HME Devices
Patent Information
- Application Number
- JP2023562785
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2021-04-12
- Filing Date
- 2022-04-04
- Publication Date
- 2025-01-17
- Estimated Expiration
- Not applicable · inactive patent
AI Technical Summary
Existing HME devices require disconnection and reconnection for drug administration, leading to temporary ventilation interruption and inefficiency, and existing bypass systems are bulky and cumbersome.
An HME device with a selective bypass mode that allows gas to bypass the HME unit through a compact internal channel, enabling seamless drug administration without external piping, and a rotatable coupling system for easy HME unit replacement.
Facilitates drug administration without interrupting ventilation, reduces device bulk, and minimizes waste by allowing reusable components, enhancing clinical efficiency and cost-effectiveness.
Smart Images
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Abstract
Description
[Technical field]
[0001] The present invention relates to HME devices. [Background technology]
[0002] When a patient breathes through a tube inserted into the trachea, such as a tracheostomy tube or an endotracheal tube, the gas flow to the bronchi is not warmed or humidified by passing through the nose. Unless the gas is warmed and humidified in some way, it can cause damage and discomfort to the patient's throat. This gas can be conditioned by a humidifier in the ventilation circuit, but is most conveniently achieved by using a heat and moisture exchange device (HME). HMEs are small, lightweight devices that contain one or more exchange elements, such as paper or foam treated with a hygroscopic substance. When the patient exhales, the gas passes through the exchange element, giving up most of its heat and moisture to the element. When the patient inhales, the gas passes in the opposite direction through the exchange element, picking up most of the heat and moisture in the exchange element, thereby warming and humidifying the gas that the patient inhales. These HME devices are low cost and disposable for a single use. The HME device can be connected to the breathing circuit or simply connected to the machine end of the tracheal tube and opened to the atmosphere as the patient breathes spontaneously. The HME can be used in conjunction with other breathing devices, such as a face mask.
[0003] HME is marketed by Smiths Medical International Limited, Ashford, Kent, United Kingdom under the trade name Thermovent (Thermovent is a registered trademark of Smiths Medical International Limited), by Hudson RCI AB under the trade name Trach Vent (Trach Vent is a registered trademark of Hudson RCI AB), and by Dar, Medisize, Intersurgical and other manufacturers. Examples of HMEs are described in U.S. Pat. No. 6,233,663; ... and U.S. Pat. No. 6,233,663. The "Thermovent T" HME sold by Smiths Medical has a T-shaped configuration with two HME elements attached to either end of a straight tubular housing that extends transversely to a connection port where the device is attached to a tracheostomy tube or the like. The tubular housing for the HME elements may be curved to follow the anatomical profile of the neck as described in U.S. Pat. No. 6,233,663.
[0004] HMEs are often used in the breathing circuits of patients in intensive care who may need to be able to administer medication to the lungs by nebulization. Administering nebulized medication through the HME medium is undesirable as it may interact with or trap the nebulized medication, reducing the amount that reaches the lungs. This also reduces the efficiency of the HME. In such a situation, the breathing circuit must be disconnected to remove the HME and connect the nebulizer, leaving the patient temporarily unventilated. After administration of the medication, the HME is reconnected to the breathing circuit, again meaning that the patient is temporarily unventilated. This can be harmful to the patient and time consuming for the clinician. To avoid this, bypass systems can be used, in which an additional length of tubing is connected to the breathing system by a two-way valve and extends around the HME, allowing gas to flow through this tubing without passing through the HME when medication needs to be administered. However, these systems tend to be bulky and cumbersome, and increase the weight and dead space of the breathing circuit. The bypass tubing can also get caught on adjacent equipment. [Prior art documents] [Patent documents]
[0005] [Patent Document 1] British Patent No. 2391816 [Patent Document 2] International Publication No. 01 / 72365 Brochure [Patent Document 3] U.S. Pat. No. 5,505,768 [Patent Document 4] Swedish Patent No. 516666 [Patent Document 5] U.S. Pat. No. 3,881,482 [Patent Document 6] German Utility Model No. 20302580 [Patent Document 7] German Utility Model No. 20114355 [Patent Document 8] International Publication No. 97 / 01366 Brochure [Patent Document 9] US Patent Application Publication No. 2002 / 0157667 [Patent Document 10] U.S. Patent No. 6,422,235 [Patent Document 11] European Patent Application Publication No. 1208866 [Patent Document 12] U.S. Pat. No. 4,971,054 [Patent Document 13] European Patent Application Publication No. 1699515 [Patent Document 14] U.S. Pat. No. 5,035,236 [Patent Document 15] European Patent No. 535016 [Patent Document 16] U.S. Patent No. 5,647,344 [Patent Document 17] British Patent No. 2267840 [Patent Document 18] European Patent Application Publication No. 856327 [Patent Document 19] European Patent Application Publication No. 1699515 [Patent Document 20] U.S. Patent No. 7,363,925 [Patent Document 21] WO 15 / 107320 Brochure [Patent Document 22] US Patent Application Publication No. 2008 / 0099013 [Patent Document 23] British Patent No. 2540456 [Patent Document 24] International Publication No. 2017 / 216508 Brochure [Patent Document 25] European Patent No. 1888157 Summary of the Invention [Problem to be solved by the invention]
[0006] It is an object of the present invention to provide an alternative HME device. [Means for solving the problem]
[0007] According to the present invention, there is provided an HME device, the device can be selectively set to an HME mode or a bypass mode, the device includes an outer housing having at least two parts, the parts can be connected or disconnected to each other to allow access to the interior of the housing, one of the parts has an external port through which gas can flow into the housing and an internal port in selective fluid communication with the external port, the device includes an HME unit arranged to be connected and disconnected to each other with the internal port, the two parts of the housing can be separated from each other to allow removal and replacement of the HME unit on the internal port, the exterior of the HME unit and the interior of the outer housing have a bypass channel therebetween and are configured to pass gas flow through the device along the bypass channel in the bypass mode, the device includes a selector that, in the bypass position, selectively blocks gas flow through the internal port such that gas flow through the device bypasses the HME unit and instead flows along the bypass channel, and the selector, in the HME position, blocks flow along the bypass channel while passing flow through the HME unit to the device.
[0008] The two parts of the outer housing may be interconnected by a bayonet lug on one part and a slot on the other part arranged to receive the lug when the two parts are twisted relative to one another. The bypass channel is preferably provided by an annular passage between the outside of the HME unit and the inside of the outer housing. The HME unit preferably has a tapered coupling at one end which is removably fitted onto a tapered fitting on one part of the outer housing. The selector may include a shutter plate movable in a plane perpendicular to the axis of the device between a position covering an opening to the HME unit and exposing the bypass opening, and a position exposing an opening to the HME unit and covering the bypass opening.
[0009] An HME device according to the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which: [Brief description of the drawings]
[0010] [Figure 1] FIG. 2 illustrates a perspective view of the HME device from the patient end. [Diagram 2] FIG. 1 is a perspective view of an HME device from the appliance end. [Diagram 3] FIG. 2 is a side cross-sectional view of the HME. [Figure 4] FIG. 13 is an end view from the patient end of the HME device in bypass mode. [Diagram 5] FIG. 13 is an internal end view of the device in bypass mode. [Figure 6] FIG. 13 is an end view from the patient end in HME mode. [Figure 7] FIG. 13 is an internal end view of the device in HME mode. [Figure 8] FIG. 1 is a perspective view of the device from the equipment end showing the two pieces of the outer housing unlocked and separated. [Figure 9] FIG. 1 is a perspective view of the device with the two parts of the housing separated and the HME unit removed for removal and replacement. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0011] 1-3, there is shown an HME device 1 having an outer housing 10 of circular cross section with a patient end coupling or inlet 11 adapted to fit over a mating male connector on the end of a breathing device (not shown), such as an endotracheal or tracheotomy tube. At the opposite end of the device 1, an instrument end coupling or outlet 12 is axially aligned with the patient end coupling 11. Between the two couplings 11 and 12, the housing is radially enlarged to have a circular cross section. The outer housing 10 has two parts 13 and 14 which are interconnected by a releasable and rotatable coupling arrangement such that they can be separated to allow access to the interior of the housing. More specifically, the left instrument end part 13 includes the instrument end coupling 12 and an intermediate section 15 which tapers to a cylindrical enlarged end 16. As shown most clearly in FIGS. 8 and 9, the cylindrical section 16 has six bayonet lugs 17 at its free end 16' which project outwardly at equal intervals around the cylindrical section.
[0012] The other part of the outer housing 10 is provided by a right patient-end piece 14 which comprises two moulded components 21 and 22 joined end to end. The right patient-end component 21 includes a patient-end coupling 11 which has an internal tapered surface 23 adapted for mating connection with a standard 15mm male coupling on the end of a tracheal tube or other breathing device. The patient-end component 21 also has an intermediate section 24 which tapers outwardly to an enlarged cylindrical collar 25 which has at its end a tapered inner surface 26 which is joined to a co-operating tapered surface 27 on the right patient end of the other component 22. The tapered intermediate section 24 of the patient-end component 21 is also formed with a short outwardly projecting reduced diameter sleeve 28 in which a knob 30 of a mode selector 31 is supported. 5 and 7, the mode selector 31 has a C-shaped curved, planar shutter plate 32 with the plane extending perpendicular to the axis of the HME device 1. One end of the plate 32 is fixedly attached to the knob 30 such that twisting the knob within the sleeve 28 rotates the plate about the axis of the knob. The knob 30 has a short radially outwardly projecting locking finger 33 which can be positioned in one of two notches 34 or 35 in the outer end of the sleeve 28, the two notches being spaced approximately 60° apart from each other. The operation of the mode selector 31 is described in more detail below.
[0013] The device end component 22 of the patient end piece 14 has a slightly enlarged rim 40 at its patient end, with a tapered outer surface 27 that fits over and is bonded to the inside of the collar 25 of the patient end component 21. A wall 42 extends laterally from the patient end of the component 22 as a single piece. The wall 42 has a circular central opening 43 that communicates with a bore 44 that passes through an axial tubular structure or port 0.45. A structure 45 extends coaxially with the housing 10 toward the device end, approximately half the length of the patient end piece 14. This tubular structure 45 is tapered on its outer surface to provide an internal port of the same shape and size as a standard 15 mm male coupling. The wall 42 also has a second opening provided by a curved slot 46 (FIG. 5) extending approximately 120° about the axis of the device toward the outer edge of the wall. The dimensions of the slot 46 are slightly smaller than the dimensions of the shutter plate 32 so that the slot is completely covered when the shutter plate is fully displaced counterclockwise as shown in FIG.
[0014] The opposite instrument end of the component 22 is formed with an enlarged rim 47 adapted to receive the patient end 16' of the instrument part 13. The end face of the rim 47 is interrupted by six L-shaped slots 48. The size and shape of the slots 48 are selected to allow for a rotational coupling between the two parts by inserting the lugs 17 of the instrument end part 13 and rotating them approximately 30° to lock the two parts 13 and 14 together in a substantially airtight manner.
[0015] As shown in FIG. 3, the device 1 includes a conventional HME unit 50 of the kind having an HME element 51 housed within an outer plastic housing 52 having a patient end coupling 53 at one end. The patient end coupling 53 has an internal tapered surface that results in a female 15 mm fitting adapted to be fitted over a 15 mm tapered male fitting provided by the internal port 45. At its opposite end, the HME unit 50 has an instrument end fitting 54 having an external tapered surface that results in a 15 mm male fitting. In this example, the instrument end fitting 54 of the HME unit 50 opens into the interior of the outer housing 10 and is not connected to any other components. The end fittings 53 and 54 are axially aligned with each other with the HME element 51 positioned therebetween so that all gas flow through the HME unit 50 passes through the HME element in either direction. The HME element 51 may be of a conventional kind such as comprising a coil of corrugated cardboard treated with a hygroscopic salt. Alternatively, the HME element 51 may be foam. The HME may also include a filter. The maximum outer diameter of the HME unit 50 is less than the inner diameter of the outer housing 10 such that there is a bypass channel in the form of annular passage 55 that extends around the outer periphery of the HME unit between the outside of the HME unit and the inside of the outer housing 10.
[0016] The HME device 1 can be set in HME mode during normal use, or in bypass mode when nebulized or medication needs to be delivered to the airway. In bypass mode, gas is prevented from flowing through the HME unit 50, as this would absorb the nebulized medication and reduce the amount that reaches the patient, which also reduces the subsequent effectiveness of the HME. The device 1 can be switched between the two modes by using the knob 30 to move the shutter plate 32 in its plane perpendicular to the axis of the device 1. In the state shown in Figures 6 and 7, the knob 30 is in its counterclockwise furthest position, with the locking finger 33 positioned in the counterclockwise notch 35. In this position, the shutter plate 32 swings counterclockwise to its full extent to engage the inside of the collar 25. The shutter plate 32 thus covers the bypass opening 46, exposing the central opening 43 to the internal port 45 and thus to the HME unit 50. Thus, in this mode, all gas flowing between the two couplings 11 and 12 of the device flows through the HME unit 50.
[0017] When the clinician needs to administer a nebulized medication, he or she lifts the locking finger 33 of the knob 30 out of the HME notch 35 and twists the knob fully clockwise (approximately 60°) until the locking finger engages the bypass notch 34 as shown in FIG. 4. FIG. 5 shows that in this position, the shutter plate 32 swings fully clockwise to close the central opening 43 leading to the HME. The shutter plate 32 also moves away from the bypass opening 46 so that most of the bypass opening 46 is not covered. Gas can then flow through the bypass opening 46 and along the bypass channel 55 around the outside of the HME unit between the end couplings 11 and 12 without flowing through the HME unit 50. When the dose is finished, the clinician simply twists the selector knob 30 back to its HME mode position to allow gas to flow in the forward and reverse directions again through the HME unit 50.
[0018] Conventional HMEs need to be replaced approximately every 24 hours to avoid bacterial buildup in the HME elements and to maintain maximum efficiency. To accomplish this in the configuration of the present invention, the instrument end piece is simply twisted approximately 30° relative to the patient end piece so that the bayonet lugs 17 of the instrument end piece 13 of the outer housing 10 disengage from the L-shaped slots 48 in the patient end piece 14 of the outer housing 10, thereby allowing the two pieces of the outer housing to be separated from one another as shown in FIG. 8. This can be accomplished without the need to disconnect the couplings 11 and 12 from the breathing circuit. In this condition, it can be seen that the instrument end of the HME unit 50 protrudes beyond the instrument end of the patient end piece 14 of the housing 10 so that it can be easily grasped and twisted relative to the patient end piece to disconnect the patient end of the HME unit from the internal port 45 as shown in FIG. 9. The HME unit 50 can thus be removed from the outer housing 10, discarded, and replaced with a new HME unit. After this, the instrument end 13 of the outer housing 10 is reconnected with the patient end 14 of the housing.
[0019] The configuration of the present invention allows for the bypass of the HME in a compact configuration without external tubing that can tangle or snag on adjacent equipment. The present invention also allows for the main parts of the device to be reused with several different HMEs. This saves money and reduces the amount of plastic waste, which is particularly advantageous with medical devices since the cost of disposing of medical waste is greater than traditional waste.
Claims
1. 1. An HME device comprising: the HME device (1) being capable of being selectively set in an HME mode or a bypass mode; The HME device comprises an outer housing (10) having at least two parts (13, 14), said at least two parts being capable of being manually connected or disconnected from one another to allow access to an interior of said outer housing; One of the components (22) has an external port (11) through which gas can flow into the outer housing and an internal port (45) in selective fluid communication with the external port (11); the HME device comprises an HME unit (50) arranged to be manually connected and disconnected from said internal port (45), and the two parts (13, 14) of the outer housing are separable from each other to allow removal and replacement of the HME unit (50) on said internal port (45); an exterior of the HME unit (50) and an interior of the outer housing having a bypass channel (55) therebetween configured to pass gas flow along the bypass channel to the HME device (1) in the bypass mode; the HME device includes a selector (31) that, in a bypass position, selectively blocks gas flow through the internal port (45) such that gas flow through the HME device bypasses the HME unit (50) and instead flows along the bypass channel (55); and The selector (31), in an HME position, allows flow through the HME unit (50) to the HME device (1) and blocks flow along the bypass channel (55).
2. 2. The HME device of claim 1, wherein the two parts (13, 14) of the outer housing (10) are interconnected by a bayonet lug (17) of one part (13) and a slot (48) of the other part (14) arranged to receive the bayonet lug (17) when the two parts are twisted relative to each other.
3. 3. The HME device of claim 1 or 2, wherein the bypass channel is provided by an annular passage (55) between the outside of the HME unit (50) and the inside of the outer housing (10).
4. 3. The HME device of claim 1 or 2, wherein the HME unit (50) has a tapered coupling (53) at one end removably fitted onto a tapered fitting (45) of one part (14) of the outer housing (10).
5. 3. An HME device as claimed in claim 1 or 2, characterized in that the selector (31) includes a shutter plate (32) movable in a plane perpendicular to the axis of the device (1) between a position covering an opening (43) leading to the HME unit (50) and exposing a bypass opening (46) and a position exposing the opening (43) leading to the HME unit (50) and covering the bypass opening (46).