Reservoir filling systems and methods

• US 8,393,357 B2
• Filed: 07/06/2010
• Issued: 03/12/2013
• Est. Priority Date: 07/08/2009
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Chong, Colin A., Luan, Truong Gia, Bikovsky, Rafael, Ibranyan, Arsen
• Primary Examiner(s): Stigell, Theodore
• Assistant Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US12/831,113
• Publication Number:
  US 20110009823A1
• Time in Patent Office: 980 Days
• Field of Search: 294/28, 141/2, 604/93.01, 604/111, 604/131, 604151-155, 604/218, 604/221, 604/228, 604/500, 604/503, 604/890.1
• US Class Current: 141/2
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/3114 Filling or refilling
• CPC Class Codes: A61M 2005/3142 Modular constructions, e.g. supplied in separate pieces to be assembled by end-user
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• 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 5/3135 characterised by constructional features of the proximal end
• CPC Class Codes: A61M 5/31511 Piston or piston-rod constructions, e.g. connection of piston with piston-rod A61M5/5066 takes precedence
• CPC Class Codes: A61M 5/31515 Connection of piston with piston rod
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A method of making a system for transferring fluidic media may include placing a reservoir body in an aseptic environment; filling an interior volume of the reservoir body with fluidic media; placing a plunger head into the reservoir body, the plunger head adapted to be movable in an axial direction within the reservoir body; removing the reservoir body from the aseptic environment; and attaching a casing adjacent to at least a portion of the reservoir body with the reservoir body outside the aseptic environment, the casing configured to envelope at least a portion of a plunger arm operatively connected to the plunger head, the casing further configured to allow the plunger arm to move in the axial direction relative to the reservoir body and at least partially within the reservoir body.

Claims

1. A method of making and filling a reservoir with a selectable amount of fluidic media comprising:

providing a reservoir body with a wall and a central bore, the reservoir body having a first portion with a first fluidic capacity, and a second portion axially aligned with the first portion with an additional fluidic capacity;

providing a selectively breakable zone that separates the first portion and the second portion of the reservoir body;

arranging a plunger head for axial movement within the bore at least between the selectively breakable zone and a port of the reservoir body to expel fluidic media in the bore through the port of the reservoir body; and

selecting whether;

to fill only the first portion of the reservoir body with fluidic media, in which case the method includes filling the first portion of the reservoir body with fluidic media, inserting the plunger head to a position in the bore to seal the first portion of the reservoir body, and breaking off the wall at the selectively breakable zone;

or

to fill the first portion and the second portion of the reservoir body with fluidic media, in which case the method includes filling the first portion and the second portion of the reservoir body with fluidic media and inserting the plunger head to a position in the bore to seal the second portion of the reservoir body.

2. The method of claim 1, further comprising:

scoring a perimeter around the reservoir body to form the selectively breakable zone.

3. The method of claim 2, wherein a portion of the wall defining the first portion of the reservoir body has a thickness different from a thickness of a portion of the wall defining the second portion of the reservoir body.

4. The method of claim 2, further comprising:

providing a portion of the reservoir body corresponding to a perimeter made of a different material than a material of the first portion of the reservoir body to provide said selectively breakable zone.

5. The method of claim 1, wherein the selectively breakable zone comprises perforations around the reservoir body.

6. The method of claim 3, wherein the thickness of the first portion of the reservoir body is less than the thickness of the second portion of the reservoir body.

7. The method of claim 1, wherein the second portion of the reservoir body is made of a material different from a material of the first portion of the reservoir body.

8. The method of claim 1,

wherein the selectively breakable zone is produced by providing an annular body sized and dimensioned to fit around at least a portion of the reservoir body;

the annular body separating the first portion of the reservoir body and the second portion of the reservoir body.

9. The method of claim 1, wherein the filling of the reservoir body and the insertion of the plunger head in the reservoir body occurs in an aseptic environment.

10. The method of claim 9, wherein the reservoir body is removed from the aseptic environment prior to breaking off the wall along the selectively breakable zone.

11. The method of claim 1, further comprising:

operatively connecting a plunger arm to the plunger head.

12. The method of claim 11, wherein the plunger arm and the plunger head are integral with one another.

17. The method of claim 1, wherein selectively filling the reservoir body comprises filling the reservoir body to a fill line.

18. The method of claim 1, wherein a portion of the wall defining the first portion of the reservoir body has a thickness different from a thickness of a portion of the wall defining the second portion of the reservoir body.

21. The method of claim 1, wherein the first portion is defined by a first end of the reservoir body and the selectively breakable zone, the first end of the reservoir body having the port of the reservoir body.

22. The method of claim 21, wherein the second portion is defined by the selectively breakable zone and a second end of the reservoir body, the second end of the reservoir body opposite the first end of the reservoir body.

23. The method of claim 22, wherein the plunger head is arranged to sealingly slide axially within the bore between the first end and the second of the reservoir body.

24. The method of claim 1, wherein the reservoir body has a first diameter at a first end of the reservoir body, the first end having the port;

and

wherein the reservoir body has a second diameter at the selectively breakable zone, the second diameter being larger than the first diameter.

13. A method of making and filling a reservoir with a selectable amount of fluidic media comprising:

providing a reservoir body with a wall and a central bore, the reservoir body having a first portion with a first fluidic capacity, and a second portion axially aligned with the first portion with an additional fluidic capacity;

providing a plunger head dimensioned to sealingly slide axially within the bore and thereby propel fluidic media in the bore;

providing a selectively breakable zone that separates the first portion and the second portion of the reservoir body;

selecting whether;

to fill only the first portion of the reservoir body with fluidic media, in which case the method includes filling the first portion of the reservoir body with fluidic media, inserting the plunger head to a position in the bore to seal the first portion of the reservoir body, and breaking off the wall at the selectively breakable zone;

or

to fill the first portion and the second portion of the reservoir body with fluidic media, in which case the method includes filling the first portion and the second portion of the reservoir body with fluidic media and inserting the plunger head to a position in the bore to seal the second portion of the reservoir body;

attaching a casing adjacent to at least a portion of the reservoir body, the casing configured to envelop at least a portion of a plunger arm operatively connected to the plunger head, the casing further configured to allow the plunger arm to move in an axial direction relative to the reservoir body and at least partially within the reservoir body.

14. The method of claim 13, further comprising:

locating the plunger arm at least partially in the casing; and

operatively connecting the plunger arm to the plunger head after the casing is attached to the reservoir body.

15. The method of claim 13, wherein attaching a casing adjacent to at least a portion of the reservoir body comprises welding the casing to the reservoir body.

16. The method of claim 15, wherein the casing is laser welded to the reservoir body.

19. A method of making and filling a reservoir with a selectable amount of fluidic media comprising:

providing a reservoir body with a wall and a central bore, the reservoir body having a first portion with a first fluidic capacity, a second portion axially aligned with the first portion with a second fluidic capacity, and a third portion with a third fluidic capacity;

providing a plunger head dimensioned to sealingly slide axially within the bore and thereby propel fluidic media in the bore;

providing a first selectively breakable zone that separates the first portion and the second portion of the reservoir body;

providing a second selectively breakable zone that separates the second portion and the third portion of the reservoir body; and

selecting whether;

to fill only the first portion of the reservoir body with fluidic media, in which case the method includes filling the first portion of the reservoir body with fluidic media, inserting the plunger head to a position in the bore to seal the first portion of the reservoir body, and breaking off the wall at the first selectively breakable zone;

to fill the first portion and the second portion of the reservoir body with fluidic media, in which case the method includes filling the first portion and the second portion of the reservoir body with fluidic media, inserting the plunger head to a position in the bore to seal the second portion of the reservoir body, and breaking off the wall at the second selectively breakable zone;

or

to fill the first portion, the second portion, and the third portion of the reservoir body with fluidic media, in which case the method includes filling the first portion, the second portion, and the third portion of the reservoir body with fluidic media and inserting the plunger head to a position in the bore to seal the third portion of the reservoir body.

20. A system for containing fluidic media, the system comprising:

a reservoir body having a wall and a central bore, the reservoir body having a first portion with a first fluidic capacity and a second portion axially aligned with the first portion with an additional fluidic capacity; and

a plunger head arranged for axial movement within the bore to expel fluidic media in the bore through a port of the reservoir body;

wherein the wall of the reservoir body includes a selectively breakable zone that separates the first portion and the second portion of the reservoir body, the selectively breakable zone for allowing selective filling of the reservoir body such that (i) in a case where only the first portion of the reservoir body is to be filled with fluidic media, the plunger head is positioned in the bore to seal the first portion of the reservoir body, and the second portion of the reservoir body is removable from the first portion of the reservoir at the selectively breakable zone; and

(ii) in a case where the first portion and the second portion of the reservoir body are to be filled with fluidic media, the plunger head is positioned in the bore to seal the second portion of the reservoir body; and

wherein the plunger head is arranged for axial movement to slide at least between the selectively breakable zone and the port of the reservoir body.

25. A method of making and filling a reservoir with a selectable amount of fluidic media, comprising:

providing a reservoir body having a central bore, the reservoir body comprising;

a first wall portion defining a first interior volume of the central bore for containing a first fluidic capacity; and

a second wall portion defining a second interior volume of the central bore for containing a second fluidic capacity, the second wall portion axially aligned with the first wall portion providing a selectively breakable zone that separates the first wall portion and the second wall portion;

providing a plunger head arranged for movement along the central bore at least between the selectively breakable zone and a port of the reservoir body to expel fluidic media out of the central bore through the port of the reservoir body; and

selecting whether;

(a) to fill only the first interior volume with fluidic media, in which case the method comprises (i) filling the first wall portion of the reservoir body with fluidic media, (ii) inserting the plunger head to a position in the central bore to seal the first wall portion of the reservoir body, and (iii) removing the second wall portion at the selectively breakable zone;

or

(b) to fill the first interior volume and the second interior volume with fluidic media, in which case the method comprises (i) filling the first wall portion and the second wall portion of the reservoir body with fluidic media and (ii) inserting the plunger head to a position in the control bore to seal the second wall portion of the reservoir body.