According to the regulation of 35U.S.C. § 119 (e), the application requires in the priority of the U.S. Provisional Patent Application serial number the 60/833rd, 678 of submission on July 27th, 2006.
Background technology
During therapeutic treatment, usually wish monitoring and analysis patient's expiration, to determine the gas componant in the expiration.For example, the carbon dioxide (CO during the monitoring patient exhales2) content usually is desirable.Usually, be sent to suitable sense mechanism and monitoring system, monitor the content of the carbon dioxide (or other gas) in patient's expiration by a part or sample with patient institute breath.
Can finish monitoring with main flow monitoring system or effluent monitoring system to breath.In the main flow monitoring system, the gas content in patient's gas circuit (circuit) that is couple to patient airway or ducted original place measurement patient expiration.On the other hand, in the effluent monitoring system, gas sample is transferred to the sense mechanism that is used to monitor that is positioned at apart from patient's gas circuit certain distance from patient's gas circuit by the gas sampling circuit.Because the gas that the patient breathes out is fully saturated usually about 35 ℃ steam, so the natural result of gas transmission is the hydrogenesis that occurs in warm, moist breath.
Fig. 1 is the sketch map of conventional sidestream gas sampling system 10.This system comprisesgas sensor 20 andgas sampling assembly 22, and it is transferred to gas sensor with air-flow from the sampling location.Gas sampling assembly 22 is single use portion of sidestream gas sampling system, and the meaning is to be generally each patient new gas sampling assembly is provided.Filter in gas sampling assembly or dehumidification element also be necessary for same patient and periodically changegas sampling assembly 22, because can become obstruction.Yetgas sensor 20 is recycled and reused for the gas with various sampling apparatus.
Gas sampling assembly 22 generally includespatient interface portion 24,adapter portion 26, and it is connected togas sensor 20 and one sectionhollow tube 28, and it extends between patient interface and adapter.Usually, this pipe has the length of 4-8 foot, and permanently is attached to patient interface and adapter, so thatpipeline 28,patient interface portion 24 andadapter portion 26 are complete unit.As a result,, will integral body abandon it, comprise pipeline, adapter and patient interface in casegas sampling assembly 22 has arrived its life-span in service life.
A plurality of factors are depended in accurate analysis to gas componant in patient's expiration, comprise the collection of gas sample, and it is substantially free of the liquid condensate that can make the analysis result distortion.Along with the breath sample cools off in the process that is transferred to the sense mechanism in the effluent monitoring system by the gas sampling circuit, the steam that is included in the sample can be condensed into liquid or condensate.If allow liquid or condensate to arrive sense mechanism, then liquid or condensate can cause adverse effect to sense mechanism structure function, and can cause inaccurate monitoring result.By being brought into once more in the breath sample subsequently, agglomerative liquid also can pollute this sample subsequently in the gas sampling circuit.
Except condensing, other undesired material usually also can appear, for example be included in blood in the breath sample, mucus, medicine etc.In these each is if in the gas sample that will monitor, all can provide the analysis result that can not accurately reflect the patient medical state.
Exist many modes to protect sense mechanism, in these modes, undesired material and/or liquid are separated from patient's exhaled air flow.For example, the known moisture catcher (trap) that is provided with between patient and sense mechanism before moisture enters sense mechanism, is separated it from breath.With reference to figure 1, this is corresponding to any position that the moisture catcher is arranged on alonggas sampling assembly 22, for example in the abutment betweenadapter portion 26 and pipe 28.Yet, do not influencing the parameter that will measure, the gas waveform that for example will monitor, the situation of characteristic under realize that described separation is difficult.
As an example, CO2In fact only appear in patient's the breath.Therefore, the CO in the breath sample2Be transferred to sense mechanism by the gas sampling circuit, and according to the CO that is present in the some place that obtains this sample2And fluctuate.Certainly, CO2Level also changes along with patient respiratory cycle.Interference to this fluctuation (is CO2Reducing in the waveform fidelity) be undesirable, can influence CO because this disturbs2Measure and CO2The accuracy of the pictorial display of waveform.For this reason, wish not reduce CO basically2The mode of waveform fidelity is finished liquid and other material is removed from the breath sample.Unfortunately, conventional moisture catcher basically usually can interference waveform.
Having utilized various technology that undesired condensate is filtered out from exhaled air flow attempts to make the waveform that is transmitted interference-free simultaneously.This type of technology comprises: absorbent, centrifugal filter, desiccant, hydrophobic membrane and hydrophilic film.A kind of this type of technology comprises the permeable steam of crossing of a part that makes sampling tube, for example by means of using dehumidification pipe, for example
The pipe of board.
The also known moisture catcher that is positioned at along certain some place on the sampling tube length direction that provides equally along the water strainer of sampling tube setting, perhaps is provided with the combination in any of dehumidification pipe, moisture catcher and water strainer.There is variation in the effectiveness of moisture catcher and water strainer between manufacturer, but moisture catcher or water strainer all can be subjected to final the obstruction and the influence of carbon dioxide continuous record figure (capnographic) wave distortion, if especially under the inadequate situation of preventative maintenance.At U.S. Patent application the 11/039th, 749 and 11/266, in No. 864 (U.S. Patent Publication 2005/0161042A1 and 2006/0086254A1 number), the both is entitled as " Liquid absorbing filter assembly andsystem ", can find the embodiment of the exemplary filter that is suitable for sidestream gas sampling, its content is on the whole by being incorporated herein by reference.
Even under the situation of fully having safeguarded the breathing gas circuit, " life-span " that the existing sidestream gas sampling of use filter is disposable also is subjected to the suction quantitative limitation of filter, thereby the cost of the existing patient interface of integrated sidestream gas sampling has limited their extensive employings to some application.Use dehumidification pipe, for example Nafion also can aggravate this problem, and dehumidification pipe still is relatively costly assembly.As mentioned above, because other assembly of filter and gas sampling assembly integrates as one disposable,, just must abandon whole gas sampling assembly, and replace with new device in case " life-span " of filter finishes.
Known these problems of effluent carbon dioxide continuous record figure (capnography) system, be desirable to provide a kind of patient interface solution of saving cost, its: even still keep the performance of robust in (a) during whole monitoring under condensate and the cumulative situation of patient's secretions, and (b) also can not reduce the waveform fidelity of measured breath.
The specific embodiment
Fig. 2 schematically showsgas vehicle 40 in accordance with the principles of the present invention, and it is adapted at comprising in the sidestreamgas sampling system 30 ofgas sensor 20 and uses.Gas vehicle 40 is air-flow, i.e. the effluent of gas, and from gas sample site, for example patient airway or patient's gas circuit are transferred togas sensor 20, so that can be measured the composition of air-flow by gas sensor.
In the one exemplary embodiment that illustrates,gas vehicle 40 comprisespatient interface device 42 and gas sensorelectrical connector 44, and the two optionally reaches releasedly and is coupled to each other, to form the gas vehicle.During use,patient interface device 42 also is couple to gas sample site, and gas sensorelectrical connector 44 is couple to gas sensor.
Patient interface device 42 comprisespatient interface portion 46, and it is communicated with the gas sample site fluid.In one embodiment, gas sample site is user's a air flue.Therefore, patient interface portion is communicated with user's air flue fluid, for example by means of nasal cannula, oral cavity sleeve pipe or the two are provided.In other embodiments, gas sample site is patient's gas circuit, is also referred to as to breathe gas circuit or ventilation (ventilation) gas circuit.Therefore, patient interface portion takes to be couple to the airway adapter form of patient's gas circuit.For example see Fig. 6.Therefore can recognize that the present invention has imagined the patient interface portion that many kinds of equipment can be used as patient interface device, comprise for example face shield, airway adapter (Fig. 6), nasal cannula (Fig. 4), nose/oral cavity sleeve pipe (Fig. 5) or oral cavity sleeve pipe.
Patient interface device 42 also comprisesgas sampler 48 and adapter portion 50.Pipeline 48 is flexible pipes, has length L 1, and it is 48-144 inch (4-12 foot) normally.
Gas sensorelectrical connector 44 comprisesgas sampler 52, and it has length L 2.End atpipe 52 is provided withadapter portion 54, at the other end gassensor adapter portion 56 is set.The present invention has imagined gassensor adapter portion 56 can have any structure that is suitable forpipe 52 is connected to gas sensor 20.In the one exemplary embodiment that illustrates,gas sensor 20 comprisessocket 23, at least a portion of adjusting its size and being configured to admit gas sensor adapter portion 56.Pipe 52 can be soft, inflexible, semirigid or its any combination.The present invention has also imaginedremoval pipe 52 fully, thereby constitutes gassensor adapter portion 56 andadapter portion 54 by single element, and this single element is inserted betweengas sensor 20 and thepatient interface device 42.
Configuration is also arrangedadapter portion 54 andadapter portion 50, thereby they are coupled in together, and provides level and smooth basically and interference-free fluid flow betweengas sampler 48 and gas sampler 52.For example, by disposingadapter 50,54 so that when they are linked together, on the interior shape of the current path that constitutes by these two adapters or inside diameter, there is not variation basically, realizes this level and smooth, interference-free air-flow via this connection ofadapter 50,54.
In order to carry out the gas-monitoring of using gases pick off 20, the user couplespatient interface device 42 so that be communicated with patient's air flue fluid, for example breathe in the gas circuit, gas sampler is connected to airway adapter by nasal cannula or face shield being connected to the patient or airway adapter being connected to.By gassensor adapter portion 56 is connected to gas sensor, gas sensorelectrical connector 44 and gas sensor are assembled together.Bycoupling adapter 50 and 54, alsopatient interface device 42 and gas sensorelectrical connector 44 are assembled together.Can start the pump that is connected with gas sensor, thereby the air-flow that will be derived from the sampling location is incorporated in thegas vehicle 40, is used for by the gas sensor analysis.
The present invention has imagined extra element, and such as filter and one or more water treatment assembly, for example dehumidifier, moisture catcher etc. offerpatient interface device 42, gas sensorelectrical connector 44 or the two.In an exemplary embodiment, in gas sensorelectrical connector 44, provide the dehumidifying element.
Gas vehicle 40 is configured to a plurality of separate type elements, and promptlypatient interface device 42 and gas sensorelectrical connector 44 have obtained several benefits.The gas sensor electrical connector becomes the reusable assembly of gas vehicle, andpatient interface device 42 becomes disposable assembly.The assembly that this allows higher cost such as filter and water treatment element, is arranged in the gas sensorelectrical connector 44, and gas sensorelectrical connector 44 can use with a plurality of patient interface devices subsequently.This allows common gas sensor electrical connector (having continuous filter and/or water treatment assembly) to be used till its life-span exhausts, even this is opposite with the situation of also having to lose whole device after only by an of short duration use of patient.For example, can suction portion be set in gas sensorelectrical connector 44, it can be used for a plurality of patients now, and each patient has its oneselfpatient interface device 42.
As shown in Figure 3, this is arranged and also allows different patient interface device 42a, 42b and 42c to use with same gas sensorelectrical connector 44, wherein, each patient interface device 42a, 42b have different patient interface portion 46a, 46b and 46c with 42c.This allows for identical patient, changes the patient interface device of another kind of type at him or she into from one type patient interface device, for example becomes from the face shield that is used for pressure supporting treatment and/or oxygen therapy only to be used for oxygen therapy and CO2The monitoring nasal cannula the time, use a filter and/or water treatment assembly.
In addition, because the patient moves in whole hospital, and disconnect with fixed monitoring station (gas sensor 20) and to be connected, so patient interface device can be remained on the patient.Subsequently, it can be connected with different monitoring stations, promptly uses the gas with various pick off of gas with various sensor connector device.These two gas sensor electrical connectors (44) needn't have identical connectingportion 56, as long as the connectingportion 54 that the gas sensor electrical connector has and theadapter portion 50 in patient's patient interface device is complementary.Therefore, the gas sensor electrical connector serves as adapter, moves to different monitors to allow the user, and needn't change the patient interface type that they use.
In addition, preferably, dehumidification pipe (supposing to have higher price) is set on the part of gas vehicle, it can be reused to greatest extent for concrete application.For example, for the long term monitoring (must change water treatment portion at this) of same patient, it is to save cost most that dehumidification pipe is arranged on the patient interface portion.For short-term monitoring (can frequently abandon patient interface portion at this), it is more to save cost that dehumidification pipe is arranged in the water treatment portion.
Forward Fig. 4-6 now to, will discuss the various embodiment more specifically ofgas vehicle 40 in accordance with the principles of the present invention.In each of these embodiment, gassensor adapter portion 56 is corresponding at Respironics LoFloTMEffluent CO2The sample unit that uses in the system.Disclose this sample unit in U.S. Patent application the 10/384th, No. 329 (U.S. Patent Publication 2003/0191405A1 number), its content is by being incorporated herein byreference.Gas sensor 20 comprisessocket 23, and at least a portion of adjusting its size and being configured to admit sample unit is so that be fixed to gas sensor with sample unit.When by sample unit being inserted at least in part in thesocket 23sample unit 56 and gas sensor being assembled together, one or more windows that will be provided with in sample unit are randomly aimed at the gas-monitoring assembly of gasmonitor.Sample unit 56 comprises optical window and light path, and it allows to be launched the energy that passes gas stream and passes through sample unit, so that can measure the composition by the gas of sample unit.
Fig. 4 showsgas vehicle 40, and it haspatient interface device 42, andpatient interface device 42 comprises that loop-type of nasal cannula is as patient interface portion 46.More specifically,patient interface device 42 comprisesnasal portion 58,flexible pipe portion 60 and 62,gas sampler 48,slip ring 64,adapter 66 and adapter portion 50.Nasal portion 58 compriseshollow tube body 68, and has twonose protuberances 70, its each all stretch out, and be suitable for being installed in the corresponding nasal meatus of patient's nose.The nose protuberance provides enteringtubular bodies 68 inside.Gas from the user transmits alongpipeline 60, by managing 48 and 52, arrives sample unit 56.The end offlexible pipe 62 is locked in the adapter 66.Yet the end that the present invention has also imaginedflexible pipe 62 is connected topipe 48, for example uses Y-connection, so that flow throughpipe 60 and 62 from patient's gas.Even because of managing in 60 or 62 has stopped up, gas also can flow to sample unit, so this configuration will be more reliable.
Nasal portion 58 across formula rest on patient's nose region, and by makeflexible pipe portion 60 and 62 behind patient's ear, downwards under lower jaw zone and chin the patient to become annular, makenasal portion 58 remain on the patient on the face.Yet, can use any other known mode that nasal portion is remained on the nose region, and for to provide support at patient's patient interface on theface.Slip ring 64 has enough diameters usually and surroundsflexible pipe portion 60 and 62, and can be adjusted, and promptly the length direction along flexible pipe portion moves, thereby nasal portion is firmly remained on patient's the appropriate location, and these two pipes are strained inadequately.
Gas sensorelectrical connector 44 comprisessample unit 56,water treatment assembly 74,second gas sampler 52 and connecting portion 54.The water treatment assembly can comprise one or more in suction portion and the dehumidification portion.In the embodiment shown, the water treatment assembly only comprises suction portion, and it is shown as filter 74.Filter 74 comprises shell, usually constitutes by the polymer that is fit to, and PVC for example, and have first upstream extremity and second downstream.In this embodiment, shell is columniform.Yet, imagined shell and can have any suitable shape or length.
Sample unit 56 comprises main part, and one partial interior volume has constituted sample room, has collected filtered breath in sample room, for use in will be to its measurement of carrying out, as detailed below.In an exemplary embodiment, the main part of sample unit is made of Merlon.Sampleunit 56 also comprises first side surface part, and its a part of outer surface couples with the mode of fluid-tight and air seal and second downstream offilter 74.
When connectingportion 54 is connected toadapter portion 50,, has just constituted pipe and connected as by shown in the arrow 76.It is the setting of fluid-tight and air seal that pipe connects, as is known to persons skilled in theart.Adapter portion 50 comprises that with 54 connection mode the moon/sun is connected, but and the fixedly connected pattern of any known release type, include but not limited to that use the pneumatic combination of pallet, pallet provides one-handed performance and audible " click ".Adapter portion 50 and 54 can also have Any shape, size or structure, as long as but realized carrying out the fixed function of release type level and smooth basically and interference-free fluid flow also being provided betweengas sampler 48 and 52 simultaneously managing 48 and 52 end.
As an example but be not as the restriction,flexible pipe portion 60 and 62 can have from about 15 feet to about 30 inches total length, preferably be about 24 inches, although any length all is fit to.The total length offirst gas sampler 48 andsecond gas sampler 52, promptly L1+L2 can more preferably be about 96 inches, although this length can vary depending on the application from about 75 inches to about 100 inches.
Fig. 5 shows the embodiment of
gas vehicle 40, and it is basically to shown in Figure 4 similar.Yet in the embodiment of Fig. 5,
patient interface portion 46 is nose/mouth interfaces.In other words,
nasal portion 58 also comprises oral
cavity sampling portion 78, and it is suitable for receiving the air-flow that is present in the patient mouth.In addition, gas sensor
electrical connector 44 comprises dehumidification portion 80.In the one exemplary embodiment that illustrates,
dehumidification portion 80 is one section dehumidification pipe, and it is the 2-3 inch normally.Yet, can imagine the dehumidification pipe of other length by means of the present invention.An example of this type of dehumidification pipe is
It is Du Pont (DuPont) copolymer, and it has high selectivity aspect removal of steam.Moisture moves through membranous wall, and is evaporated in surrounding air or the gas in being called the process of pervaporation.This process is by driving in the inboard of pipe and the moist gradient between the outside.
The embodiment ofgas vehicle 40 shown in Figure 6 is similar to shown in the Figure 4 and 5 also, and exceptpatient interface portion 46 isairway adapters 81,airway adapter 81 is set in patient's gas circuit 82.In the illustrated embodiment,airway adapter 81 is low dead zone (low-deadspace) airway adapters, is used for new life/infant patients.Yet, to have imagined any airway adapter and used with patient interface independently, described airway adapter links to each other with the patient respiratory gas circuit of sample gas therein.At United States Patent (USP) the 7th, 059, the example of the airway adapter that is fit to is disclosed in 322 and 6,935,338, its content is by being incorporated herein by reference.
Except the gas of monitoring by patient's exhalation, the present invention has imagined make-up gas, and for example oxygen, helium, nitrogen or its any combination (for example helium-oxygen gas mixture) offer the user.Fig. 7-9 shows sidestreamgas sampling system 30 and assembly thereof in accordance with the principles of the present invention, and it comprises make-up gas transfer system 90, is used to finish this function.As shown in Figure 7, make-up gas transfer system 90 comprises gas source 92 and is used to transport the make-upgas dispatch tube 94 of make-up gas.In the illustrated embodiment, supplemental air flow is transferred to thepatient interface portion 46 ofgas vehicle 40.
Gas source can be the gas source of any kind.For example, in oxygen delivery system, source of oxygen can comprise, but be not limited to: (a) storage is the compressed oxygen of gas in the jar, (b) be stored at liquid oxygen in the fixing big standing tank at home or the liquid oxygen that produces at home, and the oxygen that (c) extracts from space air with any conventional gas isolation technics, for example the pressure oscillating that is provided by oxygen concentrator usually absorbs (pressure swing absorption).Gas is preserved equipment, and for example demand inspiratory flow system or pulsed dosage air delivery system also can be used to control the air-flow that sends the user to.
Fig. 8 showsgas vehicle 40, and it comprises gas-monitoring and gas transfer capability.Embodiment beforegas vehicle 40 is similar to generally is except having increased make-up gas dispatch tube 94.In this embodiment, an end of make-up gas dispatch tube is couple toflexible pipe 62 via adapter 96.The other end of make-up gas dispatch tube comprises connectingportion 98, and it allows the make-up gas dispatch tube optionally to be couple to the outlet of source of oxygen.The end that the present invention has also imagined optionally the make-up gas transfer canal is connected toadapter 96, and for the gas transport unit of adapter provides end cap, so that this gas vehicle has the motility that is used as the monitoring isolated plant or is used as monitoring and gas transport means.In addition, can be similar to the adapter portion ofadapter portion 50,54 along any position setting on make-upgas dispatch tube 94 length directions, thereby this pipeline can be divided into a plurality of parts.
Nose protuberance 100 is couple toflexible pipe 62, is used for make-up gas is transferred to patient's a nostril.Anothernose protuberance 102 is from user's receiver gases.The nose protuberance physically is isolated from each other, thereby can provide gas-monitoring and gas transmitting function by a pair of nose protuberance.For example, can be at (a)nose protuberance 100 and (b) provide wall, barrier film or other obturator in thepipeline 60,62 betweennose protuberance 102 and the oralcavity sampling portion 102, to serve asgas sampling portion 102,78 andgas transport unit 100 isolating barriers with nasal interface portion.In this embodiment, have onlynose protuberance 100 to serve as the gas transport unit.Nose gas sampling portion is served as by anothernose protuberance 102 and oralcavity sampling portion 78, and the two transmitsnose protuberance 100 with gas physically and isolates.
Fig. 9 shows another embodiment ofgas vehicle 40, and wherein,patient interface portion 46 comprisesface shield 104, and it is arranged on the patient on theface.Face shield 104 covers user's nose and mouth usually, and is included in theexhaust portion 106 that forms in the mask shell, is used for making gas to be discharged into surrounding air.Will appreciate that any conventional face shield, comprise the face shield that is used to provide the pressure supporting treatment, may be used among this embodiment.Provide optionalhead cap band 108, so that face shield is remained on the user on the face.
Gas sampler 48 is connected toface shield 104 via gas sampling connecting portion 110.This allows gas sampler optionally to be connected to face shield.Yet the end that the present invention has also imaginedgas sampler 48 is integrated in the face shield.Make-upgas dispatch tube 94 transmits connectingportion 112 via gas and is connected to face shield.Yet the end that the present invention has also imagined make-upgas dispatch tube 94 is integrated in the face shield.
In an exemplary embodiment,face shield 104 is low dead zone oxygen transmission/gas sampling face shields, and it is arranged on the facial nose and oral cavity part.Yet, imagined any face shield that can be suitable for gas sampling and come to use with patient interface independently.The nasal mask, face mask, full facepiece mask and other device that are connected to the patient have been imagined.These face shields can be used for monitoring and treatment, for example oxygen, aerosol and the treatment of non-intruding forced ventilation.
The present invention has imaginedadapter portion 50 and 54 and has comprised electric or optics is connected, thereby can carry out electric betweenpatient interface device 42 and gas sensorelectrical connector 44 or optics contacts.This has just allowed to be provided with one or more electric components inpatient interface device 42, for example temperature sensor, humidity sensor, mike, oxygen determination pick off, plethysmogram pickup, motion sensor etc., it is communicated with hardware mode with gas sensor via gas sensorelectrical connector 44.
In an exemplary embodiment, provide gas vehicle of the present invention with the form of suite, it is included in the common packing.This suite comprisespatient interface device 42 and gas sensor electrical connector 44.Dehumidification pipe can also be provided, and it optionally is couple to patient interface device or gas sensor electrical connector.In a further embodiment, this suite comprises a gas sensorelectrical connector 44 and a plurality of patient interface device, and each patient interface device all has different patient interface portion, so that the user can select to use which patient interface device.Other suite can comprise one or more patient interface devices, so that in case with gas sensor electrical connector placed in position, the user just can utilize other patient interface device that comprises identical or different patient interface portion.
Although based on current being thought of as is most realistic and preferred embodiment, describe the present invention for illustrative purposes in detail, should be understood that, this details only is used for this purpose, the invention is not restricted to the disclosed embodiments, in contrast, its intention covers the interior modification and the equivalent arrangements of spirit and scope of claims.For example, it being understood that the present invention has imagined within the bounds of possibility, one or more features of any embodiment can merge with one or more features of any other embodiment.