Thermoelectric generator for powering an auto-injector

Abstract

Provided herein is a wearable drug delivery device comprising: a housing having a skin-facing surface defining a cannula opening and a viewing window; a container disposed within the housing and configured to store a pharmaceutical composition therein; a cannula in fluid communication with the container, the cannula being movable from an initial position in which the cannula is disposed within the housing to a use position in which the cannula extends through the cannula opening; a visual identifier aligned with a portion of the viewing window, the position of the visual identifier relative to the viewing window being dependent on the volume of the pharmaceutical composition in the container; and a thermoelectric generator configured to power the drug delivery device, wherein the housing is configured to be removably attached to the skin of a patient.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to European Patent Application No. 21306832.3, filed December 17, 2021, the entire disclosure of which is incorporated herein by reference in its entirety. FIELD OF THEINVENTION The present disclosure relates to a wearable drug delivery device that includes one or more components powered by a thermoelectric generator. [Background technology]

[0002] 2. Description of Related Art Wearable medical devices, such as drug delivery devices, have the advantage of providing treatment to a patient at a location away from a clinical facility and / or while worn separately under the patient's clothing. The wearable medical device may be worn on the patient's skin and may be configured to automatically deliver a dose of a pharmaceutical composition within a predetermined time, e.g., 27 hours, after wearing the wearable medical device on the patient's skin. After the device delivers the pharmaceutical composition to the patient, the patient may then remove and discard the device.

[0003] Such wearable devices are typically powered by one or more batteries. For example, such devices may include an electric motor for expelling the pharmaceutical composition. Furthermore, such wearable devices are increasingly equipped with "smart" features, such as indicators (light emitting diodes, LEDs, etc.), communication devices (such as BLUETOOTH modules), and similar functional components. The use of batteries in such applications brings about increasing waste concerns. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Pat. No. 10,449,292 [Patent Document 2] International Publication No. 2015 / 081337 [Patent Document 3] International Publication No. 2013 / 155153 [Patent Document 4] International Publication No. 2014 / 179774 [Non-patent literature]

[0005] [Non-Patent Document 1] Jaziri et al., "A comprehensive review of thermoelectric generators: technology and common applications," Energy Reports 2020, No. 6, pp. 264-287. Summary of the Invention [Problem to be solved by the invention]

[0006] Thus, there is a need in this field for sustainable energy sources that can be used in wearable drug delivery devices and that may have the potential to be reused. [Means for solving the problem]

[0007] Provided herein is a wearable drug delivery device comprising a housing having a skin-facing surface and a viewing window defining a cannula opening, a container disposed within the housing and configured to store a pharmaceutical composition therein, a cannula in fluid communication with the container, the cannula being movable from an initial position in which the cannula is disposed within the housing to a use position in which the cannula extends through the opening, the cannula, a visual identifier aligned with a portion of the viewing window, the position of the visual identifier relative to the viewing window being dependent on the volume of the pharmaceutical composition in the container, and a thermoelectric generator configured to power the drug delivery device, the housing configured to be removably attached to the skin of a patient.

[0008] According to another aspect of the invention, the container is a flexible container.

[0009] According to another aspect of the invention, the container is a syringe barrel.

[0010] According to another aspect of the invention, the delivery device further includes at least one of an indicator capable of communicating a status of the delivery device to a user and a communication module configured to transmit data related to a status of at least one characteristic of the delivery device.

[0011] According to another aspect of the invention, the thermoelectric generator is configured to power at least one of the indicator and / or the communication module.

[0012] According to another aspect of the invention, the at least one indicator is an LED.

[0013] According to another aspect of the invention, a thermoelectric generator is configured to be disposed between a skin-facing surface of the medication delivery device and the skin of a patient.

[0014] In accordance with another aspect of the present invention, a thermoelectric generator includes a plurality of thermocouples disposed on a substrate.

[0015] In accordance with another aspect of the invention, a plurality of thermocouples are disposed laterally on the substrate.

[0016] According to another aspect of the invention, a plurality of thermocouples are vertically disposed on a substrate.

[0017] According to another aspect of the invention, the one or more thermocouples include one or more polymers.

[0018] According to another aspect of the invention, the one or more polymers include one or more of poly(3,4-ethylenedioxythiophene) polystyrene sulfonate, and / or nickel ethene tetrathiolate.

[0019] According to another aspect of the invention, the one or more thermocouples include silicon, gold, silver, nickel, palladium, copper, antimony, tellurium, bismuth, selenium, magnesium, and / or mixtures and alloys thereof.

[0020] According to another aspect of the invention, the substrate comprises one or more of silicon, alumina, polyimide, cellulose, ceramic, fabric, and / or paper.

[0021] According to another aspect of the invention, the device further includes a motor configured to expel the pharmaceutical composition from the container, the motor being powered by the thermoelectric generator. [Brief description of the drawings]

[0022] [Figure 1] FIG. 1 is a perspective view of a drug delivery device according to non-limiting embodiments or aspects described herein. [Diagram 2] FIG. 1 is a perspective view of a drug delivery device according to non-limiting embodiments or aspects described herein. [Diagram 3] FIG. 1 is a schematic diagram of a drug delivery device according to non-limiting embodiments or aspects described herein. [Figure 4] FIG. 1 is a perspective view of a drug delivery device according to non-limiting embodiments or aspects described herein. [Diagram 5] FIG. 1 is a perspective view of a drug delivery device according to non-limiting embodiments or aspects described herein. [Figure 6] FIG. 1 is a side view of a medication delivery device according to a non-limiting embodiment or aspect described herein. [Figure 7] FIG. 2 is a top view of a drug delivery device according to a non-limiting embodiment or aspect described herein. [Figure 8] FIG. 1 is a schematic diagram of a thermoelectric generator for use with a drug delivery device according to non-limiting embodiments or aspects described herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] Description of the invention The following description is provided to enable a person skilled in the art to make and use the described embodiments contemplated for practicing the invention. However, various modifications, equivalents, changes, and alternatives will be readily apparent to those skilled in the art. Any and all such modifications, modifications, equivalents, and alternatives are intended to be within the spirit and scope of the present invention.

[0024] For purposes of the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives will refer to the present invention as oriented in the drawings. It should be understood, however, that the present invention may assume various alternative modifications unless expressly specified to the contrary. It should also be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. Hence, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting.

[0025] All numerical values ​​used in the specification and claims should be understood in all instances to be modified by the term "about." By "about" is meant a range of plus or minus ten percent of the stated value. As used in the specification and claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. "First," "second," and similar terms are not intended to refer to a particular order or chronology, but instead to different conditions, characteristics, or elements. By "at least" is meant "greater than or equal to."

[0026] As used herein, the term "cannula" may refer to needles, cannulas, catheters, and similar structures that allow fluid communication between a pharmaceutical composition container and a patient.

[0027] As used herein, the term patient may refer to a human or a non-human animal.

[0028] 1-3, provided herein is a drug delivery device 10. The drug delivery device 10 may include a reservoir 12, a power source 14, an insertion mechanism 16, control electronics 18, a cover 20, and / or a base 22. In a non-limiting embodiment or aspect, the drug delivery device 10 is a wearable auto-injector, such as an insulin or bone marrow stimulant delivery device. The drug delivery device 10 may be worn on the skin of a patient and actuated to inject a pharmaceutical composition from the reservoir 12 into the patient. The drug delivery device 10 may be pre-loaded with the pharmaceutical composition or may be loaded with the pharmaceutical composition by the patient or a medical professional prior to use.

[0029] The drug delivery device 10 is configured to deliver a dose of a pharmaceutical composition, e.g., any desired pharmaceutical composition, into the patient's body by subcutaneous injection at a slow, controlled infusion rate, e.g., through the use of a motor (e.g., an electric motor) or a pump, causing the pharmaceutical composition to be expelled from the container 12, e.g., by compressing one or more regions of the container 12, or by causing a stopper to move within the container 12 to reduce the volume of the container 12, or by other similar mechanisms known to those skilled in the art. An exemplary duration of delivery achieved by the drug delivery device 10 can range from about 5 minutes to about 60 minutes, but is not limited to this exemplary range. An exemplary volume of the pharmaceutical composition delivered by the drug delivery device 10 can range from about 0.1 milliliters to about 10 milliliters, but is not limited to this exemplary range. The amount of the pharmaceutical composition delivered to the patient can be adjusted.

[0030] 1-3, in one aspect or embodiment, the power source 14 is a thermoelectric generator 66 that may provide power to other components, such as, for example, the pump, the motor, the control electronics 18, the indicators, and / or the fluidic components. The control electronics 18 may include a microcontroller 24, a sensing electronics 26, a pump / motor and valve controller 28, a sensing electronics 30, and a deployment electronics 32, which control the operation of the drug delivery device 10. The drug delivery device 10 may also include a fluidic subsystem that includes the reservoir 12, a volume sensor 34 of the reservoir 12, a reservoir fill port 36, and a metering system 38 that includes a pump and valve actuator 40 and a pump and valve mechanism 42. The fluidic subsystem may further include an occlusion sensor 44, a deployment actuator 46, a cannula 48 for insertion into the patient's skin, and a fluid line 50 in fluid communication with the reservoir 12 and the cannula 48. In another aspect or embodiment, the occlusion sensor is a system that measures the motor current. In one aspect or embodiment, the insertion mechanism 16 is configured to move the cannula 48 from a retracted position, in which the cannula 48 is fully disposed within the device 10, to an extended position, in which the cannula 48 extends outside the device 10. The drug delivery device 10 may operate in the same manner as described in U.S. Patent Application Publication No. 2007 / 0139994, the contents of which are incorporated herein by reference in their entirety.

[0031] Further, with respect to the thermoelectric generator 66, one skilled in the art will appreciate that multiple arrangements of thermoelectric generators are known, as described in "Thermoelectric Generators for Medical Devices," vol. 13, no. 1, the contents of which are incorporated herein by reference in their entirety. Such thermoelectric generators operate by the Seebeck effect, for which a temperature difference is converted into a voltage via a thermocouple, as shown diagrammatically in FIG. 8. In a non-limiting embodiment or aspect, the thermoelectric generator 66 is disposed on the patient's skin. In a non-limiting embodiment or aspect, a temperature gradient exists between the patient's skin and the surrounding air and / or the interior of the drug delivery device 10. In a non-limiting embodiment or aspect, the thermoelectric generator 66 is disposed between the base 22 of the drug delivery device 10 and the patient's skin.

[0032] The thermoelectric generator 66 described herein may include multiple thermocouples, a heat spreader, and / or a heat sink. Suitable thermocouples may be formed from any suitable material known to one of skill in the art, including, but not limited to, polymers and metals. In non-limiting embodiments or aspects, one or more of the thermocouples are formed from poly(3,4-ethylenedioxythiophene) polystyrene sulfonate and / or nickel ethene tetrathiolate. In non-limiting embodiments or aspects, one or more of the thermocouples are formed from silicon, gold, silver, nickel, palladium, copper, antimony, tellurium, bismuth, selenium, and / or mixtures and alloys thereof. In non-limiting embodiments or aspects, the thermocouple is an N-type thermocouple formed from an alloy of nickel and silicon (e.g., an alloy of nickel, chromium, silicon, and magnesium). In non-limiting embodiments or aspects, the thermocouple is a P-type thermocouple formed from an alloy of palladium (e.g., an alloy of palladium, platinum, and gold). In non-limiting embodiments or aspects, thermoelectric generator 66 includes one or more different types of thermocouples. For example, as shown in the non-limiting embodiment of Figure 8, a microelectromechanical system (MEMS) thermoelectric generator includes a plurality of N-type and P-type thermocouples. Thermoelectric generator 66 may also include one or more heat spreaders to increase the efficiency of conversion of a temperature gradient to a voltage.

[0033] The thermocouples used in the thermoelectric generator 66 may be provided on a substrate. Suitable substrates may be formed from any suitable material known to those of skill in the art, including, but not limited to, silicon, alumina, polyimide, cellulose, ceramic, fabric, and / or paper. Those skilled in the art will appreciate that for use with a wearable drug delivery device, flexible substrates, such as those formed from paper and / or fabric, may provide superior comfort and performance.

[0034] 4-7, another non-limiting embodiment or aspect of the drug delivery device 110 is shown. The drug delivery device 110 can be used to deliver any desired pharmaceutical composition into the patient's body by subcutaneous injection at a slow, controlled infusion rate. An exemplary duration of delivery achieved by the delivery device 110 ranges from about 5 minutes to about 60 minutes, but is not limited to this exemplary range. An exemplary volume of the pharmaceutical composition delivered by the delivery device 110 ranges from about 0.1 milliliters to about 10 milliliters, but is not limited to this exemplary range. The amount of the pharmaceutical composition delivered to the patient can be adjusted.

[0035] 4-7, a drug delivery device 110 according to one embodiment of the present invention may include a drive assembly 112, a reservoir 114 having a pierceable closure 136, a valve assembly 116, and a cannula actuator assembly 118. The drive assembly 112, reservoir 114, valve assembly 116, and cannula actuator assembly 118 are at least partially disposed within a housing 120. The reservoir 114 and valve assembly 116 may be the reservoir 114 and valve assembly 116 shown and described in U.S. Patent No. 5,399,992, which is incorporated herein by reference in its entirety. The cannula actuator assembly 118 may include a cannula actuator body having a cannula shuttle 1102 and a cannula 128 configured to be received by the cannula shuttle 1102 and to be in fluid communication with the reservoir 114, as described above. The cannula actuator body, and thus the cannula shuttle 1102, is biased from the pre-use position to the post-use position via tension spring 1106, although other suitable biasing arrangements may be utilized. Upon engagement of actuation button 126, the cannula actuator body is released and is free to move from the pre-use position to the use position.

[0036] The housing 120 may include an upper portion 122 and a lower portion 124, although other suitable configurations for the housing 120 may be utilized. In one aspect, the drug delivery system 110 is an injection device configured to be worn or secured to a user and to deliver a predetermined amount of a pharmaceutical composition provided in a container 114 to the user by injection. The system 110 may be utilized to deliver a "bolus injection" where the pharmaceutical composition is delivered within a set time. The pharmaceutical composition may be delivered over a period of up to 45 minutes, although other suitable injection amounts and durations may be utilized. The bolus administration or delivery may be performed with or without specific speed control. The drug delivery device 110 may deliver the pharmaceutical composition to the user at a constant pressure and with a rate that is variable. The general operation of the drug delivery device 110 is described and illustrated in U.S. Patent Nos. 5,993,333 and 5,993,352, which are incorporated herein by reference in their entirety. However, briefly, in the pre-use position of the drug delivery device 110, the reservoir 114 is spaced from the drive assembly 112 and the valve assembly 116, and the cannula 128 is in a retracted position.

[0037] During initial actuation of the drug delivery device 110, the drive assembly 112 engages the container 114 and moves the container 114 towards the valve assembly 116, which is configured to pierce the closure 136 of the container 114 and place the pharmaceutical composition in the container 114 in fluid communication with the cannula 128 via a tube (not shown) or other suitable arrangement. The drive assembly 112 is configured to engage a stopper of the container 114, and the drive assembly 112 will initially move the entire container 114 into engagement with the valve assembly 116 due to the incompressibility of the fluid or pharmaceutical composition in the container 114. The stopper is then displaced by a force from the drive assembly 112, thereby expelling the pharmaceutical composition from the container 114 through the cannula 128. Initial actuation of the drug delivery device 110 is caused by engagement of the actuation button 126 by a user, which releases the cannula actuator assembly 118 and the drive assembly 112, as described in more detail below. During initial actuation, the cannula 128 is still in the retracted position and is about to move to the extended position to inject the user of the drug delivery device 110. Once injection of the pharmaceutical composition is complete, the cannula 128 is withdrawn.

[0038] The housing 120 of the drug delivery device 110 may include an indicator window 130 for viewing an indicator arrangement 132 configured to provide notification to a user of the status of the drug delivery device 110, and a receptacle window 131 for viewing the receptacle 114. The indicator window 130 may be a magnifying lens for providing clear viewing of the indicator arrangement 132. The indicator arrangement 132 may move with the cannula actuator assembly 118 during use of the drug delivery device 110 to indicate a pre-use state, a use state, and a post-use state of the drug delivery device 110. The indicator arrangement 132 may provide a visual indication of the status, although other suitable indications, such as audio or tactile, may be provided as alternative or additional indications.

[0039] The drug delivery device 110 may include a thermoelectric generator 166, such as those described above. The thermoelectric generator 166 may be disposed on the patient's skin, optionally between the housing 120 of the drug delivery device 110 and the patient's skin.

[0040] As described above, in non-limiting embodiments or aspects, the drug delivery device 10, 110 may include one or more indicators 90, 190, such as visual, audio, and / or tactile indicators. In non-limiting embodiments or aspects, the thermoelectric generator 66, 166 may power the one or more indicators. In non-limiting embodiments or aspects, the visual indicators are one or more light emitting diodes (LEDs). The LEDs may be multi-color LEDs. In non-limiting embodiments or aspects, multiple LEDs of the same color or different colors may be provided. The LEDs may be provided on the top surface of the drug delivery device 10, 110 for easy viewing by the patient. The LEDs may be configured to walk through a particular drug delivery procedure and / or error messages for the benefit of the patient, for example, via a microcontroller as described herein, by changing the color of the LEDs, the rate at which the LEDs blink, or through a transition between blinking and a constant LED signal. The LEDs may be configured to indicate errors with the device, such as improper placement on the patient, a blocked drug ejection mechanism, a low battery warning, etc. The LEDs may also be configured to display an end-of-dose indicator to the patient. Optionally, multiple indicators, such as multiple LEDs, may be provided on opposite sides of the medication delivery device 10, 110 to optimize visibility from multiple directions.

[0041] As briefly described above, in non-limiting embodiments or aspects, the medication delivery device 10, 110 may include one or more microcontrollers, sensors, and other electronic devices. The one or more microcontrollers may communicate with a wireless communication module, such as, but not limited to, a Wi-Fi module, a BLUETOOTH module, a Near Field Communication (NFC) module, or other wireless communication circuitry. The wireless communication module may be configured to enable the medication delivery device 10, 110 to communicate with one or more other electronic devices, such as a smartphone, a smartwatch, a tablet, a computer, or other electronic devices, via a wireless connection. The wireless connection may be any Wi-Fi, BLUETOOTH, NFC, or other wireless connection. The wireless communication module may be configured to automatically pair with one or more other electronic devices that are within range of the wireless signal transmitted by the medication delivery device 10, 110. In non-limiting embodiments or aspects, the thermoelectric generator 66, 166 provides power to the microcontroller and / or the wireless communication module.

[0042] In non-limiting embodiments or aspects, the wireless communication module may be configured to provide one-way communication with one or more other electronic devices, such as a smartphone, a smartwatch, a tablet, a computer, or other electronic device. The one-way communication with the one or more electronic devices may include communicating information regarding at least one characteristic of the drug delivery device 10, 110, such as, but not limited to, a delivery status of the drug delivery device 10, 110, a fill level of the drug delivery device 10, 110, whether the drug delivery device 10, 110 is paired with one or more other electronic devices, and / or a type of pharmaceutical composition delivered to a patient.

[0043] In non-limiting embodiments or aspects, the wireless communication module may be configured to provide bidirectional communication with one or more other electronic devices, such as a smartphone, a smartwatch, a tablet, a computer, or other electronic devices. The bidirectional communication with the one or more electronic devices may include communicating information regarding at least one characteristic of the drug delivery device 10, 110, such as, but not limited to, a delivery status of the drug delivery device 10, 110, a fill level of the drug delivery device 10, 110, whether the drug delivery device 10, 110 is paired with one or more other electronic devices, and / or a type of pharmaceutical composition delivered to a patient, and receiving information from the one or more electronic devices. In non-limiting embodiments or aspects, receiving information from the one or more electronic devices may include a control signal for controlling at least one aspect of the drug delivery device 10, 110, such as a delivery status of the drug delivery device 10, 110.

[0044] Although the present invention has been described in detail for purposes of illustration based on what are presently considered to be the most practical and preferred embodiments, it should be understood that such detail is for this purpose only and that the present invention is not limited to the disclosed embodiments, but rather is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

Claims

1. 1. A wearable medication delivery device, comprising: a housing including a skin-facing surface defining a cannula opening and a viewing window; a container disposed within the housing and configured to store a pharmaceutical composition therein; a cannula in fluid communication with the container, the cannula being movable from an initial position in which the cannula is disposed within the housing to a use position in which the cannula extends through the cannula opening; a visual identifier aligned with a portion of the viewing window, the position of the visual identifier relative to the viewing window being dependent on the volume of the pharmaceutical composition within the container; and a thermoelectric generator configured to power the medication delivery device; A wearable drug delivery device, wherein the housing is configured for removably attachment to a patient's skin.

2. The wearable drug delivery device according to claim 1 , wherein the container is a flexible container.

3. 2. The wearable medication delivery device of claim 1, wherein the container is a syringe barrel.

4. A wearable drug delivery device as described in claim 2 or 3, characterized in that the delivery device further includes at least one of an indicator capable of communicating a status of the delivery device to a user and a communication module configured to transmit data regarding the status of at least one characteristic of the delivery device.

5. 5. The wearable drug delivery device of claim 4, wherein the thermoelectric generator is configured to provide power to the at least one indicator and / or the communication module.

6. 5. The wearable drug delivery device of claim 4, wherein the at least one indicator is an LED.

7. 10. The wearable drug delivery device of claim 1, wherein the thermoelectric generator is configured to be disposed between the skin-facing surface of the drug delivery device and the patient's skin.

8. 10. The wearable drug delivery device of claim 1, wherein the thermoelectric generator comprises a plurality of thermocouples disposed on a substrate.

9. 9. The wearable drug delivery device of claim 8, wherein the plurality of thermocouples are laterally disposed on the substrate.

10. 9. The wearable drug delivery device of claim 8, wherein the plurality of thermocouples are vertically disposed on the substrate.

11. 10. The wearable drug delivery device of claim 8, wherein the one or more thermocouples comprise one or more polymers.

12. 12. The wearable drug delivery device of claim 11, wherein the one or more polymers include one or more of poly(3,4-ethylenedioxythiophene) polystyrene sulfonate and / or nickel ethene tetrathiolate.

13. 9. The wearable drug delivery device of claim 8, wherein one or more of the thermocouples comprises silicon, gold, silver, nickel, palladium, copper, antimony, tellurium, bismuth, selenium, magnesium, and / or mixtures and alloys thereof.

14. A wearable drug delivery device as described in any one of claims 8-13, characterized in that the substrate comprises one or more of silicon, alumina, polyimide, cellulose, ceramic, fabric, and / or paper.

15. 2. The wearable drug delivery device of claim 1, further comprising a motor configured to expel the pharmaceutical composition from the container, the motor being powered by the thermoelectric generator.

Images