Device for subcutaneous delivery of fluid medicament

• US 10,603,430 B2
• Filed: 03/12/2019
• Issued: 03/31/2020
• Est. Priority Date: 07/07/2017
• Status: Active Grant

• Current Assignee: NeuroDerm Ltd. (Mitsubishi Chemical Group Corp.)
• Original Assignee: NeuroDerm Ltd. (Mitsubishi Chemical Group Corp.)
• Inventors: Shor, Eran, Mor, Tsabar, Ben David, Tamir, Lilach, Nir, Grossfeld, Rami, Alfandari, Shai, Nadler, Ram, Golom, Dmitry, Shaki, Daniel, Tikochinsky, Yoav, Ozsumer, Serdar
• Primary Examiner(s): Farrar, Lauren P
• Assistant Examiner(s): Ponton, James D
• Application Number:
  US16/351,061
• Publication Number:
  US 20190214967A1
• Time in Patent Office: 385 Days
• CPC Class Codes: A61J 1/2003 Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/14506 mechanically driven, e.g. spring or clockwork
• CPC Class Codes: A61M 2005/14573 with a replaceable reservoir for quick connection/disconnection with a driving system
• CPC Class Codes: A61M 2005/1586 Holding accessories for holding infusion needles on the body holding devices for catheters A61M25/02
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2005/3125 specific display means, e.g. to indicate dose setting
• CPC Class Codes: A61M 2202/0468 non-physiological
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2210/04 Skin
• CPC Class Codes: A61M 5/1407 Infusion of two or more substances
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14216 Reciprocating piston type
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1456 with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/1782 : Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003
• CPC Class Codes: A61M 5/31528 : by means of rotational movements, e.g. screw-thread mechanisms
• CPC Class Codes: A61M 5/345 : Adaptors positioned between needle hub and syringe nozzle
• CPC Class Codes: H03H 9/0509 : consisting of adhesive elements
• CPC Class Codes: H03H 9/0585 : consisting of an adhesive layer
• CPC Class Codes: H03H 9/54 : comprising resonators of piezoelectric or electrostrictive material H03H9/64 takes precedence
• CPC Class Codes: H03H 9/64 : using surface acoustic waves

Abstract

An improved device delivers a fluid medicament to the subcutaneous tissue of a user. The device is better suited for patients with Parkinson'"'"'s Disease and other central nervous system disorders, than conventional infusion devices. The device can include a reusable part including a drive component (e.g., motor) and control electronics and a disposable part including a medicament reservoir. Medicament can be evacuated from the medicament reservoir by a plunger assembly that includes a plunger attached to a lead screw that is rotated by a nut, all within the disposable part. The device can be fluidically coupled with the tissue via a flexible cannula. Various embodiments relate to an improved cannula insertion mechanism that delivers the cannula under a force applied by a spring. Various embodiments relate to improved filling of the device, for example, using a vial adapter and an automated filling station.

Claims

1. A device for delivering a fluid medicament into or through the skin of a user, the device comprising:

a reusable part having a generally T-shaped configuration including a middle leg portion, the middle leg portion having a first side including a first sensor and a second side, opposite the first side, including a second sensor, the reusable part comprising;

a drive component contained in the middle leg portion; and

a control unit for controlling the drive component; and

a disposable part engageable with the reusable part, the disposable part comprising;

a first reservoir for containing the fluid medicament;

a first plunger head moveable by a first lead screw in the first reservoir; and

a first nut threadedly engaged with a thread of the first lead screw and operable to displace the first lead screw upon rotation of the first nut, wherein when the reusable part and the disposable part are attached, the first nut is operably coupled with and rotatable by the drive component in a direction controllable by the control unit.

2. The device of claim 1, wherein the first reservoir comprises a first bushing and wherein the first nut is concentrically secured by and rotatable in the first bushing, the first nut configured to, upon rotation of the first nut, linearly move the first lead screw in a direction dependent on a rotation direction of the first nut.

3. The device of claim 2, wherein the first nut is insertable into and axially locked by the first bushing.

4. The device of claim 2, wherein the reusable part further comprises a first void for receiving the first lead screw when the first lead screw is retracted from the first reservoir.

5. The device of claim 4, wherein the disposable part further comprises:

a second reservoir for containing additional fluid medicament;

a second plunger head for driving the additional fluid medicament out of the second reservoir, the second plunger head moveable in the second reservoir by a second lead screw; and

a second nut operable to displace the second lead screw, wherein when the reusable part and the disposable part are attached, the second nut is operably coupled with and rotatable by the drive component in a direction controllable by the control unit.

6. The device of claim 5, wherein the second reservoir comprises a second bushing, and wherein the second nut is concentrically secured by and rotatable in the second bushing, the second nut configured to, upon rotation of the second nut, linearly move the second lead screw and the second plunger head, in the second reservoir in a direction dependent on the rotation direction of the second nut.

7. The device, of claim 5, wherein the drive component is configured to drive both the first plunger head and the second plunger head simultaneously.

8. The device of claim 5, wherein the drive component is configured to drive each of the first plunger head and the second plunger head separately.

9. The device of claim 5, wherein the reusable part comprises a second void for receiving the second lead screw when the second lead screw is retracted from the second reservoir.

10. The device of claim 5, wherein the reusable part further comprises a control button to select a mode of operation of the device.

11. The device of claim 10, wherein the mode of operation is selected from the group of modes consisting of:

a priming mode, in which the control unit controls the drive component to fill up an infusion set with medicament;

a medicament delivery mode, in which the control unit controls the drive component to deliver medicament to a user according to a desired rate or schedule;

a filling mode, in which the control unit controls the drive component to perform at least one of the following actions;

(i) retract the first plunger head to fill up the first reservoir, (ii) retract the second plunger head to fill up the second reservoir, and (iii) retract both the first plunger head and the second plunger head to fill up both the first reservoir and the second reservoir; and

a pause mode.

12. The device of claim 5, further comprising at least one of (i) a contact sensor for sensing contact between an exterior surface of the disposable, part and a skin surface of the user, and (ii) connection sensor for determining a connection state between the reusable part and the disposable part.

13. The device of claim 5, further comprising a physiological sensor for sensing at least one physiological characteristic of the user, wherein the physiological sensor comprises:

(i) a temperature sensor for measuring a skin temperature of the user,

(ii) a conductivity sensor for measuring a sweat level of the user,

(iii) a movement sensor for measuring body motion of the user,

(iv) a neural activity sensor,

(v) an oxygen saturation level sensor,

(vi) a sound sensor for measuring bowel activity,

(vii) an ECG sensor for detecting a heart rate of the user,

(viii) an EMG sensor for detecting a muscle spasm of the user, or

(ix) any combination of (i) through (viii).

14. The device of claim 5, further comprising:

a cannula fluidically coupled to at least one of the first reservoir and the second reservoir, wherein the cannula is operable to deliver the fluid medicament from at least one of the first reservoir and the second reservoir to the subcutaneous tissue of the user; and

a functionality sensor for sensing at least one functional parameter of the device or the fluid, wherein the functionality sensor comprises at least one of a flow rate sensor, a pressure sensor, a DC current sensor, and a temperature sensor to measure a temperature of the fluid medicament in the cannula or the first reservoir or the second reservoir, or combinations thereof.

15. The device of claim 5, wherein the fluid medicament in the first reservoir or in the second reservoir, or combinations thereof, comprises levodopa, carbidopa, or combinations thereof.

16. The device of claim 5, wherein the reusable part and the disposable part are engageable and detachable regardless of a position of the first plunger head in the first reservoir and the second plunger head in the second reservoir, or regardless of the amount of fluid medicament in the first reservoir or the second reservoir.

17. The device of claim 5, wherein the reusable part is engageable with the disposable part in a first orientation and in a second orientation rotated 180 degrees relative to the first orientation, wherein in each orientation each of the first nut and the second nut is engaged with a load gear of the drive component.

18. The device of claim 5, wherein the reusable part and the disposable part are engageable only in a particular orientation of the reusable part and the disposable part.

19. The device of claim 5, wherein the first sensor and the second sensor are configured, when the reusable part and the disposable part are engaged, to face the first reservoir and the second reservoir, respectively, to provide an output related to a quantity of fluid contained in the first reservoir and the second reservoir, respectively.

20. The device of claim 19, wherein the middle leg portion comprises a magnet to enable attachment of the reusable part and the disposable part with a magnetic force.

21. The device of claim 1, wherein the drive component comprises a motor and a planetary gear, the planetary gear comprising, in series, a drive gear, an idler gear and a load gear, and wherein the first nut comprises a profile engageable with a mating profile of the load gear.

22. The device of claim 1, wherein the disposable part further comprises an exterior surface adherable to skin of the user.

23. The device of claim 22, further comprising an adhesive layer adhered to the exterior surface, wherein a skin surface side of the adhesive layer comprises continuous adhesive and an opposing device side of the adhesive layer comprises discontinuous adhesive.

24. The device of claim 1, wherein the disposable part further comprises a cannula fluidically coupled to the first reservoir, wherein the cannula is operable to deliver the fluid medicament from the first reservoir to the subcutaneous tissue of the user.

25. The device of claim 1, wherein the reusable part and the disposable part are attachable by using a magnetic force, a snap connection, or combinations thereof.

26. The device of claim 1, wherein, the reusable part and the disposable part are co-planar during attachment and when they are attached.