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"Medical Tubes And Connectors For Gases Delivery Systems"

Abstract: A medical circuit comprising a medical tube and a connector transports gases to and/or from a patient via a patient interface. The connector has a plurality of rigid components at least partially surrounded by an overmold. The medical tube has a first elongate member and a second elongate member. The first elongate member is substantially hollow. A vent can be coupled to the first elongate member such that it maintains gaseous communication with the lumen. The vent may provide a pathway between the lumen and the atmosphere, such that gases may move into and/or out of the lumen during cleaning. The vent may also provide a barrier to liquid and/or substance ingress into the first elongate member during cleaning of the medical circuit. The medical circuit can be reusable.

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Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
28 December 2016
Publication Number
27/2018
Publication Type
INA
Invention Field
MECHANICAL ENGINEERING
Status
Email
Parent Application
Patent Number
Legal Status
Grant Date
2023-12-07
Renewal Date

Applicants

FISHER & PAYKEL HEALTHCARE LIMITED
15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND,2013, NEW ZEALAND

Inventors

1. MOODY, PAUL JOSEPH
C/O FISHER & PAYKEL HEALTHCARE LIMITED 15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND, 2013, NEW ZEALAND
2. MUNKELT, SVEN ANDREAS
C/O FISHER & PAYKEL HEALTHCARE LIMITED 15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND, 2013, NEW ZEALAND
3. FYFE, KATIE
C/O FISHER & PAYKEL HEALTHCARE LIMITED 15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND, 2013, NEW ZEALAND
4. PEIRUS, TELGE NISHAN CHATURANGA
C/O FISHER & PAYKEL HEALTHCARE LIMITED 15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND, 2013, NEW ZEALAND
5. POWELL, KEVIN BLAKE
C/O FISHER & PAYKEL HEALTHCARE LIMITED 15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND, 2013, NEW ZEALAND

Specification

[0001] This application incorporates herein by reference, in their entireties, U.S. Provisional Application No. 62/021,591, filed July 7, 2014, U.S. Provisional Application No. 62/054,559, filed September 24, 2014, U.S. Provisional Application No. 62/084,259, filed November 25, 2014, and U.S. Provisional Application No. 62/132,780, filed March 13, 2015.

BACKGROUND

Technical Field

[0002] The present disclosure relates generally to medical tubes and connectors to deliver gases to patients and more particularly to reusable medical tubes and connectors for gases delivery systems, such as respiratory assistance and insufflation systems.

Description of the Related Art

[0003] A gases delivery system delivers gases to a patient. Gases delivery systems include respiratory assistance systems and insufflation systems. The gases may be heated and/or humidified prior to delivery to the patient. The gases are conveyed from a humidifier or other gases source via a medical circuit to a patient interface. A medical circuit may be formed from a medical tube and one or more connectors and may be disposable or reusable. To prevent condensate formation within the medical tube, the medical tube may be insulated and/or heated using a heater wire. A connector for a gases delivery system may comprise a rigid body that can be integrally coupled to a medical tube.

SUMMARY

[0004] Medical tubes, connectors, and methods of manufacturing medical tubes and connectors are disclosed herein in various embodiments.

[0005] According to at least one aspect of the present disclosure, a medical circuit for a gases delivery system can have one, some, or all of the following features, as well as other features described herein. The medical circuit comprises a medical tube. The medical tube comprises a first elongate member. The first elongate member comprises a lumen. The medical circuit comprises a vent coupled to the first elongate member such that it maintains gaseous communication with the lumen of the first elongate member. The vent allows gaseous communication between the lumen of the first elongate member and the atmosphere. The vent substantially prevents ingress of liquid into the lumen of the first elongate member.

[0006] The vent can comprise a material with a low surface tension. The vent can be inserted directly into the lumen of the first elongate member. The vent can be coupled to the first elongate member via a housing. The housing can be inserted into the lumen of the first elongate member. The housing can couple the vent to the first elongate member via an inner conduit. The housing can be coupled with a connector via overmolding. The medical tube can comprise a second elongate member. The second elongate member can comprise heater wires. The second elongate member can comprise sensing wires. The second elongate member can comprise a combination of heater wires and sensing wires. The housing can comprise an electrical connection between the heater wires and/or the sensing wires and the connector. The housing can comprise a gases pathway from the vent to the atmosphere. The housing can comprise a plug and a receiving portion. The housing can comprise a piercing member. The vent can be made from polytetrafluoroethylene. The vent can be a solid component. The vent can be a film.

[0007] According to at least one aspect of the present disclosure, a medical circuit for a gases delivery system can have one, some, or all of the following features, as well as other features described herein. The medical circuit comprises a medical tube. The medical tube comprises a first elongate member. The medical tube comprises a second elongate member. The medical circuit comprises a connector configured to connect the medical tube to a gases delivery system component. The connector comprises a plurality of rigid components. One or more of the plurality of rigid components forms at least part of a preassembled structure. The preassembled structure is at least partially surrounded by an overmold.

[0008] The plurality of rigid components can comprise a rigid cuff, a power adaptor port, and/or a carrier part. The power adaptor port can comprise an internal surface comprising an undercut formed from the overmold. The carrier part can comprise a probe port configured to receive a sensing probe. The probe port can comprise an internal surface comprising an undercut formed from the overmold. The overmold can extend axially beyond the preassembled structure to form a lip. The overmold can comprise a recessed portion that forms a gripping area. The plurality of rigid components can protrude through the overmold to at least partially define the gripping area. The rigid cuff can be configured to form a connection between the medical tube and a gases delivery system component.

[0009] According to at least one aspect of the present disclosure, a gases delivery system to deliver gases to a patient can have one, some, or all of the following features, as well as other features described herein. The gases delivery system comprises a gases source. The gases delivery system comprises a humidifier. The humidifier is configured to receive gases provided by the gases source and to heat and/or humidify the gases. The gases delivery system comprises a medical circuit configured to deliver heated and/or humidified gases provided by the humidifier to the patient via a patient interface. The medical circuit comprises a medical tube. The medical tube comprises a first elongate member. The medical tube comprises a second elongate member. The medical circuit comprises a connector. The connector comprises a plurality of rigid components at least partially surrounded by an overmold. The medical circuit is reusable.

[0010] According to at least one aspect of the present disclosure, a reusable connector for a gases delivery system can have one, some, or all of the following features, as well as other features described herein. The reusable connector comprises a plurality of rigid components. The reusable connector comprises an overmold. The overmold comprises a recessed portion that forms a gripping region. The plurality of rigid components is at least partially surrounded by the overmold. The plurality of rigid components at least partially defines the gripping region.

[0011] The plurality of rigid components can comprise at least one of a rigid cuff, a power adaptor port, and a carrier part. The carrier part can comprise a probe port configured to receive a sensing probe. The overmold can form an undercut on an internal surface of the power adaptor port and/or the probe port.

[0012] According to at least one aspect of the present disclosure, a medical circuit for a gases delivery system can have one, some, or all of the following features, as well as other features described herein. The medical circuit comprises a medical tube. The medical tube comprises a first elongate member. The medical tube comprises a second elongate member. The first elongate member comprises a lumen. The medical circuit comprises a connector configured to connect the medical tube to a gases delivery system component. The connector comprises a plurality of rigid components, some of which form at least part of a preassembled structure. The plurality of rigid components comprise a power adaptor port comprising a vent configured to be in gaseous communication with the lumen of the first elongate member via a gases pathway. The vent allows gases to move between the lumen of the first elongate member and the atmosphere. The vent substantially prevents ingress of liquid into the lumen of the first elongate member.

[0013] At least part of the preassembled structure can be at least partially surrounded by an overmold. The connector can comprise an edge adjacent the medical tube. A portion of the edge can follow a helical orientation of the first elongate member. The edge can comprise an offset portion. The offset portion can allow the portion of the edge to follow the helical orientation of the first elongate member. The vent can comprise a membrane. The power adaptor port can comprise an inner conduit inserted into the first elongate member and a vent path between the vent and the inner conduit. The medical tube can comprise a compressed or flattened extension portion extending in the connector past a point where the vent communicates with the lumen of the first elongate member.

[0014] For purposes of summarizing the disclosed systems and apparatus, certain aspects, advantages and novel features of the disclosed systems and apparatus have been described herein. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular embodiment of the disclosed systems and apparatus. Thus, the disclosed systems and apparatus may be embodied or carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] These and other features, aspects, and advantages will be described with respect to the following figures, which are intended to illustrate and not to limit the disclosed embodiments.

[0016] Fig. 1 shows a schematic of a gases delivery system.

[0017] Fig. 2 shows a perspective view of a medical circuit according to an embodiment of the present disclosure.

[0018] Fig. 3 shows an axial cross-section of the medical circuit according to the embodiment of Fig. 2.

[0019] Figs. 4A, 4B, 4C, and 5 show components of the medical circuit according to the embodiment of Fig. 2.

[0020] Fig. 6 shows a perspective view of the medical circuit according to the embodiment of Fig. 2.

[0021] Figs. 7 and 8 show perspective views of a medical tube comprising a vent according to an embodiment of the present disclosure.

[0022] Figs. 9, 10, and 11 show perspective views of a medical circuit comprising a vent according to an embodiment of the present disclosure.

[0023] Fig. 12 shows a perspective view of a medical circuit according to an embodiment of the present disclosure.

[0024] Fig. 13 shows a perspective view of a medical circuit comprising a vent according to an embodiment of the present disclosure.

[0025] Fig. 14 shows a front sectional view of a vent comprising a housing according to an embodiment of the present disclosure.

[0026] Fig. 15 shows a perspective view of a medical circuit according to an embodiment of the present disclosure.

[0027] Fig. 16 shows a cross-sectional view of a housing according to the embodiment of Fig. 15.

[0028] Fig. 17 shows an exploded view of a housing according to the embodiment of Fig. 15.

[0029] Fig. 18 shows a perspective view of a medical circuit according to the embodiment of Fig. 15.

[0030] Fig. 19A shows an isometric view of a medical circuit according to an embodiment of the present disclosure.

[0031] Fig. 19B shows a top plan view of the medical circuit according to the embodiment of Fig. 19 A.

[0032] Fig. 19C shows a bottom plan view of the medical circuit according to the embodiment of Fig. 19 A.

[0033] Fig. 20A shows an isometric view of a medical circuit according to an embodiment of the present disclosure.

[0034] Fig. 20B shows a top plan view of the medical circuit according to the embodiment of Fig. 20A.

[0035] Fig. 20C shows a bottom plan view of the medical circuit according to the embodiment of Fig. 20A.

[0036] Fig. 21 A shows a top plan view of a medical circuit according to an embodiment of the present disclosure.

[0037] Fig. 2 IB shows a bottom plan view of the medical circuit according to the embodiment of Fig. 21 A.

[0038] Fig. 22A shows a side perspective view of a power adaptor port according to an embodiment of the present disclosure.

[0039] Fig. 22B shows a top perspective view of the power adaptor port according to the embodiment of Fig. 22A.

[0040] Fig. 22C shows a bottom perspective view of the power adaptor port according to the embodiment of Fig. 22A.

[0041] Fig. 22D shows a side cross-sectional view of the power adaptor port according to the embodiment of Fig. 22A.

[0042] Fig. 22E shows another side cross-sectional view of the power adaptor port according to the embodiment of Fig. 22A.

[0043] Fig. 22F shows a top plan view of a medical circuit incorporating the power adaptor port according to the embodiment of Fig. 22A.

[0044] Fig. 22G shows a cross-sectional, bottom plan view of the medical circuit according to the embodiment of Fig. 22F.

[0045] Fig. 23 shows a perspective view of a medical circuit according to an embodiment of the present disclosure.

[0046] Fig. 24A shows an isometric view of a medical circuit according to an embodiment of the present disclosure.

[0047] Fig. 24B shows a top plan view of the medical circuit according to the embodiment of Fig. 24A.

[0048] Fig. 24C shows a bottom plan view of the medical circuit according to the embodiment of Fig. 24A.

[0049] Fig. 25A shows an isometric view of a medical circuit according to an embodiment of the present disclosure.

[0050] Fig. 25B shows a top plan view of the medical circuit according to the embodiment of Fig. 25A.

[0051] Fig. 25C shows a bottom plan view of a connector according to the embodiment of Fig. 25A.

DETAILED DESCRIPTION

Terminology

[0052] A gases delivery system as herein described may refer to a respiratory system or a surgical system such as, but not limited to, a laparoscopic insufflation system.

[0053] A vent as herein described may refer to a filter, or medium that has properties that contribute to permeability to gases, and impermeability to another substance or substances, such as a liquid.

[0054] Gases as herein described may refer to air, oxygen, carbon dioxide, or any combination of two or more of these.

[0055] A substance or substances as herein described may refer to a liquid such as water, detergent, or cleaning chemicals.

[0056] A medical tube or circuit as herein described may refer to a tube, conduit, or hose that may transport gases to and/or from a patient via a patient interface. In some embodiments, the medical tube or circuit may transport respiratory or insufflation gases to and/or from a patient.

[0057] A patient interface as herein described may refer to a face mask, endotracheal tube, nasal cannula, nasal mask, oral mask, tracheal mask, laparoscopic cannula, or diffuser.

[0058] A cycle as herein described may refer to a cleaning cycle. Thus, cleaning a medical tube using conventional cleaning approaches such as autoclaving, soaking, or pasteurizing, either prior to or after use may be termed a cycle.

[0059] A reusable medical tube or reusable circuit as herein described may refer to a medical tube or circuit that can undergo multiple cleaning cycles. The medical tube or circuit can thus be reused by the same patient, or by different patients.

[0060] A user as herein described may refer to an individual or healthcare provider that prepares the medical tube for the patient. It is to be understood that a user may perform other actions with regards to use of a medical tube that are included in the scope of the present disclosure.

[0061] A plurality of heater wires and/or sensing wires as herein described may refer to no heater wires and/or sensing wires, at least one heater wire and/or sensing wires, or multiple heater wires and/or sensing wires. The heater wire may take the form of a heating element or heating filament.

[0062] A respiratory assistance system as herein described may refer to a system that delivers respiratory gases, such as oxygen, carbon dioxide, and/or air, or any combination of these, to and/or from a patient.

[0063] A gases supply as herein described may refer to an apparatus that supplies gases to a gases delivery system such that the gases may be delivered to a patient. The gases supply may, for example, take the form of a ventilator or blower.

[0064] A patient interface as herein described may refer to, but is not limited to, a mask, oral mask, nasal mask, nasal cannula, nasal pillows, endotracheal tube, trache, or tracheal mask.

[0065] A gases delivery system component as herein described may refer to, but is not limited to, a humidification apparatus, a humidification chamber, a patient interface, a water trap, a gases supply, a wye-piece, a medical tube, a connector for any these, or any other component or accessory used in a gases delivery system.

Gases Delivery Systems

[0066] Fig. 1 shows a schematic of a typical gases delivery system 100, wherein a gases supply 110 supplies gases to a humidification apparatus 150, which supplies heated and humidified gases to a patient 190 via a medical circuit, for example an inspiratory circuit 170, and a patient interface 180. The gases supply 110 and the humidification apparatus 150 may be integrated into a shared housing or may comprise separate housings. In some embodiments, another medical circuit, such as a supply circuit 130, may be used to transport gases from the gases supply 110 to the humidification apparatus 150. In some embodiments, exhaled gases may be transported to the gases supply 110 or elsewhere via another medical circuit, such as an expiratory circuit 160. It is to be understood that some gases delivery systems may not comprise the expiratory circuit 160 and that other variations from the gases delivery system shown may exist.

Medical Circuit

[0067] Medical circuits used in hospital settings, such as the expiratory circuit 160, the supply circuit 130, and the inspiratory circuit 170, are often disposable, meant for single patient use and/or a pre-defined maximum duration of use, and thus are disposed of following treatment. Reusable medical circuits have been developed that have a longer lifespan and are able to be cleaned such that they can be reused. Robustness is a key feature of reusable medical circuits, which must undergo many cycles of high level disinfection or sterilisation in between patient uses. As a result, many reusable medical circuits are heavy and cumbersome in use, which may result in patient discomfort.

[0068] A heated reusable medical circuit may comprise a heater wire located in the lumen of the medical circuit. The heater wire may need to be removed prior to cleaning. Following cleaning, the heater wire must then be reinserted into the medical circuit and electrically connected to a connector before the medical circuit can be used for the next patient. This process can be complicated and time consuming.

Medical Tube

[0069] An example medical circuit 205 is shown in Fig. 2. The medical circuit 205 comprises a medical tube 220 that comprises a first elongate member 224 and a second elongate member 228. The medical tube 220 is described in International Patent Publication No. WO 2014/088430, published June 12, 2014, corresponding to International Patent Application No. PCT/NZ2013/000222, filed December 4, 2013, and entitled MEDICAL TUBES AND METHODS OF MANUFACTURE, which is incorporated herein by reference in its entirety.

[0070] As shown in Fig. 3, the first elongate member 224 is hollow, which enables the medical tube 220 to be lightweight. The first elongate member 224 provides thermal insulation, improved humidity performance, and increased flexibility to the medical tube 220. The first elongate member 224 may be at least partially transparent to enable a user to inspect the lumen of the medical tube 220 for blockage or contaminants, or to confirm the presence of moisture. The medical tube 220 is preferably thermally insulating, and as such prevents or reduces heat loss from the gases transported through the lumen of the medical tube 220 to the atmosphere. The first elongate member 224 can be filled with a gas, for example air, to increase insulating performance.

[0071] The second elongate member 228 of Figs. 2 and 3 acts as structural support for the first elongate member 224. The second elongate member 228 can comprise at least one heater wire or sensing wire (not shown), or a combination of heater and sensing wires. Thus, a heater wire, a sensing wire, or a combination of heater and sensing wires can be integrated into the wall of the medical tube 220. This reduces the steps required to prepare the medical tube 220, and thus the medical circuit 205, for cleaning and for use on a patient. The medical tube 220 is a spirally wound structure comprising a flexible, hollow body and an integral support. This provides crush resistance, while leaving the medical tube 220 flexible enough to permit short-radius bends without kinking, occluding, or collapsing. This structure can also provide a smooth internal wall for the medical tube 220, which helps keep the medical tube 220 free from deposits and improves gas flow.

[0072] The medical tube 220 may be constructed of materials having properties that enable the medical tube 220 to withstand the rigorous cleaning approaches of autoclaving, pasteurization, high level disinfection, thermal sterilisation, or soaking in chemicals. The materials for the medical tube 220 can be chosen to make the medical tube 220 easier to manufacture, to make the medical tube 220 lighter weight and less cumbersome than other medical tubes, and to form a bond between the medical tube 220 and a connector that can limit or eliminate areas where dirt or potentially harmful substances may become trapped and that can withstand repeated connection and disconnection of the medical circuit 205 to and from a gases delivery system component.

Connector

[0073] In gases delivery systems, connectors are often single use or disposable connectors. In some cases, connectors may be made to be cleaned using washer-disinfector machines, pasteurization, or by soaking and/or autoclaving between patients or between uses, such that a circuit comprising such a connector can be classed as a reusable circuit. Reusable circuits may have a defined duration of use and/or may be designed for a specified number of cleaning or disinfection cycles. Such circuits may be desirable for long term solutions.

[0074] A reusable connector may comprise a rigid body with appropriate ports for power adaptors and/or external probes. A connector may have a limited life span following the rigorous cleaning processes it undergoes. In some cases, a connector may have a soft body and a soft taper used to form a connection with a gases delivery system component. In some cases, a connector may have a rigid part suspended within a soft body to provide structural integrity to the body. A medical tube may have a heating component to heat the gases within the tube such that less condensate is produced when using a humidified system. The heating component may be within the lumen of the tube, embedded into the wall of the tube, or

outside of the tube. The heating component may need to interact with the connector to form or terminate an electrical connection.

[0075] It is recognised that some disadvantages may exist in other connectors. For example, connectors with a soft body and a soft connection cuff, which may in some cases comprise a taper, may have highly variable connection, disconnection, and retention forces, which reduce substantially if the connector is wet. The forces for connection and/or disconnection may be elevated when the connection cuff is dry so that sufficient disconnection and/or retention forces are still achieved when the taper is wet. Thus, the connection or disconnection may require high user force input and may be difficult to use when the connector is not wet.

[0076] A heated reusable circuit may have a heating component, such as a heating wire located within the lumen of the circuit. This may need to be removed manually to prepare the circuit for cleaning and may be reinserted into the circuit following the cleaning procedure in preparation for the next use. Such a process may be time consuming, complex, and demanding, thus reducing the overall usability of the circuit.

[0077] A rigid connector body may include a plurality of rigid components to interact with a power adaptor and/or probes. Variation of the power adaptors and/or probes may make coupling and/or sealing between these and the plurality of rigid components more difficult.

[0078] The materials used for a reusable circuit may not be autoclavable and, thus, may become damaged or may degrade during cleaning procedures. As a result, these cleaning procedures may be limited to only lower temperature procedures. In some cases, the medical tube and the connector may separate in use, which may cause the circuit to be discarded. Some reusable circuits have a limited life span and, thus, may have to be replaced more frequently than desired.

[0079] As generally shown in Fig. 2, the circuit 205 comprises a connector 200 that at least partially overcomes or ameliorates at least one disadvantage of other connectors. The connector 200 is adapted to be coupled with the medical tube 220 that comprises the first elongate member 224 and the second elongate member 228. As discussed, the first elongate

member 224 may be a hollow structure that provides insulation and flexibility to the medical tube 220, whereas the second elongate member 228 may provide structural support to the medical tube 220 and, in some embodiments, may comprise a heating and/or sensing component. The heating and/or sensing component may be embedded into the wall of the medical tube 220, which may improve the usability aspects of the medical tube 220 while enabling the circuit 205 to be heated.

[0080] As discussed in greater detail below, the connector 200 may comprise a plurality of rigid components that can be preassembled before the application of an overmold. As a result, the connector 200 may form a connection between the medical tube 220 and a gases delivery system component via a rigid taper while maintaining a soft connector body. The rigid taper may maintain a lower and more consistent connection, disconnection, or retention force regardless of the connector 200 being wet or dry. The rigid taper may also reduce the impact of side loading on the connection, which may cause disconnection between the medical tube 220 and a gases delivery system component. The soft overmold may also provide a soft surface and, in some embodiments, a flexible protrusion or undercut that may form a sealing ring on the inside of power adaptor ports and/or probe ports. This may improve the seal and coupling between the ports and a power adaptor and/or external probes. The soft surface and sealing ring may compensate for any variation that may occur.

[0081] Materials may be used that allow the circuit 205 to be autoclaved. Also, the medical tube 220 and the connector 200 may be made from materials with the same or similar thermal properties, for example the same melting point, which may reduce or eliminate the likelihood of damage to the circuit 205 occurring during manufacturing and cleaning. The circuit 205 may be able to survive at least 50 cleaning cycles with minimal damage, reduction in structural integrity, or alteration to its appearance.

[0082] The connector 200 is shown in Figs. 2 and 3 connected to the medical tube 220. The connector 200 may be permanently attached at either end of the medical tube 220 and may form a connection with a gases delivery system component. In some embodiments, the medical tube 220 and the connector 200 are reusable. The medical tube 220 comprises the first elongate member 224 and the second elongate member 228. The first elongate member 224 may be hollow, which provides an insulating and flexible component to the medical tube 220. The second elongate member 228 may be a more rigid component that provides structural strength to the medical tube 220. In some embodiments, the second elongate member 228 may comprise a heating component and, in some embodiments, a sensing component, such that heating and/or sensing can be embedded into the wall of the medical tube 220. The heating component may be in the form of a plurality of heater wires, for example, two heater wires. The plurality of heater wires may be integrated or embedded into the wall of the medical tube 220.

[0083] The first elongate member 224 and the second elongate member 228 cooperate to reduce the condensate formation and to maintain the humidity of the gases as they are transported within the medical tube 220. The connector 200 may provide an electrical interface between an embedded heating component of the medical tube 220 and a gases delivery system component. This electrical connection may be in the form of, for example, an external lead or an integral electrical connector. In some embodiments, the electrical connection may occur between the connector 200 and the electrical source when the connector 200 is connected with a gases delivery system component. An embedded heating component may substantially improve the usability of the circuit 205 when compared with other reusable circuits because the user may not need to disassemble and/or preassemble the heating component with regards to the tube in preparation for cleaning and/or future use.

[0084] The connector 200 may comprise a plurality of rigid components 230 that provide a structural component as well as a rigid taper for the connection of the connector 200 to a gases delivery system component. The plurality of rigid components 230 may be formed from a rigid material, such as, for example, polypropylene. An overmold 240 coats the plurality of rigid components 230 and provides a soft outer surface for the connector 200. Materials used for the overmold 240 may be, but are not limited to, thermoplastic elastomers.

[0085] In some embodiments, a region where the plurality of rigid components 230 protrude through the overmold 240 may at least partially define a gripping region 245. The overmold 240 may, in some embodiments, comprise a recessed and/or contoured portion to accentuate the gripping region 245. An embodiment of the gripping region 245 wherein the plurality of rigid components 230 do not protrude through the overmold 240, or an embodiment which does not comprise a recessed and/or contoured overmolded portion, or any combination of the above, also falls within the scope of the present disclosure. The gripping region 245 may improve the usability of the connector 200 as it is connected or disconnected from a gases delivery system component.

[0086] The overmold 240 may, in some embodiments, form a lip 260 that extends beyond the plurality of rigid components 230, as shown more clearly in Fig. 6. The lip 260 may comprise a flexible tip and may aid the connection between the connector 200 and a gases delivery system component. The connection may be aided due to a chamfered lead-in, which may improve the alignment of the connector 200 with a gases delivery system component.

[0087] The plurality of rigid components 230 may be arranged in such a way that the plurality of rigid components 230 form an internal wall having a smooth and continuous transition to the internal wall of the medical tube 220. Thus, areas where dirt or potentially harmful substances may become trapped may be limited or eliminated. This may contribute to the medical circuit 205 being able to be satisfactorily cleaned such that it may be reused. Cleaning mechanisms may include, but are not limited to, soaking and autoclaving. A smooth and continuous internal wall spanning between the medical tube 220 and the connector 200 may also prevent an increase in resistance to flow within the circuit 205.

[0088] The plurality of rigid components 230 may comprise, for example, a power adaptor port 430, a carrier part 420, and a rigid cuff 410, as shown in more detail in Figs. 4a, 4b, and 4c. The plurality of rigid components 230 is in no way limited to three rigid components but may, in some embodiments, comprise two or fewer rigid components (inclusive of zero rigid components, for example in an overmolded connector) and, in other embodiments, may comprise four or more rigid components.

[0089] The power adaptor port 430 is shown in more detail in Fig. 4C and may facilitate the electrical connection between the connector 200 and an electrical source, thereby providing power to the heating component of the medical tube 220. The electrical source may, in some embodiments, be at least partially associated with a gases delivery

system component or it may be a separate apparatus. An external lead may be used to provide the connection between the power adaptor port 430 and the electrical source. Some embodiments may not comprise a heating component within the medical tube 220 and, thus, the connector 200 may not comprise the power adaptor port 430. In other embodiments, multiples of the power adaptor port 430 may be used and associated with the connector 200. In some embodiments, the power adaptor port 430 may be incorporated with another of the plurality of rigid components 230, for example, with the carrier part 420.

[0090] The carrier part 420 is shown in more detail in Fig. 4B and may comprise a probe port 425 that can be configured to receive a sensor probe, for example, a temperature probe or a flow probe. In some embodiments, multiples of the probe port 425 may be associated with the connector 200 while, in other embodiments, the connector 200 may not comprise the probe port 425. In some embodiments, the overmold 240 may provide a soft inner surface to a portion of the probe port 425 and/or the power adaptor port 430. Thus, the probe port 425 and/or the power adaptor port 430 may comprise a soft portion to improve the seal between a probe and/or a power adaptor that may be inserted into the probe port 425 and/or the power adaptor port 430, respectively, by compensating for variations that exist in the contacting surfaces. In some embodiments, the overmold 240 comprises an undercut or flexible protrusion 250, as illustrated in Fig. 2 and 3. The flexible protrusion 250 may comprise an overhanging lip and may be a compressible and sealing protrusion that compensates for surface variations in the probe port 425. The flexible protrusion 250 may be used with the power adaptor port 430 in addition to, or instead of, the probe port 425 and, thus, is not limited to the probe port 425.

[0091] The rigid cuff 410 is shown in more detail in Fig. 4A and may be integrated with the medical tube 220 such that the rigid cuff 410 may interact with a port on a gases delivery system component to form a connection between the connector 200 and the gases delivery system component. The rigid cuff 410 may be configured to connect with different medical tapers, for example, but not limited to, a 22 mm tapered cuff. In some embodiments, the rigid cuff 410 may be configured to connect with a female tapered cuff. In other embodiments, the rigid cuff 410 may be configured to connect with a male tapered cuff. [0092] To remove the connector 200, an axial rotational force may be applied to break the taper or friction seal followed by removing the connector 200. The force required to remove the connector 200 following the breaking of the taper seal may, therefore, be lower than other connectors because such force may not be required to break the taper seal. As a result, it may be less difficult to remove the connector 200 than other connectors. The retention force may be maintained such that it is sufficient for the requirements of the gases delivery system 100. The rigid cuff 410 may also provide a substantially constant connection and/or disconnection force between the connector 200 and a gases delivery system component. This force may not be substantially reduced upon wetting of the connector 200. As a result, usability is improved when compared to other connectors because a substantially lower force is needed to form and/or break a connection while reducing failure rates and without impacting the connection between the connector 200 and a gases delivery system component. The rigid cuff 410 may further reduce the impact of side loading of the connector 200, which in other connectors can cause unwanted and/or accidental disconnection at low forces as a result of the elastic and/or flexible cuffs that may be used. This may improve the overall performance and usability of the connector 200.

[0093] The plurality of rigid components 230 may form at least part of a preassembled structure 500, for example, by clipping the plurality of rigid components 230 into place in preparation for overmolding, as shown in more detail in Fig. 5. In some embodiments, the preassembled structure 500 may be formed from two or more of the plurality of rigid components 230, for example, two or more of the power adaptor port 430, the carrier part 420, and the rigid cuff 410. Any combination of two or more of the plurality of rigid components 230 may be used. The plurality of rigid components 230 provide a lower cost material to fill the bulk of the connector 200, with the overmold 240 being formed around the preassembled structure 500. The thickness of the overmold 240 may be reduced when compared with other connectors, which may reduce the overall manufacturing time due to a reduced cooling time.

[0094] In some embodiments, the preassembled structure 500 may comprise a clamp (not shown) to aid with the manufacturing of the connector 200. The clamp may be

coupled with the power adaptor port 430 or, in alternative embodiments, may be coupled with other components of the plurality of rigid components 230, for example, the carrier part 420 or the rigid cuff 410. As an example, the clamp may attach to the second elongate member 228 such that it is held in place in relation to the preassembled structure 500 during manufacturing in preparation for the application of the overmold 240. In some embodiments, the clamp may attach to the first elongate member 224.

[0095] The materials of the plurality of rigid components 230 and of the overmold 240 may be chosen such that they bond to form the connector 200. The medical tube 220 may also be made from a thermoplastic elastomer that will bond with the connector 200. The bonding may aid in reducing or eliminating the likelihood of separation of the medical tube 220 and the connector 200 over repeated uses, which separation may create dirt traps that may be difficult to clean. The melting point of the material of the medical tube 220 may be comparable to that of the connector 200, such that the medical tube 220 is less likely to be damaged during manufacturing.

[0096] Material choice may also take into consideration the feel and appearance of the connector 200, such that it is aesthetically pleasing. Similarly, material choices may comprise materials that maintain this appearance throughout the life of the circuit 205. This is an improvement compared with other reusable circuits, which may discolour as the materials degrade over time and/or in response to the cleaning processes. Use of thermoplastic elastomers may also reduce the overall cost of the connector 200. A simplified embodiment may use glue or adhesive to secure the connector 200 and the medical tube 220 together.

[0097] The materials may be chosen such that the overall assembly of the medical tube 220 and the connector 200 can be autoclaved and/or soaked. As a result, the medical circuit 205 may be reused. The medical circuit 205 may last for up to 50 cycles without compromising the condition of the medical tube 220 and the connector 200.

[0098] As discussed below, in some embodiments, a vent may be incorporated into the connector 200 and/or the medical tube 220 to allow gases to move into/out of the first elongate member 224 during autoclaving.

[0099] In some embodiments, the circuit 205 may comprise an inspiratory tube that extends between a patient interface or wye-piece and a humidification apparatus.

Vent

[0100] Autoclaving exposes the medical tube 220 to a large range of pressures and temperatures. Some embodiments include the realization that a vent can advantageously allow air or other gases to move between the lumen of the first elongate member 224 and the atmosphere during autoclaving to prevent the first elongate member 224 from bursting or collapsing, which would cause the medical tube 220 to become unsightly and diminish the insulating properties of the first elongate member 224. In some embodiments, a vent is inserted directly or indirectly into the first elongate member 224 to prevent the lumen of the first elongate member 224 from bursting or collapsing during autoclaving. The vent allows a gases pathway between the lumen of the first elongate member 224 and the atmosphere. Indirect insertion of the vent involves a housing that maintains gaseous communication between the lumen of the first elongate member 224 and the vent.

[0101] The vent can comprise a material with a low surface tension to discourage liquid and/or substances from entering the lumen of the first elongate member 224 during soakage. Liquid and/or substance ingress may cause the first elongate member 224 to become unsightly and heavy, which may increase patient discomfort. In an embodiment, the vent can comprise a hole through which gases can flow. A cap seals the hole to prevent liquid and/or substances from entering the lumen of the first elongate member 224 during soakage.

[0102] Fig. 7 shows an embodiment of the medical tube 220 for use within a gases delivery system. The medical tube 220 comprises the first elongate member 224 and the second elongate member 228. The first elongate member 224 is hollow, thus comprising a lumen, that provides thermal insulation to the medical tube 220. This improves the flexibility and humidity performance of the medical tube 220 when compared with other medical tubes. The first elongate member 224 comprises a vent 720. The second elongate member 228 provides reinforcement to the medical tube 220. The second elongate member 228 comprises a plurality of heater wires (not shown) to heat the medical tube 220.

[0103] Fig. 8 shows that the vent 720 can be inserted into a lumen 830 of the first elongate member 224. At least a portion of the vent 720 protrudes from the lumen 830 of the first elongate member 224. In an embodiment, the vent 720 can be fully inserted into the lumen 830 of the first elongate member 224 so that it does not protrude from the lumen 830.

[0104] An embodiment of the connector 200 is overmolded onto the medical tube 220 as shown in more detail in Fig. 9. In some embodiments, a pin may be inserted during the molding process to maintain a gases pathway 940 between the lumen 830 of the first elongate member 224 and the atmosphere. The vent 720 is positioned within the gases pathway 940. This embodiment provides a simple option for inserting the vent 720 into the lumen 830 of the first elongate member 224.

WE CLAIMED

1. A medical circuit for a gases delivery system comprising:

a medical tube, the medical tube comprising a first elongate member, the first elongate member comprising a lumen; and

a vent coupled to the first elongate member such that it maintains gaseous communication with the lumen of the first elongate member;

wherein the vent allows gaseous communication between the lumen of the first elongate member and the atmosphere and substantially prevents ingress of liquid into the lumen of the first elongate member.

2. A medical circuit as claimed in claim 1, wherein the vent comprises a material with a low surface tension.

3. A medical circuit as claimed in claim 1 or claim 2, wherein the vent is inserted directly into the lumen of the first elongate member.

4. A medical circuit as claimed in claim 1 or claim 2, comprising a housing, the vent coupled to the first elongate member via the housing.

5. A medical circuit as claimed in claim 4, wherein the housing is inserted into the lumen of the first elongate member.

6. A medical circuit as claimed in claim 4, wherein the housing comprises an inner conduit, the vent coupled to the first elongate member via the inner conduit.

7. A medical circuit as claimed in any one of claims 4 to 6, comprising a connector, the housing coupled to the connector via overmolding.

8. A medical circuit as claimed in claim 7, wherein the medical tube comprises a second elongate member, the second elongate member comprising one or more wires.

9. A medical circuit as claimed in claim 8, wherein the one or more wires comprise heater wires.

10. A medical circuit as claimed in claim 8, wherein the one or more wires comprise sensing wires.

11. A medical circuit as claimed in claim 8, wherein the housing comprises an electrical connection between the one or more wires and the connector.

12. A medical circuit as claimed in any one of claims 4 to 11, wherein the housing comprises a gases pathway from the vent to the atmosphere.

13. A medical circuit as claimed in any one of claims 4 to 12, wherein the housing comprises a plug and a receiving portion.

14. A medical circuit as claimed in any one of claims 4 to 13, wherein the housing comprises a piercing member.

15. A medical circuit as claimed in any one of claims 1 to 14, wherein the vent comprises polytetrafluoroethylene.

16. A medical circuit as claimed in any one of claims 1 to 15, wherein the vent is a solid component.

17. A medical circuit as claimed in any one of claims 1 to 15, wherein the vent is a film.

18. A medical circuit for a gases delivery system comprising:

a medical tube, the medical tube comprising a first elongate member and a second elongate member; and

a connector configured to connect the medical tube to a gases delivery system component, the connector comprising a plurality of rigid components;

wherein one or more of the plurality of rigid components form at least part of a preassembled structure, the preassembled structure at least partially surrounded by an overmold.

19. A medical circuit as claimed in claim 18, wherein the plurality of rigid components comprise at least two of a rigid cuff, a power adaptor port, and a carrier part.

20. A medical circuit as claimed in claim 19, wherein the power adaptor port comprises an internal surface comprising an undercut formed from the overmold.

21. A medical circuit as claimed in claim 19, wherein the carrier part comprises a probe port configured to receive a sensing probe.

22. A medical circuit as claimed in claim 21, wherein the probe port comprises an internal surface comprising an undercut formed from the overmold.

23. A medical circuit as claimed in any one of claims 18 to 22, wherein the overmold extends axially beyond the preassembled structure to form a lip.

24. A medical circuit as claimed in any one of claims 18 to 23, wherein the overmold comprises a recessed portion that forms a gripping area.

25. A medical circuit as claimed in claim 24, wherein the plurality of rigid components protrude through the overmold to at least partially define the gripping area.

26. A medical circuit as claimed in any one of claims 19 to 25, wherein the rigid cuff is configured to form a connection between the medical tube and the gases delivery system component.

27. A gases delivery system to deliver gases to a patient, the gases delivery system comprising:

a gases source;

a humidifier configured to receive gases provided by the gases source and to heat and/or humidify the gases; and

a medical circuit configured to deliver heated and/or humidified gases provided by the humidifier to the patient via a patient interface, the medical circuit comprising:

a medical tube, the medical tube comprising a first elongate member and a second elongate member; and

a connector, the connector comprising a plurality of rigid components at least partially surrounded by an overmold;

wherein the medical circuit is reusable.

28. A reusable connector for a gases delivery system comprising:

a plurality of rigid components; and

an overmold, the overmold comprising a recessed portion that forms a gripping region;

wherein the plurality of rigid components is at least partially surrounded by the overmold and the plurality of rigid components at least partially defines the gripping region.

29. A reusable connector as claimed in claim 28, wherein the plurality of rigid components comprise at least one of a rigid cuff, a power adaptor port, and a carrier part.

30. A reusable connector as claimed in claim 29, wherein the carrier part comprises a probe port configured to receive a sensing probe.

31. A reusable connector as claimed in claim 29, wherein the overmold forms an undercut on an internal surface of the power adaptor port.

32. A reusable connector as claimed in claim 31, wherein the overmold forms an undercut on an internal surface of the probe port.

33. A medical circuit for a gases delivery system, the medical circuit comprising: a medical tube, the medical tube comprising a first elongate member and a second elongate member, the first elongate member comprising a lumen; and

a connector configured to connect the medical tube to a gases delivery system component, the connector comprising a plurality of rigid components forming at least part of a preassembled structure, the plurality of rigid components comprising a power adaptor port, the power adaptor port comprising a vent configured to be in gaseous communication with the lumen of the first elongate member;

wherein the vent allows gases to move between the lumen of the first elongate member and the atmosphere and substantially prevents ingress of liquid into the lumen of the first elongate member.

34. A medical circuit as claimed in claim 33, comprising an overmold, the preassembled structure at least partially surrounded by the overmold.

35. A medical circuit as claimed in claim 33 or claim 34, wherein the connector comprises an edge adjacent the medical tube, a portion of the edge following a helical orientation of the first elongate member.

36. A medical circuit as claimed in claim 35, wherein the edge comprises an offset portion, the offset portion allowing the portion of the edge to follow the helical orientation of the first elongate member.

37. A medical circuit as claimed in any one of claims 33 to 36, wherein the vent comprises a membrane.

38. A medical circuit as claimed in any one of claims 33 to 37, wherein the power adaptor port comprises an inner conduit inserted into the first elongate member and a vent path between the vent and the inner conduit.

39. A medical circuit as claimed in any one of claims 33 to 38, comprising a compressed or flattened extension portion extending in the connector past a point where the vent communicates with the lumen of the first elongate member.

Documents

Application Documents

# Name Date
1 201617044608-IntimationOfGrant07-12-2023.pdf 2023-12-07
1 Priority Document [28-12-2016(online)].pdf 2016-12-28
2 201617044608-PatentCertificate07-12-2023.pdf 2023-12-07
2 Form 5 [28-12-2016(online)].pdf 2016-12-28
3 Form 3 [28-12-2016(online)].pdf 2016-12-28
3 201617044608-FER.pdf 2021-10-17
4 Form 1 [28-12-2016(online)].pdf 2016-12-28
4 201617044608-ABSTRACT [19-11-2020(online)].pdf 2020-11-19
5 Drawing [28-12-2016(online)].pdf 2016-12-28
5 201617044608-CLAIMS [19-11-2020(online)].pdf 2020-11-19
6 Description(Complete) [28-12-2016(online)].pdf_20.pdf 2016-12-28
6 201617044608-COMPLETE SPECIFICATION [19-11-2020(online)].pdf 2020-11-19
7 Description(Complete) [28-12-2016(online)].pdf 2016-12-28
7 201617044608-DRAWING [19-11-2020(online)].pdf 2020-11-19
8 Other Patent Document [08-04-2017(online)].pdf_197.pdf 2017-04-08
8 201617044608-FER_SER_REPLY [19-11-2020(online)].pdf 2020-11-19
9 201617044608-FORM 3 [19-11-2020(online)].pdf 2020-11-19
9 Other Patent Document [08-04-2017(online)].pdf 2017-04-08
10 201617044608-FORM-8 [19-11-2020(online)].pdf 2020-11-19
10 Form 26 [25-04-2017(online)].pdf 2017-04-25
11 201617044608-Information under section 8(2) [19-11-2020(online)].pdf 2020-11-19
11 201617044608-Power of Attorney-280417.pdf 2017-05-01
12 201617044608-Correspondence-280417.pdf 2017-05-01
12 201617044608-OTHERS [19-11-2020(online)].pdf 2020-11-19
13 201617044608-FORM 18 [02-07-2018(online)].pdf 2018-07-02
13 201617044608-PETITION UNDER RULE 137 [19-11-2020(online)].pdf 2020-11-19
14 201617044608-MARKED COPIES OF AMENDEMENTS [05-10-2018(online)].pdf 2018-10-05
14 201617044608-Proof of Right [19-11-2020(online)].pdf 2020-11-19
15 201617044608-AMMENDED DOCUMENTS [05-10-2018(online)].pdf 2018-10-05
15 201617044608-FORM 3 [14-03-2019(online)].pdf 2019-03-14
16 201617044608-Amendment Of Application Before Grant - Form 13 [05-10-2018(online)].pdf 2018-10-05
17 201617044608-FORM 3 [14-03-2019(online)].pdf 2019-03-14
17 201617044608-AMMENDED DOCUMENTS [05-10-2018(online)].pdf 2018-10-05
18 201617044608-Proof of Right [19-11-2020(online)].pdf 2020-11-19
18 201617044608-MARKED COPIES OF AMENDEMENTS [05-10-2018(online)].pdf 2018-10-05
19 201617044608-FORM 18 [02-07-2018(online)].pdf 2018-07-02
19 201617044608-PETITION UNDER RULE 137 [19-11-2020(online)].pdf 2020-11-19
20 201617044608-Correspondence-280417.pdf 2017-05-01
20 201617044608-OTHERS [19-11-2020(online)].pdf 2020-11-19
21 201617044608-Information under section 8(2) [19-11-2020(online)].pdf 2020-11-19
21 201617044608-Power of Attorney-280417.pdf 2017-05-01
22 201617044608-FORM-8 [19-11-2020(online)].pdf 2020-11-19
22 Form 26 [25-04-2017(online)].pdf 2017-04-25
23 201617044608-FORM 3 [19-11-2020(online)].pdf 2020-11-19
23 Other Patent Document [08-04-2017(online)].pdf 2017-04-08
24 Other Patent Document [08-04-2017(online)].pdf_197.pdf 2017-04-08
24 201617044608-FER_SER_REPLY [19-11-2020(online)].pdf 2020-11-19
25 Description(Complete) [28-12-2016(online)].pdf 2016-12-28
25 201617044608-DRAWING [19-11-2020(online)].pdf 2020-11-19
26 Description(Complete) [28-12-2016(online)].pdf_20.pdf 2016-12-28
26 201617044608-COMPLETE SPECIFICATION [19-11-2020(online)].pdf 2020-11-19
27 Drawing [28-12-2016(online)].pdf 2016-12-28
27 201617044608-CLAIMS [19-11-2020(online)].pdf 2020-11-19
28 Form 1 [28-12-2016(online)].pdf 2016-12-28
28 201617044608-ABSTRACT [19-11-2020(online)].pdf 2020-11-19
29 Form 3 [28-12-2016(online)].pdf 2016-12-28
29 201617044608-FER.pdf 2021-10-17
30 Form 5 [28-12-2016(online)].pdf 2016-12-28
30 201617044608-PatentCertificate07-12-2023.pdf 2023-12-07
31 201617044608-IntimationOfGrant07-12-2023.pdf 2023-12-07
31 Priority Document [28-12-2016(online)].pdf 2016-12-28

Search Strategy

1 2019-10-2514-07-43_25-10-2019.pdf

ERegister / Renewals

3rd: 27 Feb 2024

From 07/07/2017 - To 07/07/2018

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