Therapy delivery device

Abstract

A system 10 for delivering respiratory therapy to a patient includes a patient interface device 20 for delivering pressurized gas to a patient, a connector system 60 for connection to a source of pressurized gas and a conduit system 40 fluidly connecting the connector system 60 to the patient interface device 20. The connector system 60 includes a plurality of closable ports 68, 32 that allow a plurality of different modes of respiratory therapy to be provided. The conduit system 40 may include a first gas line 42, a second gas line 46 and a third gas line 46. The second gas line 46 and third gas line 44 may be contained within the first gas line 42 along at least part of their length.

Claims

1. A ventilation system for delivering respiratory therapy to a patient, the ventilation system comprising: a patient interface device for delivering pressurized respiratory gas to a patient; a connector system for connection to a source of pressurized respiratory gas, the connector system comprising a hollow body having a cavity therein; a conduit system fluidly connecting the connector system to the patient interface device, wherein the conduit system includes a first gas line and a second gas line, and the second gas line is positioned within the first gas line for a length of the second gas line which extends between the patient interface device and the connector system; a first valve forming a pressure relief valve configured to control a maximum pressure of the respiratory gas in the system; and a plurality of closable ports that allow a plurality of different modes of respiratory therapy to be provided, the plurality of closable ports comprising: a first closable port in the hollow body for connection to the source of pressurized respiratory gas; and a second closable port forming an exhaust port closable manually or via a second valve; wherein, in a first mode, the second gas line provides respiratory gas to the patient interface device and the first gas line provides an exhaust channel to remove exhaled gases from the ventilation system by venting exhaled gas through the exhaust port and, in a second mode, respiratory gas is supplied via the first closable port such that the first gas line provides respiratory gas to the patient interface device and the exhaust port is closed manually or via the second valve such that respiratory gas is directed to the patient at the maximum pressure.

2. The system of claim 1, wherein the conduit system includes a third gas line, the third gas line is positioned within the first gas line along at least part of its length, and the third gas line is configured for connection to a pressure monitor such that a pressure at the patient interface device can be monitored.

3. The ventilation system of claim 2, wherein the third gas line extends from the patient interface device to the body of the connector system, the third gas line terminating at the connector system and connecting to a conduit within the connector system.

4. The ventilation system of claim 2, wherein the third gas line extends from the patient interface device and through the body of the connector system for connection to the pressure monitor.

5. The ventilation system of claim 4, wherein the connector system further comprises a distal port at a distal end of the hollow body, the first gas line, second gas line and third gas line extending from the distal port to the patient interface device, the first closable port positioned at an opposed end of the hollow body to the distal port.

6. The ventilation system of claim 5, wherein the first gas line terminates at the distal port and the second gas line extends through the distal port and the connector system.

7. The ventilation system of claim 6, wherein the second gas line extends through a sealed port of the connector system for connection to a source of air, the sealed port positioned at the opposed end of the hollow body to the distal port.

8. The ventilation system of claim 1, wherein, in the second mode, the second gas line is closed by one of the plurality of closable ports.

9. The ventilation system of claim 1, further comprising a fixation device for securing the patient interface device to the head of a patient.

10. The ventilation system of claim 1, wherein the pressure relief valve is mounted on the connector system.

11. The ventilation system of claim 1, wherein the pressure relief valve forms part of a source of pressurized respiratory gas connected to the first port.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) Some embodiments of the disclosure will now be described by way of example only and with reference to the accompanying drawings in which:

(2) FIG. 1A shows a ventilator system according to an embodiment of the invention;

(3) FIG. 1B shows a cross-sectional detail view of the conduit system of FIG. 1A;

(4) FIG. 2 shows, schematically, the ventilator system of FIG. 1A attached to the head of an infant for providing respiratory therapy;

(5) FIG. 3 shows a detail view of a patient interface device according to an embodiment of the invention;

(6) FIG. 4A show a cross-sectional view through the center of the patient interface device of FIG. 3;

(7) FIG. 4B shows an off-center cross-sectional view of the patient interface device taken to one side of the pressure and inlet ports;

(8) FIG. 5 shows a connector system according to an embodiment of the invention;

(9) FIG. 6A shows an alternative connector system according to a further embodiment of the invention;

(10) FIG. 6B shows an insert for the connector system of FIG. 6A;

(11) FIG. 7A shows another alternative connector system according to a yet further embodiment of the invention;

(12) FIG. 7B shows a bottom view of the connector system of FIG. 7A viewed in the direction of arrow A;

(13) FIG. 8 shows a fixation device according to an embodiment of the invention;

(14) FIG. 9A shows a front view of the fixation device of FIG. 8 mounted to the head of an infant;

(15) FIG. 9B shows a front view of an alternative embodiment of the fixation device of FIG. 9A;

(16) FIGS. 9C and 9D show a cross-sectional view of fixation means of the fixation device of FIG. 9B;

(17) FIG. 9E shows a rear view of the fixation device of FIG. 8 mounted to the head of an infant;

(18) FIG. 10A shows a schematic diagram of flow though the ventilation system during CPAP therapy when the patient is inhaling;

(19) FIG. 10B shows a schematic diagram of flow though the ventilation system during CPAP therapy when the patient is exhaling;

(20) FIG. 10C shows a schematic diagram of flow though the ventilation system during CPAP therapy when the patient is exhaling, in an alternative configuration;

(21) FIG. 11A shows a schematic diagram of flow though the ventilation system during resuscitation when the patient's lungs are deflated;

(22) FIG. 11B shows a schematic diagram of flow through the ventilation system during resuscitation when the patient's lungs are deflated in an alternative configuration;

(23) FIG. 11C shows a schematic diagram of flow though the ventilation system during resuscitation when the patient's lungs are inflated; and

(24) FIG. 12 shows a schematic diagram of flow though the ventilation system during highflow therapy.

DETAILED DESCRIPTION

(25) With reference to FIG. 1, an exemplary ventilation system 10 is illustrated. The ventilation system is configured to provide respiratory therapy to an infant such as a pre-term, neonatal infant. In particular the ventilation system 10 is configured to provide CPAP therapy to infants. The ventilation system is also adaptable to provide high flow therapy and resuscitation to infants.

(26) The ventilation system 10 has a patient-facing or distal end 2 and a caregiver-facing or proximal end 4. The ventilation system includes a patient interface device 20 at its distal end 2 and a connector system 60 at its proximal end 4. The patient interface device 20 and connector system 60 are fluidly connected to each other via a conduit system 40 therebetween. That is, the conduit system 40 is connected to the patient interface device 20 at its distal end and connected to the connector system 60 at its opposed, proximal end.

(27) The patient interface device 20 is configured to engage with the nares of an infant in order to deliver respiratory therapy thereto. The conduit system 40 includes an first gas line 42 for exhausting exhaled air from the patient (in CPAP mode), second gas line 46 for providing pressurized air to the patient interface device (in CPAP mode) and a third gas line 44 for monitoring air pressure within the patient interface device 20 and thereby allowing the control and/regulation of the respiratory therapy. The first gas line 42 may be a resilient, corrugated plastic tube. The connector system 60 is adaptable to allow variation in the modes of respiratory therapy deliverable by the ventilation system 10 as described in more detail below.

(28) As shown in more detail in FIG. 1B, the second gas line 46 and third gas line 44 are positioned within the first gas line 42 for a portion of their length. More particularly, they are positioned within the first gas line 42 for their entire length between the patient interface device 20 and connector system 60. The first gas line 42 terminates at the connector system 60. The second gas line 46 and the third gas line 44 extend through the connector system 60 for connection to an air source 200 and pressure monitoring equipment 300, as shown in FIG. 2. However, it will be appreciated that the second and third gas lines 46, 44 could also terminate at the connector system 60 and connect to further conduits provided therein.

(29) The first gas line 42 is attached to the patient interface device 20 via an exhaust port 28. The second gas line 46 and third gas line 44 are attached to the patient interface device 20 via ports positioned within the exhaust port 28, as will be explained in more detail below with reference to FIGS. 3, 4A and 4B. The first gas line 42 is attached to the connector system 60 via a first port 62 through which the air second gas line 46 and third gas line 44 extend, as will be explained in more detail below with reference to FIG. 5.

(30) FIG. 2 shows the ventilation system attached to the head of an infant 100 for delivery of respiratory therapy such as nCPAP thereto. The ventilation system 10 is secured to the head of the infant 100 via a fixation device 90 which circumscribes the head of the infant 100 as will be described below.

(31) FIGS. 3, 4A and 4B show the patient interface device 20 of the ventilator system 10 described above. The patient interface device 20 is in the form of a nasal prong device for delivering pressurized air to the nares of an infant 100. The patient interface device includes a main body 30 having an internal cavity 36 and first and second fluid passages 25, 27 (shown in detail in FIG. 4A). A pressure port 24 is suitable for connection with a third gas line 44, as described above. An air supply port 26 is suitable for connection with a second gas line 46 as described above and is fluidly connected to the cavity 36 via a second fluid passage 27. An exhaust port 28 is suitable for connection with the first gas line 42. The pressure port 24 and air supply port 26 are positioned within and surrounded by the exhaust port 28, i.e. the ports 24, 26 are located radially within the exhaust port 28, reactive to the axis along which the exhaust port 28 extends. More specifically, the pressure port 24 and air supply port 26 comprise conduits supported within the exhaust port 28 by a strut 39. The strut 39 extends from one side of the exhaust port 28 to the opposite side thereof. Two gaps 21 are positioned either side of the strut 39 within the exhaust port 28 to allow gas to flow out of the exhaust port 28, around the strut 39, pressure port 24 and air supply port 26.

(32) The patient interface device further includes two air outlets (or therapy outlets) 22 which are configured for connection to nasal prongs (not shown) to provide airflow to the nares of an infant 100. The nasal prongs facilitate an airtight seal between the patient interface device 20 and the nares of the patient to provide effective respiratory therapy. An airtight seal is particularly important when administering CPAP therapy.

(33) Respiratory gas is provided at air supply port 26 from the second gas line 46 and is directed along a flow path shown by the arrow 27a to a chamber 38. Gas exits the chamber 38 via two holes 29 that provide a straight conduit for gas in a direction towards each air outlet 22. Each hole 29 is sized sufficiently small such that the gas exiting therefrom forms a fine jet which can reach the nares of the patient 100 via the air outlets 22 along flow path 27b. Each hole has an axis substantially aligned with the axis of the air outlet 22.

(34) When the patient exhales, the jet of air from holes 29 is redirected (or flipped) towards one of the exhaust outlets 28 or 32 along the flow paths shown by the arrows 37, 37b, 37c. The first pressure port 24 is fluidly connected to port 23 (shown in FIG. 3) adjacent the air outlets 22 for measuring the gas pressure at the patient. The port 23 is in fluid communication with, and thus at the same pressure as, the interior of the air outlets 22 via cut outs 22a.

(35) The patient interface device 20 further includes an auxiliary exhaust port 32 with a removable first closure 33. The auxiliary exhaust port 32 is separate from the exhaust port 28 and provides an alternative flow path for exhaled air during respiratory therapy as will be described below. When the first closure 33 is removed, the auxiliary exhaust port 32 establishes a direct flow path between the internal cavity 36 of the patient interface device 20 and the external atmosphere.

(36) FIG. 5 shows a detail view of the connector system 60 of the ventilation system 10 in a resuscitation configuration. The connector system 60 includes a first body 61 that is a hollow connector body having a cavity therein. The first body 61 includes a first port 62 at a first end of the body 61 for connection to the first gas line 42 having the second gas line 46 and the third gas line 44 extending therethrough.

(37) The first body 61 further includes a second port 64 for connection to an exhaust or resuscitation air supply.

(38) A third port 66 contains the second gas line 46 and third gas line 44. A sealing element 67 creates a seal between the cavity of the first body 61 and the third port 66 to prevent gas, such as air, leaking from the cavity to the external environment via the third port 66. It will be appreciated that the third port 66 could be replaced with two ports each containing one of the second gas line 46 and third gas line 44 and each having a seal as described above.

(39) The first body 61 further includes a fourth port 68 with a removable second closure 69. When the second closure 69 is removed from the fourth port 68, the cavity of the first body 61 is in direct fluid communication with the external atmosphere.

(40) The first body 61 may further include a pressure relief valve 600 (shown schematically in FIGS. 10A-C, 11-C and 12).

(41) A second body 70 is a connector body which includes two separate fluid conduits therethrough the first fluid conduit has a distal inlet 71 for connection to the third gas line 44 and a first outlet 72 for connection to a pressure monitoring system (not shown). The second conduit has an inlet 73 for connection with the second gas line 46 and a second outlet 74 for connection with e.g. a CPAP air supply. The second outlet 74 of the second conduit includes a removable third closure 75 for sealing the second outlet 74. The removable third closure 75 is in the form of a plug attached to the second connector body. It is envisaged that other closure means such as flaps or valves might also be used.

(42) FIG. 6A shows an alternative embodiment of a first body 161 for the connector system 60. The first body 161 of FIG. 6 is substantially the same as the first body 61 of FIG. 5 except that the axes of second and third ports 164 and 166 are substantially parallel. FIG. 6B shows an insert 167 which may be positioned within the port 166 of FIG. 6A to hold and seal the pressure and second gas lines as described above. Such a configuration may be easier to manufacture.

(43) FIGS. 7A and 7B show a further alternative embodiment of a first body 261 for the connector system 60. As shown in FIG. 7A, the axes of the first port 262 and third port 266 are aligned to provide a substantially straight path for the second gas line and third gas line from the first port 262 to the third port 266. The second port 264 is parallel to and offset from the first and thirds ports 262, 266. FIG. 7B shows a bottom view of the first body 261 looking into the first port 262. In this embodiment, instead of an insert for positioning and sealing against the third gas line and second gas line, a sealing plate 267 is positioned in the third port 266 and is integrally formed with the first body 261. The sealing plate 267 includes first and second holes 263, 265 each for positioning and sealing against one of a second gas line 46 and a third gas line 44.

(44) FIGS. 8 and 9A to 9E show a fixation device 90 for securing the ventilation system 10 to the head of a patient. The example fixation device 90 is suitable for attachment to the head of an infant 100 however it will be appreciated that such a fixation device 90 could be easily adapted for use with an adult by adjusting the dimensions accordingly.

(45) The fixation device 90 includes a first part 92 and a separately provided second part 94 as shown in FIG. 8. The first part 92 includes a central portion 99 having five arms 93a, 93b, 95, 97a, 97b extending therefrom. A first side arm 93a and a second side arm 93b are diametrically opposed from one another either side of the central portion 99. A single rear arm 95 extends from the central portion 99 at approximately 90 from the first and second side arms 93a, 93b. First and second attachment arms 97a, 97b extend from the first and second side arms 93a, 93b from points 97c, 97d on either side of the central portion 99. The first and second side arms 93a and 93b may be the same length. Optionally, the rear arm 95 may also be the same length as the first and second side arms 93a, 93b or within 10% of the length thereof.

(46) The side arms 93a, 93b, rear arm 95, and attachment arms 97a, 97b of the first part each have attachment portions 98 at their respective ends (ends distal from central portion 99). The attachment portion 98 of each arm allows the end of that arm to be attached to multiple positions on an intermediate portion of that arm in order to form loops of adjustable size. In the illustrated embodiment, the arms of the first part 92 are made from double-sided brush nylon and the attachment portions 98 are made from a hook material for engagement with the nylon.

(47) The second part 94 is generally T-shaped (or triangular) and includes three slots 96a, 96b, 96c at each end of the T for engagement with the loops formed by the arms of the first part 92. More particularly, the side arms 93a, 93b engage with the diametrically opposed first and second slots 96a, 96b and the rear arm 95 engages with the third slot 96c. The slots 96a and 96b may be parallel to one another and the slot 96c may be aligned substantially perpendicular to slots 96a and 96b.

(48) The second part also includes two tube fixation means 91a, 91b for attachment to the conduit system 40 of the ventilation system 10. In the embodiment illustrated in FIG. 9A, the fixation means 91a, 91b include hook and loop material, however, it will be appreciated that other fixation means such as adhesive means, clip or clamps could also be used. It will be further appreciated that any number of tube fixation means could be used.

(49) FIG. 9B shows an alternative embodiment of the fixation device 90 of FIG. 9A, in which the fixation means comprises a removable fixation member 91c. The removable fixation member 91c is shown in cross-section in FIG. 9C. The removable fixation member is a substantially U-shaped block, forming an opening for receiving a tube of the conduit system 40. The member 91c removably attaches to the second part 94. The member 91c may be made of a foam material comprising a hook/loop fastening tape base for affixing to a complementary surface on the second part 94. Alternatively, other materials may be used to form the member 91c and/or the member may be differently attached to the second part 94. As shown in FIG. 9D, the fixation device 90 may further comprise tape 91d attached to the second part 94, overlying the removable fixation member 91c and covering the opening. The tape 91d may compress the fixation member 91c and secure the tube of the conduit system 40 therein. The fixation member 91c may securely hold the tube in place and prevent any twisting of the tube relative to the patient.

(50) In use, the central portion 99 of the first part 92 is positioned behind the head of the infant adjacent the nape of the neck. The second part 94 is positioned on the forehead of the infant such that the diametrically opposed slots 96a, 96b are above and generally aligned with the eyebrows of the infant. The free end 95a of the rear arm 95 is inserted through the third slot 96c and doubled back on itself and secured to an intermediate portion of the back arm 95.

(51) First and second side arms 93a, 93b are inserted through first and second slots 96a, 96b and secured to themselves in a similar manner.

(52) First and second attachment arms 97a,97b therefore extend from the ear region of the infant as shown in FIG. 8 and can each form loops for attachment to the patient interface device.

(53) The fixation device is sized to fit head circumferences of 17 cm-42 cm. A number of fixation devices of different sizes may be provided in a kit. For example, the fixation devices may come in a set of 5 or 6 devices of varying sizes to suit a broad range of head circumferences.

(54) FIGS. 10 to 12 are schematic diagrams showing the ventilation system in various modes of respiratory therapy.

(55) CPAP (e.g. nCPAP) Configuration

(56) The ventilator system 10 as described above may be configured to deliver CPAP or nCPAP therapy to a patient by the following method.

(57) In a CPAP configuration, an air ssource 200 is fluidly coupled with the second body 70 of the connector system 60 via the second gas line 46 extending through the third port 66. A pressure monitoring device 300 is fluidly coupled with the connector system 60 via the third gas line 44 extending through the third port 66. An air exhaust line is connected to the connector system 60 via one of the second port 64 or auxiliary exhaust port 32. The fourth port 68 is closed with the removable second closure 69. The auxiliary exhaust port 32 of the patient interface device may also be closed by the removable first closure 33.

(58) FIGS. 10A-C show the flow through the ventilator system configured to deliver CPAP. FIG. 10A shows respiratory gas flow 6, pressure monitor flow 7 through the system when the patient is breathing in (inhaling). Respiratory gas flow 6 enters the system 10 via the second gas line 46 in the third port and is directed though the conduit system 40 and to the patient via air outlets 22. In this mode either second port 64 or auxiliary exhaust 32 may be open.

(59) FIGS. 10B and 10C show flow of exhaled air 8 through the system 10 when the patient is breathing out (exhaling) in alternative system configurations. In FIG. 10B second port 64 is open and connected to an exhaust and auxiliary exhaust 32 is closed. Exhaled air 8 from the patient enters the system via air outlets 22 and collides with the respiratory gas flow 6 path.

(60) The greater pressure and/or flow rate of the exhaled air 8 diverts the respiratory gas flow path 6 from the hole 29 in to the cavity 36 such that both the exhaled air 8 and supply gas exit the system as exhaust gas 9 via the second port 64. In FIG. 10C, the auxiliary exhaust 32 is connected to a first gas line. Exhaled air 8 and supply gas 6 flow into the cavity 36 and then exit the system via the auxiliary exhaust 32.

(61) The fourth port 68 is closed in the CPAP configuration described above. However, in a further CPAP configuration, the fourth port 68 may be used as an exhaust instead of the second port 64 or auxiliary exhaust.

(62) In arrangements where the second port 64 is not used for exhaust gas (such as when the auxiliary exhaust 32 or fourth port 68 is used for exhaust), the second port 64 may be connected to a further air supply (not shown). The further air supply may be isolated from the system by a switch, valve or flow prevention means during the first mode. Once the further gas supply is switched on the initial gas supply may be switched off or may remain in fluid communication with the system. This embodiment allow switching between modes simply by actuating a switch or valve of the further gas supply and requires no reconnection of the conduit system or gas supplies between modes.

(63) The pressure relief valve 400 may be used. The pressure relief valve 400 may be mounted on the connector system or anywhere else on the assembly where it can function to control the maximum pressure in the system.

(64) Resuscitation Configuration

(65) In a resuscitation configuration, a high flow air supply is fluidly connected to the connector system 60 via the second port 64. A pressure monitoring device 300 is connected to the connector system 60 via the third gas line 44 extending through the third port 66. The second gas line 46 is closed by a valve such as the closure described in relation to the second body 70 above.

(66) In a first arrangement (as shown in FIG. 5), the fourth port 68 is opened by removing the removable second closure 69 and the auxiliary exhaust port 32 of the patient interface device is closed by the removable first closure 33.

(67) In a second arrangement, the fourth port 68 is closed with the removable second closure 69 and the auxiliary exhaust port 32 of the patient interface device is opened by removing the removable first closure 33.

(68) In resuscitation mode, the nasal prong device may be replaced with a resuscitation mask.

(69) FIGS. 11A-C show the flow through the ventilator system 10 configured to deliver resuscitation breaths to the patient. FIGS. 11A and 11B show alternative configurations for when the patient's lungs are deflating. In the configuration of FIG. 11A the fourth port 68 is closed and the auxiliary exhaust is open. As the lungs deflate, supply gas thus escapes from the system via the auxiliary exhaust 32. In the configuration of FIG. 11B the fourth port 68 is open and the auxiliary exhaust 32 is closed. Supply air thus escapes from the system via the fourth port.

(70) FIG. 11C shows the flow through the system when the lungs are being inflated. Both the fourth port 68 and the auxiliary exhaust 32 are now closed such that air is directed to the patient at maximum pressure and flow rate. The port 68 and/or auxiliary exhaust 32 may be closed manually or via a valve to control the transition between inflation breaths and allowing deflation.

(71) Highflow Configuration

(72) In a highflow therapy configuration, a high flow air supply is fluidly coupled with the first body 61 of the connector system 60 via the second port. A pressure monitoring device 300 is fluidly coupled with the second body 70 of the connector system 60 via first outlet 72. Second outlet 74 is closed with a removable third closure 75.

(73) The fourth port 68 is closed with the removable second closure 69 and the auxiliary exhaust port 32 of the patient interface device is closed with the removable firt closure 33. The nasal prongs of the patient interface device are held loosely inside or adjacent the nares of the patient (i.e. not in sealing contact therewith).

(74) FIG. 12 show flow through the ventilation system 10 configured to deliver highflow therapy to the patient.

(75) TABLE-US-00001 Valve Second Auxiliary Third gas Second Port Fourth Exhaust Mode line 44 gas line 46 64 Port 68 32 nCPAP Pressure Open- Open/ closed Open/ Patient Monitor connected closed closed Breathing In to gas supply nCPAP Pressure Open - Open - closed closed Patient Monitor connected connected Breathing to gas to exhaust Out (1) supply nCPAP Pressure Open - closed closed Open - Patient Monitor connected connected Breathing to gas to exhaust Out (2) supply nCPAP Pressure Open - closed Open - closed Patient Monitor connected connected Breathing to gas to exhaust Out (3) supply Resuscitation Pressure closed Open - closed Open - Lung Monitor connected connected Deflation (1) to gas to exhaust supply Rescusitation Pressure closed Open - Open - closed Lung Monitor connected connected Deflation (2) to gas to exhaust supply Resuscitation Pressure closed Open - closed closed Lung Monitor connected Inflation gas supply Highflow Pressure closed Open - closed closed Monitor connected to gas supply

(76) The ventilation system 10 is therefore capable of providing respiratory therapy in at least three modes i.e. nCPAP, highflow and resuscitation. A practitioner can deliver various modes of respiratory therapy using a single system.

(77) For example, an infant may be receiving nCPAP therapy for respiratory stress syndrome. If the infant then becomes critical, the practitioner can easily provide resuscitation by adjusting the inputs and outputs as described above. Alternatively, an infant may require resuscitation immediately after birth and then subsequently require breathing support either via CPAP or high flow therapy. Additionally or alternatively, an infant may start respiratory therapy with CPAP and the practitioner may wish to switch to high flow therapy as the infant's condition changes or improves and vice versa.