Medical Tubing
The medical tubing with a support structure and barrier, featuring an integrally formed connector, addresses the issues of conventional tubing by enhancing patient comfort and reducing assembly time and leaks, achieving tailored mechanical properties for improved usability.
Patent Information
- Application Number
- JP2025522126
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-10-21
- Filing Date
- 2023-10-20
- Publication Date
- 2025-10-09
AI Technical Summary
Conventional medical tubing for delivering breathable gas to patients is not tailored for specific applications, leading to a less than desirable patient experience, and the assembly processes for connectors are time-consuming and prone to leaks or mechanical failure.
The development of medical tubing with a support structure and barrier that forms a tube wall, where the connector is integrally formed with the support structure, allowing for tailored mechanical properties and reduced likelihood of detachment, and includes features like a swivel connector and visual indicators for orientation.
The solution provides improved patient comfort and reduced manufacturing time with enhanced mechanical properties, such as flexibility and reduced risk of leaks, by integrating the connector with the support structure and varying mechanical properties along the tube wall.
Smart Images

Figure 2025534070000001_ABST
Abstract
Description
Related Applications
[0001] This application is based on and claims priority to U.S. Provisional Patent Application No. 63 / 380,475, filed October 21, 2022, the entire contents of which are incorporated by reference. [Technical Field]
[0002] The present disclosure relates to medical tubing, and more particularly to medical tubing for delivering gas to a patient. The present disclosure also relates to a patient gas delivery system. [Background technology]
[0003] A variety of medical tubing is available for delivering breathable gas to patients. For example, some medical tubing has a corrugated monolithic polymer wall to assist in delivering breathable gas to the patient. Other medical tubing has a polymer membrane assisted by reinforcing beads to deliver the gas to the patient. However, these conventional tubings are applied in a relatively general manner and are not tailored for a specific application. This can lead to, for example, a less than desirable patient experience.
[0004] Alternatively, connector portions associated with medical tubing may be press-fit, glued, fastened, or overmolded onto the tubing wall. These assembly processes are time consuming and add to the cost of the tubing. Furthermore, given the nature of the connection between the connector and the tubing wall, some assemblies may leak and / or mechanically fail, which presents a number of problems.
[0005] With this in mind, the inventor(s) developed an improved medical tubing.
[0006] Any reference or discussion in this specification to any document, act, or article of knowledge is included solely for the purpose of providing a context for the present invention, and is not intended to suggest or assert that any of these matters, or any combination of these, formed part of the common general knowledge at the priority date or was known to be relevant to any attempt to solve any problem to which this specification pertains. Summary of the Invention
[0007] Aspects of the present disclosure are summarized below. It should be noted that aspects and embodiments of the present disclosure may be combined such that features and / or embodiments of one aspect may be used with features and / or embodiments of any other aspect where compatible.
[0008] In one aspect, the present disclosure provides a medical tube for delivering gas to a patient, the medical tube comprising: Barriers and a support structure that, together with the barrier, forms a tube wall so as to provide a lumen; a connector configured to connect to a device to allow gas flow within the lumen; At least a portion of the connector is integrally formed with the support structure.
[0009] In a second aspect, the present disclosure provides a medical tube for delivering gas to a patient, the medical tube comprising: Barriers and a support structure forming a tube wall with the barrier so as to provide a lumen for gas flow; The tube wall includes a difference in mechanical properties along the tube wall.
[0010] In a third aspect, the present disclosure provides a medical tube for delivering gas to a patient, the medical tube comprising: Barriers and a support structure forming a tube wall with the barrier so as to provide a lumen for gas flow; The barrier encases the support structure.
[0011] In a fourth aspect, the present disclosure provides a medical tube for delivering gas to a patient, the medical tube comprising: a barrier; and a support structure configured to interact with the barrier and assist in defining a tube wall; The support structure includes one or more tube wall forming members connected to one or more connecting members to help resist the Brazier effect.
[0012] In a fifth aspect, the present disclosure provides a medical tube for delivering gas to a patient, the medical tube comprising: Barriers and a support structure forming a tube wall with the barrier so as to provide a lumen for gas flow; The support structure includes a difference in mechanical properties along the support structure.
[0013] In a sixth aspect, the present disclosure provides a medical tube for delivering gas to a patient, the medical tube comprising: Barriers and a support structure forming a tube wall with the barrier so as to provide a lumen for gas flow; The support structure includes a visual indicator to provide a connection indication.
[0014] In a seventh aspect, the present disclosure provides a medical tube for delivering gas to a patient, the medical tube comprising: Barriers and a support structure that, together with the barrier, forms a tube wall so as to provide a lumen; a patient interface; At least a portion of the tube wall is integrally formed with at least a portion of the patient interface.
[0015] In an eighth aspect, the present disclosure provides a medical tube for delivering gas to a patient, the medical tube comprising: Barriers and a support structure that, together with the barrier, forms a tube wall so as to provide a lumen; accessories, At least a portion of the tube wall is integrally formed with the accessory.
[0016] The accessory may be a coupler. The coupler may be a tube clip.
[0017] The coupler may include an engagement portion.
[0018] The engagement portion may be configured to engage with a patient interface.
[0019] The connection indication can assist in determining the orientation for the connection.
[0020] The connection indication may include color and / or shading.
[0021] The color and / or shading may be different from the color and / or shading of the surrounding medical tubing.
[0022] The support structure may provide one or more openings laterally for gas flow.
[0023] The tube wall may be provided with a contour, which is varied to provide differences in mechanical properties.
[0024] The contours have associated cross sections that may vary to provide differences in mechanical properties.
[0025] The profile may vary relative to the longitudinal axis of the tube wall.
[0026] The profile may include a taper to provide a difference in mechanical properties.
[0027] The taper can provide a portion of the first cross-sectional area that is larger than another portion of the second cross-sectional area.
[0028] The support structure may comprise one or more members.
[0029] One or more of the components may be varied to provide differences in mechanical properties.
[0030] The one or more members may comprise at least one member that varies in size along its length.
[0031] The one or more members may comprise one set of members positioned outwardly, in a direction away from the central axis, relative to other sets of members.
[0032] One or more members can help define the contour.
[0033] One or more of the members may be integrally formed.
[0034] The one or more members may comprise a plurality of members providing a skeleton-type structure.
[0035] The one or more members may comprise one or more tube wall forming members and / or one or more bridging members.
[0036] One or more of the tube wall forming members may be annular.
[0037] The inner molding surface of one or more of the tube wall forming members may be different from the outer molding surface of one or more of the tube wall forming members.
[0038] The inner molding surface may lie in a substantially plane in a direction parallel to the longitudinal axis of the tube wall.
[0039] One or more of the tube wall forming members may extend at an oblique angle relative to the longitudinal axis of the tube wall.
[0040] The thickness of one or more of the tube wall forming members may vary along the tube wall.
[0041] The pitch of one or more of the tube wall forming members may vary.
[0042] The pitch may vary relative to the longitudinal axis of the tube wall.
[0043] The pitch may be measured in the unstretched state of the tube wall.
[0044] One or more bridging members may connect one or more tube wall forming members to one another.
[0045] The number of one or more bridging members connecting one or more tube wall forming members may vary from region to region of the tube wall.
[0046] The one or more bridging members may connect to the one or more tube wall forming members in a first orientation and a second orientation, where the first orientation is different from the second orientation, and the first orientation may be in a first region and the second orientation may be in a second region.
[0047] The first orientation may be offset from the second orientation by approximately 90 degrees.
[0048] The one or more bridging members may comprise at least two bridging members providing a connection between parts of the one or more tube wall forming members.
[0049] At least two bridging members may be disposed on opposite sides of the tube wall.
[0050] One or more of the bridging members may extend in a linear direction.
[0051] The one or more bridging members may extend parallel to the longitudinal axis of the tube wall.
[0052] A region of the support structure may be favored to bend about a side of the support structure where one or more bridging members are omitted.
[0053] A region of the support structure may be restricted from bending around a further side of the support structure by one or more bridging members.
[0054] The support structure and the barrier may define a second lumen for gas flow.
[0055] The second lumen may be adjacent to the inner lumen, may be nested with the inner lumen, may be coaxial with the inner lumen, may be separated from the inner lumen, and / or may be collinear with the inner lumen.
[0056] The support structure may be resiliently biased to conform to a first curvature along the length of the tube wall.
[0057] The support structure may comprise a first region and a second region.
[0058] The first region may be configured to have a first flexibility and the second region may be configured to have a second flexibility.
[0059] The second flexibility may be greater than the first flexibility.
[0060] The first region and the second region may have different radial compliances.
[0061] The first region may be configured to bend in a first direction relative to a first plane, and the second region is configured to bend in a second direction relative to a second plane.
[0062] The first direction and the second direction may be different.
[0063] The first region may be restricted from bending in a second direction and / or the second region may be restricted from bending in a first direction.
[0064] The structure of the first region may be different from the structure of the second region.
[0065] The barrier may encase the support structure so as to mechanically hold the support structure in place.
[0066] A portion of the barrier may be configured to rotate relative to a portion of the support structure.
[0067] The barrier thickness may be between about 10 μm and 200 μm.
[0068] The thickness of the barrier may be adjusted along the tube wall.
[0069] The barrier may be a breathable material.
[0070] The connector may be integrally formed with the support structure.
[0071] The connector may include a swivel connector.One end of the tube wall may be provided with a swivel connector.
[0072] The support structure may be connected to a manifold, which may form part of the patient interface.
[0073] The support structure may include a connector at the second end configured to connect to a patient interface and / or a medical device.
[0074] The connector at the second end may be integrally formed with the support structure.
[0075] The medical tubing may further comprise a filter.
[0076] The filter may be integrally formed with the tube wall.
[0077] The tube wall may include one or more vent holes.
[0078] One or more of the vents may comprise an exhalation port.
[0079] The exhalation port may have a non-linear surface at one end.
[0080] The tube wall may include two or more rims.
[0081] The tube wall may include three or more rims.
[0082] The size of one rim may be different from the size of the other rim.
[0083] The size of one rim or the other may relate to diameter, cross-sectional area, and / or length.
[0084] The diameter may be the inner diameter. The diameter may relate to the inner diameter of one rim and / or the other rim.
[0085] One limb may have a different connector than the other limb.
[0086] The support structure and barrier may help define at least three lumens.
[0087] The tube wall may be configured to contract and / or expand from a first configuration to a second configuration.
[0088] The support structure aids in the formation of the one or more frustoconical portions.
[0089] One or more of the frustoconical portions may be configured to contract and / or expand.
[0090] The one or more frusto-conical portions may include two frusto-conical portions, wherein the two frusto-conical portions may be different sizes.
[0091] The barrier may have a deflection crease.
[0092] The deflection creases may facilitate deflection into or out of the lumen during bending or water absorption of the tube.
[0093] In a ninth aspect, the present disclosure provides a patient gas delivery system, said system comprising one or more of the medical tubing described herein.
[0094] The one or more medical tubes may comprise a plurality of medical tubes.
[0095] The system may further comprise a patient interface connected to one or more medical tubes.
[0096] The patient interface may be a nasal cannula, a mask, and / or an inhalation tube.
[0097] The mask may be in the form of a continuous positive airway pressure (CPAP) mask.
[0098] Further features and advantages of the present disclosure will become apparent from the following detailed description. [Brief explanation of the drawings]
[0099] Various preferred embodiments of the present disclosure will now be described, by way of example only, with reference to the accompanying drawings, in which:
[0100] [Figure 1] 1 illustrates a perspective view of a medical tube for delivering gas to a patient, according to one embodiment of the present disclosure. [Figure 2] 2 shows a perspective view of a support structure for the medical tube shown in FIG. 1. [Figure 3] An enlarged view of the support structure shown in Figure 2 is shown as "A." [Figure 4] An enlarged view of the support structure shown in Figure 2, "B," is shown. [Figure 5] 3 shows an end view of the support structure shown in FIG. 2. [Figure 6] 6 shows a side cross-sectional view of the support structure taken at line CC in FIG. 5. [Figure 7] 2 shows a perspective view of the support structure shown in FIG. 1, including a reference plane. [Figure 8] 2 shows a partial cross-sectional view of the medical tube shown in FIG. 1. [Figure 9] 10 shows a perspective cross-sectional view of a further support structure according to one embodiment of the present disclosure. [Figure 10] 1 illustrates an end view of a first multi-lumen arrangement according to one embodiment of the present disclosure. [Figure 11] 10 shows an end view of a second multi-lumen arrangement according to one embodiment of the present disclosure. [Figure 12] 10 shows an end view of a third multi-lumen arrangement according to one embodiment of the present disclosure. [Figure 13] 10 shows an end view of a fourth multi-lumen arrangement according to one embodiment of the present disclosure. [Figure 14] 1 shows a perspective view of a bifurcated medical tube according to one embodiment of the present disclosure. [Figure 15] 1 shows a perspective view of a further branched medical tube according to one embodiment of the present disclosure. [Figure 16] 1 illustrates a front view of a patient gas delivery system according to one embodiment of the present disclosure. [Figure 17] 1 shows a front view of medical tubing incorporating a filter according to one embodiment of the present disclosure. [Figure 18] 18 shows a perspective view of the medical tubing of FIG. 17 connected to a patient interface according to one embodiment of the present disclosure. [Figure 19] 1 shows a perspective view of a medical tube in a first configuration according to one embodiment of the present disclosure. [Figure 20] 1 shows a perspective view of a medical tube in a second configuration according to one embodiment of the present disclosure. [Figure 21] 21 shows a partial front view of the medical tubing of FIG. 20. [Figure 22] 22 shows a partial view of the member shown in FIG. 21. [Figure 23] 1 shows a perspective view of a medical tube with a patient interface according to one embodiment of the present disclosure. [Figure 24] 1 shows a perspective view of a patient gas delivery system according to one embodiment of the present disclosure. [Figure 25] FIG. 25 shows a front view of the connection portion shown in FIG. 24. [Figure 26]1 shows a perspective view of a medical tube according to one embodiment of the present disclosure. [Figure 27] 27 shows a cross-sectional view of the medical tube shown in FIG. 26. [Figure 28] 27 shows a cross-sectional end view of the medical tubing shown in FIG. 26. [Figure 29] 28 illustrates a partial view of the cross-sectional view shown in FIG. 27 according to one embodiment of the present disclosure. [Figure 30] 27 shows a further cross-sectional end view of the medical tubing shown in FIG. 26. [Figure 31] 1 shows a perspective view of a further medical tube according to an embodiment of the present disclosure. [Figure 32] 32 shows a cross-sectional view of the further medical tubing shown in FIG. 31. [Figure 33] 1 shows a partial cross-sectional view of a medical tube according to one embodiment of the present disclosure. [Figure 34] 1 shows a partial cross-sectional view of a further medical tube according to an embodiment of the present disclosure. [Figure 35] 10 shows a perspective cross-sectional view of a further support structure according to one embodiment of the present disclosure. [Figure 36] 1 shows a perspective view of a multi-limbed medical tube according to one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION
[0101] The present disclosure relates to medical tubing that can be tailored to provide a range of mechanical properties, including at both the structural and material levels, to achieve better patient outcomes. For example, as described in more detail below, the stiffness, weight, and strength of medical tubing can be varied from tubing to tubing to provide a better, tailored product.
[0102] FIG. 1 shows a perspective view of a medical tubing 10a according to an embodiment of the present disclosure. The medical tubing 10a includes a tubing wall 100a and connectors 200a and 300a. As discussed below, the tubing wall 100a is formed from a support structure 1000a and a barrier 2000a. In this regard, a reference number followed by a lowercase letter herein generally indicates an alternative embodiment of the general element represented by that reference number. Thus, for example, support structure 1000a is similar to, but not identical to, support structure 1000b. Furthermore, reference to an element designated by number alone refers to all embodiments of that element. Thus, for example, a reference to support structure 1000 is intended to include both support structure 1000a and support structure 1000b.
[0103] The tube wall 100a and connectors 200a, 300a provide a lumen 110a for delivering breathable gas to a patient. A longitudinal axis 12 extends along a central, central portion of the lumen 110a. The tube wall 100a has an outer contour 120a. Thus, the outermost portion and / or surface of the tube wall 100a defines its outer contour 120a. In this embodiment, the outer contour 120a tapers along the longitudinal axis 12. That is, the cross-section of the tube wall 100a transverse to the longitudinal axis 12 transitions from a larger area to a smaller area. In this embodiment, the tube wall 100a tapers continuously along its length. In this regard, the tube wall 100a extends transverse to the longitudinal axis 12. By having a tapered profile 120a, the narrower portion closer to the patient may provide greater flexibility in usability, while the larger flow area further away from the patient may reduce potential pressure loss (or resistance to flow) in the tubing 10a. Additionally, tubing sizing can be tailored to the relevant patient population. For example, smaller tubing is desirable for the face of smaller patients, such as neonates and pediatric patients, but these increase resistance to flow. Having a tapered tubing can have the advantage of positioning a smaller tubing on the patient's face, for example, without the flow resistance that would occur if the entire tubing were smaller.
[0104] The connector 200a is located at one end of the tube wall 100a. The connector 200a comprises a connector body 210a, which in this embodiment is substantially cylindrical. The connector body 210a is configured to connect with a cylindrical body of another medical component. In this regard, the connector 200a may comprise a sealing surface for sealing with the other medical component. The connector body 210a may form a "male" or "female" connector. The connector 200a may also form part of an assembly comprising a patient interface, a manifold, or a further connector comprising a swivel component. Based on this, the connector 200a may be configured to be attached to, for example, another device and / or a patient interface.
[0105] The protrusion 220a extends from the connector body 210a. The connector 200a is integrally formed with the support structure 1000a. Similarly, the connector 300a is integrally formed with the support structure 1000a and is located at the opposite end of the tube wall 100a. Integrating the support structure 1000a with the connectors 200a, 300a helps reduce the likelihood of the connectors 200a, 300a becoming detached from the tube 10a. This reduces the risk of gas leakage and increases manufacturability. The connector 300a includes a connector 310a that is substantially cylindrical (like the connector body 210a). The connector body 310a has a smaller diameter / cross-section compared to the connector body 210a. The (cylindrical) walls of the connectors 200a, 300a extend substantially linearly, parallel to the longitudinal axis 12.
[0106] 2-8 show support structure 1000a in further detail. Support structure 1000a can be manufactured, for example, by injection molding or additive manufacturing (including 3D printing). Other methods can be used to provide various structures with one or more areas / regions with locally tailored responses. In some embodiments, support structure 1000a can be manufactured by extrusion combined with segmentation by laser or other means to manufacture similar structures. That is, support structure 1000a can be in the form of, for example, an extruded tube that is subsequently segmented. Support structure 1000a can be formed from polymers, including thermoplastics and thermosets. In this embodiment, support structure 1000a is formed from nylon, but as previously mentioned, a range of polymers (including thermosets, or preferably thermoplastics) can be implemented. Overall, support structure 1000a is uniquely different from prior art forms, for example, it is not limited to two-dimensional die shapes. Desirable properties of the material from which the support structure 1000a is formed include suitable elastic or flexural modulus, toughness (including fracture recovery), flexibility or hardness (including flexibility of patient-contacting portions), optical transmittance / transparency (including intraluminal condensation, sputum, and other foreign matter), biocompatibility, rheology (for processing), reusability (including sterilizability and other such characteristics), and other such properties. Additionally, desirable properties of the support structure (and barrier 2000a) may include considerations of service life (e.g., reusable, disposable, etc.).
[0107] The support structure 1000a comprises a plurality of members 1100a. The members 1100a form a skeleton-type structure; that is, the (separate) members 1100a are bonded together to form a framework. The framework supports the barrier 2000a. The members 1100a, in this embodiment, comprise tube wall forming members 1110a and bridging members 1120a. In other embodiments, the tube wall forming members 1110a may, for example, be provided alone. In these other embodiments, the tube wall forming members 1110a may, for example, be tapered, which then fold with or sink into the barrier 2000a as part of the overall structure. Further examples of these possible other embodiments are shown in Figures 19 and 20.
[0108] The tube wall forming member 1110a is substantially annular or ring-shaped. The tube wall forming member 1110a includes an inner forming surface 1112a and an outer forming surface 1114a. As shown in FIG. 8, the inner forming surface 1112a extends about the longitudinal axis 12. In this manner, the inner forming surface 1112a helps define the perimeter of the lumen 110a. Furthermore, in the primary direction of gas flow along the lumen 110a, the inner forming surface 1112a extends substantially parallel to the longitudinal axis 12 of the lumen 110a. Separately, as described in further detail below, the barrier 2000a substantially forms the inner surface of the lumen 110a.
[0109] The outer molding surface 1114a includes a curved region in a direction parallel to the longitudinal axis 12. In this regard, the inner and outer surfaces 1112a, 1114a are different in this embodiment. More specifically, a cross-section of each tube wall forming member 1110a taken along the longitudinal axis 12 may be substantially D-shaped (as shown in FIG. 8). The dimensions and shape of the inner and outer surfaces 1112a, 1114a may vary depending on the application. For example, the thickness of the tube wall forming member 1110a may be increased or decreased depending on the desired structural strength. In further embodiments, the inner and outer surfaces 1112a, 1114a may provide a cross-section for each tube wall forming member 1110a that is triangular, rectangular, trapezoidal, polygonal, circular, or any other shape.
[0110] The support structure 1000a defines multiple openings 1116a. The openings 1116a are located either i) between portions of the tube wall forming members 1110a or ii) between separate tube wall forming members 1110a. The openings 1116a extend transverse to the flow of gas through the lumen 110a. In this regard, the openings 1116a extend in a direction toward the longitudinal axis 12. The openings 1116a extend circumferentially around the support structure 1000a. In this embodiment, the openings 1116a are partially annular. That is, the openings 1116a are at least partially ring-shaped. The openings 1116a also extend a greater distance circumferentially around the tube 10a in this embodiment than they do parallel to the longitudinal axis 12.
[0111] The bridging member 1120a in this embodiment helps define at least a portion of the opening 1116a (as further shown in FIG. 4). The bridging member 1120a connects to one or more of the tube wall forming members 1110a. The bridging member 1120a extends substantially linearly. In this embodiment, the bridging member 1120a extends substantially parallel to the longitudinal axis 12. In further embodiments, the bridging member 1120a may extend transversely to the longitudinal axis 12. For example, the bridging member 1120a may extend in a direction at an oblique angle to the longitudinal axis 12. The bridging member has a first end 1122a connected to a portion of one tube wall forming member 1110a. A second end 1124a of the bridging member 1120a connects to a separate tube wall forming member 1110a, but in further embodiments, may connect to a further portion of the same tube wall forming member 1110a. By way of example only, this may occur when the tube wall forming member 1110a extends along an arcuate path, or when the bridging member 1120a, for example, extends arcuately.
[0112] As further shown in FIG. 6 , the members 1100a are differentially positioned among the first region 1010a, the second region 1020a, the third region 1030a, and the fourth region 1040a of the support structure 1000a. Varying the positioning and / or orientation of the members 1100a can tailor mechanical properties. For example, the fourth region (closer to the patient) can be more flexible than one or more of the other regions 1020a, 1030a, and 1040a. In other words, the stiffness of the tube 10a is much greater than that of the connector 300a. This can be due to a variety of reasons, including the placement of the bridging members 1120a (or the lack of bridging members 1120a closer to the patient). The fracture resistance, or radial compliance, can also vary among the regions of the support structure 1000a. In this regard, the stiffness, flexural strength, toughness, and weight of the tube 10a can be varied to suit a particular application. This variation can be achieved, for example, by i) varying the size, position, and / or number of bridging members 1120a between tube wall forming members 1110a, ii) varying the shape and / or size of tube wall forming members 1110a, iii) varying the pitch of the tube wall forming members 1110a (pitch relative to the longitudinal axis 12 when the tube 10a is in a resting, unstretched state), and / or i) varying the material of some or all of the bridging members 1120a and / or the tube wall forming members 1110a. a) Increasing the thickness, density, and / or axial alignment of the bridging members 1120a can increase stiffness and bending strength (depending on the relative plane of bending). For example, increasing the area moment of inertia of the bridging members 1120a by an amount equal to the thickness reduces stresses induced in the bridging members 1120a, resulting in greater bending strength. Similarly, increasing the area moment of inertia of the bridging members 1120a increases bending stiffness. Additionally, more bridging members 1120a help distribute the force load associated with the tube 10a. Aligning the bridging members 1120a can also increase stiffness / bending strength at the aligned plane of the bridging members 1120a.
[0113] b) Increasing the thickness of the tube wall forming member 1110a increases mechanical properties such as radial crush resistance and strength. For example, in a manner similar to increasing the thickness of the bridging member 1120a, increasing the thickness of the tube wall forming member 1110a increases the area moment of inertia of the tube wall forming member 1110a. This increases the strength and stiffness of the tube wall forming member 1110a, as well as other mechanical properties such as crush resistance. Crush resistance can be thought of as the ability of a tube to resist the application of force(s) that reduce the cross-sectional area of its lumen.
[0114] c) Increasing the pitch between the tube wall forming members 1110a may increase the flexibility of the tube 10a. In other words, spacing the tube wall forming members 1110a further apart will result in a larger bending moment between the tube wall forming members 1110a, making the tube 10a more flexible for a given force.
[0115] d) Varying the material modulus of one or more elements is another consideration; a less stiff material will result in a more flexible structure. For example, a polypropylene member 1000a will have a greater stiffness than a thermoplastic elastomer member 1000a (assuming the same geometry).
[0116] Additionally, because the support structure 1000a can provide tensile strength, a relatively thin barrier 2000a can be implemented. In other words, the (tuned) support structure 1000a allows loads to pass through the support structure 1000a, reducing the likelihood of barrier failure, etc. Also, prior art tubing typically lacks an area adjacent to the connector portion due to stress concentrations caused by the transfer of the load path from the connector to the barrier. The support structure 1000a disclosed herein has a continuous load path through the support structure 1000a between the connectors 200a, 300a, thereby reducing stresses at the barrier 2000a.
[0117] With the above in mind, the first region 1010a includes two bridging members 1120a between each of the tube wall forming members 1110a. The two bridging members 1120a are positioned equidistant from each other around the tube wall forming member 1110a. In this regard, the two bridging members 1120a are positioned substantially 180 degrees from each other around the tube wall forming member 1110a. The position / orientation of the bridging members 1120a varies between adjacent tube wall forming members 1110a. That is, the positions of the two bridging members 1120a are offset by 90 degrees between each tube wall forming member 1110a. Thus, the bridging members 1120a are located i) on the left / right side of one side of the tube wall forming member 1110a, and ii) above / below the other side of the tube wall forming member 1110a. The tube wall shaping member 1110a closest to the connector 200a is integrally formed with the connector 200a, either directly or through integrally formed bridging member(s) 1120a. The diameter of the tube wall shaping member 1110a is much closer to the connector 200a than the connector 300a. Considering the structural differences between the regions 1010a and 1020a, the first region 1010a is configured to bend along the xz and yz planes and all rotational planes between the xz and yz planes. Based on this, the first region 1010a bends, for example, toward and away from the z-axis. The first plane 1012a extends in the same direction as the xy plane shown in FIG. 7. The varying nature of the bridging members 1120a in the first region 1010a also limits the ability of the first region 1010a to twist or stretch along the longitudinal axis 12. This ability to resist kinking or stretching may also allow for a thinner barrier 2000a, which may be desirable compared to a relatively thin barrier 2000a because it may, for example, increase breathability (if a breathable material is used), increase clarity, increase flexibility, and / or minimize material utilization. As will be understood below, other regions of the tube 10a may be restricted in a particular manner, which also provides the option of varying the thickness of the barrier 2000a around the tube 10a.The placement of the bridging members 1120a helps determine how much bending, twisting, and extension are restricted in a particular region. Based on this, each pair of tube wall shaping members 1110a are restricted from moving relative to each other by pivoting about the opposing bridging member 1120a. Each pair of tube wall shaping members 1110a can form a unit, and as these units are connected together, the overall properties of a region are provided based on the properties and connections of these units.
[0118] The second region 1020a includes two bridging members 1120a between each of the tube wall forming members 1110a. The bridging members 1120a in the second region 1020a are arranged in a linear array. Thus, a series of bridging members 1120a extend in a linear fashion along opposite sides of the tube wall forming members 1110a in the second region 1020a. This creates a difference in flexibility of the support structure 1000a between the horizontal and vertical planes of the second region 1020a. That is, the second region 1020a can also bend in the yz plane. However, the second region 1020a is limited in bending (from left to right) in the xz plane. This is due to the bridging members 1120a extending along the xz plane in the second region 1020a. In other words, the second region 1020a is limited in compressing / extending in the xz plane. Thus, the second region 1020a is configured to pivot / bend about the second plane 1022a on the side of the tube wall forming member 1110a where the bridging member 1120a is omitted.
[0119] Similar to the second region 1020a, the third region 1030a includes two bridging members 1120a arranged in a linear array between each of the tube wall forming members 1110a. However, the linear array of the bridging members 1120a in the third region 1030a is offset by 90 degrees compared to the linear array of the bridging members 1120a in the second region 1020a. That is, the bridging members 1120a extend along the xz plane in the second region 1020a, but extend along the yz plane in the third region 1030a. In this regard, the bridging members 1120a in the third region 1030a extend along a different side of the support structure 1000a compared to the bridging members 1120a in the second region 1020a. With this in mind, the third region 1030a is configured to pivot / bend about either the second plane 1022a or the third plane 1032a on the side of the tube wall forming member 1110a where the bridging member 1120a is omitted. In this regard, the third region 1030a is restricted from pivoting in the yz plane. However, the third region 1030a is configured to bend in line with the xz plane shown in FIG. 7.
[0120] In further embodiments, the support structure 1000a can be deflected to allow the tubes to conform to the curvature of the patient's cheek / face (or another area of the patient). That is, the support structure 1000a has a neutral position that corresponds to the curvature of the patient's area. Furthermore, as detailed above, the support structure can have areas that preferentially bend in certain directions (while being restricted in one or more other directions). Based on this, and as described in further detail below, the thickness of the barrier 2000a can also be varied to provide preferential bending. For example, the thickness of the barrier 2000a can be thinner in certain areas, thereby providing more flexibility. In other areas, the barrier 2000a can be thicker, restricting bending.
[0121] The fourth region 1040a includes a tube wall-forming member 1110a that spirals toward the connector 300a, tapering annularly. The tube wall-forming member 1110a in the fourth region is therefore angled at an oblique angle relative to the longitudinal axis 12. The fourth region 1040a does not have a bridging member 1120a between parts of the tube wall-forming member 1110a. Thus, the tube wall-forming member 1110a is continuous in this region and is not formed from separate components. The tube wall-forming member 1110a extends along a helical path in the fourth region 1040a, somewhat similar to a (tapered helical) spring. Based on this, it will be understood that the tube wall-forming member 1110a in the fourth region 1040a is primarily a single structure, although separate tube wall-forming portions may be provided therealong. The fourth region 1040a of the support structure is also relatively unrestricted compared to the other regions 1010a, 1020a, 1030a. That is, there is no restriction on the direction in which the fourth region 1040a can bend. The fourth region 1040a can bend / twist about the xy, yz, and xz planes without being restricted by the bridging members 1120a. The fourth region 1040a can also extend longitudinally of the tube 10a, with this extension being limited primarily by the properties of the barrier 2000a. This may, for example, help to provide increased comfort to the patient, as the fourth region 1040a can be more easily manipulated to suit the patient's requirements.
[0122] As shown in FIG. 8, the barrier 2000a, together with the support structure 1000a, forms the tube wall 100a. The barrier 2000a is applied to the support structure 1000a to form a gas seal that defines the gas flow path (i.e., the lumen 110a). The barrier 2000a can have a thickness of, for example, 20 μm to 200 μm. As described above, this thickness can be adjusted along the tube wall 100a, providing another option for tailoring the tube 10a and varying its mechanical properties along the tube 10a. That is, the layered thickness of the barrier 2000a can be set at different thicknesses during manufacturing, resulting in different measured thicknesses along the length of the tube wall 100a when in an unstretched state. The barrier 2000a can include polyurethane. In further embodiments, other polymers can be used in addition or instead. These can include copolymers including polyester. The barrier 2000a can include a breathable material. This is advantageous when the tube 110a is used as a patient interface tube delivering humidified gas to a patient to mitigate the formation of condensation within the lumen 110a. In this regard, in some embodiments, Moisture Vapor Transmission Rate (MVTR) is prioritized.
[0123] "Breathable material" refers to a non-porous, permeable material that allows water molecules to pass through the monolithic wall of the permeable material by a solution-diffusion mechanism, without allowing bulk passage of liquid water or bulk flow of aspirating gas through the wall. It should be understood by those skilled in the art that the water molecules within the wall are dispersed at a molecular level in the medium and therefore are not in one state (solid, liquid, or gas), sometimes referred to in the art as vapor (e.g., migration rate is often referred to as MVTR, etc.). It should further be understood that the monolithic wall does not contain open channels or pores from one major surface to the other, and that pathogens can be delivered through such channels along with air or liquid water droplets by a pore-flow mechanism. However, this definition is not intended to exclude tubes formed from breathable materials that may not have one or more holes provided by the material, such as those that may result from manufacturing defects, which may result in negligible pore flow that does not affect the overall performance of the tube and meets the leakage requirements of ISO 5367:2014. It should further be understood that, as with all polymers, some small molecule transport of respiratory gases (such as oxygen, carbon dioxide, or nitrogen) may occur in trace or minimal amounts (i.e., not "bulk" flow), which for breathable materials as defined herein will typically be at least an order of magnitude less than the rate of water molecules. Furthermore, with particular reference to respiratory gases being delivered to or from a patient, such small molecule transport of respiratory gases will be less than that allowed for gas compliance by the relevant standard, for example, in a leak test tested by the method described in Appendix E of Chapter 5.4 of ISO 5367:2014, which is incorporated herein by reference in its entirety.
[0124] The barrier 2000a can be applied to the support structure 1000a by folding, wrapping, injection molding, or a dipping process. There are many ways in which a lightweight polymer barrier can be applied to the support structure 1000a. Each of these methods has its own advantages and tradeoffs. For example, dipping / solution coating can provide a tube 10a with a smoother internal lumen 110a compared to wrapping. The support structure 1000a is typically immersed in a polymer / solvent bath during the dipping process. The viscosity of the dipping solution and the resulting surface tension of the polymer solution can affect the design of the support structure 1000a and the distance between adjacent tube wall forming members 1110a. In this regard, how the support structure 1000a is constrained during the dipping process affects the resulting structure. With regard to injection molding, this can increase the precision of the tube 10a and allow parts to be manufactured more quickly. However, this process can also limit design geometries (due to draft angles, etc.) and increase initial capital costs for tooling.
[0125] The barrier 2000a may encapsulate the support structure 1000a. That is, the barrier 2000a continuously surrounds the support structure 1000a. Therefore, the barrier 2000a mechanically encapsulates the support structure 1000a, and in this embodiment, chemical bonding is not necessary. This provides many advantages, such as a wider range of materials to comprise the support structure 1000a, since the materials are not compromised during manufacturing. This non-chemically bonded arrangement may also be useful for designing the flex / resistance of the tube wall, including when the tube wall 100a comprises a breathable material. Furthermore, the absence of chemical bonding allows portions of the barrier 2000a to be configured to rotate relative to portions of the support structure 1000a. This may reduce stress transfer between the barrier 2000a and the support structure 1000a, which may be useful for limiting torsional transfer between these components. In a further embodiment, the support structure 1000a and the barrier 2000a may be chemically bonded. An intermediate layer may also be located between the support structure 1000a and the barrier 2000a. The intermediate layer may facilitate adhesion.
[0126] The barrier 2000a includes an inner surface 2100a, an outer surface 2200a, an inner support engagement surface 2300a, and an outer support engagement surface 2400a. The inner surface 2100a provides a substantially smooth cylindrical surface. The inner surface 2100a defines the outer periphery of the lumen 110a. The inner surface 2100a is uniformly formed, avoiding, for example, seams and / or depressions that could create additional flow disturbances (and greater pressure drops). The outer surface 2200a includes an area / region that continues from the outer molding surface 1114a for containing the support structure 1000a. Thus, in this embodiment, the outer surface 2200a is undulating. The inner support engagement surface 2300a rests on the inner molding surface 1112a and surrounds this portion of the support structure 1000a while remaining supported by the inner molding surface 1112a. The outer support engagement surface 2400a surrounds and is supported by the outer molding surface 1114a of the support structure 1000a, i.e., the outer molding surface 1114a extends along at least a portion of the perimeter of the support structure 1000a and aids in the containment of the support structure 1000a.
[0127] The barrier 2000a may also at least partially cover the connectors 200a, 300a. In this regard, the barrier 2000a can interact with the connector bodies 210a, 310a to form a gas seal. The protrusions 220a, 330a can assist in positioning the barrier 2000a to avoid interaction with additional connecting devices. In this regard, during manufacturing of the tube 10a, certain areas (including the connectors 200a, 300a, or other sensitive areas) can be covered and the barrier 2000a can be prevented from covering certain areas. For example, during the dipping process, the connectors 200a, 300a can be partially masked so that the barrier 2000a does not surround the free ends of the connectors 200a, 300a.
[0128] FIG. 9 illustrates a further support structure 1000b according to an embodiment of the present disclosure. Member 1100b is arranged similarly to member 1100a. However, connectors 200b, 3300b differ from connectors 200a, 300a. First connector 200b includes connection and alignment features. Connector 200b includes a pair of locking fingers 230b having recesses 232b. Each of the recesses 232b is configured to receive or engage a connection feature of a corresponding connector. Connector 200b may provide a visual alignment aid with the corresponding connector. The locking fingers 230b can serve to rotationally orient the connector during connection with the corresponding connector. Connector 3300b forms part of patient interface 3100b. Connector 3300b forms a manifold. The manifold includes protrusions 3320b and interface connections 3340b. The manifold is connected to support structure 1000b. The interface connection 3340b can aid in engagement with distal parts, including (nose) prongs or other parts of the patient interface. As described in further detail below, the prongs can optionally be continuous with the barrier material. In further embodiments, the interface connection 3340b can form an integral modular headgear connector.
[0129] The connector 3300b (or the support structure 1000b) may also include, for example, one or more integrally formed accessories. For example, the accessories may include a coupler. The coupler may, for example, facilitate connection to another part of the patient interface. In this regard, the tube 10 may form part of a patient gas delivery system. The system may include multiple tubes 10 and may interface with a number of other devices (e.g., patient interfaces in the form of full face, total face, oral, oral-nose, or nasal masks with nasal pillows).
[0130] As a further example, Figure 35 shows a further support structure 1000o similar to support structure 1000b. That is, support structure 1000o includes support structure 1000o having connectors 200o, members 1100o, etc. However, patient interface 3100o includes protrusions 3400o. In this regard, connectors 3300o form a manifold integrally formed with support structure 1000o. This helps to mitigate unintended leakage from tubing 10o. Furthermore, the barrier covering support structure 1000o may be integrally formed with protrusions 3400o. That is, when a barrier covers support structure 1000o in a second step, support structure 1000o may include protrusions 3400o. Thus, patient interface 3100o may be, at least in part, integrally formed with tubing 10o. This further reduces the possibility of unintended leakage.
[0131] Although the above-described embodiments relate to a single lumen, in other embodiments multiple lumens may be implemented. For example: a) Figure 10 shows a tube 10c having a first lumen 110c adjacent to a second lumen 110c'.
[0132] b) Figure 11 shows a tube 10d having a first lumen 110d coaxial with a second lumen 110d'.
[0133] c) Figure 12 shows a tube 10e having a first lumen 110e nested with a second lumen 110e'.
[0134] d) Figure 13 shows a tube 10f having a lumen that is compartmentalized into a first lumen 110f and a second lumen 110f'.
[0135] In this regard, for adjacent lumens 110c, 110c', the lumens 110c, 110c' are disposed adjacent to one another. This allows at least a portion of the outer surface of one lumen to face at least a portion of the outer surface of the other lumen. For coaxial lumens 110d, 110d', the lumens 110d, 110d' share a common axis, with one lumen 110d' being surrounded by the other lumen 110d. For nested lumens 110e, 110e', one lumen 110e is positioned inside the other lumen 110e (and they do not necessarily have to be coaxial). For compartmentalized lumens 110f, 110f', they typically share at least a common wall (allowing them to extend in a similar path). Based on this, the lumens may share the same (straight) line and be collinear. With these various configurations in mind, one lumen may be the main conduit for delivering gas to the patient, along with other possible configurations. Subsequent lumens may provide inspiratory / expiratory gases or may be used to sense gas properties of the main lumen. Lumens may also have non-circular cross-sections.
[0136] With the above in mind, FIG. 14 illustrates a multi-ribbed medical tubing 10g having a first lumen 110g coaxial with a second lumen 110g'. The medical tubing 10g includes a support structure 1000g. The support structure 1000g includes multiple members 1100g. The members 1100g include tube wall-forming member(s) 1110g having bridging member(s) 1120g therebetween. A barrier 2000g is connected to the support structure 1000g. The combination of the support structure 1000g and the barrier 2000g forms a Y-shaped profile 120g. Similarly, the combination of the support structure 1000g and the barrier 2000g helps define the lumen 110g. The support structure 1000g' and the barrier 2000g' help define the lumen 110g'. Support structures 1000g and 1000g' can interact to form an overall structure that helps define lumens 110, 110g'.
[0137] FIG. 36 illustrates a further multi-ribbed medical tubing 10p. The medical tubing 10p includes a first connector 200p, a second connector 300p, a third connector 400p, and a fourth connector 500p. The connectors 200p, 300p, 400p, and 500p are configured to connect to other components. The connectors 200p, 300p, 400p, and 500p may be standard medical connectors. As shown in FIG. 36, the nature of the connectors may differ between one or more of the connectors 200p, 300p, 400p, and 500p. That is, one connector may be, for example, a twist-type connector, while the other connector may be a plug-in connector or a swivel connector. A swivel connector can pivot about an axis. At least a portion of the connectors 200p, 300p, and 400p may be integrally formed with the support structure 1000p. In this regard, a swivel connector may have a portion integrally formed with the support structure and another portion configured to swivel.
[0138] The support structure 1000p includes tube wall shaping member(s) 1110p with bridging member(s) 1120p therebetween. The support structure 1000p forms a multi-rib structure to aid in defining multiple lumens. The size and / or shape of the tube wall shaping member(s) 1110p may vary. For example, the size of the shaping member(s) 1110p may vary with each rib. In this regard, the size may vary with, for example, diameter, cross-section, and / or length. This aids in defining lumens of various sizes. The diameter of the lumen may define the inner diameter of the tube wall 100p.
[0139] Multi-ribbed medical tubing 10p includes three lumens 110p, 110p', and 110p''. One lumen 110p is in fluid communication with first connector 200p. The other lumens 110p' and 110p'' are in fluid communication with second connector 300p and third connector 400p, respectively. Lumens 110p, 110p', and 110p'' are also in fluid communication with fourth connector 500p. In this regard, the limb divisions / joins of medical tubing 10p do not have to be located at the same location. For example, one limb can be divided into two limbs, and then one of these limbs can be further divided. The limb divisions / divisions can be tailored to medical requirements.
[0140] 15 shows a further multi-limb medical tubing 10h having one lumen 110h. The lumen 110h is Y-shaped. The medical tubing 10h includes a support structure 1000h. The support structure 1000h includes member(s) 1100h of various shapes. The member(s) 1100h include tube wall shaping member(s) 1110h and bridging member(s) 1120h. The tube wall shaping member(s) 1110 vary in shape to define the Y-shaped branching medical tubing 10h. The length, curvature, and / or orientation of the bridging member 1120h also vary to correspond to the Y-shape.
[0141] FIG. 16 illustrates a patient gas delivery system 3000h. The system 3000h includes multiple tubes and adapters. In some embodiments, each tube may include a tailored support structure. In this regard, the tubes may be modularized, thereby reducing the number of connection points through which respiratory gas can leak. As can be seen in FIG. 16, the system 3000h includes a patient interface 3100h. The patient interface 3100h may include a laryngeal mask airway (LMA). Alternatively, the patient interface 3100h may include an endotracheal tube (ET). The patient interface 3100h is connected to one of the multi-limb tubes 10g, 10h. The multi-limb tubes 10g, 10h may be modularized to provide functionality similar to a comprehensive inspiratory tube, expiratory tube, Y-piece, and / or catheter mount. In this regard, the multi-limb tubes 10g, 10h may be up to approximately several meters in length. As previously described with respect to tube 10g, the multi-limbed tube can be further sub-divided into multi-lumen tubes.
[0142] FIG. 17 illustrates a medical tubing 10i. The medical tubing 10i includes a support structure 1000i and a barrier 2000i. The support structure 1000i may include a visual indicator. The visual indicator may be used to provide connection indication (including orientation, etc.) for the tubing 10i. The visual indicator may include one or more colors and / or shading. The medical tubing 10i includes a filter 2600i. The filter 2600i is located between an inspiratory tube 2500i and an expiratory port 2700i. The expiratory port 2700i may include a non-straight end to help prevent blockage, for example, by a blanket. In some embodiments, the inspiratory tube 2500i may be integrally formed with the filter 2600i and the expiratory port 2700i. In another embodiment (not shown), the tubing 10i may include a series of vent holes (i.e., a series of holes providing functionality similar to the expiratory port 2700i). Optionally, a vent is downstream of the filter 2600j for exhaust gases. As further shown in FIG. 18, the medical tubing 10i can also include a patient interface 3100i. The patient interface 3100i can be a non-invasive ventilation patient interface. The patient interface 3100i can include a sealing interface for NIV / CPAP. The patient interface 3100i can include a full face, total face, mouth, mouth-nose, or nasal mask with nasal pillows.
[0143] FIG. 19 illustrates a medical tubing 10j. The medical tubing 10j includes a first connector 200j and a second connector 300j. The connectors 200j and 300j form part of a support structure 1000j. The support structure 1000j includes a plurality of members 1100j, each of which includes a tube wall shaping member 1100j. The tube wall shaping member 1110j includes a first size tube wall shaping member 1100j and a second size tube wall shaping member 1100j. Between the first and second size tube wall shaping members 1110j is a bridging member 1120j. The bridging member 1120j is resiliently flexible. The combination of the tube wall shaping member 1110j and the bridging member 1120j forms a frustoconical portion. The frustoconical portion may be bi-stable or multi-stable. Accordingly, the shape of the frusto-conical portion and the resiliently flexible nature of the bridging members 1120 allow the tube 10j to be adjusted in a variety of ways to aid in patient therapy. For example, the tube 10j can be expanded from the configuration shown in FIG. 19 to the configuration shown in FIG. 20. More specifically, as shown in FIG. 22, the different angles between the bridging members 1120j connecting each tube wall forming member 1110j allow the frusto-conical portion to resiliently expand and contract. In this regard, the tube 10j can be configured, for example, to bend to a certain position and then retain that bent position.
[0144] The tube wall forming member 1110j is also connected to a complementary portion of the barrier 2000j. Because the barrier 2000j is resiliently flexible, this allows the tube 10j to expand and contract. In further embodiments, the bridging member 1120j may be omitted, with the barrier 2000j connecting the tube wall forming member 1110j. In these further embodiments, the resiliently flexible nature of the barrier 2000j may be such that the tube 10j can contract in a variety of ways to aid in patient therapy. For example, the tube 10j can expand and contract based on the patient's position in bed.
[0145] FIG. 23 shows a medical tubing 10k having a tailored support structure 1000k integrated with a patient interface 3100k. The patient interface 3100k can be a full-face, total-face, oral, oral-nose, or nasal mask with nasal pillows. The support structure 1000k includes a first region 1010k and a second region 1020k. The tube wall molding member 1110k in the first region 1010k is positioned differently from the second region 1020k. This results in different mechanical characteristics between the regions 1010k, 1020k. For example, the support structure 1000k proximal to the patient interface 3100k can be configured to be more flexible than the support structure 1000k distal to the patient interface. Additionally, integrating the patient interface 3100k with the tube wall molding member 1110k can aid in interchangeable elbow structures and ball-and-socket connections. That is, by tailoring the barrier 2000k and support structure 1000k, sufficient flexibility can be provided to the patient interface 3100k, thereby eliminating the need for, for example, elbow structures and ball-and-socket connections. Furthermore, integrating the support structure 1000k, barrier 2000k, and patient interface 3100k reduces the possibility of any uncontrolled leakage, thereby improving reliability. The tubing 10k can be provided with a series of openings / vents to maintain leakage control for deflected flow in NIV / CPAP systems.
[0146] FIG. 24 illustrates a patient gas delivery system 3000l. The patient system 3000l includes a patient interface 3100l. The patient interface 3100l may be a nasal cannula for nasal high flow (NHF). The patient interface 3100l connects to / forms a portion of the medical tubing 10l. The medical tubing 10l includes a patient interface tube and / or a heated breathing tube. The patient interface tube may include a (tailored) support structure 1000l. The heated breathing tube may include a (tailored) support structure 1000l'. In some embodiments, the interface tube and the heated breathing tube may be releasably connected. However, in other embodiments, they may be integrally formed. Barriers 2000l, 2000l' overlap the support structures 1000l, 1000l', respectively, and help define at least a portion of the outer shape 120l of the tubing 10l.
[0147] The tube 10l may further comprise accessories, such as a connecting portion 3200l. The connecting portion 3200l is in the form of a coupler. The coupler may be a tube clip. As further shown in FIG. 25 , the connecting portion 3200l comprises a patient interface retaining portion 3210l and a tube connecting portion 3220l. The patient interface retaining portion 3210l helps provide an engaging portion 3215l. The engaging portion 3215l may be slid over a portion of the patient interface 3100l to retain it to the patient interface 3100l. For example, the engaging portion 3215l may be slid over a portion of the head strap / head gear of the patient interface 3100l. The engaging portion may also be slid over a portion of the head strap of the patient interface 3100k. The tube connecting portion 3220l comprises a tube receiving portion 3222l. In some embodiments, the tube receiving portion 3222l is substantially circular, but may be other shapes in other embodiments. The tube receiving portion 3222l is configured to receive a patient interface tube. In some embodiments, the connecting portion 3200l is integrally formed with the support structure 1000l and / or the barrier 2000l. This secures the connecting portion 3200l in place and prevents the connecting portion 3200l from sliding along the tube 10. Furthermore, the fewer separate parts there are in the system, the easier it is to manufacture, assemble, and use.
[0148] FIG. 26 shows a further medical tubing 10m. The medical tubing 10m can provide a connection between the heated breathing tubing and a protrusion (or a portion thereof). For example, at one end, the tubing 10m can be connected (integrally) to one of the connectors 3300b, 3300o in the form of a manifold, while at the other end, the tubing 10m can be connected to the heated breathing tubing. The protrusion can also include a protrusion 3400o. The medical tubing 10m includes a tube wall 100m. The tube wall 100m helps define a lumen 110m. The tube wall 100m has an outer shape 120m. As further shown in FIG. 29, the outer shape 120m is made up of a tube wall forming member 1100m and an outer surface 2200m of a barrier 2000m. The tube wall 100m helps define the lumen 110m. The medical tubing 10m includes a first connector 200m and a second connector 300m. A tube wall molding member 1100m of the support structure 1000m is connected to the first connector 200m and the second connector 300m. The first connector 200m may be configured to connect to a heated breathing tube. The second connector 300m may be configured to connect to a cannula manifold. In this regard, the support structure 1000m is similar to the support structures 1000b and 1000o shown in FIGS. 9 and 35, respectively, by, among other things, providing a tapered structure.
[0149] As shown in FIG. 28, the first connector 200m may be substantially circular, while as shown in FIG. 30, the second connector 300m may be slightly elliptical. In this regard, the outer shape 120m transitions from circular to elliptical along the lumen 110m. Second, in some embodiments, the gas flow through the lumen 110m transitions from flowing along a circular surface to flowing along an elliptical surface. The outer shape 120m of the tube wall 100m may also be tapered. Having a tapered tube wall 100m allows the portion of the tube closest to the patient to be smaller, which is more comfortable on the patient's face compared to, for example, a larger tube. As the tube 10m becomes larger in size, resistance to flow through the tube 10m also decreases. The gradual transition from a circular to an elliptical shape along the patient interface tube also reduces resistance to flow. Additionally, the elliptical shape of the tube wall closest to the patient allows the tube 10m to lie flatter on the patient's face. This can prevent the tube 10m from protruding too far from the patient's face. The support structure 1000m can be configured to provide adequate flexibility to align the tube 10m along the patient's face.
[0150] As further shown in FIG. 29, the barrier 2000m can include a first thickness "a" and a second thickness "b." The thickness variation can occur between adjacent tube wall forming members 1100m. The first thickness "a" can be configured for flexibility of the tube 10m. In this regard, the outer surface 2200m of the barrier 2000m can include valleys between adjacent tube wall forming members 1100m. The second thickness "b" allows for more surface area to bond to the tube wall forming member 1100m. Thus, varying the thicknesses "a" and "b" can aid in tailoring various portions of the tube 10m. The inner surface 2100m of the barrier 2000m extends substantially linearly between adjacent tube wall forming members 1100m. In some further embodiments, the barrier 2000m can be of a constant thickness, if desired.
[0151] FIG. 31 illustrates a medical tubing 10n. The medical tubing 10n includes a tube wall 100n. The tube wall 100n defines a lumen 110n therethrough. As further shown in FIG. 32, the tube wall 10n includes a support structure 1000n. The support structure 1000n includes a plurality of tube wall forming members 1110n. Barriers 2000n are located on the interior surfaces of the tube wall forming members 1110n. The thickness of the barriers 2000n can vary (either similarly to or different from the barriers 2000m). The barriers 2000n connect with adjacent tube wall forming members 1110n. Each tube wall forming member 1110n varies in thickness therealong. For example, as shown in FIG. 32, the tube wall forming members 1110n can increase or decrease in size (depending on the direction of movement) about axis 12n. In other words, the tube wall shaping members 1110n can vary in thickness between different sides of the tube wall 100n. This allows the support structure 1000n to potentially provide a first bend radius in a first direction and a different second bend radius in a second direction. This is applicable to any of the tubes 10 discussed herein and can provide advantages in terms of adaptability to patient requirements. Furthermore, this allows the support structure 1000n to provide varying mechanical properties around the support structure 1000n. For example, if a cross section is taken across the tube 10n in a direction perpendicular to the axis 12n, the mechanical properties of the support structure 1000n will vary around the cross section. That is, the mechanical properties will vary around the axis 12n.
[0152] With the above in mind, Figure 33 shows bending the tube 10n in a first direction, toward the thicker side of the tube wall forming member 1110n. Figure 34 shows bending the tube 10n in a second direction, toward the thinner side of the tube wall forming member 1110n. As can be seen, the bend R toward the thicker side of the tube wall forming member 1110n is greater compared to the thinner side. This can be useful when the tube 10n needs to bend more easily on one side in a medical treatment.
[0153] Other tailored features may also include barrier 2000a with deflection creases to facilitate deflection into or out of the main gas lumen during bending or water absorption of the tube, which may be added by post-processing annealing.
[0154] The tube 10 offers a number of non-obvious advantages. For example, the connectors 200, 300 may be modularized integrally with the support structure 1000 before the barrier 2000 is applied, which is particularly advantageous for reducing the likelihood of gas leakage within the lumen 110, at the connector portion. This arrangement also helps mitigate disconnection of the tube 10, for example, at the cuff portion. That is, the connectors 200, 300 are generally prevented from breaking away from the rest of the tube 10, thereby creating a more secure connection. The support structure 1000 can also include multiple distinct regions with tailored responses depending on the position and orientation of the member 1100. This, again, can result in better patient outcomes.
[0155] Mechanical properties, including flexibility, strength, toughness, weight, fracture resistance, and / or hardness, can also be tailored along the support tube wall 100 by varying the shape and / or material of the support structure 1000. The barrier 2000 can also be tailored to achieve different mechanical properties along the tube wall 100. For example, the material of the barrier 2000 can be tailored to achieve different moduli, hardness, or biocompatibility. Separately, the gas compliance of the tube 10 can be modified along the tube 10 by the support structure 1000 and / or the barrier 2000. Gas compliance is the change in volume for a given change in pressure. This is particularly important in therapeutic procedures where controlled delivery of gas volume is important.
[0156] As used herein, adjectives such as left and right, top and bottom, hot and cold, first and second, etc. may be used to distinguish one element or action from another without necessarily requiring or suggesting any such actual relationship or order. Where the context permits, a reference to a component, integer, or step (or the like) should not be construed as being limited to just one of that component, integer, or step, but may be one or more of that component, integer, or step.
[0157] As used herein, the term "comprises," "comprising," "includes," "including," or similar terms is intended to mean a non-exclusive inclusion, and a method, system, or apparatus that includes a list of elements does not include only those elements, but may include other elements that are not listed as well.
[0158] The above description of embodiments of the present disclosure is provided for the purpose of explanation to one skilled in the art. It is not intended to be exhaustive or to limit the disclosure to a single disclosed embodiment. As noted above, various alternatives and modifications to the present disclosure will be apparent to those skilled in the art from the above teachings. Thus, while several alternative embodiments have been specifically discussed, other embodiments will be apparent to or relatively easily developed by those skilled in the art. The present disclosure is intended to encompass all modifications, alternatives, and variations discussed herein, as well as other embodiments that fall within the spirit and scope of the above description.
[0159] [Table 1]
[0160] [Table 2]
Claims
1. A medical tube for supplying gas to a patient, Barriers and a support structure that, together with the barrier, forms a tube wall so as to provide a lumen; a connector configured to connect to a device to allow gas flow within the lumen; A medical tubing, wherein at least a portion of the connector is integrally formed with the support structure.
2. A medical tube for supplying gas to a patient, Barriers and a support structure forming a tube wall with the barrier so as to provide a lumen for gas flow; A medical tubing, wherein the tube wall includes a difference in mechanical properties along the tube wall.
3. A medical tube for supplying gas to a patient, Barriers and a support structure forming a tube wall with the barrier so as to provide a lumen for gas flow; The medical tubing, wherein the barrier encases the support structure.
4. A medical tube for supplying gas to a patient, Barriers and a support structure forming a tube wall with the barrier so as to provide a lumen for gas flow; A medical tubing, wherein the support structure includes a difference in mechanical properties along the support structure.
5. A medical tube for supplying gas to a patient, Barriers and a support structure that, together with the barrier, forms a tube wall so as to provide a lumen; a patient interface; A medical tubing, wherein at least a portion of the tubing wall is integrally formed with at least a portion of the patient interface.
6. The medical tubing of claim 5 , wherein the patient interface comprises a nasal cannula.
7. A medical tube for supplying gas to a patient, Barriers and a support structure that, together with the barrier, forms a tube wall so as to provide a lumen; accessories, A medical tube, wherein at least a portion of the tube wall is integrally formed with the accessory.
8. The medical tubing of claim 7 , wherein the accessory is a coupler.
9. The medical tubing of claim 8 , wherein the coupler comprises an engaging portion.
10. The medical tubing of claim 9 , wherein the engagement portion is configured to engage a patient interface.
11. The medical tubing of claim 10 , wherein the patient interface is a nasal cannula.
12. A medical tube for supplying gas to a patient, Barriers and a support structure forming a tube wall with the barrier so as to provide a lumen for gas flow; The medical tubing, wherein the support structure includes a visual indicator to provide a connection indication.
13. The medical tubing of claim 12 , wherein the connection indicia aid in determining an orientation for connection.
14. The medical tubing of claim 12 or 13, wherein the connection indication comprises color and / or shading.
15. 15. The medical tubing of claim 14, wherein the color and / or shading is different from the color and / or shading of the surrounding area of the medical tubing.
16. The medical tubing of any one of claims 1 to 15, wherein the support structure is connected to a manifold.
17. The medical tubing of claim 16 , wherein the manifold forms part of a patient interface.
18. The medical tubing of any one of claims 1 to 17, wherein the support structure provides one or more openings transversely to the gas flow.
19. The medical tubing of any one of claims 1 to 18, wherein the tube wall comprises a contour, the contour varying to provide a difference in mechanical properties.
20. 20. The medical tubing of claim 19, wherein the contours have associated cross sections, the associated cross sections varying to provide differential mechanical properties.
21. 21. The medical tubing of claim 19 or 20, wherein the profile varies relative to the longitudinal axis of the tube wall.
22. The medical tubing of any one of claims 19 to 21, wherein the profile comprises a taper to provide a difference in mechanical properties.
23. 23. The medical tubing of claim 22, wherein the taper provides a portion of a first cross-sectional area that is larger than another portion of a second cross-sectional area.
24. The medical tubing of any one of claims 1 to 23, wherein the support structure comprises one or more members.
25. 25. The medical tubing of claim 24, wherein the one or more members are varied to provide differences in mechanical properties.
26. 26. The medical tubing of claim 24 or 25, wherein the one or more members comprises at least one member that varies in size along its length.
27. The medical tube according to any one of claims 24 to 26, wherein the one or more members comprise one set of members positioned outward in a direction away from the central axis compared to other sets of members.
28. A medical tube according to any one of claims 24 to 27 when dependent on any one of claims 19 to 23, wherein the one or more members help define a contour.
29. The medical tube according to any one of claims 24 to 28, wherein the one or more members are integrally formed.
30. The medical tubing of any one of claims 24 to 29, wherein the one or more members comprise a plurality of members providing a skeletal structure.
31. The medical tubing of any one of claims 24 to 30, wherein the one or more members comprise one or more tube wall forming members and / or one or more bridging members.
32. 32. The medical tubing of claim 31, wherein the one or more tube wall forming members are annular.
33. 33. The medical tubing of claim 31 or 32, wherein an inner molding surface of the one or more tube wall forming members is different from an outer molding surface of the one or more tube wall forming members.
34. 34. The medical tubing of claim 33, wherein the inner molding surface lies substantially in a plane in a direction parallel to the longitudinal axis of the tube wall.
35. 35. The medical tubing of any one of claims 31 to 34, wherein the one or more tube wall shaping members extend at an oblique angle relative to the longitudinal axis of the tube wall.
36. 36. The medical tubing of any one of claims 31 to 35, wherein the thickness of the one or more tube wall forming members varies along the tube wall.
37. 37. The medical tubing of any one of claims 31 to 36, wherein the pitch of the one or more tube wall forming members varies.
38. 38. The medical tubing of claim 37, wherein the pitch varies relative to the longitudinal axis of the tube wall.
39. 39. The medical tubing of claim 37 or 38, wherein the pitch is measured with the tubing wall in an unstretched state.
40. The medical tubing of any one of claims 31 to 39, wherein the one or more bridging members connect the one or more tube wall forming members to one another.
41. 41. The medical tubing of claim 40, wherein the number of said one or more bridging members connecting said one or more tube wall shaping members varies from region to region of the tube wall.
42. The one or more bridging members are attached to the one or more tube wall forming members. The first orientation, and connecting in a second orientation, 42. The medical tubing of claim 40 or 41, wherein the first orientation is different from the second orientation.
43. 43. The medical tubing of claim 42, wherein the first orientation is offset from the second orientation by approximately 90 degrees.
44. 44. The medical tubing of claim 42 or 43, wherein the first orientation and the second orientation alternate between sides of the one or more tube wall forming members.
45. The medical tubing of any one of claims 31 to 44, wherein the one or more bridging members comprise at least two bridging members providing connections between parts of the one or more tube wall shaping members.
46. 46. The medical tubing of claim 45, wherein the at least two bridging members are disposed on opposite sides of the tubing wall.
47. The medical tubing according to any one of claims 31 to 46, wherein the one or more bridging members extend in a linear direction.
48. The medical tubing of any one of claims 31 to 47, wherein the one or more bridging members extend parallel to the longitudinal axis of the tube wall.
49. A medical tubing according to any one of claims 31 to 48, wherein the region of the support structure is favorable for bending around the side of the support structure from which the one or more bridging members are omitted.
50. 50. The medical tubing of any one of claims 49, wherein a region of the support structure is restricted from bending around a further side of the support structure by the one or more bridging members.
51. The medical tubing of any one of claims 1 to 50, wherein the support structure and barrier define a second lumen for gas flow.
52. 52. The medical tubing of claim 51, wherein the second lumen is adjacent to, nested with, coaxial with, separated from, and / or collinear with the inner lumen.
53. 53. The medical tubing of any one of claims 1 to 52, wherein the support structure is resiliently biased to conform to a first curvature along the length of the tube wall.
54. The medical tubing of any one of claims 1 to 53, wherein the support structure comprises a first region and a second region.
55. 55. The medical tubing of claim 54, wherein the first region is configured to have the first flexibility and the second region is configured to have the second flexibility.
56. 56. The medical tubing of claim 55, wherein the second flexibility is greater than the first flexibility.
57. 57. The medical tubing of any one of claims 54 to 56, wherein the first region and the second region have different radial compliances.
58. 58. The medical tubing of any one of claims 54 to 57, wherein the first region is configured to bend in a first direction relative to a first plane, and / or the second region is configured to bend in a second direction relative to a second plane.
59. 59. The medical tubing of claim 58, wherein the first direction and the second direction are different.
60. 60. The medical tubing of claim 58 or 59, wherein the first region is restricted from bending in the second direction and / or the second region is restricted from bending in the first direction.
61. 61. The medical tubing of any one of claims 54 to 60, wherein the structure of the first region is different from the structure of the second region.
62. 62. The medical tubing of any one of claims 1 to 61, wherein the barrier encapsulates the support structure to mechanically position the support structure in place.
63. The medical tubing of any one of claims 1 to 62, wherein a portion of the barrier is configured to rotate relative to a portion of the support structure.
64. 64. The medical tubing of any one of claims 1 to 63, wherein the barrier has a thickness of about 10 μm to 200 μm.
65. 65. The medical tubing of any one of claims 1 to 64, wherein the barrier thickness is controlled along the tubing wall.
66. The medical tube of any one of claims 1 to 65, wherein the barrier is a breathable material.
67. 67. The medical tubing of any one of claims 1 to 66, wherein one end of the tube wall comprises a swivel connector.
68. 68. The medical tubing of any one of claims 1 to 67, wherein the support structure comprises a connector at a second end configured to connect to a patient interface and / or medical device.
69. 69. The medical tubing of claim 68, wherein the connector at the second end is integrally formed with the support structure.
70. 70. The medical tubing of any one of claims 1 to 69, wherein the medical tubing further comprises a filter.
71. 71. The medical tubing of claim 70, wherein the filter is integrally formed with the tubing wall.
72. 72. The medical tubing of any one of claims 1 to 71, wherein the tubing wall comprises one or more vent holes.
73. 73. The medical tubing of claim 72, wherein the one or more vent holes comprise an exhalation port.
74. 74. The medical tubing of claim 73, wherein the expiratory port comprises a non-linear surface at one end.
75. 75. The medical tubing of any one of claims 1 to 74, wherein the tube wall comprises two or more rims.
76. 75. The medical tubing of any one of claims 1 to 74, wherein the tube wall comprises three or more limbs.
77. 77. The medical tubing of claim 75 or 76, wherein one rim is a different size than the other rim.
78. 78. The medical tubing of claim 77, wherein the size of the one limb or the other limb relates to diameter, cross-sectional area, and / or length.
79. 79. The medical tubing of claim 78, wherein the diameter is related to the inner diameter of the one rim and / or the other rim.
80. 80. The medical tubing of any one of claims 75 to 79, wherein one limb has a different connector than the other limb.
81. 81. The medical tubing of any one of claims 1 to 80, wherein the support structure and barrier help define at least three lumens.
82. 82. The medical tubing of any one of claims 1 to 81, wherein the tube wall is configured to contract and / or expand from a first configuration to a second configuration.
83. 83. The medical tubing of any one of claims 1 to 82, wherein the support structure aids in the formation of one or more frusto-conical sections.
84. 84. The medical tubing of claim 83, wherein the one or more frusto-conical portions are configured to contract and / or expand.
85. 85. The medical tubing of claim 83 or 84, wherein the one or more frusto-conical portions include two frusto-conical portions, the two frusto-conical portions being different sizes.
86. 86. The medical tubing of any one of claims 1 to 85, wherein the barrier has deflection folds.
87. 87. The medical tubing of claim 86, wherein the deflection folds facilitate deflection into or out of the lumen during bending or water absorption of the tubing.
88. 1. A patient gas delivery system comprising: A patient gas delivery system comprising one or more medical tubing according to any preceding claim.
89. 90. The system of claim 88, wherein the one or more medical tubes comprise a plurality of medical tubes.
90. 90. The system of claim 88 or 89, wherein the system further comprises a patient interface connected to the one or more medical tubes.
91. 91. The system of claim 90, wherein the patient interface is a nasal cannula, a mask, and / or an inhalation tube.
92. 92. The system of claim 91, wherein the mask is in the form of a continuous positive airway pressure (CPAP) mask.