CN110432912A

CN110432912A - Therapeutic device, method and system comprising piston type detector

Info

Publication number: CN110432912A
Application number: CN201910368706.6A
Authority: CN
Inventors: J·乐弗; A·J·利文斯顿; G·克罗索尔; J·约翰逊
Original assignee: Big Ford Biomedical Ltd
Current assignee: Big Ford Biomedical Ltd
Priority date: 2018-05-04
Filing date: 2019-05-05
Publication date: 2019-11-12
Also published as: CN211094134U

Abstract

A kind of pen cap for medication delivery pen includes piston type detector body.The piston type detector body includes at least one inner casing, includes the first open end, the medication delivery pen can be inserted by first open end；The second end opposite with the first end；Side wall is limited by outer surface and opposite inner surface；And channel, the inner surface is extended to from the outer surface.The side wall extends between the first end and the second end, thus defines therebetween pen and receives chamber.The piston type detector body further includes at least one switch and a translatable axis being at least partly placed in the channel.The translatable axis includes main body, and the main body at least receives the bonding part in chamber to extend to the switch engaging portion in the pen receiving chamber from the pen.The translatable axis is oriented at during medication delivery pen is covered into the inner casing and advances at least second position from first position to stir at least one described switch.

Description

Therapeutic device, method and system comprising piston type detector

Technical field

The present invention relates to the device, method and system comprising piston type detector.In a particular embodiment, piston type detects Device can be located in the lid set of the dosage administration set such as medication delivery pen.Device, method and system presented herein can Collect about from dosage administration set remove and/or replace lid set time data, the time data so as to determination control Treat setting and/or treatment recommendations.

Background technique

Diabetes be it is a kind of due to human insulin hyposecretion cause human body can not normal absorption sugar chronic metabolic Disorders.This hypoinsulinism leads to hyperglycemia, i.e., there are excessive glucose in blood plasma.Long term hyperglycemia Disease can lead to the long-term complications of a variety of serious symptoms and threat to life, for example, dehydration, ketoacidosis, diabetic coma, Cardiovascular disease, chronic renal failure, retinal damage and neurotrosis and its subsidiary amputation risk.Treat glycosuria The typical method of disease is Blood glucose self-monitoring and insulin self medication.However, " correct " dosage of insulin is in blood Glucose content and become.Insulin dose deficiency can lead to hyperglycemia, and excessive insulin dose can lead to hypoglycemia. Hypoglycemia can lead to clumsy, difficult to speak, the clouding of consciousness, loss of consciousness, epileptic attack or death.Therefore, diabetic (PWD) sizable cognitive load is faced when determining whether insulin dose is appropriate.

The treatment data for collecting PWD can be used for improving Treatment decsion, therefore reliable and powerful data gathering tool is people Need.

Summary of the invention

In one embodiment, a lid set for medication delivery pen includes piston type detector body.The piston Formula detector body includes at least one inner casing, includes the first open end, the medication delivery pen can pass through described first Open end insertion；The second end opposite with the first end；Side wall is limited by an outer surface and an opposite inner surface It is fixed；And channel, the inner surface is extended to from the outer surface.The side wall is in the first end and the second end Between extend, thus define therebetween pen receive chamber.The piston type detector body further includes at least one switch The translatable axis being at least partly placed in the channel with one.The translatable axis includes main body, and the main body is at least The bonding part in chamber is received to extend to the switch engaging portion in the pen receiving chamber from the pen.It is described to put down Shifting axis, which is oriented at, advances at least second position from first position during medication delivery pen is covered into the inner casing to dial At least one dynamic described switch.

In one embodiment, a capping method for detecting medication delivery pen includes: medication delivery pen lid is entered In lid set comprising the piston type detector body；During capping, the movement of medication delivery pen is passed to described The translatable axis of piston type detector body, so that the switch engaging portion and switch interaction promote to dial Move the switch.

In one embodiment, a system includes: the lid set comprising the piston type detector body；It is covered with lid The analyte sensor system of communication, wherein the analyte sensor includes: blood glucose meter, dynamic glucose monitoring devices connect Continuous glucose monitoring devices and the mobile computing device that can be carried out wireless communication with the lid set.

Other advantages of the part of embodiment will be set forth in the description below, and extra section can understand from the description, or can It is learnt by practicing embodiment.By combining the element pointed out in the appended claims, advantages of the present invention can be achieved And it obtains.

It is discussed above and described in detail below merely illustrative and solve the relevant technologies in technical field, therefore not It should be considered as the limitation to scope of the claims.

Detailed description of the invention

Institute's attached drawing as part of this specification illustrates the embodiment of teachings of this disclosure, and describes one with described It rises to illustrate present patent application principle disclosed.

Figure 1A illustrates a diabetes-management system, may include described herein including lid set, injection of insulin The embodiment of pen, glucose sensor and mobile device.

Figure 1B shows blood-sugar content and the user how PWD detects PWD on arm using glucose sensor How using the lid set having been fixed on Semilente Insulin pen, the embodiment comprising covering set as described in this article, from grape Sugared sensors for data.

The lid that Fig. 1 C to 1E shows one embodiment is covered when for example covering or going lid, can show example on lid set display Such as time, recommended doses and canteen suggestion information.

Fig. 2 shows an exemplary communication frameworks for system in Figure 1A.

Fig. 3 A to 3D is the perspective view of the lid set comprising piston type detector body of the invention, and Fig. 3 C is top side view (close up view comprising piston type detector), Fig. 3 D are bottom side view (close up view comprising piston type detector).

Fig. 3 E is the inner casing section view of the lid set shown in Fig. 3 A to 3D.

Fig. 4 A to 4B is the piston type detector body when the medication delivery pen with syringe needle is inserted into the lid set of embodiment Movable section view.

Fig. 5 A to 5B is the piston type detector machine when the medication delivery pen of not no syringe needle is inserted into the lid set of embodiment The movable section view of structure.

Fig. 6 A to 6C is to contain at least two near-field communication (Near Field Communication, NFC) in embodiment The perspective view of the different degrees of details of the lid set of antenna.

Fig. 6 D is the perspective view of double NFC antennas in the lid set for can be used for Fig. 6 A to 6C.

Fig. 7 A to 7B shows how PWD uses glucose sensor (Fig. 7 A) or its left arm (figure B) on right arm, To detect the blood-sugar content of PWD and how user is fixed on Semilente Insulin pen using the lid set in Fig. 6 A to 6C and comes up Data are obtained from glucose sensor.

It is worth noting that, the relevant technologies in for a better understanding of the present invention, the attached drawing in the disclosure has done simplification And the attached drawing in the disclosure does not strictly observe structure accuracy, details and ratio.

Specific embodiment

Embodiment of the disclosure is described in detail with reference to the drawings, section Example shows in the accompanying drawings.Identical attached drawing is compiled Number identical or corresponding component will be referred to as much as possible.

Although being used to state the widely applied numberical range of embodiment and parameter being approximation, given in specific example Numerical value out is reported as precisely as possible.But any numerical value has it centainly to be missed caused by testing measurement Plays difference Difference.In addition, all ranges in the disclosure are interpreted as covering any and all subranges included in it.For example, The range of " less than 10 " may include any and institute of between minimum value of zero and maximum value 10 (and including minimum value and maximum value) There is subrange, that is to say, that any and all subranges are with the minimum value equal to or more than zero and most equal to or less than 10 Big value, such as 1 to 5.In some cases, as negative value can be presented in the numerical value for parameter states.In this situation, " it is being less than Numerical value in 10 " range can be negative value, such as -1, -2, -3, -10, -20, -30 etc..

Merely for illustrative purpose, following embodiment is described with reference to the accompanying drawings.Those skilled in the art will be appreciated that following tool Body is described as the description to non-limiting exemplary embodiment, and can be in the feelings for not departing from the scope of embodiments of the invention It modifies under condition to parameter set forth herein.This specification and example should not be limiting, and be only embodiment Example.It between different embodiments and does not have to be mutually exclusive, some embodiments can be combined with one or more of the other embodiment to be formed New embodiment.It may include other features it will be understood that the structure shown in attached drawing has simplified, while the knot shown in attached drawing Structure can be removed or altered.

Any technology appropriate can be used to obtain pen and cover information in lid set in the disclosure.In some cases, this public affairs Lid set in opening can have a piston type detector body, and the piston type detector body includes piston, and the piston prolongs Injection pen is received in inner casing and contacted when injection pen is inserted into lid set to the injection pen for reaching lid set, and is fastened in lid set Against switch press when injection pen.

In the disclosure in the exemplary embodiment of provided Case management system, lower Figure 1A illustrates diabetes management System 10, diabetes-management system 10 include insulin injection pen 110 and 120, glucose sensor 130 and mobile device 140.Mobile device can be any suitable computer application equipment, such as smart phone or tablet computer.Mobile device can Storage and carry out mobile applications be used for show from the other component wireless receivings of diabetes-management system to associated treatment believe Breath.

As shown, each insulin injection pen 110 and 120 includes corresponding lid set 112 and 122, each lid set is respective Include button and display.It is shown in Fig. 1 go out embodiment in, novopen can be on the market containing any suitable The mechanical novopen of insulin, suitable insulin include that protamine zine insulin and Semilente Insulin (sometimes referred to as imitate pancreas islet fastly Plain or ultrafast Semilente Insulin).Can be used as Semilente Insulin has Humalog^TM、Novolog^TM、Apidra^TMAnd Fiasp^TM。 Can be used as protamine zine insulin has Lantus^TM、Levemir^TM、Toujeo^TMAnd Tresiba^TM.As shown, injection of insulin 110 representativenesses of pen illustrate a protamine zine insulin pen, while 120 representativeness of insulin injection pen illustrates a quick-acting pancreas islet Plain pen.

As shown, lid set 112 and 122 can have unique color, shape or other physical or digitized difference Feature, to assist diabetic (PWD) to distinguish long-acting lid set 112 and quick-acting lids set 122.Lid set can be with mobile device 140 Wireless communication, so that the data from lid set can be received and be shown by mobile applications.

Glucose sensor 130 can be any suitable glucose sensor, such as blood glucose meter (BGM) and dynamic grape Sugared sensor or continuous glucose sensor (CGM).In some cases, glucose sensor can pass through reader device (for example, using NFC communication) is wirelessly transmitted data when reading data.In some cases, glucose sensor 130 can make Data are wirelessly transmitted at a predetermined interval (for example, using radio frequency) with any suitable communication standard (for example, BLE). In some cases, a variety of communication technology transmission glucose datas can be used in glucose sensor 130.In some cases, it moves One or more of dynamic device 140 and/or insulin injection pen or lid set may include NFC reader.When in glucose sensing When in the interrogating range of device, the NFC reader is applicable to obtain blood glucose level data.In some cases, mobile device 140 And/or insulin injection pen 110,120 or lid set one or more of 112,122 can wireless receiving with predetermined time interval The blood glucose level data that (for example, per minute, every 5 minutes etc.) are broadcasted from glucose sensor 130.

When using example diabetes-management system 10, PWD (or its caregiver) can be responsible for determining when insulin injection With injection how much insulin, but system 10 can according to from glucose sensor current data, joined according to the treatment that is stored It counts and/or PWD (or caregiver) is assisted to determine insulin dosage appropriate according to the related data of injection of insulin.One Under a little situations, the data that lid set can reflect according to the piston type detector body in the disclosure are provided about when carrying out The data of injection of insulin.For example, lid set 112 and 122 can be examined by the piston type detector body in the disclosure The time that each lid set is applied to its insulin injection pen again is surveyed, this time can be considered injection time.In some situations Under, lid set 112 and 122 can pay attention to the insulin surplus in insulin injection pen and can determine each injection of insulin Amount.It can be with reference to the 62/599,963rd and No. 62/648,064 beauty of the co-pending being incorporated herein by reference In state's patent application, and the disclosed patent and application number WO 2017/009724 that are incorporated herein by reference A1；US 8,817,258 B1；With described in 2,987 518 B1 of EP.

Figure 1B illustrates how glucose sensor 130 can be applied to its arm by PWD 20, to detect the blood of PWD How sugared content and user can be read using the lid set 122 for being fastened to Semilente Insulin pen 120 from glucose sensor 130 Access evidence.Before or after user slides the set of the lid in Figure 1B 122, lid set 122 can show associated treatment information.One Under a little situations, associated treatment information may include the information about the one or many insulin injected recently, glucose data and / or one or more insulin dose suggestion.For example, lid set 122 can show nearest pancreas islet before or after sliding The time of plain medication.In some cases, in lid set 122 before the sliding of glucose sensor 130, lid set 122 can be shown For the insulin dose suggestion for not including correction component of canteen.In some cases, in lid set 122 adjacent to glucose sensing After device 130 slides, lid set 122 can show correction insulin dose suggestion or be directed to canteen and include the insulin for correcting component Dosage suggestion.

For example, the display 124 on lid set 122 is illustrated in Fig. 1 C, can show nearest medication or " last time is used Medicine " the time 125.Time 125 can assist user to recall whether they have been the used medicament of nearest canteen and/or have helped to use Family avoids unexpected repeated drug taking.In some cases, such as when lid set is capable of detecting when dosage, display can be additional Show last time dosage value.In some cases, last administration time can indicate the last use of distance with a clock How long medicine has passed.In some cases, display can show the blood-sugar content measured recently and time of measuring. In some cases, display can be electronic ink display.In some cases, display may include identification information (example Such as the name of user, such as the mark of " pen of Sarah (Sarah) ") and/or its novopen type information (for example, pancreas islet The brand of element).

Fig. 1 D illustrates the lid set 122 that blood glucose level data 129 is presented.Blood glucose level data 129 may include current blood glucose content and blood Sugared content trend arrow, blood-sugar content trend arrow can be after lid set cover as shown in fig. 1b from glucose sensor 130 It receives.Fig. 1 D also includes that correction dose suggests 127d and corresponding correction dose icon 126d.

Fig. 1 E illustrates the lid set 122 for suggesting 127a to 127c with canteen dosage, and the suggestion of canteen dosage can be according to meal Different size of canteen represented by food icon 126a to 126c provides.Additionally or alternatively, user can be to canteen icon 126a Personal settings are carried out to 126c to indicate different types of canteen (for example, B, L, D label are used to refer to breakfast, lunch, evening The picture of meal or canteen type, such as salad icon, sandwich icon and macaroni icon).For example, in use, After the display for seeing Fig. 1 D, user can be obtained canteen dosage suggestion by lower button 123.In some cases, canteen The setting value that dosage suggestion can be arranged during setting using mobile applications based on health care professionals, PWD or caregiver It provides, or the updated value of the canteen dosage updated by health care professionals, PWD or caregiver provides.In some cases, it eats The individual subscriber dosimetry parameter that food dosage suggestion can be automatically updated according to system using any suitable algorithm provides.One Under a little situations, when (for example, in last 5,10,15,20 or 30 minutes) read blood-sugar content to user recently, canteen dosage is built Discussing 127a to 127c can be simultaneously comprising both canteen dosage and correction dose.In some cases, if lid set 122 has identified Other nearest administration times are (for example, dynamic by the capping of the lid set in detection last 3 hours, last 4 hours or 5 hours last Make), and it is unaware of dosage, lid set is rejected by addition correction component, repeats to take correction medicament to prevent unexpected.Some Under situation, canteen icon 126a to 126c may indicate that whether canteen dosage suggests comprising correction component.In some cases, may be used Using additional icon or display data instruction canteen dosage suggest whether include correction dose suggestion and/or suggestion correction The number of dosage.In some cases, by pressing lower button 123, user can be seen display and show current blood glucose value, trend Information (for example, trend arrow) and the correction dose suggested.In some cases, if the nearest medication (example of existing insulin Such as, in last 1,2,3 or 4 hour), correction dose suggestion may occur in which warning warning medication recently near or over, thus anti- It is only unexpected to reuse insulin.In some cases, notification icon 128 can be presented on lid set 122, to indicate to the user that User can get more detailed suggestion, prompt, warning or alarm in the mobile applications in mobile device 140.

Lid set 112 and 122 and the disclosure provided in other methods, devices and systems can be simple and easy mentioned for user For treatment relevant information and/or treatment recommendations, while and/or collecting and pen is used to cover information.

Lid set 112 and 122 can be configured to fill with one or more glucose sensors and/or one or more mobile computing Set wireless communication.In some cases, lid set provided in the disclosure may be adapted to wirelessly receive Portugal from glucose sensor Grape sugar data and glucose data is transmitted wirelessly to mobile computing device from glucose sensor.In some cases, originally Lid set provided in open the first wireless communication technique can be used to receive glucose data from glucose sensor and use the Glucose data is transferred to mobile computing device by two wireless communication techniques.In certain situations, compared to the second communication skill Art, the first wireless communication technique can have closer expected communication range.In some cases, user must use first to lead to Letter technology obtains glucose data from glucose sensor, while carrying out glucose data automatically via second communication technology Transmission.In some cases, Gai Taoyu glucose sensor 130 using NFC communication and user must will lid set close to subcutaneously The glucose sensor 130 for being implanted into human body obtains glucose data.In some cases, lid set can make with mobile computing device It is communicated with BLE.BLE communication can trigger at regular intervals and/or receive glucose data from glucose sensor in lid set Automatic trigger later.In some cases, also any suitable technology can be used to connect from glucose sensor for mobile device 140 It receives glucose data and glucose data can be transferred to lid set 112 or 122 from mobile computing device 140.In some situations Under, glucose data may include that lid can be made to cover to prolong at one from the single transmission that glucose sensor is transferred to lid set The data of at least two glucose estimation values (EGV) are determined between long at least 30 minutes in section.In some cases, once Data single transmission may include at least 1 hour glucose data, at least 2 hours glucose datas, at least 4 hours Portugals Grape sugar data, at least 6 hours glucose datas, or at least 8 hours glucose datas.

Lid set 112 and 114 may include one or more processors and memory, for controlling wireless communication, control user Interface and/or determining treatment recommendations.In some cases, lid set provided in the disclosure may include processor and be associated Memory, can determine EGV value from sensor raw data together with algorithm.In some cases, glucose sensor EGV value can be transmitted.In some cases, lid set provided in the disclosure may include that memory is used to store individual subscriber agent Parameter is measured (for example, the daily dose suggestion of protamine zine insulin or daily total basic dosage (TDBD), insulin sensitivity sexual factor (ISF), carbohydrate-insulin ratio (CR), daily total insulin dose (TDD), target glucose value etc.).Some Under situation, individual subscriber dosimetry parameter can be time or day relevant parameter, such as CR and ISF value with the daily time And change.In some cases, lid set provided in the disclosure can have memory to be used to store for different canteens or needle Semilente Insulin dosage suggestion to different canteen classifications.In some cases, individual subscriber dosimetry parameter and/or for not Various dose suggestion with canteen can be updated via the mobile computing device with lid set wireless communication.For example, mobile computing These parameters or dosage suggestion may be updated in algorithm in device or cloud.In some cases, parameter or dosage suggestion can be by Health care professionals are updated or are updated manually by PWD or caregiver.In some cases, lid set may include that a kind of algorithm is covering It covers in memory, the algorithm updates individual subscriber dosimetry parameter or dosage suggestion after being executed by processor.

In some cases, lid set provided in the disclosure can be based on from Continuous Glucose monitor, flash glucose The glucose data that monitor, blood glucose meter or any other suitable glucose sensor receive is shown to user or with it Its mode informs user's current blood glucose content and/or blood glucose trend data (for example, change rate).Lid provided in the disclosure Set can also be based on blood glucose level data, individual subscriber measuring parameter, the dose suggestion being arranged by user or health care professionals, daily In time, canteen data or canteen classification or any other suitable input in one or more information provide insulin Dosage suggestion.

Adding and removing cover information (that is, temporal information that lid set is fastened to injection pen and/or discharges from the injection pen) can wrap Containing about the current information covered the period (for example, the elapsed time from last cover), about one or many lids that go Time interval information and every time go lid and cover every time temporal information (for example, daily adding and removing cover the specific time or since Last adding and removing cover plays elapsed time).In some cases, Gai Taoke displays for a user adding and removing cover information.In some shapes Under condition, adding and removing cover information can notify user by the loudspeaker in lid set.For example, in some cases, set can provide one A timer clock timing elapsed time in total from the lid set last time is fastened to injection pen.In some cases, Gai Taoke Adding and removing cover information is wirelessly passed to mobile device 140 (for example, the smart phone of an operation mobile applications, flat Plate computer etc.).

Adding and removing cover information can be used to adjust user experience.In some cases, lid set can according to adding and removing cover information come The user of adjustment for the treatment of relevant information and/or suggestion is presented.For example, in some cases, lid set can be passed according to glucose The data of sensor, which carry out suggestion, can correct the correction drug dose of raised blood-sugar content, but covering set can be only when adding and removing cover This correction medicament suggestion is presented in interval when being greater than threshold time period (for example, at least 3 hours, at least 4 hours or at least 5 hours). In some cases, lid set can provide a user notice, warning or alarm according to adding and removing cover information.For example, if lid (for example, in 30 minutes or 1 hour) are covered in the threshold time period apart from adding and removing cover time last time to remove from injection pen, that Lid set can provide sense of vision, audio or with vibration notice to prompt the possible user recently of user to use and be somebody's turn to do Injection pen insulin injection.In some cases, lid set can be with mobile computing device (for example, smart phone, tablet computer) The one or more notices generated according to adding and removing cover information, police can be notified or shown in wireless communication and mobile computing device Announcement or alarm.

It stores, show together, analysis adding and removing cover information and glucose data can determine whether that user behavior, such as this user are It is no correctly to use insulin for canteen and/or the raised blood-sugar content of correction.In some cases, adding and removing cover letter Breath can be presented on the blood glucose level data chart of user, and be presented to the user simultaneously and/or health care professionals.In some situations Under, assessing the blood glucose level data after each adding and removing cover in a period of time can determine whether user correctly uses in adding and removing cover Insulin and whether user under medication or over administration.

Fig. 2 illustrates the exemplary communication framework for the system in Figure 1A, and illustrates between the component of Figure 1A system Possible communication link.Various assemblies can be connected with each other via wireless control, NFC or BLE communication protocol.According to specific Time point ongoing system workflow, each component shows, transmits and receives information in system.As shown, grape Sugared sensor 130 can be covered via NFC and quick-acting lids 122, communication link 231 and/or with mobile device 140, communication link 232 Communication.In some cases, long-acting lid set 112 can be communicated via NFC communication with glucose sensor 130.In some situations Under, because the insulin for being used as correction or canteen dosage only has Semilente Insulin, to prevent user from obscuring long-acting lid set 112 It is not communicated via NFC communication with glucose sensor directly.In some cases, glucose sensor 130 can be additionally via nothing Line electricity is communicated with mobile device, and the radio transmits blood glucose value at a predetermined interval.Lid set 112 and 122 can be logical via BLE Letter is communicated with mobile device 140.Blood glucose level data, programmed therapy parameter (for example, the daily dose of protamine zine insulin, for difference Dosage (it can change according to Time of Day), the insulin sensitivity sexual factor, carbohydrate-insulin ratio of canteen size Deng), adding and removing cover data (can add can be not added by the dose data that detects of lid set) can be in mobile device 140 and each lid set It is conveyed between 112 and 122, and system data can be passed to network service via WiFi or cellular connection 241 250 (it can be Any remote server).In some cases, each lid set can configure included processor and memory to execute algorithm To determine dosage suggestion.In some cases, the practicable treatment recommendations of mobile device or implementation treat parameter more new algorithm to push away It recommends the change to programmed therapy parameter and/or automatically updates programmed therapy parameter.In some cases, network service 250 Practicable algorithm is to recommend to change and/or automatically update programmed therapy parameter.

In some cases, in the mobile applications on initial treatment parameter programmable to mobile device 140 and via BLE communication link 211 and 221 is transferred to lid set.In some cases, lid set 122 can be used receives from mobile applications Treatment parameter correction dose and canteen dosage suggestion are provided.In some cases, treatment parameter may include for different or not Canteen with size is (for example, small-sized canteen, medium-sized canteen and large-scale canteen；Or breakfast, lunch and dinner；Or salad, Sanming City Control and macaroni) canteen dosage.In some cases, treatment parameter may include the treatment parameter for correcting blood glucose value, example Such as insulin sensitivity sexual factor.In some cases, lid set 112 can receive controlling to regulation protamine zine insulin daily dose Treat parameter.In some cases, lid set 112 can receive the suggestion of protamine zine insulin from mobile device mobile applications 140 It uses time (for example, 9 points of every night, 8 points of every morning, 8 a.m. and at 8 points in afternoon twice a day etc.).

Lid set is also configured to the dosage suggestion that may be followed for understanding user.For example, the such as the 15/717th, Described in No. 805 U.S. Patent applications, lid set (regardless of whether lid set has the feature for capturing dosage) may include that canteen is logical The classification (such as S, M, L) known, and the data in each notice can be shown that whether user may be directed to the use of S, M or L canteen Insulin dose appropriate.No. 15/717,805 U.S. Patent application is incorporated herein by reference.In some shapes Under condition, the button repeatedly pressed on gland set 122 can show dosage suggestion to S canteen successive later, M canteen and L canteen, And method and system provided in the disclosure may be assumed that user used pancreas islet according to the preceding dosage suggestion once shown Element.In some cases, added on mobile applications in different time intervals (once a day, per once a few days, Weekly) information of insulin residual volume can indicate whether user generally follows treatment recommendations or whether user neglects in pen The slightly described treatment recommendations.In some cases, method and system provided in the disclosure can by analysis glucose data, Insulin surplus data and/or the problem of providing in mobile applications, are answered in adding and removing cover information, one or more pens Case follows a possibility that dosage is suggested or to user's scoring to measure user.Method and system provided in the disclosure can make With a possibility that the measurement or scoring to determine a need for adjustment dosage suggestion or for user provides guidance.

Method and system provided in the disclosure can be additionally included in and one or more lid set channel radios in the disclosure Believe the mobile applications run in the mobile device (for example, smart phone or tablet computer) of (for example, via BLE).In Under some situations, blood glucose level data can be transmitted from glucose sensor via lid set and/or directly be transmitted from glucose sensor. In some cases, mobile applications can have a user interface to carry out chart display blood glucose level data.In some cases, One chart for showing blood glucose level data at any time may include the indicant for conveying adding and removing cover information.

In order to collect adding and removing cover information as described above, one is able to detect capping and/or goes to the mechanism of lid that can place In lid set, such as it is placed in lid set 112 and/or lid set 122.Fig. 3 A to 3D is illustrated (not to be shown to such as medication delivery pen The lid set 312 that dosage administration set out) uses.In figure 3 a, lid set 312 includes an outer housing 301, and several components can It is contained in outer housing 301, as shown in Figure 3B.Outer housing 301 may include that first part 301a and second part 301b are connecing It stitches and is linked together at 302 to limit the first opening 304 and the second opening 306.First part 301a and second part 301b can It is connected by friction, fastening, welding, gluing, melting or any other suitable adhesive method.In some embodiments, outside Shell 301 can have integral type space configuration (not shown).

Such as the internal component of display 314 and/or button 309 can be placed in outer housing 301.Display 314 can be with It is LCD, Electronic Paper, LED, OLED or any other suitable display, can be checked by the opening 308 in outer housing 301 The display.Button 309 can be mechanical spring loaded button, touch reaction button (that is, touch screen and/or tactile are anti- Answer), user can use button 309 via opening 308 or via single opening.Outer housing 301, first part 301a and/or Two part 301b may include the class of plastics, metal, any other suitable material, a combination thereof or any other suitable material One of type is a variety of.Shell can for different transparencies, comprising from substantially transparent (for example, can be seen by shell Internal component) to being substantially non-transparent (for example, can not see inside by shell).Any suitable system can be used in shell Process and its material manufacture appropriate are made, such as machining (for example, CNC, turning etc.), increasing material manufacturing are (for example, 3D is beaten Print), injection-molded, blown-moulding, casting, punching press, laser cutting etc..

As shown in the decomposition view of the lid set 312 shown in Fig. 3 B, piston type detector body 315 is together with display and presses Button is placed in together in outer housing 301.Display, button and piston type detector body 315 could attach to together, such as shape At a common element.Common element, which can have, enables each component that can be separately attached to other components or tear open from other components The modularized design unloaded.For example, display 314, button 309 and piston type detector body 315 may be mounted at for example In common support base (invisible), and circuit board (invisible), the place can be connected to together with memory and processor Reason device communicates with memory and is configured to carry out the instruction being stored in memory；And airborne power supply (not shown), such as can Storage battery.

Piston type detector body 315 includes: inner casing 350, one for being designed to receive insulin delivery pen work as Insulin delivery pen is fastened on lid and puts on (capping movement) or cover from lid mutual with insulin delivery pen when removing (lid is gone to act) The piston assembly 360 of effect and for piston assembly will cover or go lid movement be passed to circuit board and finally arrive processing The electronic circuit 370 of device offer power path.For example, the piston group during medication delivery pen is covering or removes lid When component 360 and medication delivery pen interact, electronic circuit 370 transmits signal via opening 303.

As shown in Fig. 3 C to 3E, 4A to 4B and 5A to 5B and it is as follows it is middle further describe, inner casing 350 includes pen Main body fastening part 351, syringe needle fastening part 353 and opening 303, pen can be inserted into pen by the opening 303 and receive chamber So that piston assembly 360 enters in lid set in (invisible) and channel (invisible).

As shown in the enlarged view of Fig. 3 C to 3E, the inner casing 350 of piston type detector body 315 be can further include and the The opposite second end 356 in one end 303, and the side wall 358 limited by outer surface 352 and opposite inner surface 354.Side wall 358 Extend between first end 303 and second end 356, receives chamber 351' to limit pen.Second end 356 can further limit needle Head storage chamber 353'.Channel 355 includes the first opening 355' and the second opposite opening 355 " adjacent to chamber 351'.It is logical Road 355 enables to be placed at least part that the translatable axis 360 in inner casing slidably passes through inner casing 350.

For example, electronic circuit 370 is including, for example, the piston in combination when medication delivery pen 380 is by 303 insertion of opening At least one switch 371 workable for part 360.At least one described switch can be the microswitch with toggle arm 371'. In some embodiments, at least one described switch can be " normally opened " switch, thus when place circuit does not have external action In the case where carrying out toggle switch, at least one described switch is defaulted as open-loop configuration.In some embodiments, it is described at least One switch can be " normally closed " switch, thus in the case that place circuit does not have external action to carry out toggle switch, default For open-loop configuration.

Piston assembly 360 includes the translatable axis 361 that can be at least partially positioned in channel 355.Translatable axis 361 It may include main body, the main body at least extends to its switch engaging portion 362 " from a bonding part 362'.It is as follows further It is illustrated in greater detail in description and Fig. 4 A to 4B and 5A to 5B, translatable axis 361 is oriented at defeated to drug using lid set At least second position is advanced to stir at least one switch from first position during sending pen to be covered.Removing, drug is defeated After sending pen, translatable axis 361 can be configured to back to first position.For example, piston return 363 can be configured to certainly It is dynamic to make translatable axis 361 back to first position.

Piston type is examined when Fig. 4 A to 4B is illustrated in the lid set that the medication delivery pen for having syringe needle is inserted into embodiment The section view of the operation of Ce Qi mechanism.As described above, translatable axis 361 can be opened via the first opening 355' and second Mouth 355 " is slidably positioned in channel 355.As shown in Fig. 4 A to 4B and Fig. 5 A to 5B, defeated to drug using lid set When pen being sent to be covered or gone lid, translatable axis is oriented from first position and advances at least second position.As shown, living Filling in return 363 may include spring, and being concentrically placed between the first 355 " and switch engaging portion 361' of opening can On translation shaft.Translatable axis 361, which slides entirely over channel 355 and enters pen, in order to prevent receives chamber 351', may include limitation Device 364, such as collar assemblies or integrated shoulder portion, the integrated shoulder portion have the second opening than channel 355 355 " broader diameters.

In addition, the inner casing 350 of outer housing 301 and piston type detector body 315 cooperate with limit at least inner cavity chamber to prevent Sealing point or any other may endanger can for example be positioned at individually or together it is interior between such as inner casing 350 and outer housing 301 The foreign matter of some components of piston types detector body such as the indoor circuit 370 of chamber and at least one switch 371' enters.Shell Body 301 can cooperate with inner casing 350 prevents liquid from entering to therefore form waterproof inner cavity chamber in inner cavity chamber, or formation has The chamber of IPX5 or more preferably (IEC standard 60529) waterproofing grade.Moisture or any other foreign matter are from a receiving compartment in order to prevent Room 351' enters inner cavity chamber, and sealing element 365 can be placed in 355 " place of the second opening.The sealing element can be protective cover sealing Part can compress between the first opening 365' and pen 380.Sealing element can also or further include coating, such as coated in work Sealant and/or lubricant compositions on the surface of the main body of plug.

In embodiment, switch 371 is one detectable, two, three or different configurations.For example, dial type is opened Two different locations (for example, first position and second position) or three different locations (first, second can be toggled it to by closing 371' And third).For example, tumbler switch 371' can stir position in the first "off", wherein because lid set and pen do not fasten Together, so translatable axis is in its original undisturbed position；And tumbler switch 371' can be stirred second Position, wherein because lid set is fastened on the injection pen without syringe needle, piston traveling first segment distance.Dial type is opened In addition pass 371' may also be in third and stir position, wherein because lid set is fastened to the injection pen with syringe needle, piston row Into second segment distance, depending on the configuration of pen, the second segment distance can be first or second distance.

For the foreign matter being inserted into lid set, such as pen, the offers of various contacts may depend on shape, the size of piston And orientation.For example, in some cases, piston may include having the first section of first external diameter and with second external diameter The second section so that switch is moved to third and stirs configuration by piston in the case where there is fastening syringe needle, but do not fastening needle The second configuration is moved in the case where head.In another example, piston can have the length along piston main body from first position The diameter being gradually reduced to the second position, so that switch can determine the relative depth that pen is inserted into lid set, thus further really Whether the pen being inserted into surely has syringe needle.The data whether pen of the insertion detected has syringe needle can be used to whether judge user Syringe needle may be replaced after per injection or carries out multiple injection using same syringe needle.In some cases, what is detected inserts The syringe needle that the data whether pen entered has syringe needle may be used to determine user re-supplies quantity and/or provides for user about needle The operation instruction that head is suitably replaced.In embodiment, switch may include proximity sensor detect that translatable axis advances away from From so that whether distance or medication delivery pen that analysis such as medication delivery pen has been inserted into lid set inner casing are fully inserted into (that is, fastening) is into the inner casing of lid set.

In embodiment, the channel for translatable axis is arranged parallel to the long axis of inner casing.In embodiment, it is used for The channel 355 of translatable axis 361 is configured to the long axis of parallel offset inner casing.In embodiment, translatable axis is positioned in parallel Deviate the central axis (b-b') of inner casing 350 and direction (a-a') uplink in the central axis (b-b') for being parallel to inner casing 350 Into.Therefore, detection pen is covered or drowning is gone to have an impact with the presence or absence of syringe needle on pen.This is because pen and piston type detection machine Bonding station 383 between structure is at main body shoulder 381.

Similar to the lid set 112 and 122 shown as described above and in Figure 1A to 1E, lid set 312 can be the portion of system Point, the system further includes the analyte sensor system communicated with lid set (for example, blood glucose meter, dynamic glucose monitoring Instrument or continuous glucose monitoring devices), and/or can be used to configure the mobile computing device for the treatment of parameter, the treatment parameter includes For the dosage suggestion of different size of canteen, insulin sensitivity sexual factor, carbohydrate-insulin ratio, long-acting pancreas islet The generally combination of dosage or information above.Lid set can be wirelessly communicated with mobile computing device, thus will such as administration time data It is transferred to remote subscriber interface.The wireless communication may include that will cover set to match with analyte sensor system, is arranged or updates It treats parameter and sends treatment information.The wireless communication may include that will treat information to be sent to cloud, for analyzing, more New treatment one or more of parameter or combination of the above.The wireless communication also may include that treatment information for example covers data, divides Analyse the combination of object data or information above.

Lid set may include NFC reader, for reading glucose sensing when in the interrogating range in glucose sensor The blood glucose level data of device.The blood-sugar content of PWD is detected by the way that glucose sensor to be applied on arm, which can be in grape The inquiry for being fastened on the lid set of Semilente Insulin pen to start glucose sensor is brandished in the interrogating range of sugared sensor.

Fig. 6 A to 6C illustrates the perspective of the lid set 612 for dosage administration set such as medication delivery pen (not shown) Figure.As shown, lid set 612 includes outer housing 601, display 614 and inner casing 650 matched with outer housing 601.Inner casing 650 may include: the first open end 603, and pen can be inserted by the first open end 603；The second end opposite with first end 603 656；And side wall, limited by outer surface and opposite inner surface, wherein side wall first end (opening 603) and second end it Between extend, thus limit pen receive chamber (invisible).First NFC antenna 691 can be configured to receive to be generated by transcutaneous sensor At least one signal.First NFC antenna 691 can be between shell and the first side of inner casing 650.Meanwhile the 2nd NFC days Line 693 can be configured to receive at least one signal generated by transcutaneous sensor and be located at the of outer housing 601 and inner casing 650 Between two sides.In an example, inner casing 650 is placed between the first NFC antenna 691 and the second NFC antenna 693.

Also may include for the lid set 612 of medication delivery pen as described in this article: memory (invisible) and storage (invisible) communication of device and being configured to carry out the processor of instruction being stored in memory and with the processor communication NFC reader (invisible).

Similar to the lid set 112 and 122 shown in as described above and Figure 1A to 1E, lid set 612 can be system Part, the system further includes and covers the analyte sensor system that communicates of set (for example, blood glucose meter, dynamic glucose Monitor or continuous glucose monitoring devices), and/or can be used to configure the mobile computing device for the treatment of parameter, the treatment parameter Comprising for the dosage of different size of canteen suggestion, insulin sensitivity sexual factor, carbohydrate-insulin ratio, long-acting The daily dose of insulin or the combination of information above.Lid set can with mobile computing device wirelessly communicate to will such as medication when Between data be transferred to remote subscriber interface.Wireless communication may include will cover set with analyte sensor system match, setting or more New treatment parameter and transmission treatment information.Wireless communication may include that will treat information to be sent to one or more points of cloud progress Analysis, the combination function for updating treatment parameter or above functions.The wireless communication also may include treatment information such as adding and removing cover number According to the combination of, analyte data or information above.

As shown in Fig. 6 C to 6D, the antenna for covering in set 612 includes to be placed on mutual substratej and by base part 695 the first NFC antennas 691 and the second NFC antenna 693 separated.The substrate includes: base part 695, the first NFC antenna 691 are placed in substrate first part above and the second NFC antenna 693 is placed in the second substrate portions above.Described One NFC antenna 691 is separated by the first bending or hinged part 697 with base part.Second NFC antenna 693 passes through Second bending or hinged part 699 are separated with base part.Antenna can be connected to circuit 670 by means of contact 694.It can By the reinforcer shown at 692 be added to as described in antenna with prevent antenna damage.First NFC antenna 691 and the 2nd NFC Antenna 693 can be placed on the opposite side of display 614.For example, the first NFC antenna 691 can be placed in display 614 The first side on and the second antenna 693 can be placed in opposite second side of display 614.First NFC antenna 691 and Two NFC antennas 693 can be oriented to the main display surface for being substantially perpendicular to display 614.For example, the first NFC antenna 691 and second NFC antenna 693 can be oriented respectively or respectively it is substantially parallel with display 614 or with its it is substantially vertical between, Such as the main display surface relative to display 614 is in the angle of about 0o to about 90o, in about 15o to the angle of about 85o and It is even in the angle of about 35o to about 65o, the angle comprising being in about 45o.

It should be noted that the feature of above-mentioned middle cover set 312 can be combined with the feature of lid set 612.For example, it is used for dosage The lid set of medicine device such as medication delivery pen can be simultaneously comprising the piston type detector body for detecting the insertion/removal of pen And the dual-antenna system with such as the first NFC antenna and the second NFC antenna.Therefore, inner housing 650 may include inner housing 350 any and all features.

The method that Fig. 7 A to 7B illustrates the signal of detection sensor collection, such as an analyte sensor can be used as one A subcutaneous sensor detects signal.Specifically, this method describe PWD can be how in its right arm (Fig. 7 A) or its left arm (figure 7B) using glucose sensor to detect PWD blood-sugar content and user can be how using being fastened on Semilente Insulin Lid set in Fig. 6 A to 6C on pen reads data from the glucose sensor on any arm.

Analyte sensor is neighboringly placed on comprising the lid of the first NFC antenna 691 and the second NFC antenna 693 set 612 631.As shown in Figure 7 A, in some embodiments, when lid set is neighboringly placed on the subcutaneous analyte sensor 630 of PWD right arm When, 691 to the second antenna 693 of first antenna is closer to subcutaneous sensor.In instances, as shown in Figure 7 B, in some embodiment party In case, when lid set is neighboringly placed on the subcutaneous analyte sensor 630 of PWD right arm, 693 to the one NFC of the second NFC antenna Antenna 691 is closer to subcutaneous sensor.A NFC reader can be activated to read the first NFC antenna 691 and the 2nd NFC to replace Antenna 693.Referring to Fig. 6 A to 6C, the first NFC antenna 691 and the second NFC antenna 693 can be located at outer housing 601 and inner casing 350 Between, when lid set 612 is oriented for example in the first orientation relative to analyte sensor 630 (for example, such as Fig. 7 A institute Show), 691 to the second NFC antenna 693 of the first NFC antenna is for example generated by analyte sensor with the reception of higher signal strength At least a signal signal strength.Also, when lid set 612 is oriented for example relative to analyte sensor 630 the When in two orientations (for example, as shown in Figure 7 B), 693 to the first NFC antenna 691 of the second NFC antenna is connect with higher signal strength Receive the signal strength of at least one signal.

When user holds glucose sensor 630 of 612 scanning of lid set on its right arm " R " as shown in Figure 7A, use Family can hold lid set 612 and make it have the first orientation.Alternatively, exist when user holds 612 scanning of lid set as shown in fig.7b When glucose sensor 630 on its left arm " L ", user can hold lid set 612 and make it have the second orientation.In some realities It applies in scheme, the display information provided by display 614 can rotate automatically.This reads letter with allowing user " face-up " It is inconvenient to remove the text bring that " inversion " is presented by the display of not automatic rotation function from for breath.Therefore, information is shown It is on its left arm or on its right arm that direction, which will help the quick identification sensor of user,.

It is selected according to the direction for example stored until opposite side is scanned until glucose sensor in last scanning The instruction for selecting information display direction is storable in memory and is executed by processor.The instruction can according to user input or The case where according to sensing, such as the variation of gravity direction that airborne accelerometer is sensed, Lai Shihang.Alternatively, display 614 provide information can not rotate automatically, from the direction but regardless of shell or scanning which arm information keep it is quiet Only.

Although embodiment referring to one or more embodiment explanations, can not depart from the appended claims Spirit and scope in the case where change and/or modification are made to illustrated example.In addition, an although spy of embodiment Determining feature may be disclosed with regard to the only one in several embodiments, but in order to need with it is advantageous any given Or specific function, the category feature can be combined with one or more of the other feature of other embodiments.

In addition, with regard to using term " including (including, includes) " in detailed description and claims, " having For (having, has, with) " or the degree of its version, such term is intended to have packet as term "comprising" Containing property.As used herein, phrase such as A, B and C " one or more of " mean it is any of following: individually A, B or C；Or two combinations, such as A and B, B and C and A and C；Or the combination of three A, B and C.

Practice in view of this specification and to description disclosed herein, other embodiments will be to those skilled in the art Member is apparent.This specification and example are exemplary only, and the correct scope and spirit of embodiment are by following following claims Book indicates.

Claims

1. a kind of lid set for medication delivery pen comprising:

Detector body comprising:

Outer housing；

Inner casing, the inner casing include

First open end is configured as receiving medication delivery pen,

Second end, it is opposite with the first end, and

Side wall, with outer surface and inner surface, the side wall extends between first open end and the second end, with And

Channel extends through the inner casing,

At least one of electronic circuit switch；And

Translatable axis, is at least partially positioned in the channel and including main body, and the main body at least receives chamber from pen In a bonding part extend to its switch engaging portion, wherein the translatable axis is oriented from first position and advances at least The second position is to stir at least one described switch.

It further comprise the first NFC antenna, the second NFC antenna and NFC reader 2. lid according to claim 1 set, First NFC antenna is configured to receive at least one signal generated by analyte sensor, and first NFC antenna Between the outer housing and the first side of the inner casing, second NFC antenna is configured to receive at least one by described The signal that analyte sensor generates, and second NFC antenna be located at the outer housing and the inner casing second side it Between, the NFC reader is communicated with first NFC antenna and the second NFC antenna.

3. lid set according to claim 1, further comprising:

Display；

Memory；And

The processor communicated with the memory.

4. lid set according to claim 1, wherein the second end of the inner casing, which limits syringe needle, stores chamber.

5. lid set according to claim 4, further comprises limiter, limits the row of the translatable axis Into.

6. lid set according to claim 4, further comprises spring, the spring positioning is at and peace concentric with the axis It is placed between the first opening and the switch engaging portion.

7. lid set according to claim 4, wherein the translatable axis deviates the central axis for being parallel to the inner casing It direction and is travelled upwardly in the side for the central axis for being parallel to the inner casing.

8. lid set according to claim 4, wherein at least one described switch is open type switch.

9. lid set according to claim 4, further comprises sealing element.

10. lid set according to claim 9 can be put down wherein the sealing element includes protection shield closure around described The pen that extends to for moving axis receives the part in chamber to extend.

11. lid set according to claim 9 or 10, wherein the sealing element includes along the described logical of the translatable axis Hydrophobic lubricant in road.

12. the lid set according to one in preceding claims, further comprises proximity sensor, wherein described close Degree sensor is configured to sense the travel distance of the translatable axis.

13. a kind of for detecting the method using the time of medication delivery pen, which comprises

Medication delivery pen is received into receiving compartment room, it is described that chamber is received to be defined by the side wall of lid set；

Translatable axis is engaged into channel, to advance at least second position from first position, to stir in electronic circuit Switch；

Store the time of nearest toggle switch；And

It calculates since the nearest toggle switch plays elapsed time.

14. according to the method for claim 13, wherein the electronic circuit stirs the switch in the translatable axis Afterwards by electronic signal transmission to processor.

15. the method according to claim 11, the method comprise the steps that

The time of nearest toggle switch is transmitted to remote subscriber interface；

Show the time of nearest toggle switch.

16. a kind of system comprising:

For the lid set of medication delivery pen, the lid set includes piston type detector body, wherein the piston type detector machine Structure includes:

Channel extends to inner surface from outer surface,

At least one switch；

Translatable axis is at least partially positioned in the channel, wherein the translatable axis is oriented from first position row At least second position is entered to stir at least one described switch；

Analyte sensor system is covered with the lid and is wirelessly communicated；And

Remote subscriber interface is covered with the lid and is wirelessly communicated.

17. system according to claim 16, wherein the remote subscriber interface and cloud wirelessly communicate.

18. system according to claim 16, wherein the wireless communication between the remote subscriber interface and the lid set Include: transmission stir recently the switch time and from the analyte sensor system to the remote subscriber interface to Few primary reading, and setting or update treatment parameter.

19. system according to claim 17, wherein the wireless communication packet between the remote subscriber interface and the cloud It includes: reporting the time for stirring the switch recently and from the analyte sensor system to the reading at least once of the cloud, To be analyzed at least once, treatment parameter is updated.

20. a kind of system comprising:

Channel extends to inner surface from outer surface,

At least one switch；

Translatable axis is at least partially positioned in the channel, wherein the translatable axis is oriented from first position row At least second position is entered to stir at least one described switch；And

21. system according to claim 20, wherein the remote subscriber interface and cloud wirelessly communicate.

22. system according to claim 20, wherein the wireless communication between the remote subscriber interface and the lid set It include: that the time for stirring the switch recently is transmitted to the remote subscriber interface, and setting or update treatment parameter.

23. system according to claim 21, wherein the wireless communication packet between the remote subscriber interface and the cloud It includes and reports the time for stirring the switch recently to the cloud, for analyzing at least once, and update treatment parameter.