AXIAL FLOW VAPOR TRANSFER CARTRIDGE WITH LARGE DIAMETER FIBERS
20170182280 ยท 2017-06-29
Inventors
Cpc classification
A61M16/147
HUMAN NECESSITIES
International classification
Abstract
Systems, methods, and devices are disclosed for humidifying a breathing gas that reduces and/or eliminates the dangers and discomforts experienced by a patient. In one aspect, a system for humidifying gases includes a body, extending along a first axis from a first face to a second face, a first lumen at the first face, through which fluid enters the body, a second lumen at the first face through which fluid exits the body and a nonporous membrane located inside the body and extending from the first face to the second face wherein gas moving through the nonporous membrane is humidified by the fluid.
Claims
1. A system for humidifying gases, the system comprising: a body, extending along a first axis from a first face to a second face; a first lumen, at the first face, through which fluid enters the body; a second lumen, at the first face, through which the fluid exits the body; and a first non-porous membrane, inside the body, extending from the first face to the second face, wherein gas moving through the first non-porous membrane is humidified by the fluid.
2. The system of claim 1, wherein the first lumen and the second lumen are substantially parallel to the first axis.
3. The system of claim 1, wherein the first lumen and the second lumen have different lengths.
4. The system of claim 1, wherein the first lumen includes an aperture allowing the fluid to contact the first non-porous membrane while inside the body.
5. The system of claim 1, wherein the first non-porous membrane comprises a plurality of fibers.
6. The system of claim 5, wherein each of the plurality of fibers has a diameter of about 0.5 millimeters to about 2.0 millimeters.
7. The system of claim 1, wherein the first non-porous membrane is permeable to the gas.
8. The system of claim 1, further comprising a second non-porous membrane, inside the body, extending from the first face to the second face, wherein the second non-porous membrane is bonded to the first non-porous membrane at the first face and the second face.
9. The system of claim 1, wherein the fluid moves in a first direction and the gas moves in a second direction that is substantially parallel to the first direction.
10. The system of claim 1, further comprising: a first fluid passageway connecting to the first lumen through which the fluid is delivered to the body; a second fluid passageway connecting to the second lumen through which the fluid is removed from the body; and a first gas passageway through which the gas is delivered to the body, wherein the first fluid passageway and the second fluid passageway are housed within the first gas passageway.
11. The system of claim 10, further comprising a first end cap connecting the body to the first gas passageway at the first face, wherein the first fluid passageway and the second fluid passageway pass through the first end cap.
12. The system of claim 11, further comprising a second gas passageway at the second face, wherein the second gas passageway delivers the humidified gas from the body to a patient.
13. The system of claim 12, further comprising a water jacket located at the second gas passageway, wherein the water jacket warms the humidified gas as the humidified gas is delivered from the body to the patient.
14. A method of manufacturing a humidifier component, the method comprising: inserting a plurality of non-porous membranes into a first lumen of an extruded body, wherein the first lumen extends in an axial direction from a first side of the extruded body to a second side of the extruded body; bonding the plurality of non-porous membranes together at the first side of the extruded body and the second side of the extruded body; connecting a first fluid passageway to a second lumen extending in the axial direction from the first side of the extruded body; and connecting a second fluid passageway to a third lumen extending in the axial direction from the first side of the extruded body.
15. The method of claim 14, wherein the first fluid passageway and the second fluid passageway are housed within a first gas passageway, and wherein the first gas passageway delivers gas to the first lumen.
16. The method of claim 14, wherein the first lumen opens to an interior area of the extruded body through an interior opening located between the first side and the second side.
17. The method of claim 16, wherein the interior opening is created in the first lumen by: penetrating a third side of the extruded body; and sealing the third side of the extruded body after penetration.
18. The method of claim 16, further comprising a fourth lumen, wherein the fourth lumen extends in the axial direction from the first side of the extruded body to the second side of the extruded body without opening to the interior area.
19. The method of claim 17 wherein the bonding the plurality of non-porous membranes together further comprises: fitting a first end cap to the first side of the extruded body and a second end cap to the second side of the extruded body, wherein the placement of the first cap and the second cap completely closes the first lumen of the extruded body except at the interior opening; and injecting a potting material into the extruded body.
20. The method of claim 17 further comprising centrifuging the extruded body such that the potting material is deposited at the first side of the extruded body adjacent to the first cap and at the second side of the extruded body adjacent to the second cap.
21. The method of claim 14, wherein the extruded body, first lumen, and second lumen comprise a single extrusion.
22. The method of claim 14, wherein the second lumen is defined by a first interior passageway and the third lumen is defined by a second interior passageway, and wherein the first interior passageway and the second interior passageway are housed within the extruded body and bonded to the plurality of non-porous membranes.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] The foregoing and other objects and advantages will be apparent upon consideration of the following detailed description, taken in conjunction with the accompanying drawings, in which like reference characters refer to like parts throughout, and in which:
[0021]
[0022]
[0023]
[0024]
[0025]
[0026]
[0027]
[0028]
[0029]
[0030]
[0031]
[0032]
[0033]
[0034]
[0035]
[0036]
[0037]
DETAILED DESCRIPTION
[0038] To provide an overall understanding of the systems, devices, and methods described herein, certain illustrative embodiments will be described. Although the embodiments and features described herein are specifically described for use in connection with a high flow therapy system, it will be understood that all the components and other features outlined below may be combined with one another in any suitable manner and may be adapted and applied to other types of respiratory therapy and respiratory therapy devices, including low flow oxygen therapy, continuous positive airway pressure therapy (CPAP), mechanical ventilation, oxygen masks, Venturi masks, and tracheotomy masks.
[0039] The systems, methods, and devices described herein reduce condensation of humidified gas (e.g., breathable air) by moving the vapor transfer unit proximal to the patient. The vapor transfer unit is configured to be positioned proximate to the patient interface, for optimum heating and humidification of breathing gas without condensation of the humidified gas over a long transport length. By transporting the gas and fluid (e.g., water) from the capital unit separately, the gas is not exposed to water vapor prior to entering the humidifier. As a result, the systems, methods, and devices reduce the distance that heated and humidified breathing gas has to travel before reaching the patient. This reduces the length of tubing over which the heated and humidified gas can cool and allow moisture to condense. Thus, by moving the location of vapor transfer proximate to the patient, the amount of condensation that can occur during operation is reduced and the need for systems to control condensation is reduced. Patient safety is further increased by use of nonporous membranes which do not allow transfer of bacteria from the fluid into the gas flow. Since the gas and fluid are not in contact until they enter the vapor transfer system and then only through the nonporous membrane, this leads to a safer humidified breathing gas provided to the patient.
[0040] The systems, methods, and devices described herein also limit the cost and system requirements of the vapor transfer unit. The vapor transfer unit has an axial flow design in which the gas and fluid tubes are attached at an end, which minimizes the bulk of the unit and is also easily extruded. The fiber membranes used in the vapor transfer unit are large diameter fibers which are cost effective and easily extruded in addition to being effective in heating and humidifying the gas flow. Additionally, the system is configured to run with lower pressure, allowing a blower to be used at the capital unit for quieter operation and use in locations without available high pressure air sources.
[0041] Furthermore, the systems provide a humidifier with a sleek profile that maximizes patient comfort. The vapor transfer unit is designed as a cylinder with gas and fluid tubes attached at a port at the end and no lateral ports or tubes. This places the tubes away from the sides of the vapor transfer unit so that they are less likely to be tangled, kinked or dislodged. Further, the fluid tubes transporting heated fluid may be disposed inside the gas tube in order to insulate the fluid during transport from the capital unit and prevent a drop in temperature. This further allows the capital unit to be moved away from the patient.
[0042] Additionally, systems are provided which allow the vapor transfer unit to be placed farther away from the patient. The use of a water jacket around the gas tubing from the vapor transfer unit to the patient prevents cooling of the gas and condensation. Patient comfort is increased by moving the vapor transfer unit away from the body, resulting in lowered sensation of heat from the vapor transfer unit and increased range of motion during therapy.
[0043]
[0044] Capital unit 170 includes blower 192 to propel the gas through first gas passageway 146 to body 102. The nonporous membrane may be comprised of a plurality of fibers. The large diameter of the fibers of the nonporous membrane (not shown) in body 102, through which the gas moves, allows for use of blower 192. Small diameter fiber membranes typically require a high pressure air source, such as building air to push the gas through the membrane. Advantageously, use of a blower instead of a high pressure gas source reduces noise associated with the therapy while maintaining a high flow rate. Additionally, capital unit 170 employing blower 192 is more portable, allowing for home use or use in other environments in which room air or other high pressure sources are not available. Blower 192 may also be used with oxygen from a portable tank attached to gas supply 198 in home use scenarios. The gas source may alternatively or additionally be a gas blender, mechanical ventilator, high flow therapy system, oxygen concentrator or oxygen tank. The humidifier can also be used with a continuous positive airway pressure (CPAP) or bubble CPAP system.
[0045] The gas is provided to first gas passageway 146 from gas supply 198 and is propelled by blower 192. The gas and fluid may be heated at heater 194 in capital unit 170 prior to transport to humidifier 101. The fluid is propelled through first fluid passageway (not shown) by pump 196. Pump 196 may be disposable for ease of use in patient care settings and may be inserted into capital unit 170 before use. The heated gas and fluid are transported from capital unit 170 to humidifier 101 where the heated fluid humidifies the gas. The gas is then provided to patient 162 through cannula 160.
[0046] Humidifier 101 is positioned proximal to patient 162 to reduce the distance over which the heated and humidified gas travels from humidifier 101 to reach patient 162. The heated gas and the heated fluid travel from capital unit 170 to humidifier 101 over a length of tubing before the gas is humidified. This prevents condensation of moisture from the gas over a long length of tubing and also reduces the length of tubing over which the heated and humidified gas moves from humidifier 101 to patient 162 over which the gas can cool. The heated gas does not need to be insulated during transport between capital unit 170 and humidifier 101 because as it does not contain moisture, there is no risk of condensation occurring in first gas passageway 146 due to heat loss. Transport of the gas between capital unit 170 and humidifier 101 without the need for a water jacket or other insulation mechanism prevents a drop in the pressure of the gas. Thus, by moving the location of humidifier 101 proximate to patient 162, the pressure of the gas is maintained while the amount of condensation that occurs during operation is reduced and the need for additional systems to control condensation is reduced. Use of axial flow humidifier 101 proximate to patient 162 allows patient 162 to comfortably and safely receive respiratory therapy.
[0047] Capital unit 170 may also include user-input interface 199 which allows a user to select values associated with the therapy, such as temperature and humidity regulation, flow rate, and timers, as well as to turn the unit on and off. In some embodiments, capital unit 170 may include control circuitry. Control circuitry may receive data via an input/output path from one or more sensors (e.g., that measure flow rate, temperature, humidity, etc.). Control circuitry may be used to send and receive commands (e.g., to operate the humidifier). The control circuitry may be based on any suitable language and/or operating system and may execute instructions for the humidifier that are stored in memory. A patient may also send instructions to the control circuitry (e.g., instructing the capital unit to deliver gas) using any suitable user interface, such as a keypad, keyboard, voice command, etc. Capital unit 170 may also include a display and/or speakers that may be provided as stand-alone devices or integrated with other elements of capital unit 170. For example, the display and/or speakers may issue alerts on a current status or measurement (e.g., flow rate, temperature, humidity, etc.).
[0048]
[0049] The fluid is transported to body 102 through first fluid passageway 242. The fluid is heated at capital unit (e.g., capital unit 170 (
[0050] First and second nonporous membranes (218, 230) may be hollow fiber-like membranes through which the gas flows from first face 206 of humidifier body 202 to second face 208. Membranes with a relatively large inner diameter, such as 0.65 mm, may be used in order to allow gas to pass more easily through the membranes. The large membrane diameters allow the use of a blower for portability of the respiratory therapy system. Large fiber diameter also decreases the cost of manufacture by extrusion because fibers of large diameter have greater surface area per unit length, so fewer fibers may be necessary to achieve the same flow and humidification of gas.
[0051] First and second nonporous membranes (218, 230) may additionally have thinner walls, allowing for more precise temperature control of the gas. The gas passing through a thin-walled fiber is heated and humidified by the fluid to achieve a temperature similar to the humidifying fluid's. The walls of the nonporous membranes may be 35/1000 mm, 40/1000 mm, 50/1000 mm, for example; however, vapor pressure will need to be increased with increasing thickness of the wall. A nonporous membrane fiber with a 2 mm outer diameter may have a wall with thickness 0.1 mm. Because of the large diameter fiber and thin wall, the pressure drop of the gas flowing through the nonporous membranes to be heated is only 0.01 psi, which allows the system to operate using a blower rather than room air. Fibers having diameters larger or smaller may also be used in the system, for example, nonporous fibers with diameters from 0.5 mm to 4 mm. In some embodiments, body 101 may house fewer nonporous membranes as the larger surface area of the larger diameter fibers maintains the desired surface area of the nonporous membranes. Additionally, or alternatively, the size of the body may be increased to accommodate more larger diameter nonporous membranes and/or to ensure a desired surface area of the nonporous membranes.
[0052] After the fluid has moved from first lumen 210 through body 202 and humidified the gas passing through first and second nonporous membranes (218, 230), the fluid travels toward first face 206 and exits body 202 along fluid exit path 216 at second lumen 214. The fluid passes through first end cap 248 at first face 206 at second aperture 252 of first end cap 248 and into second fluid passageway 244. First and second fluid passageways (242, 244) are, in some implementations, contained within first gas passageway 246. This protects first and second fluid passageways (242, 244) from being kinked or dislodged from the body 202 while also insulating the heated fluid with the air surrounding first and second passageways (242, 244). Moreover, the likelihood that first and second fluid passageways (242, 244) become tangled or damaged is reduced by housing them inside first gas passageway 246.
[0053] As the gas passes through first and second nonporous membranes (218, 230), it is humidified by the fluid moving through body 202 past first and second nonporous membranes (218, 230). In some implementations first and second nonporous membranes (218, 230) may be manufactured as a water-absorbing plastic which allows water or other fluids to absorb into the plastic and pass through to the interior of the membrane. A nonporous membrane will allow a fluid to pass through but may be constructed so as to inhibit the passage of bacteria or other harmful substances into the gas on the interior of the membrane. The fluid passes through first and second nonporous membranes (218, 230) into the interior of the membrane and is entrained into the gas flow. The humidified gas passes out the end of first and second nonporous membranes (218, 230) at second face 208 and into second gas passageway 254 connected to cannula 260 attached to body 202 at cannula adapter 258.
[0054] The nonporous membrane allows the heated fluid to interact with the gas inside the membrane in order to heat and humidify the gas. The nonporous membrane may be permeable to gas, but impermeable to liquid. Thus, water vapor is permitted to permeate the membrane, while liquid water is not. Water vapor may penetrate the membrane and become entrained in the gas flow, thus humidifying and heating the gas. Furthermore, the membrane is nonporous and as such there are no direct openings in the membrane through which liquid water may travel.
[0055]
[0056] The ends of nonporous membranes (318, 330) are visible at first face 306 of body 302. Nonporous membranes (318, 330) are arranged in body 302 extending from first face 306 to second face 308. Nonporous membranes (318, 330) are constructed as hollow fibers through which gas may be passed.
[0057] During use, fluid passes into body 302 through first fluid passageway 342 along fluid entrance path 312. The fluid exits body 302 along fluid exit path 316, exiting body 302 into second fluid passageway 344. First and second fluid passageways (342, 344) may have an inner diameter of between 1 mm and 8 mm, or any other suitable size. Fluid passageways (342, 344) allow the fluid to be transported to and from the humidifier. After use, fluid may be returned to capital unit (not shown) to be recycled or disposed of.
[0058]
[0059]
[0060]
[0061] The fluid enters body 602 with a flow direction substantially parallel to longitudinal axis 604 of body 602. The fluid leaves first lumen 610 and flows past first nonporous membrane 618, humidifying gas flowing through first nonporous membrane 618. The fluid may flow through body 602 generally in a direction similar to the first direction of fluid flow 636 as it moves toward second face 608. Second lumen 614 extends from first face 606 and has aperture of the second lumen 680 proximal to second face 608. The fluid, once exited from first lumen 610, moves through body 602 and into second lumen 614 toward first face 606 according to second direction of fluid flow 638, which is counter to first direction of fluid flow 636. A liquid return path through body 602 which is counter to the first direction of fluid flow may be more efficient when the humidifier is oriented in an upright position such as on a bed rail or on an upright patient. The gas may pass through body 602 in the first nonporous membrane 618 and out through second face 608. The gas may then travel along second gas passageway 652 to a patient interface (not shown).
[0062]
[0063] The alternative fluid flow paths through the body of the axial flow humidifier illustrated in
[0064]
[0065] First extended fluid passageway 886 and second extended fluid passageway 888 may be configured to surround second gas passageway 854 such that the gas in second gas passageway 854 is insulated by the water in first and second extended fluid passageways (886, 888). This decreases heat loss of the gas as it moves through second gas passageway 854 to the patient and minimizes condensation of the humidified gas. The application of first and second extended fluid passageways (886, 888) to surround and insulate second gas passageway 854 may be referred to as a water jacket. In some implementations an additional coating or wrapping of second gas passageway 854 and first and second extended fluid passageways (886, 888) may be used to further insulate the humidified gas. A water jacket allows humidifier 800 to be placed at a greater distance from the patient without increasing the condensation of the humidified gas over the distance from the humidifier to the patient by maintaining a constant temperature. For example, the humidifier with a water jacket may be placed on a bed rail or a stand at a distance from the patient without increased risk of condensation. This increases patient comfort as the humidifier does not need to be in direct contact with the patient.
[0066]
[0067]
[0068] In
[0069] In
[0070]
[0071]
[0072]
[0073] In
[0074] Manufacture of the axial flow humidifier by extrusion is cost-effective and efficient. The manufacture process is simple and allows the humidifier to be produced with a seamless and sleek cylindrical shape for patient comfort and ease of use. Use of end caps which connect fluid and gas to the humidifier further adds to the sleek design and is compatible with manufacture of the humidifier body by extrusion. The end cap may allow the first and second fluid passageways to be disposed within the first gas passageway.
[0075]
[0076] The foregoing is merely illustrative of the principles of the disclosure, and the systems, devices, and methods can be practiced by other than the described embodiments, which are presented for purposes of illustration and not of limitation. It is to be understood that the systems, devices, and methods disclosed herein, while shown for use in high flow therapy systems, may be applied to systems, devices, and methods to be used in other ventilation circuits.
[0077] Variations and modifications will occur to those of skill in the art after reviewing this disclosure. The disclosed features may be implemented, in any combination and subcombination (including multiple dependent combinations and subcombinations), with one or more other features described herein. The various features described or illustrated above, including any components thereof, may be combined or integrated in other systems. Moreover, certain features may be omitted or not implemented.
[0078] Examples of changes, substitutions, and alterations are ascertainable by one skilled in the art and could be made without departing from the scope of the information disclosed herein. All references cited herein are incorporated by reference in their entirety and made part of this application.