Implantable Heart Sensor

Abstract

An implantable measurement device is disclosed, the implantable measurement device comprising: a first anchoring member that engages a first inner wall defining a first chamber of the heart; a first sensing element that performs a physiological measurement in the first chamber; and a second sensing element that performs a physiological measurement in a second chamber of the heart.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims the benefit of Provisional Application No. 62 / 783,902, filed on December 21, 2018; Provisional Application No. 62 / 783,935, filed on December 21, 2018; Provisional Application No. 62 / 845,386, filed on May 9, 2019; Provisional Application No. 62 / 894,260, filed on August 30, 2019; and Provisional Application No. 62 / 901,105, filed on September 16, 2019, all of which are hereby incorporated by reference in their entirety for all purposes. Technical Field

[0003] This disclosure relates to systems for measuring physiological parameters such as blood pressure, and more particularly, to systems for measuring cardiac physiological parameters. Background Art

[0004] Over the past decade, due to medical and therapeutic advancements, the number of coronary heart disease deaths in the United States has steadily declined, but the number of deaths due to heart failure has relatively increased, indicating that more people than ever are living at high risk of heart failure. Generally, heart failure occurs when the heart cannot supply enough blood to the body. Thus, a lower volume output results in a higher filling pressure in the left heart to help compensate for the insufficient output. A lower volume output also leads to lower organ perfusion, including a reduction in kidney or renal perfusion. Reduced kidney perfusion may result in fluid retention. An acute decompensation episode refers to a period when the fluid level rises and / or the vascular blood distribution drops to a level that causes the patient to experience fatigue and dyspnea (difficult breathing), thus presenting at the hospital. If left untreated, this can lead to serious complications and ultimately death.

[0005] It has been observed that heart failure is mainly caused by left - sided heart problems. In a normal healthy heart, oxygenated blood first passes from the pulmonary veins through the left atrium into the left ventricle, and then into the aorta, after which the blood is transported throughout the body. Thereafter, deoxygenated blood is transported from the two vena cavae into the right atrium, through the right ventricle, and into the pulmonary artery, which then transports the blood to the lungs for oxygenation. The pumping performance of the left ventricle can be affected by thickening / thinning of the left ventricular wall or damage to the aortic valve / mitral valve, resulting in less blood being pumped to other parts of the body.

[0006] There are at least two types of heart failure: HFrEF (heart failure with reduced ejection fraction) and HFpEF (heart failure with preserved ejection fraction). In HFrEF, the left ventricle fills with enough blood, but due to poor myocardial contraction, it cannot pump out enough blood. This is also known as systolic heart failure. In HFpEF, the heart can pump blood out normally, but due to poor myocardial relaxation, the left ventricle fills with less blood, resulting in a smaller blood volume in the ventricle. This is also known as diastolic heart failure. In either case, usually not enough blood is pumped into the body. Less commonly, biventricular failure may occur, where the left heart cannot pump enough blood to the body and the right heart cannot pump enough blood to the lungs.

[0007] Pharmacological treatment is usually used to reduce cardiac stress and prevent acute decompensation episodes. In the remote situation, the specific drugs used are usually determined by trial and error using signs / symptoms (such as weight gain) or by a single intracardiac blood pressure measurement. Currently, the drugs used to reduce cardiac stress and prevent acute decompensation episodes mainly include diuretics and vasodilators (nitrate, hydralazine, angiotensin-converting enzyme inhibitor (aceinhibitor), etc.), while other drugs can be beta-blocker, inotrope, etc. Diuretics mainly target the excessive accumulation of fluid volume (fluid retention) and act by causing the kidneys to release more sodium into the urine. Then the sodium takes water away from the bloodstream, thus reducing the amount of fluid flowing through the blood vessels and ultimately lowering blood pressure. Loop diuretics, which are common in chronic heart failure, are also known to have vasodilatory effects on the venous vascular system, resulting in an increase in venous capacitance. Therefore, diuretics mainly help to reduce the preload of the heart by reducing the blood volume in circulation.

[0008] Vasodilators are drugs that open or dilate blood vessels and can include, among other examples, nitrates, hydralazine, angiotensin-converting enzyme inhibitors, and angiotensin receptor blockers. As a result, blood can flow more easily through the blood vessels (mainly the arterial resistance vessels) and the heart does not need to pump as hard, thus reducing the blood pressure within the heart. For example, nitrates are venous dilators at very low initial doses but mainly affect arterial dilation at moderate to high doses (typical doses in heart failure). Different from diuretics, vasodilator therapy is mainly used to help reduce vascular resistance and the afterload of the heart, thus increasing the stroke volume and cardiac output, and leading to a secondary reduction in the left ventricular preload and venous pressure, thereby reducing the left-sided filling pressure. The role of beta blockers is to slow down the heart's pumping, that is, to reduce the heart rate, and reduce the effort, thus reducing the blood pressure. Cardiac inotropes act to increase the strength of ventricular contraction, thus increasing the heart rate. This drug can be used in severe cases where there is extremely low perfusion and a ventricular assist device (VAD) or cardiac implantation is required.

[0009] Early preventive analysis has been shown to be effective in reducing readmissions due to heart failure. As Figure 1A shown, by monitoring predictive biomarkers and performing appropriate early interventions, the risk of patient readmission is significantly reduced. For example, at an early stage before a possible hospitalization event when the cardiac hemodynamics are stable, an increase in the filling pressure of the heart measured using a measuring device can treat the earliest symptoms. Subsequently, when the heart experiences pre-symptomatic congestion, the intrathoracic impedance changes. Subsequently, other signs (such as a sudden increase in weight, swelling of the feet and ankles, weakness or shortness of breath (dyspnea), and changes in the frequency of urination) indicate that the body is retaining fluid. However, at this time the disease is usually in an advanced stage and is very dangerously close to the decompensation of important organs within the body (including the kidneys in many cases). Therefore, it is best to treat at the earliest indications because when late symptoms develop that appear before the onset of decompensation, it may already be too late because the organs may have suffered permanent damage.

[0010] To understand and treat a patient's heart failure, hospitals perform many acute analyses using various measurement means. These measurement means include non-invasive measurements and invasive measurements, enabling healthcare providers to better understand the patient's disease. Non-invasive measurements include: echocardiogram, which is used to diagnose diseases, monitor blood flow, and visualize physiological changes; weight gain, which determines changes in fluid retention; visual inspection of the jugular vein, which determines the fluid retention status; blood pressure readings, which are used to estimate the body's blood flow; heart rate; electrocardiogram (ECG); and blood oxygen saturation. Invasive measurements include: right heart catheterization and left heart catheterization.

[0011] Right heart catheterization, performed using a pulmonary artery catheter (Swan-Ganz) catheter, can measure central venous pressure, right atrial pressure (RAP), right ventricular diastolic and systolic pressures, pulmonary artery diastolic and systolic pressures, and pulmonary artery wedge pressure (PAWP). In addition, this method can also measure the patient's oxygen status, temperature, and heart rate, as well as calculate cardiac output, systemic vascular resistance, and pulmonary vascular resistance. Right heart catheterization is mainly used to examine the pressure, cardiac output, resistance, and fluid status in the heart. Left heart catheterization can measure left atrial pressure and left ventricular diastolic and systolic pressures. Right heart catheterization can remain in the patient's body for several days while healthcare providers attempt to use medications to lower the patient's intracardiac blood filling pressure back to an acceptable level. In acute situations, this is an effective practice. During the ESCAPE clinical trial, the use of pressure measurements was determined to be a viable method for improving the patient's overall status in acute situations, such as by targeting RAP: s; 8 mm Hg, PAWP: s; 15 mm Hg. However, this is not a sustainable solution and thus does not prevent readmission, as it is assumed that the pressure will change relatively quickly after leaving the hospital. Therefore, right heart catheterization is mainly used to guide treatment to relieve symptoms and pressure in acute situations.

[0012] Current diagnostic methods can be divided into two major situations: acute and remote. Acute situations occur when a hospital evaluates a patient using various methods (invasive or non-invasive). Remote situations correspond to blood pressure readings of a patient obtained remotely outside the hospital.

[0013] In acute situations, right heart catheterization can be used to give information to healthcare providers for selecting appropriate medications. Typically, right heart catheterization is considered helpful in separating the effects of fluid retention and fluid distribution (e.g., by observing PAWP and right atrial pressure). Healthcare providers will look at absolute values and ratios to distinguish between these two issues, especially in left heart failure, so that they know when fluid is being unloaded and then can determine the state of blood distribution. In current practice, acute situations generally allow for a more accurate measurement of the heart's health because pressure readings from different locations within the heart are considered simultaneously. Usually, acute situation measurements are more accurate than remote situation measurements.

[0014] Figure 1B shows an implementation of right heart catheterization. The measuring device 40 is attached to the end of the pulmonary artery catheter 18, which passes through the right atrium 1, the tricuspid valve 7, the right ventricle 2, through the pulmonary valve 58, and into the pulmonary artery 16, where the device 40 measures blood pressure as deoxygenated blood enters the lungs 22. Then, fresh air enters the lungs 22 from the trachea 23, and subsequently oxygenated blood flows through the pulmonary veins 17, the left atrium 3, the mitral valve 6, the left ventricle 4, and the aortic valve 57. The catheter 18 also has a proximal injection port and a thermistor 21, which injects cold saline boluses 20 into the right atrium, and the thermistor 21 is located at the distal end of the catheter to measure the blood temperature in the pulmonary artery 16. This measurement method is called thermodilution, which measures blood flow based on the premise that when cold saline boluses are added to the circulating blood, the blood flow rate is inversely proportional to the rate of change of blood temperature caused by the cold saline boluses over time. This provides a measurement of cardiac output.

[0015] Pulmonary artery wedge pressure and pulmonary artery diastolic pressure are surrogate measurements of left ventricular pressure, which are typical areas of concern in heart failure. Studies have shown that in most cases, pulmonary artery and left ventricular filling pressures are related, except for certain comorbidities such as primary pulmonary hypertension. Such pressures change due to an increase in circulating volume (fluid retention) or a decrease in left ventricular pumping efficiency (e.g., thickening, dilation, or vasoconstriction of peripheral resistance vessels).

[0016] To identify more effective pharmacological treatment procedures, various attempts have been made to remotely monitor cardiac pressure. These systems seek to monitor increases in intracardiac pressure to provide early predictors of impending acute decompensation for patients with a history of heart failure (e.g., as a more reliable indicator than other measurements such as weight gain from fluid injection, thoracic impedance, etc.). For example, Abbott's CardioMEMS TM Heart Failure Monitoring System resides in the pulmonary artery and seeks to effectively monitor pulmonary artery pressure as a surrogate for left atrial pressure.

[0017] Other examples of remote monitoring systems include: Medtronic's and the HeartPOD from Abbott / St. Jude TM . A brief overview of these systems is provided below.

[0018] Utilizing A measurement device resides in the right ventricle and reports an estimated pulmonary artery diastolic pressure (ePAD) to a receiving device. It has been shown that the measurement shows a correlation between right ventricular diastolic pressure, right ventricular systolic pressure, and ePAD, where an increase in all of these pressure readings serves as an indicator of impending hospitalization.

[0019] HeartPOD TM uses a lead-and-can design that delivers the measurement device via transseptal puncture, where the measurement device remains within the atrial septum and measures left atrial pressure.

[0020] Another example includes the Vectorious from Vectorious Medical Technologies TM left atrial pressure (LAP) monitoring system, which uses a pressure sensor to measure blood pressure within the left atrium.

[0021] Over the past few decades, the development of remote systems has focused on finding reliable predictors of impending hospitalization events. Measuring left-sided filling pressures and surrogates has shown some indication as a more predictive form of remote monitoring, although this has not yet translated into a reliable technology for effective patient management. These systems are generally even less effective than acute right heart catheterization, as such systems provide limited data for accurately detecting the root cause. One impact of the limited data is that, whether remotely or acutely, healthcare providers need to utilize trial-and-error medication techniques to treat patients.

[0022] For example, if a healthcare provider believes that elevated blood pressure is due to a fluid retention problem, they may first try a diuretic to lower the monitored blood pressure. If this does not work, they may increase the dose of the diuretic again. If this still does not work, the healthcare provider may conclude that the problem is not fluid retention but rather fluid distribution, and may then try medications such as vasodilators, and ultimately inotropes. In other words, the treatment approach often heavily relies on the personal experience and intuition of the healthcare provider, which not only varies from provider to provider but may also prolong the time required to reliably arrive at the correct diagnosis.

[0023] Overall, there is a continuing need for improved physiological measurements to assist in developing appropriate treatment regimens for patients at risk of heart failure hospitalization. Summary of the Invention

[0024] This disclosure relates to medical devices for performing measurements in the heart, such as implantable measurement devices.

[0025] In Example 1, an implantable measurement device includes: a first anchoring member configured to engage a first inner wall defining a first chamber of the heart; a first sensing element configured to perform a physiological measurement in the first chamber; and a second sensing element configured to perform a physiological measurement in a second chamber of the heart.

[0026] In Example 2, the implantable measurement device of Example 1 further includes a second anchoring member configured to engage a second inner wall defining the second chamber.

[0027] In Example 3, the implantable measurement device of Example 2 further includes an electronics housing member configured to extend between the first anchoring member and the second anchoring member.

[0028] In Example 4, the implantable measurement device of either Example 2 or 3, wherein at least one of the first anchoring member and the second anchoring member is configured to be opened, fenestrated, punctured, traversed, or passed through via an invasive or non-invasive procedure.

[0029] In Example 5, the implantable measurement device of any one of Examples 2-4, wherein the first anchoring member and the second anchoring member are configured to be positioned relatively against the atrial septum of the patient.

[0030] In Example 6, the implantable measurement device of any one of Examples 1-5, wherein the second sensing element is substantially flat against the inner wall.

[0031] In Example 7, the implantable measurement device of any one of Examples 1-6 further includes a membrane configured to cover at least a portion of the second sensing element to facilitate tissue ingrowth.

[0032] In Example 8, the implantable measurement device of any one of Examples 1-6 further includes a membrane configured to cover at least a portion of the second sensing element to prevent tissue ingrowth.

[0033] In Example 9, the implantable measurement device of either Example 7 or 8, wherein the membrane is a separate component from the first anchoring member and the second anchoring member.

[0034] In Example 10, the implantable measurement device of any one of Examples 7-9, wherein the membrane includes at least one feature configured to reduce tensile stress on the second sensing element.

[0035] In Example 11, the implantable measurement device of Example 10, wherein at least one feature comprises a non-inflatable ring, a highly inflatable portion, or both.

[0036] In Example 12, the implantable measurement device of any one of Examples 1-11, wherein a tissue layer is disposed on at least one of the first sensing element and the second sensing element.

[0037] In Example 13, the implantable measurement device of any one of Examples 1-12 further comprises a first remote sensing element, the first remote sensing element being coupled to a first anchoring member by a first sensing tie, the first remote sensing element being configured to perform a physiological measurement at a location remote from the first sensing element.

[0038] In Example 14, the implantable measurement device of Example 13, wherein the first sensing tie is configured to extend from the atrium to the ventricle.

[0039] In Example 15, the implantable measurement device of Example 13 further comprises a second remote sensing element, the second remote sensing element being coupled to a second anchoring member by a second sensing tie, the second remote sensing element being configured to perform a physiological measurement at a location remote from the second sensing element.

[0040] In Example 16, the implantable measurement device of Example 15, wherein each of the first sensing tie and the second sensing tie is configured to extend from the atrium to the ventricle.

[0041] In Example 17, the implantable measurement device of any one of Examples 15 or 16, wherein each of the first sensing tie and the second sensing tie is configured to extend from the atrium to a distal artery or vein.

[0042] In Example 18, the implantable measurement device of any one of Examples 16-17, wherein the first sensing element and the second sensing element are configured to perform measurements at the right atrium and the left atrium, respectively, and the first remote sensing element and the second remote sensing element are configured to perform measurements at the right ventricle and the left ventricle, respectively.

[0043] In Example 19, the implantable measurement device of any one of Examples 1-18 further comprises a memory unit, the memory unit being configured to store data received from at least one of the first sensing element and the second sensing element.

[0044] In Example 20, the implantable measurement device of any one of Examples 3-19, wherein the housing member extends beyond at least one of the first anchoring member and the second anchoring member into at least one of the first chamber and the second chamber of the heart.

[0045] In Example 21, the implantable measurement device of Example 20, wherein the first sensing element is disposed in the first end of the housing member, and the second sensing element is disposed in the second end of the housing member.

[0046] In Example 22, the implantable measurement device of Example 21 further includes an anticoagulant layer disposed on at least a portion of the surface of at least one of the first sensing element and the second sensing element to prevent ingrowth of tissue on at least one of the first sensing element and the second sensing element.

[0047] In Example 23, the implantable measurement device of any one of Examples 2-22, wherein at least one of the first sensing element and the second sensing element is substantially flush with a corresponding first anchoring member or a corresponding second anchoring member.

[0048] In Example 24, the implantable measurement device of any one of Examples 2-23 further includes a biocompatible material layer disposed on at least a portion of the surface of at least one of the first sensing element and the second sensing element and at least one of the first anchoring element and the second anchoring element to promote ingrowth of tissue.

[0049] In Example 25, the implantable measurement device of any one of Examples 2-24, wherein the first sensing element is disposed in the first anchoring member, and the second sensing element is disposed in the second anchoring member.

[0050] In Example 26, the implantable measurement device of Example 25, wherein the first sensing element and the second sensing element are respectively substantially flush with the first anchoring member and the second anchoring member.

[0051] In Example 27, the implantable measurement device of Example 26 further includes: a first biocompatible material layer disposed on at least a portion of the surface of the first sensing element and the first anchoring element to promote ingrowth of tissue; and a second biocompatible material layer disposed on at least a portion of the surface of the second sensing element and the second anchoring element to promote ingrowth of tissue.

[0052] In Example 28, the implantable measurement device of Example 27, wherein the position of the first sensing element and the position of the second sensing element are aligned relative to each other.

[0053] In Example 29, the implantable measurement device of Example 27, wherein the position of the first sensing element and the position of the second sensing element are offset relative to each other.

[0054] In Example 30, the implantable measurement device of any one of Examples 27-29 further includes another layer of biocompatible material, which is disposed between at least one of the first sensing element and the second sensing element and at least one of the first inner wall and the second inner wall to facilitate ingrowth of tissue.

[0055] In Example 31, the implantable measurement device of Example 30 further includes a fourth layer of biocompatible material, which is disposed between the other of the first sensing element and the second sensing element and the other of the first inner wall and the second inner wall to facilitate ingrowth of tissue.

[0056] In Example 32, the implantable measurement device of any one of Examples 1-31 further includes at least one reinforcing strut that connects the electronic device housing to at least one of the first anchoring member and the second anchoring member.

[0057] In Example 33, the implantable measurement device of any one of Examples 3-32, wherein the electronic housing component includes a battery and an antenna, and the antenna is configured to transmit measurement data from the first sensing element and the second sensing element.

[0058] In Example 34, the implantable measurement device of Example 33, wherein the antenna defines the periphery of at least one of the first anchoring member and the second anchoring member.

[0059] In Example 35, the implantable measurement device of any one of Examples 2-34, wherein the electronic device housing component includes an antenna, and the antenna is configured to be wirelessly coupled to an external power source to power the device.

[0060] In Example 36, the implantable measurement device of any one of Examples 33-35, wherein the antenna is configured to transmit measurement data to an external monitoring device.

[0061] In Example 37, the implantable measurement device of any one of Examples 1-36, wherein the first sensing element and the second sensing element are configured to perform pressure measurement.

[0062] In Example 38, the implantable measurement device of any one of Examples 1-37, wherein at least one of the first sensing element and the second sensing element is configured to perform at least one of temperature measurement and blood oxygen saturation measurement.

[0063] In Example 39, the implantable measurement device of any one of Examples 1-37, wherein at least one of the first sensing element and the second sensing element is configured to perform temperature measurement after an air cold pellet is inhaled into the patient's lungs.

[0064] In Example 40, an implantable measurement device according to any one of Examples 22 - 39, wherein the anticoagulant is heparin.

[0065] In Example 41, an implantable measurement device according to any one of Examples 24 - 40, wherein the biocompatible material is expanded polytetrafluoroethylene (ePTFE).

[0066] In Example 42, an implantable measurement device according to any one of Examples 2 - 41, wherein the first anchoring element and the second anchoring element conform to different diaphragm thicknesses.

[0067] In Example 43, an implantable measurement device according to any one of Examples 2 - 42, wherein the first anchoring element and the second anchoring element are made of a fluoropolymer film and nitinol.

[0068] In Example 44, an implantable measurement device according to any one of Examples 2 - 43, wherein the first anchoring element and the second anchoring element are re - traversable.

[0069] In Example 45, an implantable measurement device according to any one of Examples 2 - 44, wherein the first sensing element and the second sensing element respectively extend beyond the first anchoring element and the second anchoring element.

[0070] In Example 46, an implantable measurement device according to any one of Examples 1 - 45 further includes a treatment device.

[0071] In Example 47, the implantable measurement device of Example 46, wherein the treatment device is an occluder.

[0072] In Example 48, the implantable measurement device of Example 46, wherein the treatment device is a shunt.

[0073] In Example 49, an implantable measurement device includes: a first anchoring member configured to engage a first inner wall defining a first chamber of the heart; a second anchoring member configured to engage a second inner wall defining a second chamber of the heart; an electronic device housing member configured to extend between the first anchoring member and the second anchoring member; a first sensing element wirelessly coupled to the electronic device housing member and configured to perform a physiological measurement in the first chamber; and a second sensing element wirelessly coupled to the electronic device housing member and configured to perform a physiological measurement in the second chamber.

[0074] In Example 50, the implantable measurement device of Example 49, wherein the first sensing element and the second sensing element are piezoelectric capacitive sensors.

[0075] In Example 51, a method of using an implantable measurement device of any of the foregoing examples to monitor heart failure in a patient's body, the method comprising: receiving first measurement data based on a first set of physiological measurements performed in the right side of the patient's heart, wherein the first measurement data is transmitted from the implant measurement device; and receiving second measurement data based on a second set of physiological measurements performed in the left side of the patient's heart, wherein the second measurement data is transmitted from the implant measurement system.

[0076] In Example 52, the method of Example 51 further comprises: determining whether to modify a drug treatment regimen based on the received first measurement data and the received second measurement data.

[0077] In Example 53, the method of any of Examples 51 or 52 further comprises: displaying instructions regarding which drug to administer and its dosage based on a determination of trends in the first set of physiological measurements and the second set of physiological measurements.

[0078] In Example 54, the method of any of Examples 51-53 further comprises: setting a baseline level for the patient prior to receiving the measurement data.

[0079] In Example 55, the method of Example 54 further comprises: determining whether the first set of physiological measurements and the second set of physiological measurements exceed the baseline level in response to administering a drug according to the instructions; and displaying a second instruction to bring the patient in for a possible diagnosis of heart failure in response to determining that the first set of physiological measurements and the second set of physiological measurements exceed the baseline level.

[0080] In Example 56, a method of performing measurements in a heart, comprising: approaching the heart wall of a patient; using a first anchoring member to abut an implantable measurement device against the heart wall of the patient such that a first sensing element of the implantable measurement device is located in the right atrium of the patient; positioning a second sensing element of the implantable measurement device in the left atrium of the patient; and performing physiological measurements in the first atrium and the second atrium of the heart using the first sensing element and the second sensing element.

[0081] In Example 57, the method of Example 56, wherein the method comprises extending the implantable measurement device across the atrial septum, and the heart wall of the patient is the atrial septum.

[0082] In Example 58, the method of any of Examples 56 or 57 further comprises storing data corresponding to the physiological measurements.

[0083] In Example 59, the method of any of Examples 56-58 further comprises transmitting data corresponding to the physiological measurements outside the patient's body through the implantable measurement device.

[0084] In Example 60, the method of any of Examples 56-59, wherein the physiological measurement comprises a blood pressure measurement.

[0085] In Example 61, the method of any one of Examples 56 - 60 further comprises: inhaling cold air pills into the patient's lungs, and performing a blood temperature measurement using an implantable measurement device.

[0086] In Example 62, a cardiac measurement system comprises: an implantable measurement device including: a first sensing element configured to be implanted through a needle to engage a first internal location in the inner wall of the heart to perform a physiological measurement therein, and a first tether coupled to the first sensing element; and a remote receiver configured to receive physiological measurement data from at least one of the first sensing element and a second sensing element.

[0087] In Example 63, for the cardiac measurement system of Example 62, the implantable measurement device further comprises: a second sensing element configured to be implanted through a needle to engage a second internal location in the inner wall of the heart to perform a physiological measurement therein, and a second tether coupled to the second sensing element.

[0088] In Example 64, the cardiac measurement system of Example 63 further comprises: a subcutaneous implant device coupled to at least one of the first tether and the second tether, the subcutaneous implant device being configured to receive physiological measurement data from at least one of the first sensing element and the second sensing element, and wirelessly transmit the received physiological measurement data to the remote receiver.

[0089] In Example 65, the cardiac measurement system of Example 62 or 64 further comprises: a first gauze configured to engage a first external location on the outer wall of the heart adjacent to the first internal location; and a second gauze configured to engage a second external location on the outer wall of the heart adjacent to the second internal location.

[0090] In Example 66, the cardiac measurement system of Example 65 further comprises: a first plug configured to engage a first fenestration formed by the needle between the first sensing element and the first gauze; and a second plug configured to engage a second fenestration formed by the needle between the second sensing element and the second gauze.

[0091] In Example 67, for the cardiac measurement system of any one of Examples 62 - 66, wherein the physiological measurement comprises a blood pressure measurement.

[0092] The above examples are limited to this and should not be construed as limiting or otherwise narrowing the scope of any inventive concept otherwise provided by the present invention. While multiple examples are disclosed, those skilled in the art will clearly see other embodiments from the following detailed description, which illustrate and describe exemplary examples. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0093] The drawings are included to provide a further understanding of the present disclosure and are incorporated into and constitute a part of this specification, illustrate embodiments, and together with the description are used to explain the principles of the present disclosure.

[0094] Figure 1A is a useful graph showing data of alternative measurements from left atrial pressure in reducing readmissions due to heart failure;

[0095] FIG. 1B is a schematic diagram of the heart and lungs of a patient using a prior art measurement device (pulmonary artery catheter right heart catheter) as discussed herein;

[0096] Figure 2 is a cross-sectional view of a heart using a measurement device according to some embodiments;

[0097] Figure 3 is a cross-sectional view of a heart using a measurement device according to some embodiments;

[0098] Figure 4 is a cross-sectional view of the commissure of the tricuspid valve;

[0099] Figure 5 is a cross-sectional view of the commissure of the mitral valve;

[0100] Figure 6 is a schematic diagram of the heart and lungs of a patient using a measurement device according to some embodiments;

[0101] Figure 7 is a schematic diagram of the heart and lungs of a patient using another measurement device according to some embodiments;

[0102] Figure 8 is a close-up view of a measurement device according to some embodiments;

[0103] Figure 9 is at Figure 8 a cross-sectional view of the contents of the right atrial electronics in the measurement device;

[0104] Figure 10 is at Figure 8 a cross-sectional view of the contents of the left atrial electronics in the measurement device;

[0105] Figure 11 A close-up view of a measurement device according to some embodiments;

[0106] Figure 12 is in Figure 11 Cross-sectional views of two examples of the contents of the right atrial electronics in the measurement device;

[0107] Figure 13 is in Figure 11 Cross-sectional view of the contents of the left atrial electronics in the measurement device;

[0108] Figure 14 A cross-sectional view of a heart using a measurement device according to some embodiments, wherein a portion of the measurement device is punctured by a septal puncture needle;

[0109] Figure 15 is the punctured Figure 14 Close-up view of the measurement device;

[0110] Figure 16 A close-up view of using another measurement device according to some embodiments, wherein a portion of the measurement device is punctured by a septal puncture needle;

[0111] Figure 17 A close-up view of a grid configuration used in a measurement device according to some embodiments;

[0112] Figure 18 A schematic diagram of a wearable strap of an external reader device for a measurement device according to some embodiments;

[0113] Figure 19 A schematic diagram of a syringe or catheter having a needle containing a sensor tethered to a wire according to some embodiments;

[0114] Figure 20 A schematic diagram of a sensor connected to a subcutaneous implant according to some embodiments;

[0115] Figure 21 A cross-sectional view of a heart with an implanted sensor fixed using a small swab according to some embodiments;

[0116] Figure 22 Shows an example of the position of a subcutaneous implant within a patient's body according to some embodiments;

[0117] Figure 23 Shows a block diagram of a method for determining an action to be taken based on pressure measurements according to some embodiments;

[0118] Figure 24 Shows the use of Figure 23 A drug administration reference table for two sets of measurement data implemented by the method in;

[0119] Figure 25 is a cross-sectional view of a measuring device according to some embodiments;

[0120] Figure 26 is a cross-sectional view of a measuring device according to some embodiments;

[0121] Figure 27 is a cross-sectional view of a measuring device according to some embodiments;

[0122] Figure 28 is a cross-sectional view of a measuring device according to some embodiments;

[0123] Figure 29 is a cross-sectional view of a measuring device according to some embodiments;

[0124] Figure 30 is a cross-sectional view of a measuring device according to some embodiments;

[0125] Figure 31 is a side view of a measuring device according to some embodiments;

[0126] Figure 32 is Figure 31 a cross-sectional view of the measuring device;

[0127] Figure 33 is according to some embodiments Figure 31 a side view of the sensing element; and

[0128] Figure 34 is a schematic view of an electronic device housing component according to some embodiments. DETAILED DESCRIPTION

[0129] Definitions and Terms

[0130] This disclosure is not meant to be read in a limiting sense. For example, terms used in the application should be read broadly in the context of the meaning that a person in the art would ascribe to such terms as attributes.

[0131] Since the terms "about" and "approximate" as used herein with respect to a measurement range may be used interchangeably to refer to a measurement result that includes the stated measurement result and also includes any measurement result that is reasonably close to the stated measurement result but may differ by a reasonably small amount (such as may be caused by measurement error, differences in measurement and / or manufacturing equipment calibration, human error in reading and / or setting measurements, adjustments made to optimize performance and / or structural parameters in view of measurement differences associated with other components, particular implementation scenarios, imprecise tuning, and / or manipulation of objects by people or machines).

[0132] Certain terms are used in this document for convenience only. For example, words such as "top", "bottom", "upper", "lower", "left", "right", "horizontal", "vertical", "upwardly", and "downwardly" merely describe the orientation of the configurations or parts shown in the figures in the installed position. In fact, the components referred to can be oriented in any direction. Similarly, throughout this disclosure, where a process or method is shown or described, the method can be performed in any order or simultaneously, unless the context clearly indicates that the method depends on certain actions being performed first.

[0133] Description of Various Embodiments

[0134] Various embodiments relate to implantable medical devices, such as devices for performing physiological measurements on the left and right sides of the heart. In certain instances, aspects of the present disclosure relate to methods and devices for performing pressure measurements. Additionally, the present disclosure also includes a medical system for determining the administration of a drug to a patient based on the measurements performed.

[0135] Various examples relate to systems and methods for directly performing left atrial and / or left ventricular measurements (e.g., blood pressure). The left side of the heart receives oxygenated blood from the lungs and distributes it to other parts of the body, while the right side of the heart transports deoxygenated blood from the body to the lungs. Various examples relate to sensor designs that avoid clots (emboli) and other undesirable side effects of placing sensors in the heart. When a foreign object, such as a sensor, is implanted within the heart, a blood clot may form on the surface of the implanted foreign object, and the blood clot may break off and form an embolus. The damage caused by an embolus depends on its location. If the implanted foreign object is located on the right side of the heart, the embolus may migrate to the lungs, but if the implanted foreign object is located on the left side, the associated embolus may migrate to any part of the body, including the arteries leading to the brain, resulting in an atherosclerotic thrombotic stroke. In addition to effectively remotely setting left-sided measurements, various examples also relate to measuring the in vivo condition of two different parts of the heart (e.g., rather than just measuring a single region).

[0136] Figure 2 An embodiment of a measurement device 41 according to the present disclosure is shown. The measurement device has a right-side sensing element 10 and a left-side sensing element 11, both of which sense and measure the pressure level within the respective side in which they are integrated. For example, in this example, the right-side sensing element 10 measures the pressure level in the right atrium 1 of the patient's heart, while the left-side sensing element 11 measures the pressure level in the left atrium 3 of the patient's heart. The pressure sensing elements 10, 11 can incorporate MEMS technology, such as but not limited to piezocapacitive or piezoresistive MEMS sensors or other pressure measurement devices as appropriate, to measure the intracardiac pressure level.

[0137] As shown, the measurement device 41 has a right anchoring disk 8 and a left anchoring disk 9 that work together to help hold the measurement device 41 in place. As shown, the two disks 8, 9 are designed to sandwich the atrial septum 5 between the two atria 1, 3 (e.g., actively engage or contact each side in an opposing manner). Placement of the measurement device 41 can be achieved using a catheter procedure and septal puncture. The sensing elements 10, 11 can be used with various devices anchored to and extending through the atrial septum. Suitable examples can be found in various patent disclosures of the applicant, including US9949728 “Septal closure device with centering mechanism”; US20170042705 “Implantable Product with Improved Aqueous Interface Characteristics and Method for Making and Using the Same”; US9861346 “Patent foramen ovale (PFO) closure device with linearly elongating petals”; US9636094 “Sealing device and delivery system”; and US20170105711 “Sealing device and delivery system”.

[0138] In Figure 2 an example, since the anchoring disks 8, 9 act as occluders, the measurement device 41 does not leave a hole after surgery. The measurement device 41 can be configured to promote tissue ingrowth (e.g., into the anchoring disks 8, 9) for any of a variety of reasons, including better tissue integration, reduced erosion, reduced thrombus formation, or other beneficial characteristics. Reduction of thrombus formation may be particularly important on the left side of the heart. In some configurations, the measurement device 41 is configured such that the left sensing element 11 has a relatively low profile (e.g., the profile is relatively flat). The relatively low profile can help reduce the likelihood of thrombus formation. In some examples, while still allowing the left sensing element 11 to function properly, some degree of tissue overgrowth on the sensor can also be allowed. For example, if necessary, the pressure on the left side (e.g., the left atrium) can be read through a relatively thin layer of tissue.

[0139] Figure 3 shows another embodiment of the measurement device 42 according to the present disclosure. In addition to Figure 2 the shown anchoring discs 8, 9 and sensing elements 10, 11, there are also sensing laces 12, 14 that extend into the respective ventricles. Specifically, the right ventricle sensing lace 12 extends from the right side of the measurement device 42 (e.g., from the right sensing element 10) into the right ventricle. A remote right ventricle sensing element 13 can be attached to the right ventricle wall (e.g., using soft tissue anchors and / or tissue ingrowth features). The remote right ventricle sensing element 13 is configured to measure the pressure in the right ventricle. The remote sensing element includes a MEMs sensor, such as a piezoelectric capacitive embodiment or a piezoresistive embodiment, but does not necessarily include associated electronics, but rather has leads that provide a direct signal transmission back to the electronics housing.

[0140] Similarly, the left ventricle sensing lace 14 extends from the left side of the measurement device 42 (e.g., from the left sensing element 11) into the left ventricle. A remote left ventricle sensing element 15 can be attached to the left ventricle wall (e.g., using soft tissue anchors and / or tissue ingrowth features). The remote left ventricle sensing element 15 is configured to measure the pressure in the left ventricle.

[0141] The remote sensing elements 13, 15 (rather than the measurement elements 10, 11) are configured to measure the pressure in different parts of the heart. At least in this way, the measurement device 42 is configured to provide additional measurement data for analysis (e.g., left and right ventricle pressure data). The sensing laces 12, 14 can be arranged or otherwise positioned to extend through the commissures of the valves residing between the right atrium and right ventricle (tricuspid valve) and between the left atrium and left ventricle (mitral valve). Figure 4 and Figure 5 shows alternative positions of the sensing laces 12, 14, which include positions near the commissure 59 located between the leaflets of the tricuspid valve 7 ( Figure 4 ) or the leaflets of the mitral valve leaflet 6 ( Figure 5 ) through which the sensing laces 12, 14 extend to reach their respective ventricles. In various examples, by positioning the laces 12, 14 near the commissure 59, the impact of the laces on valve function and the risk of thrombus formation can be reduced.

[0142] In one example, additional sensors can be incorporated into sensing tethers 12, 14. In another example, the additional sensors can be implemented as other elements of the measurement device 42 at the tether attachment points to measure the forces on the tethers 12, 14, i.e., the tensile stress. The forces on the tethers 12, 14 can be used as an indication of the local blood flow velocity within the heart, and this measurement data can be used alone or in combination with other measurement parameters to evaluate the patient's cardiac function. Advantages of measuring such forces on the tethers 12, 14 include the ability to obtain data that serves as an indicator related to cardiac function, such as mitral inflow velocity, tricuspid blood flow, and the severity of possible regurgitation. For example, this data may be difficult to detect using other measurement means. To effectively measure such forces, in this example, the tethers 12, 14 and the remote sensing elements 13, 15 are at least partially free-floating (i.e., not attached to the atrial wall or ventricular wall). In addition to or as an alternative to measuring pressure and / or force, various sensing elements can be configured to measure temperature (e.g., by including one or more thermistor elements). By including temperature sensing capabilities, a cold bolus (e.g., a fluid) can be introduced into the cardiac system, and the rate of temperature equilibration can be used to determine the cardiac output at various locations within the heart. Different from the method of using a cold fluid bolus, various examples include using a cold air bolus in the lungs to measure the rate of temperature equilibration of the blood returning from the lungs.

[0143] Figure 6 Shows how cardiac output is affected by thermal dilution using a cold air bolus and thus how cardiac output can be measured via thermal dilution using a cold air bolus and a left atrial sensor or thermistor 21. Initially, a cold air bolus 24 is injected into the lungs 22 (e.g., by introducing the cold air bolus into the lungs by inhalation through the patient's trachea 23). Then, heat exchange 25 occurs when the warmer hypoxic blood 26 enters the lungs through the pulmonary artery 16 and is then cooled by the cold air bolus 24 during oxygenation. After that, the cooler oxygenated blood 27 leaves the lungs and enters the left atrium 3 through the pulmonary vein 17, and the temperature in the left atrium 3 is measured at the left atrium 3 using the thermistor 21 fixed with the left anchor disk 9. If there is more blood flow, the temperature within the left atrium 3 will return to normal temperature faster than when there is less blood flow. Thus, in this case, the inhalation of cold air can be used to determine the initial drop in the blood temperature in the left atrium 3, which is used to correlate the time for the temperature to return to normal. The rate at which the temperature returns to normal is related to the cardiac output.

[0144] As a further additional or alternative feature, one or more 02 sensors can be included at one or more of the sensing elements of the first pair of sensing elements 10, 11 and the remote second pair of sensing elements 13, 15. Figure 7A diagram showing the blood flow from the right side of the heart through the lungs to the left side is presented and can be used to describe how cardiac output is measured via 02 blood saturation sensors 28, 29 (e.g., using Fick's Law). According to various examples, the right 02 saturation sensor 28 is placed in the right atrium 1 (e.g., associated with a sensing element 10 fixed using a right anchoring disk 8), and the left 02 saturation sensor 29 is placed in the left atrium 3 (e.g., associated with a sensing element 11 fixed using a left anchoring disk 9) to measure the Sv02 and Sa02 levels in their respective measurement regions.

[0145] Fick's Law states that a marker substance can be used to calculate the blood flow to a patient's heart, and in this case, this marker substance is oxygen (02). The necessary data for such calculations includes the oxygen uptake by the heart per unit time, the 02 blood saturation in the pulmonary artery, and the 02 blood saturation in the pulmonary vein. In this case, the 02 blood saturation of the pulmonary artery 16 is measured at the right atrium 1, and the 02 blood saturation of the pulmonary vein 17 is measured at the left atrium 3. Other data for the calculation can include the maximum oxygen uptake (V02 max) and a hemoglobin test. The maximum oxygen uptake is the maximum rate of oxygen consumption measured during incremental exercise, and the hemoglobin test combined with the arterial percentage and venous percentage will determine the oxygen concentration.

[0146] As explained above, different sensors (e.g., pressure, flow, temperature, and / or 02) can be implemented in the embodiments disclosed herein, where each measurement provides important data regarding the patient's cardiac health. The sensors themselves can have various shapes and sizes that are considered suitable by those of ordinary skill in the art for implementation within the patient's heart.

[0147] Figures 8 - 10 Additional details of a possible sensor element configuration are shown. As Figure 8 shown, the measuring device 43 has a right atrium sensing element 30 included in the right atrium electronics 37 and a left atrium sensing element 31 included in the left atrium electronics 38. As Figure 8 shown, the electronics 37, 38 are attached to their respective anchoring disks 8, 9. Figure 9 Shown is that both the electronics 37, 38 include a control module 33 (e.g., a printed circuit board), which is located in the proximal portion 34 of the housing 36 relative to the anchoring disks 8, 9. The housing 36 can be made of titanium, stainless steel, or other suitable materials. The right atrium electronics 37 further includes a right atrium sensing element 30 and an antenna coil 35. The left atrium electronics 38 further includes a left atrium sensing element 31 and a power source 32 (e.g., a battery and / or a wireless power source). In this configuration, an external reader device (such as Figure 18The external charger and communication relay 70) in it charges the power supply 32 and communicates with the electronic devices 37, 38 to obtain the measurement data stored in the memory implemented in the control module 33.

[0148] The control modules 33 can be designed such that they are configured to perform a series of steps for making measurements (whether it is blood pressure, temperature, and / or blood oxygen saturation) within different parts of the heart (e.g., each chamber in the cavities), and storing the data until the external reader device can access (usually wirelessly access) the data. In addition, the power supply 32 can be any suitable power supply that can be used in this embodiment. For example, the power supply can be coupled to a charging coil that implements inductive charging of the power supply, such that the external reader device can remotely charge the power supply from outside the patient's body, which reduces the need to replace the power supply when it runs out. For example, in addition to performing the relay / communication function, the antenna coil 35 can also be used as a charging coil.

[0149] Figures 11 - 13 Shows various configurations that can be used in various examples. As shown, the left atrial electronics 38 of the measurement device 44 only includes the left atrial sensing element 31 (e.g., sensing, temperature, and / or O2). Minimizing the number of components / elements on the left side of the device can help minimize the overall size of the device and the number of foreign objects in the associated left atrium. As described above, this can reduce the likelihood of thrombosis and foreign body reaction. Thus, in various examples (e.g., as shown in the illustration view of configuration 398), the right atrial electronics 37 includes a power supply 32 that powers the sensing element 31, any associated data storage elements, and more generally the control module 33. In Figure 12 In another example, as shown in the illustration view of configuration 39A, the right atrial electronics 37 does not include an on-board power supply. In such embodiments, measurement data can only be obtained when the external reader device is turned on to power the measurement device 44 (e.g., using an inductive power supply to activate the sensing elements 30, 31, and the control module 33).

[0150] In various examples, one or more of the measurement devices 41, 42, 43, 44 (e.g., one or both of the anchoring disks 8, 9) are configured to be fenestrated or penetrated by a surgical instrument (e.g., a septal puncture needle) after implantation. Figure 14 and Figure 15 Shows a puncture needle 51 attached to the end of the catheter sheath 50 on the surface of the penetrating anchoring disks 8, 9 to indicate that the measurement device 45 can be penetrated again (e.g., can be penetrated by the needle and then by the sheath).

[0151] During certain procedures or operations, it may be necessary to access the left atrium 3, even if the measurement device 45 has been implemented in the atrial septum 5 between the atria 1, 3. In such cases, the measurement device 45 is configured to have a re-crossable surface in the anchor discs 8, 9 such that a puncture needle 51 can penetrate these surfaces to perform the procedure. Figure 14 The needle 51 and catheter sheath 50 are shown entering the right atrium 1 from the inferior vena cava 53, but in some instances, access to the right atrium 1 can be made from the superior vena cava 52 as needed. In this embodiment, the surfaces of the anchor discs 8, 9 include a material that can be safely penetrated, such as an expanded polytetrafluoroethylene (ePTFE) membrane 54, although other suitable materials can be implemented to provide the re-crossability. The outer edge of the anchor disc 9 is defined by a nitinol frame 55 that also radially extends from the left sensing element 11 to the outer edge, although other suitable materials can also be used for the frame. The needle 51 forms a puncture hole 56 in the membrane 54 to allow the catheter sheath 50 to pass through.

[0152] Figure 16 Another embodiment disclosed herein is shown, where the left sensing element 60 of the measurement device 46 is located on a portion of the left anchor disc 9. For example, the left sensing element 60 can be located on the membrane material (e.g., ePTFE membrane 54) of the left anchor disc 9, opposite the frame (e.g., central eyelet or outer frame) of the left anchor disc 9. In this embodiment, the left sensing element 60 is coupled to the membrane 54 to help prevent the sensing element 60 from protruding outwardly from the septal wall, or to reduce the amount of protrusion of the left sensing element 60 of the measurement device 46 from the septal wall. In this embodiment, an antenna coil 61 is implemented in the anchor disc 9. As shown, the sensing element 60 is attached to the antenna coil 61, and the antenna coil 61 is wound around the ePTFE membrane 54 to form the outer edge of the left anchor disc 9, thereby defining the periphery of the left anchor disc 9. Additional embodiments can further reduce the amount of protrusion of the left sensing element 60 from the septal wall. For example, in one embodiment, the left anchor disc 9 can be replaced with a small tissue anchoring structure that helps to align the outer surface of the left sensing element 60 to be substantially flush with the surface of the surrounding septal wall, such that the sensing element 60 does not protrude significantly from the septal wall. For example, small hooks or other suitable structures can be implemented to hold the left sensing element 60 in place. In another embodiment, a cover or other similar component can be employed above the left sensing element 60 to prevent the sensing element from substantially protruding into the left atrium. The cover can be made of a chemically inert material (such as low temperature isotropic (LTI) carbon and diamond-like carbon (DLC)) or made of a polymer (such as polytetrafluoroethylene (PTFE), expanded PTFE, or polyethylene terephthalate (PET)). In some examples, the cover can be a thin film placed above the left sensing element 60 to promote in-growth of tissue on the sensing element.

[0153] Figure 17 Another possible configuration of the medical device 46 is shown, where the left anchor disk 62 uses a frame (e.g., Nitinol) having a mesh design configured to define the left disk(s) and / or the right disk(s). Figure 17 The configuration may or may not employ a cover or membrane 54 (e.g., ePTFE). The design is re-crossable such that a catheter having a French gauge suitable for being mounted between the frame elements (e.g., up to 24Fr) can pass through the anchor disk without disturbing the electronics. Additionally, it should be understood that although the anchor disks shown in the figures are relatively flat and circular in structure, any of the anchor disk configurations described herein may also use other shapes (e.g., rectangular, triangular, etc.). Further, the anchor disk may be configured with a curved side profile (e.g., concave and / or convex) to accommodate different profiles of the surface within the heart to which the anchor disk will engage.

[0154] In one embodiment, the measurement devices 45, 46 can also be used as treatment devices, such as an intra-atrial shunt, a controllable intra-atrial shunt, an atrial septal defect (ADS) occluder, etc. The measurement devices 45, 46 can act as a controllable shunt because they are located at the interatrial septum between the left atrium and the right atrium, and the membrane 54 can be opened via an invasive procedure or a non-invasive procedure. Thus, the membrane 54 can be expanded, contracted, opened, closed, fenestrated, sealed, punctured, resealed, traversed, or pierced using appropriate tools during different procedures to actuated the controllable shunt. As described above, creating a puncture hole 56 in the membrane 54 using a needle is an example of an invasive procedure. Other invasive procedures include mechanical, thermal, laser, ultrasonic, and inductive methods. On the other hand, the opening of the hole can be triggered via wireless, extracorporeal excitation (including inductive energy transfer and ultrasonic energy transfer). In one embodiment, after the membrane 54 is exposed to thermal energy or ultrasonic energy (i.e., via thermal activation), the membrane 54 can be melted to form an opening. Advantages of having an opening in the membrane 54 include reducing the left atrial pressure when the left atrial pressure rises to a life-threatening level when the measurement devices 45, 46 are located between the left atrium and the right atrium. One advantage of this configuration is that the measurement devices 45, 46 can continue to make measurements in both atria even after the opening is formed. The size of the shunt can be adjusted based on the desired degree of pressure reduction. For example, if the pressure is significantly higher than the normal level such that the pressure must be immediately reduced, the shunt can be opened wider. Embolism can also be prevented when the shunt is opened via mechanical puncture or thermal ablation. Additionally, pressure-sensitive valves can be implemented in the measurement devices 45, 46 such that the membrane 54 opens to form a shunt above a threshold pressure level. In another example, the valve can also track and transmit its state (i.e., whether the shunt is open or closed in the valve, and the degree of opening in the shunt), which can be used as an indication of the intracardiac pressure difference. Thus, a remote monitoring system (e.g., Figure 18 the remote device 72 in

[0155] Figure 18An example of an external charging and communication relay according to some examples is shown. As shown, the external charger and communication relay 70 is a device that can charge or supply power to the power source of the measurement device (e.g., the battery 32 in the measurement devices 43, 44) via electromagnetic induction, and communicate with the measurement device 43 or 44 to obtain measurement data. In one example, the external charger communication relay 70 is a device that is inductively coupled to the measurement devices 43, 44 to directly supply power to the measurement devices 43, 44, thus eliminating the need for an on-board power source, such as a battery implemented within the measurement devices 43, 44. In one example, the external charger communication relay 70 wirelessly powers the wireless devices 43, 44 via radio frequency (RF) electromagnetic radiation. The external charger and communication relay 70 can be worn (e.g., using the strap 71) such that the position of the charger and relay 70 is at an operable position of the charger and relay 70 to charge the measurement device and obtain data from the measurement device. A monitoring system 72, which can be a smart device such as a smartphone, can be used by a patient or other party (e.g., a healthcare provider or a remote monitoring facility) to receive information about the measurement data via an application software in the monitoring system. For example, the remote device 72 can visually display blood pressure, temperature, and / or blood oxygen saturation in a simple and user-friendly interface. If the patient has impaired vision or prefers an audio notification, the remote device 72 can provide an audio output to alert the patient if the sensor measurements indicate that the patient's heart may be at risk of an acute decompensation episode, so that the patient can go to the hospital for further examination. The remote device 72 can also upload the measurement data to a server (not shown) for collection by a healthcare provider or a database to remotely monitor the patient's heart condition.

[0156] Based at least on the above, it should be understood that various sensor positions are envisioned and can be implemented in any combination.

[0157] For example, to measure left ventricular pressure, the tethered sensor can be sent from the left anchor disk between the mitral valve leaflets and then into the left ventricle, where tissue ingrowth can implant the sensor in the wall of the left ventricle. The sensor directly measures the left ventricular systolic and diastolic pressures and can also give a direct indication of the systolic systemic blood pressure.

[0158] To measure aortic pressure, the tethered sensor can be sent from the left anchor disk between the mitral valve leaflets, through the aortic valve, and into the aorta, where the sensor is fixed to the wall of the aorta. This placement allows for the direct measurement of aortic pressure, thus giving a direct indication of the systolic and diastolic pressures.

[0159] To measure right ventricular pressure, a tethered sensor can be sent from the right anchor disc between the tricuspid valve leaflets and then into the right ventricle where tissue ingrowth can embed the sensor in the wall of the right ventricle. The sensor directly measures right ventricular pressure, thereby giving a direct indication of right ventricular systolic pressure and right ventricular diastolic pressure.

[0160] To measure pulmonary artery pressure, a tethered sensor can be sent from the right anchor disc between the tricuspid valve leaflets, through the pulmonary valve, and into the pulmonary artery where it is secured. This placement allows for direct measurement of pulmonary artery pressure, thereby giving a direct indication of lung status via pulmonary systolic pressure and pulmonary diastolic pressure.

[0161] In addition, implantable devices for measuring left atrial and right atrial pressure can be used in combination with other medical devices. Examples of such medical devices include, but are not limited to, blood pressure cuffs, pulse oximeters, scales, creatinine test devices, smart devices, and wearable medical tracking devices, among others. The measurement device 41 can also be combined with other implantable devices such as ventricular assist devices (VADs), drug delivery shunts or systems, or other devices. The measurement device 41 can provide feedback to (one or more) other implantable devices as part of a closed-loop or open-loop feedback system.

[0162] Figures 19 to 22 Examples of additional sensor elements and associated delivery systems and methods are shown. As shown, the left sensing element 11 can be coupled to a tether 80, where the sensing element 11 and the tether 80 are configured to be delivered by the Figure 19 needle delivery system 81 schematically shown therein. Generally, the delivery system 81 can include a catheter and an associated delivery needle 82 located at the distal end of the catheter for accessing a target area within the body (e.g., via ultrasound, radiography, optical, or other guidance). For example, the needle can be used to puncture the wall of the heart (e.g., the left atrial wall), and the left sensing element 11 can be advanced through the needle 82 into the target space (e.g., the left atrium). The needle 82 can then be retracted, and the sensing element 11 can be pulled taut or tensioned against the inner wall of the heart (e.g., the inner wall defining the left atrium). A gauze or other anchor 84 (e.g., above the tether 80) can be advanced to a position on the opposite side of the heart wall from the sensing element 11 (e.g., a position on the outer wall of the heart near the position of the sensing element 11) to help secure the sensing element 11 in place (e.g., as Figure 21 shown). As Figure 20 shown, the tether 80 can be connected to a subcutaneous implant 83 that processes power, signal processing, and data transmission functions.

[0163] The subcutaneous implant 83 may include a battery, an antenna, and a control module (e.g., a microchip) to facilitate control of data collection and communication functions. In one example, the measuring device 47 may include a plug 85 placed between the sensing element 11 and the gauze 84 to help fill the aperture left by the needle 82.

[0164] Figure 22 The subcutaneous implant 83 is shown at the other end of the tie 80 opposite the sensing element 11. A plurality of sensor elements similar to the left sensing element 11 may be placed at any different location of the heart that the healthcare provider deems appropriate. For example, after placing the left sensing element 11 in the left atrium, another sensing element (such as the right sensing element 10) may be implemented in the right atrium using the same technique for placing the sensing element 11 in the left atrium. Another similar sensing element may be implanted in the left ventricle, right ventricle, or any other location in the heart or vasculature as needed. Thus, any number of sensor elements may be implemented by penetrating the wall of the heart to make measurements (pressure, temperature, and / or blood oxygen saturation) in any one of the chambers of the heart or associated vasculature.

[0165] The (multiple) ties associated with the sensor elements may be coupled to the same subcutaneous implant or different subcutaneous implants as needed. Whether a single subcutaneous implant or different subcutaneous implants with data receiving and communication capabilities, it should be understood that any combination of measurements at any combination of locations (e.g., left atrium, right atrium, left ventricle, and / or right ventricle) may be used in combination with Figures 19 to 22 the tie sensor elements described.

[0166] The pressure measurement data obtained using the sensing elements 10, 11, 13, 15 described herein may be used to perform pulse contour analysis, which is another method for measuring a patient's cardiac output. This method uses continuous pressure measurement data to plot a pressure-versus-time graph of the patient's heart, and then uses pressure integration (i.e., the area under the plotted line on the pressure-versus-time graph) to determine the stroke volume (SV) of the portion of the heart being measured. The value of SV multiplied by the heart rate is the cardiac output.

[0167] Figure 23 is a flowchart showing a telemedicine monitoring method 99 that may be implemented using one or more electronic devices (such as the monitoring system 72) using measurement data received from, for example, the measuring device 41 or any one of the sensor elements described herein. In some examples, the method 99 is used for patients with a history of left heart failure to determine a treatment regimen guided by measured right and left heart physiological parameters (e.g., pressure, temperature, and / or blood oxygen saturation).

[0168] In any case, in some embodiments, in an optional first step 90, the service provider determines whether the patient receiving treatment has a history of left heart (LH) or right heart (RH) / biventricular failure. Method 99 can be used for patients at risk of LH or RH / biventricular failure as determined by a healthcare provider, regardless of history. In an optional step 91, the healthcare provider sets a baseline "normal" level for applicable physiological metrics (e.g., left atrial pressure and right atrial pressure) in an acute situation by performing various tests on the patient to determine how normal levels (pressure, cardiac output, and / or oxygen saturation) should be based on the patient's current condition. The baseline values can then be input into the system, which transmits the data to the monitoring system 72. In the example shown in this figure, the pressures being measured are left atrial pressure (LAP) and right atrial pressure (RAP). Other embodiments can include other measurements of other parts of the heart that the healthcare provider deems appropriate.

[0169] In some examples, in step 92, the monitoring system 72 receives RAP and LAP measurements from sensors such as the right sensing element 10 and the left sensing element 11. In one implementation, the measurements include whether the pressure values in the right and left atria tend to be lower than, equal to, or higher than the normal level. In another example, the method can also consider whether the pressure values are increasing, decreasing, or remaining stable as additional inputs for the overall assessment.

[0170] In an optional step 93, the monitoring system 72 confirms whether the patient has a history of LH or RH / biventricular failure. In step 94, the monitoring system 72 optionally uses Figure 24 the drug administration reference table 100 in to determine and indicate whether the dose of certain drugs needs to be increased or decreased. Alternatively, the healthcare provider (e.g., a physician) optionally directly uses the data to evaluate what treatment regimen (e.g., pharmacology) is appropriate based on the data using the method in table 100.

[0171] As shown in the figure, Table 100 has three columns and three rows, where the columns are about "RAP tends to be lower than normal" 101, "RAP tends to be normal" 102, and "RAP tends to be higher than normal" 103, and the columns are about "LAP tends to be lower than normal" 104, "LAP tends to be normal" 105, and "LAP tends to be higher than normal" 106. For example, if RAP tends to be lower than normal but LAP tends to be higher than normal, then according to Table 100 the method will include the step of "increasing vasodilator". If automated, a consistent "message" or communication can be sent to the user of the monitoring system. On the other hand, if RAP also tends to be higher than normal, then the method will include the step of "increasing diuretic". Similarly, if automated, a consistent "message" or communication can be sent to the user of the monitoring system. It should be noted that when both the LAP and RAP values are at normal levels (i.e., the box defined by the "LAP normal" row and the "RAP normal" column), a method will include not changing any medications.

[0172] After administering the initial medication, method 99 includes, in step 95, verifying to see if RAP still tends to be higher than normal and if the RAP value is not affected by the diuretic. This may occur in the second example shown above, where both LAP and RAP tend to be higher than normal, so the diuretic dose administered to the patient is increased, but subsequent measurements of RAP show that the pressure is still higher than normal. In this instance, in step 96, the monitoring system 72 can display an indication instructing the healthcare provider to bring the patient in for a possible diagnosis of RH failure (or the healthcare provider can perform step 96 based on the data). Other possible causes of high RAP include primary pulmonary hypertension. When the healthcare provider tests the patient for a possible diagnosis of these conditions, the healthcare provider can set a new baseline value range for the "RAP normal" level and update the patient's status to have a history of RH / biventricular failure in order to advance the method to step 97 in the future instead of step 95. Otherwise, if RAP drops to the normal level, the monitoring system 72 optionally returns to step 92 for subsequent RAP and LAP measurements.

[0173] Return to step 93. If the monitoring system 72 (or the healthcare provider) confirms that the patient has a history of RH / biventricular failure, method 99 proceeds to step 97 after determining which drug to increase or decrease based on the analysis outlined in Table 100. In step 97, method 99 includes determining whether the drug administered in step 94 is effective. For example, method 99 can include comparing the previous LAP value and RAP value with the new LAP value and new RAP value after the drug is administered. If this comparison shows an inadequate change in status in a way that indicates the administered drug is ineffective (e.g., if the LAP or RAP is still below normal and the drug has not increased it towards the normal level, or if the LAP or RAP is still above normal and the drug has not decreased it towards the normal level, etc.), then in step 98, the healthcare provider can bring the patient in for an adjusted treatment, and / or the monitoring system 72 can provide a message or other communication indicating the need for further diagnosis / treatment. A possible lack of effectiveness of the drug efficacy can be a sign of increased urgency or the need for immediate medical attention. Otherwise, if the administered drug shows significant efficacy in moving the LAP and RAP towards the nominal or desired levels, the method returns to step 92, and the monitoring system 72 continues to receive and evaluate new measurements for assessing the patient's health status.

[0174] Using at least two sets of measurement data (in this example, LAP and RAP measurements) when evaluating cardiac function is superior to prior art methods that use only one set of measurement data for various reasons, including that the second set helps with a more accurate root cause diagnosis and treatment.

[0175] In another embodiment, method 99 can be programmed such that instead of using the actually measured LAP value and RAP value, the ratio of LAP to RAP (or the ratio of RAP to LAP) can be used to determine which drugs to administer and the dosage. This method may be based on the understanding that the pressures within the left and right atria should correspond to the desired ratio in a healthy heart (e.g., 2:1 LAP:RAP), so an ideal LAP:RAP ratio (e.g., an ideal 2:1 pressure ratio) can be determined, and any ratio significantly less than or greater than the desired ratio (e.g., 2:1) poses a threat to the patient's health.

[0176] In some examples, if the ratio of LAP to RAP is higher than a threshold (i.e., LAP is much higher than RAP) in a patient with a history of LH heart failure and continues to increase, the method can include determining that the amount of vasodilator to be administered should be increased. The threshold ratio value of LAP to RAP that triggers such a determination can be periodically determined and updated by a healthcare provider (e.g., after examining the patient). In other words, the various methods include one or more healthcare providers determining a range of "normal" baseline ratios that will then be used in a drug administration reference table. Alternatively, a set of general guidelines regarding the appropriate baseline can be provided to the healthcare provider.

[0177] Method 99 can be adjusted to be more specific in terms of the amount by which pharmacology or drug therapy needs to be increased or decreased, which can vary based on how much LAP and RAP tend to be above or below normal levels. This can be achieved by implementing another table or another set of guidelines in Table 100 that indicates the amount of drug to be administered (e.g., such that the treatment dose can be adjusted for the patient without the need for healthcare provider intervention). Table 100 can include any of a variety of medical recommendations / directions, such as those shown for beta blockers and cardiotonics in a set of specific physiological measurements and associated guidelines of Table 100. Additionally, to inform the patient of which drug and its dose to select, the type of drug to be administered (e.g., diuretic or vasodilator) and its dose can be displayed on, for example, the screen of a computer used by the patient or the display of a smart device.

[0178] As described above, the measurement data and associated monitoring and treatment methods are not necessarily limited to LAP and RAP measurements. In some examples, additional or alternative locations (e.g., pulmonary artery, ventricle, pulmonary vein, aorta, etc.) and / or additional or alternative metrics (e.g., temperature and / or blood oxygen saturation) can be used in implementing the monitoring and treatment methods (such as Method 99).

[0179] As explained above, method 99 can be performed manually or can be partially or fully automated using any device capable of receiving and processing measurement data from measurement device 41. For example, method 99 can be implemented entirely in a monitoring system 72 (e.g., such as a smart device) that performs all comparisons, calculations, and determinations after receiving LAP and RAP measurement data from measurement system 41. In some examples, the method can be partially implemented in monitoring system 72 and partially in communication relay 70, which can include a processing unit to receive LAP and RAP measurement data from sensors, determine whether LAP and RAP are above / at / below normal levels, and decrease / stabilize / increase, and then transfer this information to remote device 72 to perform the remainder of the method. In yet another example, subcutaneous implant 83 can be programmed to perform part or all of the method.

[0180] In a further example, method 99 can be implemented in a device having a user interface that allows a patient to administer a drug based on the results of the method. The method can also be implemented in an electronic health record (EHR) or electronic medical record (EMR) system of a healthcare provider that tracks the necessary records for each patient. Thus, the EHR or EMR system can access a local or remote database to obtain a patient's LH or RH / biventricular failure history and whether the healthcare provider believes the patient is at risk of such failure. The data obtained by the method can be displayed on a dashboard of the user interface, which has multiple options for users (e.g., patients and healthcare providers), including: LAP and RAP averages, trend arrows, line graphs over time, waveforms, and a history of the drugs taken by the patient, etc. The dashboard can also be configured such that the user can first extract the most meaningful information (such as averages and trends) and then drill down further for a more detailed analysis (such as waveforms). This can be achieved by organizing the multiple options in a hierarchical manner based on the importance of each option. In one example, the hierarchical order of the options can be customized according to the user's preference such that the most preferred information can be extracted first.

[0181] Figure 25 An embodiment of a measurement device 110 in accordance with the present disclosure is shown. As Figure 34As shown, the measurement device 110 has an electronic device housing component 114 that stores an antenna (such as antenna coil 35) and a battery or power source 32. After the measurement device 110 including the housing component 114 is inserted through an aperture formed in the atrial septum 5, the housing component 114 protrudes from and extends beyond the two walls of the septum 5 and the anchor discs 8, 9. The antenna 35 transmits the measurement data acquired by the sensing elements 10, 11 to an external monitoring system (not shown), which receives, tracks, and performs data analysis. The measurement device 110 enables the right anchor disc 8 and the left anchor disc 9 to work together to help fix the housing component 114 in place such that the housing component 114 is fixed relative to the septum 5. As shown, the two discs 8, 9 are designed to clamp the atrial septum 5 by actively engaging or contacting each side in a relative manner. In one example, the housing component 114 is made of a suitable metal such as titanium, stainless steel, or other biocompatible metals. In another example, the housing component 114 is made of plastic or other suitable polymer materials. In other examples, the housing component 114 is made of a biocompatible ceramic material (such as glass).

[0182] The sensing elements 10, 11 are implemented or disposed in the housing component 114 such that these sensing elements 10, 11 are located at both ends where the housing component 114 extends into the atrium. In some examples, the sensing elements 10, 11 protrude into the atrium to achieve better sensing functions. For example, in some examples, it may be more beneficial to position the sensing elements 10, 11 at both ends of the housing component 114 to separate the sensing elements 10, 11 from the septum 5 to prevent tissue ingrowth from affecting the measurement efficiency of the sensing elements 10, 11.

[0183] One advantage of the sensing elements 10, 11 protruding into the atrium and above the surface of the septum 5 is that the sensing elements 10, 11 can perform more effective (e.g., accurate) physiological measurements over a long term compared to a position where the sensing elements 10, 11 are flush with the diaphragm 5. In some examples, as Figure 25 shown, an anticoagulant layer 120 is provided on a part or all of the surface close to the surface of one or both of the sensing elements 10, 11 to effectively reduce the risk of thrombus formation on the device or due to fluid turbulence that may cause a stroke or embolism event. For example, the anticoagulant layer 120 can be located on one or more of the housing component 114, the sensing elements 10, 11, and / or the anchor discs 8, 9.

[0184] Possible anticoagulants that can be used include, but are not limited to: heparin, warfarin, rivaroxaban, dabigatran, apixaban, edoxaban, enoxaparin, and fondaparinux. In one example, layer 120 can be an anti-inflammatory agent layer (such as dexamethasone) to reduce inflammation of the tissue near the sensing elements 10, 11, thereby improving the accuracy of the measurement. In some examples, the anticoagulant layer 120 is formed by a heparin surface treatment available from Gore W.L. and Associates Inc formed.

[0185] Figure 26 An embodiment of the measurement device 112 according to the present disclosure is shown. In the measurement device 112, the housing component 114 is positioned such that one end of the housing component 114 is substantially flush with the corresponding anchoring component (in this example, the anchoring disk 9), thereby reducing the amount of flow interruption and the potential for subsequent device-related thrombosis. Therefore, it is necessary to control tissue growth to achieve reliable chronic sensor performance. Accordingly, a biocompatible material layer 116 is provided on a part or all of the surface of one or more of the housing component 114, the sensing elements 10, 11, and / or the anchoring disks 8, 9. In some embodiments, a biocompatible material (such as expanded polytetrafluoroethylene (ePTFE)) has a suitable structure for controlling tissue ingrowth. Other examples of biocompatible materials include, but are not limited to, suitable polymers or synthetic or natural materials such as polyethylene terephthalate (PET), polyethylene (PE), polypropylene (PP), silicone, polylactic acid (PLA), polyglycolic acid (PGA), polyglycolic acid: trimethylene carbonate (PGA:TMC), stainless steel, nitinol, acellular tissue matrix, fluorinated ethylene propylene (FEP), tetrafluoroethylene (TFE), and perfluoro(propyl vinyl ether) (PFA) copolymer, polychlorotrifluoroethylene (PCTFE) homopolymer and its copolymers with TFE, ethylene chlorotrifluoroethylene (ECTFE), ethylene tetrafluoroethylene (ETFE), polyvinylidene fluoride (PVDF), and polyvinyl fluoride (PVF). Other examples of structures include, but are not limited to, suitable fabrics, non-wovens, weaves, knits, films, or microporous films, and microporous films include electrospun meshes, expanded polymers, foams, meltblown meshes, etc. The tissue that promotes ingrowth can be vascular endothelial cells.

[0186] In some embodiments, the biocompatible material 116 may include one or more features that reduce or prevent tensile stress applied to the sensing element 11. Tensile stress may result from tissue growth, septal wall bending, and / or pulsation, and in some cases, may result in erroneous pressure measurements. The biocompatible material 116 including one or more features that reduce or prevent tensile stress may reduce the potential for these erroneous pressure measurements. In some embodiments, the feature that reduces or prevents tensile stress may be, for example, (i) a non-expandable ring or (ii) a highly expandable portion, both of which may protect the sensor from resultant normal forces and erroneous pressure measurements.

[0187] Figure 27 Embodiments of a measurement device 118 are shown in accordance with various examples. The measurement device 118 further includes an additional layer of anticoagulant 120 on top of the biocompatible material layer 116 from Figure 26 . In one example, the layer 120 is sized to cover the surface of the sensing element 11 such that the anticoagulant prevents ingrowth of tissue onto the sensing element 11, thereby minimizing errors in the physiological measurements performed by the sensing element 11 or otherwise enhancing the efficacy (e.g., precision and / or accuracy) of the sensing element 11 over time.

[0188] In another example, the layer 120 may cover a smaller or larger area of the layer 116, depending on the implementation. Other examples of thin film layers may allow selective tissue ingrowth such that tissue ingrowth is allowed or encouraged around the peripheral portion of the anchor disc 9 (or a portion of the anchor disc 9), while providing a "window" or portion with less or no tissue ingrowth corresponding to an area on and / or around the sensing element 11. For example, the biocompatible material layer 116 may inject or incorporate an anticoagulant into specific areas, thereby reducing or minimizing tissue ingrowth in that specific area to optimize the function of the sensing element 11. Given the above, different combinations of agents and polymers may be used to adjust the amount of tissue ingrowth achieved such that there is sufficient tissue ingrowth and anchoring, but not so much that the tissue impedes effective measurements by the sensing elements 10, 11.

[0189] Figure 28An embodiment of a measurement device 122 according to the present disclosure is shown. The sensing elements 10, 11 of the measurement device 122 are respectively disposed on the anchoring discs 8, 9. As explained previously, the surfaces of the disc 9 and the sensing element 11 are covered by a layer 116, and the surfaces of the disc 8 and the sensing element 10 are covered by another layer 124 which is a biocompatible material the same as that of the layer 116, so as to facilitate the in-growth of tissue on the two discs. In one example, the biocompatible materials used for the two layers 116, 124 may be different. In some examples, the housing member 114 extends through the second layer 124 but is substantially flush with the first layer 116.

[0190] In some examples, the sensing elements 10, 11 are positioned or otherwise positioned relative to each other such that the sensing elements 10, 11 are aligned with each other across the atrial septum 5, or are aligned with each other on opposite sides of the atrial septum 5. That is, the distance between the sensing elements 10, 11 is reduced to help minimize the total surface area of the septum occupied by the sensing elements 10, 11. One advantage of this configuration is that in the case where an opening or aperture (fenestration) is formed in the atrial septum 5, the remaining space occupied by the discs 8, 9 but not occupied by the sensing elements 10, 11 can be obtained to facilitate transseptal access (e.g., as part of device delivery from the right atrium to the left atrium), to facilitate selective fluid flow, or for other desired purposes.

[0191] As previously shown in Figures 14 - 16 the anchoring discs 8, 9 may have a re-passable surface such that an opening or aperture can be formed without disturbing the electronic device. In one example, if the measurement device 112 is placed between the left atrium and the right atrium of the heart, the measurement device 112 can act as an atrial shunt. Figure 29 An embodiment of a measurement device 126 is shown, in which the sensing elements 10, 11 are positioned such that the positions of the sensing elements 10, 11 are offset from each other across the atrial septum 5 and thus are generally not aligned across the septum. In one example, the measured angle (or angular offset) between the positions of the sensing elements 10, 11 relative to the longitudinal axis of the housing member 114 can be, for example, less than 15 degrees, between 15 degrees and 30 degrees, between 30 degrees and 45 degrees, between 45 degrees and 60 degrees, between 60 degrees and 90 degrees, between 90 degrees and 135 degrees, between 135 degrees and 180 degrees, although various arrangements are contemplated. Figure 29 An example in which the angle is 180 degrees is shown, and this configuration achieves the maximum distance (or angular offset) between the sensing elements 10, 11.

[0192] Figure 30An embodiment of a measurement device 128 according to the present disclosure is shown. The measurement device 128 includes two additional layers 130, 132 of biocompatible material. Layer 130 is disposed between the disc 8 and the septum 5, and layer 132 is disposed between the anchor disc 9 and the septum 5. In one example, the biocompatible material used in the additional layers 130, 132 is the same as the biocompatible material used in the previously mentioned layers 116, 124, but this need not be the case in other examples. In one example, Figures 28 - 30 the sensing elements 10, 11 in any of the embodiments of Figures 28 - 30 can be attached, tethered, sutured, stapled, nailed, or adhered to the anchor discs 8, 9. In another example, the anchor discs 8, 9 are formed as integral parts within the discs 8, 9 by the sensing elements 10, 11. Additionally, in one example, the sensing elements 10, 11 are wirelessly coupled (including but not limited to Bluetooth technology) to electronics (e.g., Figure 34 the antenna 35 in Figure 34 ) within the housing component 114. In another example, the sensing elements 10, 11 are coupled to the electronics via one or more tethers.

[0193] Figure 31 and Figure 32 Another embodiment of a measurement device 134 is shown according to some examples. Figure 32 is a side view, while Figure 31 shows an internal view of one of the atria adjacent to the atrial septum 5 from the direction of arrow A in Figure 32 The measurement device 134 has an anchor disc 9 that is placed against and attached to the wall of the septum 5, and the disc 9 has an opening 136 through which a tether 80 extends from an electronics housing component 114 located behind the disc 9 into the atrium and terminates at the sensing element 11. In this example, the sensing element 11 is decoupled from the housing component 114 and is located at a position away from the disc 9 and the housing component 114, rather than inside the anchor disc 9 or the housing component 114. In another example, the measurement device 134 can have a sensing element in the disc and another sensing element at a remote location such that additional physiological measurements can be performed using the additional sensing element. In some examples, the tether 80 extends from the atrium to the ventricle or a distal artery / vein such that the sensing element 11 performs physiological measurements inside the ventricle.

[0194] The lacing 80 can be partially or entirely covered by a biocompatible material layer 138. The layer 138 can be configured to promote tissue ingrowth and can have a sufficient length to help prevent the lacing 80 from separating from the surface of the septum 5. In another example, instead of a single elongated layer 138, there can be multiple separate layers covering the lacing 80 at different portions of the lacing 80. Additionally, the sensing element 11 can be covered by a biocompatible material layer 142. In some examples, the layer 142 is optionally configured to be similar to the layer 116 cited herein. In one example, similar to Figure 30 the illustrated embodiment, a biocompatible material layer 132 can be disposed between the sensing element 11 and the septum 5.

[0195] Figure 33 An embodiment is shown in which the sensing element 11 is sandwiched between two biocompatible material layers, one of the biocompatible materials being the aforementioned layer 142. In the illustrated embodiment, the sensing element 11 is sandwiched between a bottom layer 144 and a top layer, which in this case is the layer 142. The proximal layer 144 can be positioned on the side of the sensing element 11 opposite the layer 142 such that the sensing element 11 does not directly contact the surface of the septum 5. In one example, the two layers 142, 144 sandwiching the sensing element 11 cover the same surface area such that the top layer 142 completely covers the other layer 144 to laminate the sensing element 11. In another example, the two layers 142, 144 have different surface areas such that when they overlap each other, one layer extends beyond the other. In one example, the two layers 142, 144 are made of the same biocompatible material, while in another example, the layers can be made of different biocompatible materials.

[0196] In some examples, the right anchor disc 8 is disposed in the right atrium of the heart and the left anchor disc 9 is disposed in the left atrium of the heart such that the electronic housing components 114 of the measurement devices 112, 118, 122, 126, and 128 all extend into the right atrium of the heart while being substantially flush with the left anchor disc 9 in the left atrium. In other examples, the housing component 114 can alternatively extend into the left atrium of the heart such that the housing component 114 is substantially flush with the right anchor disc 8 in the right atrium. In some examples, due to the imbalance created between the protrusion on one end of the housing component 114 and the flush surface on the other end, one or more reinforcing struts 140 are employed to better support the housing component 114 using one or both of the anchor discs 8, 9 to help stabilize the implant, prevent unwanted device movement that can lead to increased inflammatory response and tissue growth, and prevent unnecessary flexure and / or decoupling of the housing component 114. Figure 32Shown is a reinforcing strut 140 that supports a housing member 114 against an anchor disk 8. In some examples, the reinforcing strut is a nitinol wire or any other suitable material capable of stabilizing the housing member 114.

[0197] In one example, one or more of the biocompatible material layers employed are hydrophobic. In such examples, one or more of these layers may be covered, coated, absorbed, or otherwise associated with a hydrophilic material such that the material is relatively more “echolucent.” For reference, an echolucent material allows ultrasound waves to pass therethrough such that the material does not interfere with an echogram or ultrasound waves. A microporous membrane (such as, ePTFE) may also be modified to be echolucent by adding vinyl monomers (such as PVA polymerized within the pores of the membrane). The hydrophilic material helps reduce or eliminate air within the material, thereby reducing interference between the air and ultrasound transmission. Other examples of hydrophilic layers formed by applying polymeric hydrophilic surfactants are taught in U.S. Patent No. 7,871,659 to Cook et al., assigned to Gore W.L. and Associates Inc.

[0198] In some examples, the properties of one or more components of the measurement device (including the anchor disk, the biocompatible material layer, and / or the sensing element) may be adjusted to better suit the physiological measurement being performed. For example, the sensing element may be a flow sensor (e.g., an ultrasound or other type of flow sensor), a temperature sensor, a pressure sensor, and combinations thereof, or other sensor types as needed. Accordingly, the material for the biocompatible material layer may be configured to facilitate or otherwise effectively transmit the mechanical / hydraulic response, thermal response, or other response of the portion of the heart or other areas of the body being measured.

[0199] The sensing element may have high thermal conductivity, a high level of water permeability, or otherwise promote sensitivity to environmental changes measured by the sensor. In addition to examples describing pressure measurements, for example, various measurement devices may be configured to perform temperature measurements to monitor cardiac function. In some monitoring methods, a cold bolus (e.g., a fluid) may be introduced into the cardiac system, and the cardiac output within the heart may be determined using the temperature equilibration rate and then measured by a thermometer. In such instances, the components may need to have thermal conductivity properties to transfer heat from the environment for sensing temperature changes.

[0200] The sensing element can be a blood oxygen saturation sensor, which measures the diffusion characteristics of oxygen in the atrium. In such instances, the component may need to be sufficiently exposed to the environment to be able to detect such changes in the diffusion characteristics, or be configured to effectively deliver oxygen to the sensing component. These are just a few examples, and additional examples include adjusting other physical properties of the layers and components of the measuring device to improve sensor functionality.

[0201] In addition, in some examples, the sensing element or portion of the measuring device can be incorporated into flexible printed electronics, which include patterned traces deposited on one or more layers (e.g., to provide an antenna, inductive power, communication or signal traces, or other functionality). In one example, such patterned traces connect the sensing element to a housing component rather than a lanyard that is part of the sensor assembly. In another example, such patterned traces are configured to provide sensed data or otherwise make measurements.

[0202] Those skilled in the art will readily understand that various aspects of the present disclosure can be implemented by any number of methods and apparatuses configured to perform the intended functions. It should also be noted that the accompanying drawings referred to in the present disclosure are not necessarily drawn to scale and may be exaggerated to illustrate various aspects of the present disclosure, and in this regard, the drawings should not be construed as restrictive.

[0203] The invention of the present application has been generally and based on specific embodiments described above. It will be apparent to those skilled in the art that various modifications and variations can be made in the embodiments without departing from the scope of the present disclosure. Accordingly, the present disclosure is intended to cover various modifications and variations of the embodiments as long as these modifications and variations are within the scope of the appended claims and their equivalents.

Claims

1. An implantable measurement device, comprising: a first anchoring member configured to engage a first inner wall defining a first chamber of the heart; a second anchoring member configured to engage a second inner wall defining a second chamber of the heart different from the first chamber; wherein when implanted and engaged with the heart, both the first anchoring member and the second anchoring member are defined by a frame including an outer edge member and a plurality of radial members radially extending to the outer edge member, wherein the frame defines a plurality of regions extending between the outer edge member and the plurality of radial members, wherein all of the plurality of regions in both the first anchoring member and the second anchoring member extend over the entire length of the radial members, and wherein the outer edge member and the plurality of radial members of each of the first anchoring member and the second anchoring member are formed of the same material; a first sensing element coupled to the first anchoring member and configured to perform a physiological measurement in the first chamber; and a second sensing element coupled to the second anchoring member and configured to be disposed in the second chamber of the heart and configured to perform a physiological measurement in the second chamber of the heart; and an electronic device housing member configured to extend between the first anchoring member and the second anchoring member; and wherein both the first anchoring member and the second anchoring member include a membrane, wherein the membrane fills the plurality of regions and is configured to be opened, fenestrated, punctured, traversed, or penetrated via an interventional procedure.

2. The implantable measurement device according to claim 1, wherein, the first anchoring member and the second anchoring member are configured to be positioned relatively against the atrial septum of the patient.

3. The implantable measurement device according to claim 1, wherein, the second sensing element is substantially flat against the inner wall.

4. The implantable measurement device according to claim 1, further comprising a thin film configured to cover at least a portion of the second sensing element to promote tissue ingrowth.

5. The implantable measurement device according to claim 1, further comprising a thin film configured to cover at least a portion of the second sensing element, the thin film being configured to prevent tissue ingrowth.

6. The implantable measurement device according to any one of claims 4 or 5, wherein, the thin film is a component separate from the first anchoring member and the second anchoring member.

7. The implantable measurement device according to any one of claims 4 or 5, wherein, the thin film includes at least one feature configured to reduce tensile stress on the second sensing element.

8. The implantable measurement device according to claim 7, wherein, The at least one feature includes a non-inflatable ring, a highly inflatable portion, or a non-inflatable ring and a highly inflatable portion.

9. The implantable measurement device according to claim 1, wherein, a tissue layer is disposed on at least one of the first sensing element and the second sensing element.

10. The implantable measurement device according to claim 1, further comprising a first remote sensing element, the first remote sensing element being coupled to the first anchoring member by a first sensing tie, the first remote sensing element being configured to perform a physiological measurement at a position remote from the first sensing element.

11. The implantable measurement device according to claim 10, wherein, the first sensing tie is configured to extend from the atrium to the ventricle.

12. The implantable measurement device according to claim 10, further comprising a second remote sensing element, the second remote sensing element being coupled to the second anchoring member by a second sensing tie, the second remote sensing element being configured to perform a physiological measurement at a position remote from the second sensing element.

13. The implantable measurement device according to claim 12, wherein, each of the first sensing tie and the second sensing tie is configured to extend from the atrium to the ventricle.

14. The implantable measurement device according to claim 12, wherein, each of the first sensing tie and the second sensing tie is configured to extend from the atrium to a distal artery or vein.

15. The implantable measurement device according to any one of claims 13-14, wherein, the first sensing element and the second sensing element are configured to perform measurements at the right atrium and the left atrium respectively, and the first remote sensing element and the second remote sensing element are configured to perform measurements at the right ventricle and the left ventricle respectively.

16. The implantable measurement device according to claim 1, further comprising a memory unit, the memory unit being configured to store data received from at least one of the first sensing element and the second sensing element.

17. The implantable measurement device according to claim 1, wherein, the electronic device housing member extends beyond at least one of the first anchoring member and the second anchoring member into at least one of the first chamber and the second chamber of the heart.

18. The implantable measurement device according to claim 1, wherein, the first sensing element is disposed at a first end of the electronic device housing member, and the second sensing element is disposed at a second end of the electronic device housing member.

19. The implantable measurement device according to claim 1, further comprising an anticoagulant layer, the anticoagulant layer being disposed on at least a portion of the surface of at least one of the first sensing element and the second sensing element to prevent ingrowth of tissue on at least one of the first sensing element and the second sensing element.

20. The implantable measurement device according to claim 1, wherein, At least one of the first sensing element and the second sensing element is substantially flush with a corresponding first anchoring member or a corresponding second anchoring member.

21. The implantable measurement device according to claim 1, further comprising a biocompatible material layer disposed on at least a portion of the surface of at least one of the first sensing element and the second sensing element and at least one of the first anchoring member and the second anchoring member to promote tissue ingrowth.

22. The implantable measurement device according to claim 1, wherein, the first sensing element is disposed in the first anchoring member, and the second sensing element is disposed in the second anchoring member.

23. The implantable measurement device according to claim 1, wherein, the first sensing element and the second sensing element are respectively substantially flush with the first anchoring member and the second anchoring member.

24. The implantable measurement device according to claim 1, further comprising: a first biocompatible material layer disposed on at least a portion of the surface of the first sensing element and the first anchoring member to promote tissue ingrowth, and a second biocompatible material layer disposed on at least a portion of the surface of the second sensing element and the second anchoring member to promote tissue ingrowth.

25. The implantable measurement device according to claim 1, wherein, the positions of the first sensing element and the second sensing element are aligned relative to each other.

26. The implantable measurement device according to claim 1, wherein, the positions of the first sensing element and the second sensing element are offset relative to each other.

27. The implantable measurement device according to claim 24, further comprising another biocompatible material layer disposed between at least one of the first sensing element and the second sensing element and at least one of the first inner wall and the second inner wall to promote tissue ingrowth.

28. The implantable measurement device according to claim 1, further comprising a fourth biocompatible material layer disposed between the other of the first sensing element and the second sensing element and the other of the first inner wall and the second inner wall to promote tissue ingrowth.

29. The implantable measurement device according to claim 1, further comprising at least one reinforcing strut connecting the electronic device housing member to at least one of the first anchoring member and the second anchoring member.

30. The implantable measurement device according to claim 1, wherein, the electronic device housing member includes a battery and an antenna configured to transmit measurement data from the first sensing element and the second sensing element.

31. The implantable measurement device according to claim 30, wherein, The antenna defines the periphery of at least one of the first anchoring member and the second anchoring member.

32. The implantable measurement device according to claim 1, wherein, the electronic device housing member includes an antenna configured to wirelessly couple with an external power source to power the device.

33. The implantable measurement device according to any one of claims 30-32, wherein, the antenna is configured to transmit measurement data to an external monitoring device.

34. The implantable measurement device according to claim 1, wherein, the first sensing element and the second sensing element are configured to perform pressure measurements.

35. The implantable measurement device according to claim 1, wherein, at least one of the first sensing element and the second sensing element is configured to perform at least one of temperature measurement and blood oxygen saturation measurement.

36. The implantable measurement device according to claim 1, wherein, at least one of the first sensing element and the second sensing element is configured to perform a temperature measurement after an air cold pellet is inhaled into a patient's lungs.

37. The implantable measurement device according to claim 19, wherein, the anticoagulant is heparin.

38. The implantable measurement device according to any one of claims 21, 24, 27, 28, wherein, the biocompatible material is expanded polytetrafluoroethylene (ePTFE).

39. The implantable measurement device according to claim 1, wherein, the first anchoring member and the second anchoring member conform to different diaphragm thicknesses.

40. The implantable measurement device according to claim 1, wherein, the first anchoring member and the second anchoring member are made of a fluoropolymer film and nitinol.

41. The implantable measurement device according to claim 1, wherein, the first anchoring member and the second anchoring member are re-passable.

42. The implantable measurement device according to claim 1, wherein, the first sensing element and the second sensing element respectively extend beyond the first anchoring member and the second anchoring member.

43. The implantable measurement device according to claim 1, further comprising a treatment device.

44. The implantable measurement device according to claim 43, wherein the treatment device is an occluder.

45. The implantable measurement device according to claim 43, wherein the treatment device is a shunt.

46. The implantable measurement device according to claim 1, wherein, the first sensing element and the second sensing element are piezoelectric capacitive sensors.

47. The implantable measurement device according to claim 1, wherein, at least some of the regions defined by the frames of both the first anchoring member and the second anchoring member are large enough to allow a puncture device and a catheter to pass through the at least some regions during the interventional procedure.

48. The implantable measurement device according to claim 47, wherein, At least some of the regions defined by the frames of both the first and second anchoring members are large enough to allow a 24Fr catheter to pass through the at least some regions.

49. The implantable measurement device according to claim 47, wherein, all of the regions defined by the frames of both the first and second anchoring members are large enough to allow the access device and the catheter to pass through all of the regions during the interventional procedure.

50. The implantable measurement device according to claim 49, wherein, the frames of both the first and second anchoring members include up to five radial members.

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