WO2013083258A1 - Nasenadaptersystem für cpap-beatmung - Google Patents
Nasenadaptersystem für cpap-beatmung Download PDFInfo
- Publication number
- WO2013083258A1 WO2013083258A1 PCT/EP2012/004983 EP2012004983W WO2013083258A1 WO 2013083258 A1 WO2013083258 A1 WO 2013083258A1 EP 2012004983 W EP2012004983 W EP 2012004983W WO 2013083258 A1 WO2013083258 A1 WO 2013083258A1
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- WIPO (PCT)
- Prior art keywords
- proximal
- adapter
- nose
- channel
- adapter system
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/06—Respiratory or anaesthetic masks
- A61M16/0605—Means for improving the adaptation of the mask to the patient
- A61M16/0633—Means for improving the adaptation of the mask to the patient with forehead support
- A61M16/0644—Means for improving the adaptation of the mask to the patient with forehead support having the means for adjusting its position
- A61M16/065—Means for improving the adaptation of the mask to the patient with forehead support having the means for adjusting its position in the form of a pivot
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/0057—Pumps therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/06—Respiratory or anaesthetic masks
- A61M16/0666—Nasal cannulas or tubing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
- A61M16/0816—Joints or connectors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
- A61M16/0816—Joints or connectors
- A61M16/0825—Joints or connectors with ball-sockets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
- A61M16/0816—Joints or connectors
- A61M16/0833—T- or Y-type connectors, e.g. Y-piece
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
- A61M16/0875—Connecting tubes
Definitions
- the present invention generally relates to a nasal adapter system for CPAP Ventilation
- the invention relates to a nasal adapter system which is used in CPAP respiration or NIV-CPAP respiration and is preferably designed to connect a nasal mask or a nose insert part (hereinafter referred to as "prong") to the respiratory tubes (inspiration tube, Expiratory tube and optional extra tubes) on a ventilator or other ventilator.
- a nasal adapter system which is used in CPAP respiration or NIV-CPAP respiration and is preferably designed to connect a nasal mask or a nose insert part (hereinafter referred to as "prong") to the respiratory tubes (inspiration tube, Expiratory tube and optional extra tubes) on a ventilator or other ventilator.
- NIV ventilation non-invasive forms of ventilation
- CPAP or NIV CPAP ventilation is designed to prevent upper respiratory tract damage that can result from intubation.
- NIV ventilation either nasal masks or prongs or nasal prongs are commonly used.
- Nasal masks are mostly masks made of silicone rubber, which preferably surround only the nose of the patient and are provided with connections for the breathing hoses.
- prongs usually have on their proximal side two small nasal tubes which are inserted into the two nostrils of the patient, and on its distal side a connection for an adapter for connection to the breathing tubes.
- Both nasal masks and prongs often use intermediate tubes (hereafter referred to as "proximal" tubes) which are coupled at their distal ends with distal breathing tubes leading to the ventilator or other ventilators.
- proximal tubes intermediate tubes
- the prongs (as well as the nasal masks) are attached to a headband or cap by laterally attached, stretchable straps (usually with the help of velcro straps) so that the prong can be snugly held on the nose and will not slip off if the patient moves ,
- the prongs are usually connected to a nose adapter, which can be coupled at its one end to the distal prong port and connected at its other end to the proximal intermediate tubes.
- Prongs come in a variety of sizes, depending on the size of the patient, the diameter, and the distance between the patient's nostrils into which the nasal tubes of the prong are inserted. Ventilation or respiratory assistance is usually carried out by applying a continuous, positive airway pressure (CPAP).
- CPAP continuous, positive airway pressure
- CPAP is a form of respiratory support that requires spontaneous breathing by the patient.
- Different methods are used to generate the CPAP.
- the pressure is generated by damming a free jet of high speed (English: Jet).
- Jet there are methods in which a fan feeds a more or less constant volume flow via the inspiratory tube into the respiratory system, while an adjustable flow resistance is attached to the end of the expiratory tube. The pressure arises as a result of this flow resistance and the friction in the expiratory tract of the respiratory system.
- the adjustable flow resistance can by a so-called Water lock (known as "bubble CPAP”) or generated by a regulated expiratory valve.
- the inspiration gas must be supplied to the patient via hoses. At least in the latter method, the expiratory gas must be piped from the patient to the ventilator or water lock. But even in the jet process, the expiratory gas is usually routed away from the patient so that no C0 2 accumulations form near the patient.
- the tubes of new and premature babies, but also of small children are generally smaller than in adults.
- tubing with inner diameters of 11 or 15 mm is used, while tubing for adults is practically always 22 mm inside diameter.
- CPAP adapter systems or nasal adapter systems, or simply nasal adapters.
- nasal adapter systems can also be used in infants or adult patients.
- face masks are preferred for use in adult patients for ventilation.
- Known nasal adapter systems usually have two proximal tubes or tubes with an inner diameter reduced in relation to the distal breathing tubes and, for example, a Y-shaped one Adapter head piece on.
- Various nose adapter systems are known from the prior art.
- WO 03/022341 A1 shows a respiratory support device with a nose adapter provided with a detachable prong, two ports for the breathing tubes and a sensor port.
- the Prong has two nasal tubes that can be inserted into the patient's nostrils.
- a disadvantage of the nasal adapter of WO 03/022341 A1 is that the prong or the nasal tubes of the prong can not or only insufficiently be adapted to different nasal sizes (distance and diameter of the nostrils) of different patients.
- prong and nasal tubes may be made of a rubber or silicone material, this allows only limited adaptation to different nasal shapes (nostril spacing and diameter, and nostrils relative to the head) such that a large number of different prongs must be kept ready. Especially the adaptation to the angle of the nostrils causes great difficulties, since the correct angle of the used Prongs usually can only be determined when the complete nose adapter is attached to the head of the patient. It may happen that the nasal adapter is attached several times with different prongs to the patient until the optimal matching prong with an optimal angle of the nasal tubes is found.
- a further disadvantage of the nose adapter of WO 03/022341 A1 is that the air flow at the transition between the proximal end of the adapter and the distal end of the prong is deflected by 180 °.
- the extraction of a desired amount of air from the prong is adversely affected because the inspiratory air is forced into the nasal tubes with a high momentum, thereby making it difficult for the patient to exhale, which is a disadvantage, especially in newborn and premature babies.
- the design of the Prong has a relatively large dead volume, which is why the newborn or premature infant a relatively large part of the previously exhaled air in a subsequent breathing cycle inhaled again.
- the breathing tubes of the known nose adapter are relatively stiff and can be difficult to adapt to different head sizes and head shapes of patients.
- DE 10 2009 016 150 A1 discloses a nose adapter or an atraumatic nose tube for non-invasive breathing assistance, in which the angular position of the entire nose tube can be changed by means of a tilting holder relative to the forehead rest.
- the angle of the nasal tube or the nasal tubes relative to the nose tube can not be adjusted.
- the central tube of the nose tube is elastic and provided with a flexible metal strip in order to adapt the nose tube as well as possible to the head shape of the patient, but the degree of freedom achieved thereby is not sufficient to an optimal angular adjustment of the nasal tube or the nasal tubes to the nostrils reach the patient.
- a further disadvantage is that corrugated bellows tubes are used in DE 10 2009 016 150 A1, which on the one hand are not infinitely adjustable and on the other hand produce a flow resistance which is increased compared to a smooth hose due to the folds present in the interior of the hoses.
- the folding of the tubes causes their length and thus the internal volume as well as the tube compliance between the ground state and the adapted state to vary very widely. This usually has a very adverse effect on the control behavior of the fan when generating the constant CPAP pressure. Since the nasal nozzle has no separating wall between the inspiratory and the expiratory gas, the functional dead space is very large.
- a rod-shaped, plastically deformable element is attached between the proximal breathing tubes of a nasal mask device, with which the curvature of these proximal tubes can be permanently changed, thereby reducing the curvature of the tubes to the head size or head To be able to adapt the head shape.
- That in the DE 103 29 818 A1 has a nasal mask whose position relative to the proximal tubes but obviously can not be adjusted, so that the nasal mask can be adapted only inadequate to the nose of the patient.
- the ventilation hoses (as in DE 10 2009 016 150 A1) must be deformed for handling reasons, before they are attached to the head of the patient.
- US 2010/0147302 A1 relates to a respiratory system with a mask system having a nozzle assembly with two nozzles for connection to the nostrils of a patient.
- This nozzle assembly has a tubular structure and is provided at its opposite ends with two end portions that can be independently rotated relative to the nozzle assembly and connected to the breathing tubes.
- the breathing tubes thus run separately on both sides of the head of the patient. As the patient's head moves, it may happen that the nozzle assembly disengages from the patient's nose.
- DE 202 06 692 U1 generally discloses a device for generating a continuous positive airway pressure with an adapter to which a nose tube Prong can be attached.
- these nasal tubes are not adjustable, so that no angle adjustment of the nasal tubes to the nostrils of the patient can be performed even in this device.
- the connection between the distal tubing connected to the ventilator or other ventilator and the proximal tubing of the nasal adapter system is usually via conical connectors. Due to the frictional engagement, such connectors transmit not only tensile forces and bending moments but also torques. This can cause the proximal tubing of the nasal adapter system to twist and even occlude as the patient rotates.
- the disadvantage of all known Nasenadaptersysteme is that they do not allow optimal adaptation of the adapter system to the size and shape of the head of the patient.
- no optimal adaptation of the coupled Prongs or the adapter itself to the nostrils of the patient to be ventilated can be achieved.
- the nose adapter may come off the patient's nose as the patient moves his head.
- the coupling between the adapter and the Prong designed so that the breathing resistance is not optimal and sets a relatively large so-called dead space. The latter may cause the patient to re-inhale some of the exhaled air in a subsequent breathing cycle.
- the present invention has for its object to provide a Nasenadapter- system or a CPAP-Nasenadaptersystem available, with the help of which the pneumatic connection between the breathing tubes (In particular, the distal breathing tubes) and a prong or a nasal mask can be designed so that an optimal adaptation of the entire nose adapter system to the head shape and the head size of the patient to be ventilated can be realized.
- the adapter system must be able to be adapted to the head of the patient, especially to the head of a newborn or preterm infant, that the prong or nasal mask is not altered by movements of the child with respect to its position relative to the nose as possible.
- the smallest possible dead space is to be achieved by the nose adapter system according to the invention, so that in a current breathing cycle only the smallest possible proportion of exhaled in the previous breathing cycle air is inhaled again, so as a C0 2 accumulation in the patient's airways and / or keep minimal in the dead space of the adapter system.
- a nasal adapter system or a CPAP nasal adapter system with the features of claim 1 is used.
- advantageous and preferred further developments of the nasal adapter system according to the invention are disclosed.
- the nasal adapter system of the invention is described in this specification generally for use with patients to be ventilated.
- the adapter system is preferably used in newborns and premature babies.
- the adapter system is preferably used in non-invasive CPAP ventilation. but theoretically other forms of ventilation can be used as well.
- the nasal adapter system of the present invention must preferably be configured to (1) permit angular adjustment of the prongs or nasal mask coupled to the nasal adapter system (or integrally formed) relative to the actual adapter, (2) adaptation of the proximal ones (4) allow the breathing space of the nasal adapter system to the shape and size of the head of the child (3) through the adapter system as many degrees of freedom as possible to limit the freedom of movement of the child to be respirated, (4) the dead space of the nose adapter in combination with the prong or to keep the nasal mask as small as possible, and (5) to minimize flow resistance, especially during expiration.
- the CPAP nasal adapter system is provided with a hinge by means of which movement of the nasal adapter with respect to a nasal mask (Prong) in at least one direction is made possible.
- the breathing tubes (preferably proximal breathing tubes) coupled to the distal end of the adapter are provided with a plastically deformable fiber so as to be able to adapt the tubes to the shape and size of the patient's head, in particular a neonate or premature infant.
- the proximal breathing tubes which are preferably provided between the adapter and the distal breathing tubes, but can also be omitted.
- at least the proximal ends of the breathing tubes may be provided with a plastically deformable fiber.
- the proximal breathing tubes of the adapter may be rotatably and / or pivotally coupled to the distal breathing tubes that are directly or indirectly connected to the ventilator.
- the nasal adapter and the articulation between the adapter and the nasal mask or prong are designed to form as small a dead space as possible in order to minimize accumulation of C0 2 within the adapter system and subsequently in the respiratory tract of the patient.
- the geometry of the nose adapter, the breathing gas is guided so that a low flow resistance.
- the nasal adapter system of the present invention for use in non-invasive respiratory support includes a nasal adapter having proximal and distal ends, the proximal end configured for coupling to the nose of a patient to be ventilated, and the distal end adapted for coupling to a respirator, an inspiratory channel, and an expiratory channel extending between the proximal and distal ends of the nasal adapter and connected to each other, a tube member rotatably held between the proximal ends of the channels and provided in its peripheral surface with a through-hole, and a connector grommet on the outside is formed of the tubular element in alignment with the passage opening, wherein the connecting sleeve is designed for coupling with the nose of the patient to be ventilated.
- the nasal adapter system preferably includes proximal breathing tubes connected to the distal end of the nasal adapter.
- the proximal breathing tubes may be interconnected and coupled to a plastically deformable fiber, wherein the deformable fiber may be a metal wire having a round or rectangular cross-section.
- the tube member is preferably held between the proximal ends of the channels to effect fluid communication between the proximal ends of the inspiratory channel and the expiratory channel.
- the distal ends of the inspiratory channel and the expiratory channel are each formed with a connecting piece for connecting a proximal inspiratory tube or a proximal expiratory tube.
- proximal ends of the inspiratory channel and the expiratory channel may each be bent inwardly at an angle of about 90 ° such that the proximal openings of the channels face each other.
- the adapter may comprise an upper housing shell and a lower housing shell, which are interconnected by gluing, welding or by latching means.
- the inspiration channel, the expiratory channel and the connecting pieces can be formed by the upper and the lower housing shell.
- two extensions may be formed, between which the tubular element is held.
- the two extensions are respectively formed on the proximal side of the lower and the upper housing shell, wherein in one extension a 90 ° bend of the inspiratory channel is formed and in the other extension a 90 ° bend of the expiratory channel is formed.
- the extensions can have an end region, between whose mutually facing flat inner surfaces the rotatable tube element is held in connection with the proximal openings of the channels.
- the proximal end portions of the inspiratory channel and the expiratory channel each extend in the form of a quarter toroid within the associated extensions.
- connection spout communicates with the interior of the tube element, and the two axial end openings of the tube element communicate with the corresponding proximal openings of the inspiratory channel and the expiration channel, respectively.
- a projection is provided on the tubular element, which in a
- the connector can be designed to be coupled to a nasal mask or prong.
- the proximal openings of the inspiratory channel and the expiratory channel preferably have a circular cross section which coincides with the cross section of the cylindrical tubular element.
- the tube member may be held between the proximal openings of the inspiratory channel and the expiratory channel so as to allow a change in the angular adjustment between the nose adapter and the connector grommet.
- proximal breathing tubes and associated distal breathing tubes may each be interconnected by a barrel joint such that each of the proximal breathing tubes is rotatable relative to the associated distal breathing tube.
- Figure 1 shows an embodiment of the Nasenadapter- system according to the invention, wherein at the distal end of the nose adapter, the proximal breathing tubes are attached and wherein the proximal end of the adapter is provided with a cylinder joint.
- Figure 2 shows the cylinder joint of Figure 1 in cross section.
- FIG. 3 shows an alternative embodiment of the nasal adapter system of FIG. 1, wherein the proximal breathing tubes are attached to the distal end of the nose adapter and the proximal end of the adapter is provided with an alternative embodiment of the cylinder joint used in FIG.
- FIG. 4 shows the cylinder joint from FIG. 3 in cross section.
- Figure 5 shows the proximal tubing (i.e., the expiratory tubing and the inspiratory tubing) of the adapter system of the present invention, between which a third tubing is provided, with all three tubing secured together by clips.
- Figure 6 shows a modification of the solution shown in Figure 5, in which the three hoses are manufactured or connected integrated.
- Figure 7 shows a modification of the solutions shown in Figures 5 and 6, in which the breathing tubes are connected to each other, wherein between the two tubes a round metal wire is provided, which is preferably integrated in the material of the breathing tubes.
- Figure 8 shows a modification of the solution shown in Figure 7, in which instead of the round metal wire, a flat metal wire is provided between the two breathing tubes, which is preferably integrated in the material of the breathing tubes.
- Figures 9a and 9b show in cross-section two embodiments of the paired proximal breathing tubes, with circular profiles used in the first embodiment and non-circular profiles in the second embodiment.
- FIG. 10 shows a barrel joint in cross-section, by means of which each of the proximal breathing tubes is connected to an associated distal breathing tube.
- FIG. 11 shows a perspective view of a further embodiment of the nose adapter system according to the invention.
- Figure 12a shows an embodiment of the adapter joint of the adapter system of Figure 1 1 in cross section.
- FIG. 12b shows a view of the joint from FIG. 12a in another sectional plane.
- Figure 13a shows a modification of the adapter joint of Figures 12a and 12b in cross section.
- FIG. 13b shows a view of the adapter joint from FIG. 13a in another sectional plane.
- FIG. 14 shows a perspective view of an alternative embodiment of the nose adapter system according to the invention.
- FIG. 15 shows a perspective view of the proximal breathing tubes from FIG. 14.
- FIG. 16 shows a perspective view of the nose adapter from FIG. 14.
- FIG. 17 shows a cross-sectional view of the adapter from FIG. 16.
- FIGS. 18 a and 18 b show the flow pattern of the ventilation air through the adapter from FIGS. 16 and 17.
- FIGS. 19a and 19b show two further views of the flow pattern of the respiratory air through the adapter from FIGS. 16 and 17.
- the nose adapter system 1 essentially comprises the actual nose adapter 2, which is provided at its proximal end with a joint 3 and at the distal end of which the proximal breathing tubes 4 of the adapter system are attached.
- the distal breathing tubes which are coupled to the distal ends of the proximal breathing tubes 4 and lead to a respirator (not shown) or to other ventilation devices.
- the distal breathing tubes can also be connected directly to the distal end of the adapter 2.
- the proximal breathing tubes 4 comprise an inspiratory tube and an expiratory tube, which are arranged side by side and connected to each other, as will be explained later. As described above, the proximal ends of the proximal are
- Ventilation hoses 4 coupled to distal terminals of the adapter 2.
- the adapter 2 has two inner channels (inspiratory channel 6 and expiratory channel 7) through which the inspiratory air or the expired air is guided from the respiratory tubes to the joint 3 or away from it.
- the joint 3 is a cylindrical joint (cylinder joint) whose middle section, on which a connection for a prong or a nasal mask is provided, is rotatable relative to the actual housing of the adapter 2 (and thus also relative to the proximal tubes 4) is pivotable. Through this rotatable central portion of the cylinder joint, a fine adjustment can be performed.
- the swivel or cylinder joint 3 should be smooth, but do not move independently under the usual forces that can occur during movements of the new or premature baby.
- FIG. 2 An embodiment of the joint 3 of Figure 1 is shown in Figure 2, which represents a cross section of this joint.
- a substantially cylindrical inner tube 5 extends between the inspiratory channel 6 and the expiratory channel 7 of the adapter 2.
- this tube 5 is mounted between the proximal end portions of the channels 6 and 7 or with formed this integrated.
- these end portions are formed substantially hemispherical, so that the air flow from the end portion of the inspiratory channel 6 into the tube 5 and from the tube 5 in the end portion of the expiratory 7 in each case in a gentle 90 ° - deflection takes place on this Way to cause a low-turbulence air flow in and out of the tube 5.
- an opening 8 is provided which points substantially towards the nostrils of the patient when the adapter system is positioned at the head of the patient.
- the outer surface of this inner tube 5 is provided with a recess or recess 10 which extends almost around the entire circumference of the tube 5 and is interrupted only by a projection 9.
- a part-cylindrical slide 1 1 is clamped or snapped onto the part-cylindrical recess 10.
- the slide 1 1 also has an opening 12 which is substantially aligned with the opening 8 of the tube 5 and aligned therewith.
- the opening 12 of the slider 1 1 has a smaller extension or size in the circumferential direction than the opening 8 of the cylindrical inner tube 5.
- the adjacent and mutually facing sides of the projection 9 and the slider 1 1 are provided with corresponding undercuts, so that the slider 1 1 can not be accidentally pushed over the projection 9, since the undercuts interlock.
- the limitation of the rotation of the slider 1 1 by the projection 9 prevents the openings 8, 12 can close each other.
- the opening 12 of the slide thus always remains substantially in alignment with the opening 8 of the tube 5, wherein the opening cross section of the overlapping openings 8 and 12 regardless of the angle of rotation of the slide 1 1 remains constant relative to the tube 5 in that the opening 8 of the inner tube 5 extends over a greater length in the circumferential direction of the tube 5 than the opening 12 of the slide 11.
- the cross section of the overlapping openings 8 and 12 is thus defined by the smaller cross section of the opening 12 of the slider 1 1.
- the opening 12 of the slider 1 1 but also have a greater extension than the opening 8 of the tube 5, whereby the same effect is achieved.
- a connector grommet 13 is provided, which serves to be coupled to a nasal mask or to a prong.
- the distal ends of the inspiratory channel 6 and of the expiratory channel 7 of the adapter 2 are coupled via their extended connecting tubes or connecting pieces to the proximal breathing tubes or alternatively directly to the distal breathing tubes.
- the gas flow of the ventilator thus leads from the proximal inspiratory tube into the inspiratory channel 6 of the adapter 2, flows past the cylindrical inner tube 5 past the openings 8 and 12 (mutually displaceable windows), and escapes through the expiratory channel 7 of the nasal adapter 2 and through the proximal expiratory tube back to the ventilator.
- the patient can remove a required amount of air from the air flowing through the tube 5 via the connection spout 13 or re-inject it when exhaling.
- the projection 9, which forms a kind of rotation it is prevented that the gas path between the tube 5 and the spout 13 is closed by an excessive pivotal movement of the slider 1 1.
- the patient to be ventilated wearing the prong (whose nasal tubes are inserted into the nostrils of the patient and which is coupled to the port spout 13 of the spool 1 1), takes the necessary through the port spout 13 and through the openings 8, 12 at each respiratory cycle Amount of air from the air flowing through the tube 5 and the exhaled air back into the adapter 2 (ie in the tube 5) back, the exhaled air is entrained by the air flowing through the inner tube 5 air flow.
- the flow characteristics within the adapter 2 will be discussed in detail later.
- the inspiratory channel 6 and the expiratory channel 7 are shown as separate channels in FIGS. 1 and 2, the channels 6, 7 may also be interconnected (preferably along their longitudinal direction) or formed integrally.
- the channels 6, 7 may be formed in the form of a "Y" with each other.
- the nose adapter 2 of the nose adapter system 1 has substantially the same structure as in Figures 1 and 2.
- the proximal ends of the inspiratory channel 6 and of the expiratory channel 7 are each provided with a connection part 14, each having a circular connection opening, ie the inspiration channel 6 ends with a connection part 14, from which the inspiratory air exits, and the expiratory channel 7 ends with an opposite connection part 14, enters the air.
- a tubular element 15 which is rotatably coupled to the two connection parts 14.
- the two connecting parts 14 are substantially hemispherical in order to effect a smooth 90 ° deflection of the air in and out of the tubular element 15.
- the tube member 15 is formed with an opening 16 and provided on its outer surface with a connector grommet 17, which is aligned with the opening 16.
- the connector sleeve 17 can be connected to a corresponding terminal of a Prongs or a nasal mask. In both embodiments, it is possible to replace the ferrule, best seen in Figures 2 and 4, with two nasal tubes that can be inserted directly (ie, without using a prong) into the nostrils of the patient.
- connection spout 13 or 17 intersects with the axis of the inner tube 5 or of the tubular element 15.
- the connector grommet 13 or 17 is substantially tangential to the inner tube 5 (or to the tube element 15), whereby the flow characteristics are improved.
- the channels in the region of the web 17 shown in FIG. 4 can also be firmly connected or integrated with one another.
- the adapter has substantially the shape of a "Y", as shown in Figure 3.
- the adapter (with the exception of the tubular element 15) can be made in one piece. Consequently, the channels 6, 7 (as in the embodiment of Figures 1 and 2) are substantially parallel to each other.
- the distal ends or connections for connecting the breathing tubes are arranged side by side, whereby the connection of the breathing tubes is facilitated, which are formed as "twin hoses" (preferably integrated) and thus parallel to each other. In this way, the channels 6, 7 of the adapter and the ventilation hoses connected thereto run essentially parallel to one another.
- the object of the invention is, inter alia, to provide a nose adapter system with the aid of which as many degrees of freedom as possible are realized.
- a substantial degree of freedom is achieved by the cylinder joint (which is also referred to as a barrel joint) in the adapter housing itself, whereby the connection sleeve, which is connected to the prong or the nasal mask, can be freely rotated relative to the nose adapter or to the channels 6 and 7, which in turn allows the prong or nasal mask to be optimally adapted to the patient's nose.
- Another degree of freedom can be achieved by providing a rotatable coupling between the proximal breathing tubes 4 and the associated inspiratory channel 6 or expiratory channel 7 of the nose adapter. In this way, the proximal inspiratory tube may be rotated relative to its associated inspiratory channel 6, and the proximal expiratory tube may be rotated relative to its associated expiratory channel 7.
- the coupling between these tubes is also designed to be rotatable.
- Such a coupling is shown by way of example in Figure 10 and will be described in more detail later.
- the rotatable couplings between the proximal tubing and the distal tubing substantially obviate the transmission of axial distortions of the distal tubing to the nasal adapter system. Consequently, it is largely prevented that movements of the patient lead to undesirable forces and moments on the nasal mask or the prong.
- proximal breathing tubes 4 of the present invention An embodiment of the proximal breathing tubes 4 of the present invention will now be described with reference to FIG.
- a plastically deformable fiber 20 which is located between the two tubes.
- a total of three tubes are provided, namely two breathing tubes and a third intermediate tube, in which the fiber 20 is received.
- all three hoses run parallel to each other.
- the fiber 20 directly (ie without the third tube) between the breathing tubes.
- the connection of all three hoses for example, by external Elements (for example retaining clips 21) or can be achieved in that the three tubes are made integrated with each other, as shown in Figure 6. In this case, for example, an extrusion process can be used.
- the plastically deformable fiber 20 for example a round metal wire or a flattened metal wire
- the plastic deformation of the fiber By the plastic deformation of the fiber, a deformation of the entire proximal tube and thus an improved adaptation of the nose adapter system to the head of the patient can be achieved.
- a flattened metal wire ie, a metal wire having a substantially rectangular cross section
- the wire 20 can be made of a different material instead of metal.
- This rough adjustment option is particularly suitable for pre-adaptation to size ratios, as they correspond approximately to the size of a child's head.
- This adjustment can be made before attaching the adapter to the child's head.
- a finer fit of the nasal mask or prong to the geometry of the nose, e.g. the angle between the septum and the face is expediently only when the adapter is already attached to the child's head.
- a fine adjustment by means of a plastically deformable fiber would be unsuitable, because a fine adjustment of the angle of a few degrees against the force necessary to bend the fiber on the child's head is not practical. Attempting to bend the fiber while the adapter is in place may result in damage to the skin at the pads.
- Figures 7 and 8 show further embodiments of the proximal breathing tubes with a plastically deformable fiber 20.
- the fiber 20 is located at the junction between the two parallel ventilation tubes and has a circular cross-section.
- the fiber is also at the junction between the two hoses, but has a substantially rectangular cross-section and is embedded in the tubing. In the embodiment of Figure 8, however, the fiber may also have a different cross section, such as a round cross section.
- the proximal breathing tubes 4 have a circular cross-section (as shown in Figure 9a) because such tubes are easy to manufacture (preferably integral and integrated) and can be inexpensively manufactured in large numbers. If such hoses are to be guided closely parallel, a specific lateral extent 22 results for a given hose diameter. If this length is to be kept as small as possible, for example, because the hoses over the bridge of the nose of the child may be distracting and cause squinting in the child with a circular cross-section of the hoses whose diameter is reduced. A reduction of the diameter leads to a reduction of the cross-sectional area which is available to the flow and thus to an increase of the flow resistance.
- non-circular profiles may for example consist of a circular or elliptical segment and a rectangle (see FIG. 9b), wherein expediently the two rectangular regions of the tube cross-sections of the inspiratory and expiratory tubes are arranged parallel to one another and are preferably integrated with one another.
- the plastically deformable fiber may be embedded in the material of the tubes at the junction between the two tubes.
- FIG. 10 shows an example of a rotatable coupling 23 between a proximal breathing tube 4 and a distal breathing tube 24 using the example of a simple locking connection, in which a circumferential annular collar on the end piece of the proximal tube 4 with a correspondingly shaped groove in the distal end Hose 24 rotatably engages.
- a circumferential annular collar on the end piece of the proximal tube 4 with a correspondingly shaped groove in the distal end Hose 24 rotatably engages.
- FIG. 1 1 shows a further embodiment of the nasal adapter system 1 according to the invention.
- the proximal breathing tubes 4 are coupled to the nose adapter 2, the plastically deformable fiber being embedded between the two breathing tubes in the tube material such that the tube pair at least at the top has a flat surface.
- the adapter 2 will be discussed below.
- FIGS. 12a and 12b show the adapter 2 of Figure 1 1 in different sectional planes.
- FIG. 12a shows a substantially central sectional plane
- FIG. 12b shows a sectional plane offset slightly to the front.
- the inspiration channel 6 is shown in section.
- a partition wall 25 extends inside the adapter, by means of which the inspiration channel or the expiratory channel is lengthened into the proximal part of the adapter housing, in order to reduce the dead space in this way. If the partition 25 were not present, the dead space would extend over the entire interior of the adapter 2, which would lead to an undesirable accumulation of CO2 inside the adapter.
- the channels 6, 7 run next to one another and parallel to one another.
- the channels 6, 7 are integrally formed with each other, as shown in Figure 12b.
- the ferrule 13 which is connected to a prong or nasal mask, is integrally formed with a ball portion 26 dimensioned to be rotatable and pivotal in all directions in a suitably shaped and dimensioned 'ball socket' 27. In this way, a joint with maximum freedom of movement with regard to the alignment of the connector sleeve 13 is achieved.
- Figures 13a and 13b show a modification of the adapter shown in Figures 12a and 12b.
- the housing of the adapter 2 of Figures 13a and 13b has a substantially hemispherical shape, whereby the flow behavior of the air flowing into the adapter and out of the adapter air is improved.
- the channels can be arranged parallel to each other and preferably formed integrally with each other.
- FIG. 14 shows a further embodiment of the nasal adapter system 1 according to the invention
- FIG. 15 shows a view of the proximal breathing tubes 4 with an inserted channel for accommodating a plastically deformable fiber 20.
- the joint 3 shown in FIG. 14 for the movable alignment of the connection sleeve 13 will be described in more detail with reference to the following figures.
- FIG. 16 shows an enlarged perspective illustration of the adapter 2 from FIG. 14.
- the housing of this adapter essentially has an upper housing shell 28 and a lower housing shell 29, which are connected to one another by gluing, welding or by latching means.
- connection tubes are formed, which are arranged side by side and parallel to one another, whereby the tube 31 is connected to the proximal inspiratory tube and the tube 30 to the proximal expiratory tube. Due to the parallel arrangement of the tubes 30, 31 and the tubes can be arranged parallel to each other and preferably connected to each other, as already explained above. With regard to the embodiments of Figures 1 to 4 it is apparent that the tube 31 (or connecting piece) is connected to the inspiratory channel of the adapter, and that the tube 30 is connected to the expiratory channel of the adapter, wherein the two channels extend parallel to each other and separated by a partition (not shown).
- the tubes 30, 31 may be integrally formed with the lower shell 29 and / or with the upper shell 28 (as well as the channels).
- two extensions 32, 33 are formed, so that the adapter housing has a substantially Y-shaped configuration. In this case, the inspiration channel in the extension 32 is continued, and the expiratory channel is continued in the extension 33.
- Both extensions 32, 33 have a substantially quarter-spherical end region, in whose mutually facing planar side surfaces circular openings are formed, between which a rotatable tube element 34 is held, on which the connection sleeve 13 is formed.
- the axis of the tubular element 34 coincides with the centers of the two apertures formed in the extensions 32, 33, so that the tubular element 34 can be rotated about its axis, the connection between the circular ends of the cylindrical tubular element 34 and circular openings of the extensions 32 and 34 is substantially airtight.
- the port spout 13 communicates with the interior of the tubular member 34, and the two axial end openings of the tubular member communicate with associated apertures in the two extensions 32,33. In this way, a flow path from the tube or nozzle 31 through the inspiratory channel of the adapter, through the tube member 34, through the expiratory channel of the adapter to the tube or nozzle 30 is achieved.
- the air flow in the tubular element 34 in this case flows past the opening in the wall of the tubular element, on which the connecting sleeve 13 is formed.
- the extensions 32 and 33 are slightly inclined downwardly relative to the adapter housing, as seen in Figure 16, to allow for an expanded angle of rotation.
- a projection 35 is formed on the connection spout 13, which serves as a stop for the prong or the nasal mask.
- Another projection 36 on each narrow side of the spout 13 serves to better support the Prongs or the mask on the spout.
- FIG. 17 shows a cross-sectional view of the adapter 2 from FIG. 16.
- the upper housing shell 28, the lower housing shell 29 and the dividing wall 37, through which the inspiration channel is separated from the parallel expiratory channel, can be seen. It can also be seen that the laterally inwards pointing opening in the extension 33 of the expiratory channel to the associated axial end opening of the tubular element 34 is open.
- a further projection 38 is provided, is prevented by the over-rotation of the tubular member to the rear, when the projection 38 abuts against a stop 39 on the lower housing shell of the adapter housing 2.
- Figures 18a and 18b show further cross-sectional views of the adapter 2 of Figures 16 and 17 in different sectional planes. These views also show the flow pattern of the air flowing through the tube 31 into the inspiratory channel. As can be clearly seen, the air flows in a smooth 90 ° bend from the inspiration channel in the tube member 34, which is due to the fact that the extensions shown in Figures 16 and 17 have the shape of a quarter ball. As a result of this low-flow inflow into the tubular element 34, strong turbulences are also avoided in the interior of the tubular element. The so-called WOB (Work of Breathing) is thus kept low. Furthermore, it is achieved that the dead space has an extremely low volume. In addition, it can be seen that a compact design of the adapter can be achieved by the parallel arrangement of the channels.
- Figures 19a and 19b show the flow of air within the tube 34. Specifically in Figure 19a, it can be seen that the dead space, theoretically defined by the internal volume of the ferrule 13, is in practice due to the partial inflow of fresh inspiratory air into the spout and This washing effect achieved is further reduced.
- FIG. 19b again clearly shows the flow path from the inspiratory channel of the adapter, through the tube element 34 and back through the expiration channel.
- the solution proposed in the introduction to the description and described in detail in the description of the figure offers advantages in terms of handling by the nursing staff compared to the previously known solutions.
- the nursing staff can adjust the curvature of the proximal tubing to the size of the infant's head before attaching the nose adapter system of the present invention to the head.
- a fine adjustment can then be made when the adapter is already attached. This can largely be avoided that not optimally adapted nose adapter to which masks or prongs are attached, exert tension on the respective support surface and thereby lead to potentially irreparable damage to the nose or face. Only through the combination of coarse and fine adjustment an optimal adaptation to the individual geometry of the child's head is guaranteed.
- the rotatable coupling means between the proximal and the distal breathing tubes offer over the previously known connections via rigid cone plug connectors the advantage that axial rotations of the distal tubes can be decoupled from the proximal tubes.
- a rotation of the distal tubes therefore causes no or a significantly lower moment on the adapter and thus on the child's head than in a connection via a frictional connection.
- the cross-sectional area of the tubes can be increased and thus the flow resistance can be reduced.
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- Health & Medical Sciences (AREA)
- Pulmonology (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Emergency Medicine (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
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- Otolaryngology (AREA)
- Respiratory Apparatuses And Protective Means (AREA)
Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201280059702.6A CN103987418B (zh) | 2011-12-05 | 2012-12-03 | 用于cpap呼吸的鼻部适配器*** |
US14/362,740 US9937313B2 (en) | 2011-12-05 | 2012-12-03 | Nasal adapter system for CPAP respiration |
DE112012005071.1T DE112012005071A5 (de) | 2011-12-05 | 2012-12-03 | Nasenadaptersystem für CPAP-Beatmung |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE102011120217.3 | 2011-12-05 | ||
DE102011120217A DE102011120217A1 (de) | 2011-12-05 | 2011-12-05 | Nasenadaptersystem für CPAP-Beatmung |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2013083258A1 true WO2013083258A1 (de) | 2013-06-13 |
Family
ID=47326053
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/EP2012/004983 WO2013083258A1 (de) | 2011-12-05 | 2012-12-03 | Nasenadaptersystem für cpap-beatmung |
Country Status (4)
Country | Link |
---|---|
US (1) | US9937313B2 (de) |
CN (1) | CN103987418B (de) |
DE (2) | DE102011120217A1 (de) |
WO (1) | WO2013083258A1 (de) |
Families Citing this family (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2014124323A1 (en) * | 2013-02-11 | 2014-08-14 | Monitor Mask Inc. | Oxygen face mask and component system |
US9999546B2 (en) | 2014-06-16 | 2018-06-19 | Illinois Tool Works Inc. | Protective headwear with airflow |
NZ714595A (en) * | 2014-06-19 | 2017-06-30 | Resmed Ltd | Patient interface for respiratory therapy |
US20160345894A1 (en) * | 2015-05-29 | 2016-12-01 | Bohnas LLC | Method of Sampling Systemic Biomarkers |
DE102015217751A1 (de) * | 2015-09-16 | 2017-03-16 | Medin Medical Innovations Gmbh | Mehrteilige Beatmungsmaske, zugehöriges Nasenanschlusselement und zugehörige Kombination eines Schlauchanschlusselements und eines Kopplungselements |
US10589051B2 (en) | 2015-10-20 | 2020-03-17 | Steven Salter | CPAP compliance notification apparatus and method |
DE102016014347A1 (de) * | 2016-12-02 | 2018-06-07 | Drägerwerk AG & Co. KGaA | Atemschlauch für ein Medizingerät |
US11812816B2 (en) | 2017-05-11 | 2023-11-14 | Illinois Tool Works Inc. | Protective headwear with airflow |
DE102017011909A1 (de) * | 2017-12-21 | 2019-06-27 | Dräger Safety AG & Co. KGaA | Maskenadapter für den Anschluss von zwei Atemschläuchen eines Kreislaufatemschutzgerätes an einer Atemmaske |
US10827244B1 (en) * | 2018-10-12 | 2020-11-03 | E.D. Bullard Company | Breathing tube adapter for a respirator with an internal speaker |
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DE20206692U1 (de) | 2002-04-26 | 2002-08-01 | Med In Medical Innovations Ver | Vorrichtung zur Erzeugung eines kontinuierlichen positiven Atemwegdrucks (CPAP-Vorrichtung) und entsprechender Hohlkörper |
WO2003022341A1 (en) | 2001-09-13 | 2003-03-20 | Fisher & Paykel Healthcare Limited | Breathing assistance apparatus |
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US6508249B2 (en) * | 2000-10-05 | 2003-01-21 | Vital Signs, Inc. | Connecting apparatus for placing fluid flow paths in fluid communication |
AUPR315401A0 (en) * | 2001-02-16 | 2001-03-15 | Resmed Limited | An apparatus for supplying clean breathable gas |
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US20090032018A1 (en) | 2007-08-03 | 2009-02-05 | Eaton Jason P | System Adapted to Provide a Flow of Gas to an Airway of a Patient |
AU2009286376B2 (en) * | 2008-08-25 | 2014-03-13 | Koninklijke Philips Electronics N.V. | Respiratory patient interfaces |
-
2011
- 2011-12-05 DE DE102011120217A patent/DE102011120217A1/de not_active Withdrawn
-
2012
- 2012-12-03 US US14/362,740 patent/US9937313B2/en active Active
- 2012-12-03 CN CN201280059702.6A patent/CN103987418B/zh active Active
- 2012-12-03 WO PCT/EP2012/004983 patent/WO2013083258A1/de active Application Filing
- 2012-12-03 DE DE112012005071.1T patent/DE112012005071A5/de active Pending
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US20070137653A1 (en) * | 2000-03-13 | 2007-06-21 | Wood Thomas J | Ventilation interface for sleep apnea therapy |
WO2003022341A1 (en) | 2001-09-13 | 2003-03-20 | Fisher & Paykel Healthcare Limited | Breathing assistance apparatus |
DE20206692U1 (de) | 2002-04-26 | 2002-08-01 | Med In Medical Innovations Ver | Vorrichtung zur Erzeugung eines kontinuierlichen positiven Atemwegdrucks (CPAP-Vorrichtung) und entsprechender Hohlkörper |
DE10329818A1 (de) | 2003-06-25 | 2005-01-13 | Ket Kunststoff-Und Elasttechnik Gmbh Liegau Augustusbad | Nasenmaskengerät |
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WO2008005578A2 (en) * | 2006-07-07 | 2008-01-10 | Aeiomed, Inc. | Composite masks and methods for positive airway pressure therapies |
DE102009016150A1 (de) | 2009-04-04 | 2010-10-07 | F. Stephan Gmbh | Atraumatischer Nasentubus für die nichtinvasive Atemunterstützung (NIV-CPAP) |
WO2011110961A1 (en) * | 2010-03-08 | 2011-09-15 | Koninklijke Philips Electronics N.V. | Patient interface device with cheekbone stabilization |
Also Published As
Publication number | Publication date |
---|---|
CN103987418B (zh) | 2016-12-21 |
DE112012005071A5 (de) | 2014-09-18 |
DE102011120217A1 (de) | 2013-06-06 |
CN103987418A (zh) | 2014-08-13 |
US9937313B2 (en) | 2018-04-10 |
US20140332005A1 (en) | 2014-11-13 |
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