Patent Grant
12213817
The present technology generally relates to implantable medical devices and, in various aspects, to methods for monitoring implantable interatrial systems for selectively controlling blood flow between cavities of a patient's heart.
Heart failure is a medical condition associated with the inability of the heart to effectively pump blood to the body. Heart failure affects millions of people worldwide, and may arise from multiple root causes, but is generally associated with myocardial stiffening, myocardial shape remodeling, and/or abnormal cardiovascular dynamics. Chronic heart failure is a progressive disease that worsens considerably over time. Initially, the body's autonomic nervous system adapts to heart failure by altering the sympathetic and parasympathetic balance. While these adaptations are helpful in the short-term, over a longer period of time they serve to make the disease worse.
Heart failure (HF) is a medical term that includes both heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF). The prognosis with both HFpEF and HFrEF is poor; one-year mortality is 26% and 22%, respectively, according to one epidemiology study. In spite of the high prevalence of HFpEF, there remain limited options for HFpEF patients. Pharmacological therapies have been shown to impact mortality in HFrEF patients, but there are no similarly-effective evidence-based pharmacotherapies for treating HFpEF patients. Current practice is to manage and support patients while their health continues to decline. Moreover, people may live unknowingly with heart failure until treatment options are limited. For example, a patient with HFpEF may not be symptomatic until the heart failure disease has progressed to the late stages or the patient presents with comorbidities.
A common symptom among heart failure patients is elevated left atrial pressure. In the past, clinicians have treated patients with elevated left atrial pressure by creating a shunt between the left and right atria using a blade or balloon septostomy. The shunt decompresses the left atrium (LA) by relieving pressure to the right atrium (RA) and systemic veins. Over time, however, the shunt typically will close or reduce in diameter. More recently, percutaneous interatrial shunt devices have been developed which have been shown to effectively reduce left atrial pressure. However, these percutaneous devices generally have an annular passage with a fixed diameter which fails to account for a patient's changing physiology and condition. For this reason, existing percutaneous shunt devices may have a diminishing clinical effect after a period of time. Many existing percutaneous shunt devices typically are also only available in a single size that may work well for one patient but not another. Also, sometimes the amount of shunting created during the initial procedure is later determined to be less than optimal months after implantation. Accordingly, there is a need for improved devices, systems, and methods for treating heart failure patients, particularly those with elevated left atrial pressure.
The present technology is generally directed to systems and methods for monitoring interatrial shunting systems. A system configured in accordance with an embodiment of the present technology can include, for example, a shunting element implantable into a patient at or adjacent to a septal wall. The shunting element can include a lumen fluidly connecting cavities of the patient's heart (e.g., the LA and the RA) to facilitate blood flow therebetween. The geometry (e.g., size and/or shape) of the lumen can be selectively adjustable (e.g., non-invasively adjustable) to control the amount of blood flow therethrough.
In some embodiments, the shunting element includes one or more radiopaque elements associated with the lumen to allow for non-invasive monitoring of the lumen geometry. For example, to determine the size of the lumen (e.g., before, during, and/or after adjusting the lumen), the clinician can obtain radiographic images of the shunting element and the radiopaque elements from multiple viewing angles (e.g., orthogonal and/or orthonormal viewing angles). Subsequently, the size of the lumen can be calculated based on the locations of the radiopaque elements in the images, the locations of the radiopaque elements relative to the lumen, the viewing angles from which the images were taken, and/or scaling information for the images. The present technology is expected to improve treatment efficacy by allowing the clinician to monitor lumen geometry, determine whether lumen adjustments would be beneficial, and/or confirm whether lumen adjustments were successful.
The terminology used in the description presented below is intended to be interpreted in its broadest reasonable manner, even though it is being used in conjunction with a detailed description of certain specific embodiments of the present technology. Certain terms may even be emphasized below; however, any terminology intended to be interpreted in any restricted manner will be overtly and specifically defined as such in this Detailed Description section. Additionally, the present technology can include other embodiments that are within the scope of the examples but are not described in detail with respect to
Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present technology. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features or characteristics may be combined in any suitable manner in one or more embodiments.
Reference throughout this specification to relative terms such as, for example, “generally,” “approximately,” and “about” are used herein to mean the stated value plus or minus 10%.
As used herein, the terms “interatrial device,” “interatrial shunt device,” “IAD,” “IASD,” “interatrial shunt,” and “shunt” are used interchangeably to refer to a device that, in at least one configuration, includes a shunting element that provides a blood flow between a first region (e.g., a LA of a heart) and a second region (e.g., a RA or coronary sinus of the heart) of a patient. Although described in terms of a shunt between the atria, namely the left and right atria, one will appreciate that the technology may be applied equally to devices positioned between other chambers and passages of the heart, or between other parts of the cardiovascular system or other system. For example, any of the shunts described herein, including those referred to as “interatrial,” may be nevertheless used and/or modified to shunt between the LA and the coronary sinus, or between the right pulmonary vein and the superior vena cava. Moreover, while the disclosure herein primarily describes shunting blood from the LA to the RA, the present technology can be readily adapted to shunt blood from the RA to the LA to treat certain conditions, such as pulmonary hypertension. For example, mirror images of embodiments, or in some cases identical embodiments, used to shunt blood from the LA to the RA can be used to shunt blood from the RA to the LA in certain patients.
Although certain embodiments herein are described with respect to radiopaque elements configured to be visualized via radiographic imaging, it will be appreciated that the principles of the present technology can be adapted for use with other imaging methods. For example, the present technology can alternatively or additionally use markers with selective echogenicity (e.g., largely hyperechoic) configured to be visualized through ultrasound imaging and related imaging methods.
The headings provided herein are for convenience only and do not interpret the scope or meaning of the claimed present technology.
A. Interatrial Shunts for Treatment of Heart Failure
Heart failure can be classified into one of at least two categories based upon the ejection fraction a patient experiences: (1) HFpEF, historically referred to as diastolic heart failure or (2) HFrEF, historically referred to as systolic heart failure. One definition of HFrEF is a left ventricular ejection fraction lower than 35%-40%. Though related, the underlying pathophysiology and the treatment regimens for each heart failure classification may vary considerably. For example, while there are established pharmaceutical therapies that can help treat the symptoms of HFrEF, and at times slow or reverse the progression of the disease, there are limited available pharmaceutical therapies for HFpEF with only questionable efficacy.
In heart failure patients, abnormal function in the left ventricle (LV) leads to pressure build-up in the LA. This leads directly to higher pressures in the pulmonary venous system, which feeds the LA. Elevated pulmonary venous pressures push fluid out of capillaries and into the lungs. This fluid build-up leads to pulmonary congestion and many of the symptoms of heart failure, including shortness of breath and signs of exertion with even mild physical activity. Risk factors for HF include renal dysfunction, hypertension, hyperlipidemia, diabetes, smoking, obesity, old age, and obstructive sleep apnea. HF patients can have increased stiffness of the LV which causes a decrease in left ventricular relaxation during diastole resulting in increased pressure and inadequate filling of the ventricle. HF patients may also have an increased risk for atrial fibrillation and pulmonary hypertension, and typically have other comorbidities that can complicate treatment options.
Interatrial shunts have recently been proposed as a way to reduce elevated left atrial pressure, and this emerging class of cardiovascular therapeutic interventions has been demonstrated to have significant clinical promise.
One challenge with many conventional interatrial shunts is determining the most appropriate size and shape of the shunt lumen. A lumen that is too small may not adequately unload the LA and relieve symptoms; a lumen that is too large may overload the RA and right heart more generally, creating new problems for the patient. Moreover, the relationship between pressure reduction and clinical outcomes and the degree of pressure reduction required for optimized outcomes is still not fully understood, in part because the pathophysiology for HFpEF (and to a lesser extent, HFrEF) is not completely understood. As such, clinicians are forced to take a best guess at selecting the appropriately sized shunt (based on limited clinical evidence) and generally cannot adjust the sizing over time. Worse, clinicians must select the size of the shunt based on general factors (e.g., the size of the patient's anatomical structures, the patient's hemodynamic measurements taken at one snapshot in time, etc.) and/or the design of available devices rather than the individual patient's health and anticipated response. With many such traditional devices, the clinician does not have the ability to adjust or titrate the therapy once the device is implanted, for example, in response to changing patient conditions such as progression of disease. By contrast, interatrial shunting systems configured in accordance with embodiments of the present technology allow a clinician to select shunt size—perioperatively or post-implant—based on the patient and, as discussed above, allow for non-invasive monitoring of lumen geometry to determine whether lumen adjustments would be beneficial and/or confirm whether lumen adjustments were successful.
B. Select Embodiments of Methods for Monitoring Interatrial Shunting Systems
As provided above, the present technology is generally directed to methods for monitoring interatrial shunting systems. Such systems include a shunting element implantable into a patient at or adjacent to a septal wall. The shunting element can include a lumen fluidly connecting the LA and the RA of the patient to facilitate blood flow therebetween. In some embodiments, the lumen is invasively or non-invasively adjustable to selectively control blood flow between the LA and the RA. To allow for monitoring of the lumen geometry (e.g., to confirm whether a desired adjustment was successfully achieved, determine whether an adjustment would be beneficial, etc.), the shunting element can include at least two radiopaque elements positioned such that the spatial relationship between the radiopaque elements varies based on the lumen geometry. Accordingly, the clinician can determine the lumen geometry by taking radiographic images of the radiopaque elements from different viewing angles and calculating the spatial relationship between the radiopaque elements from the image data.
The shunting element 202 can be secured to the septal wall via one or more first anchoring elements 206a and one or more second anchoring elements 206b. Anchoring elements 206a/206b may assume a variety of shapes, such as struts, flanges, coils, braids, cones, etc. In some embodiments, the first anchoring elements 206a are configured to engage a portion of the septal wall facing a first heart chamber (e.g., the RA) and the second anchoring elements 206b are configured to engage a portion of the septal wall facing a second heart chamber (e.g., the LA). In other embodiments the shunting element 202 is anchored in place using anchoring elements positioned on only one side of the septal wall. Optionally, a single anchoring element may be used on one or both sides of the septal wall. In yet other embodiments, the system 200 does not include first and second anchoring elements 206a-b and is instead secured in place by exerting a radially outward pressure against the septal wall or by other suitable mechanisms.
The system 200 can include a first membrane 208a and a second membrane 208b operably coupled to the shunting element 202 (e.g., carried by, connected to, and/or at least partially covering the shunting element 202). In the illustrated embodiment, for example, the first membrane 208a is connected to an end portion of the shunting element 202 near the lumen 204 and the first anchoring elements 206a, while the second membrane 208b is connected to the remaining portions of the shunting element 202 and to the second anchoring elements 206b. The membranes 208a-b can be flexible and can be made of a material that is impermeable to or otherwise resists blood flow therethrough. Optionally, the material can be an anti-thrombogenic material. In some embodiments, the membranes 208a-b are made of a thin, elastic material such as a polymer. For example, the membranes 208a-b can be made of polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), silicone, nylon, polyethylene terephthalate (PET), polyether block amide (pebax), polyurethane, blends or combinations of these materials, or other suitable materials. It will be appreciated that the first and second membranes 208a-b can be configured in many different ways. In other embodiments, for example, the first and second membranes 208a-b can be connected to different portions of the shunting element 202. In further embodiments, the first and second membranes 208a-b can be combined into a single unitary membrane. Optionally, one or both of the first and second membranes 208a-b can be omitted.
In some embodiments, the system 200 includes a flow control mechanism 210 configured to change a size, shape, and/or other characteristic of the shunting element 202 to selectively modulate the flow of fluid through the lumen 204. For example, the flow control mechanism 210 can be configured to selectively increase and/or decrease a size (e.g., diameter) of the lumen 204 in response to an input. In other embodiments, the flow control mechanism 210 is configured to otherwise affect the geometry (e.g., size and/or shape) or another characteristic of the lumen 204. In the illustrated embodiment, for example, the flow control mechanism 210 includes an annular structure 212 (e.g., a band, ring, frame, etc.) surrounding the lumen 204. The portions of the first membrane 208a around the perimeter of the lumen 204 can be coupled to the annular structure 212. As a result, the geometry of the lumen 204 can be altered directly or indirectly by adjusting the geometry of the annular structure 212 (e.g., by deforming, deflecting, or otherwise changing the annular structure 212 from a first configuration to a second configuration). The changes in the geometry of the annular structure 212 can deform (e.g., stretch, compress) or otherwise move the portions of the first membrane 208a surrounding the lumen 204 thereby altering the geometry of the lumen 204.
In some embodiments, the geometry of the annular structure 212 can be altered directly using mechanical techniques (e.g., dilating with a balloon). Alternatively or in combination, one or more portions of the annular structure 212 can be made of a shape memory material (e.g., nitinol). In such embodiments, for example, changes to the geometry of the annular structure 212 (and therefore the lumen 204) can be induced by applying external stresses to the annular structure 212 and/or by inducing internal stresses in the annular structure 212 via the application of energy (e.g., heating the annular structure 212 beyond a transition temperature that results in at least a temporary alteration of the material state).
Alternatively or in combination, the system 200 can include other types of flow control mechanisms configured to selectively change the geometry of the lumen 204. In some embodiments, for example, the flow control mechanism 210 can include one or more motors, such as electromagnetic motors, implanted battery and mechanical motors, MEMS motors, micro brushless DC motors, piezoelectric based motors, solenoids, and other motors. In other embodiments, the flow control mechanism 210 includes one or more shape memory elements. A shape memory element can be configured to change in shape (e.g., transform between a first configuration and a second configuration) in response to a stimulus (e.g., heat or mechanical loading) as is known to those of skill in the art. In embodiments of the present technology that utilize heat or another form of energy applied to a shape memory element or another component of the system 200, the energy/heat can be applied both invasively (e.g., via a catheter delivering laser, radiofrequency, or another form of energy, via an internal stored energy source such as a supercapacitor, etc.), non-invasively (e.g., using radiofrequency energy delivered by a transmitter outside of the body, by focused ultrasound, etc.), or through a combination of these methods.
The system 200 further includes a first radiopaque element 214a and a second radiopaque element 214b (shown schematically) carried by the shunting element 202. The radiopaque elements 214a-b can be made of any material having sufficient density to reduce or inhibit the transmission of X-rays or other forms of electromagnetic radiation so that the radiopaque elements 214a-b can be visualized using radiographic imaging techniques (e.g., X-ray imaging). For example, the radiopaque elements 214a-b can be made of a metal (e.g., tantalum, gold, platinum), a polymer, a composite, a dye, a contrast medium (e.g., barium sulfate), or any other suitable material known to those of skill in the art. In some embodiments, the system 200 may alternatively or in combination contain markers with selective echogenicity (e.g., largely hyperechoic) to enable visualization through ultrasonic and related imaging methods.
The geometry (e.g., size, shape) of the radiopaque elements 214a-b can be configured in many different ways. For example, the radiopaque elements 214a-b can be bands, markers, discs, rivets, fasteners, beads, bearings, or any other structure suitable for incorporation in the system 200. The shape of the radiopaque elements 214a-b can be selected to facilitate visualization in radiographic images. In some embodiments, for example, the radiopaque elements 214a-b each have a spherical, circular, or cylindrical shape so that at least one dimension (e.g., diameter) of the element is fixed and readily ascertainable even when imaged from different viewing angles (e.g., for determining scaling as described in greater detail below). Alternatively, the radiopaque elements 214a-b can have another shape (e.g., square, rectangular, triangular, elliptical, polygonal, curvilinear, etc.). In some embodiments, some or all of the radiopaque elements 214a-b can have different sizes and/or shapes so they can be distinguished from each other.
In some embodiments, some or all of the radiopaque elements 214a-b are coupled to another component of the system 200 via adhesives, fasteners, bonding, etc. In the illustrated embodiment, for example, the radiopaque elements 214a-b can be attached to one or more of the shunting element 202, anchoring elements 206a-b, membranes 208a-b, flow control mechanism 210, or annular structure 212. Alternatively or in combination, some or all of the radiopaque elements 214a-b can be integrally formed with or otherwise be a part of another component. For example, one or more portions of the first membrane 208a surrounding the lumen 204 can be made from or otherwise include a radiopaque material. Radiopaque materials can be incorporated in the components of the system 200 in many different ways, such as by coating, printing, impregnating, or other techniques known to those of skill in the art. Optionally, in some embodiments the radiopaque elements 214a-b are not discrete components, but instead are features of a continuous radiopaque component that can be distinguished from each other in images. For example, the annular structure 212 can be made from a radiopaque material and can include distinct features (e.g., peaks, rivets, points, etc.) that serve as the radiopaque elements 214a-b for purposes of the methods described herein.
The radiopaque elements 214a-b can be operably coupled to and/or associated with the lumen 204 such that changes in the geometry of the lumen 204 produce corresponding changes in the spatial relationship of the radiopaque elements 214a-b to each other. For example, the system 200 can include a structure at least partially surrounding the lumen 204 (e.g., a frame, stent, membrane, ring, band, etc.) such that changes in the geometry of the structure correlate to changes in the geometry of the lumen. The radiopaque elements 214a-b can be included in, coupled to, or otherwise associated with the structure so that changes in the geometry of the structure alter the positions of the radiopaque elements 214a-b in one or more dimensions. In the illustrated embodiment, for example, the radiopaque elements 214a-b are positioned at or near the perimeter of the lumen 204 (e.g., attached to or incorporated into the first membrane 208a). The radiopaque elements 214a-b can be at diametrically opposed locations relative to the lumen 204 such that the distance D between the radiopaque elements 214a-b corresponds directly to a dimension (e.g., a diameter) of the lumen 204. As a result, the dimension of the lumen 204 can be determined based on the spacing between the radiopaque elements 214a-b in radiographic images, as described in greater detail below.
Although
In some embodiments, the system 200 can optionally include one or more calibration elements 216. As described in detail below with respect to
Beginning at block 310, the method 300 includes receiving a first radiographic image of at least two radiopaque elements from a first viewing angle. The method continues with receiving a second radiographic image of the at least two radiopaque elements from a second viewing angle (block 320). The at least two radiopaque elements can be identical or generally similar to the radiopaque elements 214a-b described with respect to
The first and second radiographic images can be any type of image data (e.g., still images, video) obtained via radiographic imaging techniques, such as an X-ray (e.g., a chest X-ray). Radiographic imaging techniques suitable for use with the embodiments herein include, but are not limited to, fluoroscopy (e.g., biplane fluoroscopy), C-arm X-ray imaging, and computed tomography (CT) imaging. In some embodiments, the first and second radiographic images are obtained by a suitable radiographic imaging device and transmitted to a computing device or system for subsequent processing and analysis. In embodiments of the system that include echogenic markers, the radiographic images may alternatively or in combination include ultrasonic images.
A radiographic imaging device can include at least one radiation source (e.g., an X-ray source) that is oriented relative to the patient's body to produce a radiographic image of the body along a corresponding viewing angle. In the method 300, the first radiographic image can be taken from a first viewing angle and the second radiographic image can be taken from a second viewing angle. The first and second viewing angles can be different viewing angles, e.g., the first viewing angle is a posterior-anterior viewing angle and the second viewing angle is a lateral viewing angle. In some embodiments, the first and second viewing angles are orthogonal or generally orthogonal such that they differ from each other by approximately 90 degrees. In some embodiments, the first and second viewing angles are orthonormal or generally orthonormal. In other embodiments the first and second viewing angles may not be orthogonal or orthonormal to each other.
The first and second radiographic images can be obtained in many different ways. For example, the first and second radiographic images can be taken by a radiographic imaging device having multiple radiation sources for taking images from multiple viewing angles (e.g., biplane fluoroscopy). In such embodiments, the first radiographic image can be obtained using a first radiation source oriented along the first viewing angle and the second radiographic image can be obtained using a second radiation source oriented along the second viewing angle. As another example, the first and second radiographic images can be taken by an imaging device having a single radiation source movable between a plurality of different orientations relative to the patient (e.g., a C-arm). In such embodiments, the first radiographic image can be obtained while the radiation source is oriented along the first viewing angle. The radiation source can then be moved to the second viewing angle to obtain the second radiographic image.
In some embodiments, the first and second radiographic images are obtained while the patient remains generally stationary. In such embodiments, radiographic images can be obtained by multiple radiation sources oriented along different viewing angles and/or by a single radiation source that is movable between different viewing angles. This approach is expected to improve the accuracy of capturing images at the desired viewing angles (e.g., orthonormal viewing angles). In other embodiments, however, the radiation source(s) can remain fixed while the patient is moved to different orientations. For example, the patient can be placed in a first orientation relative to the radiation source(s) to produce the first radiographic image, then subsequently moved to a second orientation to produce the second radiographic image.
In some embodiments, the first and second radiographic images are gated to reduce or prevent bodily movements of the patient (e.g., movements of the heart and/or lungs) from affecting measurement accuracy. For example, respiratory and/or cardiac movements can affect the position of the patient's body relative to the radiation source(s) as well as the position and geometry of implanted components (e.g., the shunting element, the lumen, the radiopaque elements). To limit the effect of these movements, the radiographic images can be gated based on the patient's respiratory cycle and/or cardiac cycle so that that the locations of the implanted components remain identical or generally similar across different images.
The method 300 further includes determining a lumen size based at least in part on the first and second radiographic images (block 330). In some embodiments, the first and second radiographic images each provide a two-dimensional (2D) projection of the three-dimensional (3D) locations of the radiopaque elements within the patient's body. Each radiographic image can be used to calculate various 2D measurements of the radiopaque elements. For example, the radiographic images can be used to calculate 2D locations or coordinates of each radiopaque element relative to a plane within a reference coordinate system (e.g., a coordinate system generally aligned with the patient's anatomical axes). The collective 2D measurements of the radiopaque elements in the images can be used to calculate the corresponding 3D spatial relationship of the radiopaque elements in the patient, which in turn is used to determine the geometry of the lumen (e.g., a lumen diameter). For example, in embodiments where a pair of radiopaque elements are positioned at diametrically opposed locations around the lumen perimeter, the 2D measurements can be used to calculate the 3D distance between the elements, which corresponds to a lumen diameter. Additional details of techniques for determining the lumen size are described with respect to
In some embodiments, the method 300 also optionally includes calculating a scaling factor for converting 2D distances in the radiographic images (e.g., distances expressed in pixels) to actual 3D distances in the patient's body (e.g., distances expressed in mm). For example, to calculate the scaling factor, the sizes of the radiopaque elements in the radiographic images can be measured and compared to the known actual sizes of the radiopaque elements. Alternatively or in combination, the scaling factor can be calculated based on the size of at least one calibration element shown in the radiographic images. The calibration element(s) can have a spherical, circular, or cylindrical shape so that at least one dimension (e.g., diameter) of the calibration element(s) remains generally fixed when imaged from different viewing angles. In some embodiments, one or more calibration elements are located in the patient's body. For example, the calibration element(s) can be carried by the shunting element (e.g., the calibration element(s) 216 shown in
It will be appreciated that the method 300 can be implemented in many different ways. In some embodiments, for example, the method 300 further includes obtaining and/or receiving additional radiographic images of the radiopaque elements. For example, rather than taking a single radiographic image at each viewing angle, multiple images can be taken at each viewing angle, and the measurements from those images can be averaged or otherwise combined to improve accuracy. As another example, a third radiographic image can be obtained at a third viewing angle different from the first and second viewing angles and used to determine lumen size.
In some embodiments, the method 300 is performed before, during, and/or after a shunt adjustment operation. For example, a clinician can use the techniques described herein to non-invasively determine the lumen geometry of an implanted shunting element before making any adjustments to the shunting element, e.g., to assess the current state of the shunting element, determine whether the shunting element was implanted properly, evaluate whether adjustments would be beneficial, etc. The techniques herein can also be used for radiographic monitoring during a shunt adjustment procedure, e.g., to provide fluoroscopic guidance for invasive adjustments. Optionally, the techniques herein can also be used to measure the lumen geometry after the adjustment procedure has been completed, e.g., to confirm whether the intended adjustments were successfully achieved, assess whether additional adjustments would be beneficial, etc.
Optionally, the method 300 can be repeated multiple times to obtain radiographic images and determine the lumen size at multiple time points. For example, a first set of radiographic images can be obtained at a first time point to determine the lumen size at the first time point (e.g., before making an adjustment to a shunting element, during an initial phase of treatment, etc.). After a desired time period has passed (e.g., hours, days, weeks, months, years, etc.), a second set of radiographic images can be obtained at a second time point to determine the lumen size at the second time point (e.g., after making an adjustment to a shunting element, during a subsequent phase of treatment, etc.). This process can be repeated to determine the lumen size at as many additional time points as desired. The lumen sizes across the different time points can be compared to each other, e.g., to confirm whether an adjustment was successful, track the size of the lumen over time, detect whether undesirable changes in the lumen size have occurred. In some embodiments, the comparison of lumen sizes over time is used to evaluate the patient's condition (e.g., physiological state, health status, etc.).
Optionally, the measured lumen size can be compared to an estimated lumen size. In embodiments where adjustments to the shunting element are made via an implanted flow control mechanism (e.g., the flow control mechanism 210 of
Referring first to
Referring next to
Referring to
Referring to
The 3D spatial relationship between the radiopaque elements 402a-b can be reconstructed based on the first and second sets of 2D measurements (e.g., X1, Y1, Z1, Y2). In the illustrated embodiment, X1 corresponds to the x-distance between the radiopaque elements 402a-b, Y1 and/or Y2 correspond to the y-distance, and Z1 corresponds to the z-distance. In some embodiments, either Y1, Y2, or both can be used to calculate the y-distance. As can be seen in
Although
As one of skill in the art will appreciate from the disclosure herein, various features of the methods and systems described above can be omitted without deviating from the scope of the present technology. Likewise, additional features not explicitly described above may be added to the methods and systems without deviating from the scope of the present technology. Accordingly, the methods and systems described herein are not limited to those configurations expressly identified, but rather encompasses variations and alterations of the described methods and systems. Moreover, the following paragraphs provide additional description of various aspects of the present technology. One skilled in the art will appreciate that the following aspects can be incorporated into any of the methods and systems described above.
Several aspects of the present technology are set forth in the following examples:
1. A method for monitoring a shunting element implanted in a patient and having a lumen fluidly coupling a first body region of the patient and a second body region of the patient, the method comprising:
2. The method of example 1 wherein the second viewing angle is orthogonal to the first viewing angle.
3. The method of example 1 wherein the second viewing angle is orthonormal to the first viewing angle.
4. The method of any of examples 1-3 wherein the at least two radiopaque elements are positioned at or near a perimeter of the lumen.
5. The method of example 4 wherein the at least two radiopaque elements include a first radiopaque element and a second radiopaque element positioned at diametrically opposite locations at or near the perimeter of the lumen.
6. The method of example 4 wherein the at least two radiopaque elements include three or more radiopaque elements spaced around the perimeter of the lumen.
7. The method of any of examples 1-6 wherein the shunting element includes a structure at least partially surrounding the lumen, and wherein the structure includes the at least two radiopaque elements.
8. The method of example 7 wherein the structure comprises one or more of a frame, a stent, a membrane, a ring, or a band.
9. The method of any of examples 1-8 wherein the at least two radiopaque elements comprise bands, markers, discs, rivets, fasteners, or beads.
10. The method of any of examples 1-9 wherein the at least two radiopaque elements each have a spherical, cylindrical, or circular shape.
11. The method of any of examples 1-10 wherein:
12. The method of example 11 wherein the at least one calibration element is carried by the shunting element.
13. The method of example 11 wherein the at least one calibration element is external to the patient's body.
14. The method of any of examples 1-13 wherein:
15. The method of any of examples 1-13 wherein:
16. The method of any of examples 1-15 wherein:
17. The method of any of examples 1-16 wherein the first viewing angle is an anterior-posterior viewing angle and the second viewing angle is a lateral viewing angle.
18. The method of any of examples 1-17, further comprising:
19. The method of any of examples 1-18 wherein the first and second radiographic images are gated based on one or more of a respiratory cycle or a cardiac cycle of the patient.
20. The method of any of examples 1-19 wherein determining the size of the lumen comprises:
21. The method of any of examples 1-20 wherein the first and second radiographic images are X-ray images.
22. The method of any of examples 1-21 wherein the lumen of the shunting element is selectively adjustable to control fluid flow therethrough.
23. The method of example 22, further comprising adjusting the lumen of the shunting element before, during, and/or after obtaining the first and second radiographic images.
24. The method of any of examples 1-23 wherein the first body region includes a first cavity of a heart of the patient and the second body region includes a second cavity of the heart of the patient, and wherein the first and second cavities of the heart of the patient include: (a) a left atrium and a right atrium, (b) a left ventricle and a right ventricle, or (c) a coronary sinus and the left ventricle.
25. The method of any of examples 1-24 wherein:
26. The method of example 25, further comprising comparing the first and second lumen sizes.
27. The method of example 26, further comprising evaluating one or more of a physiological state or health status of the patient based, at least in part, on the comparison of the first and second lumen sizes.
28. A system for monitoring a shunting element implanted in a patient and having a lumen fluidly coupling a first body region of the patient and a second body region of the patient, the system comprising:
29. The system of example 28, further comprising a radiographic imaging device configured to obtain the first and second radiographic image data.
30. The system of example 28 or 29 wherein the second viewing angle is orthogonal to the first viewing angle.
31. The system of example 28 or 29 wherein the second viewing angle is orthonormal to the first viewing angle.
32. The system of any of examples 28-31 wherein the first body region includes a first cavity of a heart of the patient and the second body region includes a second cavity of the heart of the patient, and wherein the first and second cavities of the heart of the patient include: (a) a left atrium and a right atrium, (b) a left ventricle and a right ventricle, or (c) a coronary sinus and the left ventricle.
33. A non-transitory computer-readable medium storing instructions that, when executed by a processor of a system for monitoring a shunting element implanted in a patient and having a lumen fluidly coupling a first body region of the patient and a second body region of the patient, cause the system to perform operations comprising:
34. The non-transitory computer-readable medium of example 33 wherein the second viewing angle is orthogonal to the first viewing angle.
35. The non-transitory computer-readable medium of example 33 wherein the second viewing angle is orthonormal to the first viewing angle.
36. The non-transitory computer-readable medium of any of examples 33-35 wherein the first body region includes a first cavity of a heart of a patient and the second body region includes a second cavity of a heart of the patient, and wherein the first and second cavities of the heart of the patient include: (a) a left atrium and a right atrium, (b) a left ventricle and a right ventricle, or (c) a coronary sinus and the left ventricle.
Embodiments of the present disclosure may include some or all of the following components: a battery, supercapacitor, or other suitable power source; a microcontroller, FPGA, ASIC, or other programmable component or system capable of storing and executing software and/or firmware that drives operation of an implant; memory such as RAM or ROM to store data and/or software/firmware associated with an implant and/or its operation; wireless communication hardware such as an antenna system configured to transmit via Bluetooth, WiFi, or other protocols known in the art; energy harvesting means, for example a coil or antenna which is capable of receiving and/or reading an externally-provided signal which may be used to power the device, charge a battery, initiate a reading from a sensor, or for other purposes. Embodiments may also include one or more sensors, such as pressure sensors, impedance sensors, accelerometers, force/strain sensors, temperature sensors, flow sensors, optical sensors, cameras, microphones or other acoustic sensors, ultrasonic sensors, ECG or other cardiac rhythm sensors, SpO2 and other sensors adapted to measure tissue and/or blood gas levels, blood volume sensors, and other sensors known to those who are skilled in the art. Embodiments may include portions that are radiopaque and/or ultrasonically reflective to facilitate image-guided implantation or image guided procedures using techniques such as fluoroscopy, ultrasonography, or other imaging methods. Embodiments of the system may include specialized delivery catheters/systems that are adapted to deliver an implant and/or carry out a procedure. Systems may include components such as guidewires, sheaths, dilators, and multiple delivery catheters. Components may be exchanged via over-the-wire, rapid exchange, combination, or other approaches.
Embodiments of the present disclosure may be implemented as computer-executable instructions, such as routines executed by a general-purpose computer, a personal computer, a server, or other computing system. The present technology can also be embodied in a special purpose computer or data processor that is specifically programmed, configured, or constructed to perform one or more of the computer-executable instructions explained in detail herein. The terms “computer” and “computing device,” as used generally herein, refer to devices that have a processor and non-transitory memory, as well as any data processor or any device capable of communicating with a network. Data processors include programmable general-purpose or special-purpose microprocessors, programmable controllers, ASICs, programming logic devices (PLDs), or the like, or a combination of such devices. Computer-executable instructions may be stored in memory, such as RAM, ROM, flash memory, or the like, or a combination of such components. Computer-executable instructions may also be stored in one or more storage devices, such as magnetic or optical-based disks, flash memory devices, or any other type of non-volatile storage medium or non-transitory medium for data. Computer-executable instructions may include one or more program modules, which include routines, programs, objects, components, data structures, and so on that perform particular tasks or implement particular abstract data types.
The above detailed description of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise forms disclosed above. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology as those skilled in the relevant art will recognize. For example, although steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments. For example, although this disclosure has been written to describe devices that are generally described as being used to create a path of fluid communication between the LA and RA, the LV and the right ventricle (RV), or the LA and the coronary sinus, it should be appreciated that similar embodiments could be utilized for shunts between other chambers of heart or for shunts in other regions of the body.
From the foregoing, it will be appreciated that specific embodiments of the technology have been described herein for purposes of illustration, but well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. Where the context permits, singular or plural terms may also include the plural or singular term, respectively.
Unless the context clearly requires otherwise, throughout the description and the examples, the words “comprise,” “comprising,” and the like are to be construed in an inclusive sense, as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to.” As used herein, the terms “connected,” “coupled,” or any variant thereof, means any connection or coupling, either direct or indirect, between two or more elements; the coupling of connection between the elements can be physical, logical, or a combination thereof. Additionally, the words “herein,” “above,” “below,” and words of similar import, when used in this application, shall refer to this application as a whole and not to any particular portions of this application. Where the context permits, words in the above Detailed Description using the singular or plural number may also include the plural or singular number respectively. As used herein, the phrase “and/or” as in “A and/or B” refers to A alone, B alone, and A and B. Additionally, the term “comprising” is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and/or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with some embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.
This application is a 35 U.S.C. § 371 U.S. National Phase application of International Patent Application No. PCT/US2021/028787, filed Apr. 23, 2021, which claims the benefit of U.S. Provisional Patent Application No. 63/014,318, filed Apr. 23, 2020, each of which is herein incorporated by reference in its entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2021/028787 | 4/23/2021 | WO |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO2021/216964 | 10/28/2021 | WO | A |
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| Number | Date | Country | |
|---|---|---|---|
| 20240000404 A1 | Jan 2024 | US |
| Number | Date | Country | |
|---|---|---|---|
| 63014318 | Apr 2020 | US |
