Injection pump assembly having a disposable housing assembly and a blow-molded reservoir

Abstract

To provide an infusion pump assembly having a disposable housing assembly and a blowmolded reservoir.SOLUTION: A disposable housing assembly is disclosed. The disposable housing assembly includes: a reservoir cavity; a needle located within the reservoir cavity; a fluid path fluidly connected to the needle; and a cover, the cover is configured that when the cover is in a first position, the reservoir cavity and needle are exposed, and when the cover is in a second position, the reservoir and needle are not exposed. In one embodiment, the needle comprises a first end and a second end, the first end inside a gasket and the second end inside an overmolded portion needle cover.SELECTED DRAWING: Figure 2I

Description

Technical Field

[0001] (Field of the Invention) The present application generally relates to fluid delivery systems, and more specifically to infusion pump assemblies.

Background Art

[0002] (Background) Many potentially valuable drugs or compounds, including biopharmaceuticals, are not orally active due to poor absorption, hepatic metabolism, or other pharmacokinetic factors. In addition, some therapeutic compounds can be absorbed orally but are dosed at frequencies that make it difficult or impossible for patients to maintain a desired schedule using oral formulations. In these cases, parenteral delivery is often or can be employed.

[0003] Effective parenteral routes of drug delivery, such as subcutaneous injection, intramuscular injection, and intravenous (IV) administration, as well as other fluids and compounds, involve penetration of the skin using a needle or stylet. Insulin is an example of a therapeutic fluid that is self-injected by many diabetic patients. Users of parenterally delivered drugs can benefit from wearable devices that automatically deliver the required drug / compound over a period of time.

[0004] For this purpose, efforts have been made to design portable and wearable devices for the controlled release of therapeutic agents. Such devices are known to have reservoirs such as cartridges, syringes, or bags and to be electronically controlled. These devices are plagued by several drawbacks, including failure rates. Reducing the size, weight, and cost of these devices is also an ongoing challenge. In addition, these devices are often applied to the skin and present the issue of frequent site changes for application.

Summary of the Invention

Means for Solving the Problems

[0005] According to the first implementation, a disposable housing assembly is disclosed. The disposable housing assembly includes a reservoir cavity, a needle located within the reservoir cavity, a fluid channel connected to the needle, and a cover, the cover such that when the cover is in a first position, the reservoir cavity and the needle are exposed, and when the cover is in a second position, the reservoir and the needle are not exposed.

[0006] Some embodiments of this implementation of the present invention include one or more of the following: A needle comprising a first end and a second end, the first end being inside the gasket and the second end being inside the needle cover of an overmolded portion. A needle cover of a rigid portion. A needle comprising a first end and a second end, the first end being exposed to the reservoir cavity and the second end being exposed to the flow path. A cylindrical guide positioned around the gasket. The needle comprising a bend. A gasket, the needle being positioned within the gasket. An outlet fluidly connected to a flow path. A hinged door, the hinged door comprising at least one fastening feature. At least one seal positioned around the needle. The hinged door comprising at least one knob configured to assist in pulling the reservoir toward the reservoir cavity. The hinged door comprising at least one fastening feature. The reservoir cavity comprises a barrier layer and a fluid, the fluid being maintained between the reservoir cavity and the barrier layer. Tubes of a predetermined length attached to the outlet. Luer connectors for the injection set attached to the tubes. Cannulas attached to the Luer connectors. The cover comprises at least one fastening feature. The cover comprises a plurality of fastening features. The cover moves vertically from a first position to a second position. The cover moves horizontally from a first position to a second position. The cover comprises a needle holder feature. The cover comprises a support feature. The needle comprises a first end and a second end, the first end being attached to a gasket.

[0007] According to the first implementation, a blow-molded reservoir is disclosed. The blow-molded reservoir comprises a first section, a port section comprising an opening and at least one leg, the port section comprising a port section fluidly connected to the first section, and a tail section.

[0008] Some embodiments of the present implementation of the present invention include one or more of the following: The tail section is sealed from the first section and the port section. The first section is a dome-shaped section. The first section is bellows-shaped. The first section is crushable. The port section includes a bulkhead. The port section includes a gasket. The partial section includes a needle.

[0009] According to the first implementation, a blow-molded reservoir is disclosed. The blow-molded reservoir comprises a first section and a port section comprising an opening and at least one leg, the port section comprising a port section, a tail section and a sacrificial neck section, which are fluidly connected to the first section.

[0010] Some embodiments of the present implementation of the present invention include one or more of the following: The tail section is sealed from the first section and the port section. The first section is a dome-shaped section. The first section is bellows-shaped. The first section is crushable. The port section includes a bulkhead. The port section includes a gasket. The port section includes a needle.

[0011] According to the first implementation, a blow-molded reservoir is disclosed. The blow-molded reservoir comprises a first section and a port section comprising an opening and at least one leg, the port section being fluidly connected to the first section.

[0012] Some embodiments of the present implementation of the present invention include one or more of the following: The first section is a dome-shaped section. The first section is bellows-shaped. The first section is crushable. The port section includes a partition wall. The port section includes a gasket. The subsection includes a needle.

[0013] According to the first implementation, a disposable housing assembly is disclosed. The disposable housing assembly comprises a reservoir cavity, a needle located within the reservoir cavity, a fluid passage connected to the needle, and a hinged door, the hinged door being such that when the hinged door is in a first open position, the reservoir cavity and the needle are exposed, and when the hinged door is in a second closed position, the reservoir and the needle are not exposed.

[0014] Some embodiments of this implementation of the present invention include one or more of the following: a gasket, wherein a needle is located within the gasket; an outlet fluidly connected to a flow path; a hinged door comprising at least one fastening feature; at least one seal located around the needle; a hinged door comprising at least one knob configured to assist in pulling the reservoir toward the reservoir cavity; a hinged door comprising at least one fastening feature; a reservoir cavity comprising a barrier layer and a fluid, the fluid being maintained between the reservoir cavity and the barrier layer; tubing of a predetermined length attached to the outlet; a luer of an injection set attached to the tubing; a cannula attached to the luer.

[0015] According to the first implementation, a disposable housing assembly is disclosed. The disposable housing assembly comprises a reservoir cavity, a needle located within the reservoir cavity, a fluid passage connected to the needle, and a hinged door, the hinged door being such that when the hinged door is in a first open position, the reservoir cavity and the needle are exposed, and when the hinged door is in a second closed position, the reservoir and the needle are not exposed.

[0016] Some embodiments of this implementation of the present invention include one or more of the following: A disposable housing assembly further includes a latch; further includes a gasket, the needle being located within the gasket; further includes an outlet fluidly connected to a flow path; a hinged door comprising at least one fastening feature; further includes at least one seal located around the needle; the hinged door comprising at least one knob configured to assist in pulling the reservoir toward the reservoir cavity; the hinged door comprising at least one fastening feature; the reservoir cavity comprising a barrier layer and a fluid, the fluid being maintained between the reservoir cavity and the barrier layer; further includes tubing of a predetermined length attached to the outlet; further includes a luer for an injection set attached to the tubing; further includes a cannula attached to the luer.

[0017] According to the first implementation, a reservoir system is disclosed. The reservoir system comprises a blow-molded reservoir and a disposable housing assembly comprising a reservoir cavity, a flow path, a cover for the reservoir cavity, and a needle, wherein moving the cover from a first position to a second position creates a fluid connection between the needle and the blow-molded reservoir and priming the flow path.

[0018] Some embodiments of this implementation of the present invention include one or more of the following: a gasket, wherein a needle is located within the gasket; a cover is hinged to a disposable housing assembly; the cover can be positioned in a first open position and a second closed position; the cover moves from the first open position to the second closed position; the cover is prevented from moving from the second closed position to the first open position; the cover moving from the first open position to the second closed position acts to prime the disposable housing assembly; the disposable housing assembly further comprises an outlet that is fluidly connected to a flow path; tubing of a predetermined length attached to the outlet; a luer for an injection set attached to the tubing; a cannula attached to the luer. A blow-molded reservoir comprises a first section and a port section comprising an opening and at least one leg, the port section being fluidly connected to the first section. The first section is a dome-shaped section; the first section is crushable. The port section includes a partition wall. The port section includes a gasket. The port section includes a needle. The reservoir cavity includes a barrier layer and a fluid, the fluid being maintained between the reservoir cavity and the barrier layer. The first section has a bellows shape.

[0019] According to the first implementation, a blow-molded reservoir is disclosed. The blow-molded reservoir comprises a first section, a port section comprising an opening and at least one leg, the port section comprising a port section fluidly connected to the first section, and a tail section.

[0020] Some embodiments of the present implementation of the present invention include one or more of the following: The tail section is sealed from the first section and the port section. The first section is a dome-shaped section. The first section is bellows-shaped. The first section is crushable. The port section includes a bulkhead. The port section includes a gasket. The port section includes a needle.

[0021] According to a first implementation, an injection molded reservoir is disclosed. The injection molded reservoir comprises a first section, a port section having an opening and at least one leg, the port section being fluidly connected to the first section, the port section comprising a tail section, and a sacrificial neck section.

[0022] Some embodiments of this implementation of the present invention include one or more of the following. The tail section is sealed from the first section and the port section. The first section is a domed section. The first section is a bellows-shaped. The first section is crushable. The port section comprises a partition. The port section comprises a gasket. The port section comprises a needle.

[0023] Details of one or more embodiments are set forth in the accompanying drawings and the description below. Other features and advantages will be apparent from the description, the drawings, and the claims. For example, the present application provides the following items. (Item 1) A disposable housing assembly comprising a reservoir cavity, a needle located within the reservoir cavity, a flow path fluidly connected to the needle, a cover, wherein when the cover is in a first position, the reservoir cavity and the needle are exposed, and when the cover is in a second position, the reservoir and the needle are not exposed. A disposable housing assembly comprising the above. (Item 2) The needle of the disposable housing assembly according to any one or more of Items 1 to 22, comprising a first end and a second end, the first end being inside a gasket and the second end being inside a needle cover of an overmolded part. (Item 3) The disposable housing assembly according to any one or more of Items 1 to 22, further comprising a rigid part needle cover. (Item 4) The needle includes a first end and a second end, the first end is exposed to the reservoir cavity, and the second end is exposed to the flow path. The disposable housing assembly according to any one or more of items 1 to 22. (Item 5) The disposable housing assembly according to any one or more of items 1 to 22, further comprising a cylindrical guide located around the gasket. (Item 6) The disposable housing assembly according to any one or more of items 1 to 22, wherein the needle has a bend. (Item 7) The disposable housing assembly according to any one or more of items 1 to 22, further comprising a gasket, and the needle is located within the gasket. (Item 8) The disposable housing assembly according to any one or more of items 1 to 22, further comprising an outlet fluidly connected to the flow path. (Item 9) The disposable housing assembly according to any one or more of items 1 to 22, further comprising a hinged door, and the hinged door has at least one fastening feature. (Item 10) The disposable housing assembly according to any one or more of items 1 to 22, further comprising at least one seal located around the needle. (Item 11) The disposable housing assembly according to any one or more of items 1 to 22, wherein the hinged door has at least one knob configured to assist in pulling the reservoir towards the reservoir cavity. (Item 12) The disposable housing assembly according to any one or more of items 1 to 22, wherein the hinged door has at least one fastening feature. (Item 13) The reservoir cavity a barrier layer, a fluid, and the fluid is maintained between the reservoir cavity and the barrier layer. A disposable housing assembly comprising one or more of the features described in items 1 to 22. (Item 13) A disposable housing assembly according to any one or more of items 1 to 22, further comprising pipes of a predetermined length attached to the outlet. (Item 14) A disposable housing assembly according to any one or more of items 1 to 22, further comprising a luer for an injection set to be attached to the aforementioned pipes. (Item 15) A disposable housing assembly according to any one or more of items 1 to 22, further comprising a cannula to which the lure is attached. (Item 16) The cover comprises at least one fastening feature, as described in one or more of items 1 to 22 of the disposable housing assembly. (Item 17) The cover is a disposable housing assembly according to one or more of items 1 to 22, comprising a plurality of fastening features. (Item 18) The cover moves vertically from a first position to a second position, as described in one or more of the disposable housing assemblies described in items 1 to 22. (Item 19) The cover moves horizontally from a first position to a second position, as described in one or more of the disposable housing assemblies described in items 1 to 22. (Item 20) The cover is a disposable housing assembly according to any one or more of items 1 to 22, comprising a needle holder feature. (Item 21) The cover is a disposable housing assembly according to one or more of items 1 to 22, comprising support features. (Item 22) The needle comprises a first end and a second end, the first end being attached to a gasket, as described in one or more of items 1 to 22 of the disposable housing assembly. (Item 23) A blow-molded reservoir, The first category and, Port classification, The opening and At least one leg and The port section is provided with a port section that is flexibly connected to the first section, Caudication and A blow-molded reservoir equipped with [a specific feature]. (Item 24) The tail section is sealed from the first section and the port section, and is a blow-molded reservoir according to one or more of items 23 to 30. (Item 25) The first section is a dome-shaped section, a blow-molded reservoir as described in one or more of items 23 to 30. (Item 26) The first category is a blow-molded reservoir having a bellows shape, as described in one or more of items 23 to 30. (Item 27) The first category is a blow-molded reservoir that is crushable, as described in one or more of items 23 to 30. (Item 28) The port section is a blow-molded reservoir according to any one or more of items 23 to 30, comprising a partition wall. (Item 29) The port section is a blow-molded reservoir according to one or more of items 23 to 30, comprising a gasket. (Item 30) The port section is a blow-molded reservoir according to any one or more of items 23 to 30, comprising a needle. (Item 31) A blow-molded reservoir, The first category and, Port classification, The opening and At least one leg and The port section is provided with a port section that is flexibly connected to the first section, Caudication and Sacrificial head classification and A blow-molded reservoir equipped with [a specific feature]. (Item 32) A blow-molded reservoir according to any one or more of items 31 to 38, wherein the tail section is sealed from the first section and the port section. (Item 33) The first section is a dome-shaped section, a blow-molded reservoir as described in one or more of items 31 to 38. (Item 34) The first category is a blow-molded reservoir having a bellows shape, as described in one or more of items 31 to 38. (Item 35) The first category is a blow-molded reservoir described in any one or more of items 31 to 38, which is crushable. (Item 36) The port section is a blow-molded reservoir according to any one or more of items 31 to 38, comprising a partition wall. (Item 37) The port section is a blow-molded reservoir according to any one or more of items 31 to 38, comprising a gasket. (Item 38) The port section is a blow-molded reservoir according to any one or more of items 31 to 38, comprising a needle. (Item 39) A blow-molded reservoir, The first category and, Port classification, The opening and At least one leg and The port section is provided, and the port section is flexibly connected to the first section. A blow-molded reservoir equipped with [a specific feature]. (Item 40) The first section is a dome-shaped section, a blow-molded reservoir as described in one or more of items 39 to 45. (Item 41) The first category is a blow-molded reservoir having a bellows shape, as described in one or more of items 39 to 45. (Item 42) The first category is a blow-molded reservoir described in any one or more of items 39 to 45, which is crushable. (Item 43) The port section is a blow-molded reservoir according to any one or more of items 39 to 45, comprising a partition wall. (Item 44) The port section is a blow-molded reservoir according to any one or more of items 39 to 45, comprising a gasket. (Item 45) The port section is a blow-molded reservoir according to any one or more of items 39 to 45, comprising a needle. (Item 46) A disposable housing assembly, Reservoir cavity, The needle located within the reservoir cavity, A flow channel connected to the needle in a fluid manner, A hinged door wherein, when the hinged door is in a first open position, the reservoir cavity and the needle are exposed, and when the hinged door is in a second closed position, the reservoir and the needle are not exposed. A disposable housing assembly equipped with the following features. (Item 47) A disposable housing assembly according to any one or more of items 46 to 56, further comprising a gasket, wherein the needle is located within the gasket. (Item 48) A disposable housing assembly according to any one or more of items 46 to 56, further comprising an outlet fluidly connected to the aforementioned flow path. (Item 49) The hinged door is a disposable housing assembly according to any one or more of items 46 to 56, comprising at least one fastening feature. (Item 50) A disposable housing assembly according to any one or more of items 46 to 56, further comprising at least one seal located around the needle. (Item 51) The disposable housing assembly according to any one or more of items 46 to 56, wherein the hinged door comprises at least one knob configured to assist in pulling the reservoir toward the reservoir cavity. (Item 52) The hinged door is a disposable housing assembly according to any one or more of items 46 to 56, comprising at least one fastening feature. (Item 53) The reservoir cavity is, barrier layer, A fluid, the fluid being maintained between the reservoir cavity and the barrier layer, and A disposable housing assembly comprising one or more of the features described in items 46 to 56. (Item 54) A disposable housing assembly according to any one or more of items 46 to 56, further comprising pipes of a predetermined length attached to the aforementioned outlet. (Item 55) A disposable housing assembly according to any one or more of items 46 to 56, further comprising a luer for an injection set to be attached to the aforementioned pipes. (Item 56) A disposable housing assembly according to any one or more of items 46 to 56, further comprising a cannula to which the lure is attached. (Item 57) A disposable housing assembly, Reservoir cavity, The needle located within the reservoir cavity, A flow channel connected to the needle in a fluid manner, A hinged door wherein, when the hinged door is in a first open position, the reservoir cavity and the needle are exposed, and when the hinged door is in a second closed position, the reservoir and the needle are not exposed. A disposable housing assembly equipped with the following features. (Item 58) A disposable housing assembly, further comprising a latch, as described in one or more of items 57-68. (Item 59) A disposable housing assembly according to any one or more of items 57 to 68, further comprising a gasket, wherein the needle is located within the gasket. (Item 60) A disposable housing assembly according to any one or more of items 57 to 68, further comprising an outlet fluidly connected to the aforementioned flow path. (Item 61) The hinged door is a disposable housing assembly according to any one or more of items 57 to 68, comprising at least one fastening feature. (Item 62) A disposable housing assembly according to any one or more of items 57 to 68, further comprising at least one seal located around the needle. (Item 63) The disposable housing assembly according to any one or more of items 57 to 68, wherein the hinged door comprises at least one knob configured to assist in pulling the reservoir toward the reservoir cavity. (Item 64) The hinged door is a disposable housing assembly according to any one or more of items 57 to 68, comprising at least one fastening feature. (Item 65) The reservoir cavity is, barrier layer, A fluid, the fluid being maintained between the reservoir cavity and the barrier layer, and A disposable housing assembly comprising one or more of the features described in items 57 to 68. (Item 66) A disposable housing assembly according to any one or more of items 57 to 68, further comprising pipes of a predetermined length attached to the aforementioned outlet. (Item 67) A disposable housing assembly according to any one or more of items 57 to 68, further comprising a luer for an injection set to be attached to the aforementioned pipes. (Item 68) A disposable housing assembly according to any one or more of items 57 to 68, further comprising a cannula to which the lure is attached. (Item 69) It is a reservoir system, A blow-molded reservoir, A disposable housing assembly, Reservoir cavity, Flow channels and A cover for the reservoir cavity, needle and A disposable housing assembly comprising Equipped with, Moving the cover from a first position to a second position creates a fluid connection between the needle and the blow-molded reservoir and prims the flow path in the reservoir system. (Item 70) A reservoir system according to any one or more of items 69 to 87, further comprising a gasket, wherein the needle is located within the gasket. (Item 71) The cover is hinged to the disposable housing assembly, in the reservoir system according to any one or more of items 69 to 87. (Item 72) The reservoir system according to any one or more of items 69 to 87, wherein the cover can be positioned in a first open position and a second closed position. (Item 73) The reservoir system according to any one or more of items 69 to 87, wherein the cover moves from the first open position to the second closed position. (Item 74) The reservoir system according to any one or more of items 69 to 87, wherein the cover is prevented from moving from the second closed position to the first open position. (Item 75) The reservoir system according to any one or more of items 69 to 87, wherein the movement of the cover from the first open position to the second closed position acts to prime the disposable housing assembly. (Item 76) The reservoir system according to any one or more of items 69 to 87, wherein the disposable housing assembly further comprises an outlet that is fluidly connected to the flow path. (Item 77) A reservoir system according to any one or more of items 69 to 87, further comprising pipes of a predetermined length attached to the outlet. (Item 78) A reservoir system according to any one or more of items 69 to 87, further comprising a lure for an injection set to be attached to the aforementioned pipes. (Item 79) A reservoir system according to any one or more of items 69 to 87, further comprising a cannula to be attached to the lure. (Item 80) The aforementioned molded reservoir is The first category and, Port classification, The opening and At least one leg and The port section is provided, and the port section is flexibly connected to the first section. A reservoir system comprising one or more of the features described in items 69 to 87. (Item 81) The first category is a dome-shaped category, and the reservoir system is as described in one or more of items 69 to 87. (Item 82) The first category is a reservoir system described in one or more of items 69 to 87, which is crushable. (Item 83) The port section is a reservoir system according to one or more of items 69 to 87, comprising a partition wall. (Item 84) The port section comprises a gasket, and is a reservoir system as described in one or more of items 69 to 87. (Item 85) The port section comprises a reservoir system according to one or more of items 69 to 87, wherein the port section is equipped with a needle. (Item 86) The reservoir cavity is, barrier layer, A fluid, the fluid being maintained between the reservoir cavity and the barrier layer, and A reservoir system comprising one or more of the features described in items 69 to 87. (Item 87) The first classification is a reservoir system according to any one or more of the items 69 to 87, which has a bellows-like shape. (Item 88) A blow-molded reservoir, The first category and, Port classification, The opening and At least one leg and The port section is provided with a port section that is flexibly connected to the first section, Caudication and A blow-molded reservoir equipped with [a specific feature]. (Item 89) The tail section is sealed from the first section and the port section, and is a blow-molded reservoir according to one or more of items 88 to 95. (Item 90) The first section is a dome-shaped section, a blow-molded reservoir as described in one or more of items 88 to 95. (Item 91) The first category is a blow-molded reservoir having a bellows shape, as described in one or more of items 88 to 95. (Item 92) The first category is a blow-molded reservoir that is crushable, as described in one or more of items 88 to 95. (Item 93) The port section is a blow-molded reservoir according to any one or more of items 88 to 95, comprising a partition wall. (Item 94) The port section is a blow-molded reservoir according to any one or more of items 88 to 95, comprising a gasket. (Item 95) The port section is a blow-molded reservoir according to any one or more of items 88 to 95, comprising a needle. (Item 96) A blow-molded reservoir, The first category and, Port classification, The opening and At least one leg and The port section is provided with a port section that is flexibly connected to the first section, Caudication and Sacrificial head classification and A blow-molded reservoir equipped with [a specific feature]. (Item 97) A blow-molded reservoir according to any one or more of items 96 to 103, wherein the tail section is sealed from the first section and the port section. (Item 98) The first section is a dome-shaped section, a blow-molded reservoir as described in one or more of items 96 to 103. (Item 99) The first category is a blow-molded reservoir, as described in one or more of items 96 to 103, which has a bellows-like shape. (Item 100) The first category is a blow-molded reservoir that is crushable, as described in one or more of items 96 to 103. (Item 101) The port section is a blow-molded reservoir according to any one or more of items 96 to 103, comprising a partition wall. (Item 102) The port section is a blow-molded reservoir according to any one or more of items 96 to 103, comprising a gasket. (Item 103) The port section is a blow-molded reservoir according to any one or more of items 96 to 103, comprising a needle. [Brief explanation of the drawing]

[0024] [Figure 1A] Figures 1A to 2B show various diagrams of one embodiment of a disposable housing assembly. [Figure 1B] Figures 1A to 2B show various diagrams of one embodiment of a disposable housing assembly. [Figure 1C] Figures 1A to 2B show various diagrams of one embodiment of a disposable housing assembly. [Figure 1D] Figures 1A to 2B show various diagrams of one embodiment of a disposable housing assembly. [Figure 1E] Figures 1A to 2B show various diagrams of one embodiment of a disposable housing assembly. [Figure 1F] Figures 1A to 2B show various diagrams of one embodiment of a disposable housing assembly. [Figure 1G] Figures 1A to 2B show various diagrams of one embodiment of a disposable housing assembly. [Figure 1H] Figures 1A to 2B show various diagrams of one embodiment of a disposable housing assembly. [Figure 2A] Figures 1A to 2B show various diagrams of one embodiment of a disposable housing assembly. [Figure 2B] Figures 1A to 2B show various diagrams of one embodiment of a disposable housing assembly. [Figure 2C] Figures 2A to 2J are various diagrams of one embodiment of a disposable housing assembly. [Figure 2D] Figures 2A to 2J are various diagrams of one embodiment of a disposable housing assembly. [Figure 2E] Figures 2A to 2J are various diagrams of one embodiment of a disposable housing assembly. [Figure 2F] Figures 2A to 2J are various diagrams of one embodiment of a disposable housing assembly. [Figure 2G] Figures 2A to 2J are various diagrams of one embodiment of a disposable housing assembly. [Figure 2H] Figures 2A to 2J are various diagrams of one embodiment of a disposable housing assembly. [Figure 2I] Figures 2A to 2J are various diagrams of one embodiment of a disposable housing assembly. [Figure 2J] Figures 2A to 2J are various diagrams of one embodiment of a disposable housing assembly. [Figure 3A] Figures 3A to 3G are various diagrams of one embodiment of the needle system. [Figure 3B] Figures 3A to 3G are various diagrams of one embodiment of the needle system. [Figure 3C] Figures 3A to 3G are various diagrams of one embodiment of the needle system. [Figure 3D] Figures 3A to 3G are various diagrams of one embodiment of the needle system. [Figure 3E] Figures 3A to 3G are various diagrams of one embodiment of the needle system. [Figure 3F] Figures 3A to 3G are various diagrams of one embodiment of the needle system. [Figure 3G] Figures 3A to 3G are various diagrams of one embodiment of the needle system. [Figure 4A] Figures 4A to 4I show various diagrams of one embodiment of a blow-molded reservoir. [Figure 4B] Figures 4A to 4I show various diagrams of one embodiment of a blow-molded reservoir. [Figure 4C] Figures 4A to 4I show various diagrams of one embodiment of a blow-molded reservoir. [Figure 4D] Figures 4A to 4I show various diagrams of one embodiment of a blow-molded reservoir. [Figure 4E] Figures 4A to 4I show various diagrams of one embodiment of a blow-molded reservoir. [Figure 4F] Figures 4A to 4I show various diagrams of one embodiment of a blow-molded reservoir. [Figure 4G] Figures 4A to 4I show various diagrams of one embodiment of a blow-molded reservoir. [Figure 4H] Figures 4A to 4I show various diagrams of one embodiment of a blow-molded reservoir. [Figure 4I] Figures 4A to 4I show various diagrams of one embodiment of a blow-molded reservoir. [Figure 5A] Figures 5A to 5C are various diagrams of one embodiment of a blow-molded reservoir. [Figure 5B] Figures 5A to 5C are various diagrams of one embodiment of a blow-molded reservoir. [Figure 5C] Figures 5A to 5C are various diagrams of one embodiment of a blow-molded reservoir. [Figure 6A] Figures 6A to 6E are various diagrams of one embodiment of a blow-molded reservoir. [Figure 6B] Figures 6A to 6E are various diagrams of one embodiment of a blow-molded reservoir. [Figure 6C] Figures 6A to 6E are various diagrams of one embodiment of a blow-molded reservoir. [Figure 6D] Figures 6A to 6E are various diagrams of one embodiment of a blow-molded reservoir. [Figure 6E] Figures 6A to 6E are various diagrams of one embodiment of a blow-molded reservoir. [Figure 7A] Figures 7A to 7C show various diagrams of one embodiment of a blow-molded reservoir. [Figure 7B] Figures 7A to 7C show various diagrams of one embodiment of a blow-molded reservoir. [Figure 7C] Figures 7A to 7C show various diagrams of one embodiment of a blow-molded reservoir. [Figure 8A] Figures 8A and 8B show various diagrams of one embodiment of a blow-molded reservoir. [Figure 8B]Figures 8A and 8B show various diagrams of one embodiment of a blow-molded reservoir. [Figure 9A] Figures 9A to 9G are various diagrams of one embodiment of a disposable housing assembly. [Figure 9B] Figures 9A to 9G are various diagrams of one embodiment of a disposable housing assembly. [Figure 9C] Figures 9A to 9G are various diagrams of one embodiment of a disposable housing assembly. [Figure 9D] Figures 9A to 9G are various diagrams of one embodiment of a disposable housing assembly. [Figure 9E] Figures 9A to 9G are various diagrams of one embodiment of a disposable housing assembly. [Figure 9F] Figures 9A to 9G are various diagrams of one embodiment of a disposable housing assembly. [Figure 9G] Figures 9A to 9G are various diagrams of one embodiment of a disposable housing assembly. [Figure 10A] Figures 10A to 10M are various diagrams of one embodiment of a disposable housing assembly. [Figure 10B] Figures 10A to 10M are various diagrams of one embodiment of a disposable housing assembly. [Figure 10C] Figures 10A to 10M are various diagrams of one embodiment of a disposable housing assembly. [Figure 10D] Figures 10A to 10M are various diagrams of one embodiment of a disposable housing assembly. [Figure 10E] Figures 10A to 10M are various diagrams of one embodiment of a disposable housing assembly. [Figure 10F] Figures 10A to 10M are various diagrams of one embodiment of a disposable housing assembly. [Figure 10G] Figures 10A to 10M are various diagrams of one embodiment of a disposable housing assembly. [Figure 10H] Figures 10A to 10M are various diagrams of one embodiment of a disposable housing assembly. [Figure 10I]Figures 10A to 10M are various diagrams of one embodiment of a disposable housing assembly. [Figure 10J] Figures 10A to 10M are various diagrams of one embodiment of a disposable housing assembly. [Figure 10K] Figures 10A to 10M are various diagrams of one embodiment of a disposable housing assembly. [Figure 10L] Figures 10A to 10M are various diagrams of one embodiment of a disposable housing assembly. [Figure 10M] Figures 10A to 10M are various diagrams of one embodiment of a disposable housing assembly. [Figure 11A] Figures 11A to 11C are various diagrams of one embodiment of a disposable housing assembly. [Figure 11B] Figures 11A to 11C are various diagrams of one embodiment of a disposable housing assembly. [Figure 11C] Figures 11A to 11C are various diagrams of one embodiment of a disposable housing assembly. [Figure 12A] Figures 12A to 12D are various diagrams of one embodiment of the needle device. [Figure 12B] Figures 12A to 12D are various diagrams of one embodiment of the needle device. [Figure 12C] Figures 12A to 12D are various diagrams of one embodiment of the needle device. [Figure 12D] Figures 12A to 12D are various diagrams of one embodiment of the needle device. [Figure 13A] Figures 13A to 14 show various diagrams of one embodiment of a disposable housing assembly. [Figure 13B] Figures 13A to 14 show various diagrams of one embodiment of a disposable housing assembly. [Figure 13C] Figures 13A to 14 show various diagrams of one embodiment of a disposable housing assembly. [Figure 13D] Figures 13A to 14 show various diagrams of one embodiment of a disposable housing assembly. [Figure 13E]Figures 13A to 14 show various diagrams of one embodiment of a disposable housing assembly. [Figure 14] Figures 13A to 14 show various diagrams of one embodiment of a disposable housing assembly. [Figure 15A] Figures 15A to 15G show various diagrams of one embodiment of a blow-molded reservoir. [Figure 15B] Figures 15A to 15G show various diagrams of one embodiment of a blow-molded reservoir. [Figure 15C] Figures 15A to 15G show various diagrams of one embodiment of a blow-molded reservoir. [Figure 15D] Figures 15A to 15G show various diagrams of one embodiment of a blow-molded reservoir. [Figure 15E] Figures 15A to 15G show various diagrams of one embodiment of a blow-molded reservoir. [Figure 15F] Figures 15A to 15G show various diagrams of one embodiment of a blow-molded reservoir. [Figure 15G] Figures 15A to 15G show various diagrams of one embodiment of a blow-molded reservoir. [Figure 16A] Figures 16A to 16G show various diagrams of one embodiment of a blow-molded reservoir. [Figure 16B] Figures 16A to 16G show various diagrams of one embodiment of a blow-molded reservoir. [Figure 16C] Figures 16A to 16G show various diagrams of one embodiment of a blow-molded reservoir. [Figure 16D] Figures 16A to 16G show various diagrams of one embodiment of a blow-molded reservoir. [Figure 16E] Figures 16A to 16G show various diagrams of one embodiment of a blow-molded reservoir. [Figure 16F] Figures 16A to 16G show various diagrams of one embodiment of a blow-molded reservoir. [Figure 16G] Figures 16A to 16G show various diagrams of one embodiment of a blow-molded reservoir. [Figure 17A] Figures 17A to 17G show various diagrams of one embodiment of a blow-molded reservoir. [Figure 17B] Figures 17A to 17G show various diagrams of one embodiment of a blow-molded reservoir. [Figure 17C] Figures 17A to 17G show various diagrams of one embodiment of a blow-molded reservoir. [Figure 17D] Figures 17A to 17G show various diagrams of one embodiment of a blow-molded reservoir. [Figure 17E] Figures 17A to 17G show various diagrams of one embodiment of a blow-molded reservoir. [Figure 17F] Figures 17A to 17G show various diagrams of one embodiment of a blow-molded reservoir. [Figure 17G] Figures 17A to 17G show various diagrams of one embodiment of a blow-molded reservoir. [Figure 18] Figure 18 is a graphical representation of the wall thickness of one embodiment of a blow-molded reservoir.

[0025] Similar symbols in various drawings represent the same elements. [Modes for carrying out the invention]

[0026] In various embodiments, the blow-molded reservoir may be used in conjunction with injection devices and systems and methods thereof. In various embodiments, the injection device is inserted into the subcutaneous layer of the user's skin and configured to be fluidly connected to a fluid source. In various embodiments, the injection device may be fluidly connected to a tube and / or injection pump of a certain length. Infusion pumps are not limited to, but include U.S. Patent Application No. 13 / 788,260, filed on March 7, 2013, titled "Infusion Pump Assembly" (published on April 17, 2014, current U.S. Patent Publication No. US-2014-0107579 (Agent Reference Number K40)), issued on July 23, 2013, titled "Infusion Pump Assembly" (U.S. Patent No. 8,491,570 (Agent Reference Number G75)), issued on April 9, 2013, titled "Fluid Delivery Systems and Methods" (U.S. Patent No. 8,414,522 (Agent Reference Number E70)), issued on September 11, 2012, titled "Infusion Pump This includes various infusion pumps and systems, as well as methods thereof, including disposable housing assemblies, reservoirs, filling assist devices, charging systems, etc., as shown and described in U.S. Patent No. 8,262,616 (Agent Reference No. F51), titled “Assembly”, and U.S. Patent No. 7,306,578 (Agent Reference No. C54), issued December 11, 2007, titled “Loading Mechanism for Infusion Pump”, all of which are incorporated herein by reference in their entirety. In various embodiments, various embodiments of the infusion device described herein may be used alone or in combination with a blow-molded reservoir.

[0027] In various embodiments, a blow-molded reservoir is disclosed, which includes a reservoir produced using a molding-and-filling technique. The molding-and-filling technique involves extruding molten plastic into a parasine, then clamping a mold onto the molten plastic while the plastic is molten, thereby expanding the molten plastic into a certain shape. In some embodiments, the plastic reservoir / blow-molded reservoir may be filled simultaneously while it is being formed. However, in various embodiments, the blow-molded reservoir may be formed and filled at a later time (i.e., after the formation is complete). The plastic material may be any plastic, including, but not limited to, one or more of rigid plastics or crushable plastics.

[0028] In various embodiments, the blow-molded reservoir may be configured to fit into any injection pump, including, but not limited to, any one or more of the various references disclosed and / or described herein by reference. In some embodiments, the blow-molded reservoir may be configured to fit into a disposable housing assembly, which in some embodiments may be one or more of the various embodiments shown and / or described herein by reference. For illustrative purposes, the various embodiments of the blow-molded reservoir described below will be described with reference to the disposable housing assembly 100 shown in Figures 1A–1H and Figures 2A–2H. The disposable housing assembly 100 includes a hinged door 102, which in some embodiments includes one or more of the features shown and described in one or more embodiments of the disposable housing assembly shown and described in one or more of the various references disclosed and described herein by reference. In various embodiments, the shape of the hinged door 102 may be configured to optimize the force applied to the blow-molded reservoir when the blow-molded reservoir is located inside the disposable housing assembly 100.

[0029] Referring still to Figures 1A to 2H, in various embodiments, a blow-molded reservoir 108 is installed inside a reservoir cavity 104 and fluidly connected to a disposable housing assembly 100 using a connection mechanism, the connection mechanism may include many, but is not limited to, one of the mechanisms shown in Figures 3A to 3G.

[0030] Referring again to Figures 3A to 3G, in some embodiments, the blow-molded reservoir 108 may be fluidly connected to the disposable housing assembly 100 through a needle 106 located within the reservoir cavity 104 and connected to the disposable housing assembly 100. In practice, in some embodiments, once the blow-molded reservoir 108 is installed inside the reservoir cavity 104, a hinged door 102 may be closed over the blow-molded reservoir, which in turn pushes the blow-molded reservoir toward the needle 106, creating a fluid connection between the blow-molded reservoir and the disposable housing assembly 100. In some embodiments, the needle 106 may include a barb 112, which may be beneficial / desirable for several reasons, including, but not limited to, securing the blown-molded reservoir 108 to the disposable housing assembly 100, and which may be beneficial / desirable for several reasons, including, but not limited to, ensuring that when the blown-molded reservoir 108 is removed from the disposable housing assembly 100, the needle is removed along with the blown-molded reservoir 108, rendering the disposable housing assembly 100 unusable. This may be beneficial / desirable for several reasons, including, but not limited to, preventing unsafe reuse of the reservoir and / or disposable housing assembly.

[0031] Still referring to Figures 3A to 3G, in various embodiments, the needle 106 may include one or more seals, including, but not limited to, a rubber ridge seal 116 and / or an overmolded rubber sleeve 114 that radially seal after the needle 106 punctures the port 204 of the blow-molded reservoir. In various embodiments, the blow-molded reservoir 108 may include a gasket 110 that can be punctured by the needle 106. In various embodiments, the needle 106 may be crimped into a disposable housing assembly 100 to form a seal. In various embodiments, the portion of the disposable housing assembly 100 containing the needle 106 may be made from any material, including, but not limited to, rubber and / or rigid plastic.

[0032] In some embodiments, the blow-molded reservoir 108 may include a partition / gasket 110. The blow-molded reservoir 108 may be fluidly connected to a disposable housing assembly 100 using a needle 106 that punctures the gasket 110. In practice, in some embodiments, once the blow-molded reservoir 108 is installed inside the reservoir cavity 104, a hinged door 102 may be closed over the blow-molded reservoir 108, which in turn pushes the blow-molded reservoir 108 toward the needle 106, which passes through the gasket 110 and creates a fluid connection between the blow-molded reservoir 108 and the disposable housing assembly 100.

[0033] The embodiments shown in Figures 3A to 3G may be used in either a disposable housing assembly and / or a blow-molded reservoir embodiment.

[0034] Various embodiments of blow-molded reservoirs are disclosed and described herein. These are meant to be representative embodiments and are not intended to be limiting or restrictive embodiments. Referring here to Figures 4A to 8E, various figures of various embodiments of blow-molded reservoirs are shown. However, many variations of the various embodiments and variations of blow-molded reservoirs have been considered, and Figures 4A to 8E are simply representative examples of various embodiments of blow-molded reservoirs.

[0035] Referring again to Figures 4A to 4I, some embodiments of the blow-molded reservoir 200 may include a dome-shaped section 202 formed by the mold during the molding-filling process. In various embodiments, the blow-molded reservoir 200 may include a port section 204, which includes an opening and, in some embodiments, a partition or gasket, or, in other embodiments, a needle configured to be fluidly attached to a disposable housing assembly 100, which is not shown in Figures 4A to 4I but is illustrated in Figures 3A to 3G.

[0036] In various embodiments, the port section 204 may include legs 206, 208 that interact with knobs 210, 212 (see Figure 2I) located on the underside of the hinged door 102. When the hinged door 102 is closed over the blow-molded reservoir 200 located within the reservoir cavity 104, the knobs 210, 212 on the hinged door 102 grip the legs 206, 208 on the blow-molded reservoir port 204, causing the blow-molded reservoir 200 to move toward a needle 106 located within the reservoir cavity 104. This pushes the needle 106 through the bulkhead / gasket 110 located within the port section 204.

[0037] In some embodiments, the hinged door 102 and / or disposable housing assembly 100 may include one or more fastening features. In some embodiments, when the hinged door 102 is closed over the reservoir cavity 104, the hinged door 102 may be locked in place, preventing the hinged door 102 from opening again. In some embodiments, the hinged door 102 is prevented from opening again by one or more fastening features. Thus, in some embodiments, the fastening features may also serve as locking features, and in other embodiments, the locking features may be separate from the fastening features.

[0038] The action of moving the hinged door 102 from a first or open position at the start (see at least Figures 2I to 2J) to a second or closed position at the end (see at least Figure 1A) also, in some embodiments, acts to prime the disposable housing assembly 100 with a fluid contained in a blow-molded reservoir 200.

[0039] The size and shape of the blow-molded reservoir may vary. In some embodiments, the blow-molded reservoir 200 may include a dome-shaped section 202. The dome-shaped section may be desirable / beneficial for several reasons, including, but not limited to, allowing for a larger volume of blow-molded reservoir in a fixed diameter dimension. This may be desirable / beneficial for several reasons, including, but not limited to, the removal of air from the blow-molded reservoir during the priming stage.

[0040] Referring again to Figures 5A to 5C, in some embodiments the blow-molded reservoir 300 may include a bellows-like shape. This is not limited to, but the bellows-like shape may be desirable / beneficial for several reasons, including that it contributes to the collapseability of the blow-molded reservoir 300 and / or can be configured to collapse in different ways.

[0041] In various embodiments, the blow-molded reservoir 300 may include a port section 302, which includes an opening and, in some embodiments, a partition or gasket, or, in other embodiments, a pin configured to be fluidly attached to a disposable housing assembly 100, which is not shown in Figures 5A-5C but is illustrated in Figures 3A-3G. In various embodiments, the port section 302 may also include legs 304, 306 that interact with knobs 210, 212 located on the underside of a hinged door 102. When the hinged door 102 is closed over the blown-molded reservoir 300 located within the reservoir cavity 104, the knobs 210, 212 on the hinged door 102 grip the legs 304, 306 on the blown-molded reservoir port 302, pulling the blown-molded reservoir 300 toward the needle 106 located within the reservoir cavity 104. This pushes the needle 106 through the bulkhead / gasket 110 located within the port section 302.

[0042] In some embodiments, the hinged door 102 and / or disposable housing assembly 100 may include one or more fastening features. In some embodiments, when the hinged door 102 is closed over the reservoir cavity 104, the hinged door 102 may be locked in place, preventing the hinged door 102 from opening again.

[0043] The action of moving the hinged door 102 from a first or open position at the start (see at least Figures 2I to 2J) to a second or closed position at the end (see at least Figure 1A) also, in some embodiments, acts to prime the disposable housing assembly 100 with fluid contained in a molded and filled reservoir 300.

[0044] Referring again to Figures 6A to 6E, another embodiment of the blow-molded reservoir 400 is shown. In various embodiments, when filling the blow-molded reservoir 400 during the manufacturing process (in some embodiments, this may be completed simultaneously with the molding of the blow-molded reservoir as described above, but in other embodiments, it may be completed at a later time after molding), it may be desirable / beneficial to include features that mitigate air that may remain in the blow-molded reservoir as a function of the manufacturing process. In some embodiments, a tail portion 402 may therefore be included on the blow-molded reservoir 400. In practice, the blow-molded reservoir 400 is filled near the top of the tail portion 402. The tail portion 402 may or may not be sealed between the tail portion 402 and the rest of the blow-molded reservoir 400.

[0045] In various embodiments, the blow-molded reservoir 400 may include a port section 404, which includes an opening and, in some embodiments, a partition or gasket, or, in other embodiments, a pin configured to be fluidly attached to a disposable housing assembly 100, which is not shown in Figures 6A-6E but is illustrated in Figures 3A-3G. In various embodiments, the port section 404 may also include legs 406, 408 that interact with knobs 210, 212 located on the underside of a hinged door 102. When the hinged door 102 is closed over the blown-molded reservoir 400 located within the reservoir cavity 104, the knobs 210, 212 on the hinged door 102 grip the legs 406, 408 on the blown-molded reservoir port 404, pulling the blown-molded reservoir 400 toward the needle 106 located within the reservoir cavity 104. This pushes the needle 106 through the bulkhead / gasket 110 located within the port section 404.

[0046] In some embodiments, the hinged door 102 and / or disposable housing assembly 100 may include one or more fastening features. In some embodiments, when the hinged door 102 is closed over the reservoir cavity 104, the hinged door 102 may be locked in place, preventing the hinged door 102 from opening again.

[0047] The action of moving the hinged door 102 from a first or open position at the start (see at least Figures 2I to 2J) to a second or closed position at the end (see at least Figure 1A) also, in some embodiments, acts to prime the disposable housing assembly 100 with fluid contained in a molded and filled reservoir 400.

[0048] During the process of fluidly connecting the blow-molded reservoir 400 to the disposable housing assembly 100, in embodiments including a tail section 402, the tail section 402 is pushed upward relative to the reservoir cavity 104 when the blow-molded reservoir 400 is first placed within the reservoir cavity 104, and then pushed downward when the hinged door 102 is moved to a second, or closed, position at the end.

[0049] The embodiments shown in Figures 6A to 6E include a dome-shaped blow-molded reservoir. However, various other shapes and sizes may also be used in conjunction with the tail embodiment.

[0050] Referring again to Figures 7A to 7C, in some embodiments, the dome shape of the blow-molded reservoir 500 may vary as shown. Also, in some embodiments, the dome-shaped blow-molded reservoir 500 may or may not include a tail.

[0051] Referring again to Figures 8A and 8B, in some embodiments, the blow-molded reservoir 600 may include a sacrificial neck 602, which may be filled, for example, partially or to some extent, and then a seal 606 or sealed area is introduced through the fluid. In various embodiments, the seal 606 displaces the fluid. In various embodiments, a rounded-tip riveting tool may be used to introduce the seal 606 or sealed area. In various embodiments, the riveting tool may be made of aluminum bronze or any other material. In various embodiments, the riveting tool may be heated to 285 degrees Fahrenheit using a heater cartridge. However, in various other embodiments, the riveting tool may be heated to different temperatures. This embodiment is not limiting, but may be beneficial / desirable for many reasons, including the fact that the blow-molded reservoir 600 may be filled with as little air as possible. Therefore, when the blow-molded reservoir 600 is completely filled into the sacrificial neck portion 602 and the seal 606 is then introduced, air is trapped within the sacrificial neck portion 602 and cannot be trapped within the blow-molded reservoir 600. Thus, in practice, when the blow-molded reservoir 600 is inserted into the disposable housing assembly 100, the sacrificial neck portion 602 can be removed from the remainder of the blow-molded reservoir 600, and no air is present inside the blow-molded reservoir 600. In various embodiments, a needle 106 in the disposable housing assembly 100 connects the blow-molded reservoir 600 to the disposable housing assembly 100 through a port 604.

[0052] Referring again to Figures 15A to 17G, in some embodiments, the blow-molded reservoir 1020 includes a reservoir section 1028 and may include a sacrificial neck 1022, which may be filled, for example, partially or halfway, and then the seal 1026 is a sealed or sealed area through which the fluid is introduced. In various embodiments, the seal 1026 displaces the fluid. In various embodiments, a rounded-tip riveting tool may be used to introduce the seal 1026. In various embodiments, the riveting tool may be made of aluminum bronze or any other material. In various embodiments, the riveting tool may be heated to 285 degrees Fahrenheit using a heater cartridge. However, in various other embodiments, the riveting tool may be heated to a different temperature. This embodiment may be beneficial / desirable for many reasons, including, but is not limited, that the blow-molded reservoir section 1028 can be filled with as little air as possible. Therefore, the blow-molded reservoir 1020 can be completely filled into the sacrificial neck portion 1022, and then, when the seal 1026 is introduced, air is trapped within the sacrificial neck portion 1022 and cannot be trapped within the reservoir section 1028. Thus, in practice, when the blow-molded reservoir 1020 is inserted into the disposable housing assembly 100, the sacrificial neck portion 1022 can be removed from the reservoir section 1028, and no air is present inside the reservoir section 1028. In various embodiments, a needle 106 in the disposable housing assembly 100 connects the blow-molded reservoir section 1028 to the disposable housing assembly 100 through a port 1024.

[0053] Referring again to Figures 15D to 17G, the reservoir section 1028 is shown. The reservoir section 1028 includes port 1024. The sacrificial neck section 1022 is shown in Figures 15A, 15B, and 15D to 15G.

[0054] In various embodiments, the blow-molded reservoir may be made from any plastic material, including, but not limited to, polyethylene and polypropylene. In some embodiments, following the manufacture and filling of the blow-molded reservoir, a cap or other cover may be connected to and / or fitted to the port section. In some embodiments where the partition / gasket is inside the port section, the partition / gasket may be added as part of the blow-molded sealing process or after the process is completed. In some embodiments, the blow-molded reservoir may include a bottom section and an upper section. In various embodiments, the bottom section of various embodiments of the blow-molded reservoir may be rigid, and the upper section may be flexible and / or crushable. In some embodiments, one side of the blow-molded reservoir may be thicker than the other side. In some embodiments, the top and bottom of the blow-molded reservoir may be thicker than the side walls. This may be desirable / beneficial for several reasons, including, but not limited to, increasing the crushability of blown-molded reservoirs.

[0055] In various embodiments, the blow-molded reservoir may be filled by connecting the blow-molded reservoir to a fluid-containing blister pack and squeezing the fluid into the blow-molded reservoir. In some embodiments, the blister pack may include a needle for puncturing a partition / gasket located within the blow-molded reservoir.

[0056] In some embodiments, a barrier layer may be added to the reservoir cavity, and a fluid and / or therapeutic fluid may be added to the reservoir cavity so that the fluid is maintained between the reservoir cavity and the barrier layer.

[0057] Fluidly connect the blow-molded reservoir to the consumables. In various embodiments, a blow-molded reservoir may be fluidly connected to a disposable housing assembly which may include any disposable housing assembly described herein and / or any disposable housing assembly described and / or shown in any one or more of the various references incorporated herein by reference above. Various embodiments for fluidly connecting a blow-molded reservoir to a disposable housing assembly are described below, with reference to Figures 9A to 12D.

[0058] Referring again to Figures 9A to 9G, a disposable housing assembly 700 is shown together with a blow-molded reservoir 702 and cover 704. In various embodiments, the blow-molded reservoir 702 is made from low-density polyethylene (LDPE). A Luer 706, which can be attached to any injection set known in the art (the injection set includes at least a cannula that can be fluidly connected to tubing 708), is fluidly connected to the blow-molded reservoir 702. The Luer 706 may be connected to an injection set (not shown) that is inserted into the user for the delivery of fluid from the blow-molded reservoir 702 into the user. In some embodiments, only tubing 708 is attached to the disposable housing assembly 700. In some embodiments, tubing 708 is not attached to the disposable housing assembly 700 but may be attached at a later time (e.g., after the injection set has been inserted into the user).

[0059] Referring to Figures 9A to 9D, the disposable housing assembly includes a cover 704 shown in its first non-operating position, which maintains the position of the blow-molded reservoir 702. The disposable housing assembly 700 includes a needle 720 and a gasket 718. In some embodiments, one end of the needle 720 may be located inside the gasket 718, as shown in Figure 9C. However, in other embodiments, one end of the needle 720 may be located outside the gasket 718, but in communication with the gasket 718. Nevertheless, when a force is applied to the cover 704 during operation, the cover 704 moves from a first non-operating position, as shown in Figures 9A to 9D, to a second, i.e., operating position, as the cover 704 is pushed downward onto the blow-molded reservoir 702, and this force pushes the end of the needle 720 through a point in the blow-molded reservoir 702, which may include point 722. The force applied to the blow-molded reservoir 702 is also transmitted to a gasket 718 that is crushed between the disposable housing assembly 700 and the blow-molded reservoir 702. The force moves the cover 704 from a first non-operating position to a second operating position, as shown in Figures 9E to 9G. The force also moves the blow-molded reservoir 702 from a non-operating position to an operating position.

[0060] In various embodiments, the blow-molded reservoir 702 connected to the needle 720 is sealed primarily by puncturing the blow-molded reservoir 702. However, the gasket 718 also acts as a secondary seal. This is beneficial / desirable for many reasons, including, but not limited to, when the needle 720 and the blow-molded reservoir 702 do not form a perfect seal, the gasket 718 provides an additional and / or secondary seal.

[0061] Various embodiments include a needle 720 having a sharp end and a second end which may be sharp or blunt. The second end connects the needle 720 to a flow path in a disposable housing assembly 700. The flow path connects the contents of a blow-molded reservoir 702 to a luer 706 which, in various embodiments, can be attached to an optional injection set, and in some embodiments, the injection set may include an optional inlet into a user for delivery of the fluid contained in the blow-molded reservoir 702.

[0062] Referring again to Figures 9B and 9E, in various embodiments, the cover 704 may include fastener features 710, 712, 714, and 716 that maintain the cover 704 in the second, i.e., working position once the cover 704 has been moved to the second, i.e., working position. In various embodiments, the cover 704 includes four fastener features 710, 712, 714, and 716; however, in various other embodiments, the cover 704 may include more than four or fewer fastener features. In some embodiments, the fastener features 710, 712, 714, and 716 may be designed as shown; however, in various embodiments, the fastener features may be any type of fastener, latch, and / or snap, and / or any feature that maintains the cover 704 in the second, i.e., working position. In various embodiments, the cover 704 may be captured in any one or more various ways. Therefore, any one or more features that lock / maintain the cover 704 in the operating position may be used.

[0063] Fastener features 710, 712, 714, and 716 are, but are not limited to, beneficial / desirable for several reasons, including, maintaining the cover 704 in a second, i.e., operating position, which prevents the reuse of the disposable housing assembly 700 and / or the blow-molded reservoir 702. Fastener features 710, 712, 714, and 716 also hold the blow-molded reservoir 702 in a non-operating position.

[0064] Referring again to Figures 10A to 10M, another embodiment is shown for fluidly connecting the blow-molded reservoir 802 to the disposable housing assembly 800. In this embodiment, which also includes a cover 804, the cover 804 moves horizontally or slides to fluidly connect the blow-molded reservoir 802 to the disposable housing assembly 800. In various embodiments, the blow-molded reservoir 802 is made from low-density polyethylene (LDPE). Also, although not shown, in various embodiments, the disposable housing assembly 800 may be attached to tubing, the tubing may be attached to luers, and the luers may be attached to an injection set. In various embodiments, the system may or may not include tubing.

[0065] Referring to Figures 10A to 10G, as far as the cover 804 is depicted, the cover 804 is in a first, i.e., non-operating position. The cover 804 includes a needle holder feature 814, a support feature 806, and a fastener feature 808. The disposable housing assembly 800 includes a matching fastener feature 816, a meshing support feature 818, and a support block 820 in the reservoir for the blow-molded reservoir 802.

[0066] In various embodiments, the shape of the needle 812 may be as shown in Figures 10A to 10M, or it may be various other shapes and sizes. In the embodiments shown in Figures 10A to 10G, the needle 812 includes an end that is attached to the gasket 814. In some embodiments, the gasket 814 and needle 812 may be as shown in Figures 10A to 10G, however, in other embodiments, the tip of the needle 812 may be inside the gasket 814 in the first, i.e., non-operating position. The rest of the body of the needle 812 rests on top of the reservoir 802, as shown in Figure 10D.

[0067] Referring again to Figures 10H to 10M, the cover 804 is moved to the second, i.e., the operating position. In Figures 10I and 10J, the cover 804 is not shown, however other components of the device are shown in the operating position. In Figure 10K, the reservoir 802 is not shown, and some features of the cover are shown, however the entire cover is not shown. However, other components of the device are shown in the operating position.

[0068] The cover 804 moves from a first, i.e., non-operating position to a second, i.e., operating position, with a force applied to the cover 804. In the second, i.e., operating position, the cover 804 is moved horizontally, and the force on the cover 804 pushes the needle 812 so that it punctures through the reservoir 802. The force applied to the cover 804 is also transmitted to the gasket 814, which is crushed against the blow-molded reservoir 802. The force moves the cover 804 from the first non-operating position to the second operating position, as shown in Figures 10H to 10M.

[0069] In various embodiments, the blow-molded reservoir 802 connected to the needle 812 is sealed primarily by puncturing the blow-molded reservoir 802. However, the gasket 814 also acts as a secondary seal. This is beneficial / desirable for many reasons, including, but not limited to, when the needle 812 and the blow-molded reservoir 802 do not form a perfect seal, the gasket 814 provides an additional seal.

[0070] As the cover 804 moves from a first, i.e., non-operating position to a second, i.e., operating position, the support feature 806 slides under the interlocking support feature 818 of the disposable housing assembly 800. This prevents the cover 804 from being lifted or moved out of its relationship with the disposable housing assembly 800. Additionally, the fastener feature 808 slides under the interlocking fastener feature 816 on the disposable housing assembly 800, locking the cover 804 in place.

[0071] In various embodiments, the disposable housing assembly 800 also includes a support block 820 for the blow-molded reservoir 802. The support block 820 supports the position of the blow-molded reservoir 802 so that the blow-molded reservoir 802 maintains its position and moves when the cover 804 slides and the needle 812 punctures the blow-molded reservoir 802.

[0072] With respect to the needle 812, in various embodiments, when the cover 804 slides to a second, i.e., operating position, the shape of the needle 812 changes slightly as it extends and / or unbends. The sliding of the cover 804 also provides the force required for the needle 812 to puncture the reservoir.

[0073] Referring again to Figures 11A to 11C, in some embodiments the needle 902 may be of any shape or size, and in some embodiments it may include a gasket 904. The gasket 904 may be as shown in Figures 11A to 11C, and the end of the needle 902 is outside the gasket 904 in the first, i.e., non-working position. However, in various embodiments the end of the needle 902 may be inside the gasket 904 in the first, i.e., non-working position. In various embodiments a blow-molded reservoir (not shown in Figures 11A to 11C) may be inserted into the reservoir receiving area 906 of a disposable housing assembly 900. A cover (not shown) may be attached to the disposable housing assembly 900, and a force applied to the cover may bring the blow-molded reservoir and the needle 902 into contact, causing the needle 902 to puncture the blow-molded reservoir. As discussed above, in various embodiments, the needle 902 and the blown-molded reservoir may form a seal; however, in some embodiments, the gasket 904 may be included to serve as a backup or secondary seal.

[0074] The needle is formed / constructed and sized as shown in these various figures, but other shapes / constructions and sizes may be used in any of the various embodiments described herein. Thus, in various embodiments, the needle may have any shape / construction including one or more folds, bends, curves, etc. Furthermore, although gaskets are shown herein, gaskets of other shapes and / or sizes or other types of seals may be used. In addition, in some embodiments, more than one gasket and / or seal may be used.

[0075] Referring again to Figures 12A to 12D, in various embodiments, a mechanism other than a cover may be used to push the needle into a blow-molded reservoir (not shown). For example, in some embodiments, a needle 1000, which includes at least one sharp end and in some embodiments may be in close proximity to a gasket 1002, may be held in place by a shuttle 1004. In various embodiments, the shuttle 1004 is connected to a spring 1006 and contained by a latch feature 1008. When the latch feature 1008 is displaced, the spring 1006, which is adjacent to the shuttle 1004 and in some embodiments attached to the shuttle 1004, propels the shuttle 1004 along its axis and the needle 1000 through the blow-molded reservoir (not shown). One configuration is shown in Figures 12A to 12D, but in various embodiments, the shuttle, spring, needle shape, and / or latch feature may be molded and / or configured differently. In some embodiments, the latch feature 1008 may be displaced by a cover, trigger, or any other mechanism capable of displacing the latch feature 1008. In various embodiments, the flow path 1010 connects the contents of the blow-molded reservoir to an injection set, the injection set may be any injection set in various embodiments, and in some embodiments may include an optional inlet into a user for delivery of the fluid contained in the blow-molded reservoir. In some embodiments, the flow path 1010 may be incorporated into a disposable housing assembly, may be separate tubing, or may be molded directly into the disposable housing assembly.

[0076] As discussed above, the gasket 1002 may contain the sharp end of the needle 1000, or the sharp end of the needle 1000 may protrude from the gasket 1002 in the first, i.e., non-operating state. In various embodiments, the gasket 1002 provides a seal and / or secondary and / or backup seal for sealing between the needle 1000 and the blow-molded reservoir.

[0077] Referring again to Figures 13A to 14, another embodiment of the disposable housing assembly 1100, which may include tubing 1102 of a certain length and a Luer connector 1104 (not shown in various embodiments, but which may be attached to an infusion set 1124 including a cannula 1126 shown in Figure 13A), may be used in conjunction with any of the above-described embodiments of various covers and / or blow-molded reservoirs. As shown in Figures 13A to 14, the disposable housing assembly 1100 is depicted without any cover. However, in various embodiments, the disposable housing assembly 1100 includes a cover, which includes, but is not limited to, any of the various covers described herein. In various embodiments, the disposable housing assembly 1100 may or may not include tubing 1102 and / or the Luer connector 1104.

[0078] Still referring to Figures 13A–14, the disposable housing assembly 1100 includes a reservoir cavity 1110 configured to receive a blow-molded reservoir. In various embodiments, the shape of the needle 1106 may be as shown in Figures 13A, 13E, and 14, or may be various other shapes and sizes. In the embodiments shown in Figures 13A, 13E, and 14, the needle includes a single bend, and the needle 1106 includes an end that attaches to the gasket 1108. In various embodiments, the end of the needle 1106 that attaches to the gasket 1108 includes a cylindrical guide 1114. The cylindrical guide 1114 may be beneficial / desirable for several reasons, including, but is not limited to, that the cylindrical guide 1114 contributes to keeping the needle 1106 in a straight configuration. In some embodiments, the gasket 1108 and needle 1106 may be as shown in Figures 13A, 13E, and 14; however, in other embodiments, the tip of the needle 1106 may be inside the gasket 1108 (for a cover, although not shown in Figures 13A, 13E, or 14, but whose various embodiments are described herein) in the first, i.e., non-operating position. The rest of the body of the needle 1106 rests on top of the reservoir, for example, as shown in Figure 10D.

[0079] The needle 1106 includes a second end that is press-fitted into the needle cover 1118 of the overmolded portion. The needle cover 1116 of the rigid portion is also included, and both maintain the position of the needle 1106. When the needle 1106 is pressed into the needle cover 1118 of the overmolded portion, the needle 1106 may float. This may be beneficial / desirable for several reasons, including, but is not limited to, that the end of the needle 1106 that interacts with the reservoir and is located inside the reservoir cavity 1110 may be constrained.

[0080] The needle 1106 thus has a first end exposed to the reservoir cavity 1110 and a second end exposed to the flow path 1112. The overmolded portion of the needle cover 1118 includes a fluid seal 1120, which in turn creates an O-ring surface seal, and this portion of the material is crushed against the fluid cover 1122 of the disposable housing assembly 1100. The rigid portion of the needle cover 1116 is ultrasonically welded in various embodiments to attach the fluid cover 1122 portion of the disposable housing assembly 1100 to the bottom portion of the disposable housing assembly 1100.

[0081] The cover moves from a first, i.e., non-operating position to a second, i.e., operating position, with a force applied to the cover. In the second, i.e., operating position, the cover is in motion, and the force on the cover pushes the needle 1106 so that it punctures through the reservoir. The force applied to the cover is also transmitted to the gasket 1108, which is crushed against the blow-molded reservoir. The force moves the cover from the first and non-operating positions to the second and operating positions.

[0082] In various embodiments, the blow-molded reservoir connected to the needle 1106 is sealed primarily by puncturing the blow-molded reservoir. However, the gasket 1108 also acts as a secondary seal. This is beneficial / desirable for several reasons, including, but not limited to, when the needle 1106 and the blow-molded reservoir do not form a perfect seal, the gasket 1108 provides an additional seal.

[0083] Still referring to Figures 13A, 13E, and 14, in some embodiments the needle 1106 may be of any shape or size, and in some embodiments it may include a gasket 1108. The gasket 1108 may be as shown in Figures 13A, 13E, and 14, and the end of the needle 1106 is outside the gasket 1108 in the first, i.e., non-operating position. However, in various embodiments the end of the needle 1106 may be inside the gasket 1108 in the first, i.e., non-operating position. In various embodiments a blow-molded reservoir (not shown in Figures 13A, 13E, or 14, but including any embodiment described herein) may be inserted into the reservoir cavity 1110 of a disposable housing assembly 1100. A cover (not shown) may be attached to the disposable housing assembly 1100, and a force applied to the cover may bring the blown-molded reservoir and the needle 1106 into contact, causing the needle 1106 to puncture the blown-molded reservoir. As discussed above, in various embodiments the needle 1106 and the blown-molded reservoir may form a seal; however, in some embodiments a gasket 1108 may be included to serve as a backup or secondary seal.

[0084] In various embodiments of a blow-molded reservoir, the blow-molding process may be designed to make specific portions of the blow-molded reservoir thinner in area. Therefore, in various embodiments, the walls of the blow-molded reservoir may not be consistent throughout with respect to thickness, but rather the wall thickness may vary in specific locations. In various embodiments, corner sections of the blow-molded reservoir are thinner than the rest of the reservoir. This may be beneficial / desirable for several reasons, including, but not limited to, increasing the crushability of the blow-molded reservoir. In other embodiments, the reservoir may be manufactured using molding equipment and dies to include thinner sections. However, in various embodiments, the blow-molded reservoir is manufactured with intentional geometric shapes and variations in wall thickness. Referring again to Figure 18, graphical representations of various wall sections of embodiments of the blow-molded reservoir shown in Figures 15A–17G are provided. Areas 1200 and 1202 represent the corners of the reservoir, and in various embodiments, the thickness of these areas 1200 and 1202 is less than the thickness of the non-corner section 1204.

[0085] In various embodiments, the cover of the disposable housing assembly may include at least one notch and / or feature. In some embodiments, the notch may be of any shape or size, may be any number (including a single notch), may include a slit or a rounded notch, or may include one or more notches. The feature may be any feature, including, but not limited to, tabs, interlocking features, and / or marks. In various embodiments, the notch and / or feature may also be any of those described in the various references incorporated herein by reference above. Furthermore, in some embodiments, the cover may not include any notches and / or features.

[0086] The needle is molded / configured and sized as shown in these various figures, but other molds / configurations and sizes may also be used in any of the various embodiments described herein. Thus, in various embodiments, the needle may have any mold / configuration including one or more folds, bends, curves, etc. Furthermore, although a gasket is shown herein, other molds and / or sizes of gaskets or other types of seals may be used. In addition, in some embodiments, more than one gasket and / or seal may be used.

[0087] Several embodiments have been described. It should be understood that various modifications may be made. Therefore, other embodiments are also within the scope of the following claims.

[0088] While the principles of the present invention have been described herein, it will be understood by those skilled in the art that this description is merely an example and not a limitation of the scope of the invention. Other embodiments, in addition to the exemplary embodiments shown and described herein, are also conceivable within the scope of the invention. Modifications and substitutions by those skilled in the art are also considered to be within the scope of the invention.

Claims

1. A disposable housing assembly, Reservoir cavity, A needle, at least partially disposed within the reservoir cavity, A flow channel fluidly connected to the aforementioned needle, A cover, the cover being hinged, the cover including at least one knob, the at least one knob being configured to interact with the reservoir and to pull the reservoir toward the needle, such that the needle punctures a seal located within the reservoir when the cover is pivoted from a first position to a second position. A disposable housing assembly equipped with the following features.

2. The disposable housing assembly according to claim 1, wherein the needle comprises a first end and a second end, the first end being inside the gasket and the second end being inside the needle cover of the overmolded portion.

3. The disposable housing assembly according to claim 1, further comprising a cylindrical guide positioned around the gasket.

4. The disposable housing assembly according to claim 1, wherein the needle is bendable.

5. The disposable housing assembly according to claim 1, further comprising a gasket, wherein the tip of the needle is disposed within the gasket.

6. The disposable housing assembly according to claim 1, further comprising an outlet fluidly connected to the flow path.

7. The disposable housing assembly according to claim 1, wherein the cover comprises at least one fastening feature.

8. The aforementioned disposable housing assembly further comprises a mating feature, The disposable housing assembly according to claim 7, wherein the fitting feature is engageable with the at least one fastening feature to hold the cover in the second position.

9. The disposable housing assembly according to claim 6, further comprising a set of pipes of a predetermined length attached to the outlet.

10. The disposable housing assembly according to claim 9, further comprising a luer for an injection set attached to the tubing.

11. The disposable housing assembly according to claim 10, further comprising a cannula attached to the luer.

12. The disposable housing assembly according to claim 1, wherein the cover comprises a plurality of fastening features.

13. The disposable housing assembly according to claim 1, wherein the cover moves vertically from a first position to a second position.

14. The disposable housing assembly according to claim 1, wherein the cover moves horizontally from a first position to a second position.

15. The disposable housing assembly according to claim 1, wherein the cover is equipped with a needle holder feature.

16. The disposable housing assembly according to claim 1, wherein the needle comprises a first end and a second end, the first end being attached to a gasket.

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