Drug infusion device

Abstract

The present technology includes, for example, a sealing assembly for a drug infusion device. The seal assembly may include an annular mating seal including an upper surface, a lower surface, a radially inner surface, a radially outer surface, and a through bore extending between the radially outer surface and the radially inner surface and defining a first fluid flow path. The seal assembly may include a seal housing at least partially surrounding the mating seal and having an upper flange, a lower flange, a side portion configured to contact at least a portion of a radially outer surface of the mating seal, and a second fluid flow path, and a second fluid flow path extending through the side portion such that the second fluid flow path is in fluid communication with the first fluid flow path to define an annular passage between the side portion of the seal housing and the radially outer surface of the docking seal.

Description

[0001] Cross-references to related patent applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 514,924, filed on July 21, 2023, which is related to U.S. Provisional Application No. 63 / 514,899, filed on July 21, 2023, entitled "Drug Infusion Device" (Agent Docket No. A0009680US01), the contents of which are incorporated herein by reference. Technical Field

[0003] The present technology relates generally to medical devices, and more particularly to drug infusion devices. Background Art

[0004] Portable infusion pumps are relatively small, at least substantially self-contained devices for introducing medicines and other infusible substances (collectively referred to as "drugs") into the body of a user. Some infusion pumps are configured to be worn on a belt, in a clothing pocket, or the like. Other infusion pumps are configured to adhere to the skin in a patch-like manner. An advantage of infusion pumps is that they can be used, for example, to continuously or even continuously introduce (or "infuse") drugs subcutaneously outside of a clinical setting. An advantage of infusion pumps is also that they greatly reduce the frequency of subcutaneous access events (such as, multiple needle-based injections). An example of a drug that can be introduced by an infusion pump is a liquid formulation of insulin. Other exemplary drugs that can be introduced by an infusion pump include, but are not limited to, drugs for treating cancer and drugs for suppressing pain perception.

[0005] Many conventional infusion pumps improve the health and quality of life of users. However, the inventors have determined that conventional infusion pumps are susceptible to extensive improvements. Summary of the invention

[0006] Typically, in some embodiments of the technology according to the present invention, an insertion assembly may include a frame including a tubular sidewall defining an internal cavity. The frame may have a first end portion and a second end portion, the first end portion being configured to be positioned near the user's skin, the second end portion being opposite to the first end portion along the longitudinal axis of the frame. The frame may include a slot extending longitudinally along a portion of the sidewall. The insertion assembly may include a medical device configured to be inserted into the user's skin. The insertion assembly may further include a carrier that carries the medical device and is at least partially disposed within the internal cavity of the frame. The carrier may be axially movable within the frame from a first tilted position near the second end of the frame to a second extended position near the first end portion of the frame. The carrier may include a protrusion disposed within the slot of the frame and configured to slide within the slot when the carrier moves axially within the frame. The protrusion may be longitudinally limited between the top surface and the bottom surface, and may have a height measured between the top surface and the bottom surface. The protrusion may be laterally limited between a first side surface and a second side surface, the first side surface and the second side surface being adjacent to the sidewalls on either side of the slot. The protrusion may have a width measured between the first side surface and the second side surface. The ratio of the height of the protrusion to the width of the protrusion may be greater than 1. In some embodiments, the ratio of the height of the protrusion to the width of the protrusion is at least 2. In some embodiments, the ratio of the height of the protrusion to the width of the protrusion is at least 4.

[0007] According to some aspects of the present technology, the carrier includes a plurality of protrusions spaced apart around a circumference of the carrier, and the frame includes a plurality of slots spaced apart around a circumference of the frame. Each of the protrusions may be disposed in a corresponding one of the slots.

[0008] In some embodiments, the carrier includes a body portion disposed within an interior cavity of the frame. An outer surface of the body portion may be spaced apart from an inner surface of the frame such that the body portion does not contact the inner surface of the frame when sliding axially within the frame.

[0009] In some examples, the protrusion may terminate at or near the radially outer edge of the slot, such that the protrusion does not extend radially outward from the slot. In some embodiments, the protrusion extends completely through the slot, such that the distal end of the protrusion radially extends beyond the slot. In some embodiments, the first portion of the protrusion terminates at or near the radially outer edge of the slot, such that the protrusion does not extend radially outward from the slot, and the second portion of the protrusion extends completely through the slot, such that the distal end of the protrusion radially extends beyond the slot.

[0010] According to some embodiments, the carrier can be axially movable within the frame from the second extended position to a third retracted position proximate the second end portion of the frame. When the carrier moves from the first tilted position to the second extended position, the height of the protrusion can be greater than the height of the protrusion when the carrier moves from the second extended position to the third retracted position.

[0011] Typically, in some embodiments of the technology according to the present invention, the insertion assembly may include a frame including a tubular sidewall defining an internal cavity. The frame may have a first end portion and a second end portion, the first end portion being configured to be positioned against the skin of the user, the second end portion being opposite to the first end portion along the longitudinal axis of the frame. The frame may include a slit extending longitudinally along a portion of the sidewall. The insertion assembly may further include a needle and a needle carrier, the needle carrier carrying the needle and being at least partially disposed in the internal cavity of the frame. The needle carrier may move axially in the frame. The needle carrier may include a needle carrier protrusion, the needle carrier protrusion being disposed in the slit of the frame and being configured to slide in the slit when the needle carrier moves axially in the frame. The insertion assembly may further include a cannula and a cannula carrier, the cannula carrier carrying the cannula and being at least partially disposed in the internal cavity of the frame. The cannula carrier may move axially in the frame. The cannula carrier may include a cannula carrier protrusion, the cannula carrier protrusion being disposed in the slit of the frame and being configured to slide in the slit when the cannula carrier moves axially in the frame. The cannula carrier projection and the needle carrier projection can form a sliding interface together. The sliding interface can be longitudinally limited between the top surface of the needle carrier projection and the bottom surface of the cannula carrier projection, and has a height measured between the top surface and the bottom surface. The sliding interface can be laterally limited between a first side surface and a second side surface, and the first side surface and the second side surface are adjacent to the sidewall on either side of the slot. The sliding interface can have a width measured between the first side surface and the second side surface. The ratio of the height of the sliding interface to the width of the sliding interface can be greater than 1. In some embodiments, the ratio of the height of the sliding interface to the width of the sliding interface is 2 or greater. In some examples, the radial length of the cannula carrier projection is greater than the radial length of the needle carrier projection.

[0012] According to several embodiments, when the insertion assembly is in a pre-insertion state, the needle carrier and the cannula carrier are connected to each other. For example, the cannula carrier may include an arm extending upward and a lug extending radially inward from the distal end portion of the arm. At least in the pre-insertion state, the lug of the cannula carrier extends over the locking protrusion of the needle carrier and engages with the locking protrusion, thereby fixing the needle carrier to the top side of the cannula carrier. In some embodiments, in the pre-insertion state, the cannula carrier is configured to rotate relative to the needle carrier. When the needle carrier and the cannula carrier move axially in the frame during insertion, the needle carrier and the cannula carrier can remain connected to each other, and the rotational position of the needle carrier and the cannula carrier can be fixed during insertion. The needle carrier and the cannula carrier can be configured to separate from each other once the cannula is inserted. In some embodiments, the alignment of the arms of the cannula carrier with the opening in the frame enables the arms to move radially outward and disengage from the locking protrusion of the needle carrier, thereby releasing the needle carrier from the cannula carrier.

[0013] In some embodiments, the needle carrier includes a body portion disposed within the interior cavity of the frame. An outer surface of the body portion may be spaced apart from an inner surface of the frame such that the body portion does not contact the inner surface of the frame when sliding axially within the frame.

[0014] According to some embodiments, the sleeve carrier includes a body portion disposed within the interior cavity of the frame. An outer surface of the body portion may be spaced apart from an inner surface of the frame such that the body portion does not contact the inner surface of the frame when axially sliding within the frame.

[0015] In several embodiments, the needle carrier protrusions and the cannula carrier protrusions are radially aligned about the insertion axis.

[0016] In some embodiments, the needle carrier protrusion comprises a plurality of needle carrier protrusions spaced around a circumference of the needle carrier, each needle carrier protrusion being configured to slide within a corresponding slot in the frame.

[0017] According to some embodiments, the cannula carrier protrusion includes a plurality of cannula carrier protrusions spaced about a circumference of the cannula carrier, each cannula carrier protrusion being configured to slide within a corresponding slot in the frame.

[0018] In several embodiments, the cannula, once inserted, is configured to deliver a drug to a user.

[0019] Typically, in some embodiments of the technology according to the present invention, the insertion assembly may include a frame including a tubular sidewall defining an internal cavity. The frame may have a first end portion and a second end portion, the first end portion being configured to be positioned near the user's skin, the second end portion being opposite to the first end portion along the longitudinal axis of the frame. The frame may include a slot extending longitudinally along a portion of the sidewall. The insertion assembly may include a medical device configured to be inserted into the user's skin. The insertion assembly may further include a carrier mechanism for carrying the medical device and at least partially disposed within the internal cavity of the frame. The carrier mechanism may be axially movable within the frame from a first tilted position near the second end of the frame to a second extended position near the first end portion of the frame. The carrier mechanism may include a protrusion disposed within the slot of the frame and configured to slide within the slot when the carrier mechanism moves axially within the frame. The protrusion may be longitudinally limited between the top surface and the bottom surface, and may have a height measured between the top surface and the bottom surface. The protrusion may be laterally limited between a first side surface and a second side surface, the first side surface and the second side surface being adjacent to the sidewalls on either side of the slot. The protrusion may have a width measured between the first side surface and the second side surface. The ratio of the height of the protrusion to the width of the protrusion may be greater than 1. In some embodiments, the ratio of the height of the protrusion to the width of the protrusion is at least 2. In some embodiments, the ratio of the height of the protrusion to the width of the protrusion is at least 4.

[0020] According to some aspects of the present technology, the carrier mechanism includes a plurality of protrusions spaced apart around a circumference of the carrier mechanism, and the frame includes a plurality of slots spaced apart around a circumference of the frame. Each of the protrusions may be disposed in a corresponding one of the slots.

[0021] In some embodiments, the carrier mechanism includes a body portion disposed within the interior cavity of the frame. The outer surface of the body portion may be spaced apart from the inner surface of the frame so that the body portion does not contact the inner surface of the frame when axially sliding within the frame.

[0022] In some examples, the protrusion may terminate at or near the radially outer edge of the slot, such that the protrusion does not extend radially outward from the slot. In some embodiments, the protrusion extends completely through the slot, such that the distal end of the protrusion radially extends beyond the slot. In some embodiments, the first portion of the protrusion terminates at or near the radially outer edge of the slot, such that the protrusion does not extend radially outward from the slot, and the second portion of the protrusion extends completely through the slot, such that the distal end of the protrusion radially extends beyond the slot.

[0023] According to some embodiments, the carrier mechanism can be axially movable within the frame from the second extended position to a third retracted position proximate the second end portion of the frame. When the carrier mechanism moves from the first tilted position to the second extended position, the height of the protrusion can be greater than the height of the protrusion when the carrier mechanism moves from the second extended position to the third retracted position.

[0024] Typically, in some embodiments of the technology according to the present invention, the insertion assembly may include a frame including a tubular sidewall defining an internal cavity. The frame may have a first end portion and a second end portion, the first end portion being configured to be positioned against the user's skin, the second end portion being opposite to the first end portion along the longitudinal axis of the frame. The frame may include a slot extending longitudinally along a portion of the side wall. The insertion assembly may further include a needle and a first carrier mechanism, the first carrier mechanism being used to carry the needle and being at least partially disposed in the internal cavity of the frame. The first carrier mechanism may move axially within the frame. The first carrier mechanism may include a first carrier mechanism protrusion, the first carrier mechanism protrusion being disposed in the narrow groove of the frame and being configured to slide in the narrow groove when the first carrier mechanism moves axially within the frame. The insertion assembly may further include a sleeve and a second carrier mechanism, the second carrier mechanism being used to carry the sleeve and being at least partially disposed in the internal cavity of the frame. The second carrier mechanism may move axially within the frame. The second carrier mechanism may include a second carrier mechanism protrusion, the second carrier mechanism protrusion being disposed in the narrow groove of the frame and being configured to slide in the narrow groove when the second carrier mechanism moves axially within the frame. The second carrier mechanism protrusion and the first carrier mechanism protrusion can form a sliding interface together. The sliding interface can be longitudinally limited between the top surface of the first carrier mechanism protrusion and the bottom surface of the second carrier mechanism protrusion, and has a height measured between the top surface and the bottom surface. The sliding interface can be laterally limited between a first side surface and a second side surface, and the first side surface and the second side surface are adjacent to the sidewall on either side of the slot. The sliding interface can have a width measured between the first side surface and the second side surface. The ratio of the height of the sliding interface to the width of the sliding interface can be greater than 1. In some embodiments, the ratio of the height of the sliding interface to the width of the sliding interface is 2 or greater. In some examples, the radial length of the second carrier mechanism protrusion is greater than the radial length of the first carrier mechanism protrusion.

[0025] According to several embodiments, when the insertion assembly is in a pre-insertion state, the first carrier mechanism and the second carrier mechanism are coupled to each other. For example, the first carrier mechanism may include a first locking mechanism, and the second carrier mechanism may include a second locking mechanism. At least in the pre-insertion state, the second locking mechanism engages the first locking mechanism, thereby fixing the first carrier mechanism to the second carrier mechanism. In some embodiments, in the pre-insertion state, the second carrier mechanism is configured to rotate relative to the first carrier mechanism. When the first carrier mechanism and the second carrier mechanism move axially within the frame during insertion, the first carrier mechanism and the second carrier mechanism can remain coupled to each other, and the rotational position of the first carrier mechanism and the second carrier mechanism can be fixed during insertion. The first carrier mechanism and the second carrier mechanism can be configured to separate from each other once the sleeve is inserted. In some embodiments, the second locking mechanism is aligned with the opening in the frame to allow the second locking mechanism to disengage from the first locking mechanism, thereby releasing the first carrier mechanism from the second carrier mechanism.

[0026] In some embodiments, the first carrier mechanism includes a body portion disposed within the interior cavity of the frame. An outer surface of the body portion may be spaced apart from an inner surface of the frame such that the body portion does not contact the inner surface of the frame when axially sliding within the frame.

[0027] According to some embodiments, the second carrier mechanism includes a body portion disposed within the interior cavity of the frame. An outer surface of the body portion may be spaced apart from an inner surface of the frame such that the body portion does not contact the inner surface of the frame when axially sliding within the frame.

[0028] In several embodiments, the first carrier means protrusion and the second carrier means protrusion are radially aligned about the insertion axis.

[0029] In some embodiments, the first carrier means protrusion comprises a plurality of first carrier means protrusions spaced apart around a circumference of the first carrier means, each first carrier means protrusion being configured to slide within a corresponding slot in the frame.

[0030] According to some embodiments, the second carrier mechanism protrusion comprises a plurality of second carrier mechanism protrusions spaced around a circumference of the second carrier mechanism, each second carrier mechanism protrusion being configured to slide within a corresponding slot in the frame.

[0031] In several embodiments, the cannula, once inserted, is configured to deliver a drug to a user.

[0032] Typically, in some embodiments of the technology according to the present invention, the drug infusion device includes a reservoir assembly, which includes a reservoir configured to keep the drug therein. The reservoir can be connected to the reservoir outlet. The drug infusion device may further include a cannula carrier and an infusion cannula extending downward away from the cannula carrier. The cannula can define a cannula lumen and is configured to be inserted into the skin of the user. The drug infusion device may further include a sealing assembly, which includes an annular butt seal, which is configured to engage the cannula carrier so that the butt seal surrounds at least a portion of the cannula carrier. The butt seal may include an upper surface, a lower surface, a radial inner surface extending between the upper surface and the lower surface, a radial outer surface extending between the upper surface and the lower surface, and a through hole, wherein the radial inner surface is configured to abut the cannula carrier, and the through hole defines a first fluid flow path between the radial inner surface and the radial outer surface, wherein the first fluid flow path is configured to be in fluid communication with the cannula lumen when the butt seal engages the cannula carrier. The seal assembly may further include a seal housing circumferentially surrounding the docking seal. The seal housing may include: an upper frame portion, the upper frame portion including an upper flange, the upper flange being configured to abut against an upper surface of the docking seal; a lower frame portion, the lower frame portion including a lower flange, the lower flange being configured to abut against a lower surface of the docking seal; an annular side portion extending between the upper frame portion and the lower frame portion, wherein the annular side portion is configured to abut against at least a portion of a radially outer surface of the docking seal to define an annular channel between the side portion of the seal housing and the docking seal; and a second fluid flow path extending through the side portion and configured to be fluidically coupled to the reservoir outlet, wherein the second fluid flow path is in fluid communication with the first fluid flow path defined by the through hole of the docking seal.

[0033] In some embodiments, the annular butt seal extends circumferentially about a vertical axis and is symmetrical about a horizontal plane orthogonal to the vertical axis.

[0034] According to some examples, contact between the radially inner surface of the butt seal and the radially outer surface of the casing carrier defines a second annular channel in fluid communication with the first fluid flow path and the casing lumen.

[0035] In some embodiments, the butt seal includes a variable sidewall thickness between the radially inner surface and the radially outer surface. The butt seal may further include a middle portion having a first sidewall thickness, wherein the through hole extends through the middle portion between the radially inner surface and the radially outer surface; an upper widening portion, the upper widening portion axially disposed above the middle portion and having a second sidewall thickness greater than the first sidewall thickness, the upper widening portion defining an upper radially inner sealing surface and an upper radially outer sealing surface; and a lower widening portion, the lower widening portion axially disposed below the middle portion and having a third sidewall thickness greater than the first sidewall thickness, the lower widening portion defining a lower radially inner sealing surface and a lower radially outer sealing surface.

[0036] According to some examples, the annular channel is defined by a space between a middle portion of the butt seal and side portions of the seal housing.

[0037] In some embodiments, the second annular channel is defined by a space between a middle portion of the butt seal and a side portion of the casing carrier.

[0038] In accordance with several aspects of the present technology, contact between the upper flange and the upper surface of the docking seal creates a fluid-tight seal.

[0039] In several examples, contact between the lower flange and the lower surface of the docking seal creates a fluid-tight seal.

[0040] In some embodiments, the cannula carrier includes a through hole in fluid communication with the cannula lumen and in fluid communication with the first fluid flow path.

[0041] In some examples, the drug infusion device further includes an insertion assembly configured to move the cannula carrier between a disengaged configuration in which the cannula carrier does not contact the docking seal and an engaged configuration in which the docking seal surrounds at least a portion of the cannula carrier.

[0042] In some embodiments, a lowermost surface of the butt seal abuts the lower flange.

[0043] Typically, in some embodiments of the technology according to the present invention, a sealing assembly for a drug infusion device includes an annular butt seal, the annular butt seal including an upper surface, a lower surface, a radial inner surface, a radial outer surface, and a through hole extending between the radial outer surface and the radial inner surface, wherein the through hole defines a first fluid flow path. The sealing assembly may further include a sealing housing that at least partially surrounds the butt seal, the sealing housing including: an upper flange that is configured to contact the upper surface of the butt seal; a lower flange that is configured to contact the lower surface of the butt seal; a side portion that is configured to contact at least a portion of the radial outer surface of the butt seal to define an annular channel between the side portion of the sealing housing and the radial outer surface of the butt seal; and a second fluid flow path that extends through the side portion so that the second fluid flow path is in fluid communication with the first fluid flow path.

[0044] In some embodiments, the annular butt seal extends circumferentially about a vertical axis, and wherein the annular butt seal is symmetric about a horizontal plane orthogonal to the vertical axis.

[0045] In some embodiments, the butt seal includes a variable sidewall thickness between the radially inner surface and the radially outer surface. The butt seal may further include a middle portion having a first sidewall thickness, wherein the through hole may extend through the middle portion between the radially inner surface and the radially outer surface. The butt seal may further include an upper widened portion, which is axially disposed above the middle portion and has a second sidewall thickness greater than the first sidewall thickness, wherein the upper widened portion defines an upper radially inner sealing surface and an upper radially outer sealing surface. The butt seal may further include a lower widened portion, which is axially disposed below the middle portion and has a third sidewall thickness greater than the first sidewall thickness, wherein the lower widened portion defines a lower radially inner sealing surface and a lower radially outer sealing surface.

[0046] According to some embodiments, the annular channel is defined by a space between a middle portion of the butt seal and side portions of the seal housing.

[0047] In some examples, contact between the upper flange and the upper surface of the docking seal creates a fluid-tight seal, and contact between the lower flange and the lower surface of the docking seal creates a fluid-tight seal. In several embodiments, contact between the upper flange and the upper surface of the docking seal creates a fluid-tight seal, and contact between the lower flange and the lower surface of the docking seal creates a fluid-tight seal.

[0048] In some embodiments, a lowermost surface of the butt seal abuts the lower flange.

[0049] Typically, in some embodiments of the technology according to the present invention, a docking seal for a drug infusion device includes an annular body having a sidewall defining a radial outer surface and a radial inner surface surrounding a central opening, the central opening being configured to receive a sleeve carrier therein, wherein the sidewall has a variable thickness such that the sidewall defines: a middle portion having a first sidewall thickness; an upper widened portion, the upper widened portion being axially disposed above the middle portion and having a second sidewall thickness greater than the first sidewall thickness, the upper widened portion defining an upper radial inner sealing surface and an upper radial outer sealing surface; a lower widened portion, the lower widened portion being axially disposed below the middle portion and having a third sidewall thickness greater than the first sidewall thickness, the lower widened portion defining a lower radial inner sealing surface and a lower radial outer sealing surface; and a through hole extending through the middle portion of the sidewall between the radial inner surface and the radial outer surface.

[0050] In some embodiments, the annular body extends circumferentially around a vertical axis, and the annular body is symmetric about a horizontal plane orthogonal to the vertical axis.

[0051] According to some examples, the upper radially inner sealing surface and the lower radially inner sealing surface both protrude radially inwardly relative to the middle portion. In several embodiments, the upper radially outer sealing surface and the lower radially inner sealing surface both protrude radially outwardly relative to the middle portion.

[0052] Typically, in some embodiments of the technology according to the present invention, the drug infusion device includes a reservoir assembly, which includes a reservoir configured to keep the drug therein. The reservoir can be connected to the reservoir outlet. The drug infusion device may further include a cannula carrying mechanism and an infusion cannula extending downward away from the cannula carrying mechanism. The cannula can define a cannula lumen and is configured to be inserted into the user's skin. The drug infusion device may further include a sealing assembly, which includes an annular butt seal, which is configured to engage the cannula carrying mechanism so that the butt seal surrounds at least a portion of the cannula carrying mechanism. The butt seal may include an upper surface, a lower surface, a radial inner surface extending between the upper surface and the lower surface, a radial outer surface extending between the upper surface and the lower surface, and a through hole, wherein the radial inner surface is configured to abut the cannula carrying mechanism, and the through hole defines a first fluid flow path between the radial inner surface and the radial outer surface, wherein the first fluid flow path is configured to communicate with the cannula lumen fluid when the butt seal engages the cannula carrying mechanism. The seal assembly may further include a seal housing circumferentially surrounding the docking seal. The seal housing may include: an upper frame portion, the upper frame portion including an upper flange, the upper flange being configured to abut against an upper surface of the docking seal; a lower frame portion, the lower frame portion including a lower flange, the lower flange being configured to abut against a lower surface of the docking seal; an annular side portion extending between the upper frame portion and the lower frame portion, wherein the annular side portion is configured to abut against at least a portion of a radially outer surface of the docking seal to define an annular channel between the side portion of the seal housing and the docking seal; and a second fluid flow path extending through the side portion and configured to be fluidically coupled to the reservoir outlet, wherein the second fluid flow path is in fluid communication with the first fluid flow path defined by the through hole of the docking seal.

[0053] In some embodiments, the annular butt seal extends circumferentially about a vertical axis and is symmetrical about a horizontal plane orthogonal to the vertical axis.

[0054] According to some examples, contact between the radially inner surface of the butt seal and the radially outer surface of the cannula carrier mechanism defines a second annular channel in fluid communication with the first fluid flow path and the cannula lumen.

[0055] In some embodiments, the butt seal includes a variable sidewall thickness between the radially inner surface and the radially outer surface. The butt seal may further include a middle portion having a first sidewall thickness, wherein the through hole extends through the middle portion between the radially inner surface and the radially outer surface; an upper widening portion, the upper widening portion axially disposed above the middle portion and having a second sidewall thickness greater than the first sidewall thickness, the upper widening portion defining an upper radially inner sealing surface and an upper radially outer sealing surface; and a lower widening portion, the lower widening portion axially disposed below the middle portion and having a third sidewall thickness greater than the first sidewall thickness, the lower widening portion defining a lower radially inner sealing surface and a lower radially outer sealing surface.

[0056] According to some examples, the annular channel is defined by a space between a middle portion of the butt seal and side portions of the seal housing.

[0057] In some embodiments, the second annular channel is defined by a space between a middle portion of the dock seal and side portions of the sleeve carrier mechanism.

[0058] In accordance with several aspects of the present technology, contact between the upper flange and the upper surface of the docking seal creates a fluid-tight seal.

[0059] In several examples, contact between the lower flange and the lower surface of the docking seal creates a fluid-tight seal.

[0060] In some embodiments, the cannula carrying mechanism includes a through hole in fluid communication with the cannula lumen and in fluid communication with the first fluid flow path.

[0061] In some examples, the drug infusion device further includes an insertion assembly configured to move the cannula carrying mechanism between a disengaged configuration in which the cannula carrying mechanism does not contact the docking seal and an engaged configuration in which the docking seal surrounds at least a portion of the cannula carrying mechanism.

[0062] In some embodiments, a lowermost surface of the butt seal abuts the lower flange.

[0063] Typically, in some embodiments of the technology according to the present invention, a sealing assembly for a drug infusion device includes an annular butt seal, the annular butt seal including an upper surface, a lower surface, a radial inner surface, a radial outer surface, and a through hole extending between the radial outer surface and the radial inner surface, wherein the through hole defines a first fluid flow path. The sealing assembly may further include a sealing housing that at least partially surrounds the butt seal, the sealing housing including: an upper flange that is configured to contact the upper surface of the butt seal; a lower flange that is configured to contact the lower surface of the butt seal; a side portion that is configured to contact at least a portion of the radial outer surface of the butt seal to define an annular channel between the side portion of the sealing housing and the radial outer surface of the butt seal; and a second fluid flow path that extends through the side portion so that the second fluid flow path is in fluid communication with the first fluid flow path.

[0064] In some embodiments, the annular butt seal extends circumferentially about a vertical axis, and wherein the annular butt seal is symmetric about a horizontal plane orthogonal to the vertical axis.

[0065] In some embodiments, the butt seal includes a variable sidewall thickness between the radially inner surface and the radially outer surface. The butt seal may further include a middle portion having a first sidewall thickness, wherein the through hole may extend through the middle portion between the radially inner surface and the radially outer surface. The butt seal may further include an upper widened portion, which is axially disposed above the middle portion and has a second sidewall thickness greater than the first sidewall thickness, wherein the upper widened portion defines an upper radially inner sealing surface and an upper radially outer sealing surface. The butt seal may further include a lower widened portion, which is axially disposed below the middle portion and has a third sidewall thickness greater than the first sidewall thickness, wherein the lower widened portion defines a lower radially inner sealing surface and a lower radially outer sealing surface.

[0066] According to some embodiments, the annular channel is defined by a space between a middle portion of the butt seal and side portions of the seal housing.

[0067] In some examples, contact between the upper flange and the upper surface of the docking seal creates a fluid-tight seal, and contact between the lower flange and the lower surface of the docking seal creates a fluid-tight seal. In several embodiments, contact between the upper flange and the upper surface of the docking seal creates a fluid-tight seal, and contact between the lower flange and the lower surface of the docking seal creates a fluid-tight seal.

[0068] In some embodiments, a lowermost surface of the butt seal abuts the lower flange.

[0069] Typically, in some embodiments of the technology according to the present invention, a docking seal for a drug infusion device includes an annular body having a sidewall defining a radial outer surface and a radial inner surface surrounding a central opening, the central opening being configured to receive a sleeve carrying mechanism therein, wherein the sidewall has a variable thickness such that the sidewall defines: a middle portion having a first sidewall thickness; an upper widened portion, the upper widened portion being axially disposed above the middle portion and having a second sidewall thickness greater than the first sidewall thickness, the upper widened portion defining an upper radial inner sealing surface and an upper radial outer sealing surface; a lower widened portion, the lower widened portion being axially disposed below the middle portion and having a third sidewall thickness greater than the first sidewall thickness, the lower widened portion defining a lower radial inner sealing surface and a lower radial outer sealing surface; and a through hole extending through the middle portion of the sidewall between the radial inner surface and the radial outer surface.

[0070] In some embodiments, the annular body extends circumferentially around a vertical axis, and the annular body is symmetric about a horizontal plane orthogonal to the vertical axis.

[0071] According to some examples, the upper radially inner sealing surface and the lower radially inner sealing surface both protrude radially inwardly relative to the middle portion. In several embodiments, the upper radially outer sealing surface and the lower radially inner sealing surface both protrude radially outwardly relative to the middle portion.

[0072] Other technical features may be apparent to those skilled in the art from the following drawings, detailed description and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0073] Many aspects of the present disclosure may be better understood with reference to the following drawings. The components in the drawings are not necessarily drawn to scale. Instead, emphasis is placed on clearly illustrating the principles of the present disclosure.

[0074] Figure 1A is a perspective view of the top of an infusion device according to several examples of the present technology.

[0075] Figure 1B yes Figure 1A A perspective view of the bottom of an infusion set.

[0076] Figure 2A yes Figure 1A and Figure 1B A perspective view of a durable assembly of an infusion set.

[0077] Figure 2B and Figure 2C yes Figure 2A A perspective view of certain components of the durable assembly shown.

[0078] Figure 3A yes Figure 1A and Figure 1B A perspective view of a disposable assembly of an infusion set.

[0079] Figure 3B yes Figure 3A A perspective view of certain components of the disposable assembly is shown.

[0080] Figure 4 Schematically depicts Figure 3B Insertion assembly of the disposable assembly shown.

[0081] Figure 5 Schematically depicts Figure 3B The sealing assembly of the disposable assembly is shown, and the sealing assembly is configured according to the technology of the present invention.

[0082] Fig. 6A is a perspective view depicting an insertion assembly configured in accordance with the present teachings, showing a pre-insertion state.

[0083] Figure 6B yes Fig. 6A A cross-sectional view of the insert assembly is shown.

[0084] Figure 7 yes Fig. 6A and Figure 6B Exploded view of insert assembly shown.

[0085] Figure 8 yes Fig. 6A , Figure 6B and Figure 7 An isolated view of the needle carrier of the insertion assembly is shown.

[0086] Fig. 9 yes Fig. 6A and Figure 6B An isolated view of the cannula carrier of the insertion assembly is shown.

[0087] Fig.10 is an isolated view of an example carrier assembly according to the present technology, the carrier assembly comprising Figure 8 The needle carrier and Fig. 9 The casing carrier.

[0088] Fig.11A yes Fig. 6A and Figure 6B 0014] A perspective view of the insertion assembly of FIG. 10, showing the situation after the insertion has been triggered when the carrier assembly moves from the pre-insertion position to the extended position.

[0089] Fig. 11B yes Fig. 6A and Figure 6B A top view of the insert assembly showing the Fig.11AA portion of the cross section taken along line 11B-11B in FIG.

[0090] Fig.12 yes Fig. 6A and Figure 6B A perspective view of the insertion assembly showing that insertion is triggered by rotation of the cannula carrier.

[0091] Fig.13A and Fig. 13B The two diagrams are shown in the extended position. Fig. 6A and Figure 6B Perspective and cross-sectional views of the insert assembly.

[0092] Fig.14A and Fig. 14B The retracted position is shown Fig. 6A and Figure 6B Perspective and cross-sectional views of the insert assembly.

[0093] Fig.15 is a side cross-sectional view of a seal assembly according to an example of the present technology, the seal assembly shown coupled to an insert assembly.

[0094] Fig.16A is a side perspective view of an example butt seal in accordance with the present technology.

[0095] Fig. 16B yes Fig.16A A side cross-sectional view of a butt seal is shown.

[0096] Fig.17 is a side cross-sectional view of a seal assembly engaged with a cannula carrier in accordance with an example of the present technology.

[0097] Fig.18 is a side cross-sectional view of a portion of a seal assembly engaged with a cannula carrier in accordance with an example of the present technology. DETAILED DESCRIPTION

[0098] The present technology includes an infusion device (sometimes referred to as a "patch pump") that is configured to adhere to the user's skin over a delivery site. Figure 1A and Figure 1BA top view and a bottom view of an infusion device 100 according to several examples of the technology of the present invention are shown, respectively. The bottom surface 100b of the device 100 is configured to adhere to the skin of a user, wherein the top surface 100a faces away from the user. The device 100 can be a two-piece device, which includes a durable component 200 and a disposable component 300, each component having a corresponding housing 202 and 302. The durable component 200 and the disposable component 300 are placed on an adhesive pad 102 with an adhesive backing 104 for fixing to the skin of the user. The bottom side 100b of the device 100 can also include a pull-before-use plug (PBUP) 108 and a filling port 106. Although a two-piece device is shown as an example, in other exemplary devices, the device 100 can be a single-piece, fully disposable unit.

[0099] To use the infusion device 100, a user (e.g., a patient) connects the disposable assembly 300 to the durable assembly 200. Unless the reservoir of the disposable assembly 300 has been sufficiently preloaded, the user injects the desired amount of medication into the reservoir via the fill port 106. The plunger search procedure can be initiated by the user or automatically. To adhere the device 100 to the user, the adhesive backing 104 can be peeled off to expose the adhesive on the adhesive pad 102; the PBUP 108 can be removed; and / or the device 100 can be positioned over a selected body location and gently pressed to adhere the adhesive pad 102 to the skin surface. In some examples, no plunger search is required.

[0100] exist FIG. 2A to FIG. 2C The durable assembly 200 shown in more detail in FIG. 2 may include a housing 202, a buzzer or other alarm device 204, one or more batteries or other energy supplies 206, a microprocessor (not shown), and a coil assembly 208 (which acts as a motor stator) including one or more Hall-effect sensors 210. In some examples, the energy supply 206 is a rechargeable battery, such as a rechargeable lithium battery, which has sufficient power to continuously drive the motor without a capacitor or other additional energy storage device.

[0101] Reference now Figure 2C , Figure 3A and Figure 3B , the coil assembly 208 can be positioned around the recessed portion 212 of the durable assembly housing 202, which is configured to fit within the disposable housing 302 ( Figure 3A ) which in turn fits over the protruding portion 303 of the disposable assembly 300 ( Figure 3B) on a magnetic motor rotor 331. In this two-piece motor, the motor coil assembly 208 is in the durable component 200 and is positioned around the motor rotor 331 which is part of the disposable component 300. The Hall Effect Sensor 210 ( Figure 2B ) The coil assembly 208 is positioned in the durable assembly 200 ( Figure 2C ) above, for example, on a shelf 205 within the housing 202. In this configuration, there is a gap between the motor coil assembly 208 and the motor rotor 331. In the illustrated embodiment, some or all of the gap may be defined (and occupied) by housing portions (e.g., the durable housing portion 212 and the disposable housing portion 303). In other embodiments, the gap between the motor coil assembly 208 and the motor rotor 331 may be occupied by only a portion of the durable component housing 202, or by only a portion of the disposable component housing 302, or there may be no structure at all and may be only an air gap. The size of the gap defined by the distance between the motor coil assembly 208 and the motor rotor 331 is typically about 0.5 mm to 2.0 mm. In this way, there is no direct gear meshing or other mechanical connection between the durable component 200 and the disposable component 300. All electronic devices can be located within the durable component 200, and the energy required by the disposable component 300 is transmitted through an electromagnetic torque coupling, which is a coupling without direct mechanical coupling or electrical contact from the durable component 200. These designs offer the added advantage that it is relatively simple to make them waterproof or at least water resistant.

[0102] An exemplary motor rotor 331 may be a 2-pole, cylindrical, rare earth (such as neodymium) rotor that is magnetized on diameter, having a diameter of 5 mm and a height of 5 mm. Other suitable motor rotors may be larger or smaller, or multi-pole. A microprocessor (not shown) directs the rotation of the motor rotor 331 by sequentially energizing the coils of the motor coil assembly 208 to produce an electromagnetic torque coupling between the motor coil assembly 208 and the motor rotor 331. The position / orientation of the rotor poles relative to the rotating magnetic field generator (motor coil assembly 208) is measured by back EMF, a rotary encoder, one or more Hall effect sensors 210, and the like. For example, a Hall effect sensor 210 mounted above the coil windings of the motor coil assembly 208 may be used to provide a count, a speed signal, or a rotor position to the microprocessor, thereby achieving low-cost closed-loop control of the rotor speed. This type of brushless motor is efficient and runs cooler.

[0103] exist Figure 3A and Figure 3BThe disposable assembly 300 shown in more detail in FIG. 4 may include a reservoir assembly, a trigger assembly 304 (shown schematically), an insertion assembly 400, and a sealing assembly 500, all of which are mounted on a base plate 350. The reservoir assembly may include a drive assembly 329, a reservoir 336, a plunger pusher 335a, and a plunger 335b. The plunger pusher 335a is coupled to the drive assembly 329, and the plunger pusher 335a and the plunger 335b are both contained within the reservoir 336. The insertion assembly 400 includes a cannula 404 (see FIG. 4 ). Figure 4 ) and several components for driving the cannula 404 into the user's skin. The trigger assembly 304 can operably couple one or more components of the reservoir assembly to the insertion assembly 400 to control the insertion timing of the cannula 404. In some examples, for example, one or more components of the trigger assembly 304 can be operably coupled to the drive assembly 329 so that remote activation of the motor moves the trigger assembly 304 into engagement or disengagement with the insertion assembly 400, thereby actuating the insertion assembly 400 and releasing the cannula. In some examples, the insertion can be triggered locally, such as by a dial, a lever, a button, etc.

[0104] Still reference Figure 3A and Figure 3B , the drive assembly 329 can include a magnetic motor rotor 331 and a gear train coupling the motor rotor 331 to a plunger pusher 335a, which is positioned in a reservoir 336. The magnetic motor rotor 331 can be mechanically attached via the gear train to affect translation of the plunger pusher 335a (and the plunger 335b, when attached to the plunger pusher 335a) within the reservoir 336.

[0105] like Figure 3B As best shown in FIG. 1 , the gear train may include various gears, such as a worm drive consisting of a worm 333a and a worm wheel 333b, and also includes a lead screw nut 334a and a small pitch lead screw 351 (surrounded by the lead screw nut 334a). The worm wheel 333b is coupled to the lead screw 351 via the lead screw nut 334a. The protrusion 334b ​​on the lead screw nut 334a corresponds to a recess (not shown) inside the worm wheel 333b, and the threaded portion (not shown) inside the lead screw nut 334a mates with the threads on the lead screw 351 surrounded by the lead screw nut 334a. This configuration of the gear train prevents back driving due to reservoir pressure, thereby eliminating the need for a clutch or other locking mechanism. Suitable materials for the components of the gear train include, but are not limited to, stainless steel or high strength plastics such as nylon, acetal (e.g., Delrin ® ) or polycarbonate.

[0106] Reservoir 336 may be pre-filled with medication. For example, the medication may be U-100 insulin or U-500 insulin or other concentrations of insulin to suit different user usage profiles, or may be a medication that the user may fill via fill port 106 ( Figure 1B ) filled. In some examples, the reservoir 336 can be mounted on a reservoir support block ( Figure 3B The reservoir outlet fitting 348 is in fluid communication with the reservoir 336. The reservoir outlet fitting 348 may be made of a drug compatible material such as, but not limited to, polypropylene, cyclic olefin polymer (COP), or polyethylene.

[0107] In those cases where the reservoir 336 is filled by the user, the user may completely fill the reservoir to capacity with medication, or the user may choose to introduce less medication and not completely fill the reservoir. Since an unknown amount of medication may be injected into a user-filled reservoir, the plunger pusher zeroing procedure (or "plunger seeking") may be user-initiated, or may be an automatic aspect of pump operation. Prior to any medication dispensing, the plunger seek procedure accurately determines and / or sets exactly how far the plunger pusher 335a travels before it engages the plunger 335b, thereby enabling calculations to be performed to determine the amount of medication in the reservoir and therefore determine an estimate of the emptying time and the time for disposable component replacement.

[0108] Figure 4The insertion assembly 400 schematically shown in FIG. 4 may include a cannula carrier 402, a cannula 404 carried by the cannula carrier 402, a needle carrier 406, a needle 408 carried by the needle carrier 406, an insertion spring 410, a retraction spring 412, and a frame 414. The insertion assembly 400 is shown in a pre-insertion state. The cannula carrier 402 and the needle carrier 406 (and the associated cannula 404 and needle 408) can be coupled to the frame 414 and configured to translate and / or rotate relative to the frame 414 during insertion and / or retraction of the needle 408. The needle 408, which includes an elongated shaft with a sharp distal tip, can be made of metal (such as stainless steel) or other relatively rigid biocompatible materials (such as rigid plastics, ceramics, or other rigid biocompatible materials) and is used to penetrate the skin and penetrate a short distance into the flesh to form a channel for the cannula 404. The cannula 404 can be softer and / or more flexible than the needle 408 and can include a biocompatible polymeric material. The insertion assembly 400 can be configured to engage the trigger assembly 304 to move (or enable movement) the cannula carrier 402 relative to the frame 414 for inserting the cannula 404. Activation of the trigger assembly 304 releases the insertion spring, which pushes the needle carrier 406 and the cannula carrier 402 downward toward the insertion site. When the retraction spring 412 pushes the needle carrier 406 back upward into the frame 602, the cannula carrier 402 can remain at the insertion site, thereby withdrawing the needle 408 from the insertion site.

[0109] Figure 5 A seal assembly 500 is schematically depicted, which is used to maintain a fluid-tight seal between the interior of the drug infusion device and the external environment, preventing both the undesired leakage of the drug out of the device and the undesired entry of fluid from the patient into the device. The seal assembly 500 can also be configured to engage with the cannula carrier 402 so that when the cannula carrier 402 is deployed and the cannula 404 extends beyond the lower surface of the device housing and into the patient, a flow path is established between the reservoir 336 and the cannula 404, and a fluid-tight seal is established between the cannula carrier 402 and the seal assembly 500. The seal assembly 500 can include a butt seal 502, which includes an annular sidewall configured to circumferentially surround at least a portion of the cannula carrier 402 when the cannula carrier 402 is fired. The butt seal 502 can define at least one fluid flow path therethrough, which is coupled to the reservoir supply fluid flow path at the inlet side. The butt seal fluid flow path may be coupled to the sleeve 404 at the outlet side (eg, via an intermediate flow path in the sleeve carrier, sleeve insert, or other component of the sleeve carrier assembly).

[0110] I. Selected examples of insert components

[0111] exist Fig. 6A , Figure 6B and Figure 7 An exemplary insertion assembly 600 for use with the device 100 of the present technology is shown in more detail in FIG. Fig. 6A and Figure 6B are perspective and cross-sectional views, respectively, of the insertion assembly 600 in a first state or pre-insertion state, and Figure 7 is an exploded view showing the components of the insert assembly 600. Fig. 6A , Figure 6B and Figure 7 , the insertion assembly 600 may include a cap 700 , an insertion spring 702 , a needle carrier 800 , a needle 804 secured to the needle carrier 800 , a retraction spring 704 , a cannula carrier 900 , a cannula 904 secured to the cannula carrier 900 , and a frame 602 .

[0112] The frame 602 may include a generally tubular sidewall having an outer surface 604, an inner surface 606 surrounding and defining an interior region 608 (see Figure 6B ) and a thickness T measured between the inner surface 604 and the outer surface 606. The frame 602 can further include one or more longitudinal slots 610, each slot spanning the entire thickness T of the sidewall. The cap 700 can be disposed across the opening of the top portion of the frame 602 and can include one or more protrusions 720 extending radially beyond the outer diameter of the frame 602. In some examples, the cap 700 includes a plurality of protrusions 720 (e.g., Fig. 6A ), and in some examples, the cap 700 includes a single protrusion 720 extending around most or all of the circumference. In any case, the insertion spring 702 can be positioned around the outer surface 604 of the frame 602, longitudinally constrained between the cap protrusion 720 and the protrusions 906 on the cannula carrier 900, which extend through the slot 610 and radially beyond the slot to the outer surface 604 of the frame 602. In some examples, the insertion assembly 600 does not include the cap 700, and the top portion of the frame 602 includes one or more protrusions that engage the top surface of the insertion spring 702.

[0113] The needle carrier 800 may include a needle carrier body 802 and one or more needle carrier protrusions 806 extending radially away from the needle carrier body 802. Similarly, the cannula carrier 900 may include a cannula carrier body 902 and one or more cannula carrier protrusions 906 extending radially away from the cannula carrier body 902. The needle carrier body 802 and the cannula carrier body 902 are disposed within the interior region 608 of the frame 602, wherein the needle carrier protrusions 806 and the cannula carrier protrusions 906 extend into and / or through the slot 610. Thus, the slot 610 stabilizes and guides the movement of the needle carrier 800 and the cannula carrier 900 during insertion, and stabilizes and guides the movement of the needle carrier 800 during retraction. The needle carrier body 802 is positioned on top of the cannula carrier body 902 within the frame 602, with the retraction spring 704 disposed between the needle carrier body and the cannula carrier body.

[0114] Figure 8 800. The needle carrier 800 may include three needle carrier protrusions 806 equally spaced (i.e., 120 degrees apart) around the circumference of the needle carrier body 802. In some examples, the needle carrier 800 includes more or fewer needle carrier protrusions 806 (e.g., one needle carrier protrusion 806, two needle carrier protrusions 806, four needle carrier protrusions 806, etc.) and / or the needle carrier protrusions 806 may have different spacings. Each of the needle carrier protrusions 806 may have a length L1 measured between the outer surface 814 of the needle carrier body 802 and the distal end of the corresponding needle carrier protrusion 806, a height H1 between the topmost surface and the bottommost surface located within the slot 610, side surfaces 806a and 806b, and a width W1 measured between the side surfaces 806a, 806b. At least a portion of the length L1 of each of the needle carrier protrusions 806 extends into a corresponding slot 610 in the frame 602, and the side surfaces 806a, 806b are configured to engage and slide along portions of the frame sidewalls on either side of the slot 610. In some examples, such as Fig. 6A and Fig. 11B As best shown in , the distal ends of the needle carrier protrusions 806 are substantially aligned with or adjacent (radially inwardly of) the outer surface 604 of the frame 602 such that the needle carrier protrusions 806 do not extend radially beyond their respective slots 610 .

[0115] The needle carrier 800 further includes locking protrusions 808 that are configured to engage tabs 908 on the arms 907 of the cannula carrier 900, as described herein. The locking protrusions 808 may be equally spaced (i.e., 120 degrees apart) around the circumference of the needle carrier body 802 (e.g., 120 degrees apart). Figure 8 ), or in some examples may have different spacings. Figure 8808, but the needle carrier 800 may include more or fewer locking protrusions 808 (e.g., one locking protrusion 808, two locking protrusions 808, four locking protrusions 808, etc.). The radially outermost surface 812 of the locking protrusion 808 may include the radially outermost surface of the needle carrier 800 (other than the needle carrier protrusion 806) and may be spaced apart from the inner surface 606 of the frame 602 during insertion and retraction (i.e., the needle carrier body 802 does not contact the inner surface 606 of the frame 602). As such, the only surfaces of the needle carrier 800 that contact the frame 602 are the side surfaces 806a, 806b.

[0116] Fig. 9 600. The cannula carrier 900 may include three cannula carrier protrusions 906 equally spaced (i.e., spaced 120 degrees apart) around the circumference of the cannula carrier body 902. In some examples, the cannula carrier 900 includes more or fewer cannula carrier protrusions 906 (e.g., one cannula carrier protrusion 906, two cannula carrier protrusions 906, four cannula carrier protrusions 906, etc.) and / or the cannula carrier protrusions 906 may have different spacings. Each of the cannula carrier protrusions 906 may have a length L2 measured between the outer diameter of the cannula carrier body 902 and the distal end of the corresponding cannula carrier protrusion 906, a height H2 between the topmost surface and the bottommost surface located within the slot 610, side surfaces 906a and 906b, and a width W2 measured between the side surfaces 906a, 906b. At least a portion of the length L2 of the respective cannula carrier protrusion 906 extends into the corresponding slot 610 in the frame 602, and the side surfaces 906a, 906b engage portions of the frame sidewall on either side of the slot 610 and are configured to slide along these portions. Fig. 6A and Fig. 11B As best shown in FIG. 1 , the cannula carrier projection 906 extends completely through the slot 110 such that the distal end of the cannula carrier projection 906 is radially further from the insertion axis A than the outer surface 604 of the frame 602 ( Fig.10 ). Thus, each sleeve carrier protrusion 906 includes a slot portion 914 disposed within the slot 610 and a protruding portion 916 disposed outside the slot 610. In some variations, for example, Fig. 6A and Figure 6B As shown, at least when the insertion assembly 600 is in a loaded, pre-insertion state, the bottom end of the insertion spring 702 can be supported by the top surface of the protruding portion 916 of the cannula carrier protrusion 906. As discussed in more detail below, rotation of the cannula carrier 900 within the frame 602 causes the insertion spring 702 to unload, thereby pushing the cannula carrier 900 (and the associated needle carrier 800) downward toward the insertion site.

[0117] The radially outermost surface 915 of the sleeve carrier body 902 may be spaced apart from the inner surface 606 of the frame 602 by a gap g (see Fig. 11B ), and remain spaced apart during insertion and retraction (ie, the cannula carrier body 902 does not contact the inner surface 606 of the frame 602). Thus, the only surfaces of the cannula carrier 900 that contact the frame 602 are the side surfaces 906a, 906b.

[0118] The cannula carrier 900 further includes arms 907 extending upwardly from a top portion of the cannula carrier body 902, and each of the arms 907 includes a tab 908 extending radially inwardly from a distal end of the corresponding arm 907. When the needle carrier 800 and the cannula carrier 900 are coupled to each other to hold the needle carrier 800 against the top surface of the cannula carrier body 902, the tab 908 is configured to engage the locking protrusion 808 of the needle carrier 800. The cannula carrier 900 may include three arms 907 (e.g., spaced 120 degrees apart) equidistantly around the circumference of the cannula carrier body 902. Fig. 9 ), or in some embodiments may include more or fewer arms 907 (e.g., one arm 907, two arms 907, four arms 907, etc.) and / or the arms 907 may have different spacings.

[0119] The cannula carrier body 902 may further include an opening 910 through which the needle 804 of the needle carrier 800 is received. The opening 910 may extend through a sealing portion 930 of the cannula carrier 900 extending downwardly from the cannula carrier body 902 (at Figure 6B 904 ). The sealing portion 930 can be configured to be received within a sealing assembly of a bottom portion of the insertion assembly 600 to establish a fluid path between the reservoir and the cannula 904 .

[0120] Fig.10 The needle carrier 800 and the cannula carrier 900 are shown coupled to each other, for example, when the insertion assembly 600 is in a pre-insertion state and during insertion of the needle 804 and the cannula 904. The needle carrier 800 can be positioned on top of the cannula carrier 900 with the needle 804 disposed in the lumen of the cannula 904. The retraction spring 704 (in Figure 6B800) can be loaded between the top surface of the cannula carrier 900 and the bottom surface of the needle carrier 800. As used herein, "carrier assembly 1000" refers to this temporary coupling configuration of the needle carrier 800 and the cannula carrier 900. As previously described, the tabs 908 of the arms 907 of the cannula carrier 900 can extend radially inward from the distal ends of the arms 907 toward the insertion axis A to engage corresponding locking protrusions 808 on the needle carrier 800, thereby securing the needle carrier 800 to the cannula carrier 900. The fit between the locking protrusions 808 and the tabs 908 can be tight enough so that the cannula carrier 900 remains engaged with the needle carrier 800 (and thereby pulls the needle carrier 800 downward) during insertion, but loose enough to allow the tabs 908 to slide circumferentially along the locking protrusions 808. As discussed in more detail below, to release (or unload) the insertion spring 702, the sleeve carrier protrusion 906 can be rotated away from the support boss 612 in the frame 602 (see Fig. 6A ) and into the narrow slot 610. During the rotation of the cannula carrier 900, the needle carrier 800 can remain stationary within the frame 602 so that the tab 908 slides along the locking protrusion 808.

[0121] Fig.11A The insertion assembly 600 is shown shortly after the cannula carrier projection 906 has rotated away from the protrusion 612 and the carrier assembly 1000 begins to slide downward within the frame 602. Fig.11A 610, the insertion spring 702 has been removed to facilitate viewing of the carrier assembly 1000 within the slot 610. Before the cannula carrier 900 is rotated, the needle carrier protrusion 806 and the cannula carrier protrusion 906 are circumferentially offset about the insertion axis A (e.g., as Fig. 6A Once the cannula carrier 900 is rotated so that the cannula carrier protrusion 906 enters the adjacent slot 610, the needle carrier protrusion 806 and the cannula carrier protrusion 906 become circumferentially aligned (as shown). Fig.11A Each pair of circumferentially aligned needle and cannula carrier projections 806, 906 forms a sliding interface 1010 that engages a corresponding slot 610 in the frame 602 such that the slot 610 controls the straightness of the insertion path of the needle 804 and cannula 904, as well as the straightness of the retraction path of the needle 804.

[0122] The height H3 of each of the sliding interfaces 1010 can be greater than or equal to the combined heights H1 and H2 of the associated needle carrier protrusion 806 and cannula carrier protrusion 906, respectively. Fig.10), the height H3 of each sliding interface 1010 will be greater than the combination of H1 and H2. Similarly, each of the sliding interfaces 1010 can have a width W3 that is no greater than the greater of the width W1 of the needle carrier protrusion 806 or the width W2 of the cannula carrier protrusion 906 (if W1 and W2 are different), and no less than the smaller of the width W1 of the needle carrier protrusion 806 or the width W2 of the cannula carrier protrusion 906 (if W1 and W2 are different). If W1 and W2 are the same, the width W3 of each of the sliding interfaces 1010 can be equal to the width W1 of the needle carrier protrusion 806 and the width W2 of the cannula carrier protrusion 906.

[0123] According to several aspects of the technology, the sliding interface 1010 can have an aspect ratio (H3:W3) greater than 1 (including greater than 2, greater than 3, greater than 4, greater than 5, etc.). It may be beneficial for the sliding interface to have an aspect ratio (H3:W3) greater than 1 because it reduces the risk of the carrier assembly 1000 tilting and sticking within the frame 602 during axial movement of the carrier assembly 1000 within the frame 602. By utilizing multiple narrow rails (e.g., slots and protrusions), the sliding interface of the technology of the present invention has a relatively low effective width, thereby increasing the aspect ratio (H:W). To further increase the H:W ratio during insertion, the protrusions 806, 906 of the needle hub and cannula carrier are stacked vertically during insertion, thereby increasing the height of the sliding interface (at least relative to the case where the protrusions are not stacked or the device does not include radially aligned protrusions). After the retraction mechanism is triggered and the needle carrier 800 has been separated from the cannula carrier 900, the H:W ratio of the needle hub protrusion itself is still sufficient (e.g., greater than 1) to control the straightness of the retraction.

[0124] In use, the insertion assembly 600 begins in a first pre-insertion state (eg Fig. 6A and Figure 6B 612 and align with the slot 610 in the frame 602. Fig.12as shown. Although the cannula carrier 900 is shown as being rotated counterclockwise to release, in other examples, the cannula carrier 900 can be rotated clockwise to release (in such examples, the slot 610 can be disposed directly to the left of the protrusion 612). Once the cannula carrier 900 is no longer supported by the protrusion 612 of the frame 602, the cannula carrier 900 is no longer able to resist the force of the insertion spring 702, and the elastic energy contained in the insertion spring 702 is converted into motion. The insertion spring 702 drives the carrier assembly 1000 downward, wherein the aligned needle carrier protrusion 806 and the cannula carrier protrusion 906 slide within their corresponding slots 610 in the frame 602. As the carrier assembly 1000 moves downward, the sharp tip of the needle 804, which extends slightly beyond the distal end of the cannula 904, pierces the user's skin and inserts the cannula 904 surrounding the needle 804 so that the end of the cannula 904 is located approximately 6 mm below the surface of the user's skin. At this point, the insertion assembly 600 is in an extended configuration, as shown in FIG. Fig.13A and Fig. 13B shown.

[0125] In the extended configuration, the sealing portion 930 of the cannula carrier 900 is received within a sealing assembly (such as the sealing assembly 1500) disposed at the bottom portion of the frame 602. Also in this extended position, the arms 907 of the cannula carrier 900 are aligned with the slots 618 ( Fig.13A ) are aligned so that the arm 907 can be radially bent away from the locking protrusion 808 of the needle carrier 800 and into the narrow slot 618. The arm 907 thus engages the narrow slot 618 to lock the cannula carrier 900 and the associated cannula 904 in the appropriate position of the bottom portion of the frame 602. With the locking protrusion 808 disengaged, the needle carrier 800 can no longer resist the force of the retraction spring 704, and the retraction spring 704 drives the needle carrier 800 with the attached needle 804 upward. As the needle carrier 800 moves upward, the needle carrier protrusion 806 slides within its corresponding narrow slot 610, which prevents the needle carrier 800 from rotating. The upward movement of the needle carrier 800 within the frame 602 removes the needle 804 from the user and retracts the needle 804 into the frame 602, leaving the inserted cannula 904, as shown. Fig.14A and Fig. 14B When the device 100 is used by a user (eg, during fluid delivery), the insertion assembly 600 remains in this retracted state.

[0126] II. Selected examples of sealing components

[0127] Fig.15 yes Fig. 6A and Figure 6B600 , where the sealing assembly 1500 is disposed. The sealing assembly 1500 can be configured for use with the device 100, whether the device 100 is a two-piece device as described above or a single-piece fully disposable device. The sealing assembly 1500 can include a sealing housing 1502 and a docking seal 1600 that is secured in position relative to the frame 604 via the sealing housing 1502. When the device 100 is in use, a portion of the cannula carrier 900 is disposed within an opening 1603 extending through the docking seal 1600, and the sealing housing 1502, the docking seal 1600, and the cannula carrier 900 together establish a fluid path between a reservoir (not shown) and a cannula 904, as described below with reference to FIG. Fig.17 described.

[0128] In some embodiments, the sealed housing 1502 includes an upper frame portion 1504 disposed within the interior region 608 of the frame 602, and a lower frame portion 1506 positioned below the frame 602, the upper frame portion 1504, and the docking seal 1600. The upper frame portion 1504 and the lower frame portion 1506 are matched together to vertically fix the docking seal 1600 between the upper frame portion and the lower frame portion. In some embodiments, the lower frame portion 1506 defines the lower surface of an infusion device (such as an infusion device 100) and can be placed in contact with the patient's skin. The sealed housing 1502 and the docking seal 1600 together form a fluid-tight seal between the interior of the infusion device and the external environment, preventing both the drug from leaking undesirably from the device and preventing fluid from undesirably entering the device from the patient's body or the environment (e.g., water from a shower). In some variations, the sealed housing 1502 includes a single component, and in some embodiments, the sealed housing 1502 includes more than two parts.

[0129] Fig.16A yes Fig.15 A side perspective view of the docking seal 1600 is shown, and Fig. 16B is a side cross-sectional view. The docking seal 1600 may include a generally annular side wall having a longitudinal axis A (see Fig. 16B ), a top surface 1608, a bottom surface 1610, a radially outer surface 1612, a radially inner surface 1614, and at least one transverse through hole 1620 extending between the radially outer surface 1612 and the radially inner surface 1614. The radially inner surface 1614 can define an opening 1603 extending longitudinally through the dock seal 1600. The through hole 1620 can define a fluid flow path that allows fluid to be delivered from a reservoir (such as the reservoir 336) to the cannula 904 when the cannula carrier 900 is disposed within the opening 1603 of the dock seal 1600 (as described below with reference to Fig.17 In the illustrated example, the sidewall of the butt seal 1600 includes two opposing through holes 1620 that are aligned with each other on the diameter of the butt seal 1600. However, in other embodiments, there may be only a single through hole 1620, or there may be three, four, or more through holes.

[0130] The thickness of the side wall of the docking seal 1600 may vary along the longitudinal axis A, such that the side wall includes an upper widened portion 1602, a lower widened portion 1606, and a narrowed portion 1604 between the upper widened portion 1602 and the lower widened portion 1606. Fig. 16B As shown in the cross-sectional view of , the upper widened portion 1602 can have a first thickness T1, the narrowed portion 1604 can have a second thickness T2, and the lower widened portion 1606 can have a third thickness T3. In various embodiments, the individual first thickness T1 and third thickness T3 can be greater than the second thickness T2, so that the sidewall defines an outer annular recess 1616 at the radially outer surface 1612 and an inner annular recess 1618 at the radially inner surface 1614. Therefore, the upper widened portion 1602 and the lower widened portion 1606 define a radially outermost portion that serves as a sealing surface that contacts an adjacent structure to provide a fluid-tight seal. These radially outermost portions include an upper radially outer sealing surface 1612a that abuts and seals against a portion of the upper frame portion 1504, a lower radially outer sealing surface 1612b that abuts and seals against a portion of the lower frame portion 1506, an upper radially inner sealing surface 1614a that abuts and seals against a region of the sealing portion 930 of the sleeve carrier 900, and a lower radially inner sealing surface 1614b that abuts and seals against a region of the sealing portion 930. These abutments can provide a fluid-tight seal such that fluid positioned radially outside of the butt seal 1600 can only flow to the radial inside of the butt seal 1600 through the through holes 1620.

[0131] Fig.17 The extended position is when the needle 804 is retracted upward into the interior area 608 of the frame 602. Fig.15 A perspective cross-sectional view of an insert assembly. Fig.18 is a side cross-sectional view of a portion of the seal assembly 1500 fully engaged with the cannula carrier 900. Fig.17 and Fig.18, during normal use, the cannula carrier 900 is located within the dock seal 1600 and the cannula 904 extends distally beyond the lower surface of the seal housing 1502. In this state, the radially outer surface 912 of the sealing portion 930 of the cannula carrier 900 abuts and seals against the upper radially inner sealing surface 1614a and the lower radially inner sealing surface 1614b of the dock seal 1600, the upper radially outer sealing surface 1612a of the dock seal 1600 abuts and seals against the upper frame portion 1504, and the lower radially outer sealing surface 1612b of the dock seal 1600 abuts and seals against the lower frame portion 1506. By this mating, a series of flow segments become fluidly coupled to each other to produce a flow from the reservoir 336 (at Fig.18 1500) to the cannula lumen 952 so that the drug can be delivered from the reservoir to the patient's body. Within the seal assembly 1500, the flow path 1700 may include a first flow segment 1702 extending from the reservoir, through the space between the upper frame portion 1504 and the lower frame portion 1506, and extending from an opening at the radial inner surface of the seal housing 1502. The second flow segment 1704 extends through the through hole 1620 of the docking seal 1600 and enters a third flow segment 1706 extending through the sealing portion 930 of the cannula carrier 900. The third flow segment 1706 then passes through the cannula insert 950 disposed in the sealing portion 930 to the fourth flow segment 1708, which in turn is in fluid communication with the fifth flow segment 1710 extending through the cannula lumen 952.

[0132] The dock seal 1600, along with adjacent portions of the seal housing 1502 and the cannula carrier 900, together define an inner annular channel 1619 and an outer annular channel 1617, each of which is in fluid communication with the through hole 1620, regardless of the radial orientation of the dock seal 1600. In operation, the outer annular channel 1617 can be in fluid communication with an inlet fluid flow path (e.g., first flow segment 1702) that delivers a drug from a reservoir, and the inner annular channel 1619 can be in fluid communication with an outlet fluid flow path (e.g., third flow segment 1706) that delivers the drug through the cannula carrier 900, into the cannula lumen 952, and out of the device for delivery to a patient. The dual annular channels defined by the dock seal 1600 allow the dock seal to be inserted into the device at any rotational position while still effectively establishing a continuous fluid flow path from the reservoir to the cannula lumen 952. For example, even if the through-hole 1620 is offset 90 degrees from the inlet fluid flow path of the reservoir, fluid from the inlet fluid flow path simply changes direction along the outer annular channel 1617 until reaching the dock seal through-hole 1620, where the fluid then passes through the through-hole 1620 and continues into the inner annular channel 1619, ultimately reaching the inlet into the sleeve carrier 900. Similarly, if the dock seal through-hole 1620 is radially offset from the outlet fluid flow path (e.g., offset relative to a channel or through-hole in the sleeve carrier, such as Fig.18 ), the fluid passing through the butt seal through hole 1620 flows only along the inner annular channel 1619 until it reaches the inlet and enters the casing carrier 900. In some embodiments, the symmetrical design of the butt seal 1600 also provides overflow for manufacturing and assembly, because the butt seal can be inserted into the seal housing in any radial orientation and any horizontal orientation. For example, the butt seal 1600 can be radially symmetrical about the axis A (such as Fig. 16B ), and due to the annular channel, the radial orientation of the through hole 1620 is irrelevant. In these cases, the docking seal 1600 can be inserted into any radial position and function equally. Additionally or alternatively, the docking seal 1600 can be symmetrical about a horizontal plane perpendicular to the axis A, also enabling the docking seal 1600 to be installed in either orientation (top up or bottom up) and function equally.

[0133] Although the butt seal and seal assembly are described herein as forming an outer annular channel, in some embodiments, the outer annular channel may be formed by the frame and / or a combination of the butt seal and frame.

[0134] As previously described, the seal housing 1502 and the docking seal 1600 together form a fluid-tight seal between the interior of the infusion set and the external environment. Fig.17As shown, the fluid inlet path is blocked by multiple sealing areas, including an annular sealing area 1800 between the lower radially inner sealing surface 1614b of the docking seal 1600 and the radially outer surface 912 of the sealing portion 930 of the cannula carrier 900, and an annular sealing area 1802 between the lower radially outer sealing surface 1612b of the docking seal 1600 and the lower flange 1804 of the lower frame portion 1506 of the seal housing 1502. These contact areas provide a reliable seal to prevent fluid from the surrounding environment from undesirably invading the interior space of the drug infusion device.

[0135] Although insert assembly 600 is shown and discussed in conjunction with seal assembly 1500, insert assembly 600 can be used with other seal assemblies having different components and configurations. Likewise, although seal assembly 1500 is shown and described in conjunction with insert assembly 600, seal assembly 1500 can be used with other insert assemblies having different components and configurations.

[0136] in conclusion

[0137] Although these devices and methods are described in the context of automatic cannula insertion and patch pumps, it should be understood that these technologies are equally applicable to a variety of medical devices (e.g., infusion ports) and a variety of at least partially implantable devices (e.g., sensors). It should also be noted here that this specification describes structures and methods that are particularly suitable for subcutaneous delivery of high-concentration insulins such as U-500 insulin (i.e., U-200 insulin and above) and lower-concentration insulins such as U-100 insulin. However, it should be understood that the present invention is applicable to a variety of infusion pumps and drugs. For example, the present invention is also applicable to medicaments, such as, for example, pain-masking drugs, chemotherapy and other cancer-related drugs, antibiotics, hormones, GLP-1, glucagon, various other drugs including macromolecules and proteins that may require high levels of delivery accuracy.

[0138] The description of the technical example is not intended to be exhaustive or to limit the technology to the precise form disclosed above. Where the context permits, singular terms or plural terms may also include plural terms or singular terms, respectively. Although the specific embodiments and examples of the present technology are described above for illustrative purposes, it should be recognized by those skilled in the relevant art that various equivalent modifications may be made within the scope of the present technology. For example, although the steps are presented in a given order, alternative examples may perform the steps in a different order. The various examples described herein may also be combined to provide additional examples.

[0139] As used herein, the terms "substantially," "substantially," "about" and similar terms are used as terms of approximation rather than terms of degree, and are intended to take into account the inherent variations in measured or calculated values ​​that those of ordinary skill in the art will recognize.

[0140] In addition, unless the word "or" is explicitly limited to a single item that only means to exclude other items when referring to a list with two or more items, the use of "or" in such a list should be interpreted as including (a) any single item in the list, (b) all items in the list, or (c) any combination of items in the list. Additionally, the term "comprising" is used throughout the text to mean at least including the described features, so that any greater number of the same features and / or other features of additional types are not excluded. It should also be understood that for the purpose of illustration, specific examples have been described herein, but various modifications can be made without departing from the present technology. In addition, although the advantages associated with these examples have been described in the context of certain examples, other examples may also present such advantages, and not all examples must present such advantages to fall within the scope of the present technology. Therefore, the present disclosure and associated technology may cover other examples that are not explicitly shown or described herein.

Claims

1. A drug infusion device, comprising: a reservoir assembly including a reservoir configured to retain a drug therein, the reservoir coupled to a reservoir outlet; Casing carrier; an infusion cannula extending downwardly away from the cannula carrier, the cannula defining a cannula lumen and configured to be inserted into the skin of a user; A sealing assembly, the sealing assembly comprising: an annular butt seal configured to engage the casing carrier such that the butt seal surrounds at least a portion of the casing carrier, the butt seal comprising: upper surface; lower surface; a radially inner surface extending between the upper surface and the lower surface, the radially inner surface being configured to abut the sleeve carrier; a radially outer surface extending between the upper surface and the lower surface; and a through hole defining a first fluid flow path between the radially inner surface and the radially outer surface, wherein the first fluid flow path is configured to be in fluid communication with the casing lumen when the butt seal engages the casing carrier; A sealing housing, the sealing housing circumferentially surrounding the docking seal, the sealing housing comprising: an upper frame portion including an upper flange configured to abut the upper surface of the butt seal; a lower frame portion including a lower flange configured to abut the lower surface of the butt seal; an annular side portion extending between the upper frame portion and the lower frame portion, the side portion being configured to abut at least a portion of the radially outer surface of the butt seal to define an annular channel between the side portion of the seal housing and the butt seal; and A second fluid flow path extends through the side portion and is configured to be fluidly coupled to the reservoir outlet, wherein the second fluid flow path is in fluid communication with the first fluid flow path defined by the through hole of the docking seal.

2. The drug infusion device according to claim 1, wherein: The annular butt seal extends circumferentially about a vertical axis, and wherein the annular butt seal is symmetrical about a horizontal plane orthogonal to the vertical axis.

3. The drug infusion device according to claim 1 or 2, wherein: Contact between the radially inner surface of the butt seal and the radially outer surface of the casing carrier defines a second annular channel in fluid communication with the first fluid flow path and the casing lumen.

4. The drug infusion device according to any one of claims 1 to 3, wherein: The butt seal comprises a variable sidewall thickness between the radially inner surface and the radially outer surface, the butt seal further comprising: a middle portion having a first sidewall thickness, wherein the through-hole extends through the middle portion between the radially inner surface and the radially outer surface; an upper widened portion disposed axially above the intermediate portion and having a second sidewall thickness greater than the first sidewall thickness, the upper widened portion defining an upper radially inner sealing surface and an upper radially outer sealing surface; and A lower widened portion is axially disposed below the intermediate portion and has a third sidewall thickness greater than the first sidewall thickness, the lower widened portion defining a lower radially inner sealing surface and a lower radially outer sealing surface.

5. The drug infusion device according to claim 4, wherein: The annular channel is defined by the space between the middle portion of the butt seal and the side portions of the seal housing.

6. The drug infusion device according to claim 4 or 5, wherein: A second annular channel is defined by the space between the middle portion of the butt seal and the side portions of the sleeve carrier.

7. The drug infusion device according to any one of claims 1 to 6, wherein: Contact between the upper flange and the upper surface of the butt seal creates a fluid-tight seal.

8. The drug infusion device according to any one of claims 1 to 7, wherein: Contact between the lower flange and the lower surface of the butt seal creates a fluid-tight seal.

9. The drug infusion device according to any one of claims 1 to 8, wherein: The cannula carrier includes a through hole in fluid communication with the cannula lumen and in fluid communication with the first fluid flow path.

10. The drug infusion device according to any one of claims 1 to 9, further comprising an insertion assembly configured to move the sleeve carrier between a disengaged configuration and an engaged configuration, wherein the sleeve carrier does not contact the docking seal and the docking seal surrounds at least a portion of the sleeve carrier in the engaged configuration.

11. The drug infusion device according to any one of claims 1 to 10, wherein: A lowermost surface of the butt seal abuts the lower flange.

12. A sealing assembly for a drug infusion device, the sealing assembly comprising: an annular butt seal including an upper surface, a lower surface, a radially inner surface, a radially outer surface, and a through hole extending between the radially outer surface and the radially inner surface, the through hole defining a first fluid flow path; and a seal housing at least partially surrounding the butt seal, the seal housing comprising: an upper flange configured to contact the upper surface of the butt seal; a lower flange configured to contact the lower surface of the docking seal; a side portion configured to contact at least a portion of the radially outer surface of the docking seal to define an annular channel between the side portion of the seal housing and the radially outer surface of the docking seal; and a second fluid flow path extending through the side portion so that the second fluid flow path is fluidly connected to the first fluid flow path.

13. The seal assembly of claim 12, wherein: The annular butt seal extends circumferentially about a vertical axis, and wherein the annular butt seal is symmetrical about a horizontal plane orthogonal to the vertical axis.

14. The sealing assembly according to claim 12 or 13, wherein: The butt seal comprises a variable sidewall thickness between the radially inner surface and the radially outer surface, the butt seal further comprising: a middle portion having a first sidewall thickness, wherein the through-hole extends through the middle portion between the radially inner surface and the radially outer surface; an upper widened portion disposed axially above the intermediate portion and having a second sidewall thickness greater than the first sidewall thickness, the upper widened portion defining an upper radially inner sealing surface and an upper radially outer sealing surface; and A lower widened portion is axially disposed below the intermediate portion and has a third sidewall thickness greater than the first sidewall thickness, the lower widened portion defining a lower radially inner sealing surface and a lower radially outer sealing surface.

15. The seal assembly of claim 14, wherein: The annular channel is defined by the space between the middle portion of the butt seal and the side portions of the seal housing.

16. The sealing assembly according to claim 14 or 15, wherein: Contact between the upper flange and the upper surface of the butt seal forms a fluid-tight seal, and wherein contact between the lower flange and the lower surface of the butt seal forms a fluid-tight seal.

17. A sealing assembly according to any one of claims 14 to 16, wherein: Contact between the upper flange and the upper surface of the butt seal forms a fluid-tight seal, and wherein contact between the lower flange and the lower surface of the butt seal forms a fluid-tight seal.

18. A sealing assembly according to any one of claims 14 to 17, wherein: A lowermost surface of the butt seal abuts the lower flange.

19. A docking seal for a drug infusion device, the docking seal comprising: an annular body having a sidewall defining a radially outer surface and a radially inner surface surrounding a central opening configured to receive a sleeve carrier therein, wherein the sidewall has a variable thickness such that the sidewall defines: a middle portion having a first sidewall thickness; an upper widened portion disposed axially above the intermediate portion and having a second sidewall thickness greater than the first sidewall thickness, the upper widened portion defining an upper radially inner sealing surface and an upper radially outer sealing surface; a lower widened portion disposed axially below the intermediate portion and having a third sidewall thickness greater than the first sidewall thickness, the lower widened portion defining a lower radially inner sealing surface and a lower radially outer sealing surface; and A through hole extends through the intermediate portion of the side wall between the radially inner surface and the radially outer surface.

20. A butt seal according to claim 19, wherein The annular body extends circumferentially around a vertical axis, and wherein the annular body is symmetrical about a horizontal plane orthogonal to the vertical axis.

21. The butt seal of claim 19, wherein: The upper radially inner sealing surface and the lower radially inner sealing surface each project radially inwardly relative to the intermediate portion.

22. The butt seal of claim 19, wherein: The upper radially outer sealing surface and the lower radially inner sealing surface each project radially outwardly relative to the intermediate portion.

23. A drug infusion device, comprising: a reservoir assembly including a reservoir configured to retain a drug therein, the reservoir coupled to a reservoir outlet; a casing carrying mechanism; an infusion cannula extending downwardly away from the cannula carrying mechanism, the cannula defining a cannula lumen and configured to be inserted into the skin of a user; A sealing assembly, the sealing assembly comprising: an annular butt seal configured to engage the cannula carrier mechanism such that the butt seal surrounds at least a portion of the cannula carrier mechanism, the butt seal comprising: upper surface; lower surface; a radially inner surface extending between the upper surface and the lower surface, the radially inner surface being configured to abut the cannula carrier mechanism; a radially outer surface extending between the upper surface and the lower surface; and a through hole defining a first fluid flow path between the radially inner surface and the radially outer surface, wherein the first fluid flow path is configured to be in fluid communication with the cannula lumen when the butt seal engages the cannula carrier mechanism; A sealing housing, the sealing housing circumferentially surrounding the docking seal, the sealing housing comprising: an upper frame portion including an upper flange configured to abut the upper surface of the butt seal; a lower frame portion including a lower flange configured to abut the lower surface of the butt seal; an annular side portion extending between the upper frame portion and the lower frame portion, the side portion being configured to abut at least a portion of the radially outer surface of the butt seal to define an annular channel between the side portion of the seal housing and the butt seal; and A second fluid flow path extends through the side portion and is configured to be fluidly coupled to the reservoir outlet, wherein the second fluid flow path is in fluid communication with the first fluid flow path defined by the through hole of the docking seal.

24. The drug infusion device according to claim 23, wherein: The annular butt seal extends circumferentially about a vertical axis, and wherein the annular butt seal is symmetrical about a horizontal plane orthogonal to the vertical axis.

25. The drug infusion device according to claim 23 or 24, wherein: Contact between the radially inner surface of the butt seal and the radially outer surface of the sleeve carrier defines a second annular channel in fluid communication with the first fluid flow path and the sleeve lumen.

26. A drug infusion device according to any one of claims 23 to 25, wherein: The butt seal comprises a variable sidewall thickness between the radially inner surface and the radially outer surface, the butt seal further comprising: a middle portion having a first sidewall thickness, wherein the through-hole extends through the middle portion between the radially inner surface and the radially outer surface; an upper widened portion disposed axially above the intermediate portion and having a second sidewall thickness greater than the first sidewall thickness, the upper widened portion defining an upper radially inner sealing surface and an upper radially outer sealing surface; and A lower widened portion is axially disposed below the intermediate portion and has a third sidewall thickness greater than the first sidewall thickness, the lower widened portion defining a lower radially inner sealing surface and a lower radially outer sealing surface.

27. The drug infusion device of claim 26, wherein: The annular channel is defined by the space between the middle portion of the butt seal and the side portions of the seal housing.

28. A drug infusion device according to claim 26 or claim 27, wherein: A second annular channel is defined by the space between the middle portion of the butt seal and the side portions of the sleeve carrier mechanism.

29. A drug infusion device according to any one of claims 23 to 28, wherein: Contact between the upper flange and the upper surface of the butt seal creates a fluid-tight seal.

30. The drug infusion device according to any one of claims 23 to 29, wherein: Contact between the lower flange and the lower surface of the butt seal creates a fluid-tight seal.

31. A drug infusion device according to any one of claims 23 to 30, wherein: The cannula carrying mechanism includes a through hole in fluid communication with the cannula lumen and in fluid communication with the first fluid flow path.

32. The drug infusion device according to any one of claims 23 to 31, further comprising an insertion assembly configured to move the sleeve carrying mechanism between a disengaged configuration and an engaged configuration, wherein the sleeve carrying mechanism does not contact the docking seal and wherein the docking seal surrounds at least a portion of the sleeve carrying mechanism.

33. A drug infusion device according to any one of claims 23 to 32, wherein: A lowermost surface of the butt seal abuts the lower flange.

34. A sealing assembly for a drug infusion device, the sealing assembly comprising: an annular butt seal including an upper surface, a lower surface, a radially inner surface, a radially outer surface, and a through hole extending between the radially outer surface and the radially inner surface, the through hole defining a first fluid flow path; and a seal housing at least partially surrounding the butt seal, the seal housing comprising: an upper flange configured to contact the upper surface of the butt seal; a lower flange configured to contact the lower surface of the docking seal; a side portion configured to contact at least a portion of the radially outer surface of the docking seal to define an annular channel between the side portion of the seal housing and the radially outer surface of the docking seal; and a second fluid flow path extending through the side portion so that the second fluid flow path is fluidly connected to the first fluid flow path.

35. The seal assembly of claim 34, wherein: The annular butt seal extends circumferentially about a vertical axis, and wherein the annular butt seal is symmetrical about a horizontal plane orthogonal to the vertical axis.

36. A sealing assembly according to claim 34 or 35, wherein: The butt seal comprises a variable sidewall thickness between the radially inner surface and the radially outer surface, the butt seal further comprising: a middle portion having a first sidewall thickness, wherein the through-hole extends through the middle portion between the radially inner surface and the radially outer surface; an upper widened portion disposed axially above the intermediate portion and having a second sidewall thickness greater than the first sidewall thickness, the upper widened portion defining an upper radially inner sealing surface and an upper radially outer sealing surface; and A lower widened portion is axially disposed below the intermediate portion and has a third sidewall thickness greater than the first sidewall thickness, the lower widened portion defining a lower radially inner sealing surface and a lower radially outer sealing surface.

37. The seal assembly of claim 36, wherein: The annular channel is defined by the space between the middle portion of the butt seal and the side portions of the seal housing.

38. A sealing assembly according to claim 36 or 37, wherein: Contact between the upper flange and the upper surface of the butt seal forms a fluid-tight seal, and wherein contact between the lower flange and the lower surface of the butt seal forms a fluid-tight seal.

39. A sealing assembly according to any one of claims 36 to 38, wherein: Contact between the upper flange and the upper surface of the butt seal forms a fluid-tight seal, and wherein contact between the lower flange and the lower surface of the butt seal forms a fluid-tight seal.

40. A sealing assembly according to any one of claims 36 to 39, wherein: A lowermost surface of the butt seal abuts the lower flange.

41. A docking seal for a drug infusion device, the docking seal comprising: an annular body having a sidewall defining a radially outer surface and a radially inner surface surrounding a central opening configured to receive the cannula carrier mechanism therein wherein, wherein the sidewall has a variable thickness such that the sidewall defines: a middle portion having a first sidewall thickness; an upper widened portion disposed axially above the intermediate portion and having a second sidewall thickness greater than the first sidewall thickness, the upper widened portion defining an upper radially inner sealing surface and an upper radially outer sealing surface; a lower widened portion disposed axially below the intermediate portion and having a third sidewall thickness greater than the first sidewall thickness, the lower widened portion defining a lower radially inner sealing surface and a lower radially outer sealing surface; and A through hole extends through the intermediate portion of the side wall between the radially inner surface and the radially outer surface.

42. A butt seal according to claim 41, wherein The annular body extends circumferentially around a vertical axis, and wherein the annular body is symmetrical about a horizontal plane orthogonal to the vertical axis.

43. A butt seal according to claim 41, wherein: The upper radially inner sealing surface and the lower radially inner sealing surface each project radially inwardly relative to the intermediate portion.

44. A butt seal according to claim 41, wherein: The upper radially outer sealing surface and the lower radially inner sealing surface each project radially outwardly relative to the intermediate portion.

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