Device for the administration of a liquid medicament suspension

• US 6,033,377 A
• Filed: 02/03/1998
• Issued: 03/07/2000
• Est. Priority Date: 02/04/1997
• Status: Expired due to Fees

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: J.o slashed.rgensen, Erling Bonne, Jannasch, Patric, Rasmussen, Thomas Buch
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): Blyveis, Deborah
• Application Number:
  US09/017,963
• Time in Patent Office: 763 Days
• Field of Search: 206/219-221, 604/82, 604/89, 604/90, 604/91, 604/218, 604/903, 366/241, 366/242, 366/245, 366/273, 366/274
• US Class Current: 604/82
• CPC Class Codes: A61J 1/062 Carpules
• CPC Class Codes: A61M 5/2448 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: B01F 2101/2202 Mixing compositions or mixers in the medical or veterinary field
• CPC Class Codes: B01F 31/441 performing a rectilinear reciprocating movement
• CPC Class Codes: B01F 33/251 using balls as loose mixing element
• CPC Class Codes: B01F 33/452 using independent floating stirring elements
• CPC Class Codes: B01F 33/5011 portable during use, e.g. hand-held
• CPC Class Codes: B01F 35/32021 Shaking by hand a portable receptacle or stirrer for mixing
• CPC Class Codes: Y10S 604/903 Medical container with material agitation means

Abstract

In an ampoule for a medicament the space accommodating the medicament is defined by an ampoule wall (1) a pierceable seal (5) closing one end of the ampoule and a piston (7) closing the other end of the ampoule. A metal containing fixation element (8) is secured to one of the parts defining the medicament accommodating space. A mixing element (9, 10) also containing a metal and having a density larger than 1,0 g/cm³ is movable in medicament accommodating space. At least one of the elements, the fixation element (8) and the mixing element (9, 10), can be attracted by a magnet, and at least one of these elements is a magnetic element, the magnetic strength being so that the mixing element (9, 10) can during normal handling of the ampoule be fixed relative to this ampoule by the magnetic attraction between the fixation element (8) and the mixing element (9, 10) but may be released from its fixed position by manual operation.

Claims

1. A device for the administration of a medicament suspension comprising:

a container for storing a liquid medicament suspension having a longitudinal axis;

a fixations element axially secured against movement to said container during normal storage and handling of said device; and

a mixing element disposed in said container for movement along said axis;

wherein one of said elements comprises a magnetic material and the other of said elements comprises a material magnetically attracted to said one element, and wherein the magnetic attraction between said elements has a strength such that said mixing element remains substantially fixed within said container during normal handling of the device, but which allows said mixing element to move axially relative to said fixations element within said container when said device is shaken in order to mix the contents of the container.

2. A device according to claim 1, wherein the magnetic force between said elements is between 0.6 mN and 500 N.

3. A device according to claim 2, wherein the magnetic force between said elements is between 1 mN and 500 mN.

4. A device according to claim 3, wherein the magnetic force between said elements is between 2 mN and 50 mN.

5. A device according to claim 1, wherein said fixations device is secured within said container.

6. A device according to claim 5, wherein said container includes a piston which is axially moveable for administering a medicament suspension within said container, but which is axially stationary during normal storage and handling of said device, and wherein said fixations device is secured to said piston.

7. A device according to claim 1, wherein said container has a distal end having a neck portion, and wherein said fixations device is secured about said neck portion.

8. A device according to claim 1, wherein said container contains a liquid medicament suspension and said mixing element has an outer surface which is inert to the medicament suspension.

9. A device according to claim 8, wherein said suspension is an insulin suspension.

10. A device according to claim 1, wherein said mixing element is spherical and has a diameter between 1 and 4 mm.

11. A device according to claim 1, wherein said mixing element has a metal core and is coated with a polyolefin material.

12. A device according to claim 1, wherein said other element also comprises a magnetic material.

13. A device according to claim 1, wherein said mixing element has a volume relative to the container volume of at least 0.01% and a density of at least 1.0 g/cc.

15. A method according to claim 13, wherein sufficient magnetic material is provided in said one element that the magnetic attraction between said elements has a strength which allows said mixing element to move relative to said fixations element within said container when said device is shaken, when it is desired to mix the contents of the container, without having to remove said fixations element.

14. A method of storing a liquid medicament suspension, comprising the steps of:

(a) providing a container having a longitudinal axis;

(b) disposing a liquid medicament suspension within said container;

(c) providing a mixing element and a fixations element, wherein one of said elements comprises a magnetic material and the other of said elements comprises a material magnetically attracted to said one element,

(d) disposing said mixing element in said container so as to be axially moveable therein;

(e) securing said fixations element to said container against axial movement during normal storage and handling of said device; and

(f) storing said liquid medicament with said fixations element secured to said container, wherein sufficient magnetic material is provided in said one element that the magnetic attraction between said elements has a strength such that said mixing element remains substantially fixed within said container during normal handling of the device while said medicament remains stored.