Patch Pump

Abstract

A disposable module that can be coupled to a reusable module in order to form a pump for dispensing a medicament substance to a user in a metered manner in a coupled state, comprising a housing that encases the following components: a reservoir for receiving the substance to be dispensed; and at least one extensible cannula, which is fluidically connected to the reservoir either after being inserted or in a permanent manner. The disposable module may also comprise an electrical energy store, wherein the electrical energy necessary for the reusable module can be obtained both from the disposable module and also from a rechargeable battery in the reusable module, in order to ensure redundancy of the energy necessary for the reusable module.

Claims

1. A disposable module that can be coupled to a reusable module in order to form a pump for dispensing a substance to a user in a metered manner in a coupled state, comprising a housing that encases the following components: a reservoir for receiving the substance to be dispensed; and at least one extensible cannula, which is fluidically connected to the reservoir either after being inserted or in a permanent manner.

2. The disposable module according to claim 1, further comprising, within the disposable module housing, a cannula insertion mechanism comprising an energy source to drive the at least one cannula for the insertion or move the at least one cannula out of the housing.

3. The disposable module according to claim 1, wherein the cannula insertion mechanism automatically or independently pushes the at least one cannula out of the disposable module and/or automatically or independently performs an insertion procedure of the at least one cannula in a user.

4. The disposable module according to claim 1, further comprising a battery that provides electrical energy for at least one component of the reusable module.

5. The disposable module according to claim 4, wherein the battery is fixedly or detachably connected to the disposable module.

6. The disposable module according to claim 4, wherein the battery comprises one or more disposable batteries or button cells.

7. The disposable module of claim 4, wherein the at least one component of the reusable module comprises one necessary to dispense the substance from the reservoir.

8. The disposable module of claim 1 wherein the at least one cannula is a hard cannula and/or a soft cannula.

9. A reusable module connectable with the disposable module of claim 3, comprising: a chargeable energy store element; a drive means and a control means that can be supplied with electrical energy by the chargeable energy store element; and a mechanical interface and/or an electrical interface forming a connection between the disposable module and the reusable module, in order to trigger the cannula insertion mechanism for the insertion of the at least one cannula.

10. The reusable module according to claim 9, wherein the chargeable energy store element is a rechargeable battery fixedly or exchangeably connected to the reusable module.

11. The reusable module according to claim 9, wherein the control means communicates wirelessly with an external control device for the exchange of control signals.

12. A pump comprising: a disposable module comprising a housing that encases the following components: a reservoir for receiving the substance to be dispensed; and at least one extensible cannula, which is fluidically connected to the reservoir either after being inserted or in a permanent manner; and a reusable module comprising a mechanical and/or electrical interface forming a connection with the disposable module, in order to trigger a cannula insertion mechanism for the insertion of the at least one cannula.

13. The pump according to claim 12, wherein the pump is a patch pump.

14. The pump of claim 12, wherein the interface comprises an electrical interface, comprising: electrical contacts to transmit electrical energy from the disposable module for charging a chargeable electrical energy store or battery in the reusable module, and wherein the electrical energy necessary for the reusable module can be obtained both from the disposable module and also from the chargeable electrical energy store or battery in the reusable module, so that, during normal operation, in the case of a non-defective chargeable electrical energy store or battery, the electrical energy necessary for the reusable module can be obtained from the chargeable electrical energy store or battery, and, in the case of a disturbed or interrupted electrical energy supply from the chargeable electrical energy store or battery, the electrical energy necessary for the reusable module can be obtained from a disposable module battery, in order to ensure redundancy of the energy necessary for the reusable module.

15. A method for operating a pump comprising: a disposable module that can be coupled to a reusable module in order to form a pump for dispensing a substance to a user in a metered manner in a coupled state, the disposable module comprising a housing that encases the following components: a reservoir for receiving the substance to be dispensed; and at least one extensible cannula, which is fluidically connected to the reservoir either after being inserted or in a permanent manner, and the reusable module comprising: a chargeable energy store element; a drive means and a control means that can be supplied with electrical energy by the chargeable energy store element; and a mechanical interface and/or an electrical interface forming a connection between the disposable module and reusable module, in order to trigger a cannula insertion mechanism, wherein a battery of the disposable module is coupled to the chargeable energy store element of the reusable module and charges it, and wherein, in the case of a functioning chargeable energy store element, the energy supplied for the reusable module is provided by said chargeable energy store element, and, in the case of non-functioning chargeable energy store element, it is provided by the disposable module or its battery.

16. The method according to claim 15, wherein an energy quantity contained in the battery of the disposable module is greater than the energy quantity that is necessary for completely dispensing the substance contained in the reservoir of the disposable module.

17. The method according to claim 15, wherein a cannula insertion mechanism drives the at least one cannula for the insertion or moves it out of the housing.

18. The method according to claim 17, wherein the cannula insertion mechanism automatically or independently pushes the at least one cannula out of the disposable module and/or automatically or independently performs an insertion procedure of the at least one cannula in a user.

19. The method according to claim 15, further comprising securing the coupled disposable module and reusable module with a securing and release element.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0054] Below, the invention is described in reference to the appended figures which show embodiments of the invention.

[0055] FIG. 1 shows a diagrammatic representation of the components of a pump consisting of a disposable module and a reusable module according to an embodiment;

[0056] FIG. 2 shows the assembly of a disposable module and a reusable module according to an embodiment;

[0057] FIG. 3 shows an embodiment of a patch pump consisting of a disposable module and a reusable module;

[0058] FIG. 4 shows a diagrammatic representation of an embodiment of a disposable module with an interface with the electrical contacting;

[0059] FIG. 5 shows the energy supply design according to an embodiment of the invention.

DETAILED DESCRIPTION

[0060] FIG. 1 shows, in a diagrammatic representation, an embodiment example of a disposable module 20 that comprises a reservoir 22 for a substance to be dispensed, which can be prefilled or designed to be Tillable through a filling opening. The reservoir 22 is already permanently, that is to say without interruption, in fluidic connection with a cannula 23 in the starting state before an insertion, so that a substance can be dispensed through the cannula 23 from the reservoir 22.

[0061] The cannula 23 can be pushed or expelled, for example from a disposable module housing, by means of a cannula insertion mechanism 24 powered by an energy source (such as one or more springs) provided in the housing of the disposable module 20, in order to perform an insertion, and the cannula 23 can, for example, be inserted by puncturing through the skin of a user.

[0062] In the disposable module 20, that is to say, for example, enclosed by the disposable module housing and/or firmly connected thereto, for example, embedded by casting therein, a battery 21 is provided, for example, in the form of a disposable battery or a button cell.

[0063] In the embodiment shown, a reusable module 10 comprises an electrical energy store element in the form of a rechargeable battery 11 which, when the disposable module 20 and the reusable module 10 are electrically connected to one another, can be charged by the battery 21 of the disposable module 20. The rechargeable battery 11 is used for the current supply of the motor 12 contained in the reusable module 10 and for the control 13 (e.g., a microprocessor) that is used for the control of the motor 12 and can exchange data with an external control device 30, for example, via a radio connection. On the external control device 30, for example, software (control app) can be implemented, which enables a user to engage in a contactless interaction with the reusable module 10 and the disposable module 20 coupled thereto.

[0064] The motor 12 can act mechanically on the reservoir 22 in order to dispel a substance contained therein if, for example, via the control app running on the external control device 30, corresponding signals have been transmitted to the control 13, and the control 13 accordingly actuates the motor 12.

[0065] FIGS. 2A to 2C show the connection of the disposable module 20 to the reusable module 10 in the embodiment example of a bayonet closure. Here, first, as shown in FIG. 2A, components that are present separately, reusable module 10 and disposable module 20, are assembled, as shown in FIG. 2B, and subsequently turned relative to one another for the firm and play-free connection around the bayonet closure, until they are flush in contact with one another, as shown in FIG. 2C.

[0066] FIG. 3 shows, in a top view, an embodiment example of a patch pump 40 consisting of disposable module 20 and reusable module 10, with an adhesive plaster element 25, attached to the bottom side of the disposable module 20, with an adhesive surface for adhesion to the assembled pump.

[0067] According to an embodiment, the disposable module 20 can be filled before or after the assembly with the reusable module 10. Here, for example, a syringe that is in itself known can be used as a transfer filling aid. For example, the substance to be dispensed, such as, for example, a drug, is filled from a primary packaging means (vial) into the syringe. From the filled syringe, the substance or the drug is dispensed through a filling opening into the reservoir 22 of the disposable module 20.

[0068] After the assembly of reusable module 10 and disposable module 20, or after the actuation of the filling process, for example, the filling quantity of the reservoir 22 can be determined. For this purpose, it can be determined, for example, where the stopper of the reservoir 22, which has been shifted by the filling process of the reservoir 22, is located, for example, in that the motor 12 is actuated so that a piston rod is deployed in the direction of the stopper, and it is observed when the piston rod strikes the stopper, in that, for example, the motor current is measured.

[0069] The user can apply the patch pump to the skin and trigger the insertion of the needle and subsequently also the insulin delivery.

[0070] FIG. 4 diagrammatically shows an embodiment example of a disposable module 20 and its electrical contacts 1 to 4 at the interface 26 with the reusable module 10.

[0071] The electrical contacts are, for example, injection molded in the housing of the disposable module 20. The contacting site of the interface 26 is preferably sealed in the assembled state and thus provides protection against soiling and water. On the reusable module 10, for example, robust contact surfaces can be provided. On the disposable module 20, for example, contact springs can be implemented, which are exchanged with each exchange of the disposable module 20.

[0072] As soon as a disposable module 20 is coupled to a reusable module 10, the control 13 (e.g., microprocessor) in the reusable module 10 is started as a result of the applied disposable battery voltage at the connection 1 shown in FIG. 4. The wake-up of the reusable module 10 is also enabled, for example, with a partially discharged battery 21. If a disposable module 20 with completely discharged battery 21 is connected to a reusable module 10, then no wake-up is possible.

[0073] The rechargeable battery 11 of the reusable module 10 is charged or discharged via the battery 21 of the disposable module 20. The charging of the rechargeable battery 11 occurs, in the normal case, with as constant as possible a charging current, whereby the capacity that can be removed from the battery 21 is maximized. The charging current is adjusted, for example, to the charging state of the rechargeable battery 11. Via the applied battery voltage, the presence of the disposable module 20 on the reusable module 10 can also be verified.

[0074] The disposable module 20 contains a microcontroller MCU 28 that is designed for reading and writing information on the disposable module 20, such as, for example, version, status of the insertion mechanism 24, reservoir size or expiration date of the substance contained in the reservoir 22. The microcontroller MCU 28 can communicate via the connection 2 or 4 with the reusable module 10 coupled to the interface.

[0075] Optionally, a disposable module 20 can be invalidated at any time, if, for example, one or more filling status detections have already been carried out, or, for example, only after the insertion mechanism 24 has been triggered. If an invalidated disposable module 20 is detected by a reusable module 10, then it is rejected, i.e., the reusable module 10 does not make available any dispensing functions, such as, for example, the operating of the motor 12, to the disposable module 20 which has been determined to be invalidated.

[0076] The signal for triggering the cannula or needle insertion mechanism 24 can be transmitted to the MCU 28 via a communication interface, for example, at connection 4, which can control the needle insertion mechanism 24.

[0077] The battery 21 in the disposable module can optionally be designed to deliver the energy for triggering the needle insertion mechanism 24. This energy can be delivered, for example, via the connection 2 of the rechargeable battery 11 of the reusable module 10.

[0078] In the storage state, the switch S for supplying the needle insertion mechanism 24 is closed. During the insertion of the needle or cannula 23, the switch S, which can be switched with the change of the needle position N and which is connected or mechanically coupled to the cannula, is opened. Based on the voltage measurement between the needle insertion mechanism 24 and the switch S, on the one hand, the voltage at the connection 2 before the triggering of the needle or cannula 23 can be verified, and, on the other hand, the status of the switch S can be determined. If the switch S is closed, a voltage drop occurs when the needle or cannula insertion mechanism 24 is switched on. In the open state, no voltage can be measured. The MCU 28 stores the status, and the reusable module 10 can read out the status at any time via the connection 4.

[0079] FIG. 5 diagrammatically shows the energy supply design of the pump, which shows that the operation of the electronics unit, such as, for example, the control 13 of the reusable module 10, can be ensured by the rechargeable battery 11 in the reusable module 10. The battery 21 in the disposable module 20 is used for charging or supplementary charging of the rechargeable battery 11 of the reusable module 10 with the charging current I1. Here, with a charging electronics unit 14, for example, a voltage adaptation or an automatic charging system can be implemented. For example, depending on the type of operation of the charging electronics unit 14, the charging current I1 delivered by the battery 21 can be greater than, identical to or smaller than the charging current I2 provided for charging the rechargeable battery 11. Thus, all the components with high energy consumption, such as, for example, the motor 12 or the drive for the insulin conveyance, an optionally provided buzzer or signaling device, or the triggering of the cannula insertion mechanism 24, can be supplied with electrical energy by the rechargeable battery 11 of the reusable module 10. The battery 21 of the disposable module 20 can be discharged continuously and in a low-loss manner in order to charge the rechargeable battery 11.

[0080] If the rechargeable battery 11 is insufficiently charged, for example, for a scheduled therapy, the rechargeable battery 11 is first additionally charged by a quick charging. If, after the minimum charging state of the rechargeable battery 11 has been reached, the battery 21 is not sufficiently charged to supply the desired reservoir quantity of the connected disposable module 20, an exchange of the disposable module 20 can be necessary.

[0081] Preferably, the capacity of the battery 21 is greater than the capacity necessary for the predetermined therapy duration of 3 days, for example, and a maximum filling quantity of the reservoir 22. Thereby, the charging state of the rechargeable battery 11 can be increased with each disposable module 20 or each new battery 21.

[0082] For example, in the case of failure of the rechargeable battery 11 in the reusable module 10, the battery 21 in the disposable module 20 can be used as an energy source in order to warn the user and, for example, to provide the energy for the warning via a smartphone 30.

Pump Switching Functionality

[0083] In connection with the above-described pump, or in general when at least two pumps are used, an exchange or continuation function can be integrated in the control or communication of the pumps in order to support the user during the seamless switching between two pumps.

[0084] In the process, while one pump is still active, a second pump, for example, can be filled, activated and applied on the body. If the first pump is empty, this is detected by the first pump, and all the relevant operating parameters such as, for example, current basal rates, boluses and optionally other settings of the most recently still active first pump are transmitted to the new second pump, and the signal is given to said second pump to continue to the extent possible a seamless or interruption-free substance dispensing based on the transmitted data.

[0085] Thus, for example, a substance contained in a pump can be used up practically completely, and a discrete switch from one pump to another pump can be enabled, without the user having to intervene, in order to initiate the functional transition from one pump to the other pump.