Patent a carbon monoxide diffusing capacity measuring deviceWord文件下载.docx

Patent a carbon monoxide diffusing capacity measuring deviceWord文件下载.docx

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scondition.TheassemblyincludesaphantomwhosechamberisinterposablebetweenthemouthpieceoftheDLcodeviceandacalibrationsyringehavingaknowncapacity.Withinthechambercavityisaflowtubethatextendsbetweenvalvedmouthpieceandsyringeportsonopposingendwallofthechamber.Thevalvedportarrangementsaresuchthatwhenthesyringeisoperatedinitsnegativepressuremode,theflowtubeisthenblockedandthecavityisunblocked,thisblockingactionbeingreversedwhenthesyringeisoperatedinitspositivepressuremode.Injectedintothecavityisagivenamountofinertgaswherebywhenthesyringeisoperatedinitsnegativepressuremode,aknownamountofthegasmixtureisdrawnfromthedeviceintothecavitywhereitisintermingledwiththeinertgastherein,therebyreducingtheratioofcarbonmonoxidetotheinertgastoapredetermineddegreetoproduceatestsamplethatfillsthesyringe.Andwhenthesyringeisthereafteroperatedinitspositivepressuremode,thetestsampleisthenexpelledfromthesyringeandfedthroughthetubetotheDLcodevice.Shouldthedevicebemalfunctioning,itsanalysisofthesamplewillyieldreadingsthatdeviatefromthecorrectvalues,therebyindicatingthatthedeviceisinaccurate.

图片

（2）

权利要求（9）

Iclaim:

1.Aphantomassemblyadaptedtosimulateahumansubjecttoverifytheaccuracyofacarbonmonoxidediffusingcapacitymeasuringdevicetotestthefunctionalcapacityofthesubject'

salveolar-capillarymembrane,saiddeviceincludingamouthpiecethroughwhichthesubjectinhalesamixtureofcarbonmonoxideandaninertgasinapredeterminedratio,thesubjectafterabreathholdingintervalexhalingintothemouthpieceanalveolarsamplewhosecarbonmonoxidecontentisanalyzed,saidassemblycomprising:

（a）aphantomprovidedwithachamberhavingrespectiveportsatopposingendsthereof,andaflowtubedisposedwithinthechamberandextendingbetweentheports,thetubebeingsurroundedbyacavityhavingapredeterminedvolumeofsaidinertgasinjectedtherein;

（b）acalibrationsyringehavinganegativepressuremodeinwhichthepressurecausesagastofillthesyringeandapositivepressuremodeinwhichthepressureexpelsthegas,and

（c）meansforcouplingoneofsaidportstosaiddevice,andtheotherofsaidportstosaidsyringewherebywhensaidsyringeisoperatedinthenegativepressuremode,saidtubeisblockedandsaidgasmixtureisdrawnintosaidcavityandsaidsyringetointerminglewithsaidinertgastoalteritsratiotoaknowndegreetoproduceatestsample,andwhensaidsyringeisoperatedinthepositivepressuremode,saidcavityisthenblockedandsaidtestsampleisforcedthroughsaidtubeintosaiddevicewhichwillthenyieldareadingthatdeviatesfromacalculableandpredictablevalueonlyifthedeviceismalfunctioning.

2.Anassemblyassetforthinclaim1,whereinsaidinertgasishelium.

3.Anassemblyassetforthinclaim1,whereinsaidcalibrationsyringeincludesapistonslidableinabarrelfromaretractedpositionatoneendofthebarreltoanadvancedpositionatitsotherend.

4.Anassemblyassetforthinclaim1,whereinsaidchamberiscoupledtothemouthpieceofthedevicebyaninputcouplerandtothesyringebyanoutputcoupler.

5.Anassemblyassetforthinclaim1,whereineachportisprovidedwithafirstunidirectionalvalveelementattherelatedendofthetubewhichiscausedtoopenonlywhensubjectedtopositivepressureandasecondunidirectionalvalveelementconcentricwiththetubeattherelatedendofthecavitywhichiscausedtoopenonlywhensubjectedtonegativepressure.

6.Anassemblyassetforthinclaim1,whereinsaidfirstandsecondvalveelementsareformedbyrubberdiscs.

7.Anassemblyassetforthinclaim6,whereinsaiddiscsarejoinedtogetherattheircenterbyarivet.

8.Amethodforsimulatingahumansubjecttoverifytheaccuracyofacarbonmonoxidediffusingcapacitymeasuringdevicetotestthefunctionalcapacityofthesubject'

salveolar-capillarymembrane,saiddeviceincludingamouthpiecethroughwhichthesubjectinhalesamixtureofcarbonmonoxideandaninertgasinapredeterminedratio,thesubjectafterabreathholdingintervalexhalingintothemouthpieceanalveolarsamplewhosecarbonmonoxidecontentisanalyzed,saidmethodcomprisingthestepsof:

（a）injectingintoaphantomchamberaknownvolumeofsaidinertgas:

（b）drawingfromsaidmouthpieceapredeterminedvolumeofsaidmixtureofcarbonmonoxideandsaidinertgas,andfeedingthemixtureintothephantomchambertointerminglewiththeinertgastherein,wherebysaidmixtureratioisthenalteredtoaknowndegreetoprovideinsaidchamberatestsamplesimulatingahumansubject;

and

（c）feedingthetestsampleintothedevicethroughthemouthpieceandcausingthedevicetoanalyzethetestsampletoyieldareadingthatwilldeviatefromacalculableandpredictablevalueonlyifthedeviceismalfunctioning.

9.Amethodassetforthinclaim8,whereinsaidinertgasishelium.

说明

BACKGROUNDOFINVENTION

1.FieldofInvention

Thisinventionrelatesgenerallytodevicesadaptedtotestthecarbonmonoxidediffusingcapacity（DLco）ofthelungsofahumansubjecttodeterminethefunctionalintegrityofhisalveolar-capillarymembrane,andmoreparticularlytoaphantomassemblywhichsimulatesahumansubjectperformingastandardDLcotestandwhichyieldsareproduciblevaluefortheDLcoresult,therebymakingitpossibletoverifytheaccuracyofastandardDLcomeasuringdevice.

2.StatusofPriorArt

Thegastransferfactorforcarbonmonoxide（CO）isgenerallyreferredtoasthepulmonarydiffusingcapacity（DLco）.Thisparameteriscommonlyusedtoevaluatethetransferofgasfromthedistalairspaceintothepulmonarycapillaries.Themainreasonwhythismeasurementisusefulinmedicaldiagnosisisthatitistheonlynon-invasivetechniquefordeterminingtheintegrityofthealveolar-capillarymembrane.

DLcomeasurementmakesitpossibletodifferentiatepathologicalentitiesthatdifferinthedamagetheyinflictonthelungparenchyma,suchasthereductioninalveolar-capillarysurfaceareaencounteredinemphysemaandchangesinthepermeabilityofthealveolar-capillarymembraneasseenwithdiffuseinterstitialprocesses（e.g.,sarcoidosis,diffuseinterstitialfibroses,andmanyotherdiseases）.ItisalsoimportanttounderstandtherelationshipofhemoglobinconcentrationandDLcoinordertoavoidmisinterpretingalowDLcowhichissolelyattributabletosevereanemiaassecondarytoanon-existentlungdisease.

ThefollowingreferencesdealwiththepulmonarydiffusingcapacityofhumansubjectsanddiscloseknownDLcotestdevicesformeasuringthisparameteraswellasclinicalapplicationsforthismeasurement.

1.BatesDV,MacklemPT,ChristieRV;

RespiratoryFunctioninDisease,Philadelphia,WBSaundersCo.,1971,pp93-94.

2.Forster,RE,RoughtonFJW,CanderL,etal.:

ApparentpulmonarydiffusingcapacityforCOatvaryingalveolarO2 

tensions.J.ApplPhysiol11:

227-289,1957.

3.KrumholzRA:

Pulmonarymembranediffusingcapacityandpulmonarycapillarybloodvolume:

Anappraisaloftheirclinicalusefulness.AmRevRespirDis94:

195-200,1966.

4.ForsterRE,CohnJE,BriscoeWA,etal.:

AmodificationoftheKroghcarbonmonoxidebreathholdingtechniqueforestimatingthediffusingcapacityofthelung:

Acomparisonwiththreeothermethods.JClinInvest34:

1417-14261955.

5.MortonJW,OstensoeLG:

Acriticalreviewofthesinglebreathmethodofmeasuringthediffusingcapacityofthelungs.DisChest48:

44-54,1965.

6.CadiganJB,MarksA,EllicottMF,etal.:

AnanalysisoffactorsaffectingthemeasurementofpulmonarydiffusingcapacitybythesinglebreathmethodJClinInvest40:

1495-1514,1961.

7.CrapoRO,MorrisAH:

Standardizedsinglebreathnormalvaluesforcarbonmonoxidediffusingcapacity.AmRevRespirDis123:

185-189,1981.

8.Miller,A,ThorntonJ.C.,Warshau,R,etal.,singlebreathdiffusingcapacityinarepresentativesampleofthepopulationofMichigan.Am.Rev.Respir.Dis.127:

270-277,1983.

DiffusingcapacityisnormallymeasuredwithCO,forthisgashasahighaffinityforhemoglobinandisnormallyabsentinmixedvenousblood.Carbonmonoxidehasamembranediffusioncoefficientandarateofreactionwithhemoglobinsimilartooxygenandlinearlyrelatedthereto.Sincecarbonmonoxideisnormallynotfoundinbloodinappreciableamounts,thisfacilitatesthecalculationofCOuptake.AndbecausetheaffinityofhemoglobinforCOishundredsoftimesgreaterthanforoxygen,apartialpressureofoxygenthatremainsinthephysiologicalrangeisnotasignificantinterferingfactor.

TheconcernofthepresentinventioniswithstandarddevicesadaptedtocarryoutDLcomeasurementbythesingle-breathtechnique.Inthistechnique,thehumansubjectorpatientwhoisconnectedtoaspirometerisinstructedtoinhaleamaximumbreath（vitalcapacity）,thisinhalationstartingfro