Device for subcutaneous delivery of fluid medicament

• US 10,463,787 B2
• Filed: 03/12/2019
• Issued: 11/05/2019
• 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): Mehta, Bhisma
• Assistant Examiner(s): Ponton, James D
• Application Number:
  US16/351,072
• Publication Number:
  US 20190209773A1
• Time in Patent Office: 238 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 at least one fluid medicament to subcutaneous tissue of a user, the device comprising:

a pump module comprising at least one reservoir for containing fluid medicament; and

a cannula insertion mechanism attachable to the pump module, the cannula insertion mechanism comprising;

a cannula plunger comprising a first portion fixedly attached to an insertion needle and a second portion holding a flexible cannula, such that the flexible cannula is mounted on the insertion needle;

a hub comprising a first gear;

a second gear rotatable by and in the first gear, said second gear attached to the first portion of the cannula plunger and configured to move the first portion and the second portion of the cannula plunger when the hub rotates;

a spring to rotate the hub; and

a structure for holding the spring in a compressed position and for releasing the spring from the compressed position, wherein releasing the spring from the compressed position causes;

(i) the insertion needle and the flexible cannula to be delivered into the subcutaneous tissue, and

(ii) the insertion needle to be removed from the subcutaneous tissue while leaving the flexible cannula within the subcutaneous tissue.

2. The device of claim 1, further comprising a pin to attach the second gear to the first portion and a depressible button to release the pin.

3. The device of claim 1, wherein the spring, the hub, the first gear, the second gear, the first portion and the insertion needle are removable from the pump module after delivery of the flexible cannula to the subcutaneous tissue.

4. The device of claim 1, wherein the flexible cannula comprises two or more flexible cannulas and the at least one reservoir comprises two or more reservoirs and the cannula insertion mechanism is configured to deliver the two or more flexible cannulas into the subcutaneous tissue, such that the two or more flexible cannulas respectively couple each of the two or more reservoirs to the subcutaneous tissue.

5. The device of claim 1, wherein the cannula insertion mechanism comprises two or more cannula insertion mechanisms and the at least one reservoir comprises two or more reservoirs, wherein each of the two or more reservoirs is associated with a corresponding one of the two or more canula insertion mechanisms.

6. The device of claim 1, wherein the at least one reservoir comprises two or more reservoirs and wherein the pump module is configured to operate the two or more reservoirs such that each of the two or more reservoirs delivers a respective fluid medicament to a different injection site or to a same injection site of the user.

7. The device of claim 1, wherein the at least one reservoir comprises two or more reservoirs and wherein the pump module is configured to operate the two or more reservoirs to deliver the at least one fluid medicament from the two or more reservoirs simultaneously.

8. The device of claim 7, wherein at east two of the two or more reservoirs contain different fluid medicaments from each other.

9. The device of claim 1, wherein the at least one reservoir comprises two or more reservoirs and wherein the pump module is configured to operate the two or more reservoirs such that at least two of the two or more reservoirs deliver the fluid medicaments at different times.

10. The device of claim 9, wherein at least two of the two or more reservoirs contain different fluid medicaments from each other.

11. The device of claim 1, further comprising a temperature control unit to control a temperature of the at least one fluid medicament, wherein the temperature control unit comprises a heating element and/or a cooling element.

12. The device of claim 1, wherein the flexible cannula comprises a surface coating that reduces trauma caused by insertion of the flexible cannula.

13. The device of claim 1, wherein when the second gear is at a position within the first gear that is closest to a skin surface of the user, the flexible cannula and the insertion needle are delivered to a desired depth in the user.

14. The device of claim 13, further comprising an optical system to perform subcutaneous inspection for controlling insertion of the flexible cannula based on the subcutaneous inspection.

15. The device of claim 14, wherein the optical system is configured to deactivate insertion of the flexible cannula upon identification of an undesirable tissue structure at an insertion depth of the flexible cannula or the needle.

16. The device of claim 1, wherein the at least one fluid medicament comprises levodopa, carbidopa, or a combination thereof.

17. The device of claim 1, further comprising a pin to hold the second gear and a depressible button to release the pin.

18. The device of claim 1, further comprising a pin to hold the first portion of the cannula plunger and a depressible button to release the pin.

19. The device of claim 1, further comprising a pin to hold the hub and a depressible button to release the pin.

20. The device of claim 1, further comprising a pin to attach the hub to the second gear and a depressible button to release the pin.

21. A method of delivering a fluid medicament to subcutaneous tissue of a user, the method comprising the steps of:

providing a pump module comprising at least one reservoir for containing the fluid medicament; and

attaching a cannula insertion mechanism to the pump module, the cannula insertion mechanism comprising;

a cannula plunger comprising a first portion fixedly attached to an insertion needle and a second portion holding a flexible cannula, such that the flexible cannula is mounted on the insertion needle;

a hub comprising a first gear;

a second gear rotatable by and in the first gear, said second gear attached to the first portion of the cannula plunger and configured to move the first portion and the second portion of the cannula plunger when the hub rotates;

a spring to rotate the hub; and

a structure for holding the spring in a compressed position and for releasing the spring from the compressed position, wherein releasing the spring from the compressed position causes;

(i) the insertion needle and the flexible cannula to be delivered into the subcutaneous tissue, and

(ii) the insertion needle to be removed from the subcutaneous tissue while leaving the flexible cannula within the subcutaneous tissue.