Device for subcutaneous delivery of fluid medicament

• US 10,463,572 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:
  US16/351,076
• Publication Number:
  US 20190201614A1
• 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

The application is directed to a vial adapter for attaching a medicament vial to a medicament delivery device having a reservoir adapted to receive and contain the medicament. The vial adapter can include a housing with two ports (one for attaching the reservoir and the other for attaching to the vial), a hollow needle that pierces septums sealing each of the reservoir and the vial, and a floating part that fixedly holds the hollow needle. Clearance between the floating part and the housing can enable relative movement of the floating part.

Claims

1. A vial adapter for use with a device for delivering a fluid medicament to subcutaneous tissue of a user, the device comprising a reservoir having a fill septum and configured to contain the fluid medicament, the vial adapter comprising:

a housing forming;

a first port detachably fluidically connectable to the reservoir; and

a second port detachably fluidically connectable to a vial having a vial septum;

a hollow needle configured to pierce the fill septum and the vial septum to create a fluidic path between the vial and the reservoir for transferring the fluid medicament between the vial and the reservoir; and

a floating part captured within the housing and disposed between the first port and the second port, wherein the floating part fixedly holds the hollow needle while clearance between the floating part and the housing enables relative movement of the floating part in its entirety, wherein the floating part enables the hollow needle to move perpendicularly to an axis of the hollow needle.

2. The vial adapter of claim 1, wherein an end of the hollow needle opposite an end of the hollow needle that pierces the fill septum extends into the second port of the vial adapter.

3. The vial adapter of claim 1, wherein the hollow needle is connected to the vial adapter housing in a non-rigid manner.

4. The vial adapter of claim 1, wherein the floating part holds the hollow needle in place while enabling relative movement between the needle and the vial adapter housing.

5. The vial adapter of claim 1, wherein the floating part enables the hollow needle to move in any direction.

6. The vial adapter of claim 1, wherein the floating part further enables the hollow needle to move along an axis of the hollow needle.

7. The vial adapter of claim 1, wherein when the vial adapter is connected to the reservoir and to the medicament vial, the hollow needle extends, and fluidically couples the vial to the reservoir, through the floating part.

8. The vial adapter of claim 1, wherein the hollow needle comprises metal and is operable to pierce the vial septum under an insertion force of not greater than about 10 Newton.

9. The vial adapter of claim 1, wherein the hollow needle is shielded from inadvertent user contact.

10. The vial adapter of claim 1, wherein the fluid medicament comprises levodopa.

11. A method for filling a reservoir of a medicament delivering device with fluid medicament using a vial adapter comprising a housing that forms a first port and a second port, a hollow needle, and a floating part fixedly holding the hollow needle captured within the housing and disposed between the first port and the second port, the method comprising the steps of:

connecting the first port of the vial adapter to the reservoir by piercing a filling septum of the reservoir with the hollow needle;

connecting the second port of the vial adapter to a vial containing the fluid medicament by piercing a vial septum of the vial with the hollow needle,

wherein clearance between the floating part and the housing enables (i) relative movement of the floating part in its entirety and (ii) the hollow needle to move perpendicularly to an axis of the hollow needle, and

wherein when the first and second port of the vial adapter are respectively connected to the reservoir and to the vial, the hollow needle fluidically couples the vial to the reservoir.

12. A filling system comprising:

a device for delivering a fluid medicament to subcutaneous tissue of a user, the device comprising a reservoir for receiving and containing the fluid medicament;

a vial adapter comprising;

a housing forming;

a first port connectable to the reservoir, and

a second port connectable to a medicament vial containing the fluid medicament; and

a needle disposed in the first port and the second port, wherein when the vial adapter is connected to the reservoir and to the medicament vial, the needle fluidically couples the medicament vial with the reservoir; and

a floating part captured within the housing and disposed between the first port and the second port, wherein the floating part fixedly holds the needle while clearance between the floating part and the housing enables relative movement of the floating part in its entirety, wherein the floating part enables the needle to move perpendicularly to an axis of the needle.

13. The filling system of claim 12, wherein the needle is configured to pierce a vial septum of the vial and a filling septum of the reservoir.

14. The filling system of claim 13, wherein an end of the needle opposite an end of the needle that pierces the filling septum extends into the second port of the vial adapter.

15. The filling system of claim 12, wherein the needle is connected to the vial adapter housing in a non-rigid manner.

16. The filling system of claim 12, wherein the floating part holds the needle in place while enabling relative movement between the needle and the vial adapter housing.

17. The filling system of claim 12, wherein the floating part enables the needle to move in any direction.

18. The filling system of claim 12, wherein the floating part further enables the needle to move along an axis of the needle.

19. The filling system of claim 12, wherein when the vial adapter is connected to the reservoir and to the medicament vial, the needle extends, and fluidically couples the vial to the reservoir, through the floating part.

20. The filling system of claim 12, wherein the fluid medicament comprises levodopa.