• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    The present invention relates to a device and a system for positive pressure ventilation and continuous positive airway pressure (CPAP) treatment for neonatal resuscitation and initial respiratory support. The device and system are designed and tested for preterm and term neonatal use. The device is easy to use and allows rapid switch between PPV and CPAP without change of equipment and significantly reduces the imposed work of breathing for a breathing child treated with CPAP.
    公开号:SE1150092A1
    申请号:SE1150092
    申请日:2011-02-08
    公开日:2012-08-09
    发明作者:Kjell Nilsson；Thomas Drevhammar
    申请人:Ventinvent Ab；
    IPC主号:
    专利说明:

    Title: System and device for neonatal resuscitation and initial respiratory supportBACKGROUND OF THE INVENTIONThe present invention relates to a device and a system for positive pressure ventilation (PPV) andcontinuous positive airway pressure (CPAP) treatment for neonatal resuscitation and initial respiratorysupport. The device and system is designed and tested for preterrn and tenn neonatal use.
    Today there are two systems for positive pressure ventilation in use, i.e. the simple T-piece or a bag.Both use a mask interface to the child but can also be used via an ET-tube. The two systems are easyto handle, uncomplicated and inexpensive and have been in use for many decades.
    The T-piece systems are able to provide positive pressure ventilation as well as CPAP for a breathinginfant but the bag systems are unable to provide CPAP for the breathing infant.
    In neonatal resuscitation there is a need for both ventilation (PPV) of the non breathing child andsupport by CPAP for the spontaneously breathing child. The need for both types of support is commonand changes over time during the resuscitation period.
    Both the T-piece and the bag systems allow easy positive pressure ventilation for the non-breathingchild but only the T-piece systems can also provide CPAP. However, these systems expose theneonate to a higher imposed work of breathing than most of the specialised CPAP systems. This maylead to extended period of PPV. This could be overcome by switching between two systems - one forPPV and a specialised system for CPAP but this is unpractical in the resuscitation period.
    Therefore there is a need within the technical field of PPV/ CPAP treatment for neonatal resuscitationto overcome the problems that exists today. There is a need to achieve an easy switch between PPVand CPAP for respiratory support without change of equipment and to provide a low imposed work ofbreathing for the breathing child treated with CPAP.
    SUMMARY OF THE INVENTIONThe purpose of the present invention is to provide a solution to the above mentioned problems. Thedevice and system is designed and tested for preterrn and tenn neonatal use. The system is notintended for adult use. The two main problems will be solved by the present invention.
    First the device and system are easy to use and allows rapid switch between PPV and CPAP withoutchange of equipment. A safe and quick switch between these types of respiratory support shouldimprove care for an unstable child and lead to higher quality in resuscitation with reduced mortalityand morbidity.
    Secondly, the invention significantly reduces the imposed work of breathing for a breathing childtreated with CPAP. A reduction of imposed work of breathing should lead to higher quality inresuscitation with reduced mortality and morbidity. lt should also reduce the need for PPV.
    The new device and system have a significantly lower imposed work of breathing for a breathing childcompared to traditional T-piece systems as the results clearly shows.
    The invention relates to a device for positive pressure ventilation and continuous positive airWaypressure (CPAP) treatment for neonatal resuscitation comprising:A fresh gas floW tube 1 connected to a variable floW CPAP generator 3, a connector 9 connected to thevariable floW CPAP generator 3, a bypass floW tube 2 connected to an outlet 4 of the variable floWCPAP generator 3 or to the connector 9, a pressure release valve 6 connected to the outlet 4 of thevariable floW CPAP generator 3 or to the connector 9 or to the bypass floW tube 2, and a pressuremeasuring device 7 connected to the connector 9 or to the bypass floW tube 2 if the bypass floW tube 2is connected to the connector 9.
    In one embodiment the bypass floW tube 2 is connected to the connector 9 in the device.
    In another embodiment the bypass floW tube 2 s connected to an outlet 4 if the variable floW CPAPgenerator 3 in the device.
    The fresh gas floW in the device to the variable floW CPAP generator is in the range of 3-12 liters perminute and the bypass floW is 3-12 liters per minute.
    A device as disclosed above can be used for positive pressure ventilation and continuous positiveairWay pressure (CPAP) treatment in neonatal resuscitation.
    A system for positive pressure ventilation and continuous positive airWay pressure (CPAP) treatmentfor neonatal resuscitation comprising a device as disclosed above,Wherein the system is configured to When the open end outlet 8 of the outlet 4 of the variable floWCPAP generator is occluded the pressure Will increase from the variable CPAP generator until theopening pressure of the release valve 6 is reached, the increase in pressure results to an inspiratoryfloW, the pressure in the system Will remain at the set positive pressure ventilation pressure until theoutfloW occlusion is removed, When the occluded outfloW is opened the pressure Will retum to the setCPAP level and this reduction in pressure Will lead to an expiratory floW.
    A system for positive pressure ventilation and continuous positive airWay pressure (CPAP) treatmentfor neonatal resuscitation comprising a device as disclosed above Wherein during spontaneousbreathing the infant floW and the fresh gas floW leaves the breathing system over the variable floWCPAP generator 3 keeping the positive pressure Within the airWay stable, by varying the fraction offloW that generates the CPAP pressure the CPAP pressure in the airWay can be adjusted as needed.
    A system as disclosed above can be used for positive pressure ventilation and continuous positiveairWay pressure (CPAP) treatment in neonatal resuscitation.
    The device as disclosed above can be used in positive pressure ventilation and continuous positiveairWay pressure (CPAP) treatment for neonatal resuscitation.
    The system as disclosed above can be used for positive pressure ventilation and continuous positiveairWay pressure (CPAP) treatment for neonatal resuscitation.
    DEFINITIONSFor purposes of this invention, the words “infant” and “child” are intended to encompass a patientsuch as a newbom, a neonatal child which is in need of neonatal resuscitation and initial respiratorysupport.
    For purposes of this invention, the wording “fresh gas flow” is compressed air, compressed oxygen ora rnixture of these that flows through the system and its parts and the wording “fresh gas flow tube” iswherein the fresh gas flows.
    For purposes of this invention, the wording “bypass gas flow” is compressed air, compressed oxygenor a mixture of these that flows through the system and its parts and the wording “bypass flow tube” iswherein the bypass gas flows.
    For purposes of this invention, the wording “Variable flow CPAP generator” is a device intended toencompass any continuous positive airway pressure devices were the CPAP level is adjusted byvarying the fresh gas flow.
    For purposes of this invention, the wording “imposed work of breathing” is the additional workrequired to breathe through a device and is an established way of measuring the pressure stability of asystem. Imposed work of breathing is obtained by calculating the area within a pressure-volume loopfor one breath.
    For purposes of this invention, the word “infant interface device” is intended to encompass anyinterface that is suitable for connecting to an infant or child, such as an opposing pair of nasal prongs,a mask or any other suitable device.
    BRIEF DESCRIPTION OF THE DRAWINGSThe accompanying drawings are included to provide a further understanding of the present inventionand are incorporated in and are a part of this specification. Other embodiments of the presentinvention, and many of the intended advantages of the present invention, will be readily appreciated asthey become better understood by reference to the following detailed description. The elements of thedrawings are not necessarily to scale relative to each other. The same reference numerals designatecorresponding similar parts.
    Figure 1 is a schematic picture of the device where the bypass flow tube 2 is connected to theconnector 9 between the variable flow CPAP generator 3 and infant interface 5. The pressure releasevalve 6 is connected on the bypass flow tube 2.
    Figure 2 is a schematic picture of the device where the bypass flow tube 2 is connected to the outlet 4of the variable flow CPAP generator 3. The pressure release valve 6 is connected to the connector 9between the infant interface 5 and the variable flow CPAP generator 3.
    Figure 3 is a schematic picture of the device where the bypass flow tube 2 is connected to the outlet 4of the CPAP 3. The pressure release valve 6 is connected on the bypass flow tube 2.
    Figure 4 is a schematic picture of the device where the bypass flow tube 2 is connected to theconnector 9 between the variable flow CPAP generator 3 and infant interface 5. The pressure releasevalve 6 is connected at the connector 9 between the infant interface 5 and the Variable flow CPAPgenerator 3.
    Figure 5 a-c are schematic pictures disclosing flows in the system during positive pressure ventilation.Figure 6 is a schematic picture disclosing flows in the system during spontaneous ventilation.
    Figure 7 is a scatter plot showing the imposed work of breathing at different level of CPAP, the meanpressure, for different systems deterrnined by simulated breathing in a mechanical lung model.
    DETAILED DESCRIPTIONFor resuscitation and stabilisation of newbom infants two types of mechanical respiratory support arecommon depending on whether the infant is breathing or not. Positive pressure ventilation is used forthe non-breathing infant and continuous positive airway pressure for the breathing infant.
    An infant that is not breathing after birth should be ventilated. This can be accomplished with PPVusing a facemask or endotracheal tube. In the majority of cases a mask is used. If the child starts tobreath or was breathing after birth, support of ventilation using CPAP is the recommended treatmentfor several conditions. After return of spontaneous breathing some children will still need PPVinterrnittently as they stop breathing. This is especially common when treating premature neonates.
    The advantages with the present invention is that it allows rapid and easy switch, without change ofequipment, between PPV and CPAP treatment in combination with a significant reduction in imposedwork of breathing compared to available devices. Today in order to provide CPAP with low imposedwork of breathing a device that is unable to provide PPV has to be used. Should the infant requireventilation a switch to another system able to provide positive pressure ventilation will be needed suchas a bag or T-piece system.
    There are examples of different embodiments of the present invention. The fresh gas flow bypassingthe variable CPAP generator 3, i.e. the bypass flow tube 2, the pressure measuring device 7 and thepressure release valve 6 can be arranged in several different positions, see Figures 1-4. In allembodiments the fresh gas flow tube 1 is connected to the variable flow CPAP generator 3.
    One embodiment is disclosed in Figure 1 is a schematic picture of the device where the bypass flowtube 2 is connected to the connector 9 between the variable flow CPAP generator 3 and infantinterface 5. The pressure release valve 6 and the pressure measuring device 7 are connected to thebypass flow tube 2.
    Another embodiment is disclosed in Figure 2 is a schematic picture of the device where the bypassflow tube 2 is connected to the outlet 4 of the variable flow CPAP generator 3. The pressure releasevalve 6 and the pressure measuring device 7 are connected to the connector 9 between the infantinterface 5 and the variable flow CPAP generator 3.
    Yet another embodiment is disclosed in Figure 3 is a schematic picture of the device where the bypassflow tube 2 is connected to the outlet 4 of the CPAP 3. The pressure release valve 6 is connected onthe bypass flow tube 2. The pressure measuring device 7 is connected to the connector 9 between theinfant interface 5 and the variable flow CPAP generator 3.
    Yet another embodiment is disclosed in Figure 4 is a schematic picture of the device where the bypassflow tube 2 is connected to the connector 9 between the Variable flow CPAP generator 3 and infantinterface 5. The pressure release valve 6 and the pressure measuring device 7 are connected to theconnector 9 between the infant interface 5 and the Variable flow CPAP generator 3.
    Oxygen concentration and fresh gas flow are adjusted by a standard blender and a flow meter. Thefresh gas flow could be varied and typically between 10-15 liters (l) per minute. A fresh gas flow inthis range should prevent rebreathing, provide flow to achieve an adequate inspiration flow, volumeand time, and provide some allowance for leak in the infant interface.
    The fresh gas flow can be supplied from two different gas sources or from the same gas source. If onegas source is used then the fresh gas flow is divided into two fractions. The fresh gas flow can bedivided using a shunt valve or double rotameter or any other device capable of dividing a gas flow.One part of the fresh gas flow is used to drive the variable flow CPAP generator and the other part ofthe fresh gas flow, i.e. the bypass flow, is used to supply adequate flow for positive pressureventilation by bypassing the variable flow CPAP generator. The bypass flow is connected in such away that it ads to inspiratory patient flow when the device is occluded during positive pressureventilation. The fresh gas flow to the variable CPAP generator is always adjustable. The bypass flowcan be varied or fixed. A typical value of the fresh gas flow to the variable flow CPAP generator is 3-12 liters per minute and the bypass flow is 3-12 liters per minute. The sum of the fresh gas flow andthe bypass flow will typically be between 10-15 l per minute. To provide high CPAP the flow drivingthe variable flow CPAP generator can be increased further until the bypass flow is zero. This wouldgenerate a CPAP that is higher than normally used.
    If the open end outlet 8 of the outlet 4 of the variable flow CPAP generator 3 is occluded, see Figure5a and 5b, the pressure delivered to the infant will increase from the pressure set by the variable CPAPgenerator until the opening pressure of the release valve 6 is reached. A typical value for the pressurerelease valve to open is around 20-30 cm H20. The increase in pressure results in an inspiratory flow.The pressure in the system will remain at the set positive pressure ventilation pressure until the outletocclusion is removed. When the occluded outlet is opened, see Figure 5c, the pressure delivered to thepatient will return to the set CPAP level and this reduction in pressure will lead to an expiratory flow.
    During spontaneous breathing the infant flow and the fresh gas flow leaves the breathing system overthe variable flow CPAP generator 3, see Figure 6. This keeps the positive pressure within the airwaystable. By varying the fraction of flow that generates the CPAP pressure the CPAP pressure in theairway can be adjusted as needed. The fresh gas flow drives the variable flow CPAP generator 3 andthe bypass flow bypasses the variable flow CPAP generator 3.
    The connector 9 between variable flow CPAP generator 3 and infant interface 5 can be designed inany suitable form.
    The system could have a backup system for malfunctioning of the pressure release valve 6. This couldeither be an alarm, a second release valve or a system that cuts the fresh gas flow.
    The infant interface 5 can assume a variety of designs suitable for establishing a connection to theinfant nasal airways, not shown. Thus, the infant interface 5 can include an opposing pair of nasalprongs, a mask or any other suitable devices.
    The pressure measuring device 7 should be positioned as close to the infant as possible to provideaccurate recording of the pressure of the gas delivered to the infant. The accuracy will depend on theflow resistance of the infant interface 5 and a low resistance interface should be used if possible. Theembodiment disclosed in Figure 1 could be regarded as beneficial since there will be less tubes neededin the system.
    A comparison of the reduction in imposed work of breathing at different levels of CPAP is madebetween two embodiments of the present invention and two other systems, the results are disclosed inFigure 7. The mean pressure is the average pressure for one breath and is very similar to CPAP.Imposed work of breathing is the additional work required to breathe through a device and is anestablished way of measuring the pressure stability of a system. Imposed work of breathing is obtainedby calculating the area within a pressure-volume loop for one breath. In Figure 7 the GE Healthcare T-piece is represented by diamonds, NeopufffM from Fisher & Paykel is represented by squares,prototype A is represented by crosses and prototype B is represented by circles. Prototype A uses thesystem described in Figure 1 and prototype B uses the system described in Figure 3.
    Notably, the device, in accordance with principles of the present invention is useful with a widevariety of infant interface configurations that may or may not incorporate some or all of the featuresdescribed above with respect to the infant interface. Thus, the infant interface is in no way limiting.The infant interface is connected to the open end of the connector 9, i.e. the end which is notconnected to the variable flow CPAP generator 3.
    Notably, the device, in accordance with principles of the present invention is useful with a widevariety of variable flow CPAP generators that may or may not incorporate some or all of the featuresdescribed above with respect to the variable flow CPAP generators. Thus, the model of the variableflow CPAP generator is in no way limiting.
    Notably, the device, in accordance with principles of the present invention is useful with a widevariety of pressure release valves or similar devices that achieves the purpose releasing air dependingon the pressure in the system. Thus, the model or type pressure release valve is in no way limiting.
    Notably, the device, in accordance with principles of the present invention is useful with a widevariety of pressure measuring devices or similar devices that achieves the purpose of measuring thepressure in the system. Thus, the model or type pressure measuring devices is in no way limiting.
    Notably, the present invention has been described with reference to some preferred embodiments andexamples, workers skilled in the art will recognize that changes can be made in form and detailwithout departing from the spirit and scope of the present invention.
    EXAMPLESIn the examples disclosed below the performance of the invention in simulated neonatal breathing isillustrated.
    The additional work needed to breathe through a device can be established by deterrnining imposedwork of breathing. This is the additional energy needed for one breath and is closely related tomaintaining a stable airway pressure. The imposed work of breathing can be determined in simulatedbreathing in a mechanical lung model by calculating the area within the pressure-volume loop for onebreath.
    The method used in the tests is the mechanical lung model which uses a symmetrical sinusoid flowpattern with a flow maximum of 6 litres per minute and a respiratory rate of 60 breaths per minute.The systems and prototypes were all tested at room temperature with piped medical air and a fresh gasflow of 12 litres per minute. Two commercially available T-piece devices were tested, the GEHealthcare T-piece and the NeopufffM from Fisher & Paykel, and two prototypes A and Brepresenting the present invention. Prototype A used the system described in Figure 1 and prototype Bused the system described in Figure 3. The parts used for the two prototypes were 1) low resistanceconnectors between infant interface 5 and positive pressure release valve 6 with the narrowestdiameter of >6 mm in prototype A, and 6 mm in prototype B; 2) low resistance connectors betweeninfant interface 5 and open end outlet 8 with a narrowest part of 2x 3,5 mm diameter; 3) low restiveinfant interface 5 with a narrower part of 3x 3,5 mm diameter; 4) the pressure release valve 6 used wasa Bemer valve; 5) the pressure measure device 7 was a standard mechanical pressure meter; 6) doublerotameters were used as a shunt 11 to divide the fresh gas flow 10 and adjust the level of CPAP (meanpressure); 7) The variable flow CPAP device 3 was a jet device. 8) Other connectors or tubes hadvarying flow resistance and diameters.
    The results of the imposed work of breathing at different mean pressures for the tested systems arepresented in Figure 7. One mark represents the energy needed for one breath at that mean pressure.
    The results in Figure 7 clearly show the significant reduction in imposed work of breathing for adevice according to the present invention illustrated by the two prototypes A and B compared to thetested T-piece devices.
    A typical CPAP level for resuscitating or stabilising an infant is in the range of 5-10 cm H20. Atypical peak pressure for PPV is 20-30 cm H20. It is obtained by occluding the systems, prototypes orT-piece device, respectively and having a correctly adjusted pressure release valve.
    权利要求:
    Claims (8)
    [1] 1. A device for positive pressure ventilation and continuous positive airWay pressure (CPAP)treatment for neonatal resuscitation comprising: a fresh gas floW tube (1) connected to a variable floW CPAP generator (3), a connector (9)connected to the variable floW CPAP generator (3), a bypass floW tube (2) connected to anoutlet (4) of the variable flow CPAP generator (3) or to the connector (9), a pressure releasevalve (6) connected to the outlet (4) of the variable floW CPAP generator (3) or to theconnector (9) or to the bypass floW tube (2), and a pressure measuring device (7) connected tothe connector (9) or to the bypass floW tube (2) if the bypass floW tube (2) is connected to theconnector (9). A device according to claim 1 Wherein the bypass floW tube (2) is connected to the connector (9)- A device according to claim 1 Wherein the bypass floW tube (2) is connected to an outlet (4) ofthe variable floW CPAP generator (3). A device according to any one of the preceding claims Where the fresh gas floW to the variablefloW CPAP generator is 3-12 liters per minute and the bypass floW is 3-12 liters per minute. A system for positive pressure ventilation and continuous positive airWay pressure (CPAP)treatment for neonatal resuscitation comprising a device according to claim 1, Wherein the system is configured to When the open end outlet (8) of the outlet (4) of thevariable floW CPAP generator is occluded the pressure Will increase from the variable CPAPgenerator until the opening pressure of the release valve (6) is reached, the increase in pressureresults to an inspiratory floW, the pressure in the system Will remain at the set positivepressure ventilation pressure until the outfloW occlusion is removed, When the occludedoutfloW is opened the pressure Will return to the set CPAP level and this reduction in pressureWill lead to an expiratory floW. A system for positive pressure ventilation and continuous positive airWay pressure (CPAP)treatment for neonatal resuscitation according to claim 1 Wherein during spontaneousbreathing the infant floW and the fresh gas floW leaves the breathing system over the variablefloW CPAP generator (3) keeping the positive pressure Within the airWay stable, by varyingthe fraction of floW that generates the CPAP pressure the CPAP pressure in the airWay can beadjusted as needed. Use of a device according to claim 1 in positive pressure ventilation and continuous positiveairWay pressure (CPAP) treatment for neonatal resuscitation. Use of a system according to claim 6 or 7 for positive pressure ventilation and continuouspositive airWay pressure (CPAP) treatment for neonatal resuscitation.
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    法律状态:
    优先权:
    申请号 | 申请日 | 专利标题
    SE1150092A|SE537099C2|2011-02-08|2011-02-08|Neonatal resuscitation system and device and initial respiratory support|SE1150092A| SE537099C2|2011-02-08|2011-02-08|Neonatal resuscitation system and device and initial respiratory support|
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    ES12744807.4T| ES2674442T3|2011-02-08|2012-02-08|Neonatal resuscitation system and device and initial respiratory support|
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