Piston stopper for injection device, product container and injection device

• US 20030233075A1
• Filed: 06/13/2003
• Published: 12/18/2003
• Est. Priority Date: 06/14/2002
• Status: Active Grant

• Current Assignee: Roche Diagnostics International AG (Roche Holding AG)
• Original Assignee: Disetronic Licensing Ag
• Inventors: Huegli, Serge
• Granted Patent: US 7,195,609 B2
• Time in Patent Office: Days
• US Class Current: 604/222
• CPC Class Codes: A61M 2005/16863 Occlusion detection
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/332 Force measuring means
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 5/31513 Piston constructions to improve sealing or sliding
• CPC Class Codes: A61M 5/31515 Connection of piston with piston rod
• CPC Class Codes: A61M 5/486 Indicating injection pressure

Abstract

The invention relates to a piston stopper for an injection device, for injecting a medical or therapeutic product by axially advancing a piston stopper into a product container, wherein the piston stopper includes a stopper body and a stopper body holder detachably connected to it, and wherein a membrane body is placed like a cap onto the stopper body and connected to it, the membrane body being formed from an elastic material, while the stopper body and the stopper body holder are manufactured from an inflexible material. The invention encompasses an embodiment wherein the stopper body holder supports a sensor which measures the pressure acting on the membrane body to enable the pressure to be monitored precisely, in order to detect leaks and blockages in injection devices.

Claims

1. A piston stopper for an injection device, for injecting a medical or therapeutic product by axially advancing said piston stopper into a product container, comprising:

a stopper body;

a stopper body holder connected to a driven member of said injection device; and

at least one sealing element for sealing off said product container from said stopper body, wherein a membrane body is connected to a proximal end of the stopper body, such that the stopper body does not come in contact with the product to be injected, said membrane body comprises said at least one sealing element.

2. The piston stopper as set forth in claim 1, wherein the stopper body is formed from a generally inflexible plastic material and the membrane body is formed from a generally elastic material.

3. The piston stopper as set forth in claim 1, wherein the inner diameter of the membrane body in its resting state is smaller than the outer diameter of the proximal end of the stopper body, such that the membrane body is placed, radially expanded, onto the proximal end of the stopper body.

4. The piston stopper as set forth in claim 1, wherein said sealing element is formed on the outer circumference of the membrane body as a circumferential swelling of the membrane body which engages with a corresponding circumferential indentation on the outer circumference of the stopper body.

5. The piston stopper as set forth in claim 1, comprising a sensor for detecting the pressure exerted by the product on a proximal end of the membrane body.

6. The piston stopper as set forth in claim 5, wherein the stopper body holder comprises said sensor.

7. The piston stopper as set forth in claim 6, wherein a proximal end of the stopper body holder comprises an axial continuation which protrudes substantially axially through an opening in the stopper body, a proximal end of said continuation supports the sensor, and the sensor abuts the inner side of the membrane body.

8. The piston stopper as set forth in claim 6, wherein the stopper body comprises an axial opening and the stopper body holder supports an axially movable force transferring means which protrudes substantially axially through the opening in the stopper body, such that a proximal end of said force transferring means abuts the inner side of the membrane body.

9. The piston stopper as set forth in claim 8, wherein the force transferring means is secured against rotation in the stopper body holder.

10. The piston stopper as set forth in claim 8, wherein the force transferring means is held in the axial direction, secured against loss by a securing means in the stopper body holder.

11. The piston stopper as set forth in claim 5, wherein an indentation is provided at the proximal end of the stopper body.

12. The piston stopper as set forth in claim 8, wherein the sensor is a pressure sensor.

13. The piston stopper as set forth in claim 12, wherein the pressure sensor measures a pressure in a fluid chamber of the stopper body holder, and said fluid chamber comprises at least one sealing element in order to seal off the fluid chamber from the force transferring means protruding into the fluid chamber.

14. The piston stopper as set forth in claim 8, wherein the sensor measures an axial adjustment of the force transferring means in the stopper body holder.

15. The piston stopper as set forth in claim 1, wherein the stopper body holder comprises a connecting means for connecting the stopper body holder rigidly to the stopper body.

16. The piston stopper as set forth in claim 1, wherein the stopper body consists of polypropylene and the membrane body consists of bromobutyl caoutchouc.

17. A product container for an injection device for administering a medical or therapeutic product, comprising a piston stopper as set forth in claim 1 which may be axially moved in the product container in order to force out the product.

18. The product container as set forth in claim 17, wherein said product container is an ampoule.

19. An injection device for administering a medical or therapeutic product, comprising a piston stopper as set forth in claim 1 which can be axially advanced into a container for the product to be administered in order to force out the product.

20. The injection device as set forth in claim 19, further comprising a sensor and a pressure monitoring means for monitoring a pressure detected by the sensor.

21. The injection device as set forth in claim 20, further comprising a warning means for generating a warning signal when the pressure exceeds or falls below a pre-settable threshold value.