Device for subcutaneous delivery of fluid medicament

Patent metadata

Field	Value
Publication number	US-10463787-B2
Application number	US-201916351072-A
Country	US
Kind code	B2
Filing date	Mar 12, 2019
Priority date	Jul 7, 2017
Publication date	Nov 5, 2019
Grant date	Nov 5, 2019

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.

First claim

What is claimed is:

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.

Assignees

• Neuroderm Ltd

Inventors

• Shor Eran
• Mor Tsabar
• Ben David Tamir
• Lilach Nir
• Grossfeld Rami
• Alfandari Shai
• Nadler Ram
• Golom Dmitry
• Shaki Daniel
• Tikochinsky Yoav
• Ozsumer Serdar

Classifications

• A61M5/142 Primary

  Pressure infusion, e.g. using pumps · CPC title

• A61M5/1407 Primary

  Infusion of two or more substances · CPC title

• A61M2205/50

  with microprocessors or computers · CPC title

• A61M5/14216

  Reciprocating piston type · CPC title

• A61M2205/33

  Controlling, regulating or measuring · CPC title