Reservoir barrier layer systems and methods

• US 8,858,501 B2
• Filed: 01/26/2009
• Issued: 10/14/2014
• Est. Priority Date: 04/11/2008
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Chong, Colin A., Lorenzen, Eric M., Bikovsky, Rafael, Luan, Truong Gia, Ibranyan, Arsen
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): Snyder, Melissa A
• Application Number:
  US12/360,077
• Publication Number:
  US 20090259183A1
• Time in Patent Office: 2,087 Days
• Field of Search: 215/12.1, 206/223, 206570-571, 220/560.03, 220/502, 220/23.91, 220/662, 220/665, 210/767, 210/321.6, 604/152, 604/212
• US Class Current: 604/152
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/14573 with a replaceable reservoir for quick connection/disconnection with a driving system
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• 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 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/31501 Means for blocking or restricting the movement of the rod or piston A61M5/5013 takes precedence
• CPC Class Codes: B32B 1/00 Layered products having a non-planar shape
• CPC Class Codes: B32B 15/08 of synthetic resin
• CPC Class Codes: B32B 15/20 comprising aluminium or copper B32B15/016 and B32B15/017 take precedence
• CPC Class Codes: B32B 2307/41 Opaque
• CPC Class Codes: B32B 2307/7265 Non-permeable
• CPC Class Codes: B32B 2307/728 Hydrophilic
• CPC Class Codes: B32B 2307/73 Hydrophobic
• CPC Class Codes: B32B 2307/748 Releasability
• CPC Class Codes: B32B 2439/00 Containers; Receptacles closures therefor B32B2435/00
• CPC Class Codes: B32B 2535/00 Medical equipment, e.g. bandage, prostheses, catheter medical patches B32B2556/00
• CPC Class Codes: B32B 27/08 of synthetic resin
• CPC Class Codes: B32B 27/16 : specially treated, e.g. irradiated
• CPC Class Codes: B32B 27/285 : comprising polyethers
• CPC Class Codes: B32B 27/288 : comprising polyketones
• CPC Class Codes: B32B 27/302 : comprising aromatic vinyl (co)polymers, e.g. styrenic (co)polymers
• CPC Class Codes: B32B 27/304 : comprising vinyl halide (co)polymers, e.g. PVC, PVDC, PVF, PVDF
• CPC Class Codes: B32B 27/306 : comprising vinyl acetate or vinyl alcohol (co)polymers
• CPC Class Codes: B32B 27/32 : comprising polyolefins comprising vinyl (co)polymers or acrylic (co)polymers B32B27/30
• CPC Class Codes: B32B 27/322 : comprising halogenated polyolefins, e.g. PTFE
• CPC Class Codes: B32B 27/325 : comprising polycycloolefins
• CPC Class Codes: B32B 27/34 : comprising polyamides
• CPC Class Codes: B32B 27/36 : comprising polyesters
• CPC Class Codes: B32B 3/04 : characterised by at least one layer folded at the edge, e.g. over another layer ; characterised by at least one layer enveloping or enclosing a material
• CPC Class Codes: B32B 7/05 : the layers not being connected over the whole surface, e.g. discontinuous connection or patterned connection using interposed adhesives or bonding materials applied in spaced arrangements B32B7/14
• CPC Class Codes: B32B 7/06 : permitting easy separation
• CPC Class Codes: Y10T 137/86035 : Combined with fluid receiver
• CPC Class Codes: Y10T 29/49826 : Assembling or joining

Abstract

A reservoir and a plunger head contained within may be configured to move relative to each other in response to at least one of the reservoir being detached from a base, the base and/or the reservoir being removed from a packaging, and the base and/or the reservoir being moved relative to each other. A first layer may be configured to define a reservoir, the first layer, which may be made of a material compatible with fluidic media in the reservoir, may be adjacent a second layer for inhibiting a diffusion through the second layer. A first layer that may be less than 0.3 mm and made of a cyclic olefin copolymer may be configured to define a reservoir. A reservoir may be defined by a wall made of a cyclic olefin copolymer and the wall may be for substantially preventing light from passing through the reservoir.

Claims

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

a first layer configured to define a reservoir body having an interior volume for containing fluidic media, the first layer comprising a first material compatible with fluidic media contained in the interior volume of the reservoir body, the first material of the first layer for inhibiting diffusion of the fluidic media out of the interior volume of the reservoir body at or greater than a first rate, the reservoir body having a first portion and a second portion; and

a second layer adjacent to the first layer, the second layer comprising a second material different from the first material, the second material of the second layer for inhibiting diffusion of the fluidic media out of the interior volume of the reservoir body at or greater than a second rate, the second rate being greater than the first rate,

the second layer defining an outer body, the first portion of the reservoir body arranged in the outer body such that the second portion of the reservoir body is uncovered by the outer body;

wherein the outer body is configured to be removable from the first portion of the reservoir body.

2. The system of claim 1, the second layer for inhibiting an outward diffusion of the fluidic media in the interior volume of the reservoir body.

3. The system of claim 1, the second material of the second layer for inhibiting diffusion of preservatives present in fluidic media contained in interior volume of the reservoir body.

4. The system of claim 1, the second layer for inhibiting an inward diffusion into the reservoir body.

5. The system of claim 1, wherein the second layer is disposed outside the first layer.

6. The system of claim 5, wherein an inner surface of the second layer substantially covers an outer surface of the first layer.

7. The system of claim 5, wherein an inner surface of the second layer only covers an outer surface of the first layer.

8. The system of claim 1, wherein the second layer is circumferentially adjacent the first layer.

9. The system of claim 1, the second layer configured to define a body for receiving at least a portion of the reservoir body.

10. The system of claim 1, wherein the second layer comprises a fluid.

11. The system of claim 10, wherein the fluid provides a positive pressure relative to a pressure within the reservoir body.

12. The system of claim 1, wherein the outer body comprises a packaging material wrapped around at least a portion of the first layer.

13. The system of claim 12, wherein the packaging material is adapted to be in firm contact with the first portion of the reservoir body prior to removal of the packaging material.

14. The system of claim 1, wherein at least one of the first material and the second material comprises a material selected from the group consisting of halogenated polymers.

15. The system of claim 14, wherein the halogenated polymers is selected from the group essentially consisting of polytetrafluorethylene, polyvinylidene chloride, and polyvinylidene fluoride.

16. The system of claim 1, wherein at least one of the first layer and the second layer comprises a material selected from the group consisting essentially of polyamides, ethylene-vinyl alcohol, polyetheretherketone, nylon, and polyester.

17. The system of claim 1, wherein at least one of the first layer and the second layer comprises capillary glass.

18. The system of claim 1, wherein at least one of the first layer and the second layer is diamond coated.

19. The system of claim 1, wherein the second layer is in direct contact with the first layer.

20. The system of claim 1, the first layer for inhibiting an inward diffusion into the reservoir body.

21. The system of claim 1, the system further comprising:

an intermediate layer located between the first layer and the second layer.

22. The system of claim 21, wherein the intermediate layer comprises at least one of a hydrophobic material and a hydrophilic material.

23. The system of claim 1, wherein an inner surface of the first layer is adapted to contain a compound for regulating permeability of the first layer.

38. The system of claim 1,

wherein the fluidic media in the interior volume of the reservoir body is sealed until use of the reservoir body;

and

wherein the reservoir body is in use when the fluidic media in the interior volume of the reservoir body is being withdrawn from the interior volume of the reservoir body.

39. The system of claim 1,

wherein the outer body is separate and apart from the first layer during use of the reservoir body;

and

wherein the reservoir body is in use when the fluidic media in the interior volume of the reservoir body is being withdrawn from the interior volume of the reservoir body.

40. The system of claim 1, wherein the second material of the second layer inhibits diffusion at rate greater than the first material of the first layer such that, upon removing the outer body, a shelf life of the fluidic media in the interior volume of the reservoir body is substantially reduced.

41. The system of claim 1, wherein the second material preserves the fluidic media in the interior volume of the reservoir body for a longer period of time than the first material preserves the fluidic media in the interior volume of the reservoir body.

42. The system of claim 1, wherein the second material of the second layer inhibits a greater amount of diffusion of the fluidic media out of the interior volume of the reservoir body than the first material of the first layer.

24. A method of making a system for containing fluidic media, the method comprising:

configuring a first layer to define a reservoir body having an interior volume for containing fluidic media, the first layer comprising a first material compatible with fluidic media contained in the interior volume of the reservoir body, the first material for inhibiting diffusion of the fluidic media out of the interior volume of the reservoir body at or greater than a first rate, the reservoir body having a first portion and a second portion;

providing a second layer adjacent to the first layer, the second layer comprising a second material different from the first material the second material for inhibiting diffusion of the fluidic media out of the interior volume of the reservoir body at or greater than a second rate, the second rate being greater than the first rate, the second layer defining an outer body, the first portion of the reservoir body arranged in the outer body such that the second portion of the reservoir body is uncovered by the outer body; and

configuring the outer body to be removable from the first portion of the reservoir body.

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

a reservoir body, the reservoir body comprising;

a first layer comprising a first material, the first layer configured to define a reservoir body having an interior volume for containing fluidic media, the first layer compatible with fluidic media contained in the interior volume of the reservoir body and for inhibiting diffusion of the fluidic media into or out of the interior volume of the reservoir body through the first layer, the first layer comprising a cyclic olefin copolymer, a thickness of the first layer is less than 0.3 mm; and

a second layer adjacent to the first layer, the second layer comprising a second material different from the first material, the second material of the second layer for inhibiting diffusion of the fluidic media out of the interior volume of the reservoir body.

26. The system of claim 25, wherein the second layer is configured to substantially prevent light from passing through the reservoir body.

27. The system of claim 26, the reservoir body further comprising:

a third layer adjacent to the second layer;

wherein the third layer comprises a cyclic olefin copolymer; and

wherein a thickness of the third layer is less than 0.3 mm.

29. The system of claim 26, wherein the second wall is opaque to substantially prevent light from passing through the reservoir body.

30. The system of claim 26, wherein the second wall is adapted to be at least one of frosted, textured, and etched to substantially prevent light from passing through the reservoir body.

31. The system of claim 26, the second wall having a light transmission at 400 nm of less than 25%.

32. The system of claim 26,

the second wall of the reservoir body having at least one window for allowing light to pass into the interior volume of the reservoir body;

wherein the window prevents fluidic media in the interior volume of the reservoir body from flowing out of the interior volume of the reservoir body.

33. The system of claim 32, the at least one window having a width dimension corresponding to less than 90°

of the reservoir body.

34. The system of claim 32, the at least one window for providing a viewing angle of less than 90°

into the interior volume of the reservoir body.

35. The system of claim 32, the at least one window arranged along the reservoir body at a location corresponding to an amount of fluidic media in the interior volume of the reservoir body.

36. The system of claim 32, each of the at least one window offset less than 90°

relative to the reservoir body from any other window of the at least one window.

51. The system of claim 26, the second layer adjacent to the first layer, the second layer comprising a second material different from the first material.

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

a reservoir body having at least one wall defining an interior volume for containing fluidic media, the at least one wall having a first wall and a second wall, the first wall comprising a cyclic olefin copolymer, the second wall for substantially preventing light from passing through the reservoir body, the first wall for inhibiting diffusion of the fluidic media out of the interior volume of the reservoir body better than the second wall; and

a plunger head arranged for movement within the reservoir body;

wherein at least a portion of the plunger head is configured to be detectable through the second wall.

37. The system of claim 28, wherein the portion of the plunger head corresponds to an amount of fluidic media in the interior volume of the reservoir body.

43. The system of claim 28, wherein the portion of the plunger head is configured to be visible through the second wall.

44. The system of claim 43, wherein the portion of the plunger head has a color visible through the second wall.

45. The system of claim 43, wherein the portion of the plunger head comprises a seal member.

46. The system of claim 43, the portion of the plunger head comprising a first seal member for providing a first visibility through the second wall and a second seal member for providing a second visibility through the second wall different from the first visibility.

47. The system of claim 28,

the plunger head including a detectable feature;

the reservoir body having a detecting mechanism for detecting the detectable feature.

48. The system of claim 47, wherein the detectable feature is a magnet.

49. The system of claim 28, wherein the portion of the plunger head is configured to react with the second wall to allow detection of the portion of the plunger head.

50. The system of claim 49, wherein the detection of the portion of the plunger head corresponds to an amount of fluidic media in the interior volume of the reservoir body.

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

a first layer comprising a first material, the first layer configured to define a reservoir body having an interior volume for containing fluidic media, the first layer compatible with fluidic media contained in the interior volume of the reservoir body and for inhibiting diffusion of the fluidic media into or out of the interior volume of the reservoir body through the first layer, the first layer includes an interior surfacing facing the interior volume, the interior surface being plasma treated; and

a lubricant applied on the plasma-treated interior surface;

wherein the first layer comprises a cyclic olefin copolymer;

wherein a thickness of the first layer is less than 0.3 mm;

wherein the lubricant is plasma treated.