# US 2014/0155769 A1 · Devices, Systems, and Methods for Pulmonary Arterial Hypertension (PAH) Assessment and Treatment > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0155769 A1 - Document ID: US20140155769A1 - Status: Published application - Kind: A1 - Application number: 14/086,478 - Filed: 2013-11-21 - Published: 2014-06-05 - Earliest claimed: 2012-11-21 - Assignees: CardioMEMS, Inc. - Applicants: CardioMEMS, Inc. - Inventors: Jason White; Ralph Jordan; John Erik Moore; Jay Yadav - Web page: https://patentgrep.com/patent/US20140155769A1 ## CPC - A61B 5/0215: by means inserted into the body - A61B 5/002: {Monitoring the patient using a local or closed circuit, e.g. in a room or building (A61B5/0017 takes precedence)} - A61B 5/02028: {Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction} - A61B 5/029: Measuring blood output from the heart, e.g. minute volume - A61B 5/686: {Permanently implanted devices, e.g. pacemakers, other stimulators, biochips (A61B5/6861 takes precedence)} - A61B 5/7275: {Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor} - A61B 5/7282: {Event detection, e.g. detecting unique waveforms indicative of a medical condition (cough events A61B5/0823; seizures A61B5/4094; sleep apnoea A61B5/4818)} - G16H 20/10: relating to drugs or medications, e.g. for ensuring correct administration to patients - G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems - G16H 50/30: for calculating health indices; for individual health risk assessment - A61B 5/02: Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow - A61B 2560/0219: of externally powered implanted units - A61B 2560/0228: using calibration standards - A61B 2562/0247: Pressure sensors - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA ## Abstract Provided herein are devices, systems, and methods for assessing, treating, and for developing new treatments for pulmonary arterial hypertension (PAH) using pulmonary artery pressure (PAP) values and/or cardiac output (CO) estimates. ## Claims ### Claim 1 A method of evaluating progress of pulmonary arterial hypertension (PAH) in a subject, or an outcome in a subject having PAH, comprising: (a) obtaining a pulmonary artery pressure waveform from the subject; (b) determining one or more pulmonary artery pressure (PAP) values from the pulmonary artery waveform; (c) estimating cardiac output (CO) using the pulmonary artery pressure waveform; (d) comparing one or more of the PAP values and one or more of the CO estimates to standard PAP and CO values respectively; and (e) using the comparisons of PAP and CO to monitor the PAH progression or outcome in the subject. ### Claim 2 (depends on 1) The method of claim 1, wherein the standard PAP value is one or more previously determined PAP values from the subject. ### Claim 3 (depends on 1) The method of claim 1, wherein the standard CO value is based on one or more previously estimated CO values from the subject. ### Claim 4 (depends on 1) The method of claim 1, wherein the standard PAP value is a clinically relevant target PAP value for the subject. ### Claim 5 (depends on 1) The method of claim 1, wherein the standard CO value is a clinically relevant CO target value for the subject. ### Claim 6 (depends on 1) The method of claim 1, wherein: a. a decrease in the one or more PAP values compared to the standard PAP value combined with one or more increased or stable CO estimates compared to the standard CO value, or b. one or more stable PAP values compared to the standard PAP value combined with one or more increased CO estimates compared to the CO standard value indicates or predicts improvement of the PAH in the subject. ### Claim 7 (depends on 1) The method of claim 1, wherein: a. a decrease in one or more CO estimates compared to the standard CO value combined with one or more increased or stable PAP values compared to the standard PAP value, or b. an increase in one or more PAP values compared to the standard PAP values combined with a stable or decreased CO value compared to the standard CO value indicates or predicts worsening of the PAH in the subject. ### Claim 8 (depends on 1) The method of claim 1, wherein the obtained pulmonary artery pressure waveform is obtained with a wireless sensor implanted in the subject. ### Claim 9 (depends on 1) The method of claim 1, wherein one or more of the standard pulmonary artery pressure values are determined from a pulmonary artery pressure waveform obtained with a wireless sensor implanted in the subject. ### Claim 10 (depends on 1) The method of claim 1, further comprising administering a pharmaceutical agent to the subject. ### Claim 11 (depends on 1) The method of claim 1, wherein the pulmonary artery pressure waveform is obtained wirelessly. ### Claim 12 (depends on 11) The method of claim 11, wherein the pulmonary artery pressure waveform is obtained using an implanted sensor. ### Claim 13 (depends on 12) The method of claim 12, wherein the implanted sensor is a pressure sensor. ### Claim 14 (depends on 13) The method of claim 13, wherein the pressure sensor is implanted in a pulmonary artery. ### Claim 15 (depends on 14) The method of claim 14, wherein the sensor lacks percutaneous connections. ### Claim 16 (depends on 15) The method of claim 15, wherein the sensor is energized from an external source. ### Claim 17 (depends on 16) The method of claim 16, wherein the sensor is a passive sensor energized to return pressure readings by an electromagnetic field. ### Claim 18 (depends on 1) The method of claim 1, wherein the pulmonary artery pressure waveform is obtained while the subject is exercising. ### Claim 19 (depends on 1) The method of claim 1, wherein the pulmonary artery pressure waveform is obtained while the subject is asleep. ### Claim 20 (depends on 10) The method of claim 10, further comprising modifying or maintaining the administration of the pharmaceutical agent. ### Claim 21 (depends on 20) The method of claim 20, further comprising maintaining administration of the pharmaceutical agent at its current dosage and or dosing regimen when improvement is indicated. ### Claim 22 (depends on 20) The method of claim 20, wherein the pharmaceutical agent is changed, or the dosage or dosing regimen modified when improvement is not indicated. ### Claim 23 A method for evaluating treatment of a subject having PAH, comprising: (a) administering an agent to the subject; (b) obtaining a pulmonary artery pressure waveform from the subject; (c) determining one or more pulmonary artery pressure (PAP) values from the pulmonary artery waveform; (d) estimating cardiac output (CO) using the pulmonary artery pressure waveform; (e) comparing one or more of the PAP values and one or more of the CO estimates to standard PAP and CO values respectively; and (f) using the comparisons of PAP and CO to monitor the effect of the administered agent on the PAH condition in the subject. ### Claim 24 (depends on 23) The method of claim 23, wherein the standard PAP value is based on one or more previously determined PAP values from the subject. ### Claim 25 (depends on 23) The method of claim 23, wherein the standard CO value is based on one or more previously estimated CO values from the subject. ### Claim 26 (depends on 23) The method of claim 23, wherein the standard PAP value is a clinically relevant target PAP value for the subject. ### Claim 27 (depends on 23) The method of claim 23, wherein the standard CO value is a clinically relevant CO target value for the subject. ### Claim 28 (depends on 23) The method of claim 23, wherein: a. a decrease in the one or more PAP values compared to the standard PAP value combined with one or more increased or stable CO estimates compared to the standard CO value, or b. one or more stable PAP values compared to the standard PAP value combined with one or more increased CO estimates compared to the CO standard value indicates or predicts improvement of the PAH in the subject. ### Claim 29 (depends on 23) The method of claim 23, wherein: a. a decrease in one or more CO estimates compared to the standard CO value combined with one or more increased or stable PAP values compared to the standard PAP value, or b. an increase in one or more PAP values compared to the standard PAP values combined with a stable or decreased CO value compared to the standard CO value indicates or predicts worsening of the PAH in the subject. ### Claim 30 (depends on 23) The method of claim 23, wherein the standard is a PAP of about 25 mmHg. ### Claim 31 (depends on 30) The method of claim 30, wherein the obtained reading is less than 25 mmHg. ### Claim 32 (depends on 31) The method of claim 31, wherein one or more PAP values of the subject determined prior to determining the PAP value from the obtained pulmonary artery pressure waveform are greater than 25 mmHg. ### Claim 33 (depends on 23) The method of claim 23, wherein the pulmonary artery pressure waveform is obtained is obtained wirelessly. ### Claim 34 (depends on 33) The method of claim 33, wherein the pulmonary artery pressure waveform is obtained using an implanted sensor. ### Claim 35 (depends on 34) The method of claim 34, wherein the implanted sensor is a pressure sensor. ### Claim 36 (depends on 35) The method of claim 35, wherein the pressure sensor is implanted in a pulmonary artery. ### Claim 37 (depends on 36) The method of claim 36, wherein the sensor lacks percutaneous connections. ### Claim 38 (depends on 37) The method of claim 37, wherein the sensor is energized from an external source. ### Claim 39 (depends on 38) The method of claim 38, wherein the sensor is a passive sensor energized to return pressure readings by an electromagnetic field. ### Claim 40 (depends on 23) The method of claim 23, wherein the pulmonary artery pressure waveform is obtained while the subject is exercising. ### Claim 41 (depends on 23) The method of claim 23, wherein the pulmonary artery pressure waveform is obtained while the subject is asleep. ### Claim 42 (depends on 23) The method of claim 23, wherein the monitored effect is used to determine an effective dosage for the agent. ### Claim 43 (depends on 23) The method of claim 23, further comprising modifying or maintaining the administration of the pharmaceutical agent. ### Claim 44 (depends on 43) The method of claim 43, further comprising maintaining administration of the pharmaceutical agent at its current dosage and or dosing regimen when improvement is indicated. ### Claim 45 (depends on 43) The method of claim 43, wherein the pharmaceutical agent is changed, or the dosage or dosing regimen modified when improvement is not indicated. ### Claim 46 A method for evaluating treatment of a subject having PAH, comprising: (a) administering an agent to the subject; (b) obtaining a pulmonary artery pressure waveform from the subject; (c) determining one or more pulmonary artery pressure (PAP) values from the pulmonary artery waveform; (d) comparing one or more of the PAP values to a standard PAP value; and (e) using the comparison of PAP to monitor the effect of the administered agent on the PAH condition in the subject. ### Claim 47 (depends on 46) The method of claim 46, wherein the standard PAP value is based on one or more previously determined PAP values from the subject. ### Claim 48 (depends on 46) The method of claim 46, wherein the standard PAP value is a clinically relevant target PAP value for the subject. ### Claim 49 (depends on 46) The method of claim 46, wherein the obtained pulmonary artery pressure waveform is obtained with a wireless sensor implanted in the subject. ### Claim 50 (depends on 46) The method of claim 46, wherein one or more of the standard pulmonary artery pressure values are determined from a pulmonary artery pressure waveform obtained with a wireless sensor implanted in the subject. ### Claim 51 (depends on 46) The method of claim 46, wherein a decrease in the one or more determined PAP values compared to the PAP standard indicates a beneficial effect of the administered agent on the PAH condition in the subject. ### Claim 52 (depends on 46) The method of claim 46, wherein an increase in the one or more determined PAP values compared to the PAP standard indicates no beneficial effect of the administered agent on the PAH condition in the subject. ### Claim 53 A method for evaluating treatment of a subject having PAH, comprising: (a) administering an agent to the subject; (b) obtaining a pulmonary artery pressure waveform from the subject; (c) estimating cardiac output (CO) using the pulmonary artery pressure waveform; (d) comparing one or more of the estimated CO values to a standard CO value; and (e) using the comparison of CO to monitor the effect of the administered agent on the PAH condition in the subject. ### Claim 54 (depends on 53) The method of claim 53, wherein the standard CO value is based on one or more previously estimated CO values from the subject. ### Claim 55 (depends on 53) The method of claim 53, wherein the standard CO value is a clinically relevant target CO value for the subject. ### Claim 56 (depends on 53) The method of claim 53, wherein the obtained pulmonary artery pressure waveform is obtained with a wireless sensor implanted in the subject. ### Claim 57 (depends on 53) The method of claim 53, wherein one or more of the standard CO value is determined from a pulmonary artery pressure waveform obtained with a wireless sensor implanted in the subject. ### Claim 58 (depends on 53) The method of claim 53, wherein an increase in the one or more estimated CO values compared to the CO standard indicates a beneficial effect of the administered agent on the PAH condition in the subject. ### Claim 59 (depends on 53) The method of claim 53, wherein a decrease in the one or more estimated CO values compared to the CO standard indicates no beneficial effect of the administered agent on the PAH condition in the subject. ### Claim 60 (depends on 1) The method of claim 1, wherein the cardiac output estimate includes a proportional estimate of flow impedance, based on measured changes in the average pulmonary artery systolic, diastolic, or mean pressures from initial method calibration to subsequent readings.