Injection or infusion device comprising an improved housing and release liner for removing sterile barrier films using the release liner

Patent metadata

Field	Value
Publication number	US-12208236-B2
Application number	US-202017016933-A
Country	US
Kind code	B2
Filing date	Sep 10, 2020
Priority date	Mar 15, 2018
Publication date	Jan 28, 2025
Grant date	Jan 28, 2025

Abstract

An injection device configured for attachment to the skin of a patient includes a housing and a skin adhesive layer attached to an external surface of the housing for attaching the injection device to the skin of a patient. A release liner covering the skin adhesive layer prevents the injection device from attaching to the skin. A film with one end connected to a surface inside of the housing forms a removable sterile barrier and the other end connected to an external surface of the release liner without contacting the skin adhesive layer. The housing, skin adhesive layer and release liner each include a notch defining a passage for the film so that the second end of the film can extend from the interior to the exterior of the housing.

First claim

What is claimed is:

1. An injection device configured for attachment to skin of a patient, comprising
a housing;
a skin adhesive layer coupled to an outside surface of the housing configured for attaching the injection device to the skin of the patient,
a release liner covering the skin adhesive layer thereby preventing skin attachment of the injection device,
a first film comprising a first end and a second end, wherein the first end is coupled to an internal surface of the housing and forms a removable sterile barrier, and wherein the second end is coupled to an exterior surface of the release liner without contacting the skin adhesive layer,
wherein each of the housing, the skin adhesive layer and the release liner comprises a notch or an aperture, wherein the notches or apertures define a passage extending between an interior of the housing to an exterior of the housing, and wherein the second end of the first film extends through the passage to the exterior of the housing, and
wherein at least one of the notches or the apertures comprises a U-shaped aperture defining a notch opening configured to receive the first film.

2. The injection device according to claim 1 , further comprising a second film, the second film comprising a first end and a second end, wherein the first end is coupled to another internal surface of the housing and forms a removable sterile barrier, and wherein the second end is coupled to the exterior surface of the release liner without contacting the skin adhesive layer.

3. The injection device according to claim 2 , wherein one of the second ends of the first film or the second film is coupled to the release liner adjacent to one leg of the U-shaped aperture, and the other of the second ends of the first film or the second film is connected to the release liner adjacent to another leg of the U-shaped aperture.

4. The injection device according to claim 2 , wherein at least one of first film or the second film is configured as a monolithic film, or wherein at least one of first film or the second film comprises a pull tab, wherein the pull tab is arranged at the second end of the at least one of the first film or second film and coupled to the exterior surface of the release liner.

5. The injection device according to claim 2 , wherein a portion of the second film forming the removable sterile barrier is coupled to an end of a cartridge closed by a pierceable septum, wherein the removable sterile barrier covers a surface of the pierceable septum to maintain sterility of the surface of the septum, and wherein the cartridge is located within the housing.

6. The injection device according to claim 5 , wherein the portion of the second film forming the removable sterile barrier is coupled to an end surface of a crimp of the cartridge, wherein the crimp holds the septum to the cartridge.

7. The injection device according to claim 5 , wherein a cartridge needle within the housing is configured to be moved through a passage of a fluid path compartment into a pierceable septum of the cartridge upon removal of the first end of the first film forming the removable sterile barrier and the first end of the second film forming the removable sterile barrier connected to the end of the cartridge.

8. The injection device according to claim 1 , wherein the notch opening is closed by a cover of the housing.

9. The injection device according to claim 8 , wherein the cover is a separate component of the housing and is configured to be splined to the housing such that the cover can be guided when closing the housing and notch opening upon receipt of the first film.

10. The injection device according to claim 1 , wherein the notch or the aperture in the housing comprises rounded edges.

11. The injection device according to claim 1 , wherein a portion of the first film forming the removable sterile barrier is coupled to a surface of a passage of a fluid path compartment within the interior of the housing and covers the passage to maintain sterility within the fluid path compartment.

12. The injection device according to claim 11 , wherein the fluid path compartment comprises a cartridge needle configured to be moved through the passage.

13. The injection device according to claim 12 , wherein the cartridge needle is configured to be moved through the passage of the fluid path compartment into a pierceable septum of a cartridge upon removal of the first end of the first film forming the removable sterile barrier.

14. The injection device according to claim 1 , wherein the release liner is covered by a strengthening sheet adhesively coupled to the exterior surface of the release liner and covers the notch or the aperture in the release liner and the other end of the first film.

15. The injection device according to claim 14 , wherein the release liner further comprises another aperture for a skin piercing needle, wherein an end of the skin piercing needle is configured to be moved from a first position in the interior of the housing to a second position at the exterior of the housing, and wherein the another aperture is covered by a second film comprising a removable sterile barrier that is adhesively coupled to the strengthening sheet.

16. The injection device according to claim 15 , wherein the skin piercing needle is enclosed by a fluid path compartment within the interior of the housing and coupled to a cartridge needle by a conduit.

17. An injection device configured for attachment to skin of a patient, comprising
a housing;
a skin adhesive layer coupled to an outside surface of the housing configured for attaching the injection device to the skin of the patient;
a release liner covering the skin adhesive layer thereby preventing skin attachment of the injection device;
a first film comprising a first end and a second end, wherein the first end is coupled to an internal surface of the housing and forms a removable sterile barrier, and wherein the second end is coupled to an exterior surface of the release liner without contacting the skin adhesive layer;
a second film comprising a first end and a second end, wherein the first end is coupled to another internal surface of the housing and forms a removable sterile barrier, and wherein the second end is coupled to the exterior surface of the release liner without contacting the skin adhesive layer;
wherein each of the housing, the skin adhesive layer and the release liner comprises a notch or an aperture, wherein the notches or the apertures define a passage extending between an interior of the housing to an exterior of the housing, and wherein the second end of each of the first film and the second film extends through the passage to the exterior of the housing, and
wherein at least one of the notches or the apertures comprises a U-shaped aperture defining a notch opening configured to receive the first film.

18. The injection device according to claim 17 , wherein the removable sterile barrier of the first film covers a surface of a passage of a fluid path compartment within the housing to maintain sterility of the fluid path compartment, and the removable sterile barrier of the second film covers a surface of a pierceable septum of a cartridge within the housing to maintain sterility of the surface, and
wherein a cartridge needle within the housing is configured to be moved through the passage of the fluid path compartment into the pierceable septum of a cartridge upon removal of both the first end of the first film forming the removable sterile barrier and the first end of the second film forming th

Assignees

• Ypsomed Ag

Inventors

• Burren Stefan
• Bernhard Mario
• Schenker Susanne
• Mellenberger Andres
• Schrul Christian
• Tschirren Markus

Classifications

• A61M2005/14252

  with needle insertion means · CPC title

• A61M5/162

  Needle sets, i.e. connections by puncture between reservoir and tube {; Connections between reservoir and tube (in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14)} · CPC title

• A61M5/285

  with sealing means to be broken or opened · CPC title

• A61M39/14

  for connecting tubes having sealed ends {(needle sets A61M5/162; having valves closing automatically on disconnection of line A61M39/26)} · CPC title

• A61M2005/3121

  via the proximal end of a syringe, i.e. syringe end opposite to needle cannula mounting end · CPC title