MEMS platform to create fluid seal and path between reservoir and cannula of a device for delivering insulin

Abstract

A device for delivering medication to a user, the device configured to be mounted to the user, the device comprising: (a) a baseplate and a housing configured to engage the baseplate to form an interior therein; (b) a platform mounted to the baseplate within the interior, the platform configured to support a micropump having an inlet port for communicating with a reservoir and an outlet port for communicating with a cannula for delivering the medication to the use.

Description

MEMS PLATFORM TO CREATE FLUID SEAL AND PATH BETWEEN RESERVOIR AND CANNULA OF A DEVICE FOR DELIVERING INSULINCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. provisional application 63 / 655,709 filed June 4, 202, entitled “MEMS Package to Create Fluid Seal and Path Between Device Reservoir and Patient” which is incorporated by reference herein.FIELD OF THE INVENTION

[0002] The present invention relates to a MEMS platform and method that creates a fluid seal and path between a reservoir and cannula of a device for delivering insulin.BACKGROUND OF THE INVENTION

[0003] Insulin pumps help people with diabetes to conveniently manage their blood sugar. These devices deliver insulin at specific times. Insulin patch pumps or pods are one type of insulin pump. The patch pumps are wearable devices that adhere to the skin of a user using an adhesive patch. The patch pumps are controlled wirelessly with a handheld controller. The patch pumps deliver insulin from a chamber and internal cannula based on separately acquired CGM sensor readings. The fluidic components within the patch pumps are typically significant in number to achieve proper fluid delivery. Component integration for such pumps are complex and current solutions are thus large and expensive. This complication risks device malfunction.

[0004] It would be advantageous to provide improvements to insulin pumps described above.SUMMARY OF THE INVENTION

[0005] In accordance with an example of this disclosure, a device for delivering medication to a user, the device configured to be mounted to the user, the device comprising: (a) a baseplate and a housing configured to engage the baseplate to form an interior therein; (b) a platform mounted to the baseplate within the interior, the platform configured to support a micropump having an inlet port for communicating with a reservoir and an outlet port for communicating with a cannula for delivering the medication to the user; wherein the platform includes: (1) a first side and a second side opposing the first side; (2) first and second holes extending through the platform with first and second openings on each of the first and second sides of the platform, respectively, the first and second openings on the first side ofthe platform aligned with inlet and outlet openings of a micropump when mounted on the platform, respectively; (3) an inlet port for communicating with a reservoir filled with medication and an outlet port for communicating with a cannula for delivering the medication; (4) first and second open channels extending on the second side of the platform that are sealed when the platform is mounted on the baseplate, wherein the first open channel is configured to enable communication between (1) the inlet port of the platform and (2) the inlet opening of the micropump device through the first opening of the first hole on the second side of the platform, wherein the second open channel is configured to enable communication between the outlet opening of the micropump through the second opening of the second hole on the second side and the outlet port of the platform.

[0006] In accordance with yet another example of this disclosure, a platform for mounting on a baseplate of a device for delivering medication to a user, the platform configured to support a MEMS device for pumping the medication into the user, the platform comprising: (a) a first side and a second side opposing the first side; (b) first and second holes extending through the platform with first and second openings on each of the first and second sides of the platform, respectively, the first and second openings on the first side of the platform aligned with inlet and outlet openings of a MEMS device when mounted on the platform, respectively; (c) an inlet port for communicating with a reservoir filled with medication and an outlet port for communicating with a cannula for delivering the medication; (d) first and second channels extending on the second side of the platform that are sealed when the platform is mounted on the baseplate, wherein the first channel is configured to enable communication between (1) the inlet port of the platform and (2) the inlet opening of the MEMS device through the first opening of the first hole on the second side of the platform, wherein the second channel is configured to enable communication between the outlet opening of the MEMS device through the second opening of the second hole on the second side and the outlet port of the platform.

[0007] In accordance with another example of this disclosure, a method for integrating a MEMS device into a fluid path of a device for delivering medication to a user, the device including a baseplate and a housing configured to engage the baseplate to form an interior the MEMS device including an inlet opening and outlet opening, the method comprising: creating a platform for supporting the MEMS device and enabling the medication to flow to and from the MEMS device through the inletand outlet openings respectively, creating including forming (1) first and second holes extending through the platform and (2) first and second channels on the platform communicating with the first and second holes; attaching the platform to the baseplate within the interior thereby sealing the first and second channels to enable medication to flow through the first and second channels; and mounting MEMS device to the platform including aligning the inlet opening and the outlet opening of the MEMS device platform with openings to the first and second holes of the platform.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Fig. 1 depicts a perspective view of an example device for delivering insulin for incorporating a platform for integrating a MEMS device into a fluid path of the device.

[0009] Fig. 2 depicts a perspective view of an example platform for integrating a MEMS device into a fluid path of the device for delivering insulin.

[0010] Fig. 3 depicts a bottom view of the platform in Fig. 2.

[0011] Fig. 4 depicts a top view of the platform in Fig. 2 with the MEMs device mounted thereon.

[0012] Fig. 5 depicts a perspective view of the platform in Fig. 2 with the MEMs chip mounted thereon.

[0013] Fig. 6 depicts a top view of a baseplate of the device for delivering insulin with the platform in Figs. 4-5 fully mounted on the baseplate.

[0014] Fig. 7 depicts a side view of a baseplate of Fig. 6.

[0015] Fig. 8 depicts a block diagram of example components of device in Fig. 1 .

[0016] Fig. 9 depicts a flow diagram of a method for integrating a MEMS device into a fluid path of a device for delivering medication to a user.DETAILED DESCRIPTION OF THE INVENTION

[0017] Fig. 1 depicts a perspective view of an example device 100 for delivering insulin for incorporating platform 200 (package) for integrating MEMS device 202 into a fluid path of device 100.

[0018] In detail, a method and platform 200 are provided for integrating a Micro- Electro-Mechanical Systems (MEMS) chip or device 202 into a fluid path of device 100 for delivering insulin to a user (also known as medical device 100), such as an infusion pump or pod. MEMS device 202 is a type of micropump that is used as a pumping and / or valving mechanism as described below.

[0019] Device 100 is configured as a wearable apparatus or system that is part of an infusion system for diabetes management in which continuous glucose monitoring (CGM), insulin delivery and control functionality are provided to ensure insulin is delivered at very precise rates. Device 100 however may be configured as a system for managing and infusing other medications / fluids to a user. Medication (also referred to as medicament) may include small molecule pharmaceutical solutions, large molecule or protein drug solutions, saline solutions, blood or other fluids known to those skilled in the art. Insulin is an example fluid (medication) and described below with respect to device 100. However, device 100 may be used in other environments known to those skilled in the art.

[0020] Device 100 comprises housing 102 and base plate 104 that together form an interior that includes several components or modules within housing and baseplate 104 such as a micropump as well as a reservoir for storing the insulin, control circuitry (integrated circuit -- IC) such as a microcontroller unit (MCU), battery for powering the IC, an insulin catheter or needle and a continuous glucose monitoring (CGM) sensor (to name a few). Fig. 8 depicts an example device illustrating some of these components.

[0021] As described above, MEMS (micro-electro-mechanical systems) device 202, as known to those skilled in the art, may be used for pumping fluid, valves used for regulating flow, actuators used for moving or controlling the micropump and valves and / or sensors used for sensing pressure and / or flow. MEMS device 202 incorporates one or more piezoelectric elements 206, 208 and 210 or devices (also known herein as piezoelectric transducers), as known to those skilled in the art and described below. Example piezoelectric devices 206, 208, 210 include piezoelectric actuators and various types of MEMS sensors. The piezoelectric devices function as the active element(s) of a pump for pumping fluid and valves for preventing fluid flow and / or a sensor for sensing pressure or flow. Alternatively, the micropump may be a non-MEMS structure or technology to achieve desired results as known to those skilled in the art.

[0022] In this example, MEMS device 202, as a micropump (also referenced as 202), is a cavity substrate that includes a cavity defined by top and bottom wafers (e.g., silicon on insulator and silicon wafers or layers as known to skilled in the art). The top wafer functions as a membrane for the three chambers in this example as shown (or could be any number of chambers). The bottom wafer includes inlet andoutlet ports 202-1 and 202-2 as best shown in Fig. 2 that communicate with valve chambers of the cavity via channels that extend through the bottom wafer. In this example, micropump 202 is a three-chamber pump associated with piezoelectric devices 206, 208, 210 with a pump section and two valve sections that function together to pump fluid through the three chambers of the cavity.

[0023] Fig. 2 depicts a perspective view of example platform 200 for integrating a MEMS device 202 into a fluid path of device 100 for delivering insulin. Figs. 3-5 depict varies views of platform 202 with MEMS device 202 mounted thereon. In short, channels 200-3 and 200-4 are created in platform 200 instead of baseplate 102 of device 100 itself. This is achieved by attaching MEMS device 202 to a separate injection molded piece (the MEMS platform described above) using an adhesive such as VHB tape.

[0024] Specifically, platform 200 is a piece or structure that includes two holes 200-1 and 200-2 that extend through platform 200 with openings on each side of platform 200. The openings to holes 200-1 and 200-2 on the top side or surface of platform 200 align with the inlet and the outlet ports 202-1 and 202-2 of the MEMS device 202, respectively as mounted. Platform 200 further includes open channels 200-3 and 200-4 on the opposing side (bottom) thereof that will eventually be sealed when mounted on baseplate 104. Platform 200 also includes inlet port 200-5 (with a channel and hole 206-5a) that communicates with a reservoir and outlet port 200-6 that communicates with an introducer cannula that delivers insulin to the user.Channel 200-3 has opposing ends, one of which extends from the opening 206-5a of inlet port 206-5 as shown while the opposing end of channel 200-3 extends from and into opening 200-1 that communicates with MEMS device 202 as described herein.

[0025] Channel 200-4 has two opposing ends, one of which communicates with outlet port 202-2 of MEMS device 202 via opening 200-2 in platform 200 and the other end communicates with the cannula via outlet port 206-6 in platform 200. Platform 200 further includes a hole 200-7 that extends through platform 200. Hole 200-7 includes an opening to channel 200-4 midway between opposing ends as shown to enable a sensor 204 to measure pressure. (As shown, channel 200-4 is essentially shown as two sections or segments due to the hole / opening 200-7.)

[0026] During assembly, platform 200 (with MEMS device) is then laser welded to the baseplate 104 to create the fluidic seals. This embodiment would require a material that is compatible to laser or ultrasonic welding to the baseplate. Anotherway of creating the fluidic seal would be to heat stake a polymer film to the bottom of platform 200. When the polymer film is heat staked to the bottom, the fluidic seal is created on the individual platform 200 itself. Then, to integrate it into the full device 200 system, platform 200 can be heat staked directly onto baseplate 104.

[0027] In this way, a MEMS device 200 is allowed to be used as a pump actuator and / or valve in an infusion pump such as an insulin delivery device and connect the fluid path between the reservoir, MEMS device, and cannula / patient. This method and platform 200 are improvements over current methods and platforms as it eliminates the need for creating channels into the baseplate 104, reduces the complexity of the design, and provides an easy way to integrate MEMS device 202 to the device fluid path.

[0028] Figs. 6-7 depicts a top view of baseplate 104 of the device 100 for delivering insulin with platform 200 in Figs. 4-5 mounted on a base plate.

[0029] In summary, a method and platform 200 provide for integrating a Micro- Electro-Mechanical Systems (MEMS) device into a fluid path of a medical device 100, such as an infusion pump. The method (and platform) includes creating channels on a platform (above) instead of a baseplate of a device for delivering insulin, attaching the MEMS platform to a separate injection molded piece (baseplate), and laser or ultrasonic welding or heat staking the MEMS platform 200 to the baseplate to create a fluidic seal. This method and platform simplify the design and improve the integration of the MEMS device into the fluid path of the medical device. This method is described (high level) in Fig. 9.

[0030] Fig. 8 depicts a block diagram of example components of device 800 for delivering insulin of an infusion system as described above. (Device 100 or device 800 is represented as device 100 in Fig. 1.) Specifically, device 800 incorporates several components or modules (not shown) in the fluidic pathway including reservoir 800-1 for storing the insulin, micropump 800-2 (as described hereinabove) for pumping the insulin or other medication, sensors 800-3 (e.g., pressure) for sensing various parameters in the system and user and tubing connecting infusion catheter or infusion needle 800-7 to reservoir 800-1 . Device 800 also includes microcontroller unit (MCU) 800-4 and battery and power controller 800-5.

[0031] Device 800 further includes CGM sensor 800-6. CGM or continuous glucose monitoring, as known to those skilled in the art, tracks user glucose levels and permits those levels to be used in algorithms that control flow rate. MCU 800-4controls the operation of micropump 800-2. Infusion needle 800-7 and CGM sensor (needle) 800-6 are shown as separate components in Fig. 8 for illustration purposes. Infusion catheter or needle 800-7 and CGM sensor 800-6 may be integrated or may be separate (individually).

[0032] Reservoir 800-1 is configured to receive and store insulin (or other medication) for its delivery over a course of about three days, or as needed.However, reservoir size may be configured for storing any quantity of fluid as required.

[0033] MCU 800-5 electronically communicates with sensors 800-3 and micropump 800-2 as well as the CGM sensor 800-6, as the monitoring components. Among several functions, MCU 800-5 operates to control the operation of micropump 800-2 to deliver insulin through infusion catheter or infusion needle 800-7 from reservoir 800-1 at specific doses, i.e., flow rates over specified time intervals, based on CGM data converted to desired flow rate via control algorithms.

[0034] Battery and power controller 800-4 controls the power to MCU 800-5 and micropump 800-2 to enable those components to function properly as known to those skilled in the art. CGM sensor 800-2 is powered by battery and power controller 800-4 through MCU 800-5.

[0035] Fig. 8 depict device 800 with only a few components. Those skilled in the art know that device 800 include additional components.

[0036] Fig. 9 depicts a flow diagram of a method for integrating a MEMS device into a fluid path of a device for delivering medication to a user. At steps 900 and 902, a platform is created with holes and channels formed as described herein.Execution proceeds to step 904 wherein the platform is attached to a baseplate while aligning the hotels in the platform with the inlet and outlet openings of the MEMS device. At step 906, the platform is welded or heat staked to the baseplate to create a fluidic seal for the holes and channels. Execution proceeds to step 908 wherein a reservoir is connected to the inlet of the MEMS device and a cannula is connected to outlet of the MEMS device.

[0037] It shall be understood that this disclosure teaches examples of the illustrative embodiments and that many variations of the invention can easily be devised by those skilled in the art after reading this disclosure and that the scope of the present invention is to be determined by the claims below.

Claims

What is claimed is:1 . A device for delivering medication to a user, the device configured to be mounted to the user, the device comprising:(a) a baseplate and a housing configured to engage the baseplate to form an interior therein; and(b) a platform mounted to the baseplate within the interior, the platform configured to support a micropump having an inlet port for communicating with a reservoir and an outlet port for communicating with a cannula for delivering the medication to the user, wherein the platform includes:(1) a first side and a second side opposing the first side;(2) first and second holes extending through the platform with first and second openings on each of the first and second sides of the platform, respectively, the first and second openings on the first side of the platform aligned with inlet and outlet openings of a micropump when mounted on the platform, respectively;(3) an inlet port for communicating with a reservoir filled with medication and an outlet port for communicating with a cannula for delivering the medication; and(4) first and second open channels extending on the second side of the platform that are sealed when the platform is mounted on the baseplate, wherein the first open channel is configured to enable communication between (1) the inlet port of the platform and (2) the inlet opening of the micropump device through the first opening of the first hole on the second side of the platform, wherein the second open channel is configured to enable communication between the outlet opening of the micropump through the second opening of the second hole on the second side and the outlet port of the platform.

2. The device of claim 1 wherein the platform includes a third hole that communicates with the second open channel to enable a sensor to measure pressure.

3. The device of claim 1 further comprising a micropump for mounting to the platform.

4. The device of claim 2 wherein the micropump is a MEMS device.

5. The device of claim 1 wherein the medication is insulin.

6. A platform for mounting on a baseplate of a device for delivering medication to a user, the platform configured to support a MEMS device for pumping the medication into the user, the platform comprising:(a) a first side and a second side opposing the first side;(b) first and second holes extending through the platform with first and second openings on each of the first and second sides of the platform, respectively, the first and second openings on the first side of the platform aligned with inlet and outlet openings of a MEMS device when mounted on the platform, respectively;(c) an inlet port for communicating with a reservoir filled with medication and an outlet port for communicating with a cannula for delivering the medication; and(d) first and second channels extending on the second side of the platform that are sealed when the platform is mounted on the baseplate, wherein the first channel is configured to enable communication between (1) the inlet port of the platform and (2) the inlet opening of the MEMS device through the first opening of the first hole on the second side of the platform, wherein the second channel is configured to enable communication between the outlet opening of the MEMS device through the second opening of the second hole on the second side and the outlet port of the platform.

7. The device of claim 6 wherein the platform includes a third hole that communicates with the second channel to enable a sensor to measure pressure.

8. The device of claim 6 wherein the medication is insulin.

9. A method for integrating a MEMS device into a fluid path of a device for delivering medication to a user, the device including a baseplate and a housing configured to engage the baseplate to form an interior the MEMS device including an inlet opening and outlet opening, the method comprising: creating a platform for supporting the MEMS device and enabling the medication to flow to and from the MEMS device through the inlet and outlet openings respectively, creating including forming (1) first and second holes extending through the platform and (2) first and second channels on the platform communicating with the first and second holes;attaching the platform to the baseplate within the interior thereby sealing the first and second channels to enable medication to flow through the first and second channels; and mounting MEMS device to the platform including aligning the inlet opening and the outlet opening of the MEMS device platform with openings to the first and second holes of the platform.

10. The method of claim 9 further comprising connecting a reservoir to the inlet opening of the MEMS device and an outlet port of the MEMS device to a cannula through the first and second channels.11 . The method of claim 9 further comprising laser welding, heat staking or ultrasonic welding the platform to the baseplate to create a fluidic seal.

12. The method of claim 9 wherein attaching the platform to the baseplate includes using an adhesive or welding.

13. The method of claim 12 wherein welding includes laser or ultrasonic welding.

14. The method of claim 9 wherein the medication is insulin.

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