Infusion pump assembly having disposable housing assembly and blowmolded 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 THEINVENTION The present application relates generally to fluid delivery systems, and more specifically to infusion pump assemblies. [Background technology]

[0002] (background) Many potentially valuable drugs or compounds, including biologics, 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 a frequency that makes it difficult or impossible for patients to maintain the desired schedule using oral formulations.In these cases, parenteral delivery is often adopted or can be adopted.

[0003] Effective parenteral routes of delivery of drugs, such as subcutaneous injection, intramuscular injection, and intravenous (IV) administration, as well as other fluids and compounds, involve penetration of the skin with 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 may benefit from a wearable device that automatically delivers the needed drug / compound over a period of time.

[0004] To this end, efforts have been made to design portable and wearable devices for the controlled release of therapeutic agents. Such devices are known to have a reservoir, such as a cartridge, syringe, or bag, and to be electronically controlled. These devices suffer from 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, presenting the challenge of frequent reapplication for application. Summary of the Invention [Means for solving the problem]

[0005] According to a first implementation, a disposable housing assembly is disclosed that includes a reservoir cavity, a needle located within the reservoir cavity, a flow path fluidly connected to the needle, and a cover, where 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 invention include one or more of the following: 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; the needle cover of the rigid portion; the needle comprises 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 located around the gasket; the needle comprises a bend; a gasket, the needle being located within the gasket; an outlet fluidly connected to the flow path; a hinged door, the hinged door comprising at least one catch feature; at least one seal located around the needle; the hinged door comprising at least one tab configured to assist in drawing the reservoir towards the reservoir cavity; the hinged door comprising at least one catch feature. The reservoir cavity comprises a barrier layer and a fluid, the fluid being maintained between the reservoir cavity and the barrier layer. A length of tubing attached to the outlet. A luer of an infusion set attached to the tubing. A cannula attached to the luer. The cover comprises at least one clasp feature. The cover comprises a plurality of clasp features. The cover moves vertically from a first position to a second position. The cover moves horizontally from the first position to the 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 attached to the gasket.

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

[0008] Some embodiments of this implementation of the 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 collapsible; the port section comprises a septum; the port section comprises a gasket; the section section comprises a needle.

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

[0010] Some embodiments of this implementation of the 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 collapsible; the port section comprises a septum; the port section comprises a gasket; the port section comprises a needle.

[0011] According to a first implementation, a blow molded reservoir is disclosed that includes a first section and a port section, the port section including an opening and at least one leg, the port section fluidly connected to the first section.

[0012] Some embodiments of this implementation of the 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 collapsible. The port section comprises a septum. The port section comprises a gasket. The sub-section comprises a needle.

[0013] According to a first implementation, a disposable housing assembly is disclosed that includes a reservoir cavity, a needle located within the reservoir cavity, a flow path fluidly connected to the needle, and a hinged door, where 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 invention include one or more of the following: a gasket, where the needle is located within the gasket; an outlet fluidly connected to the flow path; a hinged door comprising at least one catch feature; at least one seal located around the needle; a hinged door comprising at least one tab configured to assist in drawing the reservoir towards the reservoir cavity; a hinged door comprising at least one catch feature; a reservoir cavity comprising a barrier layer and a fluid, the fluid being maintained between the reservoir cavity and the barrier layer; a length of tubing attached to the outlet; a luer of an infusion set attached to the tubing; a cannula attached to the luer.

[0015] According to a first implementation, a disposable housing assembly is disclosed that includes a reservoir cavity, a needle located within the reservoir cavity, a flow path fluidly connected to the needle, and a hinged door, where 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 invention include one or more of the following: The 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 the flow path; The hinged door includes at least one catch feature; Further includes at least one seal located around the needle; The hinged door includes at least one tab configured to assist in drawing the reservoir towards the reservoir cavity; The hinged door includes at least one catch feature; The reservoir cavity includes a barrier layer and a fluid, the fluid being maintained between the reservoir cavity and the barrier layer; Further includes a length of tubing attached to the outlet; Further includes a luer of an infusion set attached to the tubing; Further includes a cannula attached to the luer.

[0017] According to a first implementation, a reservoir system is disclosed that includes a blown-molded reservoir and a disposable housing assembly that includes a reservoir cavity, a flow path, a cover for the reservoir cavity, and a needle, where moving the cover from a first position to a second position creates a fluid connection between the needle and the blown-molded reservoir and primes the flow path.

[0018] Some embodiments of this implementation of the invention include one or more of the following: a gasket, the needle being located within the gasket; a cover hingedly attached to the disposable housing assembly; the cover being positionable in a first open position and a second closed position; the cover moving from the first open position to the second closed position; the cover being 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 fluidly connected to the flow path; a length of tubing attached to the outlet; a luer of an infusion set attached to the tubing; a cannula attached to the luer; the blow molded reservoir comprises a first section and a port section, the port section comprising an opening and at least one leg, the port section being fluidly connected to the first section; the first section being a dome-shaped section; the first section being crushable. The port section comprises a septum. The port section comprises a gasket. The port section comprises a needle. The reservoir cavity comprises a barrier layer and a fluid, the fluid being maintained between the reservoir cavity and the barrier layer. The first section is bellows shaped.

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

[0020] Some embodiments of this implementation of the 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 collapsible; the port section comprises a septum; the port section comprises a gasket; the port section comprises a needle.

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

[0022] Some embodiments of this implementation of the 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 collapsible; the port section comprises a septum; the port section comprises a gasket; the port section comprises a needle.

[0023] The 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, drawings, and claims. For example, the present application provides the following: (Item 1) 1. A disposable housing assembly comprising: A reservoir cavity; a needle located within the reservoir cavity; a fluid channel 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 cavity and the needle are not exposed; and A disposable housing assembly comprising: (Item 2) 23. The disposable housing assembly of any one or more of items 1-22, wherein the needle has 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 portion. (Item 3) 23. The disposable housing assembly of any one or more of items 1-22, further comprising a rigid portion needle cover. (Item 4) 23. The disposable housing assembly of any one or more of items 1-22, wherein the needle comprises a first end and a second end, the first end exposed to the reservoir cavity and the second end exposed to the flow path. (Item 5) 23. The disposable housing assembly of any one or more of items 1-22, further comprising a cylindrical guide positioned around the gasket. (Item 6) 23. The disposable housing assembly of any one or more of items 1-22, wherein the needle comprises a bend. (Item 7) 23. The disposable housing assembly of any one or more of items 1-22, further comprising a gasket, the needle being positioned within the gasket. (Item 8) 23. The disposable housing assembly of any one or more of items 1-22, further comprising an outlet fluidly connected to the flow path. (Item 9) 23. The disposable housing assembly of any one or more of items 1-22, further comprising a hinged door, the hinged door comprising at least one catch feature. (Item 10) 23. The disposable housing assembly of any one or more of items 1-22, further comprising at least one seal positioned about the needle. (Item 11) 23. The disposable housing assembly of any one or more of items 1-22, wherein the hinged door comprises at least one tab configured to assist in pulling a reservoir towards the reservoir cavity. (Item 12) 23. The disposable housing assembly of any one or more of items 1-22, wherein the hinged door comprises at least one catch feature. (Item 13) The reservoir cavity comprises: A barrier layer; and a fluid maintained between the reservoir cavity and the barrier layer; 23. The disposable housing assembly of any one or more of items 1-22, comprising: (Item 13) 23. The disposable housing assembly of any one or more of items 1-22, further comprising a length of tubing attached to the outlet. (Item 14) 23. The disposable housing assembly of any one or more of items 1-22, further comprising an infusion set luer attached to the tubing. (Item 15) 23. The disposable housing assembly of any one or more of items 1-22, further comprising a cannula attached to the luer. (Item 16) 23. The disposable housing assembly of any one or more of items 1-22, wherein the cover comprises at least one fastening feature. (Item 17) 23. The disposable housing assembly of any one or more of items 1-22, wherein the cover comprises a plurality of fastening features. (Item 18) 23. The disposable housing assembly of any one or more of items 1-22, wherein the cover moves vertically from a first position to a second position. (Item 19) 23. The disposable housing assembly of any one or more of items 1-22, wherein the cover moves horizontally from a first position to a second position. (Item 20) 23. The disposable housing assembly of any one or more of items 1-22, wherein the cover comprises a needle holder feature. (Item 21) 23. The disposable housing assembly of any one or more of items 1-22, wherein the cover comprises a support feature. (Item 22) 23. The disposable housing assembly of any one or more of items 1-22, wherein the needle comprises a first end and a second end, the first end being attached to a gasket. (Item 23) A blow molded reservoir, comprising: The first division, A port segment, An opening; At least one leg and a port section, the port section being fluidly connected to the first section; Caudal segment and A blow molded reservoir comprising: (Item 24) 31. The blow molded reservoir of any one or more of items 23-30, wherein the tail section is sealed from the first section and the port section. (Item 25) 31. The blow molded reservoir according to any one or more of items 23 to 30, wherein the first section is a dome-shaped section. (Item 26) 31. The blow molded reservoir according to any one or more of items 23 to 30, wherein the first section is bellows shaped. (Item 27) 31. The blow molded reservoir according to any one or more of items 23 to 30, wherein the first section is crushable. (Item 28) 31. The blow molded reservoir of any one or more of items 23-30, wherein the port section comprises a septum. (Item 29) 31. The blow molded reservoir of any one or more of items 23-30, wherein the port section comprises a gasket. (Item 30) 31. The blow molded reservoir of any one or more of items 23-30, wherein the port section comprises a needle. (Item 31) A blow molded reservoir, comprising: The first division, A port segment, An opening; At least one leg and a port section, the port section being fluidly connected to the first section; a tail segment; Sacrificial neck section and A blow molded reservoir comprising: (Item 32) Item 39. The blow molded reservoir of any one or more of items 31-38, wherein the tail section is sealed from the first section and the port section. (Item 33) 39. The blow molded reservoir according to any one or more of items 31 to 38, wherein the first section is a dome-shaped section. (Item 34) 39. The blow molded reservoir according to any one or more of items 31 to 38, wherein the first section is bellows shaped. (Item 35) 39. The blow molded reservoir according to any one or more of items 31 to 38, wherein the first section is crushable. (Item 36) Item 39. The blow molded reservoir of any one or more of items 31-38, wherein the port section comprises a septum. (Item 37) Item 39. The blow molded reservoir of any one or more of items 31-38, wherein the port section comprises a gasket. (Item 38) Item 39. The blow molded reservoir of any one or more of items 31-38, wherein the port section comprises a needle. (Item 39) A blow molded reservoir, comprising: The first division, A port segment, An opening; At least one leg and a port section, the port section being fluidly connected to the first section; A blow molded reservoir comprising: (Item 40) 46. ​​The blow molded reservoir according to any one or more of items 39 to 45, wherein the first section is a dome-shaped section. (Item 41) 46. ​​The blow molded reservoir according to any one or more of items 39 to 45, wherein the first section is bellows shaped. (Item 42) 46. ​​The blow molded reservoir according to any one or more of items 39 to 45, wherein the first section is crushable. (Item 43) 46. ​​The blow molded reservoir of any one or more of items 39-45, wherein the port section comprises a septum. (Item 44) 46. ​​The blow molded reservoir of any one or more of items 39-45, wherein the port section comprises a gasket. (Item 45) 46. ​​The blow molded reservoir of any one or more of items 39-45, wherein the port section comprises a needle. (Item 46) 1. A disposable housing assembly comprising: A reservoir cavity; a needle located within the reservoir cavity; a fluid channel fluidly connected to the needle; 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 comprising: (Item 47) 57. The disposable housing assembly of any one or more of items 46-56, further comprising a gasket, the needle being positioned within the gasket. (Item 48) 57. The disposable housing assembly of any one or more of items 46-56, further comprising an outlet fluidly connected to the flow path. (Item 49) 57. The disposable housing assembly of any one or more of items 46-56, wherein the hinged door comprises at least one catch feature. (Item 50) 57. The disposable housing assembly of any one or more of items 46-56, further comprising at least one seal positioned about the needle. (Item 51) 57. The disposable housing assembly of any one or more of items 46-56, wherein the hinged door comprises at least one tab configured to assist in pulling the reservoir towards the reservoir cavity. (Item 52) 57. The disposable housing assembly of any one or more of items 46-56, wherein the hinged door comprises at least one catch feature. (Item 53) The reservoir cavity comprises: A barrier layer; and a fluid maintained between the reservoir cavity and the barrier layer; 57. The disposable housing assembly of any one or more of items 46-56, comprising: (Item 54) 57. The disposable housing assembly of any one or more of items 46-56, further comprising a length of tubing attached to the outlet. (Item 55) 57. The disposable housing assembly of any one or more of items 46-56, further comprising an infusion set luer attached to the tubing. (Item 56) 57. The disposable housing assembly of any one or more of items 46-56, further comprising a cannula attached to the luer. (Item 57) 1. A disposable housing assembly comprising: A reservoir cavity; a needle located within the reservoir cavity; a fluid channel fluidly connected to the needle; 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 comprising: (Item 58) Item 69. The disposable housing assembly of any one or more of items 57-68, further comprising a latch. (Item 59) Item 69. The disposable housing assembly of any one or more of items 57-68, further comprising a gasket, the needle being positioned within the gasket. (Item 60) Item 69. The disposable housing assembly of any one or more of items 57-68, further comprising an outlet fluidly connected to the flow path. (Item 61) Item 69. The disposable housing assembly of any one or more of items 57-68, wherein the hinged door comprises at least one catch feature. (Item 62) Item 69. The disposable housing assembly of any one or more of items 57-68, further comprising at least one seal positioned about the needle. (Item 63) Item 69. The disposable housing assembly of any one or more of items 57-68, wherein the hinged door comprises at least one tab configured to assist in pulling the reservoir towards the reservoir cavity. (Item 64) Item 69. The disposable housing assembly of any one or more of items 57-68, wherein the hinged door comprises at least one catch feature. (Item 65) The reservoir cavity comprises: A barrier layer; and a fluid maintained between the reservoir cavity and the barrier layer; Item 69. The disposable housing assembly of any one or more of items 57-68, comprising: (Item 66) Item 69. The disposable housing assembly of any one or more of items 57-68, further comprising a length of tubing attached to the outlet. (Item 67) Item 69. The disposable housing assembly of any one or more of items 57-68, further comprising an infusion set luer attached to the tubing. (Item 68) Item 69. The disposable housing assembly of any one or more of items 57-68, further comprising a cannula attached to the luer. (Item 69) 1. A reservoir system comprising: a blow molded reservoir; 1. A disposable housing assembly comprising: A reservoir cavity; A flow path; a cover for the reservoir cavity; Needle and a disposable housing assembly comprising: Equipped with A reservoir system, wherein moving the cover from a first position to a second position creates a fluid connection between the needle and the blown reservoir and primes the fluid path. (Item 70) 88. The reservoir system of any one or more of items 69-87, further comprising a gasket, wherein the needle is located within the gasket. (Item 71) 88. The reservoir system of any one or more of items 69-87, wherein the cover is hinged to the disposable housing assembly. (Item 72) 88. The reservoir system of any one or more of items 69-87, wherein the cover is positionable in a first open position and a second closed position. (Item 73) 88. The reservoir system of any one or more of items 69-87, wherein the cover moves from the first open position to the second closed position. (Item 74) 88. The reservoir system of any one or more of items 69-87, wherein the cover is prevented from moving from the second closed position to the first open position. (Item 75) 88. The reservoir system of any one or more of items 69-87, wherein movement of the cover from the first open position to the second closed position acts to prime the disposable housing assembly. (Item 76) 88. The reservoir system of any one or more of items 69-87, wherein the disposable housing assembly further comprises an outlet fluidly connected to the flow path. (Item 77) 88. The reservoir system of any one or more of items 69-87, further comprising a length of tubing attached to the outlet. (Item 78) 88. The reservoir system of any one or more of items 69-87, further comprising an infusion set luer attached to the tubing. (Item 79) 88. The reservoir system of any one or more of items 69-87, further comprising a cannula attached to the luer. (Item 80) The blow molded reservoir comprises: The first division, A port segment, An opening; At least one leg and a port section, the port section being fluidly connected to the first section; 88. The reservoir system according to any one or more of items 69 to 87, comprising: (Item 81) 88. The reservoir system according to any one or more of items 69 to 87, wherein the first section is a dome-shaped section. (Item 82) 88. The reservoir system according to any one or more of items 69 to 87, wherein the first section is crushable. (Item 83) 88. The reservoir system of any one or more of items 69 to 87, wherein the port section comprises a partition. (Item 84) 88. The reservoir system of any one or more of items 69-87, wherein the port section comprises a gasket. (Item 85) 88. The reservoir system of any one or more of items 69-87, wherein the port section comprises a needle. (Item 86) The reservoir cavity comprises: A barrier layer; and a fluid maintained between the reservoir cavity and the barrier layer; 88. The reservoir system according to any one or more of items 69 to 87, comprising: (Item 87) The reservoir system according to any one or more of items 69 to 87, wherein the first section is bellows-shaped. (Item 88) A blow molded reservoir, comprising: The first division, A port segment, An opening; At least one leg and a port section, the port section being fluidly connected to the first section; Caudal segment and A blow molded reservoir comprising: (Item 89) 96. The blow molded reservoir of any one or more of items 88-95, wherein the tail section is sealed from the first section and the port section. (Item 90) 96. The blow molded reservoir according to any one or more of items 88-95, wherein the first section is a dome-shaped section. (Item 91) 96. The blow molded reservoir according to any one or more of items 88-95, wherein the first section is bellows shaped. (Item 92) 96. The blow molded reservoir of any one or more of items 88-95, wherein the first section is crushable. (Item 93) 96. The blow molded reservoir of any one or more of items 88-95, wherein the port section comprises a septum. (Item 94) 96. The blow molded reservoir of any one or more of items 88-95, wherein the port section comprises a gasket. (Item 95) 96. The blow molded reservoir of any one or more of items 88-95, wherein the port section comprises a needle. (Item 96) A blow molded reservoir, comprising: The first division, A port segment, An opening; At least one leg and a port section, the port section being fluidly connected to the first section; a tail segment; Sacrificial neck section and A blow molded reservoir comprising: (Item 97) Item 104. The blow molded reservoir of any one or more of items 96-103, wherein the tail section is sealed from the first section and the port section. (Item 98) Item 104. The blow molded reservoir according to any one or more of items 96-103, wherein the first section is a dome-shaped section. (Item 99) Item 104. The blow molded reservoir of any one or more of items 96-103, wherein the first section is bellows shaped. (Item 100) Item 104. The blow molded reservoir of any one or more of items 96-103, wherein the first section is crushable. (Item 101) Item 104. The blow molded reservoir of any one or more of items 96-103, wherein the port section comprises a septum. (Item 102) Item 104. The blow molded reservoir of any one or more of items 96-103, wherein the port section comprises a gasket. (Item 103) Item 104. The blow molded reservoir of any one or more of items 96-103, wherein the port section comprises a needle. [Brief description of the drawings]

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

[0025] Like symbols in the various drawings indicate like elements. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] In various embodiments, the blown-molded reservoir may be used in conjunction with an infusion device and system and method thereof. In various embodiments, the infusion device is configured to be inserted into the subcutaneous layer of a user's skin and fluidly connected to a fluid source. In various embodiments, the infusion device may be fluidly connected to a length of tubing and / or an infusion pump. Infusion pumps may be disclosed in any of the following publications, including, but not limited to, U.S. Patent Application No. 13 / 788,260, filed March 7, 2013, entitled "Infusion Pump Assembly," now U.S. Patent Publication No. US-2014-0107579 (Attorney Docket No. K40), published April 17, 2014; U.S. Patent No. 8,491,570, issued July 23, 2013, entitled "Infusion Pump Assembly," now U.S. Patent No. 8,414,522, issued April 9, 2013, entitled "Fluid Delivery Systems and Methods," now U.S. Patent No. 8,262,616, issued September 11, 2012, entitled "Infusion Pump Assembly," now U.S. Patent No. 8,262,616 (Attorney Docket No. F51), and published December 11, 2007, entitled "Loading Mechanism for Infusion Pump Assembly." No. 7,306,578 (Attorney Docket No. C54), entitled "Infusion Pump," which may include the various infusion pumps and systems and methods thereof, including the disposable housing assembly, reservoir, filling aid, charging system, etc., shown and described in the above U.S. Pat. No. 7,306,578, entitled "Infusion Pump," which is incorporated herein by reference in its entirety. In various embodiments, the various embodiments of the infusion device described herein may be used alone or in conjunction with a blow-molded reservoir.

[0027] In various embodiments, blow molded reservoirs are disclosed, including reservoirs produced using a mold-in-place technique. The mold-in-place technique involves extruding molten plastic into a parasine, then clamping a mold onto the molten plastic while the plastic is melted, and expanding the molten plastic into a 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 formation is complete). The plastic material may be any plastic, including, but not limited to, one or more of a rigid plastic or a crushable plastic.

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

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

[0030] 3A-3G , in some embodiments, the blow molded reservoir 108 may be fluidly connected to the disposable housing assembly 100 through a needle 106 that is connected to the disposable housing assembly 100 and located within the reservoir cavity 104. Indeed, in some embodiments, once the blow molded reservoir 108 is placed inside the reservoir cavity 104, the hinged door 102 may be closed on the blow molded reservoir, which action urges the blow molded reservoir towards 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 many reasons, including but not limited to, locking the blow molded reservoir 108 to the disposable housing assembly 100, which may be beneficial / desirable for many reasons, including but not limited to, that when the blow molded reservoir 108 is removed from the disposable housing assembly 100, the needle is removed with the blow molded reservoir 108, rendering the disposable housing assembly 100 non-reusable. This may be beneficial / desirable for many reasons, including but not limited to, preventing unsafe reuse of the reservoir and / or the disposable housing assembly.

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

[0032] In some embodiments, the blow molded reservoir 108 may include a septum / gasket 110. The blow molded reservoir 108 may be fluidly connected to the disposable housing assembly 100 using a needle 106 that pierces the gasket 110. Indeed, in some embodiments, once the blow molded reservoir 108 is placed inside the reservoir cavity 104, the hinged door 102 may be closed onto the blow molded reservoir 108, this action urging the blow molded reservoir 108 towards 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-3G may be used in any of the disposable housing assembly and / or blow molded reservoir embodiments.

[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 now to Figures 4A-8E, various views of various embodiments of blow molded reservoirs are shown. However, many variations of the various embodiments and variations of blow molded reservoirs are contemplated, and Figures 4A-8E are merely representative examples of various embodiments of blow molded reservoirs.

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

[0036] In various embodiments, the port section 204 may include legs 206, 208 that interact with tabs 210, 212 (see FIG. 2I) located on the underside of the hinged door 102. When the hinged door 102 is closed onto the blow molded reservoir 200 located within the reservoir cavity 104, the tabs 210, 212 on the hinged door 102 grip the legs 206, 208 on the blow molded reservoir port 204 and pull the blow molded reservoir 200 towards the needle 106 located within the reservoir cavity 104. This forces the needle 106 through the septum / gasket 110 located within the port section 204.

[0037] In some embodiments, the hinged door 102 and / or the disposable housing assembly 100 may include one or more catch features. In some embodiments, once the hinged door 102 is closed onto the reservoir cavity 104, the hinged door 102 may be locked in place, preventing the hinged door 102 from reopening. In some embodiments, the hinged door 102 is prevented from reopening by one or more catch features. Thus, in some embodiments, the catch feature may also serve as a locking feature, while in other embodiments, the locking feature may be separate from the catch feature.

[0038] The act of moving the hinged door 102 from a starting first or open position (see at least Figures 2I-2J) to a finishing second or closed position (see at least Figure 1A), in some embodiments, also acts to prime the disposable housing assembly 100 with fluid contained within the blown-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 many reasons, including but not limited to, allowing for a larger volume of the blow molded reservoir at a fixed diameter dimension. This may be desirable / beneficial for many reasons, including but not limited to, excluding air from the blow molded reservoir during the priming phase.

[0040] 5A-5C, in some embodiments, the blow molded reservoir 300 may include a concertina shape. This may be desirable / beneficial for a number of reasons, including, but not limited to, that the concertina shape may contribute to the collapsibility of the blow molded reservoir 300 and / or may configure the blow molded reservoir 300 to collapse in a different manner.

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

[0042] In some embodiments, the hinged door 102 and / or the disposable housing assembly 100 may include one or more catch features. In some embodiments, once the hinged door 102 is closed onto the reservoir cavity 104, the hinged door 102 may be locked in place, preventing the hinged door 102 from reopening.

[0043] The act of moving the hinged door 102 from a starting first or open position (see at least FIGS. 2I-2J) to a finishing second or closed position (see at least FIG. 1A) also acts, in some embodiments, to prime the disposable housing assembly 100 with fluid contained within the molded-in-place reservoir 300.

[0044] 6A-6E, another embodiment of a blow molded reservoir 400 is shown. In various embodiments, when filling the blow molded reservoir 400 during the manufacturing process (which in some embodiments may be completed at the same time as molding the blow molded reservoir as described above, however, in other embodiments may be completed at a later time from molding), it may be desirable / beneficial to include features that mitigate air that may be left in the blow molded reservoir as a function of the manufacturing process. In some embodiments, therefore, a tail 402 may be included on the blow molded reservoir 400. In effect, the blow molded reservoir 400 is filled near the top of the tail 402. The tail 402 may be either sealed or unsealed between the tail 402 and the remainder of the blow molded reservoir 400.

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

[0046] In some embodiments, the hinged door 102 and / or the disposable housing assembly 100 may include one or more catch features. In some embodiments, once the hinged door 102 is closed onto the reservoir cavity 104, the hinged door 102 may be locked in place, preventing the hinged door 102 from reopening.

[0047] The act of moving the hinged door 102 from a starting first or open position (see at least FIGS. 2I-2J) to a finishing second or closed position (see at least FIG. 1A) also acts, in some embodiments, to prime the disposable housing assembly 100 with fluid contained within the molded-in-place 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 402, the tail 402 is pushed upward against the reservoir cavity 104 when the blow molded reservoir 400 is initially placed within the reservoir cavity 104, and then pushed downward when the hinged door 102 is moved to a finished, second, or closed, position.

[0049] The embodiment shown in Figures 6A-6E includes a dome-shaped blow-molded reservoir, however, a variety of other shapes and sizes may also be used with the tail embodiment.

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

[0051] 8A-8B, in some embodiments, the blow molded reservoir 600 may include a sacrificial neck 602, which may be filled, for example, halfway or partway, 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 heat stake tool may be used to introduce the seal 606 or sealed area. In various embodiments, the heat stake tool may be made of aluminum bronze or any other material. In various embodiments, the heat stake tool may be heated to 285 degrees Fahrenheit using a heater cartridge. However, in various other embodiments, the heat stake tool may be heated to a different temperature. This embodiment may be beneficial / desirable for a number of reasons, including, but not limited to, allowing the blow molded reservoir 600 to be filled with as little air as possible. Thus, the blow molded reservoir 600 can be completely filled into the sacrificial neck 602, and then when the seal 606 is introduced, air can be trapped in the sacrificial neck 602 and not in the blow molded reservoir 600. Thus, in effect, when the blow molded reservoir 600 is inserted into the disposable housing assembly 100, the sacrificial neck 602 can be removed from the remainder of the blow molded reservoir 600 and there is no air inside the blow molded reservoir 600. In various embodiments, the needle 106 in the disposable housing assembly 100 connects the blow molded reservoir 600 to the disposable housing assembly 100 through the port 604.

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

[0053] 15D-17G, there is shown a reservoir section 1028. The reservoir section 1028 includes a port 1024. A sacrificial neck 1022 is shown in Figures 15A, 15B and 15D-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 manufacture and filling of the blow molded reservoir, a cap or other cover may be connected and / or attached to the port section. In some embodiments where a septum / gasket is inside the port section, the septum / gasket may be added as part of the blow molded sealing process or may be added after the process is completed. In some embodiments, the blow molded reservoir may include a bottom section and a top section. In various embodiments, the bottom section of the various embodiments of the blow molded reservoir may be rigid and the top 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 sidewalls. This may be desirable / beneficial for a number of reasons, including but not limited to, increasing the crushability of the blow molded reservoir.

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

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

[0057] Fluidly connecting a blown-molded reservoir to a consumable In various embodiments, the blown-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 the blown-molded reservoir to the disposable housing assembly are described below and with reference to Figures 9A-12D.

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

[0059] 9A-9D, the disposable housing assembly includes a cover 704 shown in its first, inactivated position that 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 FIG. 9C. However, in other embodiments, one end of the needle 720 may be located outside of the gasket 718 but in communication with the gasket 718. Regardless, in operation, when a force is applied to the cover 704, the cover 704 moves from the first, inactivated position as shown in FIGS. 9A-9D to a second, or activated position as the cover 704 is pressed downwardly onto the blow molded reservoir 702, and the force pushes the end of the needle 720 through points in the blow molded reservoir 702, which may include point 722. The force exerted on the blow molded reservoir 702 is also transferred to the 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, inactivated position to a second, activated position, as shown in Figures 9E-9G. The force also moves the blow molded reservoir 702 from a inactivated position to an activated position.

[0060] In various embodiments, the blown reservoir 702 connected to the needle 720 is sealed primarily by puncturing the blown reservoir 702. However, the gasket 718 also acts as a secondary seal. This is beneficial / desirable for a number of reasons, including, but not limited to, the gasket 718 providing an additional and / or secondary seal in the event that the needle 720 and blown reservoir 702 do not form a perfect seal.

[0061] Various embodiments include a needle 720 including a sharp end and a second end that may be sharp or blunt, as shown in Figures 9A-9E. The second end connects the needle 720 to a fluid path within the disposable housing assembly 700. The fluid path connects the contents of the blown-molded reservoir 702 to a luer 706, which in various embodiments may be attached to an optional infusion set, and in some embodiments the infusion set may include an optional inlet into the user for delivery of the fluid contained within the blown-molded reservoir 702.

[0062] 9B and 9E, in various embodiments, the cover 704 may include clasp features 710, 712, 714, 716 that maintain the cover 704 in the second or actuated position when the cover 704 is moved to the second or actuated position. In various embodiments, the cover 704 includes four clasp features 710, 712, 714, 716, however, in various other embodiments, the cover 704 may include more than four or less than four clasp features. In some embodiments, the clasp features 710, 712, 714, 716 may be designed as shown, however, in various embodiments, the clasp features may be any type of clasp, latch, and / or snap, and / or any feature that maintains the cover 704 in the second or actuated position. In various embodiments, the cover 704 may be captured in any one or more of a variety of ways. Thus, any feature or features that lock / maintain the cover 704 in the second, or actuated, position may be used.

[0063] The clasp features 710, 712, 714, 716 may be beneficial / desirable for a number of reasons, including, but not limited to, the clasp features 710, 712, 714, 716 maintain the cover 704 in the second, or activated, position, which prevents reuse of the disposable housing assembly 700 and / or the blow molded reservoir 702. The clasp features 710, 712, 714, 716 also maintain the blow molded reservoir 702 in a non-activated position.

[0064] 10A-10M, another embodiment for fluidly connecting the blow molded reservoir 802 to the disposable housing assembly 800 is shown. In this embodiment, which also includes a cover 804, the cover 804 moves or slides horizontally 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, which may be attached to a luer, which may be attached to an infusion set. In various embodiments, the system may or may not include tubing.

[0065] 10A-10G, as cover 804 is depicted, cover 804 is in a first, or non-activated, position. Cover 804 includes needle holder feature 814, support feature 806, and clasp feature 808. Disposable housing assembly 800 includes matching clasp feature 816, mating support feature 818, and in-reservoir support block 820 for blow molded reservoir 802.

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

[0067] 10H-10M, cover 804 has been moved to a second, or actuated, position. In FIG. 10I and 10J, cover 804 is not shown, however other parts of the device are shown in the actuated position. In FIG. 10K, reservoir 802 is not shown, and some features of the cover are shown, however not the entire cover, however other parts of the device are shown in the actuated position.

[0068] The cover 804 moves from a first, or unactuated, position to a second, or actuated, position with the application of a force on the cover 804. In the second, or actuated, position, the cover 804 is moving horizontally and the force of the cover 804 pushes the needle 812 as it pierces through the reservoir 802. The force exerted on the cover 804 is also transferred to the gasket 814 which is crushed against the blown reservoir 802. The force moves the cover 804 from the first, or unactuated, position to the second, or actuated, position, as shown in Figures 10H-10M.

[0069] In various embodiments, the blown reservoir 802 connected to the needle 812 is sealed primarily by puncturing the blown reservoir 802. However, the gasket 814 also acts as a secondary seal. This is beneficial / desirable for a number of reasons, including but not limited to, the gasket 814 providing an additional seal in the event that the needle 812 and blown reservoir 802 do not form a perfect seal.

[0070] In response to the cover 804 moving from a first, or non-activated, position to a second, or activated, position, the support feature 806 slides under a mating support feature 818 on the disposable housing assembly 800. This prevents the cover 804 from being lifted or moved out of relationship with the disposable housing assembly 800. The clasp feature 808 also slides under a mating clasp feature 816 on the disposable housing assembly 800, locking the cover 804 into 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 as the cover 804 slides and the needle 812 punctures the blow molded reservoir 802.

[0072] With regard to needle 812, in various embodiments, when cover 804 is slid to the second, or activated, position, needle 812 shape changes slightly as it extends and / or unbends. The sliding of cover 804 also provides the force needed for needle 812 to puncture the reservoir.

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

[0074] The needles are shaped / configured and sized as shown in these various figures, although other shapes / configurations and sizes may be used in any of the various embodiments described herein. Thus, in various embodiments, the needles may have any shape / configuration, including one or more folds, bends, curves, etc. Additionally, while a gasket is shown herein, other shapes and / or sizes of gaskets or other types of seals may be used. Additionally, in some embodiments, more than one gasket and / or seal may be used.

[0075] 12A-12D, in various embodiments, other mechanisms rather than a cover may be used to urge the needle into the blow molded reservoir (not shown). For example, in some embodiments, a needle 1000, which may include at least one sharp end and in some embodiments be in adjacent relationship with 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, adjacent to the shuttle 1004 and in some embodiments attached to the shuttle 1004, urges the shuttle 1004 along the axis and the needle 1000 through the blow molded reservoir (not shown). While one configuration is shown in FIGS. 12A-12D, in various embodiments, the shuttle, spring, needle shape, and / or latch feature may be shaped and / or configured differently. In some embodiments, the latch feature 1008 may be displaced by a cover, trigger, or any other mechanism that may displace the latch feature 1008. In various embodiments, the flow path 1010 connects the contents of the blown-molded reservoir to an infusion set, which in various embodiments may be any infusion set, and in some embodiments may include any inlet into the user for delivery of the fluid contained in the blown-molded reservoir. In some embodiments, the flow path 1010 may be incorporated into the 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, or unactuated, state. In various embodiments, the gasket 1002 provides a seal and / or a secondary and / or backup seal for the seal between the needle 1000 and the blow molded reservoir.

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

[0078] Still referring to FIGS. 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 FIGS. 13A, 13E, and 14, or may be a variety of other shapes and sizes. In the embodiment shown in FIGS. 13A, 13E, and 14, the needle includes a single bend and the needle 1106 includes an end that is attached to a gasket 1108. In various embodiments, the end of the needle 1106 that is attached to the gasket 1108 includes a cylindrical guide 1114. The cylindrical guide 1114 may be beneficial / desirable for a number of reasons, including, but not limited to, the cylindrical guide 1114 contributing to maintaining 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 in the first, or non-actuated, position (with respect to a cover not shown in Figures 13A, 13E, or 14, but various embodiments of which are described herein). The remaining 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 fits snugly into an overmolded portion needle cover 1118. A rigid portion needle cover 1116 is also included, both of which maintain the position of the needle 1106. When the needle 1106 is pressed into the overmolded portion needle cover 1118, the needle 1106 may float. This may be beneficial / desirable for a number of reasons, including, but 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 passage 1112. The overmolded part needle cover 1118 includes a fluid seal 1120 that creates an O-ring face seal and this portion of material is crushed against the fluid cover 1122 of the disposable housing assembly 1100. The rigid part needle cover 1116, in various embodiments, is ultrasonically welded 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 or inactivated position to a second or activated position with the application of a force on the cover. In the second or activated position, the cover is moving and the force of the cover pushes the needle 1106 so that it pierces through the reservoir. The force applied on the cover is also transferred to the gasket 1108 which is crushed against the blown-molded reservoir. The force moves the cover from the first and inactivated position to the second and activated position.

[0082] In various embodiments, the blown reservoir connected to the needle 1106 is sealed primarily by puncturing the blown reservoir. However, the gasket 1108 also acts as a secondary seal. This is beneficial / desirable for a number of reasons, including but not limited to, the gasket 1108 providing an additional seal in the event that the needle 1106 and blown reservoir do not form a perfect seal.

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

[0084] In various embodiments of blow molded reservoirs, the blow molding process may be designed to cause specific portions of the blow molded reservoir to have thinner areas. Thus, in various embodiments, the walls of the blow molded reservoir may not be consistent throughout in terms of thickness, but rather, the wall thickness may vary in specific locations. In various embodiments, the corner sections of the blow molded reservoir are thinner than the rest of the reservoir. This may be beneficial / desirable for a number of 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 geometries and variations in wall thickness. Referring again now to FIG. 18, a graphical representation of various sections of the walls of the blow molded reservoir embodiment shown in FIGS. 15A-17G is shown. Areas 1200 , 1202 represent the corners of the reservoir, and in various embodiments, the thickness of these areas 1200 , 1202 is less than the thickness of the non-corner sections 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 any shape or size, may be any multiple (including a single notch), may include a slit or rounded notch, may include one or more notches. The feature may be any feature including, but not limited to, a tab, a mating locking feature, and / or indicia. In various embodiments, the notch and / or feature may also be any of those described within the various references incorporated herein by reference above. Additionally, in some embodiments, the cover may not include any notch and / or feature.

[0086] The needles are shaped / configured and sized as shown in these various figures, however, other shapes / configurations and sizes may be used in any of the various embodiments described herein. Thus, in various embodiments, the needles may have any shape / configuration, including one or more folds, bends, curves, etc. Additionally, although a gasket is shown herein, gaskets or other types of seals of other shapes and / or sizes may be used. Additionally, in some embodiments, more than one gasket and / or seal may be used.

[0087] Although several embodiments have been described, it is to be understood that various modifications may be made and, therefore, other embodiments are within the scope of the following claims.

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

Claims

[Claim 1] The invention as depicted in the drawings of this application.

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