MEDICAL DEVICE WITH TACTILE INDICATION

Abstract

An inventive medical system includes a skin-mountable medical device, the skin-mountable medical device including an activatable tactile indicator. The medical system further includes a user interface configured to receive location information, the location information indicating a body location where the skin-mountable medical device shall be mounted. The medical system is configured to determine an active control pattern in dependence of the location information and to control activation of the tactile indicator in accordance with the active control pattern. Also disclosed are a remote control for use in combination with a skin-mountable medical device as well as methods for providing tactile indications to a user of a medical system.

Claims

1. A medical system, comprising: a skin-mountable medical device having an activatable tactile indicator; a user interface configured to receive location information associated with a location on a user's body where the skin-mountable medical device shall be mounted; a processor configured to determine an active control pattern associated with the location information and to control activation of the tactile indicator in accordance with the active control pattern.

2. The medical system according to claim 1, wherein the activatable tactile indicator is a vibrator.

3. The medical system according to claim 1, further comprising a memory having stored thereon a set of predetermined control patterns from which the active control pattern is selectable.

4. The medical system according to claim 1, further comprising a remote control, wherein the skin-mountable medical device and the remote control are configured for wireless data exchange with each other, wherein the user interface is provided on the remote control.

5. The medical system according to claim 4, wherein the remote control is configured to determine the active control pattern and to transmit information indicative of the active control pattern to the skin-mountable medical device.

6. The medical system according to claim 4, wherein the skin-mountable medical device is configured to determine the active control pattern based on information retrieved from the remote control.

7. The medical system according to claim 3, wherein the activatable tactile indicator is a vibrator and at least some of the control patterns among the set of predetermined control patterns differ in at least one of frequency, amplitude, number of activation bursts, sequences of activation bursts, and pauses between activation bursts.

8. The medical system according to claim 1, wherein the skin-mountable medical device includes a continuous glucose-measurement device and/or an insulin infusion pump.

9. The medical system according to claim 1, wherein the skin-mountable medical device is configured to control activation of the activatable tactile indicator in accordance with indication information indicated to the patient.

10. A remote control, comprising: a user interface configured to receive location information associated with a location on a user's body where a skin-mountable medical device, including an activatable tactile indicator, shall be mounted; wherein the remote control has a controller that is configured to determine an active control pattern in dependence of the location information and (i) to control activation of the tactile indicator of the skin-mountable medical device in accordance with the active control pattern, and/or (ii) to transmit information indicative of the control pattern from the remote control to the skin-mountable device.

11. A method of providing tactile indications to a user of a medical system that includes a skin-mountable medical device, the method comprising: a) receiving, via a user interface of the medical system, location information associated with a location on a user's body where the skin-mountable medical device shall be mounted; b) determining by the medical system an active control pattern in dependence of the location information; and c) controlling activation of an activatable tactile indicator in accordance with the active control pattern.

12. The method according to claim 11, further comprising selecting the active control pattern from a set of predetermined control patterns stored on a memory of the medical system.

13. The method according to claim 11, further comprising providing the user interface on a remote control.

14. The method according to claim 11, further comprising controlling activation of the activatable tactile indicator in accordance with indication information indicated to the patient.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0032] The above-mentioned aspects of exemplary embodiments will become more apparent and will be better understood by reference to the following description of the embodiments taken in conjunction with the accompanying drawings, wherein:

[0033] FIG. 1 schematically shows a medical system in accordance with the present disclosure;

[0034] FIG. 2 schematically shows the indications of body locations on a graphical user interface;

[0035] FIG. 3 schematically shows the storing of control patterns and control parameters; and

[0036] FIG. 4 schematically shows different tactile indications.

DESCRIPTION

[0037] The embodiments described below are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art may appreciate and understand the principles and practices of this disclosure.

[0038] FIG. 1 shows an exemplary medical system in a schematic view. In this example, the medical system includes the skin-mountable medical device 1, and a remote device 2. The skin-mountable device may be temporarily mounted to a patient's body via a cradle 3. By way of example, the skin-mountable medical device 1 is an insulin infusion pump with functionality as explained in the general description. Further by way of example, the remote device 2 is a portable handheld device. The remote device 2 may in particular be a smart phone or a dedicated remote control device for the skin-mountable medical device 1.

[0039] The skin-mountable medical device 1 includes a medical device control unit 11 (also referred to herein as a “controller”), a functional medical unit 12, a wireless medical device communication unit 13, and a tactile indicator 14.

[0040] The medical device control unit 11 serves the purpose of controlling the overall-operation of the skin-mountable medical device 1. The medical device control unit 11 may include one or more programmable circuits, such as microprocessors and/or microcontrollers, ASICs, or the like, and the corresponding programming respectively software or firmware code. Additionally, or alternatively, the medical device control unit 11 may include special-purpose circuitry.

[0041] The functional medical unit 12 comprises the diagnostic and/or therapeutically and in general medical functionality of the skin-mountable medical device 1. In case of the medical device 1 being an insulin infusion pump as assumed here, the functional medical unit 12 is or includes a pump unit. In an alternative embodiment where the skin-mountable medical device 1 is a continuous glucose measurement device, the functional medical unit 12 may be or include a glucose measurement unit. In the shown example, a transcutaneous element 16 projects from the functional medical unit 12 into the skin S or is part of the functional medical unit. In case of the functional medical unit 12 being a pump unit, the transcutaneous element 16 may be an infusion cannula. In case of the functional medical unit 12 being a glucose measurement unit, the transcutaneous element may be an electrochemical sensing element. In further embodiments, a sensing element may be fully implanted and communicate with the body-mountable wearable device transcutaneous, e.g., via a wireless near field communication link.

[0042] The wireless medical device communication unit 13 (also referred to herein as “wireless communication module” or “wireless communications”) is typically (but not necessarily) based on RF technology, for example Bluetooth or other standard or proprietary communication protocols and technics.

[0043] By way of example, the tactile indicator 14 can be a linear resonant actuator (LRA). In further similar embodiments, the tactile indicator 14 may for example be motor-based vibrator as also typically used in cell phone or pager devices and as explained in the general description above.

[0044] The operation of the functional medical unit 12, the medical device communication unit 13 and the tactile indicator 14 as well as of potential further units or components of the ambulatory medical device 1 is coordinated and controlled by the medical device controller 11. Therefore, the medical device control unit 11 is operatively coupled with the functional medical unit 12, the medical device communication unit 13 and the tactile indicator 14.

[0045] The medical device control unit 11 further includes memory 111 that stores one or more control patterns as explained further below. It is to be understood that the medical device control unit 111 may comprise further volatile and/or non-volatile memory (not explicitly shown) that stores program code and further data as generally known in the art. Such further memory may be integral with memory 111.

[0046] For the purpose of skin-attaching respectively skin-mounting the skin-mountable medical device 1, the medical system comprises in this example cradle 3 as structurally distinct additional component. The cradle 3 has a cradle body 31 that is substantially plate-shaped and may be substantially planar. The cradle body 31 has a proximal side with an adhesive layer 32 for attaching respectively mounting to the skin S. At an opposed distal side (pointing away from the patient's body during application), a medical device coupling structure 33 is present. The medical device coupling structure 33 is designed for engagement with a cradle coupling structure 15 (also referred to herein as a “cradle coupler”) of the skin-mountable medical device 1. In application, the medical device coupling structure 33 (also referred to herein as a “medical device coupler”) and the cradle coupling structure 15 form a mechanical coupling via positive locking and/or force looking. By way of example, the medical device coupling structure 33 and the cradle coupling structure 15 may, in combination, form a latch-catch structure. In dependence of the overall design and the lifetime of the skin-mountable medical device 1, the coupling between the skin-mountable medical device 1 and the cradle 3 may be releasable or non-releasable. It is further noted that the presence of a cradle 3 is not essential. In alternative embodiments, the skin-facing surface of the skin-mountable medical device 1 carries the adhesive layer 32, thereby allowing the skin-mountable medical device 1 to be directly attached to the skin S.

[0047] The remote device 2 (also referred to herein as “remote control” or “remote”) includes a remote device control unit (also referred to as a “remote controller”) 21, a wireless remote device communication unit 23 and a user interface 22.

[0048] The remote device control unit 21 may be realized in a similar manner as explained before with respect to the medical device control unit 11 and may be include programmable multi-purpose components running corresponding code respectively programming and/or special-purpose circuitry. The remote device control unit 21 controls overall operation of the remote device 2.

[0049] The remote device communication unit 23 (also referred to herein as “remote communications”) may be designed in the same way as the medical device communication unit 13. The medical device communication unit 13 and the remote device communication unit 23 are designed for data exchange with each other. The data that may be exchanged include data related to tactile indications as explained further below.

[0050] The remote device user interface 22 is in this example realized as graphical user interface (GUI) with a touchscreen that serves for both receiving respectively inputting and providing, in particular, outputting data from/to a user. The data may, in particular, be related to tactile indications. It is noted, however, that the design of the user interface 22 is not essential and could be realized in different way, too.

[0051] The operation of the remote device communication unit 23 and the user interface 22 as well as of potential further units or components of the remote device 2 is coordinated and controlled by the remote device control unit 21. Therefore, the remote device control unit 21 is operatively coupled with the remote device communication unit 23 and the user interface 22.

[0052] It is noted that the shown structure of both the body-mountable medical device 1 and the remote device 2 serves the purpose of illustration. In fact, a number or all elements or units may be realized in a fully or partly integral way.

[0053] FIG. 2 schematically shows an exemplary display on the touchscreen respectively GUI 22. For inputting location information, a schematic representation P of the patient's body is shown with an indication of body locations where the body-mountable medical device 1 may be mounted respectively attached. By way of example, the body locations are the abdomen, L1, the upper arms, L2, and the thighs, L3. Before or subsequent to attaching the body-mountable device 1, L1, the user selects the body location by touching the corresponding portion of the body representation P. As mentioned before, other ways of inputting the body location may be used as well. Information indicative of the selected body location, for example a code representing the selected body location, is transmitted to the body-mountable medical device 1 via the communication units 13, 23. By way of example, it is assumed that the abdomen, L1, is selected.

[0054] FIG. 3 schematically shows an example of storing control parameters for a number of available control patterns in the memory 111. Memory 111 stores in this example a table where each row corresponds to a specific body location L1, L2, L3, . . . and an associated available control pattern. Further, a column is provided for each control parameter of the control patterns. By way of example, the control parameters are the frequency and the amplitude for activating the tactile indicator 14, number of activation bursts, sequences of activation bursts, and pauses between activation bursts. The selection of L1 as body location (indicated by an arrow) accordingly results in an activation of the tactile indicator 14 with frequency f1 and amplitude a2 for providing tactile indications under control of the medical device control unit 11. In related embodiments with other type of tactile indicators, other control parameters and in particular more or less control parameters may be provided. By way of example, if the tactile indicator 14 is based on a standard DC motor as actuator, the voltage for powering the monitor may be the sole control parameter. It is here exemplarily assumed that the control parameters for the available control patterns are pre-stored, e.g., as factory settings, in the memory 111.

[0055] Further, it is noted that the information as shown in FIG. 3 may alternatively be stored in the remote device 2 rather than the body-mountable medical device 1, and the selected control parameters, e.g., a1 and f1 for L1 as body location, be transmitted to the body-mountable medical device 2.

[0056] The steps of the user selecting a body location is typically part of an initialization routine that is carried out in the process of attaching the body-wearable medical device 1. Typical body-wearable medical devices, in particular, continuous glucose measurement devices and insulin infusion systems, are normally carried by a Person with Diabetes (PwD) as patient substantially continuously, night and day. Maintenance actions, such as the replacement of a drug reservoir and/or the infusion cannula (for an insulin infusion pump), or the replacement of an electrochemical sensing element (for continuous a continuous glucose measurement device) need to be typically carried out in an interval of every few days up to every few weeks. As part of such maintenance action, the body location where the body-mountable medical device 1 is carried is changed by routine in order to minimize the undesired skin irritation resulting from the adhesive layer 32 contacting the skin, as well as the tissue irritation and potentially more severe complications resulting from the skin being pierced by transcutaneous element 16 for an extended time period at the same location. As part of such maintenance action, an initialization routine is generally carried out where, for example, various internal parameters of the medical system may be reset, a new sensing element is initialized, and the like.

[0057] FIG. 4 schematically illustrates various examples for providing tactile indications. In all examples, it is assumed that the tactile indicator 14 is activated by powering it with a control signal in form of a time-varying voltage U. FIG. 4 (a) and Figure (b) both illustrate the indication of a first information that may correspond to an alarm situation that requires immediate attention, such as a device defect or a blocked occlusion cannula. In this example, a continuous indication shall be provided until the alarm is acknowledged by the user. Therefore, the tactile indicator 14 is continuously activated. Figure (a) illustrates the voltage U for a first body location, for example L1.

[0058] Exemplarily, the voltage U is a square-form voltage with amplitude a1 and a period T1=1/f1 as control variables of the active control pattern. FIG. 4 (b) illustrates the voltage U for the same type of indication as in FIG. 4 (b), but for a different body location, for example L2. Exemplarily, the amplitude a2 is larger than the amplitude al and the period T2=1/f2 is larger than T1 (i.e., the frequency f2 is smaller than the frequency f1).

[0059] FIG. 4 (c) and Figure (d) both illustrate the indication of a second information that may for example correspond to a user feedback upon a data input via user interface 22. In this example, the indication that shall be provided is given by a number of, e.g., two vibration bursts that are separated by pause. Therefore, the tactile indicator 14 is activated in with two bursts B. Regarding the body location, the body location is identical for FIG. 4 (c) and FIG. 4 (a), and is further identical for FIG. 4 (d) and FIG. 4 (b). Consequently, each burst corresponds to an activation of the tactile indicator 14 with amplitude a1 and period T1 (frequency f1) in FIG. 4 (c), and an activation with amplitude a2 and period T2 (frequency f2) in FIG. 4 (d). The activation of the tactile indicator 14 respectively the generation of the control signal is controlled by the medical device control unit 11.

[0060] It can be seen that, in this example, the control pattern (determined by frequency and amplitude) only depends on the body location (independent of the indication information), while the indication information determines the timing of activating and deactivating (toggling between “on” and “off”) of the tactile indicator 14.

[0061] Particular embodiments of this disclosure may comprise the set of features listed in the following embodiments numbered 1 to 14.

Embodiment 1

[0062] Medical system, including: [0063] a) a skin-mountable medical device (1), the skin-mountable medical device (1) including an activatable tactile indicator (14); [0064] b) a user interface (22), the user interface (22) being configured to receive location information, the location information indicating a body location where the skin-mountable medical device (1) shall be mounted; [0065] wherein the medical system is configured to determine an active control pattern in dependence of the location information and to control activation of the tactile indicator (14) in accordance with the active control pattern.

Embodiment 2

[0066] Medical system according to embodiment 1, wherein the activatable tactile indicator (14) is a vibrator.

Embodiment 3

[0067] Medical system according to any of the preceding embodiments, wherein the medical system comprises a set of predetermined control patterns and the active control pattern is selected from the set of predetermined control patterns.

Embodiment 4

[0068] Medical system according to any of the preceding embodiments, wherein the medical system includes a remote device (2), wherein the skin-mountable medical device (1) and the remote device (2) are configured for wireless data exchange with each other, wherein the user interface (22) is provided on the remote device (2).

Embodiment 5

[0069] Medical system according to embodiment 4, wherein the remote device (2) is configured to determine the active control pattern and the medical system is configured for transmitting information indicative of the active control pattern from the remote device (2) to the skin-mountable medical device (1).

Embodiment 6

[0070] Medical system according to embodiment 6, wherein the medical system is configured for transmitting information indicative of the location information from the remote device (2) to the skin-mountable medical device (1) and the skin-mountable medical device (1) is configured to determine the active control pattern based on the retrieved information.

Embodiment 7

[0071] Medical system according to any of the preceding embodiments 3 to 6, wherein the activatable tactile indicator (14) is a vibrator and different control patterns among the set of predetermined control patterns for operating the activatable tactile indication (14) differ in at least one of frequency, amplitude, number of activation bursts, sequences of activation bursts, and pauses between activation bursts.

Embodiment 8

[0072] Medical system according to any of the preceding embodiments, wherein the skin-mountable medical device (1) includes a continuous glucose-measurement device and/or an insulin infusion pump.

Embodiment 9

[0073] Medical system according to any of the preceding embodiments, wherein the skin-mountable medical device (1) is configured to control activation of the activatable tactile indicator (14) in accordance with an indication information that shall be indicated to the patient.

Embodiment 10

[0074] A remote device (2), including: [0075] a user interface (22), wherein the user interface (22) is configured to receive location information, the location information indicating a body location where a skin-mountable medical device (1) including an activatable tactile indicator (14) shall be mounted; [0076] wherein the remote device (2) is configured to determine an active control pattern in dependence of the location information and [0077] i.) to control activation of the tactile indicator (14) of the skin-mountable medical device (1) in accordance with the active control pattern; or [0078] ii.) to transmit information indicative of the control pattern from the remote device (2) to the skin-mountable device (1).

Embodiment 11

[0079] Method of providing tactile indications to a user of a medical system, wherein the medical system includes a skin-mountable medical device (1), the method including: [0080] a) receiving, via a user interface (22) of the medical system, location information, the location information indicating a body location where the skin-mountable medical device (1) shall be mounted; [0081] b) determining, by the medical system, an active control pattern in dependence of the location information; [0082] c) controlling activation of an activatable tactile indicator (14) in accordance with the active control pattern.

Embodiment 12

[0083] Method according to embodiment 11, wherein the method includes selecting the active control pattern from a set of predetermined control patterns included by the medical system.

Embodiment 13

[0084] Method according to embodiment 11 or 12, wherein the method includes providing the user interface on a remote device (2).

Embodiment 14

[0085] Method according to any of embodiments 11 to 13, wherein the method includes controlling activation of the activatable tactile indicator (14) in accordance with an indication information that shall be indicated to the patient.

[0086] While exemplary embodiments have been disclosed hereinabove, the present invention is not limited to the disclosed embodiments. Instead, this application is intended to cover any variations, uses, or adaptations of this disclosure using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.

REFERENCE SIGNS

[0087] 1 skin-mountable medical device (insulin infusion pump) [0088] 11 medical device control unit [0089] 111 memory [0090] 12 functional medical unit [0091] 13 (wireless) medical device communication unit [0092] 14 tactile indication unit (vibrator) [0093] 15 cradle coupling structure [0094] 16 transcutaneous element [0095] 2 remote device [0096] 21 remote device control unit [0097] 22 user interface (GUI) [0098] 23 (wireless) remote device communication unit [0099] 3 cradle [0100] 31 cradle body [0101] 32 adhesive layer [0102] 33 medical device mounting structure [0103] a1, a2, a3 amplitudes [0104] B burst [0105] f1, f2, f3 frequencies [0106] L1, L2, L3 body location(s) [0107] S skin [0108] T 1, T2, T3 periods [0109] t time [0110] P patient body representation [0111] U control signal (voltage)