Patent Application: US-53444709-A

Abstract:
an integrated patient monitoring and control system is provided which includes a sample set , the sample set being adapted for coupling to the patient to obtain a specimen from the patient , a sensor , the sensor being adapted to receive the specimen from the sample set and to analyze the sample , a medication control unit , the medication control unit receiving information from the sensor , and utilizing that information to determine medication dosing information for the patient , and a medication administration system , the medication administration system receiving the dosing information from the medication control unit , and adapted to cause administration of the medication to the patient . if the sample set is adapted for blood draw , the system advantageously is performed in conjunction with a pneumatic pressure cuff , inflated so as to aid in blood draw .

Description:
with particular reference to fig1 , 2 , 3 and 4 , this invention describes an integrated patient measurement and control system 100 ( ipmc ) for delivering medications . the preferred elements of the system as depicted are the blood sampler / withdrawal set 110 , one or more sensors , 120 a medication control unit 130 and an integrated drug delivery technology 140 through which medication can be delivered . in one aspect , one of the key features of the ipmc system is an integrated drug delivery technology , shown in fig5 is an integrated intravenous ( iv ) infusion pump . this integration minimizes the chance for communication errors that could occur with an external infusion device leading to potentially serious consequences such as infusion without proper feedback . additional elements of the system include an integrated bar code reader 150 to read the name , dosage , and concentration of the medication to be delivered and patient id to further minimize any medication delivery errors ; intermittent sampling and control , and a cuff that can be used in conjunction with the sampler device and medication control unit . the system is capable of controlling different medications via interchangeable sensor and algorithms , or multiple medications through a multiplexed assay cassette . an alternative embodiment of the system is shown in fig6 , again containing integration of all of the elements described . the sampling system can withdrawal any biological fluid including blood , urine , interstitial fluid , or saliva . the preferred sample is blood . the sampling system preferably contains a bar code / rfid tag and interlock with the system to ensure patient safety and notify the medication control unit if any errors occur ( e . g . occlusion , attempted removal , etc ). the sampling system is capable of either intermittent sampling or could be adapted to continuous sampling based on the sensor ( s ). the preferred embodiment of the sampling system incorporates a cuff 112 ( blood pressure like cuff ) and works in conjunction with the controller and sampler to ensure smooth withdrawal of blood . the sampling system is coupled with a specific algorithm to inflate automatically prior to sampling ( an automated corresponding to a tourniquet manually used for a lab blood draw ) and use a sensing algorithm to set the pressure just above the systolic pressure to ensure a smooth draw and more frequent success to prevent vein collapse ( especially in elderly ). the sampling system is housed in a cassette that will fit into the device . in one aspect of the invention , an interlock system and optionally rfid pair it with the ipmc . the ipmc 110 is a modular system with the capability of providing feedback on different parameters from different medications or on more than one parameter ( e . g ., drug level , pharmacodynamic response ) simultaneously . this is achieved by having the sensor be interchangeable in the device or by a sensor that can be used with more than one assay parameter . one embodiment , shown below in fig7 a and 7b , is a cassette 160 which consists of multiple assays for different assays ( e . g ., a1 162 , a2 164 ( alternating ); or a1 162 , a2 164 , a3 166 , a4 168 ( in sequence )). thereby multiple assay parameters ( e . g . aptt , glucose concentration , potassium level ) can be detected in sequence . the embodiment below preferably interlocks with the system and contains a barcode / rfid tag to ensure that the correct parameters are being measured . in another aspect of the invention of the system , vital signs monitoring ( e . g . ecg , blood pressure , sp02 ) is integrated into the overall monitoring of the safety and state of patient . the blood pressure and heart rate can be analyzed using the cuff 112 that is part of the sampling system . the ipmc system is based on intermittent sampling or if the sensor allows , continuous measurement . it is important to note that the sampling system may take intermittent samples , and the mcu 130 uses algorithms to reconstruct patients state , response and then calculate drug delivery rate based on intermittent samples . in addition , the optimal sampling time to take a sample can be determined by response of patient test and if patient response is unexpected ( e . g ., in wrong direction ) the medical delivery is halted . there is also an alarm / alert infrastructure / supervisory system 100 to oversee the entire mcu . if all aspects of the ipmc system are functioning there is a “ green light ” and delivery proceed . if there is an alert , ( e . g ., a non - critical problem that is potentially correctable ) has been detected ( e . g . sampling error , communication error , etc .) a yellow alert and audible alarm occurs . if a serious condition occurs ( incorrect infusion rate , multiple missed samples , disconnected line ) occurs then the system immediately goes into alarm ( red light , audible alarm , communication to central station ). fig8 shows a representative display of a monitor 170 for the system . the medication delivery technology optionally consists of intravenous infusion pumps 142 , syringe pumps , implantable pumps , transdermal iontophoretic systems . the preferred embodiment is an intravenous infusion pump . the preferred delivery route is intravenous , but other portals such as intrarterial , transdermal , peritoneal , subcutaneous , or buccal could also be used . in the preferred embodiment , the pump is an integral part of the system rather than connected by an interface . this prevents any potential safety issues including 1 ) communication errors between devices , 2 ) incorrect information being sent between devices , 3 ) loss of control of device , 4 ) undetected error that is missed by pump and not detected by the medication control unit . optionally , the system , will contain a bar code sensor 150 that can read the identity of the medication being delivered as well as its concentration , and patient for whom it is intended . the system preferably includes telemetry ( either wired via ethernet or like , or wireless like bluetooth or wifi ) to communicate information to central station . the system has the ability to pair the system with the patients instructions to make sure the right patient is being started on the right drug . although the foregoing invention has been described in some detail by way of illustration and example for purposes of clarity and understanding , it will be readily apparent to those of ordinary skill in the art in light of the teachings of this invention that certain changes and modifications may be made thereto without departing from the spirit or scope of the appended claims . 1 the joint commission sentinel event alert : preventing errors relating to commonly used anticoagulants issue 41 , sep . 24 , 2008 . 2 granger c b , hirsh j , califf r m et al . for the gusto - i investigators . activated partial thromboplastin time and outcome after thrombolytic therapy for acute myocardial infarction : results from the gusto - i trial . circulation . 1996 ; 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