Patent Application
20240389902
The present disclosure generally relates to the field of measuring light absorption properties of blood flowing through a coronary vein. Deoxygenated blood from the myocardium can drain into the coronary veins, including the coronary sinus, which can then return the deoxygenated blood to the right atrium. Measuring the oxygenation of the blood flowing through a coronary vein can be used in monitoring various health metrics, including monitoring health of the heart.
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 the scope of the inventions. 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 inventive 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.
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.
Although certain preferred examples are disclosed below, inventive subject matter extends beyond the specifically disclosed examples to other alternative examples and/or uses and to modifications and equivalents thereof. Thus, the scope of the claims that may arise herefrom is not limited by any of the particular examples described below. For example, 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.
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 5 from the inferior vena cava 15 and superior vena cava 16 to flow into the right ventricle 4, and oxygenated blood arrive in the left atrium 2 from the pulmonary veins to flow into the left ventricle 3. During ventricular systole, deoxygenated blood from the right ventricle 4 can flow into the pulmonary trunk 11 for transport to the lungs (e.g., via the left 14 and right 13 pulmonary arteries), and oxygenated blood can flow from the left ventricle 3 to the aorta 12 for transport to the rest of the body.
Veins collecting deoxygenated blood from the myocardium can drain into the coronary sinus 18. The coronary sinus 18 can then return the deoxygenated blood into the right atrium 5 through the coronary sinus ostium 19. 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., SaO2) of blood flowing through a coronary vein, such as the coronary sinus 18, can provide information regarding the health of the heart 1. Oxygen saturation of blood flowing through the coronary vein, such as the coronary sinus 18, 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 660 nanometer (nm). The second light signal can be a red light signal, such as a light signal having a wavelength of about 940 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
The medical implant device 200 can comprise an anchor 202 associated with the housing 204 to secure the medical implant device 200 to the heart. The anchor 202 can be configured to position a portion of the housing 204 over and/or in contact with the extraluminal surface of the coronary sinus 18 to facilitate desired transmission of light signals into the coronary sinus 18 and detection of reflected light signals from the coronary sinus 18. As described in further detail herein, the anchor 202 can be configured to be secured to one or more adjacent portions of the heart wall 17 on either side of the coronary sinus 18.
An anchor 302 can be associated with, for example coupled to, the housing 304 and configured to secure the medical implant device 300 to the heart. The anchor 302 can be configured to mechanically couple the medical implant device 300 to one or more heart wall portions adjacent to the coronary sinus 18. For example, the anchor 302 can comprise a first anchor component 330 and a second anchor component 350 each comprising a portion configured to be secured to portions of the heart wall 17 on either side of the coronary sinus 18. The first anchor component 330 and a second anchor component 350 can secure the implant device 300 to the heart wall 17 such that the first wall portion 308 of the housing 304 can be positioned over and/or in contact with a portion of the extraluminal surface of the coronary sinus 18. The first wall portion 308 can be positioned over and/or in contact with the extraluminal surface of the coronary sinus 18 to facilitate transmitting light signals into and receiving light signals from the coronary sinus 18. It will be understood that although the medical implant device 300 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 300 can be powered using inductive charging. One or more batteries can be associated with one or more portions of the medical implant device 300, for example being received within the cavity 306 of the housing 304. 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.
The first and second anchor components 330, 350 can be coupled to portions of the housing 304 such that the anchor components 330, 350 do not interfere with emission of light signals by the light source 370 into the coronary sinus and detection by the light sensor 380 of reflected light signals from the coronary sinus. The first anchor component 330 can be coupled to a first housing portion 316. The second anchor component 350 can be coupled to a second housing portion 318. The first and second housing portions 316, 318 can be laterally disposed from the first and second light-transparent regions 312, 314. In some instances, the first housing portion 316 can comprise a first lateral wall portion 320 and the second housing portion 318 can comprise a second lateral wall portion 322. In some instances, the first and second lateral housing portions 320, 322 can be at an angle relative to the first wall portion 308. In some instances, the first and second lateral housing portions 320, 322 can have an orientation perpendicular or substantially perpendicular to that of the first wall portion 308. For example, the first lateral wall portion 320 can comprise a first external lateral surface 324 to which the first anchor component 330 can be coupled. The second lateral wall portion 322 can comprise a second external lateral surface 326 to which the second anchor component 350 can be coupled. In some instances, the first housing portion 316 and the second housing portion 318 can be at opposing positions on the housing 304. The first external surface 324 and the second external surface 326 can each have a perpendicular or substantially perpendicular orientation relative to the first wall portion 308, including the first surface 310 of the first wall portion 308.
The first anchor component 330 can comprise a first anchor portion 332 oriented at an angle relative to the first wall portion 308, including the first surface 310. The second anchor component 350 can comprise a second anchor portion 352 oriented at an angle relative to the first wall portion 308, including the first surface 310. A first end portion 334, 354 of each of the first and second anchor components 330, 350 can be coupled to the respective housing portions. For example, the first end portion 334 of the first anchor component 330 can be coupled to the first lateral wall portion 320, including the first external lateral surface 324. The first end portion 354 of the second anchor component 350 can be coupled to the second lateral wall portion 322, including the second external lateral surface 326. In some instances, the first end portion 334 of the first anchor component 330 can comprise a lateral anchor portion coupled to the first lateral wall portion 320. The first end portion 354 of the second anchor component 350 can comprise a second lateral anchor portion coupled to the second lateral wall portion 322. Each of the first lateral anchor portion and the second lateral anchor portion can have the same orientation as the first surface 310 of the first wall portion 308. A second end portion 336, 356 of each of the first and second anchor components 330, 350 can be configured to be coupled to respective heart wall portions. For example, the second end portion 336 of the first anchor component 330 can be secured to a first heart wall portion on a first side of the coronary sinus. The second end portion 356 of the second anchor component 350 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 336, 356 can be mechanically secured to the heart wall. In some instances, each of the second end portions 336, 356 can comprise at least one of a clip, corkscrew and barb. In some instances, each of the second end portions 336, 356 can comprise openings configured to facilitate stitching of the second end portions 336, 356 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 370 can comprise one or more light emitting diodes (LEDs). The medical implant device 300 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 370 can comprise a light emitting diode (LED) configured to emit light having a wavelength of about 940 nanometers (nm) and a light emitting diode (LED) configured to emit light having a wavelength of about 660 nanometer (nm). In some instances, the light sensor 380 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 300 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 300 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 304 receiving the light source 370 and the light sensor 380 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 330, 350 can facilitate securing the medical implant device 300 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.
In some instances, the first and second anchor components 530, 550 can be coupled to respective portions of the first wall portion 508 that are laterally disposed from a first and second light-transparent regions 512, 514 on the first wall portion 508. A first end portion 534, 554 of each of the first and second anchor components 530, 550 can be coupled to respective portions of the first surface 510 laterally disposed from the first and second light-transparent regions 512, 514 so as not to interfere with emission of light signals by the light source 570 into the coronary sinus and detection by the light sensor 580 of reflected light signals from the coronary sinus. In some instances, the first and second anchor components 530, 550 can be coupled to opposing portions on the first surface 510. A second end portion 536, 556 of each of the first and second anchor components 530, 550 can be configured to be coupled to heart wall portions on a first side and a second side of the coronary sinus, respectively.
The first and second anchor components 630, 650 can be coupled to portions of the housing 604 such that the anchor components 630, 650 do not interfere with emission of light signals by the light source 670 into the coronary sinus and detection by the light sensor 680 of reflected light signals from the coronary sinus. The first anchor component 630 and second anchor component 650 can be coupled to a first housing portion 616 and a second housing portion 618, respectively, which are each laterally disposed from the first and second light-transparent regions 612, 614. A first end portion 634, 654 of each of the first and second anchor components 630, 650 can be coupled to the respective housing portions. In some instances, the first housing portion 616 can comprise a first lateral wall portion 620 and the second housing portion 618 can comprise a second lateral wall portion 622. For example, the first lateral wall portion 620 can comprise a first external lateral surface 624 to which the first anchor component 630 can be coupled. The second lateral wall portion 622 can comprise a second external lateral surface 626 to which the second anchor component 650 can be coupled. The first and second lateral housing portions 620, 622 can be at an angle relative to the first wall portion 608. In some instances, the first and second lateral housing portions 620, 622 can have an orientation perpendicular or substantially perpendicular to that of the first wall portion 608. In some instances, the first housing portion 616 and the second housing portion 618 can be at opposing positions on the housing 604. The first external surface 624 and the second external surface 626 can each have a perpendicular or substantially perpendicular orientation relative to the first wall portion 608, including the first surface 610 of the first wall portion 608. The first end portion 634 of the first anchor component 630 can be coupled to the first lateral wall portion 620, including the first external lateral surface 624. The first end portion 654 of the second anchor component 650 can be coupled to the second lateral wall portion 622, including the second external lateral surface 626.
In some instances, a second end portion 636, 656 of each of the first and second anchor components 630, 650 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 630, 650 may not be secured to the heart wall. For example, the first and second anchor components 630, 650, such as the first and second curved surface portions 638, 658, can be configured to be coupled to the coronary sinus wall, without being coupled to the heart wall.
The medical implant devices 500, 600 described with reference to
In some instances, a medical implant device can comprise an anchor configured to magnetically secure the medical implant device to the heart.
In some instances, the first magnetic component 830 can be along at least a portion of a perimeter of the cavity 806 within the housing 804. In some instances, the first magnetic component 830 can comprise two or more discrete portions at respective positions within the cavity 806. For example, the first magnetic component 830 can comprise a first magnetic portion 832 and a second magnetic portion 834 each extending along a respective portion of the perimeter of the cavity 806 of the housing 804. In some instances, the first magnetic portion 832 and the second magnetic portion 834 can be at opposing positions around the perimeter of the cavity 806, for example, extending along opposing portions of the perimeter. The perimeter of the cavity 806 is shown in
In some instances, respective ends of the first and second mating magnetic portions 852, 854 can be coupled to one another. For example, the second magnetic component 850 can comprise a third portion 856 extending between first ends 860, 864 of the first and second mating magnetic portions 852, 854 and a fourth portion 858 extending between second ends 862, 866 of the first and second mating magnetic portions 852, 854. The first and second mating magnetic portions 852, 854 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 852, 854, and the third and fourth portions 856, 858 of the second magnetic component 850 can define an opening such that light signals can be transmitted therethrough. For example, the second magnetic component 850 can form a ring shape having a central opening configured to be aligned with the first and second light-transparent regions 812, 814 of the first wall portion 808.
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.
The medical implant device 1000 can comprise a housing 1004 and an anchor 1002 configured to magnetically secure the housing 1004 over an extraluminal surface of a coronary sinus. A light source 1070 and a light sensor 1080 can be received within a cavity 1006 of the housing 1004. A first wall portion 1008 of the housing 1004 can be configured to be positioned over the extraluminal surface of the coronary sinus. For example, a first surface 1010 of the first wall portion 1008 can be over and in contact with the extraluminal surface of the coronary sinus. The first wall portion 1008 can comprise a first light-transparent region 1012 to allow passage therethrough of an emitted light signal from the light source 1070 and a second light-transparent region 1014 to allow passage therethrough of a reflected light signal from the coronary sinus for detection by the light sensor 1080. In some instances, the first and second light-transparent regions 1012, 1014 may not be distinct regions. For example, the first and second light-transparent regions 1012, 1014 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 1008. The anchor 1002 can comprise a first magnetic component 1030 disposed externally of the housing 1004 and laterally disposed from the first and second light-transparent regions 1012, 1014. For example, the first magnetic component 1030 can comprise a first magnetic portion 1032 and a second magnetic portion 1034 coupled to a first and second housing portion 1016, 1018, respectively, that are laterally disposed from the first and second light-transparent regions 1012, 1014. In some instances, the first housing portion 1016 can comprise a first lateral wall portion 1020 and the second housing portion 1018 can comprise a second lateral wall portion 1022. In some instances, the first and second lateral housing portions 1020, 1022 can be at an angle relative to the first wall portion 1008. In some instances, the first and second lateral housing portions 1020, 1022 can have an orientation perpendicular or substantially perpendicular to that of the first wall portion 1008, including the first surface 1010. The first magnetic portion 1032 can be coupled a first external lateral surface 1024 of the first lateral wall portion 1020 and the second magnetic portion 1034 can be coupled to a second external lateral surface 1026 of the second lateral wall portion 1022. The first and second external lateral surfaces 1024, 1026 can have an orientation perpendicular or substantially perpendicular to that of the first wall portion 1008, including the first surface 1010. In some instances, the first and second lateral housing portions 1020, 1022 can be at opposing positions on the housing 1004.
In some instances, the first magnetic component 1030 can extend around at least a portion of an outer perimeter of the housing 1004. For example, the first magnetic portion 1032 and the second magnetic portion 1034 can each extend along a respective portion of the outer perimeter of the housing 1004. In some instances, the first magnetic portion 1032 and the second magnetic portion 1034 can extend along opposing portions of the outer perimeter.
The first and second mating magnetic portions 1052, 1054 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 1052, 1054 can be coupled to one another. For example, the second magnetic component 1050 can comprise a third portion 1056 extending between first ends 1060, 1064 of the first and second mating magnetic portions 1052, 1054 and a fourth portion 1058 extending between second ends 1062, 1066 of the first and second mating magnetic portions 1052, 1054. The first and second mating magnetic portions 1052, 1054, and the third and fourth portions 1056, 1058 of the second magnetic component 1050 can form a ring shape having a central opening configured to be aligned with the first and second light-transparent regions 1012, 1014 of the first wall portion 1008 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 800, 1000 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 830, 1030 and second magnetic components 850, 1050 can secure the respective housing 804, 1004 over the extraluminal surface of the great cardiac vein. The second magnetic components 850, 1050 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.
Referring to
The first anchor component 1130 and second anchor component 1150 can be coupled to a first and second housing portion 1116, 1118, respectively, that are laterally disposed from the first and second light-transparent regions 1112, 1114. In some instances, the first housing portion 1116 can comprise a first lateral wall portion 1120 and the second housing portion 1118 can comprise a second lateral wall portion 1122. In some instances, the first and second lateral housing portions 1120, 1122 can be at an angle relative to the first wall portion 1108. In some instances, the first and second lateral housing portions 1120, 1122 can have an orientation perpendicular or substantially perpendicular to that of the first wall portion 1108, including the first surface 1110. The first anchor component 1130 can be coupled a first external lateral surface 1124 of the first lateral wall portion 1120 and the second anchor component 1150 can be coupled to a second external lateral surface 1126 of the second lateral wall portion 1122. In some instances, the first and second lateral housing portions 1120, 1122 can be at opposing positions on the housing 1104. The first and second external lateral surfaces 1124, 1126 can have an orientation perpendicular or substantially perpendicular to that of the first wall portion 1108, including the first surface 1110.
In some instances, the first and second anchor components 1130, 1150 can extend along respective portions of an outer perimeter of the housing 1104. In some instances, the first anchor component 1030 and the second anchor component 1150 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 800, 1000 described with reference to
In some instances, the medical implant device 1100 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 1100 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 1100 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 1102 can be configured to be secured to the atrial wall such that the housing 1104, such as the first and second light-transparent regions 1112, 1114 of the first wall portion 1108, 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.
In block 1304, 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 1306, 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 1308, 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 1310, 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 660 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 940 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.
Provided below is a list of examples, each of which may include aspects of any of the other examples disclosed herein. Furthermore, aspects of any example described above may be implemented in any of the numbered examples provided below.
Example 1: A medical implant device comprising a light source and a light sensor, and a housing configured to receive the light source and the light sensor. The housing can comprise a first wall portion configured to be positioned over an extraluminal surface of a coronary sinus, the first wall portion comprising a first surface oriented toward the extraluminal surface. A first light-transparent region of the first wall portion can be configured to allow passage therethrough of an emitted light signal from the light source into the coronary sinus, and a second light-transparent region 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.
Example 2: The device of any example herein, in particular example 1, further comprising an anchor configured to mechanically couple to a heart wall portion adjacent to the coronary sinus and hold the first wall portion over the extraluminal surface of the coronary sinus.
Example 3: The device of any example herein, in particular example 2, wherein the anchor comprises a portion oriented at an angle relative to the first surface of the housing and configured to extend between the housing and the heart wall portion to allow securing the housing to the heart wall portion.
Example 4: The device of any example herein, in particular example 3, wherein the portion of the anchor comprises a curved surface portion configured to be oriented toward and secured to a portion of the extraluminal surface.
Example 5: The device of any example herein, in particular example 3 or 4, wherein the portion of the anchor comprises a first anchor portion coupled to a first housing portion laterally disposed from the first and second light-transparent regions and oriented at an angle relative to the first surface, and configured to be secured to a first heart wall portion on a first side of the coronary sinus; and the anchor comprises a second anchor portion coupled to a second housing portion laterally disposed from the first and second light-transparent regions and oriented at an angle relative to the first surface, and configured to be secured to a second heart wall portion on a second side of the coronary sinus.
Example 6: The device of any example herein, in particular example 5, wherein the first housing portion and the second housing portion are at opposing positions.
Example 7: The device of any example herein, in particular example 5 or 6, wherein the first anchor portion and second anchor portion each comprise at least one of a clip, corkscrew and barb configured to be secured to the heart wall portion.
Example 8: The device of any example herein, in particular examples 5 to 7, wherein the first anchor portion and second anchor portion each comprise respective openings configured to receive a stitch that is configured to be secured to the heart wall
Example 9: The device of any example herein, in particular example 2, wherein the anchor comprises a first lateral anchor portion coupled to a first housing portion laterally disposed from the first and second light-transparent regions; and a second lateral anchor portion coupled to a second housing portion laterally disposed from the first and second light-transparent regions, each of the first lateral anchor portion and the second lateral anchor portion comprising the same orientation as the first surface.
Example 10: The device of any example herein, in particular example 10, wherein the first housing portion and the second housing portion are opposing portions of the housing.
Example 11: A medical implant device comprising a light source and a light sensor and a housing configured to receive the light source and the light sensor. The housing can comprise a first wall portion configured to be positioned over a surface of a first atrial wall portion adjacent to a coronary sinus wall portion, the surface of the atrial wall portion being oriented toward a left atrium, and the first wall portion comprising a first surface oriented toward the surface of the atrial wall portion. A first light-transparent region on the first wall portion can allow passage therethrough of an emitted light signal from the light source, and a second light-transparent region on the first wall portion can allow passage therethrough of a reflected light signal from the coronary sinus for detection by the light sensor.
Example 12: The device of any example herein, in particular example 11, further comprising an anchor associated with a housing portion laterally disposed from the first light-transparent region and the second light-transparent region, and comprising a lateral portion having the same orientation as the first surface of the housing, the lateral portion being configured to mechanically couple to a second atrial wall portion adjacent to the first atrial wall portion.
Example 13: The device of any example herein, in particular example 12, wherein the anchor comprises at least one of a clip, corkscrew and barb configured to be secured to the second atrial wall portion.
Example 14: The device of any example herein, in particular example 12 or 13, wherein the anchor comprises an opening configured to receive a stitch that is configured to be secured to the second atrial wall portion.
Example 15: The device of any example herein, in particular examples 12 to 14, wherein the lateral portion comprises a first lateral anchor portion coupled to a first housing portion laterally disposed from the first and second light-transparent regions and comprising the same orientation as the first surface of the housing, and configured to be secured to a second atrial wall portion; and the anchor comprises a second lateral anchor portion coupled to a second housing portion laterally disposed from the first and second light-transparent regions and comprising the same orientation as the first surface of the housing, and configured to be secured to a third atrial wall portion.
Example 16: The device of any example herein, in particular example 15, wherein the first housing portion and the second housing portion are at opposing positions.
Example 17: The device of any example herein, in particular examples 12 to 16, wherein the anchor extends circumferentially around the housing.
Example 18: A medical implant device comprising a light source and a light sensor, a first magnetic component, a housing associated with the first magnetic component, and configured to receive the light source and the light sensor. The housing can comprise a first wall portion configured to be positioned over an extraluminal surface of the coronary sinus, the first wall portion comprising a first surface oriented toward the extraluminal surface. A first light-transparent region on the first wall portion can allow passage therethrough of an emitted light signal from the light source, and a second light-transparent region on the first wall portion can allow passage therethrough of a reflected light signal from the coronary sinus for detection by the light sensor. The medical implant device can include a second magnetic component configured to be positioned within the coronary sinus to be aligned with and magnetically couple to the first magnetic component through a coronary sinus wall portion to position the first light-transparent region and the second light-transparent region over the extraluminal surface of the coronary sinus
Example 19: The device of any example herein, in particular example 18, wherein the first magnetic component comprises a portion received within the housing at a position laterally disposed from the first and second light-transparent regions.
Example 20: The device of any example herein, in particular example 19, wherein the first magnetic component comprises a first ring shape circumferentially extending around an inner perimeter of the housing, and the second magnetic component comprises a second ring shape, a central opening of the second ring shape being configured to be aligned with the first and second light-transparent regions of the first wall portion.
Example 21: The device of any example herein, in particular example 18, wherein the first magnetic component extends circumferentially around an outer perimeter of the housing and wherein the second magnetic component comprises a ring shape configured to be aligned with the first magnetic component.
Example 22: The device of any example herein, in particular examples 18 to 21, wherein the first magnetic component comprises a first magnetic portion coupled to a first lateral housing portion at a position laterally disposed from the first and second light-transparent regions.
Example 23: The device of any example herein, in particular example 22, wherein the first magnetic component comprises a second magnetic portion coupled to a second lateral housing portion at a position laterally disposed from the first and second light-transparent region.
Example 24: The device of any example herein, in particular example 23, wherein the first lateral housing portion and the second lateral housing portion are at opposing positions.
Example 25: A method of providing a coronary sinus blood oxygen saturation measurement, the method comprising providing a medical implant device, the medical implant device comprising: a light source and a light sensor, and a housing receiving the light source and the light sensor, a first wall portion of the housing comprising a first light-transparent region to allow passage therethrough of an emitted light signal and a second light-transparent region to allow passage therethrough of a reflected light signal. The method can include emitting, using the light source, a first light signal comprising a first wavelength into a coronary sinus through the first light-transparent region of the first wall portion; 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; 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; and 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.
Example 26: The method of any example herein, in particular example 25, wherein emitting the first light signal and emitting the second light signal each comprise emitting a respective light signal through a coronary sinus wall portion; and detecting the first reflected light signal and detecting the second reflected light signal each comprise receiving a respective reflected light signal through the same and/or another coronary sinus wall portion.
Example 27: The method of any example herein, in particular example 25 or 26, wherein emitting the first light signal and emitting the second light signal each comprise emitting a respective light signal through an atrial wall portion; and detecting the first reflected light signal and detecting the second reflected light signal each comprise receiving a respective reflected light signal through the same and/or another atrial wall portion.
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. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. 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 inventive 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 inventions herein disclosed and claimed below should not be limited by the particular examples described above, but should be determined only by a fair reading of the claims that follow.
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.
Unless otherwise expressly stated, comparative and/or quantitative terms, such as “less,” “more,” “greater,” and the like, are intended to encompass the concepts of equality. For example, “less” can mean not only “less” in the strictest mathematical sense, but also, “less than or equal to.”
This application is a continuation of International Patent Application No. PCT/US2023/012366, filed Feb. 5, 2023, entitled “MEDICAL IMPLANT DEVICE,” which claims the benefit of U.S. Provisional Patent Application No. 63/308,460, filed Feb. 9, 2022, entitled “MEDICAL IMPLANT DEVICE,” the disclosures each of which are hereby expressly incorporated by reference herein in their entireties for all purposes.
| Number | Date | Country | |
|---|---|---|---|
| 63308460 | Feb 2022 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2023/012366 | Feb 2023 | WO |
| Child | 18796077 | US |
