Delivery device with separate chambers connectable in fluid communication when ready for use, and related method
View Patent ↗A device and method are provided for storing medicaments and foods and/or beverages separately during shelf life, and for mixing the medicaments and foods and/or beverages when ready for use. A body of the device defines a plurality of first chambers for receiving a medicament, and a plurality of second chambers for receiving a food and/or beverage. A first sealing portion is located between the first and second chambers and is movable between a closed position preventing fluid communication between the chambers, and an open position permitting fluid communication between the first and second chambers for mixing the medicament and the food and/or beverage when ready for use. First and second penetrable and thermally resealable portions are in fluid communication with the first and second chambers, respectively, and are penetrable by an injection member to form an injection aperture therethrough and introduce the medicament or the food and/or beverage through the injection member and into the respective chamber, and are thermally resealable to seal the injection apertures and the medicament or food and/or beverage within the respective chamber by applying energy thereto.
1. A device comprising:
a body defining at least one first chamber that is empty and sealed from the ambient atmosphere for receiving therein a first substance, and at least one second chamber that is empty and sealed from the ambient atmosphere for receiving therein a second substance;
at least one first sealing portion extending between the at least one first and second chambers in a closed position preventing fluid communication between the at least one first and second chambers, and transformable from the closed position to an open position permitting fluid communication between the at least one first and second chambers for mixing the first and second substances when ready for use;
a first penetrable and resealable portion in fluid communication with only the at least one first chamber and defining a hermetic seal between the at least one first chamber and the ambient atmosphere, wherein the first penetrable and resealable portion is penetrable by an injection member to form an injection aperture therethrough to aseptically introduce the first substance through the injection member and into the at least one first chamber while maintaining the hermetic seal between the at least one first chamber and the ambient atmosphere, and is resealable to hermetically seal the injection aperture and the first substance within the at least one first chamber; and
a second penetrable and resealable portion in fluid communication with only the at least one second chamber and defining a hermetic seal between the at least one second chamber and the ambient atmosphere, wherein the second penetrable and resealable portion is penetrable by an injection member to form an injection aperture therethrough to aseptically introduce the second substance through the injection member and into the at least one second chamber while maintaining the hermetic seal between the at least one second chamber and the ambient atmosphere, and is resealable to hermetically seal the injection aperture and the second substance within the at least one second chamber.
2. A device as defined in claim 1 , further comprising at least one dispensing port in fluid communication with at least one of the at least one first and second chambers, and a sealing member transformable from a closed position sealing the dispensing port, and an open position allowing the first and second substances to flow through the dispensing port.
3. A device as defined in claim 2 , including a plurality of dispensing ports and sealing members.
4. A device as defined in claim 1 , wherein the body includes at least one substantially flexible portion defining at least one of the at least one first and second chambers.
5. A device as defined in claim 4 , wherein the at least one substantially flexible portion includes a first substantially flexible portion and a second substantially flexible portion, and the body further includes at least one peripheral first sealing portion extending between the first and second flexible portions and forming a fluid-tight seal therebetween, at least one second sealing portion extending between the first and second flexible portions and substantially preventing fluid communication between the at least one first and second chambers.
6. A device as defined in claim 5 , wherein the at least one first sealing portion is formed within the at least one second sealing portion.
7. A device as defined in claim 6 , wherein the at least one first sealing portion is formed by a relatively weak sealing region of the at least one second sealing portion.
8. A device as defined in claim 7 , wherein the relatively weak sealing region is defined by a frangible portion that is breakable in response to pressure in at least one of the at least one first and second chambers exceeding a threshold pressure.
9. A device as defined in claim 8 , wherein the frangible portion is breakable by manually engaging and squeezing the body.
10. A device as defined in claim 1 , wherein the at least one first sealing portion is selected from the group including (i) a frangible portion, (ii) a sealing portion defining a reduced seal thickness in comparison to contiguous sealing portions, (iii) a relatively weak wall portion, and (iv) a stopper received within an aperture connectable in fluid communication between the at least one first and second chambers.
11. A device as defined in claim 1 , wherein the first and second penetrable and resealable portions are formed by at least one stopper located on the body.
12. A device as defined in claim 11 , wherein the at least one stopper is coupled to the body by one of (i) co-molding the at least one stopper and body, (ii) over-molding at least one of the at least one stopper and body to the other, (iii) thermally sealing at least one of the at least one stopper and body to the other, and (iv) adhesively attaching at least one of the at least one stopper and body to the other.
13. A device as defined in claim 1 , wherein at least one of the at least one first chamber and the at least one second chamber is sterile.
14. A device as defined in claim 1 , wherein the at least one first sealing portion is defined by a frangible portion that is breakable in response to pressure in at least one of the at least one first and second chambers exceeding a threshold pressure.
15. A device as defined in claim 14 , wherein the frangible portion is breakable by manually engaging and squeezing a flexible portion of the body.
16. A device as defined in claim 1 , including a plurality of first sealing portions between the at least one first and second chambers.
17. A device as defined in claim 1 , wherein in the open position the at least one first sealing portion is substantially not located in either of the at least one first and second chambers.
18. A device as defined in claim 1 , wherein in the open position the at least one first sealing portion is attached to the device.
19. A device as defined in claim 1 , wherein the body includes at least one portion configurable to at least one of (i) prevent fluid communication between the first penetrable and resealable portion and the at least one first chamber and (ii) prevent fluid communication between the second penetrable and resealable portion and the at least one second chamber.
20. A device as defined in claim 1 , wherein the first and second penetrable and resealable portions are thermally resealable by applying laser radiation or energy thereto.
21. A device as defined in claim 1 , wherein the at least one first chamber comprises a plurality of first chambers, the at least one second chamber comprises a plurality of respective second chambers, and the at least one first sealing portion comprises a plurality of first sealing portions.
22. A device as defined in claim 21 , wherein the plurality of first chambers are all fillable through the first penetrable and resealable portion, and the plurality of second chambers are all fillable through the second penetrable and resealable portion.
23. A device comprising:
a body defining a plurality of first chambers for receiving therein a first substance, and a plurality of respective second chambers for receiving therein a second substance;
a plurality of first sealing portions, each extending between one of the first chambers and its respective second chamber in a closed position preventing fluid communication therebetween, and transformable from the closed position to an open position permitting fluid communication therebetween for mixing the first and second substances when ready for use;
and
at least one second sealing portion, each extending between adjacent first chambers and adjacent second chambers and preventing fluid communication between said adjacent first chambers and said adjacent second chambers, wherein the at least one second sealing portion defines the plurality of first chambers located on opposite sides of the at least one second sealing portion relative to each other, and the plurality of second chambers located on opposite sides of the at least one second sealing portion relative to each other.
24. A device as defined in claim 23 , wherein the device defines a plurality of delivery devices, each delivery device including one of the plurality of first chambers, its respective second chamber, and a respective one the plurality of first sealing portions.
25. A device as defined in claim 24 , further comprising a plurality of separable portions located between adjacent delivery devices for manually engaging and separating one delivery device from its adjacent delivery device.
26. A device as defined in claim 25 , wherein each of the plurality of separable portions is selected from the group including (i) a frangible portion, (ii) a sealing portion defining a reduced seal thickness in comparison to contiguous sealing portions, and (iii) a relatively weak wall portion.
27. A device as defined in claim 24 , wherein each device further includes a dispensing port in fluid communication with at least one of the respective first and second chambers thereof, and a third sealing portion transformable from a closed position sealing the respective dispensing port, and an open position allowing the first and second substances to flow through the respective dispensing port.
28. A device as defined in claim 24 , wherein at least one of the first and second chambers is substantially airless.
29. A device as defined in claim 23 , wherein the first substance is a medicament and the at least one first chamber includes therein said medicament, and the second substance is at least one of a food and beverage and the at least one second chamber includes therein said at least one of the food and beverage.
30. A device as defined in claim 29 , wherein the at least one of the food and beverage is non-medicated.
31. A device as defined in claim 29 , wherein the form of the medicament is selected from the group including (i) a liquid, (ii) a powder, (iii) a gel, (iv) nano particles, and (v) gelules; and the form of the at least one of the food and beverage is selected from the group including (i) a liquid and (ii) a gel.
32. A device as defined in claim 29 , wherein the at least one of the food and beverage defines at least one of (i) a substantially predetermined pH selected to control at least one of absorption, residence time, transport and bioavailability of the medicament in a mammal, (ii) at least one predetermined medicament metabolizing enzyme, (iii) at least one predetermined medicament transporting enzyme, (iv) at least one predetermined flavor, and (v) a predetermined viscosity of the at least one of a food and beverage combined with the medicament.
33. A device as defined in claim 32 , wherein the at least one of the food and beverage at least one of (i) defines a substantially predetermined pH selected to control absorption of the medicament in a target tissue of a mammal, and (ii) is selected to substantially coat intestinal mucosa of a mammal to enhance tolerance of and reduce irritability of the medicament.
34. A device as defined in claim 23 , wherein when the body includes at least one portion configured to at least one of (i) prevent fluid communication between the first penetrable and resealable portion and the at least one first chamber and (ii) prevent fluid communication between the second penetrable and resealable portion and the at least one second chamber, and at least one of the first and second penetrable and resealable portions is removable from the device without a respective first and second chamber being exposed to the ambient atmosphere.
35. A device as defined in claim 34 , wherein the at least one configured portion defines a cut line sealing the at least one first chamber from the first penetrable and resealable portion and the at least one second chamber from the second penetrable and resealable portion so as to prevent fluid communication between the at least one first chamber and the first penetrable and resealable portion and the at least one second chamber and the second penetrable and resealable portion.
36. A device as defined in claim 35 , wherein the first and second penetrable and resealable portions are separable from the device along the cut line.
37. A device as defined in claim 23 , wherein the first and second penetrable and resealable portions are thermally resealable by applying laser radiation or energy thereto.
38. A device as defined in claim 23 , wherein the body includes a first substantially flexible portion, a second substantially flexible portion and at least one peripheral sealing portion extending about a periphery of the body between the at least one first and second substantially flexible portions and forming a fluid-tight seal therebetween, and the at least one second sealing portion extends between the first and second substantially flexible portions.
39. A defined as defined in claim 38 , wherein the at least one sealing portion extends substantially transversely to the plurality of first sealing portions.
40. A device comprising:
a body defining at least one empty first chamber closed to the ambient atmosphere prior to filling and fillable while closed to contain a first substance therein sealed from the ambient atmosphere, and at least one empty second chamber closed to the ambient atmosphere prior to filling and fillable while closed to contain a second substance different from the first substance therein sealed from the ambient atmosphere;
a first sealing portion extending between the at least one first and second chambers in a closed position preventing fluid communication between the at least one first and second chambers, and transformable from the closed position to an open position permitting fluid communication between the at least one first and second chambers for mixing the first substance and the second substance when ready for use; and
a dispensing port in fluid communication with at least one of the at least one first and second chambers, and a sealing member transformable from a closed position sealing the dispensing port, and an open position allowing the first substance and the second substance to flow through the dispensing port.
41. A device as defined in claim 40 , wherein the first substance is a medicament and the second substance is at least one of a food and beverage.
42. A device as defined in claim 41 , wherein the at least one of the food and beverage is non-medicated.
43. A device as defined in claim 41 , wherein the medicament is in a form selected from the group including (i) a liquid, (ii) a powder, (iii) a gel, (iv) nano particles, and (v) gelules; and the at least one of a food and beverage is in a form selected from the group including a liquid and a gel.
44. A device as defined in claim 41 , wherein the at least one of the food and beverage defines at least one of (i) a substantially predetermined pH selected to control at least one of absorption, residence time, transport and bioavailability of the medicament in a mammal, (ii) at least one predetermined medicament metabolizing enzyme, (iii) at least one predetermined medicament transporting enzyme, (iv) at least one predetermined flavor, and (v) a predetermined viscosity of the at least one of the food and beverage combined with the medicament.
45. A device as defined in claim 44 , wherein the at least one of the food and beverage at least one of (i) defines a substantially predetermined pH selected to control absorption of the medicament in a target tissue of the mammal, and (ii) is selected to substantially coat intestinal mucosa of the mammal to at least one of enhance tolerance of the medicament by, and reduce irritability of the medicament to, the mammal.
46. A device as defined in claim 40 , wherein at least one of the at least one first and second chambers is substantially airless and sealed with respect to ambient atmosphere.
47. A device as defined in claim 40 , further comprising a first penetrable and resealable portion in fluid communication with only the at least one first chamber and defining a hermetic seal between the at least one first chamber and the ambient atmosphere, wherein the first penetrable and resealable portion is penetrable by an injection member to form an injection aperture therethrough and aseptically introduce the first substance through the injection member and into the at least one first chamber, and is resealable to hermetically seal the injection aperture and the first substance within the at least one first chamber; and a second penetrable and resealable portion in fluid communication with only the at least one second chamber and defining a hermetic seal between the at least one second chamber and the ambient atmosphere, wherein the second penetrable and resealable portion is penetrable by an injection member to form an injection aperture therethrough and aseptically introduce the second substance through the injection member and into the at least one second chamber, and is resealable to hermetically seal the injection aperture and the second substance within the at least one second chamber.
48. A device as defined in claim 47 , wherein each of the first and second penetrable and resealable portions is needle penetrable and laser resealable, and includes a thermoplastic that is pierceable with a needle to form a needle aperture therethrough, and is laser resealable to hermetically seal the needle aperture by applying laser radiation at a predetermined wavelength and power thereto.
49. A device as defined in claim 40 , wherein at least one of the at least one empty first chamber and the at least one empty second chamber is sterile.
50. A device comprising:
first means for forming at least one first chamber that is empty and sealed from the ambient atmosphere for receiving therein a first substance, and at least one second chamber that is empty and sealed from the ambient atmosphere for receiving therein a second substance;
at least one second means for extending between the at least one first and second chambers in a closed position preventing fluid communication between the at least one first and second chambers, and for transforming from the closed position to an open position for permitting fluid communication between the at least one first and second chambers for mixing the first and second substances when ready for use;
third means for being in fluid communication with only the at least one first chamber and for defining a hermetic seal between the at least one first chamber and the ambient atmosphere for penetration by an injection member and forming an injection aperture therethrough for aseptically introducing the first substance through the injection member and into the at least one first chamber while maintaining the hermetic seal between the at least one first chamber and the ambient atmosphere, and for hermetically resealing the injection aperture and the first substance within the at least one first chamber; and
fourth means for being in fluid communication with only the at least one second chamber and for defining a hermetic seal between the at least one second chamber and the ambient atmosphere for penetrating by an injection member to form an injection aperture therethrough for aseptically introducing the second substance through the injection member and into the at least one second chamber while maintaining the hermetic seal between the at least one second chamber and the ambient atmosphere, and for hermetically resealing the injection aperture and the second substance within the at least one second chamber.
51. A device as defined in claim 50 , wherein the first means is a body, the at least one second means is at least one sealing portion of the body, the third means is a first penetrable and resealable portion, and the fourth means is a second penetrable and resealable portion.
52. A device as defined in claim 50 , wherein at least one of the at least one first chamber and the at least one second chamber is sterile.
53. A device as defined in claim 50 , wherein the first and second penetrable and resealable portions are thermally resealable by applying laser radiation or energy thereto.
54. A medicament delivery device, comprising:
first means for forming at least one empty first chamber closed to the ambient atmosphere prior to filling and for filling while closed to contain a first substance therein sealed from the ambient atmosphere, and at least one empty second chamber closed to the ambient atmosphere prior to filling and for filling while closed to contain a second substance different from the first substance therein sealed from the ambient atmosphere;
second means for extending between the at least one empty first and second chambers in a closed position preventing fluid communication between the at least one first and second chambers, and for transforming from the closed position to an open position for permitting fluid communication between the at least one first and second chambers for mixing the first substance and the second substance when ready for use; and
third means for being in fluid communication with at least one of the at least one empty first and second chambers for dispensing a mixture of the first substance and the second substance therethrough; and
fourth means for moving between a closed position for sealing the third means, and an open position for allowing the mixture of the first substance and the second substance to flow through the third means.
55. A device as defined in claim 54 , wherein the first means is a body, the second means is a sealing portion of the body, the third means is a dispensing port, and the fourth means is a sealing member removably connected to the dispensing port.
56. A device as defined in claim 54 , further comprising fifth means for being in fluid communication with and for sealing the at least one first chamber with respect to the ambient atmosphere, and for penetration by an injection member and for forming an injection aperture therethrough and for aseptically introducing the first substance through the injection member and into the at least one empty first chamber, and for resealing the injection aperture and the first substance within the at least one first chamber; and sixth means for being in fluid communication with and for sealing the second chamber with respect to the ambient atmosphere, and for penetration by an injection member and for forming an injection aperture therethrough and for aseptically introducing the second substance through the injection member and into the at least one second chamber, and for resealing the injection aperture and the at least one second substance within the at least one empty second chamber.
57. A device as defined in claim 56 , wherein the first and second penetrable and resealable portions are thermally resealable by applying laser radiation or energy thereto.
58. A device as defined in claim 54 , wherein at least one of the at least one empty first chamber and the at least one empty second chamber is sterile.
59. A device as defined in claim 54 , wherein the first substance is a medicament and the second substance is at least one of a food and beverage.