Devices used in respiratory support systems

The connector design for medical breathing circuits ensures a secure and releasable connection by using an inner and outer body with distinct stiffness materials and mechanisms, enhancing therapy delivery certainty and ease of disconnection.

JP7737895B2Active Publication Date: 2025-09-11FISHER & PAYKEL HEALTHCARE LTD
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Patent Information

Application Number
JP2021507849
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2018-08-13
Filing Date
2019-08-13
Publication Date
2025-09-11
Estimated Expiration
2039-08-13

AI Technical Summary

Technical Problem

Existing connectors for medical breathing circuits lack a balance between being releasable and providing a secure connection, which can compromise the certainty of respiratory therapy delivery.

Method used

A connector design featuring an inner and outer body with a retention mechanism, sealing mechanism, and lever actuation, utilizing materials with different stiffnesses to ensure a secure and releasable connection.

Benefits of technology

The design provides a secure and reliable connection that maintains the integrity of respiratory therapy delivery, allowing easy disconnection while withstanding significant separation forces.

✦ Generated by Eureka AI based on patent content.

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Patent Text Reader

Abstract

The present invention relates to a connector for a medical breathing circuit component. The connector includes an inner body and an outer body, the inner body having a retention mechanism configured to engage with another connector, and the outer body configured to at least partially surround the inner body, the outer body having a tube engagement mechanism.
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Description

[Technical Field]

[0001] The present disclosure relates generally to a connector provided at the distal end of a conduit, and more particularly to a releasable but secure connector provided at the distal end of a medical breathing conduit forming part of a medical breathing circuit for releasably but securely connecting the end of the circuit to another device in the circuit (e.g., a humidifier or flow generator or another conduit). [Background technology]

[0002] An alternative form of connector at the end of a conduit, such as a medical breathing conduit, for connecting with a device forming part of a breathing circuit, such as a medical breathing circuit, is desirable.

[0003] In particular, providing such a connector that is releasable yet provides a secure connection promotes certain advantages, such as a secure connection between the end of a conduit and a device (a flow generator such as a humidifier or blower) or between two conduits, providing the operator or user (and patient) with certainty of the delivery of the desired or intended respiratory therapy. Summary of the Invention [Problem to be solved by the invention]

[0004] It is an object of some embodiments disclosed herein to provide a connector for use in a medical breathing circuit or respiratory assistance system that promotes at least some improvement over the above, or at least provides a useful choice for the public or medical professionals. [Means for solving the problem]

[0005] In a first aspect, a connector for a medical breathing circuit component is provided, the connector including an inner body and an outer body that are separate components, the inner body having a retention mechanism configured to engage with another connector, and the outer body configured to at least partially surround the inner body, the outer body having a tube engagement mechanism.

[0006] In one embodiment, the inner body further includes a sealing mechanism configured to provide a seal between the inner body and the other connector.

[0007] In one embodiment, at least a portion of the inner body comprises a first material and at least a portion of the outer body comprises a second material.

[0008] In one embodiment, the first material is stiffer than the second material.

[0009] In one embodiment, the retention feature of the inner body includes a flex region comprising a first material.

[0010] In one embodiment, the retention mechanism includes a lever that is movable relative to the body about a flex region.

[0011] In one embodiment, the lever has a retaining portion on one side of the flex region and an actuating portion on the other side of the flex region.

[0012] In one embodiment, the lever has a retention portion in one portion of the flex region and an actuation portion in another portion of the flex region.

[0013] In one embodiment, the retaining portion of the or each lever comprises the first material.

[0014] In one embodiment, the actuating portion of the or each lever comprises the first material.

[0015] In one embodiment, the entire retention feature comprises the first material.

[0016] In one embodiment, the retention mechanism includes two levers.

[0017] In one embodiment, the distance between the retaining portions of the two levers in the disengaged configuration is the same as or smaller than the distance in the engaged configuration.

[0018] In one embodiment, the distance between the retaining portions of the two levers in the engaged configuration is the same as that distance in the disengaged configuration.

[0019] In one embodiment, the outer body has a cutout that allows a portion of the inner body to be located within the outer body and a portion of the inner body to be located outside the outer body.

[0020] In one embodiment, a portion of the inner body located outside the outer body is a retention feature.

[0021] In one embodiment, the bending region is provided by a bridge.

[0022] In one embodiment, the bridge has features that align the bridge with the outer body.

[0023] In one embodiment, the feature is an alignment boss.

[0024] In one embodiment, the bridge is disposed between the actuation portion and the retention portion.

[0025] In one embodiment, the bridge includes a reinforcing feature.

[0026] In one embodiment, the reinforcing feature includes a step at the intersection between the working portion and the bridge.

[0027] In one embodiment, the reinforcing feature includes two steps extending towards each other from opposite sides of the lever towards the central plane of the bridge.

[0028] In one embodiment, the reinforcing feature comprises a thickened portion of the bridge.

[0029] In one embodiment, a thickened portion is provided at the intersection of the working portion and the bridge.

[0030] In one embodiment, the actuation portion includes ribs that limit flexion of the actuation portion.

[0031] In one embodiment, the entire inner body comprises the first material.

[0032] In one embodiment, the first material has a higher Young's modulus than the second material.

[0033] In one embodiment, the second material comprises a polyolefin.

[0034] In one embodiment, the second material comprises polypropylene.

[0035] In one embodiment, the first material comprises polyoxymethylene.

[0036] In one embodiment, the lumens of the inner body and the outer body are substantially aligned.

[0037] In one embodiment, the lumen of the inner body and the lumen of the outer body are coaxial.

[0038] In one embodiment, the connector further includes an inner body and outer body sealing mechanism configured to seal the inner body and outer body together, and an inner body and outer body retention mechanism configured to hold the inner body and outer body together, wherein the inner body and outer body sealing mechanism and the inner body and outer body retention mechanism are separate mechanisms.

[0039] In one embodiment, the inner body and outer body sealing mechanism is further configured to hold the inner body and outer body together.

[0040] In one embodiment, the inner body and outer body sealing features include protrusions. Optionally, the sealing features are annular sealing protrusions.

[0041] In one embodiment, the inner body and outer body sealing features include complementary recesses.

[0042] In one embodiment, the inner body includes a protrusion and the outer body includes a recess, hi one embodiment, the annular sealing protrusion includes an angled cross-sectional profile.

[0043] In one embodiment, an annular sealing projection is provided on the outer surface of the inner body and is configured to be in an interference fit with the inner surface of the outer body.

[0044] In one embodiment, the inner body and outer body retention features include protrusions, preferably barbs.

[0045] In one embodiment, the inner body and outer body retention features include complementary recesses or apertures.

[0046] In one embodiment, the complementary recess or aperture is defined by one or more walls, and the or each barb is positioned within the complementary recess or aperture without abutting the one or more walls.

[0047] In one embodiment, the inner body and outer body retention mechanism protrusions are annular protrusions and annular retention protrusions.

[0048] In one embodiment, the protrusion includes an angled cross-sectional profile.

[0049] In one embodiment, the annular retention projection has a rounded cross-sectional profile.

[0050] In one embodiment, the protrusion is configured to be an interference fit with the inner surface of the outer body.

[0051] In one embodiment, the complementary recess or aperture is an annular recess or aperture.

[0052] In one embodiment, the inner body and outer body retention feature projections include complementary recesses or apertures, which are annular recesses, apertures or recesses.

[0053] In one embodiment, the annular sealing projection and the annular retention projection have different diameters.

[0054] In one embodiment, the annular sealing projection and the annular retention projection have different cross-sectional profiles.

[0055] In one embodiment, the annular retention projection has a rounded cross-sectional profile.

[0056] In one embodiment, the annular retention projection has an angled cross-sectional profile.

[0057] In one embodiment, the inner body and outer body sealing mechanism comprises an interference fit between a tapered wall of the inner body and a complementary tapered wall of the outer body.

[0058] In one embodiment, the distal end of the inner body extends beyond the end of the outer body.

[0059] In one embodiment, the distal end has a larger diameter than the remainder of the inner body.

[0060] In one embodiment, the inner body includes a wall that tapers outwardly toward the distal end.

[0061] In one embodiment, the diameter of the inner wall of the inner body at the distal end is greater than the diameter of the remainder of the inner wall.

[0062] In one embodiment, the inner wall of the distal end forms a smooth and / or continuous contour with the inner wall of the inner body.

[0063] In one embodiment, the inner body is provided as a separate component independent of the tube or without tube connection features.

[0064] In one embodiment, the outer body is provided with tube connection features and the inner body is free of tube connection features.

[0065] In one embodiment, the inner body does not include a tube connection feature.

[0066] In one embodiment, the outer body includes tube connection features, and when the inner and outer body assembly is made, the assembly is connected to tubing solely via the tube connection features of the outer body.

[0067] According to another aspect, there is provided a combination of a connector as described above with a second connector and a tube, wherein the second connector has an internal passage, the inner body is at least partially located within the internal passage of the second connector, and the retention mechanism engages with the second connector and the tube engagement mechanism engages with the tube.

[0068] In one embodiment, the second connector has one or more recesses, and the retention feature engages the one or more recesses.

[0069] In one embodiment, a combination with a second connector is provided, the second connector having an internal passageway, and the inner body is at least partially positioned within the internal passageway of the second connector such that the sealing feature substantially seals with the internal passageway and the retention feature engages with the exterior of the second connector.

[0070] In one embodiment, a combination with a second connector is provided, the second connector having an internal passageway, and the inner body is at least partially positioned within the internal passageway of the second connector such that when the connector is connected with the second connector and the tube, the sealing mechanism substantially seals with the internal passageway and the retention mechanism engages with the exterior of the second connector.

[0071] A connector for a component of a medical breathing circuit, the connector including: a body defining a gas path, the body having a retention mechanism with an actuation feature that is manually operable; and a flexible elastomeric cover configured to extend over the actuation feature while allowing the actuation feature to be manually actuated.

[0072] A connector for a component of a medical breathing circuit, the connector including: a body defining a gas path, the body having a retention mechanism with an actuation feature that is manually operable; and a flexible elastomeric cover configured to extend over the actuation feature and including at least one thickened portion and at least one thinned portion, the flexible elastomeric cover enabling the actuation feature to be manually actuated.

[0073] In one embodiment, the retention mechanism is a lever that is movable relative to the body about a bend or pivot.

[0074] In one embodiment, the lever has a retaining portion on one side of the bend or pivot and an actuation portion on the other side of the bend or pivot.

[0075] In one embodiment, the elastomeric cover has a thickened portion corresponding to the actuation portion.

[0076] In one embodiment, the thickened portion is shaped to follow the outer shape of the working portion.

[0077] In one embodiment, the thickened portion has an exterior surface feature.

[0078] In one embodiment, the elastomeric cover has a thinned portion connecting the thickened portion to the remainder of the elastomeric cover.

[0079] In one embodiment, the elastomeric cover has a base with a thickened shoulder.

[0080] In one embodiment, the elastomeric cover has a thickened shoulder adjacent the retention portion.

[0081] In one embodiment, the elastomeric cover is friction-fit or interference-fit with the body.

[0082] In one embodiment, the body is formed from a hard plastic.

[0083] In one embodiment, the elastomeric cover includes a shape that substantially conforms to the outer shape of the body.

[0084] In one embodiment, the elastomeric cover is keyed to the body.

[0085] In one embodiment, the elastomeric cover has a recess that engages a complementary flange on the body.

[0086] In one embodiment, the body has one or more ribs that support the cover.

[0087] In one embodiment, the connector further includes at least one electrical contact.

[0088] In one embodiment, the body comprises a material that provides a hermetic seal around the electrical connection.

[0089] In one embodiment, the material has ribs that support the cover.

[0090] According to another aspect, there is provided a combination of a connector as described above and a second connector, wherein the retention mechanism engages the second connector.

[0091] According to another aspect, there is provided a combination of a connector as described above and a second connector, wherein the retention mechanism engages with the second connector when the connector is connected with the second connector and the tube.

[0092] In one embodiment, the second connector has one or more recesses, and the retention feature engages the one or more recesses.

[0093] In one embodiment, the combination further includes a tube, the connector includes a tube engaging mechanism, and the tube engaging mechanism engages with the tube.

[0094] According to another aspect, a connector for a medical breathing circuit component is provided, the connector including a body defining a gas path and having an outwardly extending protrusion, and a sealing member positioned between the outwardly extending protrusion and a distal end of the body.

[0095] In one embodiment, the sealing member is positioned a distance from the distal end.

[0096] In one embodiment, the gas path is defined by an inner wall that tapers outwardly toward the distal end.

[0097] In one embodiment, the body has an outer wall that tapers outwardly toward the distal end.

[0098] In one embodiment, the diameter of the inner and / or outer wall of the distal end is greater than the diameter of the remainder of the body.

[0099] In one embodiment, the body has an assembly guide extending from the distal end toward the sealing member.

[0100] In one embodiment, the body has a shoulder between the sealing member and the distal end.

[0101] In one embodiment, the protrusions extend in a direction that is generally parallel to the longitudinal axis of the body.

[0102] In one embodiment, the body includes a plurality of outwardly extending protrusions.

[0103] In one embodiment, one or more of the plurality of outwardly extending protrusions have angled or tapered ends that act as alignment guides.

[0104] According to another aspect, a connector for a medical breathing circuit component is provided, the connector being configured to connect to a second connector having an internal passageway, the connector including a body configured to be at least partially positioned within the internal passageway of the second connector, the body having a sealing mechanism that seals with the internal passageway, and a retention mechanism that engages with an exterior of the second connector.

[0105] According to another aspect, a connector for a medical breathing circuit component is provided, the connector configured to connect to a second connector having an internal passageway, the connector including a gas flow path and a body configured to be at least partially within the internal passageway of the second connector, the body having a sealing mechanism that seals with the internal passageway, and a retention mechanism that engages an exterior of the second connector, the retention mechanism including a lever movable relative to the body about a bending region, the lever having a retention portion on one side of the bending region and an actuation portion on the other side of the bending region.

[0106] In one embodiment, the sealing mechanism includes a sealing member.

[0107] In one embodiment, the sealing member is or includes a wiper seal.

[0108] In one embodiment, the sealing member is or includes an O-ring.

[0109] In one embodiment, the body has a recess for receiving the sealing member.

[0110] In one embodiment, the sealing member has an outer resting diameter that is greater than the inner diameter of the internal passage that it seals.

[0111] In one embodiment, the retention mechanism includes a lever that is movable relative to the body about a flex region.

[0112] In one embodiment, the lever has a retaining portion on one side of the flex region and an actuating portion on the other side of the flex region.

[0113] In one embodiment, the retaining portion includes a protrusion extending toward the center of the connector.

[0114] In one embodiment, the protrusions are angled relative to a central axis extending through the center of the connector.

[0115] In one embodiment, the protrusions are angled at about 85° to about 115°, more preferably about 90° to about 110°, even more preferably about 93° to about 102°, and most preferably about 95° to about 99°.

[0116] In one embodiment, the bending region is provided by a bridge.

[0117] In one embodiment, the retention mechanism includes two levers.

[0118] In one embodiment, movement of the actuation portion toward the center of the connector causes movement of the retention mechanism, which moves away from the center of the connector.

[0119] In one embodiment, the distance between the retaining portions of the two levers in the disengaged configuration is the same as or smaller than the distance in the engaged configuration.

[0120] In one embodiment, the distance between the retaining portions of the two levers in the disengaged configuration is the same as that distance in the engaged configuration.

[0121] In one embodiment, the body is an inner body and the connector further includes an outer body, the outer body having a cutout that allows a portion of the inner body to be located within the outer body and a portion of the inner body to be located outside the outer body.

[0122] In one embodiment, the body is an inner body and the connector further comprises an outer body.

[0123] In one embodiment, a portion of the inner body is located inside the outer body and the retention feature is located outside the outer body.

[0124] In one embodiment, the bridge has features that align the bridge with the cutout.

[0125] In one embodiment, the feature is an alignment boss.

[0126] In one embodiment, the body is an inner body, and the connector further includes an outer body, an inner body and outer body sealing mechanism configured to seal the inner body and outer body together, and an inner body and outer body retention mechanism configured to hold the inner body and outer body together, wherein the inner body and outer body sealing mechanism and the retention mechanism are separate mechanisms.

[0127] In one embodiment, the inner body and outer body sealing mechanism is further configured to hold the inner body and outer body together.

[0128] In one embodiment, the inner body and outer body sealing features include protrusions. Optionally, the sealing features are annular sealing protrusions.

[0129] In one embodiment, the inner body and outer body sealing features include complementary recesses.

[0130] In one embodiment, the inner body includes a protrusion and the outer body includes a recess.

[0131] In one embodiment, the annular sealing projection includes an angled cross-sectional profile.

[0132] In one embodiment, an annular sealing projection is provided on the outer surface of the inner body and is configured to be in an interference fit with the inner surface of the outer body.

[0133] In one embodiment, the inner body and outer body retention features include protrusions, preferably barbs.

[0134] In one embodiment, the inner body and outer body retention features include complementary recesses or apertures.

[0135] In one embodiment, the complementary recess or aperture is defined by one or more walls, and the or each barb is positioned within the complementary recess or aperture without abutting the one or more walls.

[0136] In one embodiment, the inner body and outer body retention mechanism protrusions are annular protrusions.

[0137] In one embodiment, the complementary recess or aperture is an annular recess or aperture.

[0138] In one embodiment, the annular sealing projection and the annular retention projection have different diameters.

[0139] In one embodiment, the annular sealing projection and the annular retention projection have different cross-sectional profiles.

[0140] In one embodiment, the annular retention projection has a rounded cross-sectional profile.

[0141] In one embodiment, the annular retention projection has an angled cross-sectional profile.

[0142] In one embodiment, the inner body and outer body sealing mechanism comprises an interference fit between a tapered wall of the inner body and a complementary tapered wall of the outer body.

[0143] In one embodiment, the distal end of the inner body extends beyond the end of the outer body.

[0144] In one embodiment, the inner body has a tapered outer surface with the distal end having a wider diameter than the remainder of the inner body.

[0145] In another aspect, there is provided a combination of a connector as described above with a second connector, the second connector having an internal passageway, the inner body being at least partially positioned within the internal passageway of the second connector such that the sealing feature substantially seals with the internal passageway and the retention feature engages with an exterior of the second connector and the retention feature engages with the second connector.

[0146] In one embodiment, the second connector has one or more recesses, and the retention feature engages the one or more recesses.

[0147] In one embodiment, once connected, the connector can withstand a separation force of about 30 N or greater.

[0148] In one embodiment, once connected, the connector can withstand a separation force of about 50 N or greater.

[0149] In another aspect, a connector for a medical breathing circuit component is provided, the connector including a tube connection portion that engages with a tube, the tube connection portion defining a gas pathway, and the tube connection portion having first and second protrusions that enter into a helical pathway.

[0150] In one embodiment, the helical path has a first edge, a second edge, and a width between the first and second edges, and the first protrusion is positioned at the first edge of the path.

[0151] In one embodiment, the second projection is positioned at a first edge of the path.

[0152] In one embodiment, the second projection is positioned at a second edge of the path.

[0153] In one embodiment, the second projection is positioned between the first edge of the path and the second edge of the path.

[0154] In one embodiment, the connector has electrical contacts that make electrical connection with the wires in the tube.

[0155] In one embodiment, the electrical contacts are configured to make an electrical connection with the device.

[0156] In one embodiment, the connector has alignment features that guide the wires within the tubes toward the electrical contacts.

[0157] In one embodiment, the alignment features allow for lateral guidance of the wire to the electrical contact when the tube is threaded onto the collar.

[0158] In one embodiment, the connector has guides that direct the wires to the alignment features.

[0159] In one embodiment, the connector further comprises an intermediate shell that surrounds and seals the electrical contacts. Optionally, the intermediate shell comprises an overmolded portion.

[0160] In one embodiment, the material of the outer body is the same as or compatible with the material of the intermediate shell.

[0161] In one embodiment, the connector has a raised wall for the mid-shell that seals the pin insert and wires.

[0162] In one embodiment, the connector has a retention means for retaining the electrical contacts against the alignment features.

[0163] In one embodiment, the connector has an electrical contact compartment with an inner wall that is outwardly tapered.

[0164] In one embodiment, the electrical contact comprises an electrical contact assembly including an overmolded portion provided over the electrical contact.

[0165] In one embodiment, the electrical contact assembly includes an alignment feature that includes a protrusion configured to engage a slot in the connector.

[0166] In one embodiment, the alignment feature includes a shoulder that engages a recess in the connector.

[0167] According to another aspect, there is provided a respiratory assistance system including a flow generator, a housing having a screen and an outlet disposed on an upper surface of the housing, a tube, and a connector that releasably connects the tube to the outlet, the connector including a body and a tube connection portion that engages with the tube, the body and the tube connection portion defining a gas path, the tube, and the tube connection portion extending at an angle that is greater than about 0° and less than about 90° from a longitudinal axis of the body.

[0168] In one embodiment, the angle is greater than about 5° and less than about 60°.

[0169] In one embodiment, the angle is greater than about 10° and less than about 40°.

[0170] In one embodiment, the angle is greater than about 15° and less than about 20°.

[0171] In one embodiment, the connector has electrical contacts that electrically connect with wires in the tube, and the tube connection portion extends at an angle greater than about 0° and less than about 90° from the longitudinal axis of the electrical contacts.

[0172] In one embodiment, the tube connection portion is axially aligned with the end of the tube.

[0173] According to another aspect, there is provided a combination of a tube and a connector as described above.

[0174] In one embodiment, the material of the outer body is the same as or compatible with the material of the tube.

[0175] According to another aspect, a connector for a medical breathing circuit component is provided, the connector including an inner body and an outer body, an inner body and outer body sealing mechanism configured to seal the inner body and outer body together, and an inner body and outer body retention mechanism configured to hold the inner body and outer body together, the sealing mechanism and the retention mechanism being separate mechanisms.

[0176] In one embodiment, the inner body and outer body sealing mechanism is further configured to hold the inner body and outer body together.

[0177] In one embodiment, the inner body and outer body sealing features include protrusions. Optionally, the sealing features are annular sealing protrusions. The inner body and outer body sealing features may include complementary recesses. In one embodiment, the inner body includes the protrusions and the outer body includes the recesses.

[0178] In one embodiment, the annular sealing projection includes an angled cross-sectional profile.

[0179] In one embodiment, an annular sealing projection is provided on the outer surface of the inner body and is configured to be in an interference fit with the inner surface of the outer body.

[0180] In an alternative embodiment, the inner body includes a recess and the outer body includes a protrusion.

[0181] In one embodiment, the retention feature comprises a protrusion, preferably a barb. The retention feature may comprise a complementary recess or aperture. The retention feature may comprise two or more barbs. The retention feature may comprise a complementary recess or aperture.

[0182] In one embodiment, the complementary recess or aperture is defined by one or more walls, and the or each barb is positioned within the complementary recess or aperture without abutting the one or more walls.

[0183] In one embodiment, the retention feature protrusion is an annular protrusion, and the complementary recess or aperture is an annular recess or aperture.

[0184] In one embodiment, the annular sealing projection and the annular retention projection have different diameters.

[0185] In one embodiment, the annular sealing projection and the annular retention projection have different cross-sectional profiles.

[0186] In one embodiment, the annular retention protrusion has a rounded cross-sectional profile. In another embodiment, the annular retention protrusion has an angled cross-sectional profile.

[0187] In one embodiment, the inner body and outer body sealing mechanism comprises an interference fit between a tapered wall of the inner body and a complementary tapered wall of the outer body.

[0188] In one embodiment, the distal end of the inner body extends beyond the end of the outer body.

[0189] In one embodiment, the inner body has a tapered outer surface with the distal end having a wider outer diameter than the remainder of the inner body.

[0190] Certain embodiments and variations thereof will become apparent to those skilled in the art from the detailed description herein, which refers to the following figures. [Brief explanation of the drawings]

[0191] [Figure 1A] 1 shows in schematic form a respiratory assistance device in the form of a flow therapy device; [Figure 1B] FIG. 2 is a perspective view of a connector including a cover. [Figure 2] 2 is a perspective view showing the components of the connector of FIG. 1 with the cover and intermediate shell removed. [Figure 3] 3 is another perspective view of the components of the connector of FIG. 2. [Figure 4] FIG. 3 is a bottom perspective view of the components of the connector of FIG. 2. [Figure 5] 3 is another perspective view from below of the components of the connector of FIG. 2. [Figure 6A-D] FIG. 2 is a perspective view of a cover of the connector. [Figure 7] FIG. 3 is a perspective view of the inner body of the connector of FIG. 2. [Figure 8] FIG. 8 is a bottom perspective view of the inner body of FIG. 7 with a sealing member as is described herein. [Figure 9] FIG. 8 is another perspective view of the inner body of FIG. 7. [Figure 10] FIG. 8 is a front view of the inner body of FIG. 7. [Figure 11] FIG. 8 is a side view of the inner body of FIG. 7. [Figure 12] FIG. 8 is a bottom view of the inner body of FIG. 7. [Figure 13] FIG. 8 is a top view of the inner body of FIG. 7. [Figure 14] FIG. 3 is a perspective view of the outer body of the connector of FIG. 2. [Figure 15] FIG. 15 is a bottom perspective view of the outer body of FIG. 14. [Figure 16] FIG. 15 is a front view of the outer body of FIG. 14. [Figure 17] FIG. 15 is a rear view of the outer body of FIG. 14. [Figure 18] FIG. 15 is a side view of the outer body of FIG. 14. [Figure 19] FIG. 15 is a top view of the outer body of FIG. 14. [Figure 20] FIG. 15 is a bottom view of the outer body of FIG. 14. [Figure 21] FIG. 2 is a partial view of a tube connection portion and a tube. [Figure 22]1 shows a cross-sectional view of an inner body and a second connector of a connector as is described herein, also showing a sealing member of the inner body of the connector. [Figure 22A] 1A and 1B show cross-sectional views of an alternative embodiment of an inner body of a connector and a second connector embodiment as is described herein, and also show a sealing member of the inner body of the connector. [Figure 23] 1 shows an alternative retention mechanism. [Figure 24A-D] 10 illustrates variations of the sealing and retention features between the inner and outer bodies. [Figure 25] 1 shows an electrical subassembly. [Figure 26] FIG. 1C is a perspective view showing the components of the connector of FIG. 1B with the cover removed. [Figure 27] 1 shows a flow therapy device. [Figure 28] 10A-10C show side views of alternative inner body embodiments. [Figure 29] 10A-10C show side views of alternative inner body embodiments. [Figure 29A] 10A and 10B show perspective views of alternative inner body embodiments. [Figure 29B] 10A-10C show front views of alternative inner body embodiments. [Figure 29C] 10A-10C show side views of alternative inner body embodiments. [Figure 29D] 10A-10C illustrate side views of alternative inner body embodiment examples. [Figure 29E] 10A-10C show perspective views of alternative inner body example embodiments. [Figure 29F] 10A-10C illustrate side views of alternative inner body embodiment examples. [Figure 29G] 10A-10C show perspective views of alternative inner body example embodiments. [Figure 30] 1 illustrates a perspective view of an alternative embodiment of an outer body of a connector as is described herein. [Figure 31] 1 illustrates a perspective view of an alternative embodiment of an outer body of a connector as is described herein. [Figure 31A] 1 illustrates a perspective view of an alternative embodiment of an outer body of a connector as is described herein. [Figure 31B] 2A shows a bottom view of an alternative embodiment of an outer body of a connector as described herein, also showing a cover (such as the cover shown in FIG. 1B) and an electrical subassembly (such as the electrical subassembly shown in FIGS. 2 and 25). [Figure 31C] 10A-10C illustrate front and rear views of an alternative embodiment of an outer body of a connector as is described herein, also showing a conduit and electrical subassembly. [Figure 31D] 10A-10C illustrate side views of an alternative embodiment of an outer body of a connector as is described herein, also showing a conduit and electrical subassembly. [Figure 31E] 1 shows a perspective view of an alternative embodiment of an outer body of a connector as is described herein, also showing a conduit and electrical subassembly. DETAILED DESCRIPTION OF THE INVENTION

[0192] A flow therapy device 10 is shown in FIG. 1. Generally, device 10 includes a main housing 1000 that houses a flow generator 11 in the form of a motor / impeller arrangement, an optional humidifier 12, a controller 13, and a user I / O interface 14 (including, e.g., a display and input devices such as buttons, a touchscreen, etc.). Controller 13 is configured or programmed to control the components of the device, such as operating flow generator 11 to generate a flow of gas (gas stream) for delivery to a patient, operating humidifier 12 (if present) to humidify and / or heat the generated gas stream, receiving user input from user I / O interface 14 for reconfiguration and / or user-defined operation of device 10, and outputting information to a user (e.g., on a display). The user may be a patient, a healthcare professional, or another person interested in using the device.

[0193] The patient breathing conduit 300 is coupled to a gas outlet 344 in the housing 1000 of the flow therapy device 10 and is coupled to a patient interface 17, such as a nasal cannula, including a manifold 19 and nasal prongs 18. Additionally or alternatively, the patient breathing conduit 300The patient breathing conduit may be coupled to a face mask. Additionally or alternatively, the patient breathing conduit may be coupled to a nasal pillow mask, and / or a nasal mask, and / or a tracheostomy interface, or any other suitable type of patient interface. The gas flow, which may be humidified, generated by the flow therapy device 10 is coupled to the patient breathing conduit. 300 The patient is delivered through the cannula 17 via the patient breathing conduit. 300 is a heater wire that heats the gas flow that passes toward the patient. 300 It can have a heater wire 300 a is controlled by the controller 13. Patient breathing conduit 300 and / or the patient interface 17 may be part of the flow therapy device 10 or alternatively may be considered a peripheral device thereof. 300 and patient interface 17 together form a flow therapy system.

[0194] The overall operation of the flow therapy respiratory device 10 will be known to those skilled in the art and need not be described in detail herein. However, in general, the controller 13 controls the flow generator 11 to generate a gas flow at a desired rate, controls one or more valves to control the mixture of air and oxygen or other alternative gases, and controls the humidifier 12, if present, to humidify and / or heat the gas flow to an appropriate level. The gas flow is then passed through a patient respiratory conduit. 300 and directed to the patient through cannula 17. Controller 13 controls the heating element of humidifier 12 and / or the patient breathing conduit to heat the gas to a desired temperature to achieve a desired level of therapy and / or patient comfort. 300 of Heater wire 300a The controller 13 can be programmed with a preferred target temperature for the gas stream, or the controller 13 can determine the preferred target temperature for the gas stream.

[0195] Flow Therapy Device 10 and / or Patient Breathing Conduit300 Operational sensors 3a, 3b, 3c, 20, 25, such as flow sensors, temperature sensors, humidity sensors, and / or pressure sensors, may be located at various locations on the cannula 17 and / or the flow therapy device 10. Output from the sensors may be received by the controller 13 to assist the controller 13 in operating the flow therapy device 10 to provide optimal therapy. In some configurations, providing optimal therapy includes meeting the patient's inspiratory needs. The device 10 may include a controller 13 receiving signals (8) from sensors and / or sensors, including but not limited to, the flow generator 11, the humidifier 12, and the heater wires. 300 The device 10 may have a transmitter and / or receiver 15 that allows for control of various components of the flow therapy device 10, including a or ancillary or peripheral devices associated with the flow therapy device 10. Additionally or alternatively, the transmitter and / or receiver 15 may send data to a remote server or allow for remote control of the device 10.

[0196] The flow therapy device 10 can include a high-flow therapy device. As used herein, "high-flow" therapy refers to the administration of gas to a patient's airways at a relatively high flow rate that meets or exceeds the patient's peak inspiratory demand. The flow rate used to achieve "high flow" can be any of the flow rates listed below. The flow therapy device 10 can be any suitable type of device, but in some configurations, can deliver high gas flow rates or high-flow therapy (e.g., air, oxygen, other gas mixtures, or some combination thereof) to assist breathing and / or treat respiratory disorders. In some configurations, the gas is or includes oxygen. In some configurations, the gas includes a mixture of oxygen and ambient air. As used in this disclosure, "high-flow therapy" can refer to the delivery of gas to an adult patient at a flow rate of about 10 liters per minute (10 LPM) or greater, or to a neonatal, infant, or pediatric patient at a flow rate of about 1 liter per minute (1 LPM) or greater. In some configurations, for an adult patient, "high flow therapy" can refer to the delivery of gas to a patient at a flow rate of about 10 liters per minute (10 LPM) or greater, such as about 10 LPM to about 100 LPM, or about 15 LPM to about 95 LPM, or about 20 LPM to about 90 LPM, or about 25 LPM to about 85 LPM, or about 30 LPM to about 80 LPM, or about 35 LPM to about 75 LPM, or about 40 LPM to about 70 LPM, or about 45 LPM to about 65 LPM, or about 50 LPM to about 60 LPM. In some configurations, for neonatal, infant, or pediatric patients, "high flow therapy" can refer to the delivery of gas to a patient at a flow rate of about 1 LPM to about 25 LPM, or about 2 LPM to about 25 LPM, or about 2 LPM to about 5 LPM, or about 5 LPM to about 25 LPM, or about 5 LPM to about 10 LPM, or about 10 LPM to about 25 LPM, or about 10 LPM to about 20 LPM, or about 10 LPM to 15 LPM, or about 20 LPM to about 25 LPM. Thus, a high flow therapy device used with either an adult patient or a neonatal, infant, or pediatric patient can deliver gas to a patient at a flow rate of about 1 LPM to about 100 LPM, or any of the subranges outlined above. The delivered gas can include a percentage of oxygen.In some configurations, the percentage of oxygen in the delivered gas can be about 20% to about 100%, or about 30% to about 100%, or about 40% to about 100%, or about 50% to about 100%, or about 60% to about 100%, or about 70% to about 100%, or about 80% to about 100%, or about 90% to about 100%, or about 100%, or 100%. High-flow therapy has been found to be effective in increasing a patient's oxygenation and / or reducing the work of breathing to meet or exceed a patient's inspiratory demand. Additionally, high-flow therapy can create a flushing effect in the nasopharynx, such that the anatomical dead space in the upper airway is flushed with the incoming high-flow gas stream. This creates a reservoir of fresh gas available with each breath while minimizing rebreathing of carbon dioxide, nitrogen, etc.

[0197] The patient interface may be a non-sealing interface that prevents barotrauma (tissue damage to the lungs or other organs of the respiratory system due to pressure differences relative to the atmosphere), and may be a nasal cannula with a manifold and nasal prongs, and / or a face mask, and / or a nasal pillows mask, and / or a nasal mask, and / or a tracheostomy interface or any other suitable type of patient interface.

[0198] 27, in one example embodiment, the flow therapy device 10 can include a main housing, such as that indicated generally by 1000. Such a main housing 1000 can have a main housing upper chassis 102 and a main housing lower chassis 103.

[0199] The main housing upper chassis 102 has a peripheral wall configuration that defines a humidifier or liquid chamber bay that receives a removable liquid chamber 3000. The removable liquid chamber 3000 contains a suitable liquid, such as water, for humidifying the gases delivered to the patient.

[0200] The removable liquid chamber 3000 includes an outer housing defining a liquid reservoir, a liquid chamber gas inlet port 306 in fluid communication with the liquid reservoir, and a liquid chamber gas outlet port 308 in fluid communication with the liquid reservoir. A baffle may be provided within the liquid reservoir to define a gas flow path through the liquid chamber 3000. The lower edge of the liquid chamber 3000 includes an outwardly directed annular flange that interacts with a guide rail of a liquid chamber bay to position and retain the liquid chamber 3000 in the liquid chamber bay. The flange extends outward from the base of the peripheral wall of the liquid chamber 3000. The bottom wall of the liquid chamber 3000 is thermally conductive and adapted to rest on a heater plate that heats the liquid in the liquid chamber 3000.

[0201] The device 10 includes a connection manifold arrangement that fluidly couples the liquid chamber 3000 to the device 10. The liquid chamber 3000 can be fluidly coupled to the device 10 from a position on the front of the housing 1000 in a direction toward the rear of the housing 1000 by linearly sliding the liquid chamber 3000 rearward into the liquid chamber bay. The connection manifold arrangement includes a manifold gas outlet port that fluidly communicates with the gas flow passage from the motor and / or sensor module through a fixed L-shaped elbow. The fixed L-shaped elbow receives gas from the outlet of the blower of the motor and / or sensor module and connects to the inlet port 306 of the liquid chamber bay 3000. The lower portion of the elbow extends downwardly into the gas flow passage tube to receive gas from the motor and / or sensor module.

[0202] The connection manifold configuration further includes a humidified gas return port incorporated into a removable elbow 342. The removable elbow 342 is L-shaped and further includes a patient outlet port 344 that couples to the patient breathing conduit to deliver gas to the patient interface. The outlet port 344 is located toward the front of the device 10 and in front of the screen 124 on the top surface of the housing 1000. The screen 124 is located toward the rear of the device 10. The manifold gas outlet port, manifold gas inlet port, and patient outlet port 344 each include soft seals, such as O-ring seals or T-seals (not shown), to provide a sealed gas passage between the device 10, the liquid chamber 3000, and the patient breathing conduit.

[0203] The liquid chamber gas inlet port 306 is complementary to the connection manifold gas outlet port, and the liquid chamber gas outlet port 308 is complementary to the connection manifold gas inlet port, with the axes of the ports preferably parallel so that the liquid chamber 3000 can be inserted into the liquid chamber bay in a linear motion.

[0204] The device 10 has air and oxygen (or alternative auxiliary gas) inlets in fluid communication with the motor so that the motor can deliver air, oxygen, or a suitable mixture thereof to the fluid chamber 3000 and thereby to the patient.

[0205] Overall Description 1B-22, a connector 100 for a component of a medical breathing circuit is shown. The connector 100 is configured to be provided at the end of a conduit 300. In particular, the connector 100 forms part of the medical breathing circuit for a releasable but secure connection between the end of the conduit 300 and another device in the circuit. The other device may be a humidifier, a flow generator, or another conduit. If the other device is a humidifier or a flow generator, for example, the other device may be the outlet of the humidifier or flow generator. In the following description, the other device will be referred to as a second connector 800.

[0206] Connector 100 has an inner body 200 and an outer body 400. Inner body 200 and outer body 400 define a gas passageway. In one embodiment, connector 100 is used to connect a conduit or tube 300 to a second connector 800. When assembled, the gas passageway of the connector is in fluid communication with each of the conduit 300 and the second connector, thereby allowing gas to flow from the second connector through the connector to the conduit 300.

[0207] The inner body 200 and the outer body 400 are separate components. The inner body 200 has a retention mechanism configured to engage with a second connector, which will be described in more detail below.

[0208] The outer body 400 is configured to at least partially surround the inner body 200. When assembled together, the outer body 400 covers most of the front and back surfaces of the inner body 200. The outer body 400 has a cutout through which a portion of the inner body extends. The inner body 200 also extends slightly from the outer body 400 at its distal end. The distal end has a larger diameter than the remainder of the inner body.

[0209] The outer body 400 has a tube engagement mechanism that connects the connector 100 and the tube 300 to each other.

[0210] The inner body 200 has a sealing mechanism configured to seal with the second connector 800. The connector also has a sealing mechanism configured to seal the inner body 200 and the outer body 400. The sealing mechanisms between the inner body 200 and the second connector 800 and between the inner body 200 and the outer body 400 provide a sealed passageway from the conduit 300 to the second connector 800, where gas flow is prevented or at least substantially prevented from leaking to the surrounding environment.

[0211] The connector 100 has separate retention mechanisms configured to hold the inner body 200 and the outer body 400 together.

[0212] In the illustrated embodiment, the inner body 200 is a unitary component formed in one piece. In particular, the inner body 200 comprises a first material. In some embodiments, a portion of the inner body 200 can comprise a first material and another portion can comprise a different material. For example, the retention feature of the inner body 200 includes a flex region. In some embodiments, the flex region can comprise a first material and another portion of the inner body 200 can comprise a different material.

[0213] The tube engagement feature of the outer body 400 comprises a second material. In some embodiments, the first material is stiffer than the second material. That is, the first material has a higher elastic and / or flexural modulus than the second material. The first material can also or alternatively have a higher flexural modulus than the second material.

[0214] The retention mechanism includes a lever that is movable relative to the inner body 200 about a flex region. The lever has a retention portion 203B on one side of the flex region and an actuation portion 203A on the other side of the flex region. The lever may be movable by being pivotable relative to the inner body. Alternatively, the lever may be movable by being hinged relative to the inner body.

[0215] 7 to 13, the holding mechanism includes two levers. The holding mechanism (levers) are located on the outside of the outer body 400.

[0216] The distance between the holding portions 203B of the two levers in the disengaged configuration is the same as or smaller than the distance in the engaged configuration. The distance between the holding portions 203B of the two levers in the disengaged configuration is the same as the distance in the engaged configuration.

[0217] The outer body 400 has a cutout that allows a portion of the inner body 200 to be located within the outer body 400 and a portion of the inner body 200 to be located outside the outer body.

[0218] The bending region is provided by a bridge 205. The bridge 205 has a feature that aligns the bridge 205 with the cutout. As shown in Figure 7, this feature is an alignment boss 209.

[0219] In some embodiments, the or each lever's retention portion 203B comprises the first material. In some embodiments, the or each lever's actuation portion 203A comprises the first material. In some embodiments, the entire retention mechanism comprises the first material. In some embodiments, the entire inner body 200 comprises the first material. The first material can comprise polyoxymethylene (POM), which is also known as acetal or acetal copolymer. In alternative embodiments, the first material can comprise nylon, including glass-filled nylon, or acrylonitrile butadiene styrene (ABS).

[0220] In some embodiments, the second material comprises a polyolefin, hi some embodiments, the second material comprises polypropylene or high density polyethylene.

[0221] Inner body We will now describe in detail the inner body 200. As described above, the inner body 200 has a gas path for gas to flow between the second connector 800 and the tube 300. The gas path is defined by an inner wall that tapers outward toward the distal end.

[0222] The inner body 200 is configured to be at least partially positioned within the internal passage of the second connector 800. As described above, the inner body 200 is inserted into the internal passage of the second connector 800. Having a connector that is inserted into the second connector 800 is advantageous for several reasons, one of which is that it narrows the flow path in the direction of flow. This narrowing of the flow path reduces the likelihood of creating dead space in stagnant areas. Stagnant areas have various disadvantages, such as providing areas where the atomized medicament can accumulate.

[0223] The inner body 200 has a conduit 201 , a sealing mechanism in the form of a wiper seal 202 , and a retention mechanism in the form of one or more levers 203 .

[0224] The connector 100 has a sealing and retention mechanism between the inner body 200 and the second connector 800. The outer surface of the conduit 201 is complementary in shape to the inner surface of the second connector 800, so that the two surfaces form an airtight seal. The airtight seal can be facilitated, in part, by a sealing element. The sealing element can be subject to wear over time and can require periodic replacement. A preferred embodiment is one in which the seal is located somewhere on the conduit 201, as this means that the seal only needs to last until the conduit 300 is replaced.

[0225] In some embodiments, the sealing mechanism includes a sealing member. One embodiment includes a seal around the circumference of the conduit 201. In the illustrated embodiment, the sealing member is or includes a wiper seal. The wiper seal can have the shape shown in the drawings. In alternative embodiments, the wiper seal can have a different cross-sectional profile, such as a T-shaped or C-shaped cross-section. In other embodiments, there can be more than one wiper seal. Additionally or alternatively, the sealing member can be or include an O-ring or any other suitable seal. The wiper seal provides easy axial movement of the two components. The inner body 200 has a recess for receiving the sealing member. The recess walls prevent, or at least substantially prevent, axial movement of the seal relative to the inner body 200. This recess can be further reinforced by a shoulder at the edge of the recess. The sealing member has a resting outer diameter that is larger than the inner diameter of the portion where the connectors connect. That is, the resting outer diameter of the sealing member is larger than the inner diameter of the gas passage of the second connector 800. The wiper seal flexes upon contact with the inner surface of the second connector 800, providing a force that reduces the likelihood of leakage between the wiper seal and the inner wall of the second connector 800. Additionally, the outer diameter of the wiper seal is larger than the diameter of the inner wall of the second connector 800, ensuring a complete airtight seal even if the two components are slightly misaligned, such as radially misaligned.

[0226] Alternatively, the seal may be provided by one or more O-rings. Alternatively, any of the sealing elements described above may be implemented on the inner surface of the second connector 800, meaning that the seal is not replaced when the tube and connector are replaced. Alternatively, the seal may be provided by an interference fit between the inner body 200 and the second connector 800. The interference fit may be a tapered fit. In some embodiments, the seal may be provided by an interference fit in one portion of the inner body 200 and / or a sealing member, such as an O-ring or wiper seal. For example, the end of the inner body 200 may be flared outward to make sealing contact with the inner wall of the second connector 800.

[0227] The seal is positioned on the inner body 200 to sealingly engage the second connector 800 before the electrical connectors of the device and connector mate. This ensures that the gas flow (which may be enriched with oxygen) is hermetically sealed from the electrical connector before any electrical connection is made. Furthermore, this configuration prevents a user from assembling the connector 100 with a device such that the electrical connection is made but the gas flow path is not sealed. This is particularly desirable because oxygen-rich gas could leak into the electrical connection, which could be a safety risk.

[0228] The inner body 200 can have a set of assembly guides 200B that aid in positioning the seal around the inner body 200. The assembly guides 200B extend from the distal end of the inner body 200 toward the sealing member 202. When assembling the connector 100, the seal is stretched by a tool so that it can slide over the base of the inner body 200. Once the seal is aligned with the recessed portion, the tool allows the seal to contract into the recessed portion. At this point, the tool aligned with the assembly guides can be withdrawn, and the seal will hook over the shoulder, thereby leaving it in the desired position.

[0229] The inner body 200 may have a spacer for accurately positioning the inner body 200 within the second connector 800. The spacer may be provided in the form of one or a series of outwardly extending protrusions 215. The protrusions 215 may be in the form of vertical ribs located around the periphery of the outer surface of the inner body 200. The ribs 215 are dimensioned to be substantially complementary to, correspond to, and / or match the diameter of the inner surface of the second connector 800 to provide a tight and / or gap-free fit between the inner body 200 and the second connector 800. For example, there may be a space of approximately 0.05 mm between the ribs 215 and the second connector.

[0230] The ribs 215 are configured to position a portion of the inner body 200 away from the passageway wall of the second connector 800 and define a space between the inner body 200 and the passageway wall. The ribs 215 ensure concentric alignment of the inner body 200 and the second connector 800. The ribs prevent radial movement of the inner body 200 within the second connector 800. This ensures that the inner body 200 is positioned an intended distance from the inner surface of the second connector 800, thereby ensuring that an airtight seal is formed between the inner body 200 and the second connector 800. The ribs extend in a direction generally parallel to the longitudinal axis of the inner body. In some embodiments, one or more of the ribs have angled, tapered, rounded, or other contoured ends 200C. Each rib is positioned at an intended distance from the inner surface of the second connector 800. 800 The inner body 200 has angled or tapered ends to act as alignment guides to guide the inner body 200 within the passage of the inner body 200 .

[0231] The angled or tapered surfaces 200A at the distal end of the inner body also help position the inner body 200 within the second connector 800. They also prevent radial movement of the inner body 200 relative to the second connector 800. These angled or tapered surfaces 200A can also help align the connector with the second connector 800. The ribs 215 and / or surfaces 200A help ensure an optimal seal between the inner body 200 and the second connector 800. In other embodiments, the spacer can be in the form of a single annular protrusion (not shown) disposed around the outer surface of the inner body 200.

[0232] 29C, one or more of the ribs 215 may be asymmetric with respect to the other ribs. That is, not all of the ribs may have the same form and shape. The ribs 215 may include recessed features or reduced tapers or other angled radii or chamfers to help achieve suitable alignment.

[0233] The angled or tapered ends 200C of the vertical ribs prevent or at least substantially prevent the ribs from catching on the end portion of the second connector 800 when connected. In the embodiment shown in Figures 7-13, there are four ribs 215 that are equally spaced around the circumference of the body, thereby providing symmetry between the ribs 215 and other features on the inner body 200. In alternative embodiments, there can be at least three ribs, for example, five, six, or seven ribs.

[0234] The sealing member is spaced a distance from the distal end 217. The sealing member 202 is located between the protrusion 215 and the distal end 217 of the inner body 200. The sealing member 202 is configured to seal against the passageway wall of the second connector 800 so as to at least substantially prevent gas flow through the space between the inner body 200 and the passageway wall. The inner body 200 has a shoulder 219 between the sealing member and the distal end 217. This connector embodiment incorporates a plurality of assembly ribs 220 that extend from the distal end 217 to the shoulder 219. These assembly ribs can advantageously aid in the assembly process for attaching the sealing member 202.

[0235] The inner body 200 has a wall that tapers outward toward the distal end 217. The wall has an inner surface and an outer surface. The diameter of the inner wall at the distal end 217 is larger than the diameter of the remainder of the inner wall. The diameter of the outer wall at the distal end 217 is larger than the diameter of the remainder of the outer wall. The inner wall at the distal end forms a smoother / continuous contour with the inner wall at the end of the second connector 800, reducing resistance to flow and dead space.

[0236] As will be described in more detail below, on each side of each bridge 205 is an alignment feature 209 that helps align the inner body 200 with the outer body. In the embodiment shown in FIGS. 7-13, the alignment features 209 are bosses. In alternative embodiments, there may be more or fewer alignment features. For example, there may be one, two, three, five, six, or more alignment features. The alignment features may be hemispherical in shape or may have another suitable shape, such as a cube, a rectangular prism, or a pyramid. The shapes may be tapered to enhance alignment properties.

[0237] 4, the distal end of the inner body 200 extends beyond the distal ends of the other components of the connector 400 (such as the retention feature, outer body 400, and cover 700). This allows the distal end 217 to engage the second connector 800 and properly align the connector before the other components contact the second connector 800. The connector 100 can also include an alignment or lead-in feature at the distal end of the inner body. The alignment feature can be an inwardly tapered section of the outer wall so that the distal end of the inner body 200 can more easily fit into the second connector 800 and then move into alignment when the two components are fully connected.

[0238] The lower portion 200A of the inner body 200 has an inner surface with a diameter that approximately matches the diameter of the inner surface of the second connector 800. This provides a substantially smooth and / or continuous contour between the inner surface of the inner body 200 and the second connector 800, thereby reducing turbulence in the gas flow path between the two components. Furthermore, it reduces possible dead spaces, which are undesirable, particularly when the gas flow contains nebulized medicament, because some of the nebulized medicament may condense and / or accumulate in the dead spaces.

[0239] Thus, the inner surface of inner body 200 tapers from a diameter at the lower end to a narrower diameter. The smaller inner diameter provides a less turbulent profile. However, it also allows room for various surface features on the outer surface of inner body 200, as described herein.

[0240] The body is configured to be positioned at least partially within an internal passage of another connector, the protrusion is configured to position a portion of the inner body 200 away from the passage wall of the second connector 800 and define a space between the inner body 200 and the passage wall, and the sealing member is configured to seal against the passage wall of the second connector 800 so as to at least substantially prevent gas flow through the space between the inner body and the passage wall.

[0241] In one embodiment, the inner body is provided as a separate component independent of the tube or without tube connection features, hi one embodiment, the inner body does not include tube connection features.

[0242] Retention mechanism To retain the connector 100 when assembled with the second connector 800, the connector 100 includes a retention mechanism. Referring to Figures 7-13 and 22, the retention mechanism includes protrusions 207 that engage one or more recesses in the second connector 800. These protrusions 207 are located at or near the ends of a pair of levers 203 that connect to the inner member via a bridge 205. The protrusions 207 are located on lower portions of the levers 203, and upper portions of the levers 203 extend beyond the bridge 205 to form a pair of actuation tabs. Pressing the actuation tabs inward flexes the bridge and moves the protrusions 207 outward.

[0243] The lever 203, bridge 205 and inner member can be molded from a material (such as acetal) that has a higher yield strength and a higher elastic (Young's) modulus and / or flexural modulus compared to the material of the outer body, allowing the lever 203 to travel a suitable distance without plastic deformation, yielding and / or breaking, while also providing adequate holding force.

[0244] When no force is applied to the lever 203, the lever 203 relaxes to a first rest position with the two protrusions at a first distance. 803When connected to the second connector 800 with the projections 207 engaged, the lever 203 is in a second position with the projections 207 at a second distance. Preferably, the first distance is the same as or less than the second distance. This means that the projections 207 engage with the recesses without requiring additional force to hold them in place. Not having to press the projections 207 together during engagement with the connector reduces stress on the connector during use and reduces the rate of material creep. Furthermore, it may be advantageous to design the lever 203 so that in the relaxed position, the projections 207 engage with the recesses but do not contact the base of the recesses. This allows the lever 203 to be in a relaxed position when engaged, further reducing the effects of creep on the material.

[0245] When connector 100 engages with second connector 800, protrusion 207 on lever 203 engages with recess 803 in the base of second connector 800. In the illustrated embodiment, the engagement surfaces of recess 803 and protrusion 207 are substantially perpendicular to the direction of movement required to remove the conduit, and once protrusion 207 is engaged, connector 100 and conduit 300 cannot be pulled away from second connector 800 even with significant force.

[0246] 23, the protrusion may have a curved profile that is complementary to the profile of the perimeter or recess 803 of the second connector 800. The edges of the curved profile may be rounded to prevent damage and / or unintended engagement of portions of the recess 803 when the connector is connected to or removed from the outlet end.

[0247] As outlined above, the engagement force of the recess 803 and protrusion can be substantially perpendicular to the direction of movement. As shown in FIG. 22A , angle α illustrates an alternative embodiment. The angle α is measured relative to the vertical centerline of the inner body 200 and the angle of the protrusion 207. This angle can help prevent unintentional separation of the connector 100 from the second connector 800 when a force is applied along or substantially parallel to the direction of movement (which is the direction shown along the centerline of the inner body 200) without a corresponding actuation / compression of the lever 203 by the user (such as depressing an actuation tab inward via the lever 203 as described herein).

[0248] The angle α can be from about 85° to about 115°, more preferably from about 90° to about 110°, or preferably from about 93° to about 102°, or preferably from about 95° to about 99°.

[0249] To separate the connector 100 from the second connector 800, the actuation tabs move the protrusions 207 outward and into the recesses. 803 The projection 207 moves inward sufficiently to disengage from the recess. 803 When disengaged from the connector, the connector can be removed with minimal resistance.

[0250] To connect the connector 100 to the second connector 800, the actuation tabs can be pressed inward to move the protrusions 207 outward so that they can clear the outer edge of the distal end of the second connector 800. Preferably, the underside of the protrusions 207 can include an alignment or lead-in feature in the form of a taper, so that when the connector is pressed onto the second connector 800, contact between the underside of the protrusions 207 and the distal end of the second connector 800 forces the protrusions 207 outward. This can eliminate the need to depress the actuation tabs when connecting the connector, allowing the conduit 300 to be attached to the device in a single motion.

[0251] Once the protrusion 207 clears the end of the second connector 800, the connector can then be pushed further down until the protrusion 207 engages with the recess. 803 The protrusion 207 engaging with the connector can produce an audible or tactile indicator to the user that the connector is engaged.

[0252] 10, the lever 203 has a slight inward curve from the bridge 205 to the protrusion. The slight curve allows the protrusion 207 at the base of the lever 203 to fit into a recess in the second connector 800. 803 11 shows that the lever 203 tapers between the bridge 205 and the prong so that the width of the lever 203 at the prong end is smaller than the width of the lever 203 at the bridge 205 end. The thickness of the lever also varies along its length, for example being thicker near the bridge compared to the retention end. This taper allows the distal end of the finger to bend more easily than the bending portion. The taper allows the lower portion of the bridge to bend with a more even stress distribution.

[0253] The inner surface of the actuation tab can have one or more support ribs. These ribs increase the stiffness of the tab so that it is prevented from bending when depressed. If the tab were to bend, a large force could be exerted on the actuation tab without corresponding movement in the protrusion. By making the tab stiff, any movement in the tab is transferred through the fingers to the lower portion of the fingers and protrusion. The tab also has the additional function of limiting its own movement by contacting the outer body 400 and / or intermediate shell 600. That is, the walls of the outer body 400 act as a stop. The amount of movement is limited to the amount of movement required to actuate the protrusion, thereby preventing excessive bending that could damage the components.

[0254] outer body 14-20, the outer body 400 partially surrounds the inner body 200. The relative positions and orientations of the inner body 200 and the outer body 400 are shown in FIGS. 2-5. The outer body 400 and the inner body 200 can be formed from a single piece, although different materials can be used (e.g., acetal for the inner body 200 and polypropylene for the outer body) by manufacturing the two components separately and then assembling them together. This is beneficial because some materials with desirable mechanical properties for the inner member may not be suitable for the overmolding process, as will be discussed in more detail below.

[0255] The outer body 400 serves a variety of purposes, some of which are described in more detail below. These may include: · Providing connection features that allow the conduit 300 to be attached to the connector 100. · Providing a surface at the distal end of the connector 100 that abuts against the top surface of a device, such as an apparatus 10, when the conduit 300 and device are connected. · Providing receptacles for electrical pins to facilitate electrical connection between the device and the conduit. · Providing a more uniform outer surface for the connector 100.

[0256] In a preferred embodiment, the inner body 200 clips into the outer body 400. As shown, the upper portion of the outer surface of the inner body 200 has an annular protrusion / flange that preferably extends around the entire circumference of the inner body 200. The outer body 400 includes a corresponding recess. When assembling the connector, the inner body 200 and the outer body 400 are pressed together so that the protrusion of the inner body 200 clips into the recess of the outer body 400. This provides both retention and an airtight seal due to the tight fit between the protrusion and the recess.

[0257] 24A-24B show variations of the sealing and retention mechanisms between the inner body 200 and the outer body 400. Figures 24A-24B show the inner body 200, the outer body 400, an inner-body-and-outer-body sealing mechanism configured to seal the inner body 200 and the outer body 400 together, and an inner-body-and-outer-body retention mechanism configured to hold the inner body 200 and the outer body 400 together. The inner-body-and-outer-body sealing mechanism and the inner-body-and-outer-body retention mechanism are separate mechanisms.

[0258] The inner body and outer body retention mechanisms hold the inner body 200 and outer body 400 together in a substantially permanent configuration. Once assembled, the inner body 200 and outer body 400 are not easily separated (e.g., a one-time engagement). The various inner body and outer body retention mechanisms described herein prevent or at least substantially inhibit the inner body 200 and outer body 400 from separating. Once engaged, the inner body 200 and outer body 400 cannot be easily separated, e.g., the components cannot be manually separated.

[0259] In one embodiment, the inner body and outer body sealing mechanism is further configured to hold together the inner body 200 and outer body 400. In other words, the sealing mechanism includes a second inner body and outer body retention mechanism.

[0260] 24A shows the inner and outer body sealing mechanism in the form of an interference fit between the tapered wall of the inner body 200 and the complementary tapered wall of the outer body 400. The inner body 200 has a tapered outer surface with the distal end having a narrower outer diameter than the remainder of the inner body.

[0261] 24A also shows the inner and outer body retention feature in the form of a protrusion on the inner body and a corresponding recess on the outer body. The protrusion is a rounded protrusion. The interference fit between the tapered walls of the inner body 200 and outer body 400 further holds the inner body 200 and outer body 400 together.

[0262] Figure 24B shows two protrusions and complementary recesses. Both protrusions are rounded. One protrusion is larger than the other. Either of the protrusions can be configured as a sealing and / or retention feature.

[0263] 24C shows that the inner body and outer body retention features include protrusions in the form of barbs or sharp protrusions. The inner body and outer body retention features can include complementary recesses or apertures. The inner body and outer body retention features can include two or more barbs. The inner body and outer body retention features can include complementary recesses or apertures.

[0264] 24D illustrates an alternative configuration. This embodiment shows an inner body 200 with an annular protrusion having a substantially rounded cross-sectional profile 221f and another annular protrusion having an angled cross-sectional profile 221g. The substantially rounded annular protrusion 221f can be configured as a retention feature and can fit within a complementary recess 421f of the corresponding outer body 400. The angled annular protrusion 221g can be configured as a sealing feature and / or can be configured to be an interference fit with the wall of the outer body 400, for example, at an interference point 421g.

[0265] 24D, the inner body 200 and outer body 400 sealing feature includes protrusion 221g. Optionally, the sealing feature is an annular sealing protrusion. Annular sealing protrusion 221g includes an angled cross-sectional profile. The annular sealing protrusion, identified as 221g, is provided on the outer surface of the inner body 200 and is configured to be in an interference fit with the inner surface of the outer body 400, for example, at location 421g.

[0266] In the illustrated embodiment, the inner body 200 includes a protrusion and the outer body 400 includes a recess or aperture. In alternative embodiments, the inner body 200 can include a recess or aperture and the outer body 400 can include a protrusion.

[0267] In some embodiments, the complementary recess or aperture is defined by one or more walls, and the or each barb is positioned within the complementary recess or aperture without abutting the one or more walls.

[0268] In a variation of the inner body and outer body retention mechanism protrusions, each is an annular protrusion. The complementary recess or aperture is an annular recess or aperture. In an alternative embodiment, the recess or aperture is an annular recess or aperture, and the protrusion can have a shorter length, for example, can extend only around a portion of the outside of the inner body.

[0269] In some embodiments, the annular sealing projection and the annular retention projection have different diameters, i.e., the annular retention projection extends further outward from the inner body 200 than the annular sealing projection.

[0270] 24B and 24D show protrusions having different cross-sectional profiles. In some embodiments, the annular retention protrusion has a rounded cross-sectional profile. In other embodiments, the annular retention protrusion has an angled cross-sectional profile.

[0271] 24A-24D, where inner body 200 includes a protrusion and outer body 400 includes a recess. In an alternative embodiment, inner body 200 can include a recess and outer body 400 can include a protrusion.

[0272] 24A-24D, the connector 100 has an inner body and outer body sealing mechanism configured to seal the inner body 200 and the outer body 400 together. The connector 100 also has an inner body and outer body retention mechanism configured to hold the inner body 200 and the outer body 400 together. The inner body and outer body sealing mechanism and the inner body and outer body retention mechanism are separate mechanisms.

[0273] The inner and outer body sealing mechanism includes a sealing protrusion on the outer surface of the inner body 200 and a complementary sealing recess on the outer body. The inner and outer body retention mechanism includes a retention protrusion on the outer surface of the inner body 200 and a complementary retention recess on the outer body. The distal end 217 of the inner body 200 extends beyond the end of the outer body. The outer surface of the distal end 217 of the inner body 200 is outwardly tapered.

[0274] In some embodiments, the upper end of the outer surface of the inner body 200 can also include one or more barbs / protrusions (ideally two) that correspond to the cutouts in the outer body 400. The barbs are located below the annular protrusion (and therefore the cutouts are located below the annular recess) so that the barbs and cutouts do not interfere with the airtight seal provided by the recess and protrusion.

[0275] The interface between the channel in the cutout and the inner wall of the body forms an acute angle. Similarly, the lower end of the barb provides a flat base / surface that is substantially perpendicular to the outer wall of the inner body 200. When assembling the inner body 200 with the outer body 400, the barb does not prevent the two components from being pressed together. The tapered portion of the barb guides the barb into the cutout and / or gently presses the wall of the outer body 400 outward as the inner body 200 is received by the outer body 400. When the barb is positioned within the cutout, the interaction between the barb base and the cutout boundary prevents the inner body 200 and the body from being disassembled. This allows for easy assembly of the components during manufacturing but prevents disassembly during use. That is, the connector is configured as a "one-time assembly" connector so that the inner body 200 and the outer body 400 cannot be easily disassembled or separated. Once assembled, the inner body 200 and the outer body 400 are effectively permanently connected or secured to each other.

[0276] Ideally, when assembled and relaxed, the barb does not contact the wall of the cutout, e.g., floats within the cutout, in which situation its retention force is provided by the interaction of the annular projection / flange and the recess.

[0277] If the barb contacts the wall of the cutout, any small error in manufacturing tolerances can prevent the annular projection and recess from forming a proper seal. In this configuration, the barb will only contact the base of the cutout if a large enough force is applied to connector 100 such that the annular projection / flange disengages from the recess. In this scenario, the barb abuts the base of the cutout.

[0278] The force required to further disassemble the components is much greater than the force required to remove the annular projection from the recess (particularly as the component may need to be destroyed to further disassemble). In the situation where the projection comes loose from the recess and the barb catches in the cutout, the annular projection is shaped and configured to re-engage the recess upon itself, e.g., via force against the interacting surfaces of the annular projection and recess.

[0279] In some embodiments, the connector can be configured to associate with a larger diameter tube. Thus, the tube connection portion of the outer body must be configured to accommodate the larger diameter tube, which may result in the outer body expanding along at least one dimension, e.g., increasing the diameter of the outer body. Thus, the inner body must be configured to accommodate the wider (i.e., larger diameter) outer body. In some embodiments, the bridge 205 must be lengthened to allow the lever 203 to rest outside the outer body. The longer bridge 205 may result in a change in the stiffness / strength requirements of the bridge 205.

[0280] For example, in the embodiment shown in FIG. 28, as an alternative configuration to the configuration of the embodiment described with reference to FIGS. Inner body 200. In particular with respect to the embodiment of FIG. 28, this configuration includes ribs 215, as described in connection with FIG. 29. FIG. 28 also includes assembly ribs 220 and shoulders 219, again as described in connection with FIG. 29.

[0281] In the embodiment shown in Figure 29, a reinforcing feature in the form of a step 230 is provided to locally increase stiffness by reducing the size of the bending region of the bridge. The reinforcing feature can also modify the hinge point of the lever 203, allowing a lever 203 including a longer bridge 205 to achieve substantially the same compression force as a lever with a shorter bridge, as described above. The reinforcing feature in the bridge 205 can provide bending consistency of the lever between different embodiments of the connector 100. The step 230 is provided at the intersection between the actuating portion 203A and the bridge 205.

[0282] In some embodiments, a step 230 is provided at the intersection between the retaining portion 203B and the bridge 205. In some embodiments, a step 230 is provided in the bridge 205. In the illustrated embodiment, the reinforcing feature in each lever 203 includes two steps extending toward each other from either side of the lever toward the center plane of the bridge.

[0283] In some embodiments, each lever 203 can include a single step 230 extending from either side of the lever. In some embodiments, the single step 230 can be provided at a substantially central location between the sides of the lever 203.

[0284] Reinforcing features can be provided on the bridge 205 of the connector regardless of the size of the connector or the tube to which the connector connects, where the reinforcing features are used to adjust the location of the hinge point along the bridge and / or the compressive force required to bend the lever 203 to engage or disengage the connector 100 with the second connector 800.

[0285] In some embodiments, the reinforcing feature may include the bridge 205 having one or more thickened portions, or the entire bridge 205 may be thickened. In some embodiments, the reinforcing feature is provided at the intersection of the actuating portion 203A and the bridge. In some embodiments, the reinforcing feature is provided at the intersection of the retention portion and the bridge. In some embodiments, the reinforcing feature is provided in the bridge.

[0286] In some embodiments, weakening features (not shown) can be provided in the bridge to change the location of the hinge point and / or reduce the compressive force required to bend the lever 203. The weakening features can be in the form of a discrete thinned portion of the bridge 205 (e.g., a step in the bridge 205), multiple discrete thinned portions of the bridge 205 (e.g., the bridge 205 is textured, for example with dimples), or the entire bridge is thinned.

[0287] In some embodiments, a weakening feature is provided at the intersection of the actuating portion 203A and the bridge. In some embodiments, a weakening feature is provided at the intersection of the retention portion and the bridge. In some embodiments, a weakening feature is provided in the bridge.

[0288] Strengthening and weakening features can be used to adjust the force required to bend lever 203 and / or move retaining portion 203B toward or away from the center of connector 100. In some embodiments, the bridge includes one or more strengthening features. In some embodiments, the bridge includes one or more weakening features. In some embodiments, the bridge includes one or more strengthening features and one or more weakening features.

[0289] In the embodiment of FIG. 29, where the connector includes a reinforcing feature, a link portion 231 is provided that joins the actuating portion 203A and the retaining portion 203B of the lever 203 to ensure that movement of the actuating portion 203A toward the center of the connector 100 causes the retaining portion 203B to move away from the center of the connector 100.

[0290] Link section 231 If there is no step 230 extends substantially across lever 203 and between the sides of lever 203 to provide an additional hinge point about which actuation portion 203A can pivot. In such embodiments, actuation portion 203A may require a greater actuation force and / or distance of movement before moving retention portion 203B away from the center of connector 100. In some embodiments, the connector includes one or more link portions 231 and one or more steps 230. In some embodiments, the connector includes multiple link portions 231 and multiple steps 230.

[0291] 29D and 29E show various example embodiments of an alternative reinforcing feature 230' in place of the stepped section 230 outlined above. Reinforced sections 230 and 230' facilitate the transfer of force applied to actuation portion 203A (such as axially inward) to aid in the release of retention mechanical projection 207 at the end of retention portion 203B from its position in recess 803. Such reinforcement can further help resist twisting or other deflection of the lever at bridge region 205 (such as when a force is applied to lever 203 when a user is connecting or disconnecting connector 100 from second connector 800).

[0292] 29D-29G, reinforcing feature 230' is provided as an intersection between actuating portion 203A and bridge 205. In FIGS.

[0293] 29D-29E, the thickened reinforcing feature 230' comprises a step and extends from one side of the lever 203 to the other side of the (same) lever 203, i.e., the reinforcing feature 230' extends from one edge or side of the width of the bridge to another edge or side or substantially across the bridge interconnection with the lever 203. In alternative embodiments, the reinforcing feature 230' can extend at least partially between the edges or sides of the lever 203.

[0294] 29F-29G, reinforcing feature 230' includes a sloped portion and extends at least partially between the edges or sides of lever 203. Reinforcing feature 230' (which may be a thickened intersection of the bridge and lever) is positioned substantially centered between the sides of lever 203.

[0295] As can be seen from these figures, bridge 205 is disposed between actuation portion 203A and retention portion 203B. As discussed above, bridge 205 may include reinforcing features 230 or 230′. The reinforcing features may include a step (or other junction) at the intersection between actuation portion 203A and bridge 205.

[0296] The reinforcing features 230, 230' may include two (or more) steps that extend towards each other from opposite sides or edges of the lever towards the central plane of the bridge 205.

[0297] The reinforcing features 230, 230' may include thickened portions of the bridge 205. The thickened portions may be provided at the intersections of the working portion 203A and the bridge 205.

[0298] The actuating portion 203A may include ribs (or other stiffening or strengthening portions) that substantially limit bending or deflection of the actuating portion 203A when a force is applied.

[0299] Tube connection 14-19 and 21, the connector 100 has a tube connection portion 403 that engages with the conduit 300. In the illustrated embodiment, the tube connection portion 403 is part of the outer body 400. In other embodiments, the tube connection portion 403 is part of the inner body 200. The tube connection portion 403 defines a gas path. The gas path is in fluid communication with the gas path of the inner body.

[0300] 14-19 and 21, the outer body is provided with tube connection features and the inner body is devoid of tube connection features, with the outer body including tube connection features such that when an assembly of the inner and outer bodies is made, the assembly is connected to tubes only via the tube connection features of the outer body.

[0301] The tube connection portion 403 is a tubular member having at least a pair of protrusions 407 that extend into the passageway. The passageway has a generally helical profile so that the conduit 300, which has an internally threaded surface, can be threaded onto the tube connection portion 403.

[0302] In some embodiments, the protrusions 407 can be axially positioned on one side of the tube connection portion 403. That is, there can be more than one protrusion 407 on one side of the tube connection portion 403. The axially positioned protrusions 407 also fall within a helical path.

[0303] In an alternative embodiment, the tube connection portion 403 can include male threads. The threads can be full threads that extend around the circumference of the tubular member. Alternatively, the threads can be partial threads, having short sections of thread with gaps or spaces between the short sections.

[0304] The conduit 300 can be spirally wound, and the path of the protrusion 407 on the tube connection portion 403 is positioned to generally match the tapered / helical arrangement of the spirally wound conduit. In some embodiments, the path of the protrusion does not exactly match the helical arrangement of the spirally wound conduit, but the location of the protrusion is designed to engage with the threads of the tube 300. The protrusion is positioned to be positioned at the edge / boundary of the internally threaded portion of the tube 300. By using a series of protrusions 407 instead of a typical helical thread, the assembly is more tolerant of variations in tube diameter.

[0305] Preferably, the projections 407 are positioned to coincide with one revolution of the taper, with only the first and last projections being axially aligned. The axial alignment of the first and last projections 407 also prevents, or at least substantially inhibits, axial movement of the tube, as will be described below.

[0306] Conduit 300 may be a composite structure made from two or more separate components that are coiled to form an elongated tube. A suitable conduit is the tube described in WO 2012 / 164407, which is incorporated herein by reference in its entirety. Protrusions 407 are positioned to align with the tube and engage the member by compressing the hollow lumen.

[0307] A second spirally wound member can be intertwined with the first member, with the second member being made from solid plastic. The turns of the second member on either side of the first member prevent axial movement of the conduit 300 when the protrusion engages the first member, as the second member is substantially incompressible and therefore cannot move past the protrusion. Because the first member is slightly wider than the protrusion itself, slight axial movement may still be possible, allowing the protrusion 207 to move between the boundary provided by two adjacent turns of the second member.

[0308] This axial movement can be prevented / limited by the two axially aligned protrusions 407 described above. The protrusions 407 can be repositioned so that one of the protrusions 407 engages the lower boundary of the first spiral member and the other protrusion 407 engages the upper boundary of the first spiral member. Figure 21 shows one embodiment where two axially opposed protrusions provide a similar function.

[0309] In some embodiments, the location of the protrusions 407 can be selected or designed so that the protrusions pinch adjacent / nearby spiral sections of the tubing. During manufacturing, before the conduit 300 and the outer body 400 are connected, the conduit wires are exposed. The outer body 400 can have alignment or lead-in features to position the exposed respiratory conduit wires. The alignment or lead-in feature can include a tapered channel that tapers from a wide entrance to a narrow exit. This ensures that the wires are guided toward the desired location so that electrical contacts at the ends of the wires can be soldered to electrical pins, as described below.

[0310] 30 and 31, protrusions 420 may be provided as alignment or lead-ins for reinforcing features of the conduit 300 as disclosed herein. The protrusions 420 may be provided as radially outward extending protrusions and may provide guides for the conduit tube 300 as described herein.

[0311] In example embodiments, the protrusions 420 may take the form of ribs or fin-shaped portions 420. The protrusions 420 may advantageously aid in the assembly of the connector and conduit and may prevent separation during the overmolding process as described herein.

[0312] The protrusion 420 may include a raised protrusion configured to separate the reinforcing features of the conduit and guide the reinforcing features (along with any other portions of the conduit that are removed when the reinforcing features are separated) toward the wire separation protrusion 430.

[0313] The wire separating protrusion 430 may be configured to separate, maintain separation of, or guide two or more wires in the reinforcing feature of the conduit for attachment to an electrical pin as described below.

[0314] The tubing connection portion can be positioned at an angle such that the flow path of the initial section of conduit 300 is angled relative to the flow path through the final section of second connector 800, thereby offsetting the initial section of conduit 300 from being perpendicular to the surface of the device. This angle allows conduit 300 to be oriented toward the front of the device, making it more likely that conduit 300 will bend toward the front of the device, as opposed to the back of the device, which could obscure the screen 124 of the device.

[0315] A larger angle between the second connector 800 and the tube connection portion is more likely to encourage the conduit to extend away from the screen 124, while a smaller angle provides less impedance to the flow of gas through the conduit 300. The angle can be from 0° (i.e., parallel to the second connector 800) to 90° (i.e., perpendicular to the second connector 800), or from about 5° to about 45°, or from about 10° to about 30°, or from about 15° to about 20°, or between any two of the angles mentioned above.

[0316] 14 , the tube connection portion extends at an angle from the longitudinal axis of the body that is greater than about 0° and less than about 90°. This angle is greater than about 5° and less than about 60°, greater than about 10° and less than about 40°, or greater than about 15° and less than about 20°. The tube connection portion extends at an angle from the longitudinal axis of one of the electrical subassemblies 500 that is greater than about 0° and less than about 90°.

[0317] The outer body 400 has an outer wall that surrounds a substantial portion of the inner body 200. When the connector 100 is connected to a second connector 800 of the device, the outer wall further surrounds the second connector 800. The outer wall can have cut-out sections that allow passage of the bridge of the inner body 200 when the inner body 200 and the body are assembled together.

[0318] The width of the cutout preferably matches the distance between the tips of the alignment projections 209 located on each bridge 205 of the inner body 200. When assembled, the projections contact the cutout on each side to ensure precise angular alignment of the inner body 200 and outer body 400.

[0319] Electrical Pin The connector 100 includes an electrical subassembly 500. The electrical subassembly 500 includes a body 501 and electrical pins (contacts) 503 extending outward from the body 501. The electrical subassembly body 501 is formed of a non-conductive material. The electrical subassembly 500 is received by a receptacle in the outer body 400. When the electrical subassembly 500 is assembled with the outer body 400, the upper ends of the electrical pins are soldered onto the exposed electrical contacts of the conduit.

[0320] The lower ends of the electrical pins 503 pass through the receptacle and into exposed recesses in the base of the outer body. This section forms the electrical connector portion of the connector 100. When assembled with a device outlet, the protruding electrical connector on the device is inserted into the recessed electrical connector of the connector, and the electrical pins 503 are inserted into the holes in the protruding electrical connector.

[0321] The outer body 400 may also include alignment or lead-in features that help align the electrical connection between the device and the connector 100. The alignment or lead-in feature may be in the form of a tapered end of the receptacle so that the connector 100 is aligned at a precise angle with the second connector 800 when the user presses the two components together.

[0322] The body 501 can have a standoff portion designed to abut the top surface of the outer body 400 around the periphery of the receptacle. This serves to position the electrical subassembly 500 at the correct height before soldering. The base of the body can further have one or more protrusions that correspond to recesses on the inside of the receptacle. When the electrical subassembly 500 is assembled with the outer body 400, the protrusions clip into the recesses to hold the electrical subassembly 500 in place for the soldering process and further overmolding process.

[0323] The electrical subassembly 500 may have retention features in the form of tabs extending horizontally from the upper portion of the overmolded portion that are inserted into complementary recesses in the outer body 400 prior to further overmolding to provide a more secure fit between the outer body 400 and the electrical subassembly 500.

[0324] Intermediate shell Once the electrical insert 500 is assembled with the outer body 400 and soldered to the electrical contacts of the conduit, an intermediate shell 600 is applied to the outer body 400. The intermediate shell 600 resides between the outer body 400 and the cover 700 when the connector 100 is fully assembled.

[0325] Intermediate shell 600 covers electrical subassembly 500, the end portions of conduit 300, and the soldered electrical contacts. It serves to protect the electrical connections and hold the assembled electrical subassembly 500 and conduit 300 together with outer body 400. Intermediate shell 600 also acts as another protective layer to hermetically seal the electrical connections from gases, such as oxygen-rich gases, that may leak from this or other devices.

[0326] The outer body 400 and electrical subassembly 500 can be assembled with the intermediate shell 600 before assembling the outer body 400 with the inner body 200. The material used for the intermediate shell 600 is similar to or compatible with the material used for the outer body 400 so that the intermediate shell 600 and the outer body 400 can bond together. Thus, the material used for the intermediate shell 600 and the outer body 400 is similar to or compatible with the material used for the conduit 300 to facilitate bonding between the conduit 300, the intermediate shell 600, and the outer body 400.

[0327] The materials of the outer body 400 and the intermediate shell 600 can be co-molded or overmolded without the molding process of one component affecting the molding process of the other component. For example, both materials have melting temperatures that do not affect the other component. In particular, by molding the intermediate shell 600 over the outer body 400, the outer body 400 does not melt or deform. Furthermore, the intermediate shell 600 and the outer body 400 bond to each other.

[0328] As mentioned above, having separate inner body 200 and body in this scenario is beneficial because one material can be used for inner body 200 to meet the required mechanical performance, while a second material is used for outer body 400 to allow for overmolding bonding.

[0329] The outer body 400 can have raised features around the edges of the section that is overmolded with the intermediate shell 600. This makes it easier for the manufacturing tool to provide a proper seal during the overmolding process, thereby reducing the chance of defects in the overmolded part, such as flash.

[0330] When connecting the connector 100 to the second connector 800, preferably an airtight seal is created, i.e., a wiper seal of the inner body 200 that seals against the device outlet, before electrical connection is made between the electrical pins 503 of the connector 100 and the electrical connector of the device.

[0331] In the illustrated embodiment, the intermediate shell 600 is overmolded onto or co-molded with the outer body 400 .

[0332] Elastomer outer cover As discussed above, the inner body 200 and the outer body 400 define a gas pathway through which gases flow, for example, from a respiratory device to a patient interface. The accompanying drawings show details of the inner body 200 retention mechanism, including actuation features. In an alternative embodiment, the outer body 400 can have a retention mechanism that includes an actuation feature.

[0333] In another alternative embodiment, the connector can have a unitary body (without separate inner and outer bodies) that can have a retention mechanism with an actuation feature.

[0334] The actuation feature is manually operable. According to embodiments described herein, the actuation feature is an actuating portion of a lever. In alternative embodiments, the actuation feature may be a button, switch, or part of the body that moves in response to being manually operated.

[0335] A cover 700 can be provided over the connector 100 to enclose the various components. The cover 700 is formed as a sleeve 701 having a first opening 701 and a second opening 703. The first opening is smaller than the second opening. The shape of the sleeve generally corresponds to the shape of the other components of the connector, including the outer body 400 and the mid-shell 600. The cover 700 is formed from an elastomeric material. The cover 700 is flexible and resilient. The cover 700 also has a high coefficient of friction compared to the coefficient of friction of the outer body.

[0336] The cover 700 extends over the actuation features. The flexible cover 700 extends over the actuation features but also allows the actuation features to be manually manipulated by a user. The cover 700 also allows the fingers to deflect with minimal force and does not affect the operation of the actuation features.

[0337] The cover 700 can be slid over the conduit 300 before assembly, for sliding over the connector 100 after the various components are assembled. The cover 700 is fitted with a friction or interference fit to the outer body 400. The cover 700 includes a semi-annular recess 705 near the inner base of the cover 700 that is complementary to a semi-annular protrusion on the outer base of the outer body 400.

[0338] In alternative embodiments, the recesses can have other shapes. For example, the recesses can be completely annular. The interaction of the recesses 705 with the protrusions serves to retain the cover 700 on the outer body 400. Additionally or alternatively, the cover 700 and the outer body 400 can be friction and / or interference fit with one another.

[0339] The cover 700 provides a uniform outer surface. The cover 700 also protects the various components of the connector 100. The outer body 400 and mid-shell 600 can be shaped to be complimentary to the inner surface of the cover 700. This supports the cover 700 so that the assembled connector 100 has a solid feel to the cover 700 as opposed to having hollow sections. The mid-shell 600 and / or the outer body 400 can achieve this shape through a series of ribs so that the mid-shell 600 and / or the outer body 400 can achieve the desired shape without using an excessive amount of material.

[0340] When actuating lever 203, cover 700 acts as an interface that applies pressure to the upper portion of lever 203. This provides a softer and more rounded surface for the user to interact with. Cover 700 can have an indicator of where the user needs to apply pressure to actuate lever 203.

[0341] The indicator can take the form of a surface feature that is tactilely and / or visually discernible. The indicator can have a thickened cross-section, which provides a more comfortable feel to a user activating the tab. In the illustrated embodiment, the cover 700 has a thickened section 707 corresponding to the actuation portion 203A. The thickened section 707 has an exterior surface feature 709. The cover 700 has a thinned section 711 connecting the thickened section to the remainder of the cover 700. The thinned section 711 allows adjacent sections of the cover 700 to move when actuated. In particular, the thinned section 711 allows the thickened section to move inward or toward the center of the connector 100 when actuated. The cover 700 can have a thinner section of material adjacent to the indicator, which allows the section of material to fold more easily when the tab is actuated.

[0342] Because the cover 700 is made from an elastomeric material, the material of the cover 700 allows the cover 700 to move from its rest shape to its actuated shape and then return to the rest shape.

[0343] The cover 700 can have a base 713 with a thickened shoulder 715. The shoulder 715 provides a surface for a user to press against when attaching the connector to the second connector 800. The thickened portion, combined with being formed from an elastomeric material, can further provide an inwardly directed force around the periphery of the connector 100, particularly around the retention portion 203B of the lever 203. In other words, the cover 700 can be pre-formed to provide an inward bias direction. Alternatively, the cover 700 can be formed slightly smaller than the connector 100, and once the cover 700 is in place, the cover can be easily attached to the connector. 100 This can achieve a "stretching" of the cover to hold it in place over the second connector 800. This can increase the force holding the protrusions in their complementary recesses in the second connector 800.

[0344] Figures 31A and 31B show alignment features in the form of ribs 440, which can correspond to the recesses in the thickened sections outlined above.

[0345] The cover 700 has a number of features that are complementary to features of the outer body 400. In particular, the cover 700 and the outer body 400 have complementary features (e.g., ribs 440 and their corresponding recesses in thickened portions of the cover 700) that key the components together and prevent rotation or pivoting of the cover 700 relative to the outer body 400. In particular, the outer body 400 has ribs 440 and the cover 700 has complementary recesses.

[0346] Some of the ribs 440 extend transversely to the direction of possible rotation. In particular, some of the ribs extend vertically (or substantially parallel to the central axis of the connector 100) to prevent or at least substantially inhibit rotation in the vertical direction, as shown by rib 440 in FIGS. 31A and 31B. Other ribs are semicircular ribs 440A that nest within complementary recesses in the cover. Again, these ribs can prevent or at least substantially inhibit rotation of the cover 700 relative to the outer body 400 and help retain the cover on the outer body.

[0347] In some embodiments, features that key the cover and outer body 400 together and prevent rotation or pivoting of the cover 700 relative to the outer body 400 include non-circular shapes of the outer body 400 and cover 700. The outer body 400 and / or the mid-shell 600 have one or more ribs that support the cover 700. The outer body 400 has an electrical subassembly for electrical connections. The body has an overmolded portion that hermetically seals around the electrical connections.

[0348] As mentioned above, the material of the outer body 400 is the same as or compatible with the material of the conduit 300. That is, the materials of the outer body and the conduit can be co-molded or overmolded without the molding process of one component affecting the molding process of the other component. For example, both materials have melting temperatures that do not affect the other component. In particular, by molding the outer body over the conduit, the conduit does not melt or deform. Furthermore, the outer body and the conduit bond to each other.

[0349] In some embodiments, the connector 100 can be provided in combination with the conduit 300. For example, the outer body 400 can be overmolded onto the conduit 300. The intermediate shell 600 can also be overmolded onto the conduit 300, the outer body 400, or both the conduit 300 and the outer body 400. In the illustrated embodiment, the intermediate shell 600 is also overmolded onto the electrical subassembly 500.

[0350] In some embodiments, the inner body 200, the outer body 400, and the cover 700 can be made from the same material. In other embodiments, the inner body 200, the outer body 400, and the cover 700 can be made from different materials.

[0351] Unless otherwise clearly required by context, throughout this specification and claims, the words "comprises," "including," and the like are to be construed in an inclusive sense, i.e., "including but not limited to," as opposed to an exclusive or exhaustive sense.

[0352] Reference to a range of numbers disclosed herein (e.g., 1 to 10) is intended to incorporate reference to every rational number within that range (e.g., 1, 1.1, 2, 3, 3.9, 4, 5, 6, 6.5, 7, 8, 9, and 10) and any range of rational numbers within that range (e.g., 2 to 8, 1.5 to 5.5, and 3.1 to 4.7); thus, all subranges of every range explicitly disclosed herein are hereby expressly disclosed. These are merely examples of what is specifically intended, and all possible combinations of numerical values ​​between the lowest and highest values ​​recited should be considered as if they were also explicitly stated herein.

[0353] As used herein, the term "(plural)" following a noun refers to the plural and / or the singular form of that noun.

[0354] As used herein, the term "and / or" means "and" or "or," or both where the context allows.

[0355] Where the term "configured to" is used herein, the term may alternatively be replaced with "disposed to" or "adapted to."

[0356] Where the above description refers to whole entities or components that have known equivalents, those whole entities are incorporated herein as if individually set forth.

[0357] The present disclosure may be broadly said to include any and all combinations of two or more of the parts, elements and features referred to or shown in this specification of the application, individually or collectively.

[0358] The reference to any prior art in this specification is not, and should not be construed as, an acknowledgment or any form of suggestion that that prior art forms part of the common general knowledge in the field of endeavor in any country throughout the world.

[0359] Some features, aspects, and advantages of some configurations of the present disclosure have been described with respect to the use of a gas humidification system in a respiratory therapy system. However, some features, aspects, and advantages of the use of a gas humidification system as described may be advantageously used in other therapeutic or non-therapeutic systems requiring humidification of gases, or even in non-humidified systems. Some features, aspects, and advantages of the methods and devices of the present disclosure may be equally applicable to connectors and use in other systems requiring alternative connectors.

[0360] Although the present disclosure has been described with respect to several embodiments, other embodiments apparent to those skilled in the art are within the scope of the present disclosure. Accordingly, various modifications and alterations can be made without departing from the spirit and scope of the present disclosure. For example, various components can be rearranged as desired. Features from any of the above-described configurations can be combined with one another, and / or a humidifier or other component or device forming part of a respiratory assistance system or respiratory therapy system or a system for delivering gas to a patient can include one or more of the above-described configurations. Furthermore, not all features, aspects, and advantages are necessary to practice the present disclosure. Accordingly, the scope of the present disclosure is intended to be defined solely by the following claims.

Claims

1. 1. A connector for a medical breathing circuit component, comprising: Separate inner and outer body components Including, the inner body having a retention feature configured to engage a second connector; The connector comprises: an outer body configured to at least partially surround the inner body, the outer body having a tube engagement mechanism; an electrical contact; The electrical contacts are assembled with the outer body, the outer body having an overmolded portion that seals around the electrical contacts.

2. The connector of claim 1 , wherein the inner body further includes a sealing mechanism configured to provide a seal between the inner body and the second connector.

3. The connector of claim 1 or 2, wherein at least a portion of the inner body comprises a first material and at least a portion of the outer body comprises a second material.

4. The connector of claim 3 , wherein the first material is stiffer than the second material.

5. The connector of claim 4 , wherein the retention feature of the inner body includes a flex region comprising the first material.

6. The connector of claim 5 , wherein the retention mechanism includes at least one lever movable relative to the inner body about the flex region.

7. 7. The connector of claim 6, wherein the at least one lever has a retention portion at one portion of the flex region and an actuation portion at another portion of the flex region.

8. 8. The connector of claim 7, wherein the at least one lever includes a first lever and a second lever, and wherein a distance between the retaining portions of the first lever and the second lever in a disengaged configuration is the same as or less than the distance in an engaged configuration.

9. 9. The connector of claim 1, wherein the outer body has a cutout that allows a portion of the inner body to be located within the outer body and a portion of the inner body to be located outside the outer body.

10. The connector of claim 9 , wherein the portion of the inner body located outside the outer body is the retention feature.

11. The connector of claim 7 , wherein the flex region is provided by a bridge.

12. The connector of claim 11 , wherein the bridge has features that align the bridge with the outer body.

13. 13. The connector of claim 11 or 12, wherein the bridge is disposed between the actuation portion and the retention portion.

14. The connector of any one of claims 11 to 13, wherein the bridge includes a strengthening feature.

15. The connector according to any one of claims 3 to 8, wherein the first material has a higher Young's modulus than the second material.

16. 16. The connector of claim 1, further comprising an inner body and outer body sealing mechanism configured to seal the inner body and the outer body together, and an inner body and outer body retention mechanism configured to hold the inner body and the outer body together, wherein the inner body and outer body sealing mechanism and the inner body and outer body retention mechanism are separate mechanisms.

17. The connector of claim 16, wherein a distal end of the inner body extends beyond an end of the outer body.

18. The connector of claim 17 , wherein the end portion has a larger diameter than the remainder of the inner body.

19. 19. The connector of claim 17 or 18, wherein the inner body includes a wall that tapers outwardly toward the distal end.

20. 20. The connector of claim 19, wherein the diameter of the inner wall of the inner body at the distal end is greater than the diameter of the remainder of the inner wall.

Citation Information

Patent Citations

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