, for example, tend to initiate tilting after the access member(s) 16 have punctured the skin 14 (see, e.g.,
In certain examples, the access member(s) 16 may be microneedles such as any of those described herein. Where the access member(s) 16 is/are microneedle(s), the rocker member(s) 166 may be disposed on a side of the body closest the back facing edge 66 (see, e.g.,
In some examples (see, e.g.,
In some examples, the stage projection 156 may be disposed in the position of the rocker member 166 shown in
When pressure is removed from the set 12, one or more portion of the set 12 may at least partially restore from its distorted state. Thus, the set 12 may have at least one region which elastically deforms as a set 12 is transitioned to a delivery state. The at least one region which elastically deforms may be distorted from an initial state, to an intermediate state, and then elastically restore at least partially from the intermediate state during the course of the transition to the delivery state. The intermediate state may be a state during the transition in which the region is maximally distorted. The region may restore from this state back towards the initial state. The petal members 114 may, for example, at least partially restore from their maximally distorted state. As the petal members 114 of the set 12 are adhered to the skin 14 via the adhesive 54 of the set 12, the skin 14 may be pulled away from the underlying anatomy as the petal members 114 restore. This may relieve some pressure on the injection site. This decreased compression at the injection site may allow fluid to be more readily be transferred from the access member(s) 16 into the delivery destination. Additionally, depending on the orientation of the access member(s) 16, the access member(s) 16 may tug the skin 14 into which they have punctured upward away from underlying anatomy as the petal members 114 restore. Again, this may help to facilitate delivery as the compactedness of the anatomy at the delivery destination may be reduced. The shape of the petal members 114 and material used to construct the set 12 may be selected to help encourage this at least partial restoration or recoil of the petal members 114 when pressure is removed. Molding the petal member 114 in the storage state may also bestow a tendency from the petal members 114 to restore toward the storage state when pressure is relieved from the set 12 during use. Petal members 114 which restore towards their initial state during transition of a set 12 to a delivery state may be included in any set 12 embodiment shown or described herein.
Petal members 114 may be relatively devoid of curvature. For example, petal members 114 be substantially flat and/or extend from the rest of a main body 52 at an angle or angles thereto. This may assist in making the force required to cause deflection in the petal members 114 relatively low as pressure is applied to the set 12. In turn, this may help to assist in generating spreading displacement of the petal members 114 and help ensure puncture of the skin with the access member(s) 16 prior to deformation of a top surface 118 of an example main body 52.
As shown in
A living hinge may be formed at the transition between the first and second regions 620, 622. As pressure is applied to the set 12, the living hinge may allow the second regions 622 of the petal members 114 to displace relative to the first regions 620. The first regions 620 may distort to a lesser degree than the second regions 622 throughout the transition of the set 12 to the delivery state. In some examples, the first regions 620 may resist substantial deformation and remain generally undistorted throughout the transition. Thus, the first regions 620 may behave as stops which may help to limit spreading displacement of the petal members 14 after a desired amount of spreading displacement has been achieved. Curved transitions 621 may be included to assist in encouraging the petal members 114 to at least partially restore once pressure on the set 12 has been relieved. In examples including petal members 114 such as those in
Referring now to
The central region 100 in the example embodiment is shown including a base surface 170 from which a number of features extend. The base surface 170 is depicted as a plateau like surface in the example and is substantially planar. The base surface 170 may be disposed above the peripheral region 102 or even with a highest portion of the peripheral region 102. The central region 100 may include a coupling 98 to which a connector 26 from an infusion device 18 may be coupled. In various embodiments, a fitting (e.g. luer lock) may be coupled with the central region 100 and serve as the coupling 98. In some embodiments, the fitting may be molded integrally with the central region 100.
Referring now also to
The connector 26 may be disengaged from the set 12 manually as desired. This may be done, for example, if a user desires to shower or swim and the infusion device 18 is not suited for such exposure to water. As shown, the latch bodies 178 extend from outer arms 182 of the connector 26. The outer arms 182 may themselves be cantilevered from a central region of the connector 26. The outer arms 182 may be squeezed together to displace the latch bodies 178 out of engagement with the connector receivers 170 to allow the connector 26 to be removed. In the example embodiment, as the outer arms 182 are deflected toward one another, the catches 180 may be displaced out of contact with the ledge faces 176 and the latch bodies 178 may then be free to be withdrawn away from the connector receivers 172.
Sharp flanking projections 184 may also be present on the connector 26. These flanking projections 184 may extend substantially parallel to a sharp 186 included on the connector 26 and may present an obstacle which helps block accidental contact between the sharp 186 and the user. A shielding wall 188 may be provided on the central region 100 and may help to block fingers or objects from inadvertently dislodging the latch bodies 178 out of engagement with the connector receivers 172.
Referring now also to
The set 12 may also include constraining walls 194 which may, for example, prevent movement in certain directions of portions of the connector 26. For example, a bridge of material extends from the shielding wall 188 to the guide walls 192. This may prevent displacement of the latch bodies 178 in a direction perpendicular to the base surface 170 when the connector 26 is coupled to the set 12. This may inhibit the latch bodies 178 from being lifted over the connector receivers 172 to disengage the connector 26 from the set 12. In the example embodiment the guides and constraining walls 194 are arranged so as to be about even with the top surface of the connector 26 when the connector 26 is coupled to the set 12. This may help to limit potential for the set 12 or connector 26 to snag on clothing or other items when in use.
Additionally as shown, a set 12 may include a septum bay 198 (best shown in
The top of the septum 196 may be at least partially covered once the septum 196 has been installed in the septum bay 198. In certain examples, the wall 200 may include an extended region 208 most distal to the base surface 170. The extended region 208 may be swaged over after the septum 196 is installed to help retain the septum 196 in place within the septum bay 198. In alternative embodiments, a plug, cap, or cover may be coupled to the top of the wall 200 to cover the exposed face of the septum 196. Such a plug, cap, or cover may be coupled in any suitable manner (e.g. snap fit, threaded coupling, welding such as sonic welding, etc.).
Referring now to
The wall 200 of the septum bay 198 may include a port 206 such as a notch or fenestration (not shown). When a connector 26 is coupled to the set 12, the sharp 186 of the connector 26 may be displaced along a displacement path which extends through the port 206 and through a portion of the septum 196. An outlet 214 of the sharp 186 may be disposed within the fluid introduction volume formed by the recess 208 of the septum 196 when a connector 26 is coupled to the set 12. As fluid pump by an infusion device 18 (see, e.g.
It may be preferable to include a notch which extends from the top of the wall 200 toward the base surface 170 in various examples as it may facilitate molding of the set 12 without the need for side actions. The example set 12, for example could be molded using bypass shutoffs and no side actions. Various gaps or apertures 205 in the central region 100 may be included to facilitate molding.
Referring now primarily to
A rocker member 166 is also included near the periphery of the proximal side 222 of the central region 100. As the set 12 is transitioned to the delivery state (set 12 shown in storage state in
As shown in
Referring now to
As shown, the analyte sensor 30 may include a main body 352. The main body 352 of the analyte sensor 30 may have a round (e.g. circular) foot print and may include a central region 400 and a peripheral region 402. The central region 400 may be a raised region of the main body 352 and the peripheral region 402 may surround the central region 400. The main body 352 may be injection molded and the raised central region 400 and peripheral region 402 may be formed in the molding operation. The central region 400 may be substantially planar in some examples and may include a base surface 470. Conductive traces 292 communicating with the electrodes 302A, B may extend to the base surface 470 in various embodiments. The central region 400 may include one or more coupling interface which cooperates with a transmitter 32 to couple the transmitter 32 and analyte sensor 30 to one another during use. The main body 352 may include a number of slots 408. The slots 408 may extend from a peripheral edge 410 of the main body 352 toward a center or midpoint of the main body 352. In the example embodiment, the slots 408 extend in a radial direction. The slots 408 may extend through the entirety of the peripheral region 402. The main body 352 may thus include a central region 400 which is circumscribed by a number of petal members 414 which are spaced apart via the slots 408.
Referring now primarily to
The example analyte sensor 30 is depicted in a storage state in
The analyte sensor 30 may be applied to the skin 14 and a user may press down on the main body 352 to transition the analyte sensor 30 to the deployed state. This may avoid the need for a needle stick each time an analyte sensor 30 is applied. This may make use of an analyte sensor 30 more attractive, particular for certain patient populations (e.g. those with juvenile diabetes). Moreover, omission of an inserter may aid in defraying financial considerations of a patient which may dissuade some patients from opting to use an analyte sensor 30.
Referring now primarily to
In alternative embodiments, the micropenetrators themselves may not be used as the electrodes 302A, B. In such embodiments, the micropenetrators may be at least partially covered with an insulative material. A conductive trace 292 may be provided over the insulative material on each micropenetrator and may extend along the sharp bearing body 374 to the side of the sharp bearing body 374 opposite the micropenetrator(s). The transmitter 32 may establish electrical communication with the conductive traces 292 when coupled to the analyte sensor 30. In such embodiments, the counter/reference electrode and the sensing electrode may be present on the same sharp bearing body 374 so long as the respective conductive traces 292 are kept isolated from one another.
The analyte sensor 30 may be a shallow analyte level sensor. For example, the analyte sensor 30 may be an intradermal analyte level sensor. The analyte sensor 30 may be a continuous analyte sensor 30 (e.g. continuous glucose monitor) which may output analyte level data on a predefined schedule (e.g. every 1-5 minutes). Such an analyte sensor 30 may be less invasive, less painful to use, more responsive, less prone to irritation or patient reaction among other potential benefits.
The electrodes 302A, B may have a height appropriate for puncture into communication with the shallow destination. In some embodiments, the electrodes 302A, B may have a height between 500-1000 microns though shorter or taller electrodes 302A, B may be used in alternative embodiments. As the analyte sensor 30 may sense analyte levels at a shallow destination (e.g. intradermal), the sensor 30 may collect readings of blood analyte levels which are less time delayed than subcutaneous analyte level sensors. The intradermal layer for example, is highly vascularized and thus analyte levels in the intradermal space should more rapidly reflect changes to levels in blood analyte levels. As sensor 30 readings are received by the controller 20, the controller 20 may initiate, suspend, or adjust agent administration commands used to orchestrate deliveries from the infusion device 18 based at least in part on the readings. More rapid sensing of analyte level changes may allow for a controller 20 of an infusion device 18 to react more quickly to changes in blood analyte levels. Additionally, it may allow for a controller 20 of an infusion device 18 to make agent administration determinations which more accurate reflect current needs of the patient. Thus, such an analyte sensor 30 may allow tighter control of blood analyte levels with an infusion device 18.
Any suitable analyte sensing chemistry or arrangement from any manufacturer may be incorporated on the sensing electrode. A glucose sensing arrangement may be used. For example, a glucose oxidase chemistry could be used to sense glucose levels in body fluid. It shall be noted that the analyte sensor 30 is not limited to using any particular sensing chemistry or arrangement.
In certain example embodiments, an analyte sensor 30 may include multiple stage projections 358 each associated with a respective set of electrodes 302A, B. Alternatively, multiple sets of isolated electrodes 302A, B may be coupled to a single stage projection 358. Thus a plurality of analyte sensors 30 may be associated with a single main body 352. In various examples, any number of stage projections 358 may be disposed about the proximal face 422 of a central region of a main body 352. In some examples, stage projections 358 on such an analyte sensor 30 may be arranged similarly to the stage projections 156 depicted in relation to
Referring now to
The access assembly 46 may include a main body 552. The main body 552 of the access assembly 46 may have a round (e.g. circular) foot print and may include a central region 500 and a peripheral region 502. The central region 500 may be a raised region of the main body 552 and the peripheral region 502 may surround the central region 500. The main body 552 may be injection molded. The central region 500 may be substantially planar in some examples and may include a base surface 570. The main body 552 may include a number of slots 508. The slots 508 may extend from a peripheral edge 510 of the main body 552 toward a center or midpoint of the main body 552. In the example embodiment, the slots 508 extend in a radial direction. The slots 508 may extend through the entirety of the peripheral region 502. The main body 552 may thus include a central region 500 which is circumscribed by a number of petal members 514 which are spaced apart via the slots 508.
The central region 500 may include a coupling 98 which may be defined on the base surface 570 of the central region 500. The coupling 98 may be as described in relation to
Referring now primarily to
Each of the example access assemblies 46 shown in
As with various exemplary sets 12 and exemplary analyte sensors 30 described herein, example access assemblies 46 may include multiple sets of access members 16 and/or multiple sets of electrodes 302A, B. Each may, for example, be disposed on its own respective stage projection 156, 358. Where a plurality of access member 16 sets and/or a plurality of electrode 302A, B sets are included, the different access member 16 and or electrode 302A, B sets may all be substantially the same. Alternatively, they may include various differences as described elsewhere herein. For example, different sets of access members 16 may each include one or more access member(s) 16 and the height of the access member(s) 16 may differ between sets. Similarly, different sets of electrodes may differ in height. In some implementations, an access assembly 46 may include access member(s) 16 for intradermal and subcutaneous delivery (each may be a microneedle of suitable length). An example access assembly 46 may also include electrodes 302A, B for an analyte sensor 30 monitoring intradermal analyte levels and include electrodes 302A, B for an analyte sensor 30 monitoring subcutaneous analyte levels.
Still referring to
The example access assembly 46 is depicted in a storage state in
An example access assembly 46 may be applied to the skin 14 and a user may press down on the main body 552 to transition the access assembly 46 to the deployed state. This may avoid the need for a plurality of needle sticks each time an access assembly 46 is applied. This may make use of an access assembly 46 more attractive, particular for certain patient populations (e.g. those with juvenile diabetes). Example access assemblies 46 may obviate the need for a first inserter for an infusion set and a second inserter for an analyte sensor. Removal of any inserters from the application process may aid in defraying financial considerations of a patient which may dissuade some patients from opting to use an analyte sensor 30. With the omission of an inserter, financial burden associated with frequent site changes may be mitigated. This may help increase patient compliance with prescribed site change schedules or may allow for site changes to be performed more frequently (e.g. daily).
Referring now to
The shape and size of the central aperture 218 may play a role in helping to facilitate certain shallow deliveries. In various exemplary sets 12, it may be desirable that the central aperture 218 have a cross sectional area which is 60-100% the area of the footprint of the central region 100. It may also be desired that the central aperture 218 be shaped such that at least a portion of the adhesive member 54 is attached to a portion of a body 50 or proximal side 222 of the central region 100. In certain examples, the cross-sectional area of the central aperture 218 may be greater than 0.13 in2. In certain examples, the cross-sectional area of the central aperture 218 may be in a range of 0.13 in2 to 0.5 in2 (e.g. about 0.3 in2) though may be outside of this range in various embodiments.
Additionally, it may be desired that the central aperture 218 be wider in certain directions compared to others. For instance, each access member 16 (e.g. one or more microneedle) may tend to dispense fluid in an ejection direction which extends from the outlet of the respective access member (e.g. along the axis of the lumen 68 of the access member 16). It may be desired that the central aperture 218 have a larger or increased width in a direction which aligns or substantially aligns with the ejection direction. For example, the greatest width (or at least a comparatively large width portion) of the central aperture 218 may be along a direction that is parallel to a plane that includes the ejection direction. Using a set 12 including one or more microneedle similar to that shown in
Referring now primarily to
Referring now primarily to
Referring now also to
Initially when a set 12 is applied to the skin 14, adhesive at the peripheral region 102 of the set 12 may contact the skin 14. The set 12 may decrease in height as the transition to the delivery state occurs. As this occurs, adhesive on the adhesive member 54 inward of the peripheral region 102 may begin to contact and stick to the skin 14. Adhesive on the portion of the adhesive member 54 extending partially onto the proximal side 222 of the central region 100 (or alternatively a body 50 attached to the main body 52) may adhere to the skin 14 as the transition completes. The adherence of the adhesive to the skin 14 may maintain the set 12 in the delivery state and cause the skin 14 to move together with the set 12 as a unit. This may help to ensure that the access member(s) 16 remain at a desired location within the skin 14 as the set 12 is used.
Additionally, when the set 12 is in a delivery state, the stage projection 156 may press into and create a depression in the skin 14 when the set 12 is in the delivery state. The depressed skin 14 may tend to attempt restore against the stage projection 156 toward an undepressed position while the set 12 is worn. The adhesive on the adhesive member 54 in the vicinity of the stage projection 156 may help to encourage this. Thus, the skin pierced by the access member(s) 16 may tend to displace together with the access member(s) 16 and stage projection 156 even when these components move in a direction away from the skin 14. This may help to keep the access member(s) 16 firmly within the skin 14 as the set 12 is worn and help to inhibit leaks during delivery.
Referring now to
In the example delivery assembly 24, an occluder assembly 232 may isolate a filled reservoir 22 from the delivery assembly 24. Opening of the occluder assembly 232 may allow fluid to flow into the remainder of the delivery assembly 24. In order to effectuate the delivery of fluid within the reservoir 22 to the user, a controller 20 (see, e.g.,
A volume sensor valve assembly 248 may include a volume sensor valve actuator 248A and a volume sensor valve 248B. Referring also to
Referring also to
As fluid is delivered to a set 12 or an access assembly 46, at least one characteristic related to the delivery may be monitored by at least one sensor of the delivery arrangement 24. The controller 20 of an infusion device 18 may analyze data from the one or more sensor to determine whether delivery is occurring in a desired manner. For example, a controller 20 may monitor data from at least one sensor in the delivery arrangement 24 to determine information related to the impedance to fluid delivery from an access member 16. Above the skin, there is very little impedance to deliver from an access member 16 as the access member 16 is in air. In the intradermal space, the impedance is relatively high and it is relatively difficult to drive fluid into the intradermal space. Delivery impedance may be relatively low into subcutaneous tissue compared to the intradermal tissue.
As fluid is delivered to a set 12, a pressure decay may occur as fluid is expelled from the set 12 and into a shallow delivery destination. Typically fluid may flow relatively slowly out of a set 12 and into a shallow delivery destination. The associated pressure decay may be relatively slow. If an access member 16 becomes dislodge or is no longer in the skin 14 fluid may more easily pass out of the access member 16 and flow rate out of the access member 16 may be greater than expected. Pressure decay may be comparatively rapid in such a scenario. If an access member 16 punctures beyond a shallow destination and into the subcutaneous space, pressure decay may also transpire more rapidly.
In some examples, data from at least one pressure sensor monitoring fluid pumped to the set 12 may be analyzed by a controller 20 to determine how quickly the pressure decay occurs after a volume of fluid has been delivered to the set 12. In the event that the pressure decays faster than a predefined threshold (e.g. the derivative of the pressure data exceeds a predefined value) it may be determined that access member(s) 16 may have displaced from a desired location. In some examples, the predefined threshold may be preprogrammed or may be calculated based on historical data from previous deliveries of agent from an infusion device 18. A controller 20 may monitor data from the at least one pressure sensor for changes in the speed of pressure decay as volumes of fluid are delivered through the set 12. In the event that pressure decay rate changes more than a certain threshold, a controller 20 may determine that an access member 16 has changed positions.
With regard to any determinations made by a controller 20 based on data related to access members 16 and/or analyte sensors 30 described herein, a controller 20 may generate an associated alert upon making such determinations. The alert may be displayed on a user interface of an infusion device 18. The alert may also include an audible (tone, series of tones, beep, beeps, etc.) or tactile alert (a vibratory motor may be activated) issued by an infusion device 18 or other component of the system 10. The controller 20 may also orchestrate communication of the alert to various components of a system 10. For example, the controller 20 may communicate the alert to at least one smart device (e.g. smart phone, smart watch, tablet, etc.) which may display the alert and/or issue an audible or tactile alert of its own. The controller 20 may also communicate the alert to the cloud 38. The controller 20 may also determine an appropriate user intervention (e.g. new set 12, or analyte sensor(s) 30, or access assembly 46 needed) and request the user perform the intervention via a user interface of the system 10.
Additionally, pressure decay may be slower than expected in the event of an occlusion. A controller 20 may similarly analyze data from at least one pressure sensor to monitor for pressure decay characteristics (e.g. rate of decay, change in rate of decay compared to previous data) indicative of an occlusion. In the event that the pressure decays slower than a predefined threshold, a controller 20 may determine that an occlusion is present. Similarly if a change in rate of pressure decay to a rate more than a predefined amount slower than previous data is observed, a controller 20 may determine an occlusion is present.
In certain examples and still referring to
An infusion device 18 of the system 10 may deliver independently to at least one long access member 16 or at least one short access member 16 included in, for example, a set 12. In systems 10 where agent may be delivered through two or more selected access member(s) 16 of different lengths, a controller 20 may compare delivery data from deliveries to at least two of the different length access members 16. In certain examples, a set 12 or access assembly 46 may include at least one long access member 16 which communicates with a subcutaneous delivery destination and a short access member 16 which communicates with a shallow delivery destination. As mentioned elsewhere herein each may microneedles of different lengths.
Typically, a displacement of the at least one short access member 16 may be associated with a like displacement of the at least one long access member 16. The at least one short access member 16 and at least one long access member 16 may be placed as close to one another as is practicable to help ensure tight a correlation of displacement of the at least one short and at least one long access member 16. In the event that the at least one short access member 16 is displaced such that it is out of the skin 14, the at least one long access member 16 may generally displace a like amount in the same direction. This displacement of the long access member 16 may be sufficient for the long access member 16 to be positioned at an intradermal delivery destination. The height of the at least one long access member 16 and/or position of any flow lumen(s) 68 or channel(s) 70 in the at least one long access member 16 may be selected to help ensure this occurs. In the event that the at least one short access member 16 has punctured into subcutaneous space, the at least one long access member 16 may still be within the subcutaneous space.
When data indicative of the delivery impedance (e.g. pressure decay, volume dispensed as sensed by a volume sensing assembly 258) from the at least one short access member indicates the at least one short access member 16 has changed depth, the controller 20 may analyze data from a delivery to the at least one long access member 16. In some embodiments, the controller 20 may orchestrate a delivery to the at least one long access member 16 to collect data. In some embodiments, the at least one long access member 16 may not typically be used for delivery. In such examples, the at least one long access member 16 may be testing access member 16 used to collect data when desired.
Upon analysis of delivery data related to the at least one long access member 16 indicating delivery impedance characteristics which would be expected from an intradermal delivery, the controller 20 may determine that the at least one short access member 16 has become dislodged from the skin 14. The controller 20 may halt delivery to the at least one short access member 16 and deliver exclusively to the at least one long access member 16 so that therapy may be continued. Depending on the embodiment, if a controller 20 determines (in any manner describe herein) that one or more access member 16 is out of the skin 14, the controller 20 may halt delivery to the access member(s) 16. Where a controller 20 determines at least one access member 16 is still capable of delivering fluid to the patient, the controller 20 may adjust delivery such that fluid is only delivered to access member(s) 16 still in the patient. The controller 20 may generate an alert conveying that this has occurred. In some embodiments, the controller 20 may halt all delivery or prompt a user to confirm desire to divert deliveries to certain of the access member(s) 16.
In the event that delivery data related to the at least one long access member 16 indicates delivery impedance increased and subsequently decreased, it may be determined by the controller 20 that it is likely that the at least one long and at least one short access member 16 have moved out of the skin 14. The controller 20 may generate an alert to this effect for display on a user interface of the infusion device 18 and/or for communication to another component of the system 10 (e.g. for display on a smart phone and/or smart watch). The controller 20 may halt delivery and may, for example, generate an indication that the set 12 should be swapped out for a new set 12.
When analysis of delivery data related to the at least one short access member 16 indicates delivery impedance characteristics which are in line with previous deliveries form the at least one long access member 16, the controller 20 may determine the at least one short access member 16 has displaced deeper.
In still other embodiments, access members 16 to which fluid may be independently delivered may be included in at least three different heights on a set 12. The shortest access member(s) 16 may have a height which generally inhibits passage into the subcutaneous space. In such embodiments, there may be at least one long access member 16 and at least one access member 16 of intermediate height. The intermediate height access member(s) 16 may have a height sufficient to deliver to an intradermal delivery destination. The long access member(s) 16 may have a height sufficient to deliver to a subcutaneous delivery destination.
In the event that sensor data related to delivery of a volume of fluid to the shortest access member(s) 16 indicate a high delivery impedance is present, the intermediate length and long access members 16 ought to be in the skin 14. Given high delivery impedance from the shortest access member(s) 16, when data related to the impedance to flow from the intermediate access member(s) 16 indicates a drop in impedance, it may be determined by a controller 20 that the intermediate access member(s) 16 are in communication with the subcutaneous space. In the event that data related to delivery of volumes of fluid to the shortest and intermediate access member(s) 16 indicates low impedance, it may be determined by a controller 20 that these access member(s) 16 have displaced out of the skin 14. The controller 20 may generate an alert communicating such determinations for display on a user interface of the infusion device 18 and/or for communication to another component of the system 10.
The controller 20 may make delivery calculations based at least in part upon analyte sensor 30 data and expected agent absorption profiles. As the absorption profile for the agent may be dependent on the depth of the delivery destination, the controller 20 may adjust delivery calculations based on the determined depth of the access member(s) 16 using on the impedance related data. For example, the controller 20 may adjust the timing of a delivery in the event the controller determines the agent will be absorbed faster or slower. Other calculations may also be adjusted base on the determined depth of the access member(s) 16. Using the example of insulin, insulin on board (I.O.B.) calculations or duration of insulin action (D.I.A.) calculations may be adjusted. Similar agent on board or duration of agent action determinations for other agents may be adjusted where the agent is an agent other than insulin.
In analyte sensors 30 and access assemblies 46 having multiple sets of electrodes 302A, B sensing analyte levels at different depths, data from the each set 302A, B of electrodes may be compared. In the event that a pair of electrodes 302A, B of an analyte sensor 30 are in air, the reading from the analyte sensor 30 should indicate that the analyte sensor 30 is not monitoring the appropriate location. Additionally, analyte sensors 30 monitoring a highly vascularized space (e.g. shallow or intradermal location) and a less vascularized space (e.g. subcutaneous space) to determine blood analyte levels should collect data which differs in a predictable and related manner.
Using diabetes as a non-limiting example, interstitial glucose levels in the subcutaneous space may lag behind those in the blood a greater amount than interstitial glucose levels in the intradermal space. Thus, an analyte sensor 30 monitoring, for example, a subcutaneous space would see a response to blood glucose level changes which is delayed or time shifted with relation to a response to changes in blood glucose levels sensed by an analyte sensor 30 monitoring the intradermal space.
A delivery of insulin or glucagon from an infusion device 18 (or intake of carbohydrates) should alter blood glucose levels and this alteration would be most clearly seen first by the analyte sensor 30 monitoring the intradermal space. Times at which a delivery of agent from an infusion device 18 and the volume of agent delivered may be known. In some embodiments, timing of carbohydrate consumption and amount of carbohydrate consumed may also be input by a user into certain systems 10. Additionally, an expected adjustment of the blood glucose level should be engendered by the agent delivery (or carbohydrate consumption). The response to blood glucose changes in the wake of, for instance, an agent delivery observed in the subcutaneous tissue should lag that observed in the intradermal tissue. Data from a shallow and deeper analyte sensor 30 should generally track each other in a predictable way over the life time of the analyte sensors 30. An expected relationship between data from a shallow analyte sensor 30 and a deeper analyte sensor 30 may be determined (e.g. by a controller 20) based on data collected from the analyte sensors 30. For example, an expected time shift (or expected time shift window or range) between data from each of the analyte sensors 30 may be determined. This relationship may be updated periodically over the life of the analyte sensors 30 and may be initially determined during or shortly after a warm up period of the analyte sensors 30. In some examples, the expected relationship may be initialized to a predefined anticipated relationship for the patient (e.g. from data collected from previous analyte sensor 30 usage) when new analyte sensors 30 are placed.
In some examples, the controller 20 may analyze analyte sensor 30 data to determine analyte level trend information which may be displayed via a user interface to a user. For example, current data may be compared to previous data to determine a trend in analyte level. For example, a controller 20 may generate a message or other indication showing that blood glucose levels are trending downward (or downward sharply), upward (or upward sharply), or remaining generally level. In some examples, the controller 20 may determine trend information based on data from only one of the analyte sensors 30 or determine trend information by according a higher weighting to data from one of the analyte sensors 30. In the event that a deeper analyte sensor 30, for example, suggests a trend which differs from the trend sensed by an intradermal analyte sensor 30, the data from the intradermal analyte sensor 30 may be used or at least be more heavily weighted in determining a current trend for display. In some examples, the difference between data from each of the analyte sensors 30, derivatives of data, or derivatives of the difference between the data may also or instead be used to determine blood analyte level trend information.
In the event that a shallow analyte sensor 30 begins to output data indicative of the analyte sensor 30 being in air, data from a deeper analyte sensor 30 may be checked by a controller 20. In the event that the deeper analyte sensor 30 begins to output data indicative of the deeper analyte sensor 30 also being in air, a controller 20 may determine that the analyte sensors 30 have fallen out of the skin. In the event that the data from the deeper analyte sensor 30 is recording a response to blood glucose changes (e.g. due to agent administration) which conforms to that previously typical of the shallow analyte sensor 30, the controller 20 may determine that the shallow analyte sensor 30 has displaced out of the skin 14.
Additionally, data from a shallow analyte sensor 30 and a deeper analyte sensor 30 may be compared to determine a particular analyte sensor 30 is beginning to display abnormal behavior (e.g. has or is beginning to drop out). Historical data may be used to assist in such determination. In the event, for example, a first of the analyte sensors 30 is diverging from a typical or expected response relationship to changes in blood analyte levels (e.g. due to agent deliveries or user actions such as eating) while the second of the analyte sensors 30 has not diverged outside of some predefined threshold, the first of the analyte sensors 30 may be beginning to drop out, for example. Alternatively or additionally, if a typical relationship (e.g. determined from historical analyte sensor 30 data) between the data from the first and second analyte sensors 30 begins to deteriorate, this may be indicative of a dropout issue or developing dropout issue with one of the analyte sensors 30. The controller 20 may determine that a drop out event is occurring for the relevant analyte sensor 30 based on the comparisons of analyte sensor 30 data described above. The controller 20 may convey an alert to a user interface of the infusion device 18 and/or communicate an alert for display on another component of the system 10. This may help prevent a user from acting on data from an analyte sensor 30 which is beginning to drop out.
In some examples, if the expected relationship between data from the analyte sensors 30 has deteriorated beyond some threshold, the controller 20 may analyze analyte sensor 30 data to perform various troubleshooting. For example, if the expected relationship is no longer present, the controller 20 may check to see if data from one of the analyte sensors 30 is indicative that the analyte sensor is in air 30. If the shallow analyte sensor 30 and deeper analyte sensor 30 report data which does not display time shifted sensed analyte level changes, a controller 20 may determine the shallow analyte sensor 30 may have changed depths to a deeper (e.g. subcutaneous) location. That is, if the analyte sensors 30 report roughly the same analyte level at the same time and/or that the analyte levels are changing at roughly the same rate over the same time period, the controller 20 may determine each analyte sensor 30 may be monitoring the same location in a patient.
In some embodiments, data collected in relation to any puncturing bodies regardless of purpose may be used in conjunction by a controller 20 to make various determinations about the location or status of the puncturing bodies. For example, analyte sensor 30 data and data related to delivery impedance from access member(s) 16 may utilized by a controller 20 to help determine status or location of certain of the puncturing bodies. For example, if a controller 20 makes a determination about an access member 16 or sensor as described elsewhere herein data related to another puncturing body may be checked. The additional data may help to confirm or verify the determination. In some embodiments, no alert may be generated until the additional data is analyzed. Data related to other access members 16 or data from other analyte sensors 30 may be used to assist in determining or verifying that a particular puncturing body has changed depths, has developed an occlusion, or in the case of an analyte sensor, that a drop out issue is present, for example.
Using the example of an access assembly 46 (see, e.g.,
If data indicative of the delivery impedance from an access member 16 indicates a different than expected impedance, the controller 20 may analyze analyte sensor 30 data. If data from the analyte sensor 30 indicates analyte level changes in response to agent delivery through the access member 16 do not conform to expectations, the controller 20 may determine the access member 16 has changed depths (e.g. subcutaneous as opposed to intradermal if slower than expected or vice versa if faster). Where multiple analyte sensors 30 monitoring different depths are present, data from each analyte sensor 30 may be checked. If the response to administration of a volume of agent takes longer than expected to change analyte levels detected by all analyte sensors 30, it may be determined that the access member 16 has displaced to a deeper delivery destination, for example. If data from a deeper analyte sensor 30 indicates a shorter lag time in sensed analyte level changes (e.g. after agent deliveries) and delivery impedance related data from at least one longer access member 16 indicates a higher than expected impedance, a controller 20 may determine that the deeper analyte sensor 30 and longer access member(s) 16 have changed depths (e.g. from a subcutaneous to an intradermal location). When this is observed, a controller 20 may check data from a shorter analyte sensor 30 and at least one shorter access member 16 to verify they have not displaced out of the skin 14. Additionally, if a controller 20 notes that a shallow analyte sensor 30 is providing data indicative of the analyte sensor 30 being in air and delivery impedance data related to at least one short access member 16 indicates the short access member(s) 16 may be in air, the controller 20 may check data from a deeper analyte sensor 30 and/or or longer access member(s) 16. The controller 20 may verify a change in depth of the deeper analyte sensor 30 and/or or longer access member(s) 16 is reflected in the relevant data before generating an alert.
Various alternatives and modifications can be devised by those skilled in the art without departing from the disclosure. Accordingly, the present disclosure is intended to embrace all such alternatives, modifications and variances. Additionally, while several embodiments of the present disclosure have been shown in the drawings and/or discussed herein, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. And, those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto. Other elements, steps, methods and techniques that are insubstantially different from those described above and/or in the appended claims are also intended to be within the scope of the disclosure.
The embodiments shown in drawings are presented only to demonstrate certain examples of the disclosure. And, the drawings described are only illustrative and are non-limiting. In the drawings, for illustrative purposes, the size of some of the elements may be exaggerated and not drawn to a particular scale. Additionally, elements shown within the drawings that have the same numbers may be identical elements or may be similar elements, depending on the context.
Where the term “comprising” is used in the present description and claims, it does not exclude other elements or steps. Where an indefinite or definite article is used when referring to a singular noun, e.g. “a” “an” or “the”, this includes a plural of that noun unless something otherwise is specifically stated. Hence, the term “comprising” should not be interpreted as being restricted to the items listed thereafter; it does not exclude other elements or steps, and so the scope of the expression “a device comprising items A and B” should not be limited to devices consisting only of components A and B.
Furthermore, the terms “first”, “second”, “third” and the like, whether used in the description or in the claims, are provided for distinguishing between similar elements and not necessarily for describing a sequential or chronological order. It is to be understood that the terms so used are interchangeable under appropriate circumstances (unless clearly disclosed otherwise) and that the embodiments of the disclosure described herein are capable of operation in other sequences and/or arrangements than are described or illustrated herein.
The present application claims the benefit of U.S. Provisional Application Ser. No. 63/316,336, entitled Systems, Methods, and Apparatuses for Medical Agent Administration, filed Mar. 3, 2022, Attorney Docket Number 00101.00330.AA771.
| Number | Date | Country | |
|---|---|---|---|
| 63316336 | Mar 2022 | US |
