Device for subcutaneous delivery of fluid medicament

Patent metadata

Field	Value
Publication number	US-10463572-B2
Application number	US-201916351076-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

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.

First claim

What is claimed is:

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.

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

• A61M5/1413

  Modular systems comprising interconnecting elements · CPC title

• A61J1/2013

  having two piercing ends · CPC title

• A61M2205/13

  with means for the detection of operative contact with patient, e.g. lip sensor · CPC title

• A61M2005/1586

  Holding accessories for holding infusion needles on the body · CPC title