Patent Description:
<CIT> describes an intravenous implantable optical sensor which assesses the relative absorbance of multiple wavelengths of light in order to determine oxygen saturation. The calculation of oxygen saturation is enhanced by use of a function of hematocrit which is derived from the relative absorbance of light of an isobestic wavelength along two different length paths through the blood. The use of the hematocrit-dependent term and multiple wavelengths of light to calculate oxygen saturation provides results that are less susceptible to noise and variation in hematocrit and thus provides a more accurate measure of oxygen saturation over a wider range of conditions than previously possible. The optical sensor may form part of an implantable system which performs the calculation of oxygen saturation and uses the results for a diagnostic or therapeutic purpose.

The claimed invention relates to a first medical implant device as defined in independent claim <NUM>. Some preferred configurations of the first medical implant device are defined in dependent claims <NUM> to <NUM>. The claimed invention further relates to a second medical implant device as defined in independent claim <NUM>. Some preferred configurations of the second medical implant device are defined in dependent claims <NUM> to <NUM>.

Also described herein are related aspects, examples, embodiments and arrangements useful for understanding the claimed invention, and which do not necessarily constitute embodiments of the claimed invention. The subject-matter for which protection is sought is defined by the claims.

Described herein are methods and devices related to a medical implant device configured to provide light absorption information of blood flowing through a coronary vein from a position external of the coronary vein. For example, the implant device can be configured to provide light absorption information of blood flowing through a coronary sinus from a position external of the coronary sinus. The medical implant device can comprise a housing, and a light source and a light sensor received in the housing. The housing can be configured to be positioned externally of the coronary vein. For example, the housing receiving the light source and light sensor can be positioned externally of the coronary sinus, including over an external surface of a coronary sinus wall and/or over a surface of a left atrial wall portion adjacent to a portion of the coronary sinus wall. The light absorption measurements can be used to determine an oxygen saturation level of the blood flowing through the coronary vein, such as the coronary sinus.

Methods and structures disclosed herein for treating a patient also encompass analogous methods and structures performed on or placed on a simulated patient, which is useful, for example, for training; for demonstration; for procedure and/or device development; and the like. The simulated patient can be physical, virtual, or a combination of physical and virtual. A simulation can include a simulation of all or a portion of a patient, for example, an entire body, a portion of a body (e.g., thorax), a system (e.g., cardiovascular system), an organ (e.g., heart), or any combination thereof. Physical elements can be natural, including human or animal cadavers, or portions thereof; synthetic; or any combination of natural and synthetic. Virtual elements can be entirely in silica, or overlaid on one or more of the physical components. Virtual elements can be presented on any combination of screens, headsets, holographically, projected, loud speakers, headphones, pressure transducers, temperature transducers, or using any combination of suitable technologies.

For purposes of summarizing the disclosure, certain aspects, advantages and novel features have been described herein. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular example. Thus, the disclosed examples may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.

Various examples are depicted in the accompanying drawings for illustrative purposes and should in no way be interpreted as limiting. In addition, various features of different disclosed examples can be combined to form additional examples, which are part of this disclosure. Throughout the drawings, reference numbers may be reused to indicate correspondence between reference elements. However, it should be understood that the use of similar reference numbers in connection with multiple drawings does not necessarily imply similarity between respective examples associated therewith. Furthermore, it should be understood that the features of the respective drawings are not necessarily drawn to scale, and the illustrated sizes thereof are presented for the purpose of illustration of aspects thereof. Generally, certain of the illustrated features may be relatively smaller than as illustrated in some examples or configurations.

The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention, which is defined in the independent claims.

The present disclosure provides systems, devices, and methods relating to a medical implant device configured to measure light absorption properties of blood flowing through a coronary vein, including a coronary sinus, for determining oxygen saturation of the blood. A light source and a light sensor of the medical implant device can be positioned over a portion of the heart external of the coronary vein, such as the coronary sinus, to provide the light absorption measurements. For example, the light source and a light sensor can be positioned over an external surface of a coronary sinus wall and/or over a surface of a left atrial wall portion adjacent to a portion of the coronary sinus wall.

In any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding certain examples; however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures, systems, and/or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various examples, certain aspects and advantages of these examples are described. Not necessarily all such aspects or advantages are achieved by any particular example. Thus, for example, various examples may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.

Certain standard anatomical terms of location are used herein to refer to the anatomy of animals, and namely humans, with respect to the preferred examples. Although certain spatially relative terms, such as "outer," "inner," "upper," "lower," "below," "above," "vertical," "horizontal," "top," "bottom," and similar terms, are used herein to describe a spatial relationship of one device/element or anatomical structure to another device/element or anatomical structure, it is understood that these terms are used herein for ease of description to describe the positional relationship between element(s)/structures(s), as illustrated in the drawings. It should be understood that spatially relative terms are intended to encompass different orientations of the element(s)/structures(s), in use or operation, in addition to the orientations depicted in the drawings. For example, an element/structure described as "above" another element/structure may represent a position that is below or beside such other element/structure with respect to alternate orientations of the subject patient or element/structure, and vice-versa.

<FIG> is a schematic diagram showing various features of a human heart <NUM>. The heart <NUM> includes four chambers within a heart wall <NUM>, namely the left atrium <NUM>, the left ventricle <NUM>, the right ventricle <NUM>, and the right atrium <NUM>. A wall of muscle, referred to as the septum <NUM>, separates the left atrium <NUM> and right atrium <NUM>, and the left ventricle <NUM> and right ventricle <NUM>. Blood flow through the heart <NUM> is at least partially controlled by four valves, the mitral valve <NUM>, aortic valve <NUM>, tricuspid valve <NUM>, and pulmonary valve <NUM>. The mitral valve <NUM> separates the left atrium <NUM> and the left ventricle <NUM> and controls blood flow therebetween. The aortic valve <NUM> separates and controls blood flow between the left ventricle <NUM> and the aorta <NUM>. The tricuspid valve <NUM> separates the right atrium <NUM> and the right ventricle <NUM> and controls blood flow therebetween. The pulmonary valve <NUM> separates the right ventricle <NUM> and the pulmonary trunk or artery <NUM>, controlling blood flow therebetween.

In a healthy heart, the heart can receive deoxygenated blood arriving from the rest of the body generally into the right side of the heart for transport to the lungs, and oxygenated blood from the lungs generally into the left side of the heart for transport to the rest of the body. During ventricular diastole, deoxygenated blood arrive in the right atrium <NUM> from the inferior vena cava <NUM> and superior vena cava <NUM> to flow into the right ventricle <NUM>, and oxygenated blood arrive in the left atrium <NUM> from the pulmonary veins to flow into the left ventricle <NUM>. During ventricular systole, deoxygenated blood from the right ventricle <NUM> can flow into the pulmonary trunk <NUM> for transport to the lungs (e.g., via the left <NUM> and right <NUM> pulmonary arteries), and oxygenated blood can flow from the left ventricle <NUM> to the aorta <NUM> for transport to the rest of the body.

Veins collecting deoxygenated blood from the myocardium can drain into the coronary sinus <NUM>. The coronary sinus <NUM> can then return the deoxygenated blood into the right atrium <NUM> through the coronary sinus ostium <NUM>. Coronary vein blood oxygen saturation information, such as coronary sinus blood oxygen saturation information, allows monitoring of oxygen utilization by the myocardium. Determining oxygen saturation (e.g., SaO<NUM>) of blood flowing through a coronary vein, such as the coronary sinus <NUM>, can provide information regarding the health of the heart <NUM>. Oxygen saturation of blood flowing through the coronary vein, such as the coronary sinus <NUM>, can directly provide cardiac oxygen utilization data, including changes in the cardiac oxygen utilization. Cardiac oxygen utilization data and/or changes in cardiac oxygen utilization data can be used to detect and/or track the progress in inefficient myocardial oxygenation. In some instances, such data can be used to predict acute decompensated heart failure (ADHF), thereby providing an opportunity for preventative measures. The ability to take preventative measures can prevent or reduce hospital admissions and/or unscheduled medical interventions, improving outcomes for patients.

Oxygenated hemoglobin and deoxygenated hemoglobin can have different light absorption properties, for example demonstrating different ability to absorb light at certain wavelengths. Oxygenated hemoglobin and deoxygenated hemoglobin can absorb infrared light and red light differently. Oxygenated hemoglobin can absorb more infrared light than red light, for example reflecting more red light than infrared light. Deoxygenated hemoglobin can absorb more red light than infrared light, for example reflecting more infrared light than red light. The difference in light absorption properties of oxygenated and deoxygenated hemoglobin can be used to determine blood oxygen saturation information for the blood flowing through the coronary vein, including the coronary sinus.

The disclosure herein provides one or more devices and methods related a medical implant device configured to provide light absorption information of blood flowing through a coronary vein, including a coronary sinus. For example, the medical implant device can comprise a housing, and a light source and a light sensor received in the housing, where the housing is configured to be positioned externally of the coronary sinus. The light source and light sensor can provide measurements of light absorption properties for blood flowing through the coronary sinus from a location external of the coronary sinus lumen. The housing can be positioned over an external surface of a coronary sinus wall and/or over a surface of a heart wall portion adjacent to a portion of the coronary sinus wall. The medical implant device can comprise an anchor configured to mechanically and/or magnetically secure the housing over the external surface of the coronary sinus wall or the surface of the heart wall portion adjacent to the coronary sinus.

In some instances, a first wall portion of the housing can be positioned over an external surface of a coronary sinus wall. For example, the first wall portion can be over an extraluminal surface of the coronary sinus. Light signals emitted from the light source can be pass through a first light-transparent region on the first wall portion. The emitted light signals can be transmitted through the coronary sinus wall and into the coronary sinus. Portions of the light signals transmitted into the coronary sinus not absorbed by the blood flowing through the coronary sinus can be reflected back through the coronary sinus wall and pass through a second light-transparent region on the first wall portion for detection by the light sensor. In some instances, the first and second light-transparent regions may not be distinct regions. For example, light signals emitted from the light source and light signals reflected from the coronary sinus can pass through the same light-transparent region on the first wall portion.

In some instances, a first wall portion of the housing can be positioned over an atrial wall portion adjacent to a portion of the coronary sinus wall. For example, the housing can be positioned within the left atrium. As described herein, a portion of the coronary sinus can extend over an external surface of the left atrium. The first wall portion of the medical implant device can be configured to be positioned over a left atrial wall portion adjacent to a portion of the coronary sinus wall, such as a surface of the atrial wall portion oriented toward the left atrium. The light sensor can be configured to emit light signals that pass through the first light-transparent region of the first wall portion. The emitted light signals can travel through the left atrial wall portion and the adjacent portion of the coronary sinus wall, and into the coronary sinus. Portions of the light signals transmitted into the coronary sinus not absorbed by the blood flowing through the coronary sinus can be reflected back through the coronary sinus wall and the adjacent portion of the left atrial wall. The reflected light signals can pass through the second light-transparent region of the first wall portion for detection by the light sensor.

The light source can be configured to emit light signals at one or more wavelengths at which oxygenated and deoxygenated hemoglobin demonstrate differentiable light absorption properties. The light sensor can be configured to detect light signals at these one or more wavelengths. In some instances, the light source can be configured to emit a first light signal at a first wavelength and a second light signal at a second wavelength. In some instances, the first light signal can be an infrared light signal, such as a light signal having a wavelength of about <NUM> nanometer (nm). The second light signal can be a red light signal, such as a light signal having a wavelength of about <NUM> nanometers (nm). The light sensor can be configured to detect reflected portions of the infrared and red light signals that had been emitted into the coronary sinus.

Emission of light signals by the light source and detection of reflected light signals by the light sensor can occur at any number of different time intervals. In some instances, the light source and light sensor can be configured to continuously emit light and detect light for continuous monitoring of oxygen saturation of blood flowing through the coronary sinus. In some instances, the light source and light sensor can be configured to emit light and detect light at predetermined time intervals. For example, the light source and light sensor can be configured to emit and detect light for a predetermined period every hour, day, or week. In some instances, the light source and light sensor can be triggered and/or activated by an external stimulus. The external stimulus can be generated by an operator and/or auto-generated at a preset time interval. For example, the light source and light sensor can be turned on for on-demand measurements.

Monitoring of oxygen utilization by the myocardium can facilitate detection of a number of conditions. A drop in blood oxygen saturation can be due to insufficient coronary blood perfusion, indicating for example, epicardial coronary stenosis and/or coronary microvascular disease. A decrease in blood oxygen saturation can also be due to demand ischemia, such as higher oxygen demand than available oxygen supply. A high oxygen demand relative to oxygen supply can indicate hypertrophic cardiomyopathy, and/or tachycardia. Increase in blood oxygen saturation can indicate, for example, energy metabolism impairment in heart failure with preserved ejection fraction (HFpEF), myocardial fibrosis, scar formation and/or infiltrative disorders.

In some instances, coronary vein blood oxygen saturation, such as coronary sinus blood oxygen saturation, can be used in combination with other physiological metrics to monitor the physiological state of the patient, such as to improve tracking of disease progress and/or diagnosis. In some instances, coronary vein blood oxygen saturation, including coronary sinus blood oxygen saturation, can be used in combination with hemodynamic metrics (e.g., intracardiac pressures, systemic blood pressure, heart rate), electrophysiology measurements (e.g., EKG), systemic oxygen saturation (e.g., systemic SaO2), venous oxygen saturation (SvO2), and/or indices of aerobic and anaerobic metabolism (e.g., pH, lactate).

In some instances, a measurement of a systemic arterial blood oxygen saturation can be used in combination with a measurement of a coronary vein blood oxygen saturation, such as a coronary sinus blood oxygen saturation, to facilitate determining the health of the heart, including prediction of acute decompensated heart failure (ADHF). One or more systemic arterial blood oxygen saturation measurements be made to provide a blood oxygen saturation baseline for a patient, for example serving as a reference point against which coronary vein blood oxygen saturation measurements, such as coronary sinus blood oxygen saturation measurements, can be compared in determining whether the coronary vein, including coronary sinus, blood oxygen saturation measurements indicate a problem with heart function or an oxygenation problem elsewhere in the body (e.g., a deterioration of blood oxygenation in the lungs). A difference between the systemic arterial blood oxygen saturation and coronary vein blood oxygen saturation, including the coronary sinus blood oxygen saturation, can be determined. For example, the difference can be determined such that a change in the difference between the systemic arterial blood oxygen saturation and the coronary vein or the coronary sinus blood oxygen saturation, in combination with a change in the coronary vein or coronary sinus blood oxygen saturation, can indicate deteriorating heart function.

The medical implant device can comprise one or more components for performing pulse oximetry. For example, the medical implant device can comprise the light source and light sensor, and one or more other components of a pulse oximeter. In some instances, the housing of the medical implant device can be configured to receive the light source and light sensor, and the one or more other components of the pulse oximeter. In some instances, the medical implant device can comprise a pulse oximeter. In some instances, the medical implant device can comprise a reflective pulse oximeter. For example, the housing can be configured to receive all of the components of a pulse oximeter. In some instances, the light source and light sensor can be received in the housing while other components for determining the oxygen saturation information can be externally positioned. For example, measurements for light absorption properties made by the medical implant device can be communicated, transmit and/or transferred, such as by any number of wireless communication methods, to a device external of the patient such that the oxygen saturation metric can be calculated.

In some instances, the medical implant device can be powered using wireless charging, including inductive charging. For example, the medical implant device can comprise one or more batteries configured to be charged inductively. For example, the patient can be positioned over and/or in contact with an inductive charging plate for charging of the one or more batteries.

Although description herein refers primarily to the coronary sinus, it will be understood that one or more other coronary veins can be applicable. For example, one or more medical implant devices described herein can be configured to provide light absorption information of blood flowing through another coronary vein of the greater cardiac venous system, such as the great cardiac vein. In some instances, the first wall portion of the housing receiving the light source and light sensor can be positioned over an extraluminal surface of the great cardiac vein. In some instances, the first wall portion of the housing can be positioned over an atrial wall portion adjacent to a portion of a wall of the great cardiac vein. In some instances, one or more medical implant devices described herein can be configured to provide light absorption information of blood flowing through one or more of a middle cardiac vein, small cardiac vein, right marginal vein, left marginal vein, anterior cardiac vein, left and right ventricular veins, left and right atrial veins, inferior vein of the left ventricle and/or oblique vein of the left atrium. In some instances, light absorption information can be combined from multiple measurement locations. For example, each of multiple medical implant devices as described herein can be positioned at a respective location for measuring light absorption information of blood flowing through a respective coronary vein.

Any of the various systems, devices, apparatuses, etc. in this disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise sterilization of the associated system, device, apparatus, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

The term "associated with" is used herein according to its broad and ordinary meaning. For example, where a first feature, element, component, device, or member is described as being "associated with" a second feature, element, component, device, or member, such description should be understood as indicating that the first feature, element, component, device, or member is physically coupled, attached, or connected to, integrated with, embedded at least partially within, or otherwise physically related to the second feature, element, component, device, or member, whether directly or indirectly.

Referring to <FIG>, a perspective view of an exterior of a human heart is shown, and a medical implant device <NUM> is shown as being positioned over an extraluminal surface of a coronary sinus <NUM> of the heart <NUM>. Various veins <NUM> that collect deoxygenated blood from the myocardium and drain into the coronary sinus <NUM> are shown in the figure. As described in further detail herein, the medical implant device <NUM> can comprise a housing <NUM> configured to receive a light source and a light sensor. The light source can be configured to emit light signals at one or more wavelengths such that the emitted light signals can pass through the coronary sinus wall and be transmitted into the coronary sinus <NUM>. The light sensor can be configured to detect light signals at the one or more wavelengths. For example, the light sensor can be configured to detect portions of the light signals transmitted into the coronary sinus <NUM> that are not absorbed and are reflected by the blood flowing through the coronary sinus <NUM>.

The medical implant device <NUM> can comprise an anchor <NUM> associated with the housing <NUM> to secure the medical implant device <NUM> to the heart. The anchor <NUM> can be configured to position a portion of the housing <NUM> over and/or in contact with the extraluminal surface of the coronary sinus <NUM> to facilitate desired transmission of light signals into the coronary sinus <NUM> and detection of reflected light signals from the coronary sinus <NUM>. As described in further detail herein, the anchor <NUM> can be configured to be secured to one or more adjacent portions of the heart wall <NUM> on either side of the coronary sinus <NUM>.

<FIG> is a side cross-sectional view of an example of a medical implant device <NUM> configured to be positioned over an extraluminal surface of a coronary sinus <NUM>. <FIG> shows the medical implant device <NUM> positioned over the extraluminal surface of the coronary sinus <NUM>. The medical implant device <NUM> can comprise a light source <NUM> and a light sensor <NUM> configured to provide measurements of light absorption properties of blood flowing through the coronary sinus <NUM>. The light source <NUM> and light sensor <NUM> can be received within a cavity <NUM> of a housing <NUM> that is configured to be positioned over the extraluminal surface. For example, at least a portion of a first wall portion <NUM> of the housing <NUM> can be configured to be positioned over the extraluminal surface of the coronary sinus <NUM>. The first wall portion <NUM> can comprise a first surface <NUM> configured to be oriented toward and/or in contact with the extraluminal surface. A first light-transparent region <NUM> of the first wall portion <NUM> can be configured to allow passage therethrough of emitted light signals from the light source <NUM>. The emitted light signal can pass through the first light-transparent region <NUM>, and the portion of the coronary sinus wall over which the housing <NUM> is positioned and into the coronary sinus <NUM>. A second light-transparent region <NUM> of the first wall portion <NUM> can be configured to allow passage therethrough of reflected light signals from within the coronary sinus <NUM> for detection by the light sensor <NUM>. For example, portions of the emitted light signals not absorbed by the blood flowing through the coronary sinus <NUM> can be reflected back through the coronary sinus wall for detection by the light sensor <NUM>. In some instances, the first and second light-transparent regions <NUM>, <NUM> may not be distinct regions. In some instances, the first and second light-transparent regions <NUM>, <NUM> can at least partially overlap. In some instances, the first and second light-transparent regions <NUM>, <NUM> can comprise a common light-transparent region. For example, light signals emitted from the light source <NUM> for transmission into the coronary sinus <NUM> and light signals reflected from the coronary sinus <NUM> for detection by the light sensor <NUM> can pass through the same light-transparent region on the first wall portion <NUM>.

An anchor <NUM> can be associated with, for example coupled to, the housing <NUM> and configured to secure the medical implant device <NUM> to the heart. The anchor <NUM> can be configured to mechanically couple the medical implant device <NUM> to one or more heart wall portions adjacent to the coronary sinus <NUM>. For example, the anchor <NUM> can comprise a first anchor component <NUM> and a second anchor component <NUM> each comprising a portion configured to be secured to portions of the heart wall <NUM> on either side of the coronary sinus <NUM>. The first anchor component <NUM> and a second anchor component <NUM> can secure the implant device <NUM> to the heart wall <NUM> such that the first wall portion <NUM> of the housing <NUM> can be positioned over and/or in contact with a portion of the extraluminal surface of the coronary sinus <NUM>. The first wall portion <NUM> can be positioned over and/or in contact with the extraluminal surface of the coronary sinus <NUM> to facilitate transmitting light signals into and receiving light signals from the coronary sinus <NUM>. It will be understood that although the medical implant device <NUM> can comprise two anchor components, fewer or more anchor components can be applicable. For example, in some instances, a medical implant device can comprise one anchor component. The one anchor component can be configured to be secured to a heart wall portion adjacent to the coronary sinus. In some instances, a medical implant device can comprise three or four anchor components.

In some instances, the medical implant device <NUM> can be powered using inductive charging. One or more batteries can be associated with one or more portions of the medical implant device <NUM>, for example being received within the cavity <NUM> of the housing <NUM>. The one or more batteries can be charged inductively. For example, the patient can be positioned over and/or in contact with an inductive charging plate such that the one or more batteries can be charged.

<FIG> is a perspective view, and <FIG> is a side cross-sectional view, of the medical implant device <NUM> described with reference to <FIG>. The first and second anchor components <NUM>, <NUM> can each comprise a respective portion having an angled orientation relative to the first wall portion <NUM>, such as relative to the first surface <NUM>, of the housing <NUM>. The respective portions of the first and second anchor components <NUM>, <NUM> having the angled orientation can comprise at least a portion that extends between the housing <NUM> and the heart wall, such that the first and second anchor components <NUM>, <NUM> can facilitate securing the medical implant device <NUM> to a heart wall portion adjacent to a coronary sinus.

The first and second anchor components <NUM>, <NUM> can be coupled to portions of the housing <NUM> such that the anchor components <NUM>, <NUM> do not interfere with emission of light signals by the light source <NUM> into the coronary sinus and detection by the light sensor <NUM> of reflected light signals from the coronary sinus. The first anchor component <NUM> can be coupled to a first housing portion <NUM>. The second anchor component <NUM> can be coupled to a second housing portion <NUM>. The first and second housing portions <NUM>, <NUM> can be laterally disposed from the first and second light-transparent regions <NUM>, <NUM>. In some instances, the first housing portion <NUM> can comprise a first lateral wall portion <NUM> and the second housing portion <NUM> can comprise a second lateral wall portion <NUM>. In some instances, the first and second lateral housing portions <NUM>, <NUM> can be at an angle relative to the first wall portion <NUM>. In some instances, the first and second lateral housing portions <NUM>, <NUM> can have an orientation perpendicular or substantially perpendicular to that of the first wall portion <NUM>. For example, the first lateral wall portion <NUM> can comprise a first external lateral surface <NUM> to which the first anchor component <NUM> can be coupled. The second lateral wall portion <NUM> can comprise a second external lateral surface <NUM> to which the second anchor component <NUM> can be coupled. In some instances, the first housing portion <NUM> and the second housing portion <NUM> can be at opposing positions on the housing <NUM>. The first external surface <NUM> and the second external surface <NUM> can each have a perpendicular or substantially perpendicular orientation relative to the first wall portion <NUM>, including the first surface <NUM> of the first wall portion <NUM>.

The first anchor component <NUM> can comprise a first anchor portion <NUM> oriented at an angle relative to the first wall portion <NUM>, including the first surface <NUM>. The second anchor component <NUM> can comprise a second anchor portion <NUM> oriented at an angle relative to the first wall portion <NUM>, including the first surface <NUM>. A first end portion <NUM>, <NUM> of each of the first and second anchor components <NUM>, <NUM> can be coupled to the respective housing portions. For example, the first end portion <NUM> of the first anchor component <NUM> can be coupled to the first lateral wall portion <NUM>, including the first external lateral surface <NUM>. The first end portion <NUM> of the second anchor component <NUM> can be coupled to the second lateral wall portion <NUM>, including the second external lateral surface <NUM>. In some instances, the first end portion <NUM> of the first anchor component <NUM> can comprise a lateral anchor portion coupled to the first lateral wall portion <NUM>. The first end portion <NUM> of the second anchor component <NUM> can comprise a second lateral anchor portion coupled to the second lateral wall portion <NUM>. Each of the first lateral anchor portion and the second lateral anchor portion can have the same orientation as the first surface <NUM> of the first wall portion <NUM>. A second end portion <NUM>, <NUM> of each of the first and second anchor components <NUM>, <NUM> can be configured to be coupled to respective heart wall portions. For example, the second end portion <NUM> of the first anchor component <NUM> can be secured to a first heart wall portion on a first side of the coronary sinus. The second end portion <NUM> of the second anchor component <NUM> can be secured to a second heart wall portion on a second side of the coronary sinus. In some instances, each of the second end portions <NUM>, <NUM> can be mechanically secured to the heart wall. In some instances, each of the second end portions <NUM>, <NUM> can comprise at least one of a clip, corkscrew and barb. In some instances, each of the second end portions <NUM>, <NUM> can comprise openings configured to facilitate stitching of the second end portions <NUM>, <NUM> to the heart wall. For example, the openings can receive a stitch, suture, cord and/or other fastener that is configured to be secured to the heart wall.

In some instances, the light source <NUM> can comprise one or more light emitting diodes (LEDs). The medical implant device <NUM> can comprise a light emitting diode (LED) configured to emit infrared light signals and a light emitting diode (LED) configured to emit red light signals. For example, the light source <NUM> can comprise a light emitting diode (LED) configured to emit light having a wavelength of about <NUM> nanometers (nm) and a light emitting diode (LED) configured to emit light having a wavelength of about <NUM> nanometer (nm). In some instances, the light sensor <NUM> can comprise one or more photodetectors, such as photodiodes, configured to detect the infrared light signals and red light signals.

It will be understood that more or fewer anchor components can be used. Any number of mechanical fasteners can be used to secure the anchor components to the heart wall. In some instances, one or more portions of the anchor components can be flexible, deformable and/or elastic to accommodate for any changes due to beating of the heart while maintaining the housing at a desired position over the extraluminal surface of the coronary sinus.

Although description of the medical implant device <NUM> herein refers primarily to the coronary sinus, it will be understood that one or more other coronary veins can be applicable. For example, the medical implant device <NUM> can be configured to provide light absorption information of blood flowing through another coronary vein of the greater cardiac venous system, such as the great cardiac vein. For example, the housing <NUM> receiving the light source <NUM> and the light sensor <NUM> can be configured to be positioned over an extraluminal surface of the great cardiac vein to measure light absorption information of blood flowing through the great cardiac vein. The first and second anchor components <NUM>, <NUM> can facilitate securing the medical implant device <NUM> to respective heart wall portions adjacent to the great cardiac vein.

A medical implant device as described herein can be delivered using any number of techniques, including minimally invasive techniques. In some instances, a method for delivering the medical implant device can comprise any number of minimally invasive approaches for accessing the pericardial space. In some instances, a method for delivering the medical implant device can comprise a fluoro-guided minimally invasive delivery method. For example, a catheter placed in the coronary sinus can be used as a fluoroscopic target for a delivery system of the medical implant device. In some instances, a method for delivering the medical implant device can comprise using a magnetic component to guide the delivery. For example, a magnetic delivery guide component can be positioned within a coronary vein, including the coronary sinus or the great cardiac vein, to guide placement of at least a portion of a medical implant device over an extraluminal surface of the coronary vein, such as an extraluminal surface of the coronary sinus or great cardiac vein. The portion of the medical implant device positioned over the extraluminal surface can comprise another magnetic component configured to magnetically couple to the magnetic delivery guide component within the coronary vein, facilitating positioning of the portion of the medical implant device at a desired location over the extraluminal surface. A magnetic guide component within the coronary sinus or great cardiac vein can facilitate positioning of the medical implant device at a desire location over the extraluminal surface of the coronary sinus or great cardiac vein. As described in further detail herein, a magnetic anchor component of a medical implant device described herein can be used as a magnetic delivery guide for delivering the medical implant device to the desired location.

<FIG> is a perspective view, and <FIG> is a side cross-sectional view, of another example of a medical implant device <NUM> configured to be positioned over an extraluminal surface of a coronary sinus. The medical implant device <NUM> can comprise a housing <NUM> and an anchor <NUM> associated with a first wall portion <NUM> of the housing <NUM>. A light source <NUM> and a light sensor <NUM> can be received within a cavity <NUM> of the housing <NUM>. The anchor <NUM> can comprise a first anchor component <NUM> and a second anchor component <NUM> coupled to respective portions of the first wall portion <NUM>. The first anchor component <NUM> can comprise a first anchor portion <NUM> oriented at an angle relative to the first wall portion <NUM>, including a first surface <NUM> of the first wall portion <NUM>. The second anchor component <NUM> can comprise a second anchor portion <NUM> oriented at an angle relative to the first wall portion <NUM>, including the first surface <NUM> of the first wall portion <NUM>. The first and second anchor components <NUM>, <NUM> can extend between the first wall portion <NUM> and the heart wall such that the first and second anchor components <NUM>, <NUM> can facilitate securing the medical implant device <NUM> to heart wall portions adjacent to the coronary sinus. The first wall portion <NUM> can comprise a first surface <NUM> configured to be oriented toward the extraluminal surface of the coronary sinus. The first surface <NUM> of the first wall portion <NUM> can be positioned over and/or in contact with the extraluminal surface of the coronary sinus. In some instances, the first and second anchor components <NUM>, <NUM> can extend between the first surface <NUM> and respective portions of the heart wall on either side of the coronary sinus.

In some instances, the first and second anchor components <NUM>, <NUM> can be coupled to respective portions of the first wall portion <NUM> that are laterally disposed from a first and second light-transparent regions <NUM>, <NUM> on the first wall portion <NUM>. A first end portion <NUM>, <NUM> of each of the first and second anchor components <NUM>, <NUM> can be coupled to respective portions of the first surface <NUM> laterally disposed from the first and second light-transparent regions <NUM>, <NUM> so as not to interfere with emission of light signals by the light source <NUM> into the coronary sinus and detection by the light sensor <NUM> of reflected light signals from the coronary sinus. In some instances, the first and second anchor components <NUM>, <NUM> can be coupled to opposing portions on the first surface <NUM>. A second end portion <NUM>, <NUM> of each of the first and second anchor components <NUM>, <NUM> can be configured to be coupled to heart wall portions on a first side and a second side of the coronary sinus, respectively.

<FIG> shows a side cross-sectional view of yet another example of a medical implant device <NUM> configured to be positioned over an extraluminal surface of a coronary sinus. The medical implant device <NUM> can comprise a housing <NUM> and an anchor <NUM> associated with the housing <NUM>, where the anchor <NUM> includes at least a portion configured to be secured to a wall of a coronary sinus <NUM> to position the housing <NUM> over an extraluminal surface of the coronary sinus <NUM>. The anchor <NUM> can comprise a first anchor component <NUM> and a second anchor component <NUM>. At least a portion of each of the first anchor component <NUM> and the second anchor component <NUM> can extend between the housing <NUM> and a heart wall <NUM>. Each of the first component <NUM> and the second anchor component <NUM>, including respective portions extending between the housing <NUM> and the heart wall <NUM>, can comprise a curved surface portion <NUM>, <NUM> configured to be oriented toward the coronary sinus <NUM> while the housing <NUM> is positioned over the extraluminal surface of the coronary sinus <NUM>. At least a portion of the curved surface portions <NUM>, <NUM> can be secured to respective portions of the coronary sinus wall to facilitate positioning the housing <NUM> over the extraluminal surface of the coronary sinus <NUM>. For example, a first wall portion <NUM> of the housing <NUM>, including a first surface <NUM> of the first wall portion <NUM>, can be positioned over and/or in contact with the extraluminal surface. The medical implant device <NUM> can comprise a light source <NUM> and a light sensor <NUM> received within a cavity <NUM> of the housing <NUM> and configured to provide measurements of light absorption properties of blood flowing through the coronary sinus <NUM>. Light signals emitted by the light source <NUM> can pass through a first light-transparent region <NUM> on the first wall portion <NUM>, and light signals reflected from the coronary sinus <NUM> can pass through a second light-transparent region <NUM> on the first wall portion <NUM>. In some instances, the first and second light-transparent regions <NUM>, <NUM> may not be distinct regions such that emitted light signals and reflected light signals can pass through the same light-transparent region on the first wall portion <NUM>. For example, the first and second light-transparent regions <NUM>, <NUM> can at least partially overlap. The first anchor component <NUM> and second anchor component <NUM> can be coupled to respective portions of the housing <NUM> without interfering with the emission and detection of light signals by the light source <NUM> and light sensor <NUM>.

<FIG> is a perspective view, and <FIG> is a side cross-sectional view, of the medical implant device <NUM> described with reference to <FIG>. The first anchor component <NUM> can comprise a first anchor portion <NUM> and the second anchor component <NUM> can comprise a second anchor portion <NUM> extending between the housing <NUM> and a heart wall. Each of the first and second anchor portions <NUM>, <NUM> can comprise a first and second curved surface portion <NUM>, <NUM>, respectively, configured to be oriented toward the coronary sinus. For example, the first curved surface portion <NUM> can be secured to a portion of the coronary sinus wall on a first side of the housing <NUM> and the second curved surface portion <NUM> can be secured to a portion of the coronary sinus wall on a second side of the housing <NUM>. The first and second curved surface portions <NUM>, <NUM> can be secured to the coronary sinus wall using any number of techniques, including for example using an adhesive. At least a portion of each of the curved surface portions <NUM>, <NUM> can be shaped to facilitate conforming the respective portions to the coronary sinus wall so as to facilitate securing the respective portions thereto.

The first and second anchor components <NUM>, <NUM> can be coupled to portions of the housing <NUM> such that the anchor components <NUM>, <NUM> do not interfere with emission of light signals by the light source <NUM> into the coronary sinus and detection by the light sensor <NUM> of reflected light signals from the coronary sinus. The first anchor component <NUM> and second anchor component <NUM> can be coupled to a first housing portion <NUM> and a second housing portion <NUM>, respectively, which are each laterally disposed from the first and second light-transparent regions <NUM>, <NUM>. A first end portion <NUM>, <NUM> of each of the first and second anchor components <NUM>, <NUM> can be coupled to the respective housing portions. In some instances, the first housing portion <NUM> can comprise a first lateral wall portion <NUM> and the second housing portion <NUM> can comprise a second lateral wall portion <NUM>. For example, the first lateral wall portion <NUM> can comprise a first external lateral surface <NUM> to which the first anchor component <NUM> can be coupled. The second lateral wall portion <NUM> can comprise a second external lateral surface <NUM> to which the second anchor component <NUM> can be coupled. The first and second lateral housing portions <NUM>, <NUM> can be at an angle relative to the first wall portion <NUM>. In some instances, the first and second lateral housing portions <NUM>, <NUM> can have an orientation perpendicular or substantially perpendicular to that of the first wall portion <NUM>. In some instances, the first housing portion <NUM> and the second housing portion <NUM> can be at opposing positions on the housing <NUM>. The first external surface <NUM> and the second external surface <NUM> can each have a perpendicular or substantially perpendicular orientation relative to the first wall portion <NUM>, including the first surface <NUM> of the first wall portion <NUM>. The first end portion <NUM> of the first anchor component <NUM> can be coupled to the first lateral wall portion <NUM>, including the first external lateral surface <NUM>. The first end portion <NUM> of the second anchor component <NUM> can be coupled to the second lateral wall portion <NUM>, including the second external lateral surface <NUM>.

In some instances, a second end portion <NUM>, <NUM> of each of the first and second anchor components <NUM>, <NUM> can be configured to be coupled to respective heart wall portions on a first side and a second side of the coronary sinus. Alternatively, the first and second anchor components <NUM>, <NUM> may not be secured to the heart wall. For example, the first and second anchor components <NUM>, <NUM>, such as the first and second curved surface portions <NUM>, <NUM>, can be configured to be coupled to the coronary sinus wall, without being coupled to the heart wall.

The medical implant devices <NUM>, <NUM> described with reference to <FIG> can have one or more other features of the medical implant device <NUM> described with reference to <FIG> and <FIG>. For example, each of the first and second anchor components <NUM>, <NUM>, <NUM>, <NUM> can be mechanically secured to the heart wall. In some instances, each of the second end portions <NUM>, <NUM>, <NUM>, <NUM> can comprise at least one of a clip, corkscrew and barb. In some instances, each of the second end portions <NUM>, <NUM>, <NUM>, <NUM> can comprise openings configured to facilitate stitching of the second end portions <NUM>, <NUM>, <NUM>, <NUM> to the heart wall. For example, the openings can receive a stitch, suture, cord and/or other fastener that is configured to be secured to the heart wall. The medical implant devices <NUM>, <NUM> can be applicable to another coronary vein, including another coronary vein of the greater cardiac venous system. For example, the housings <NUM>, <NUM> receiving the respective light source <NUM>, <NUM> and light sensor <NUM>, <NUM> can be configured to be positioned over an extraluminal surface of the great cardiac vein. The first and second anchor components <NUM>, <NUM> can facilitate securing the medical implant device <NUM> to respective heart wall portions adjacent to the great cardiac vein. The first and second anchor components <NUM>, <NUM> can facilitate securing the medical implant device <NUM> to respective heart wall portions adjacent to the great cardiac vein and/or the great cardiac vein wall.

In some instances, a medical implant device can comprise an anchor configured to magnetically secure the medical implant device to the heart. <FIG> is a side cross-sectional view of an example of a medical implant device <NUM> comprising a magnetic anchoring mechanism. The magnetic anchor mechanism can be configured to facilitate positioning the medical implant device <NUM> over an extraluminal surface of a coronary sinus. The medical implant device <NUM> can comprise a housing <NUM>, and a light source <NUM> and a light sensor <NUM> received within a cavity <NUM> of the housing <NUM>. An anchor <NUM> can be configured to magnetically secure the housing <NUM> over an extraluminal surface of a coronary sinus <NUM>. The anchor <NUM> can comprise a first magnetic component <NUM> associated with the housing <NUM> positioned externally of the coronary sinus <NUM> and a second magnetic component <NUM> configured to be positioned within the coronary sinus <NUM>. Magnetic coupling between the first and second magnetic components <NUM>, <NUM> can secure the housing <NUM> over the extraluminal surface of the coronary sinus <NUM>.

<FIG> are various views of an example of the medical implant device <NUM> described with reference to <FIG>. <FIG> is a perspective view, and <FIG> is a side cross-sectional view, of the portion of the medical implant device <NUM> configured to be positioned over an extraluminal surface of a coronary sinus. <FIG> is a perspective view, and <FIG> is a side cross-sectional view, of the portion of the medical implant device <NUM> configured to be positioned within the coronary sinus, and magnetically coupled to the portion of the medical implant device <NUM> positioned externally of the coronary sinus. Referring to <FIG>, a first wall portion <NUM> of the housing <NUM> can be configured to be positioned over and/or in contact with the extraluminal surface of the coronary sinus, including a first surface <NUM> of the first wall portion <NUM>. The first wall portion <NUM> can comprise a first light-transparent region <NUM> to allow passage therethrough of emitted light signals from the light source <NUM> into the coronary sinus and a second light-transparent region <NUM> on the first wall portion <NUM> to allow passage therethrough of reflected light signals from the coronary sinus for detection by the light sensor <NUM>. In some instances, the first and second light-transparent regions <NUM>, <NUM> can at least partially overlap. For example, the first and second light-transparent regions <NUM>, <NUM> may not be distinct regions such that emitted light signals and reflected light signals can pass through the same light-transparent region on the first wall portion <NUM>. The first magnetic component <NUM> can be at a position within the housing <NUM> so as to not interfere with the transmission of light into the coronary sinus and detection of light reflected from the coronary sinus. For example, the first magnetic component <NUM> can be at one or more positions within the cavity <NUM> that are laterally disposed from the first and second light-transparent regions <NUM>, <NUM>.

In some instances, the first magnetic component <NUM> can be along at least a portion of a perimeter of the cavity <NUM> within the housing <NUM>. In some instances, the first magnetic component <NUM> can comprise two or more discrete portions at respective positions within the cavity <NUM>. For example, the first magnetic component <NUM> can comprise a first magnetic portion <NUM> and a second magnetic portion <NUM> each extending along a respective portion of the perimeter of the cavity <NUM> of the housing <NUM>. In some instances, the first magnetic portion <NUM> and the second magnetic portion <NUM> can be at opposing positions around the perimeter of the cavity <NUM>, for example, extending along opposing portions of the perimeter. The perimeter of the cavity <NUM> is shown in <FIG> as comprising a rounded shape, such as a circular shape. For example, the first and second magnet portions <NUM>, <NUM> can comprise a shape forming a segment of a circle. It will be understood that the perimeter of the cavity <NUM> can have a number of different shapes and the first and second magnetic portions <NUM>, <NUM> can have shapes corresponding to the shape of the perimeter and/or portion of perimeter along which they extend.

<FIG> show the second magnetic component <NUM> configured to be positioned within the coronary sinus. The second magnetic component <NUM> can comprise a configuration configured to mate with the first magnetic component <NUM>. At least a portion of the second magnetic component <NUM> can be configured to be aligned with and magnetically coupled to the first magnetic component <NUM> through a coronary sinus wall portion so as to position the first light-transparent region <NUM> and the second light-transparent region <NUM> over and/or against the extraluminal surface of the coronary sinus. The second magnetic component <NUM> can comprise respective portions configured to magnetically couple with the first and second magnetic portions <NUM>, <NUM> of the first magnetic component <NUM>. For example, a first mating magnetic portion <NUM> and a second mating magnetic portion <NUM> of the second magnetic component <NUM> can be configured to magnetically couple to the first and second magnetic portions <NUM>, <NUM>, respectively.

In some instances, respective ends of the first and second mating magnetic portions <NUM>, <NUM> can be coupled to one another. For example, the second magnetic component <NUM> can comprise a third portion <NUM> extending between first ends <NUM>, <NUM> of the first and second mating magnetic portions <NUM>, <NUM> and a fourth portion <NUM> extending between second ends <NUM>, <NUM> of the first and second mating magnetic portions <NUM>, <NUM>. The first and second mating magnetic portions <NUM>, <NUM> can be coupled to one another without interfering with the transmission of light into the coronary sinus and detection of light reflected from the coronary sinus. For example, the first and second mating magnetic portions <NUM>, <NUM>, and the third and fourth portions <NUM>, <NUM> of the second magnetic component <NUM> can define an opening such that light signals can be transmitted therethrough. For example, the second magnetic component <NUM> can form a ring shape having a central opening configured to be aligned with the first and second light-transparent regions <NUM>, <NUM> of the first wall portion <NUM>.

Alternatively, the first magnetic component can extend circumferentially around the perimeter of the cavity of the housing, for example forming a ring shape. The second magnetic component can comprise a corresponding ring shape and configured to align with and magnetically couple to the circumferentially extending first magnetic component. It will be understood that a first and second magnetic components can comprise any number of configurations, including linear and/or curved portions. The first magnetic component can be at positions other than along the perimeter of the cavity, including positions which do not interfere with the delivery into and receipt of light signals from the coronary sinus.

<FIG> are various views of another example of a medical implant device <NUM> comprising a magnetic anchoring mechanism. <FIG> is a perspective view, and <FIG> is a side cross-sectional view, of the portion of the medical implant device <NUM> configured to be positioned over an extraluminal surface of a coronary sinus. <FIG> is a perspective view, and <FIG> is a side cross-sectional view, of the portion of the medical implant device <NUM> configured to be positioned within the coronary sinus, and configured to be magnetically coupled to the portion of the medical implant device <NUM> positioned externally of the coronary sinus.

The medical implant device <NUM> can comprise a housing <NUM> and an anchor <NUM> configured to magnetically secure the housing <NUM> over an extraluminal surface of a coronary sinus. A light source <NUM> and a light sensor <NUM> can be received within a cavity <NUM> of the housing <NUM>. A first wall portion <NUM> of the housing <NUM> can be configured to be positioned over the extraluminal surface of the coronary sinus. For example, a first surface <NUM> of the first wall portion <NUM> can be over and in contact with the extraluminal surface of the coronary sinus. The first wall portion <NUM> can comprise a first light-transparent region <NUM> to allow passage therethrough of an emitted light signal from the light source <NUM> and a second light-transparent region <NUM> to allow passage therethrough of a reflected light signal from the coronary sinus for detection by the light sensor <NUM>. In some instances, the first and second light-transparent regions <NUM>, <NUM> may not be distinct regions. For example, the first and second light-transparent regions <NUM>, <NUM> can at least partially overlap. In some instances, emitted light signals and reflected light signals can pass through the same light-transparent region on the first wall portion <NUM>. The anchor <NUM> can comprise a first magnetic component <NUM> disposed externally of the housing <NUM> and laterally disposed from the first and second light-transparent regions <NUM>, <NUM>. For example, the first magnetic component <NUM> can comprise a first magnetic portion <NUM> and a second magnetic portion <NUM> coupled to a first and second housing portion <NUM>, <NUM>, respectively, that are laterally disposed from the first and second light-transparent regions <NUM>, <NUM>. In some instances, the first housing portion <NUM> can comprise a first lateral wall portion <NUM> and the second housing portion <NUM> can comprise a second lateral wall portion <NUM>. In some instances, the first and second lateral housing portions <NUM>, <NUM> can be at an angle relative to the first wall portion <NUM>. In some instances, the first and second lateral housing portions <NUM>, <NUM> can have an orientation perpendicular or substantially perpendicular to that of the first wall portion <NUM>, including the first surface <NUM>. The first magnetic portion <NUM> can be coupled a first external lateral surface <NUM> of the first lateral wall portion <NUM> and the second magnetic portion <NUM> can be coupled to a second external lateral surface <NUM> of the second lateral wall portion <NUM>. The first and second external lateral surfaces <NUM>, <NUM> can have an orientation perpendicular or substantially perpendicular to that of the first wall portion <NUM>, including the first surface <NUM>. In some instances, the first and second lateral housing portions <NUM>, <NUM> can be at opposing positions on the housing <NUM>.

In some instances, the first magnetic component <NUM> can extend around at least a portion of an outer perimeter of the housing <NUM>. For example, the first magnetic portion <NUM> and the second magnetic portion <NUM> can each extend along a respective portion of the outer perimeter of the housing <NUM>. In some instances, the first magnetic portion <NUM> and the second magnetic portion <NUM> can extend along opposing portions of the outer perimeter.

<FIG> show the second magnetic component <NUM> configured to be positioned within the coronary sinus. The second magnetic component <NUM> can comprise a configuration configured to mate with the first magnetic component <NUM>. For example, the second magnetic component <NUM> can comprise respective portions configured to align and magnetically couple with portions of the first magnetic component <NUM>. A first mating magnetic portion <NUM> and a second mating magnetic portion <NUM> of the second magnetic component <NUM> can be configured to mate with the first and second magnetic portions <NUM>, <NUM> of the first magnetic component <NUM>, respectively.

The first and second mating magnetic portions <NUM>, <NUM> can be coupled to one another without interfering with the transmission of light into the coronary sinus and detection of light reflected from the coronary sinus. In some instances, respective ends of the first and second mating magnetic portions <NUM>, <NUM> can be coupled to one another. For example, the second magnetic component <NUM> can comprise a third portion <NUM> extending between first ends <NUM>, <NUM> of the first and second mating magnetic portions <NUM>, <NUM> and a fourth portion <NUM> extending between second ends <NUM>, <NUM> of the first and second mating magnetic portions <NUM>, <NUM>. The first and second mating magnetic portions <NUM>, <NUM>, and the third and fourth portions <NUM>, <NUM> of the second magnetic component <NUM> can form a ring shape having a central opening configured to be aligned with the first and second light-transparent regions <NUM>, <NUM> of the first wall portion <NUM> such that light signals can be transmitted therethrough.

In some instances, a first magnetic component can comprise more or fewer discrete portions at respective positions around the outer perimeter of the housing. Alternatively, the first magnetic component can extend circumferentially around the outer perimeter of the housing, for example forming a ring shape. The second magnetic component can comprise a corresponding ring shape and configured to align with and magnetically couple to the circumferentially extending first magnetic component. It will be understood that a first and second magnetic components can comprise any number of configurations, including linear and/or curved portions.

In some instances, the medical implant devices <NUM>, <NUM> can be applicable to one or more coronary veins other than the coronary sinus, including one or more other coronary veins of the greater cardiac venous system. For example, magnetic coupling between the first magnet components <NUM>, <NUM> and second magnetic components <NUM>, <NUM> can secure the respective housing <NUM>, <NUM> over the extraluminal surface of the great cardiac vein. The second magnetic components <NUM>, <NUM> can be positioned within the great cardiac vein.

In some instances, a second magnetic component of a medical implant device can be configured to be a magnetic delivery guide and used to guide the delivery of a housing of the medical implant device to a desired location over the extraluminal surface of coronary vein, including the coronary sinus or the great cardiac vein. For example, the second magnetic component can be advanced into the coronary sinus and positioned over an inner surface portion coronary sinus wall adjacent to the desired location. The housing comprising the first magnetic component can subsequently be positioned over the extraluminal surface. The first magnetic component can align with and magnetically couple with the second magnetic component within the coronary sinus. Alternatively, the second magnetic component can be advanced into the great cardiac vein and positioned over an inner surface portion great cardiac vein wall adjacent to the desired location. The housing comprising the first magnetic component can subsequently be positioned over the extraluminal surface of the great cardiac vein. The first magnetic component can align with and magnetically couple with the second magnetic component within the great cardiac vein.

<FIG> shows an example of a medical implant device <NUM> positioned over an atrial wall in a left atrium <NUM>. <FIG> is a perspective view, and <FIG> is side cross-sectional view, of the medical implant device <NUM> described with reference to <FIG>. The medical implant device <NUM> can be at least partially disposed within the left atrium <NUM>. The medical implant device <NUM> can comprise an anchor <NUM> and a housing <NUM> receiving a light source <NUM> and a light sensor <NUM> in a cavity <NUM> of the housing <NUM>, where the anchor <NUM> can be configured to secure the housing <NUM> to the atrial wall. The housing <NUM> can comprise a first wall portion <NUM> configured to be positioned over the atrial wall. The first wall portion <NUM> can comprise a first light-transparent region <NUM> configured to allow passage therethrough of emitted light signals from the light source <NUM> and a second light-transparent region <NUM> configured to allow passage therethrough of reflected light signals from within the coronary sinus for detection by the light sensor <NUM>. In some instances, the first and second light-transparent regions <NUM>, <NUM> may not be distinct regions. For example, the first and second light-transparent regions <NUM>, <NUM> can at least partially overlap. In some instances, emitted light signals and reflected light signals can pass through the same light-transparent region on the first wall portion <NUM>. The anchor <NUM> can be configured to be secured to the atrial wall such that the housing <NUM>, such as the first and second light-transparent regions <NUM>, <NUM> of the first wall portion <NUM>, can be positioned over a portion of the wall of the left atrium <NUM> adjacent to a portion of a wall of a coronary sinus <NUM>. For example, light signals emitted by the light source <NUM> can pass through first light-transparent region <NUM>, and both the atrial wall and the coronary sinus wall to reach blood flowing through the coronary sinus <NUM>. Reflected light from the coronary sinus <NUM> can pass through the coronary sinus wall, the atrial wall, and the second light-transparent region <NUM> for detection by the light sensor <NUM>. In some instances, the anchor <NUM> can comprise a first lateral anchor component <NUM> and a second lateral anchor component <NUM> associated with respective housing portions laterally disposed from the first light-transparent region <NUM> and the second light-transparent region <NUM> so as not to interfere with the transmission of light signals into and reflection of light signals from the coronary sinus.

Referring to <FIG>, the first lateral anchor component <NUM> and the second lateral anchor component <NUM> can be associated with, such as coupled to, respective housing portions laterally disposed from the first light-transparent region <NUM> and the second light-transparent region <NUM>. A first surface <NUM> of the first wall portion <NUM> can be oriented toward the atrial wall. In some instances, the first and second lateral anchor components <NUM>, <NUM> can be secured to the atrial wall such that the first surface <NUM> can be oriented toward and in contact with the left atrium facing surface of the atrial wall. Each of the first and second lateral anchor components <NUM>, <NUM> can comprise a lateral portion <NUM>, <NUM> having the same orientation as the first surface <NUM> of the housing <NUM>. The first lateral portion <NUM> of the first lateral anchor component <NUM> and the second lateral portion <NUM> of the second lateral anchor component <NUM> can be configured to secure the medical implant device <NUM> to the atrial wall. For example, the first and second lateral portions <NUM>, <NUM> can be mechanically coupled a second atrial wall portion adjacent to the first atrial wall portion. In some instances, the first and second anchor components <NUM>, <NUM> can comprise at least one of a clip, corkscrew and barb configured to be secured to the second atrial wall portion. In some instances, the first and second anchor components <NUM>, <NUM> can comprise an opening configured to be stitched to the second atrial wall portion. For example, the openings can receive a stitch, suture, cord and/or other fastener that is configured to be secured to the atrial wall portion.

The first anchor component <NUM> and second anchor component <NUM> can be coupled to a first and second housing portion <NUM>, <NUM>, respectively, that are laterally disposed from the first and second light-transparent regions <NUM>, <NUM>. In some instances, the first housing portion <NUM> can comprise a first lateral wall portion <NUM> and the second housing portion <NUM> can comprise a second lateral wall portion <NUM>. In some instances, the first and second lateral housing portions <NUM>, <NUM> can be at an angle relative to the first wall portion <NUM>. In some instances, the first and second lateral housing portions <NUM>, <NUM> can have an orientation perpendicular or substantially perpendicular to that of the first wall portion <NUM>, including the first surface <NUM>. The first anchor component <NUM> can be coupled a first external lateral surface <NUM> of the first lateral wall portion <NUM> and the second anchor component <NUM> can be coupled to a second external lateral surface <NUM> of the second lateral wall portion <NUM>. In some instances, the first and second lateral housing portions <NUM>, <NUM> can be at opposing positions on the housing <NUM>. The first and second external lateral surfaces <NUM>, <NUM> can have an orientation perpendicular or substantially perpendicular to that of the first wall portion <NUM>, including the first surface <NUM>.

In some instances, the first and second anchor components <NUM>, <NUM> can extend along respective portions of an outer perimeter of the housing <NUM>. In some instances, the first anchor component <NUM> and the second anchor component <NUM> can extend along opposing portions of the outer perimeter.

In some instances, an anchor can comprise more or fewer discrete portions at respective positions around the outer perimeter of the housing. Alternatively, the anchor can extend circumferentially around the entire outer perimeter of the housing, for example forming a ring shape. In some instances, a medical implant device configured to be positioned over an atrial wall can comprise one or more portions positioned over and/or in contact with a mitral valve annulus. The one or more portions of the medical implant device can be secured to the mitral valve annulus, including for example via an anchor comprising one or more features described herein. For example, the medical implant device can be mechanically secured to the mitral valve annulus using one or more of a clip, barb, corkscrew, and stitches.

In alternative instances, a medical implant device configured to be positioned over an atrial wall can comprise a magnetic anchoring mechanism. For example, the medical implant device can comprise one or more features of the medical implant devices <NUM>, <NUM> described with reference to <FIG>. A second magnetic component of the medical implant device can be positioned against an inner surface portion of the coronary sinus wall adjacent to the atrial wall. A first magnetic component coupled to and/or received by a housing of the medical implant device can be positioned over the desired portion of the atrial wall to align and magnetically couple to the second magnetic component in the coronary sinus.

In some instances, the medical implant device <NUM> can be applicable to one or more coronary veins other than the coronary sinus, including one or more other coronary veins of the greater cardiac venous system. For example, the medical implant device <NUM> may be positioned within a heart chamber for providing light absorption properties of blood flowing through the great cardiac vein. In some instances, the medical implant device <NUM> can be positioned within the left atrium at a location to provide light absorption properties of blood flowing through the great cardiac vein. The anchor <NUM> can be configured to be secured to the atrial wall such that the housing <NUM>, such as the first and second light-transparent regions <NUM>, <NUM> of the first wall portion <NUM>, can be positioned over a portion of the wall of the left atrium adjacent to a portion of a wall of the great cardiac vein. In some instances, the medical implant device can comprise a magnetic anchoring mechanism. A second magnetic component of the medical implant device can be positioned against an inner surface portion of the great cardiac wall adjacent to the atrial wall. A first magnetic component coupled to and/or received by a housing of the medical implant device can be positioned over the desired portion of the atrial wall to align and magnetically couple to the second magnetic component in the great cardiac vein.

In some instances, a medical implant device can be positioned within another chamber of the heart to provide light absorption properties of blood flowing through the coronary sinus. In some instances, the medical implant device can be positioned within the left atrial appendage. The medical implant device can be secured within the left atrial appendage using a scaffolding component. In some instances, a light source and a light sensor of the medical implant device can emit light signals into the coronary sinus and receive reflected light signals from the coronary sinus through one or more heart wall portions adjacent to the coronary sinus.

<FIG> is a process flow diagram of an example of a process <NUM> for providing measurements used to determine oxygen saturation level of blood flowing through the coronary sinus. In block <NUM>, the process can involve providing a medical implant device comprising one or more features described herein. For example, the medical implant device can comprise a housing receiving a light source and a light sensor. A first wall portion of the housing can comprise a first light-transparent region to allow passage therethrough of emitted light signals and a second light-transparent region to allow passage therethrough of reflected light signals. The light source can be configured to generate the emitted light signals. The emitted light signals from the light source can pass through the first light-transparent region for transmission into the coronary sinus. The reflected light signals can comprise portions of the emitted light signals not absorbed within the coronary sinus and reflected from the coronary sinus. The reflected light signals can pass through the second light-transparent region for detection by the light sensor.

In block <NUM>, the process can involve emitting, using the light source, a first light signal comprising a first wavelength into the coronary sinus through the first light-transparent region of the first wall portion. In block <NUM>, the process can involve detecting, using the light sensor, a first reflected light signal from the coronary sinus comprising a reflected portion of the first light signal through the second light-transparent region of the first wall portion. In block <NUM>, the process can involve emitting, using the light source, a second light signal comprising a second wavelength into a coronary sinus through the first light-transparent region of the first wall portion. In block <NUM>, the process can involve detecting, using the light sensor, a second reflected light signal from the coronary sinus comprising a reflected portion of the second light signal through the second light-transparent region of the first wall portion.

In some instances, the first wall portion of the medical implant device can be positioned over an extraluminal surface of the coronary sinus. A first surface of the first wall portion can be oriented toward and/or in contact with the extraluminal surface of the coronary sinus such that the emitted light signals from the light source can be transmitted through the first light-transparent region, and into the coronary sinus through the coronary sinus wall. Reflected light signals from the coronary sinus can pass through the coronary sinus wall and the second light-transparent region for detection by the light sensor. In some instances, emitting the first light signal and emitting the second light signal each comprise emitting a respective light signal through a coronary sinus wall portion. For example, a first light signal comprising an infrared light signal and/or a second light signal comprising a red light signal can travel from the light source through the first light-transparent region and the coronary sinus wall portion, and into the coronary sinus. Detecting the first reflected light signal and detecting the second reflected light signal can each comprise receiving a respective reflected light signal through the same and/or another coronary sinus wall portion.

In some instances, the first wall portion of the medical implant device can be positioned over an atrial wall portion adjacent to a coronary sinus wall portion. The first wall portion of the medical implant device can be configured to be positioned over a surface of a first atrial wall portion adjacent to a coronary sinus wall portion. The surface of the first atrial wall portion can be oriented toward a left atrium. For example, a first surface of the first wall portion can be over and/or in contact with a surface of the atrial wall portion oriented toward the left atrium such that light signals emitted from the light source can pass through the first light-transparent region, the atrial wall portion and the adjacent coronary sinus wall portion, and into the coronary sinus. The reflected light signals from the coronary sinus can pass through a coronary sinus wall portion, an adjacent portion of the atrial wall and the second light-transparent region for detection by the light sensor. In some instances, emitting the first light signal and emitting the second light signal can each comprise emitting a respective light signal through an atrial wall portion. Detecting the first reflected light signal and detecting the second reflected light signal can each comprise receiving a respective reflected light signal through the same and/or another atrial wall portion.

It will be understood that one or more processes described herein can be applicable to one or more coronary veins other than the coronary sinus, including one or more other coronary veins of the greater cardiac venous system. For example, the first wall portion of the medical implant device can be positioned over an extraluminal surface of a great cardiac vein to measure light absorption of blood flowing through the great cardiac vein. A first surface of the first wall portion can be oriented toward and/or in contact with the extraluminal surface of the great cardiac vein such that the emitted light signals from the light source can be transmitted through the first light-transparent region, through a portion of a great cardiac vein wall and into the great cardiac vein. Reflected light signals from the great cardiac vein can pass through the wall of the great cardiac vein and the second light-transparent region for detection by the light sensor. In some instances, emitting the first light signal and emitting the second light signal each comprise emitting a respective light signal through the great cardiac vein wall portion. For example, a first light signal comprising an infrared light signal and/or a second light signal comprising a red light signal can travel from the light source through the first light-transparent region and the great cardiac vein wall portion, and into the great cardiac vein. Detecting the first reflected light signal and detecting the second reflected light signal can each comprise receiving a respective reflected light signal through the same and/or another great cardiac vein wall portion.

In some instances, the first wall portion of the medical implant device can be positioned over a heart chamber wall portion, such as an atrial wall portion, adjacent to a great cardiac vein wall portion. The first wall portion of the medical implant device can be configured to be positioned over a surface of a first atrial wall portion adjacent to a great cardiac vein wall portion. The surface of the first atrial wall portion can be oriented toward a left atrium. For example, a first surface of the first wall portion can be over and/or in contact with a surface of the atrial wall portion oriented toward the left atrium such that light signals emitted from the light source can pass through the first light-transparent region, the atrial wall portion and the adjacent great cardiac vein wall portion, and into the great cardiac vein. The reflected light signals from the great cardiac vein can pass through a great cardiac vein wall portion, an adjacent portion of the atrial wall and the second light-transparent region for detection by the light sensor. In some instances, emitting the first light signal and emitting the second light signal can each comprise emitting a respective light signal through an atrial wall portion. Detecting the first reflected light signal and detecting the second reflected light signal can each comprise receiving a respective reflected light signal through the same and/or another atrial wall portion.

As described herein, oxygenated hemoglobin and deoxygenated hemoglobin can absorb infrared light and red light differently. Oxygenated hemoglobin can absorb more infrared light than red light. Deoxygenated hemoglobin can absorb more red light than infrared light. The difference in light absorption properties of hemoglobin can be used to determine blood oxygen saturation information for the blood flowing through a coronary vein, including the coronary sinus or the great cardiac vein. In some instances, the light source can be configured to emit a first light signal at a first wavelength in an infrared range. For example, the first light signal can have a wavelength of about <NUM> nanometer (nm). In some instances, the light source can be configured to emit a second light signal at a second wavelength in the red range. For example, the second light signal have a wavelength of about <NUM> nanometers (nm). The medical implant device can measure and/or detect the light absorption properties of blood flowing through the coronary vein, such as the coronary sinus or great cardiac vein. The light absorption properties can be used to determine oxygen saturation level of the blood.

Emission of light signal by the light source and detection of reflected light signal by the light sensor can occur at any number of different time intervals. In some instances, the light source and light sensor can be configured to continuously emit light and detect light for continuous monitoring of oxygen saturation for blood flowing through the coronary vein. In some instances, light source and light sensor can be configured to emit light and detect light at predetermined intervals, including for example, for a predetermined period every hour, day, and/or week. In some instances, the light source and light sensor can be triggered and/or activated by an external stimulus. The external stimulus can be generated by an operator and/or auto-generated at a preset time interval, such as for on-demand measurements. For example, the light source and light sensor can be triggered and/or activated by an external stimulus using any number of wireless communication techniques to allow an operator to initiate emission and detection of light signals, such as for on-demand measurements, and/or to set time intervals between and/or number of measurements. The light source and light sensor can be triggered and/or activated by an external stimulus using any number of wireless communication techniques to allow an operator to initiate emission and detection of light signals, such as for on-demand measurements, and/or to set time intervals between and/or the number of measurements. Activation and/or control of the light source and light sensor can be performed remotely by an operator at a location different from that of the patient, such as a different room, and/or building.

In some instances, the medical implant device can be configured to perform one or more other steps for determining the blood oxygen saturation level. In some instances, computation of blood oxygen saturation using the light absorption properties of the blood can be performed by the medical implant device. In some instances, one or more other steps for determining the blood oxygen saturation level can be performed externally from the medical implant device. For example, the light absorption properties of the blood determined by the light source and light sensor can be communicated to an external device, such as by wireless communication techniques, including a device external of the patient, to be used for calculating the blood oxygen saturation information.

Monitoring of oxygen utilization by the myocardium can facilitate detection and/or prediction of a number of conditions. In some instances, coronary vein, including coronary sinus and/or great cardiac vein, blood saturation can be used to predict acute decompensated heart failure (ADHF). For example, blood oxygen saturation information obtained using the light absorption properties can be combined with one or more other physiological metrics to determine a possible acute decompensated heart failure (ADHF) event, including for example, heart rate, blood pressure, and/or electrophysiology measurements (e.g., EKG). In some instances, a drop in blood oxygen saturation can be due to insufficient coronary blood perfusion, indicating for example, epicardial coronary stenosis and/or coronary microvascular disease. A decrease in blood oxygen saturation can also be due to demand ischemia, such as higher oxygen demand than available oxygen supply. A high oxygen demand relative to oxygen supply can indicate hypertrophic cardiomyopathy, and/or tachycardia. Increase in blood oxygen saturation can indicate, for example, energy metabolism impairment in heart failure with preserved ejection fraction (HFpEF), myocardial fibrosis, scar formation and/or infiltrative disorders.

In some instances, a measurement of a systemic arterial blood oxygen saturation can be used in combination with a measurement of a coronary vein, such as coronary sinus and/or great cardiac vein, blood oxygen saturation. For example, one or more measurements of the systemic arterial blood oxygen saturation can be used in combination with one or more coronary vein blood oxygen saturation measurements to facilitate determining the health of the heart, including prediction of acute decompensated heart failure (ADHF). In some instances, one or more systemic arterial blood oxygen saturation measurements can provide a blood oxygen saturation baseline for a patient, for example serving as a reference point against which coronary vein blood oxygen saturation measurements can be compared in determining whether coronary vein blood oxygen saturation measurements indicate a problem with heart function or an oxygenation problem elsewhere in the body (e.g., a deterioration of blood oxygenation in the lungs). In some instances, a difference between the systemic arterial blood oxygen saturation and coronary vein blood oxygen saturation can be used. A change in the difference between the systemic arterial blood oxygen saturation and the coronary vein blood oxygen saturation can be used to diagnose a problem with heart function. For example, a change in the difference between the systemic arterial blood oxygen saturation and the coronary vein blood oxygen saturation in combination with a change in the coronary vein blood oxygen saturation can indicate a problem with the heart. A change in the difference between the systemic arterial blood oxygen saturation and the coronary vein blood oxygen saturation in combination with a change in the systemic arterial blood oxygen saturation can indicate a problem outside of the heart. The systemic blood oxygen saturation measurements and coronary vein blood oxygen saturation measurements may or may not be taken simultaneously. In some instances, the systemic blood oxygen saturation measurements and coronary vein blood oxygen saturation measurements can be taken close enough in time to allow desired comparison between the two, including within an hour, a day and/or a week apart.

In some instances, coronary vein, including coronary sinus and/or great cardiac vein, blood oxygen saturation can be used in combination with other physiological metrics to monitor the physiological state of the patient, such as to improve tracking of disease progress and/or diagnosis. In some instances, coronary vein blood oxygen saturation can be used in combination with hemodynamic metrics (e.g., intracardiac pressures, systemic blood pressure, heart rate), electrophysiology measurements (e.g., EKG), systemic oxygen saturation (e.g., systemic SaO2), venous oxygen saturation (SvO2), and/or indices of aerobic and anaerobic metabolism (e.g., pH, lactate). Coronary vein blood oxygen saturation can be used in combination with other physiological metrics to track progress and/or facilitate diagnosis of various cardiovascular diseases and/or abnormalities.

The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (e.g., with body parts, heart, tissue, etc. being simulated).

Depending on the embodiment, certain acts, events, or functions of any of the processes or algorithms described herein can be performed in a different sequence, may be added, merged, or left out altogether. Thus, in certain examples, not all described acts or events are necessary for the practice of the processes.

Conditional language used herein, such as, among others, "can," "could," "might," "may," "e.g.," and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is intended in its ordinary sense and is generally intended to convey that certain examples include, while other examples do not include, certain features, elements and/or steps. Thus, such conditional language is not generally intended to imply that features, elements and/or steps are in any way required for one or more examples or that one or more examples necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and/or steps are included or are to be performed in any particular embodiment. The terms "comprising," "including," "having," and the like are synonymous, are used in their ordinary sense, and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Conjunctive language such as the phrase "at least one of X, Y and Z," unless specifically stated otherwise, is understood with the context as used in general to convey that an item, term, element, etc. may be either X, Y or Z. Thus, such conjunctive language is not generally intended to imply that certain examples require at least one of X, at least one of Y and at least one of Z to each be present.

It should be appreciated that in the above description of examples, various features are sometimes grouped together in a single embodiment, Figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than are expressly recited in that claim. Moreover, any components, features, or steps illustrated and/or described in a particular example herein can be applied to or used with any other example(s). Further, no component, feature, step, or group of components, features, or steps are necessary or indispensable for each embodiment. Thus, it is intended that the scope of the claimed inventions should not be limited by the particular examples described above, but should be determined only by a fair reading of the appended claims.

It should be understood that certain ordinal terms (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply physical characteristics or ordering. Therefore, as used herein, an ordinal term (e.g., "first," "second," "third," etc.) used to modify an element, such as a structure, a component, an operation, etc., does not necessarily indicate priority or order of the element with respect to any other element, but rather may generally distinguish the element from another element having a similar or identical name (but for use of the ordinal term). In addition, as used herein, indefinite articles ("a" and "an") may indicate "one or more" rather than "one. " Further, an operation performed "based on" a condition or event may also be performed based on one or more other conditions or events not explicitly recited.

Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the examples belong. It be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

The spatially relative terms "outer," "inner," "upper," "lower," "below," "above," "vertical," "horizontal," and similar terms, may be used herein for ease of description to describe the relations between one element or component and another element or component as illustrated in the drawings. It be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation, in addition to the orientation depicted in the drawings. For example, in the case where a device shown in the drawing is turned over, the device positioned "below" or "beneath" another device may be placed "above" another device. Accordingly, the illustrative term "below" may include both the lower and upper positions. The device may also be oriented in the other direction, and thus the spatially relative terms may be interpreted differently depending on the orientations.

Claim 1:
A medical implant device (<NUM>), comprising:
a light source (<NUM>) and a light sensor (<NUM>); and
a housing (<NUM>) configured to receive the light source and the light sensor, the housing comprising:
a first wall portion (<NUM>) configured to be positioned over an extraluminal surface of a coronary sinus, the first wall portion comprising a first surface (<NUM>) oriented toward the extraluminal surface,
a first light-transparent region (<NUM>) of the first wall portion configured to allow passage therethrough of an emitted light signal from the light source into the coronary sinus, and
a second light-transparent region (<NUM>) of the first wall portion configured to allow passage therethrough of a reflected light signal from within the coronary sinus for detection by the light sensor.