Shunt implantation device with adjustable barrel

Abstract

The shunt implantation device includes one or more anchoring arms and first and second barrel wings configured to curve to form a tubular barrel configuration.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Patent Application No. 63 / 309,761, filed February 14, 2022, and entitled "SHUNT IMPLANT DEVICE WITH ADJUSTABLE BARREL," the complete disclosure of which is incorporated herein by reference in its entirety. [Background technology]

[0002] The present disclosure relates generally to the field of medical implant devices. Various medical procedures involve the implantation of medical implant devices within cardiac anatomical structures. Certain physiological parameters associated with such anatomical structures, such as fluid pressure, can affect the health outlook of a patient. Summary of the Invention [Problem to be solved by the invention]

[0003] Described herein is one or more methods and / or devices for facilitating the shunting of blood between chambers and / or vessels of a patient's cardiac and / or circulatory system. [Means for solving the problem]

[0004] Embodiments of the present disclosure further relate to monitoring physiological parameters associated with particular chambers and / or blood vessels of the heart, such as the left atrium, using one or more shunt-type sensor implantation devices.

[0005] For purposes of summarizing the disclosure, certain aspects, advantages, and novel features are described. It will be understood that not all such advantages may necessarily be achieved in accordance with any particular example. Thus, the disclosed embodiments may be practiced in a manner that achieves or optimizes one advantage or group of advantages as taught herein, without necessarily achieving other advantages that may be taught or suggested herein.

[0006] Various examples are shown in the accompanying drawings for illustrative purposes, but should not be construed as limiting the scope of the present invention in any way. In addition, various features of different disclosed embodiments may be combined to form additional embodiments that are part of the present disclosure. Throughout the drawings, reference numerals may be reused to indicate correspondence between referenced elements. [Brief description of the drawings]

[0007] [Figure 1] FIG. 1 illustrates the anatomy of the human heart, according to one or more embodiments. [Diagram 2] FIG. 2 illustrates an exemplary representation of a human heart, according to one or more embodiments. [Figure 3A] FIG. 3A shows a perspective view of a shunt structure according to one or more embodiments. [Figure 3B] FIG. 3B shows a side view of the shunt structure of FIG. 3A, including a detailed view of a barrel portion of the shunt structure, in accordance with one or more embodiments. [Figure 3C] 3C-1 and 3C-2 show axial views of the shunt structure of FIGS. 3A and 3B with its barrel in expanded and compressed configurations, respectively, in accordance with one or more embodiments. [Figure 3D] FIG. 3D illustrates the shunt structure of FIG. 3A in a planarized configuration according to one or more embodiments. [Figure 4] 4A-4D show side views of shunt structures having various barrel designs according to several embodiments. [Figure 5A] FIG. 5A shows a perspective view of a shunt design having a tilted barrel, according to one or more embodiments. [Figure 5B] FIG. 5B shows a side view of the shunt structure of FIG. 5A, as well as various alternative tilted barrel designs, according to one or more embodiments. [Figure 5C] 5C-1 and 5C-2 show axial views of the shunt structure of FIGS. 5A and 5B with its barrel in expanded and compressed configurations, respectively, in accordance with one or more embodiments. [Figure 5D]FIG. 5D illustrates an axial view of the shunt structure of FIGS. 5A and 5B according to one or more embodiments. [Figure 5E] FIG. 5E illustrates the shunt structure of FIG. 5A in a flattened configuration, as well as various alternative barrel designs, according to one or more embodiments. [Figure 6] FIG. 6 illustrates pressure waveforms associated with various chambers and blood vessels of the heart, in accordance with one or more embodiments. [Figure 7] FIG. 7 illustrates a graph showing left atrial pressure range. [Figure 8] FIG. 8 is a block diagram illustrating a system for monitoring one or more physiological parameters associated with a patient, according to one or more embodiments. [Figure 9] 9A-9D show perspective, side, and axial views, respectively, of a shunt sensor implantation device according to one or more embodiments. [Figure 10] FIG. 10 illustrates a sensor assembly apparatus according to one or more embodiments. [Figure 11] 11-1, 11-2, and 11-3 show a sensor-embedded device having various sensor holding means associated therewith, according to one or more embodiments. [Figure 12] FIG. 12 illustrates a shunt implant device implanted in the tissue wall of the coronary sinus, according to one or more embodiments. [Figure 13] FIG. 13 illustrates a sensor implant device implanted in the atrial septum with the device's sensor exposed to the left atrium, in accordance with one or more embodiments. [Figure 14-1] FIG. 14-1 provides a flow diagram illustrating a process for implanting a shunt implant device, according to one or more embodiments. [Figure 14-2] FIG. 14-2 provides a flow diagram illustrating a process for implanting a shunt implant device, according to one or more embodiments. [Figure 14-3] FIG. 14-3 provides a flow diagram illustrating a process for implanting a shunt implant device, according to one or more embodiments. [Figure 14-4]FIG. 14-4 provides a flow diagram illustrating a process for implanting a shunt implant device, according to one or more embodiments. [Figure 14-5] FIG. 14-5 provides a flow diagram illustrating a process for implanting a shunt implant device, according to one or more embodiments. [Figure 15-1] FIG. 15-1 provides images of cardiac anatomy and certain devices / systems that correspond to operations of the process of FIG. 14-1, according to one or more embodiments. [Figure 15-2] FIG. 15-2 provides images of cardiac anatomy and certain devices / systems that correspond to operations of the process of FIG. 14-2, according to one or more embodiments. [Figure 15-3] FIG. 15-3 provides images of cardiac anatomy and certain devices / systems that correspond to operations of the process of FIG. 14-3, according to one or more embodiments. [Figure 15-4] FIG. 15-4 provides images of cardiac anatomy and certain devices / systems that correspond to the operations of the process of FIG. 14-4, according to one or more embodiments. [Figure 15-5] FIG. 15-5 provides images of cardiac anatomy and specific devices / systems that correspond to the operations of the process of FIG. 14-5, according to one or more embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0008] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0009] Although certain preferred examples and embodiments are disclosed below, the inventive subject matter extends beyond the specifically disclosed examples to other alternative examples and / or uses, as well as to modifications and equivalents thereof. Thus, the scope of claims that may arise from this specification is not limited by any of the specific 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 order and are not necessarily limited to any particular disclosed order. Although various operations may be described sequentially as multiple separate operations in a manner that may be useful for understanding a particular example, the order of description should not be construed as implying that these operations are order dependent. In addition, 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 all such aspects or advantages are necessarily achieved by any particular example. Thus, for example, the various examples may be implemented in a manner that achieves or optimizes one advantage or group of advantages as taught herein, without necessarily achieving other aspects or advantages that may also be taught or suggested herein.

[0010] The methods and structures disclosed herein for treating a patient also encompass similar methods and structures performed on or placed on a simulated patient, which are useful, for example, for training, for demonstration, for treatment and / or device development, and the like. The simulated patient can be physical, virtual, or a combination of physical and virtual. The simulation may include a simulation of all or a portion of a patient, such as, for example, the entire body, a portion of the body (e.g., chest), a system (e.g., cardiovascular system), an organ (e.g., heart), or any combination thereof. The physical elements may be natural, including human or animal cadavers or portions thereof, synthetic, or any combination of natural and synthetic. The virtual elements may be entirely in computer or may be overlaid on one or more of the physical components. The virtual elements may be presented on any combination of screens, headsets, holographic, projection, loudspeakers, headphones, pressure transducers, temperature transducers, or presented using any combination of suitable technologies.

[0011] Any of the various systems, devices, equipment, etc. in this disclosure may be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use on patients, and the methods described herein may include sterilization of the associated systems, devices, equipment, etc. (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0012] Certain reference numbers are reused across different figures in all figures of this disclosure for convenience with respect to devices, components, systems, features, and / or modules having features that may be similar in one or more respects. However, with respect to any of the examples disclosed herein, the reuse of a common reference number in a figure does not necessarily indicate that such features, devices, components, or modules are identical or similar. Rather, one skilled in the art can learn from the context as to the extent to which the use of a common reference number may suggest similarity between the referenced objects. The use of a particular reference number in the context of a description of a particular figure can be understood as relating to the device, component, aspect, feature, module, or system identified in that particular figure, and not necessarily to any device, component, aspect, feature, module, or system identified with the same reference number in another figure. Furthermore, aspects of separate figures identified with a common reference number can be interpreted as sharing features or as being entirely independent of each other.

[0013] Certain standard anatomical terms of location are used herein to refer to animal, i.e., human, anatomical structures for the preferred example. While certain spatially relative terms such as "outer", "inner", "superior", "lower", "down", "upper", "vertical", "horizontal", "top", "bottom" and similar terms are used herein to describe the 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 relationships between the elements / structures illustrated in the drawings. It should be understood that the spatially relative terms are intended to encompass different orientations of the elements / structures in use or operation in addition to the orientation depicted in the drawings. For example, an element / structure described as "above" another element / structure may represent a position that is below or to the side of such other element / structure with respect to alternative orientations of the subject patient or element / structure, and vice versa.

[0014] The present disclosure relates to shunt implantation devices that include barrel components forming a fluid passageway configured to fold and / or overlap one another in a manner that allows for a reduced radial profile of the barrel of the shunt device / structure, which may advantageously facilitate transport of the shunt implantation within a delivery system, such as one or more delivery catheters / sheaths. A foldable / adjustable barrel shunt implantation device according to aspects of the present disclosure may include two barrel segments, referred to herein as "wings," "panels," "walls," and / or the like, configured to form respective semicircular arcs of a circular or elliptical flow channel / tube when the shunt implantation device is in an expanded state.

[0015] In some aspects, the present disclosure relates to systems, devices, and methods for monitoring one or more physiological parameters (e.g., blood pressure) of a patient using a sensor-integrated shunt implantation device. For example, the present disclosure relates to a cardiac shunt implantation device incorporating or associated with a pressure sensor or other sensor device. The term "associated with" is used herein according to its broad and ordinary meaning. For example, when 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, at least partially embedded within, or otherwise physically associated with, whether directly or indirectly, the second feature, element, component, device, or member.

[0016] Certain examples are disclosed herein in terms of cardiac implantation devices, however, although certain principles disclosed herein are particularly applicable to cardiac anatomy, it will be understood that a shunt implantation device according to the present disclosure may be implanted or configured to be implanted into any suitable or desired anatomical structure.

[0017] Cardiac Physiology The anatomical structure of the heart is described below to aid in understanding certain inventive concepts disclosed herein. In humans and other vertebrates, the heart generally comprises a muscular organ having four pumping chambers, flow of which is controlled, at least in part, by various cardiac valves, namely the aortic valve, the mitral valve (or bicuspid valve), the tricuspid valve, and the pulmonary valve. The valves may be configured to open and close in response to pressure gradients that exist during various phases of the cardiac cycle (e.g., relaxation and systole), thereby at least in part controlling the flow of blood to corresponding regions of the heart and / or to blood vessels (e.g., lungs, aorta, etc.).

[0018] 1 illustrates an exemplary representation of a heart 1 having various features relevant to certain examples of the present disclosure. The heart 1 includes four chambers, namely, a left atrium 2, a left ventricle 3, a right ventricle 4, and a right atrium 5. With respect to blood flow, blood generally flows from the right ventricle 4 into the pulmonary artery 11 via a pulmonary valve 9 that separates the right ventricle 4 from the pulmonary artery 11 and is configured to open during systole to allow blood to be pumped towards the lungs and to close during diastole to prevent blood from flowing back from the pulmonary artery 11 into the heart. The pulmonary artery 11 carries deoxygenated blood from the right side of the heart to the lungs.

[0019] In addition to the pulmonary valve 9, the heart 1 includes three additional valves to aid in the circulation of blood therein, including a tricuspid valve 8, an aortic valve 7, and a mitral valve 6. The tricuspid valve 8 separates the right atrium 5 from the right ventricle 4. The tricuspid valve 8 generally has three cusps or leaflets and generally can close during ventricular contraction (i.e., systole) and open during ventricular expansion (i.e., diastole). The mitral valve 6 generally has two cusps / leaflets and separates the left atrium 2 from the left ventricle 3. The mitral valve 6 is configured to open during diastole to allow blood from the left atrium 2 to flow into the left ventricle 3, and to close during systole to prevent blood from flowing back into the left atrium 2 when functioning properly. The aortic valve 7 separates the left ventricle 3 from the aorta 12. The aortic valve 7 is configured to open during systole to allow blood discharged from the left ventricle 3 to be introduced into the aorta 12, and to close during diastole to prevent blood from flowing back into the left ventricle 3.

[0020] A muscular wall called the septum separates the left heart chamber from the right heart chamber. In particular, interatrial septal wall portion 18 (referred to herein as the "atrial septum," "intraatrial septum," or "septum") separates the left atrium 2 from the right atrium 5, while interventricular septal wall portion 17 (referred to herein as the "ventricular septum," "interventricular septum," or "septum") separates the left ventricle 3 from the right ventricle 4. The inferior tip of heart 1 is called the apex and is generally located at or near the midclavicular line in the fifth intercostal space.

[0021] The coronary sinus 16 is a group of veins joined together to form a large vessel that collects blood from the heart muscle (myocardium). The entrance to the coronary sinus, which may be at least partially protected by the Thebesian valve in some patients, opens into the right atrium 5 as shown. The coronary sinus runs along the posterior surface of the left atrium 2 and supplies less oxygenated blood to the right atrium 5. The coronary sinus generally runs across the left atrioventricular groove at the posterior side of the heart.

[0022] Health Status Associated with Cardiac Pressure and Other Parameters As referenced above, certain physiological conditions or parameters associated with the anatomy of the heart can affect the health of a patient. For example, congestive heart failure is a disease associated with the relatively slow movement of blood through the heart and / or body that causes an increase in fluid pressure within one or more chambers of the heart. As a result, the heart does not pump enough oxygen as the body requires. The various chambers of the heart may respond to the increased pressure by stretching to hold more blood and pump it through the body, or by becoming relatively stiffer and / or thicker. Over time, the walls of the heart may weaken and may not be able to pump efficiently. In some cases, the kidneys may respond to the heart's failure and retain fluid within the body. Fluid may accumulate in the arms, legs, ankles, feet, lungs, and / or other organs, causing the body to become congested, hence the term congestive heart failure. Acute decompensated congestive heart failure is a leading cause of morbidity and mortality and therefore, treatment and / or prevention of congestive heart failure is of significant medical concern.

[0023] As mentioned above, pressure build-up in one or more chambers or regions of the heart can be associated with congestive heart failure. Thus, treatment and / or prevention of heart failure can advantageously involve the relief of undesirably high cardiac pressures by the use of shunts or other means. Additionally, monitoring of cardiac pressure can be performed to guide treatment and / or assess current health status. Without directly or indirectly monitoring cardiac pressure, it can be difficult to infer, determine, or predict the presence or occurrence of congestive heart failure. For example, procedures or approaches that do not involve direct or indirect pressure monitoring may include measuring or observing other current physiological conditions of the patient, such as weight measurement, chest impedance measurement, right heart catheterization, or the like.

[0024] The present disclosure provides systems, devices, and methods for shunting blood from higher (e.g., left) chambers / vessels of the heart to lower pressure chambers / vessels, thereby relieving high pressure conditions. Additionally, embodiments of the present disclosure may guide drug administration, at least in part, in connection with the treatment of congestive heart failure, by directly monitoring pressure in the left atrium or in other heart chambers or blood vessels, where the pressure measurements are indicative of left atrial pressure and / or indicative of pressure levels in one or more other blood vessels / chambers, to reduce hospital readmissions and morbidity and / or improve patient health outlook.

[0025] Cardiac Shunt Implants FIG. 3A shows a perspective view of an exemplary shunt implantation device 50, according to one or more embodiments. FIG. 3B shows a side view of the exemplary shunt device / structure 50 of FIG. 3A, including a detailed view 342 of the barrel portion 58 of the shunt structure 50, according to one or more embodiments. FIGs. 3C-1 and 3C-2 show axial views of the shunt device / structure 50 of FIGs. 3A and 3B, with its barrel 58 in expanded and compressed configurations, respectively. FIG. 3D shows the exemplary shunt device / structure 50 of FIG. 3A in a flattened configuration, according to one or more embodiments.

[0026] The shunt structure / device 50 depicted in FIGS. 3A-3D may represent an example of a cardiac implantation device that may or may not be integrated with pressure sensor functionality according to certain embodiments disclosed herein. The shunt device / structure 50 may have an expandable and compressible barrel 58, where compression of the barrel 58 may facilitate placement within a transport catheter / sheath for delivery to a target implantation site. As shown in FIGS. 3A, 3B, and 3C-1, when expanded, the central flow channel 96 of the shunt 50 may define a generally circular or elliptical opening / channel. The channel 96 may be configured to hold the sides of the puncture opening against a tissue wall to form a blood flow pathway between cardiac chambers and / or blood vessels separated by a tissue wall. For example, the shunt 50 may be configured to be implanted within the wall separating the coronary sinus and the left atrium and / or the atrial septum. Although described in some contexts as being disposed in a single tissue wall, it should be understood that the shunt devices disclosed herein can be embedded in multiple (e.g., parallel) tissue walls, thereby providing a flow path through such multiple walls. For example, the anchor arms 56 of the shunt 50 (or other shunt devices disclosed herein) can pinch / hold tissue walls together, allowing shunting through multiple walls.

[0027] The central flow channel 96 may be formed in part by a pair of arcuate panels / wings 58a, 58b emanating from a backbone / support portion 52 of the shunt structure that forms a portion of the flow channel / barrel 58, and such portions 52 may be generally circumferentially diametrically positioned / disposed in the gap 94 and / or contact interface between the distal struts / edges 59a, 59b of the barrel panels / wings 58a, 58b when the barrel is formed / expanded as shown in FIG. 3A. The term "wing" is used herein in accordance with its broad and ordinary meaning and may refer to any type of structure or form that protrudes or extends from a support or other structure of the shunt structure / device, including any type of panel, wall, tab, strap, band finger, arm, flap, etc. For example, a "wing" or "panel" of the shunt structure described herein may extend beyond the primary dimension d of one or more anchor arms of the shunt structure relative to the flattened appearance / configuration of the shunt, as shown in FIG. 3D. 1 Additionally, the "wings" or "panels" of the shunt structure may extend / project generally perpendicularly from the axial dimension d1 of the backbone / barrel support portion of the shunt structure from which one or more anchor arms and / or wings / panels emanate / project.

[0028] The barrel wings 58a, 58b may have any suitable or desired structural configuration, as described in more detail below. For example, the wings 58a, 58b may be spaced apart by a gap distance g 100 to form an array of parallel slits, cells, or openings 92. 1 The shunt structure 50 may be formed of a generally parallel arrangement of elongated thin struts 51 separated by . In some embodiments, the barrel wings / panels 58a, 58b (and / or the entire shunt structure 50) are formed of superelastic struts configured to be compressed, bent, expanded, manipulated, etc., such as fitted / placed within a delivery catheter. In some embodiments, the shunt structure 50 comprises a shape memory metal (e.g., Nitinol) configured to be compressed for delivery and automatically expand to the expanded configuration shown in FIG. 3A when released from the delivery system constraints.

[0029] Forming the shunt 50 using multiple interconnected struts forming cells therebetween may function to at least partially increase the flexibility of the shunt, thereby allowing it to be compressed as well as expand at the implantation site. The interconnected struts 51 of the barrel 58 advantageously provide a cage structure with sufficient rigidity and structure to hold the tissue at the puncture in an open position. The backbone / support portion 52 of the shunt structure 50 / barrel 58 may function to connect the wings / panels 58a, 58b and extend axially between the distal anchor arm 56a and the proximal anchor arm 56b on each axial side of the barrel 58. The barrel wings / panels 58a, 58b and the backbone / support portion 52 may together define a tubular lattice as shown, forming a cylindrical tubular form / barrel that may include axial gaps 94 between the distal / end edges / struts 59 of the respective wings 58a, 58b. The backbone support section 52 may include one or more axial struts 158, 159 and / or one or more angled / slanted (as shown) supports axially extending from the flow axis of the barrel 58 / dimension A 1 / d 1 3C-1 shows the backbone support portion 52 of the shunt 50 as being diametrically opposite the gap / interface 94 between the ends / edges of the barrel wings 58a, 58b.

[0030] While certain embodiments of shunts disclosed herein include flow channels having a substantially circular cross-section, as shown in Figure 3C-1, in some embodiments, shunt structures according to the present disclosure have oval, rectangular, diamond, or elliptical flow channel configurations. For example, in comparison to the configurations illustrated in Figures 3A-3D, relatively elongated barrel wings may form rectangular or elliptical shaped flow channels when their edges are brought together. Such shaped shunt flow channels may be desirable for larger punctures while still being configured to collapse into a relatively small delivery profile.

[0031] In some embodiments, each of the distal and proximal anchor arms 56a, 56b are configured to curl outward from the backbone support portion 52 and are aligned with the axis A of the central flow channel 96 in the expanded configuration. 1 The extended flanges / arms 56a, 56b may function to anchor the shunt 50 against the target tissue wall. As shown, the anchor arms 56a, 56b may not be annular / circular about the circumference / perimeter of the barrel 58, but may instead be oriented in a generally radial direction (e.g., in a horizontal / lateral tissue plane p) as shown. 1 Additional aspects and features of shunt, implant, and / or anchor structures that may be embodied in embodiments of the present disclosure are disclosed in U.S. Patent No. 9,789,294, issued October 17, 2017, entitled "Expandable Cardiac Shunt," the disclosure of which is expressly incorporated herein by reference in its entirety.

[0032] As shown in FIG. 3B, the expanded shunt 50 has an overall height h of about 5-10 mm, such as about 6.7±1.0 mm. 1 In some embodiments, barrel 58 may have a height h of 3 to 5 mm, such as about 3.9±0.2 mm. 2 As shown in detail image 342 of FIG. 3B, the spacing g between the posts 51 of the barrel 58 that defines the slits / cells 92 1 The thickness t of the struts 51 that define the slits / cells 92 may be 0.5 to 2 mm, such as about 1 mm. 1 may be at least 0.2 mm, such as 0.2 to 0.5 mm.

[0033] 3B and 3D, the barrel wings 58a, 58b are aligned along the axis A of the barrel 58. 13B and 3D ), or may alternatively be angled (as shown by the dashed lines in FIGS. 3B and 3D ) such that the distal portion of barrel 58 has a larger diameter than its proximal portion and may provide a converging effect / structure to funnel blood shunted through barrel 58.

[0034] As shown in the diagrams of Figures 3C-1 and 3D, the anchoring arms 56 may have a somewhat triangular plan view shape with a wide base at the central flow tube 96 narrowing to an apex at the distal end 57. The struts forming the anchoring arms 56 may be designed to easily collapse to a compact size that fits into a delivery catheter / sheath. The shunt 50 may be aligned along a horizontal plane (e.g., a tissue plane) p, which may represent the axial mid-plane of the shunt 50. 1 For example, distal anchor arm 56a may be generally the same size and shape as proximal anchor arm 56b. In some embodiments, anchor arm 56 has a length of about 7.0 mm.

[0035] The anchor arms 56 on each side of the barrel / tube 58 can converge toward one another such that when the arms 56 are expanded / extended, their ends 57 are closer to one another than the inner portions 55 of the arms, as shown in Figures 3A and 3B. 1 2 to grip the tissue wall into which the shunt 50 is implanted (e.g., generally in the plane p 1 ) and may be spaced relatively closely together in the expanded configuration to help maintain the shunt 50 in place. In some embodiments, the superelastic properties of the arms 56 may prevent the arms 56 from exerting excessive clamping forces against the tissue wall that could cause necrosis or other damage. The ends 157 of the anchor arms 56 may define particular opening features or other closed shapes such that they are configured to be engaged by an actuation rod or other engagement / manipulation means.

[0036] The slits 92 formed between adjacent parallel struts 51 of each barrel wing 58a, 58b are spaced apart over the length l of the wing / panel 58 as shown. 1 Although three parallel slits 92 are shown, separated / defined by four parallel struts 51, it should be understood that a barrel vane / panel according to embodiments of the present disclosure may include any number or arrangement of slits / struts (e.g., parallel slits / struts), such as four slits defined by five struts, or other numbers.

[0037] The cutouts / slits 92 between the lateral / circumferential struts 51 can provide increased flexibility to the barrel wings / panels 58a, 58b to provide a desired curvature of the barrel 58. The slits 92 can be formed by cutting strips of material of the barrel walls / panels 58a, 58b, such as through laser cutting or the like. When the barrel 58 expands within an opening in the target tissue wall, thereby forming a shunt channel through the tissue wall, the slits 92 can allow tissue of the tissue wall to protrude through the slits 92 and into the diameter / space of the barrel 58, thereby further securing the barrel 58 to the tissue wall. Additionally, tissue ingrowth can be encouraged / allowed for tissue disposed within the slits 92 and / or tissue protruding into the slits 92, and such tissue ingrowth can traverse one or more of the struts 51 on the inner diameter of the barrel 58, thereby further securing the shunt 50 to the tissue wall. Such tissue ingrowth may advantageously be sufficient to secure the barrel 58 to the tissue wall, but not excessively encroach upon the flow channel 96, block the channel 96, or otherwise deleteriously reduce the opening of the shunt barrel 58.

[0038] The barrel wings 58a, 58b are configured to form the arcuate walls of the barrel 58, with the ends / distal ends / edges 59a, 59b of each barrel wing / panel abutting each other to close the tubular form of the barrel 58, as shown in FIG. 3A. The ends / distal edges / struts 59a, 59b of each barrel wing / panel 58a, 58b in the expanded configuration may contact / press against each other and / or may be spaced apart by a distance g. 2 A gap 94 (see detail 343 in FIG. 3C-1 ) can be configured / positioned to exist between the wing / panel edges. If present, the gap 94 between the distal / terminal portions / edges of the barrel wings / panels 58 a, 58 b has a gap distance g 2 may advantageously be narrow / small enough to enable the barrel wings / panels to maintain the channel 96 and / or prevent substantial intrusion of biological tissue through the gap 94 into the inner diameter of the barrel 58.

[0039] 3C-1 and 3C-2 show axial views of the shunt 50 in a fully expanded and compressed / overlapped configuration, respectively. For example, as discussed above, the image in FIG. 3C-1 shows the expanded barrel 58, with the barrel wings / panels 58a, 58b forming arcuate segments of a common circumference of the barrel 58. When expanded, the radial alignment / overlap of the terminal edges / struts 59a, 59b of the respective barrel wings 58a, 58b may prevent circumferential / inward compression / overlap of the barrel walls / wings and / or their distal / terminal portions. For example, the radial alignment of the terminal edges / edges 59a, 59b and / or associated struts (e.g., axial struts of the barrel 58) may cause an interference lock, preventing circumferential overlap of the edges 59a, 59b of the respective barrel wings / panels 59a, 59b. In the expanded configuration shown in FIG. 3C-1, the edges 59a, 59b of the barrel wings 58a, 58b overlap radially and therefore cannot deflect inwardly and / or circumferentially past each other without relative radial deflection of one or both of the wings / panels 58a, 58b.

[0040] FIG. 3C-2 illustrates the diameter profile d of the barrel 58 for purposes of transporting the shunt 50 within a particular delivery system (e.g., catheter / sheath). 2 FIG. 3C-2 illustrates a radially and circumferentially compressed and circumferentially overlapping configuration of barrel wings / panels 58a, 58b that may be implemented to reduce the amount of compression that occurs when the barrel wings / panels 58a, 58b are compressed radially relative to the other, as shown in FIG. 3C-2, and the compression illustrated in FIG. 3C-2 may be implemented to reduce the amount of compression that occurs when the barrel wings / panels 58a, 58b are compressed radially relative to the other, as shown in FIG. 3C-2, and ... 1 ) to overlap its distal / terminal portions. Such overlapping generally reduces the cross-sectional area of ​​the conduit / channel 96 formed by the barrel 58, which may in turn reduce the diameter / profile of the barrel 58. For example, the compressed diameter d 2 is the expanded diameter d shown for the configuration of FIG. 1 3C-2 , by curling / deflecting the barrel wings / panels inwardly in a circumferentially overlapping manner, the shunt 50 can be configured to conform to a relatively small profile, advantageously allowing transport of the shunt 50 to target anatomy through relatively narrow and / or tortuous access paths, such as within portions of a patient's vasculature. The curling / compression of the barrel 58 may be further implemented to accommodate shunt openings in tissue walls that are relatively small in size. That is, the ability to circumferentially overlap the barrel wings / panels 58a, 58b can allow the size of the barrel to be customized to a desired diameter and / or area to fit the target opening. In such implementations, it may be desirable to implement a mechanism to lock the relative position of the barrel wings / panels in a desired compressed / overlapping configuration to prevent further compression or expansion of the barrel 58 after implantation. For example, the wings / panels may be locked together in some manner (eg, pins, ratchet mechanisms, clamps, hooks, or other locking means) when the desired compressed state is achieved.

[0041] 3D shows a flattened view of the expandable shunt 50 with the barrel wings / panels 58a, 58b and anchor arms 56a, 56b extending straight outward / away from the backbone portion 52 of the shunt structure. The various struts forming the shunt 50 may be fabricated by laser cutting shape memory metal (e.g., Nitinol) tubing. For example, the tubing may have a wall thickness of about 0.1-0.3 mm, such as about 0.2 mm.

[0042] Although an embodiment of a shunt device is disclosed herein with a single pair of axially opposed anchor arms as shown in FIG. 3A, it should be understood that the disclosed embodiment may include one or more additional anchor arms. For example, with respect to a shunt device having a pair of barrel wings / panels configured to surround a flow channel / barrel, the ends / distal edges of such wings / panels may be proximate to one another to provide a cylindrical / tubular configuration of the barrel / channel, and one or more additional anchor arms 356 may be associated with and / or emanate from the distal 357 or inner 358 lengthwise portions of the respective barrel wings / panels. For example, FIG. 3D illustrates an exemplary location of the additional anchor arms 356, shown in dashed form, and such arms may be located on either or both of the axial sides of the barrel 58. Furthermore, such arms may be circumferentially aligned with one another and emanate from a common barrel wing / panel, as shown in dashed lines in FIG. 3D, or may be circumferentially offset and / or emanate from separate barrel wings / panels.

[0043] 4A-4D show side views of exemplary shunt structures having various barrel designs according to multiple embodiments. For example, while FIGS. 3A-3D illustrate a shunt device 50 having a barrel 58 formed from barrel wings / panels 58a, 58b having circumferential / lateral struts forming elongated circumferential / lateral slits therein, it should be understood that barrel wings / panels according to embodiments of the present disclosure may have any suitable or desired structure, strut, and / or cell design. For example, FIG. 4A shows a shunt device 50a having a barrel wing / panel 401a including vertical / axial struts 441 and / or slits / cells 411. Such a configuration may provide advantageous bending flexibility to the wings / panels 401a while providing desirable axial stiffness.

[0044] Figure 4B shows a shunt device 50b having a barrel wing / panel 401b including diagonal struts 443 and / or slits / cells 413. Figure 4C shows a shunt device 50c having a barrel wing / panel 401c including vertical struts 415 and lateral / horizontal struts 417, which form rectangular (e.g., square) cells 414. In some embodiments, the structure of the barrel wing / panel forms a substantially continuous wall surface through at least a portion of the barrel, as shown in Figure 4D, and the illustrated shunt 50d includes a barrel wing / panel without slits or cells cut therein over at least a circumferential portion thereof.

[0045] 3A-3D and 4A-4D (as well as other embodiments disclosed herein) illustrate that when the distal struts / edges thereof are brought together, a horizontal / lateral tissue plane p associated with the shunt device and / or the tissue wall in which the shunt device is embedded. 1 Axis A generally perpendicular / orthogonal to 1In the drawings, the shunt device has barrel wings / panels that form a cylindrical configuration having an axis oriented at an angle relative to the horizontal / tissue plane of the respective shunt device. However, it should be understood that the foldable barrel shunt devices disclosed herein may have barrel wings / panels that come together to form a shunt conduit / channel with an axis oriented at any suitable or desired angle relative to the horizontal / tissue plane of the respective shunt device. That is, embodiments of the present disclosure can include barrel wings / panels that form an angled / tilted barrel / conduit relative to the tissue wall in which they are configured to be implanted (e.g., relative to the tissue retaining surface of the anchor arms of the shunt device).

[0046] FIG. 5A shows a perspective view of an exemplary shunt device / structure 60 having a tilted / angled barrel 68, according to one or more embodiments. FIG. 5B shows a side view of the shunt device / structure 60 of FIG. 5A, as well as various alternative tilted barrel designs. FIGs. 5C-1 and 5C-2 show axial views of the shunt structure 60 of FIGs. 5A and 5B, with its barrel in an expanded and compressed configuration, respectively. FIG. 5D shows an axial view of the exemplary shunt structure of FIGs. 5A and 5B. FIG. 5E shows the exemplary shunt structure of FIG. 5A in a flattened configuration, as well as various alternative barrel designs, according to one or more embodiments. The following disclosure relates to FIGs. 5A-5E.

[0047] The shunt device 60 includes barrel wings / panels 68a, 68b and a backbone / support portion / structure 62, which together, when the distal edges / struts 69a, 69b are brought together or proximate to each other (e.g., within 2 mm) such that the wings / panels 68a, 69a have an arcuate configuration as shown, are associated with the shunt device 60 and lie flat against the central / tissue plane p shown in FIG. 5B. 1 The tubular lattice defines a barrel / channel that is angled (e.g., "tilted" or "slanted") relative to the axial direction.

[0048] The barrel backbone / support portion 62 is aligned with the axis A of the barrel 68. 2For example, the backbone / support portion 62 of the barrel 68 may include one or more struts that may be angled in a manner similar to the barrel axis A of the barrel 68. 2 and / or the struts are aligned in the tissue plane p 1 and vertical axis A 3 , through the flow channel 96 of the barrel 68 at an acute angle θ 1 , θ 2 That is, as shown in FIG. 5B, the virtual reference axis A 3 is the angled axis A 2 is defined by the angled backbone portion 62 of the barrel 96 and the wings / panels 68a, 68b (e.g., wing edges / struts 69a, 69b). 1 In fact, the central flow tube / channel 96 may be depicted as generally perpendicular to the vertical axis A. 3 from angle θ 2 The angle θ 2 In some embodiments, the horizontal tissue plane p may be between 30 and 60 degrees, such as about 45 degrees. 1 is generally defined by the region of tissue wall (e.g., the wall between the coronary sinus and the left atrium) in which the shunt implantation device 60 is configured to be implanted proximate to the barrel 68 when the device 60 is implanted (e.g., an imaginary plane in the context of an unimplanted shunt device).

[0049] Barrel 68 is angle θ 2 5C-1 and 5D, the opening formed by the barrel 68 is oriented in the plane p 1 , and when implanted in a target tissue wall, may allow for direct blood flow between the heart chambers / vessels joined by the shunt device 60. For example, the angled barrel 68 may be configured such that the barrel 68 is aligned with the tissue plane p 1, may be wide and short enough so that proper shunting occurs as if the collapsible shunt 60 were substantially perpendicular to the axial direction of the barrel vane / panel 68a, 68b. The struts 61 of the barrel vane / panel 68a, 68b may define a tubular or circular lattice. As with other embodiments presented herein, the struts may not form a continuous wall surface, as shown, but rather may form open cells 92 (e.g., elongated circumferential / lateral slits). The inclination θ of the collapsible shunt 60 may be as follows: 2 The angled configuration of the barrel 68 can facilitate collapsing of the barrel 68 for placement within a delivery catheter and expansion of the anchor arms 66 on both axial sides of the target tissue wall. 2 Such a lateral tissue contact offset can advantageously reduce direct pinching of the tissue wall between the tissue contact pads / legs 67a, 67b.

[0050] In the illustrated example of FIG. 5A, the barrel wings / panels 68a, 68b include circumferential / lateral struts 61 separated by elongated circumferential / lateral slits / cells 92. However, as with other disclosed embodiments, variations in barrel wing / panel strut design are possible. For example, FIGS. 5B and 5D show side views of exemplary shunt structures having various angled / tilted barrel wing / panel designs, according to multiple embodiments. Images 505, 555 of FIGS. 5B and 5D, respectively, show a shunt device 507 having a barrel wing / panel 501a including angled vertical / axial struts 541 and / or slits / cells 511. Such a configuration may provide advantageous bending flexibility to the wings / panels 501a while providing desirable axial stiffness.

[0051] Images 505, 555 further show a shunt device 508 having a barrel wing / panel 501b including angled struts 543 and / or slits / cells 513. Images 505, 555 further show a shunt device 509 having a barrel wing / panel 501c including vertical struts 515 and lateral / horizontal struts 517 forming parallelogram-shaped (e.g., diamond-shaped) cells 514. Thus, the barrel wing / panel 501c is defined by a generally parallelogram-shaped arrangement of struts forming an array of parallelogram-shaped cells or openings 514. The sidewalls 501c are generally oriented along an inclined axis A through the barrel 68. 2 In fact, each of the cells 514 is inclined in the same direction. In some embodiments, as shown, the barrel axes A are longitudinally offset laterally from one another. 2 There may be two rows (or other number) of four (or other number) cells 514 stacked along a line.

[0052] In some embodiments, the barrel vane / panel structure forms a substantially continuous wall surface through at least a portion of the barrel, as shown in images 505, 555 in Figures 5B and 5D, and the illustrated shunt 510 includes a barrel vane / panel 501d without slits or cells cut therein over at least a circumferential portion thereof.

[0053] The angle of the shunt structure 60 may facilitate collapse of the shunt 60 within the delivery catheter and expansion of the anchor arms 66 on either side of the target tissue wall. The anchor arms 66 may be angled along the angled barrel axis A between the collapsed and expanded states of the shunt 60. 2For angled / tilted barrel embodiments, anchor arms 66 may include a relatively long anchor arm 66b (e.g., proximal) that extends radially outward from barrel 68 upon release from the delivery system, but to a lesser extent than the opposing (e.g., distal) anchor arm 66a, which may be relatively shorter than anchor arm 66b. For example, the shorter arm 66a may extend by rotating outward more than 90°, while the longer arm 66b may rotate / extend outward by less than 90°.

[0054] Cardiac pressure monitoring Although the shunt device embodiments disclosed herein may be implemented / configured without any pressure (or other type) sensor functionality, it should be understood that any of the shunt embodiments disclosed herein may include integrated sensor functionality, which may provide various benefits. For example, cardiac pressure monitoring according to examples of the present disclosure may provide a proactive intervention mechanism to prevent or treat congestive heart failure and / or other physiological conditions. Generally, increases in ventricular filling pressures associated with diastolic and / or systolic heart failure may occur prior to the onset of symptoms that lead to hospitalization. For example, cardiac pressure indicators may appear several weeks prior to hospitalization in some patients. Thus, a pressure monitoring system according to examples of the present disclosure may be advantageously implemented to reduce hospitalization cases by guiding appropriate or desired titration of medications and / or administration of medications prior to the onset of heart failure.

[0055] As referenced above, with respect to cardiac pressures, elevated left atrial pressure may be particularly correlated with heart failure. Figure 6 illustrates exemplary pressure waveforms associated with various chambers and blood vessels of the heart, according to one or more embodiments. Of the various cardiac pressure waveforms, the left atrial pressure waveform 25 may be considered to provide the best feedback for early detection of congestive heart failure. Furthermore, in general, there may be a relatively strong correlation between elevated left atrial pressure and pulmonary congestion.

[0056] Left atrial pressure generally correlates well to left ventricular end diastolic pressure. However, although left atrial pressure and end diastolic pulmonary artery pressure may have a significant correlation, such correlation may weaken when pulmonary vascular resistance is elevated. That is, pulmonary artery pressure generally does not correlate well to left ventricular end diastolic pressure in the presence of various acute conditions, which may include certain patients with congestive heart failure. Thus, as represented by waveform 24, pulmonary artery pressure measurements alone may be insufficient or inaccurate as an indicator of left ventricular end diastolic pressure, especially for patients with comorbidities such as pulmonary disease and / or thromboembolism. Left atrial pressure may also be at least partially correlated to the presence and / or degree of mitral valve regurgitation. Left atrial pressure readings may be less likely to be distorted or affected by other conditions, such as respiratory states or the like, as compared to the other pressure waveforms shown in FIG. 6. In general, left atrial pressure can significantly predict heart failure, such as up to two weeks before the onset of heart failure.

[0057] Monitoring cardiac pressure, such as monitoring left atrial pressure, can provide a mechanism to guide drug administration for treating and / or preventing congestive heart failure. Such treatment may advantageously reduce re-hospitalization and morbidity, and may provide other benefits. An implantable pressure sensor integrated shunt implant device according to examples of the present disclosure may be used to predict heart failure two weeks or more prior to the onset of symptoms or markers of heart failure (e.g., dyspnea). When a prediction of heart failure is recognized using examples of cardiac pressure sensors according to the present disclosure, certain preventative measures, including drug interventions, such as modifications to the patient's medication regimen, may be implemented to help prevent or reduce the effects of cardiac dysfunction. Direct pressure measurements in the left atrium may advantageously provide an accurate indication of pressure build-up that may lead to heart failure or other complications. For example, by analyzing or using trends in atrial pressure increase, the onset of cardiac dysfunction may be determined or predicted, in which case drug or other therapy may be augmented to reduce pressure and prevent or reduce further complications.

[0058] FIG. 7 illustrates a graph 700 showing left atrial pressure ranges, including a normal range 701 of left atrial pressure that is generally not associated with a substantial risk of adverse health conditions. Examples of the present disclosure provide systems, devices, and methods for determining whether a patient's left atrial pressure is within the normal range 701, above the normal range 703, or below the normal range 702 through the use of a particular sensor-embedded device. In the event that a left atrial pressure above the normal range is detected, such as may correlate to an increased risk of heart failure, examples of the present disclosure, described in detail below, can signal efforts to lower the left atrial pressure until it is within the normal range 701. Additionally, in the event that a detected left atrial pressure below the normal range 701 is detected, such as may correlate to an increased risk for acute kidney injury, myocardial injury, and / or other health complications, examples of the present disclosure, described in detail below, can function to facilitate efforts to increase the left atrial pressure to bring the pressure level within the normal range 701.

[0059] Sensor-integrated shunt implantation device and system 8 illustrates a system 40 for monitoring one or more physiological parameters (e.g., left atrial pressure and / or volume) in a patient 44 using a sensor-integrated shunt device 30, according to one or more embodiments. For example, the shunt implant device 30 may be implanted in the patient's heart or associated physiology. In some implementations, the shunt implant device 30 may be at least partially implanted within the left atrium and / or within the coronary sinus of the patient's heart.

[0060] In some embodiments, the implant device comprises a particular shunt structure 31, such as including two barrel forming wings / panels and a plurality of anchor arms, as described herein. The shunt structure 31 may be physically integrated with and / or connected to a sensor device 37. The sensor device 37 may be, for example, a pressure sensor or other type of sensor. In some embodiments, the sensor 37 includes a transducer 32, such as one or more microelectromechanical systems (MEMS) devices (e.g., a MEMS pressure sensor or other type of sensor transducer), and a particular control circuit 34, which may be embodied, for example, in one or more application specific integrated circuits (ASICs).

[0061] The control circuitry 34 may be configured to process signals received from the transducer 32 and / or may be configured to communicate signals associated with the transducer wirelessly through biological tissue using the antenna 38. The term "control circuitry" is used herein according to its broad and ordinary meaning and may refer to any collection of processors, processing circuits, processing modules / units, chips, dies (e.g., semiconductor dies including one or more active devices and / or including one or more passive devices and / or including connecting circuitry), microprocessors, microcontrollers, digital signal processors, microcomputers, central processing units, field programmable gate arrays, programmable logic devices, state machines (e.g., hardware state machines), logic circuits, analog circuits, digital circuits, and / or any device that manipulates signals (analog and / or digital) based on hard-coding of circuitry and / or operational instructions. The control circuitry referred to herein may further include one or more storage devices, which may be embodied in a single memory device, in multiple memory devices, and / or in embedded circuitry of the device. Such data storage may include read-only memory, random access memory, volatile memory, non-volatile memory, static memory, dynamic memory, flash memory, cache memory, data storage registers, and / or any device that stores digital information. It should be noted that in examples where the control circuitry includes hardware and / or software state machines, analog circuits, digital circuits, and / or logic circuits, the data storage devices / registers that store any associated operating instructions may be embedded within the circuitry including the state machines, analog circuits, digital circuits, and / or logic circuits, or may be external to such circuitry. The transducer 32 and / or antenna 38 may be considered part of the control circuitry 34.

[0062] The antenna 38 may include one or more coils or loops of conductive material, such as copper wire or the like. In some embodiments, at least a portion of the transducer 32, control circuitry 34, and / or antenna 38 are at least partially disposed or housed within a sensor housing 36, which may comprise any type of material and may advantageously be at least partially hermetically sealed. For example, the housing 36 may comprise glass or other rigid material that may provide mechanical stability and / or protection for the components housed therein. In some embodiments, the housing 36 is at least partially flexible. For example, the housing may comprise a polymer or other flexible structure / material, which may advantageously allow the sensor 37 to be folded, bent, or crushed, thereby enabling transport of the sensor through a catheter or other introduction means.

[0063] The transducer 32 may include any type of sensor means or mechanism. For example, the transducer 32 may be a force-collecting pressure sensor. In some embodiments, the transducer 32 may include a diaphragm, piston, Bourdon tube, bellows, or other strain or deflection measuring member to measure the strain or deflection applied over an area / surface of the transducer. The transducer 32 may be associated with the housing 36 such that at least a portion of the transducer is contained within the housing 36 or such that at least a portion of the transducer is attached to the housing 36. With regard to a sensor device / component being "associated" with a stent or other implant structure, such terms may refer to the sensor device or component being physically coupled, attached, connected, or integral with the implant structure.

[0064] In some embodiments, the transducer 32 may include or be a component of a piezoresistive strain gauge that may be configured to detect strain due to applied pressure using bonded or formed strain gauges, where the resistance increases as the pressure deforms the component / material. The transducer 32 may incorporate any type of material, including, but not limited to, silicon (e.g., single crystal), polysilicon thin film, bonded metal foil, thick film, silicon on sapphire, sputtered thin film, and / or the like.

[0065] In some embodiments, the transducer 32 may include or be a component of a capacitive pressure sensor that includes a diaphragm and a pressure cavity configured to form a variable capacitor for detecting strain due to pressure applied to the diaphragm. The capacitance of a capacitive pressure sensor may generally decrease as pressure deforms the diaphragm. The diaphragm may include any material, including but not limited to metal, ceramic, silicon, and the like. In some embodiments, the transducer 32 may include or be a component of an electromagnetic pressure sensor that may be configured to measure the displacement of the diaphragm by a change in inductance, by a Linear Variable Displacement Transducer (LVDT) function, by Hall effect, or by eddy current sensing. In some embodiments, the transducer 32 may include or be a component of a piezoelectric strain sensor. For example, such a sensor may determine strain (e.g., pressure) on a sensing mechanism based on the piezoelectric effect in certain materials, such as quartz.

[0066] In certain embodiments, the monitoring system 40 can include at least two subsystems, including an implantable internal subsystem or device 30 that includes a sensor transducer 32 and a control circuit 34 having one or more microcontrollers, discrete electronic components, and one or more power and / or data transmitters 38 (e.g., antenna coils). The monitoring system 40 can further include an external (e.g., non-implantable) subsystem having an external reader 42 (e.g., coil), which may include a wireless transceiver electrically and / or communicatively coupled to the particular control circuit 41. In certain embodiments, both the internal subsystem 30 and the external subsystem 42 include corresponding coil antennas for wireless communication and / or power delivery through patient tissue disposed therebetween.

[0067] The shunt structure 31 may include a percutaneously deliverable shunt device configured to be secured against and / or within a tissue wall to provide a fluid path between two chambers and / or blood vessels of the heart, as described in detail throughout this disclosure. Although certain components are illustrated in FIG. 8 as being part of the implantation device 30, it should be understood that the sensor implantation device 30 may include only a subset of the components / modules shown and may include additional components / modules not shown.

[0068] The wireless signals generated by implanted device 30 can be received by a local external monitoring device or subsystem 42, which can include a reader / antenna interface circuit module 43 disposed at least partially within patient 44 and configured to receive the wireless signal transmissions from implanted device 30. For example, module 43 can include a transceiver device / circuitry.

[0069] The external local monitor 42 may receive wireless signal transmissions from the implanted device 30 using an external antenna 48, such as a wand device, and / or may provide wireless power to the implanted device 30. The reader / antenna interface circuitry 43 may include radio frequency (RF) (or other frequency band) front-end circuitry configured to receive and amplify signals from the implanted device 30, which may include one or more filters (e.g., bandpass filters), amplifiers (e.g., low noise amplifiers), analog-to-digital converters (ADCs) and / or digital control interface circuits, phase-locked loop (PLL) circuits, signal mixers, or the like. The reader / antenna interface circuitry 43 may be further configured to transmit signals to a remote monitor subsystem or device 46 over a network 49. The RF circuitry of the reader / antenna interface circuitry 43 may further include one or more of a digital-to-analog converter (DAC) circuit, a power amplifier, a low pass filter, an antenna switch module, an antenna, or the like, for handling / processing signals transmitted over the network 49 and / or for receiving signals from the embedded device 30. In certain embodiments, the local monitor 42 includes control circuitry 41 for performing processing of signals received from the embedded device 30. The local monitor 42 may be configured to communicate over the network 49 according to known network protocols, such as Ethernet, Wi-Fi, or the like. In certain embodiments, the local monitor 42 includes a smartphone, a laptop computer, or other mobile computing device, or any other type of computing device.

[0070] In certain embodiments, the embedded device 30 includes some degree of volatile and / or non-volatile data storage. For example, such data storage may include solid-state memory utilizing an array of floating gate transistors, or the like. The control circuitry 34 may utilize the data storage to store sensed data collected over a period of time, which may be periodically transmitted to the local monitor 42 or to another external subsystem. In certain embodiments, the embedded device 30 does not include any data storage. The control circuitry 34 may be configured to facilitate wireless transmission of data generated by the sensor transducer 32 or other data associated with the sensor transducer 32. The control circuitry 34 may further be configured to receive inputs from one or more external subsystems, such as from the local monitor 42, or from a remote monitor 46, for example, via a network 49. For example, the embedded device 30 may be configured to receive signals that at least partially control the operation of the embedded device 30, such as by activating / deactivating one or more components or sensors, or by affecting the operation or performance of the embedded device 30.

[0071] One or more components of the implanted device 30 may be powered by one or more power sources 35. Due to size, cost, and / or electrical complexity concerns, it may be desirable for the power source 35 to be relatively minimal in nature. For example, high power driving voltages and / or currents within the implanted device 30 may adversely affect or disrupt operation of the heart or other body parts associated with the implanted device. In certain embodiments, the power source 35 is at least partially passive in nature, such that power may be received wirelessly from an external source by passive circuitry of the implanted device 30, such as by use of short-range or near-range wireless power transfer, or by use of other electromagnetic coupling mechanisms. For example, the local monitor 42 may act as an initiator that actively generates an RF field that may provide power to the implanted device 30, thereby allowing the power circuitry of the implanted device to assume a relatively simple form factor. In certain embodiments, the power source 35 may be configured to obtain energy from an environmental source, such as fluid flow, motion, or the like. Additionally or alternatively, power source 35 may include a battery, which may be advantageously configured to provide sufficient power as needed for a monitoring period (e.g., 3, 5, 10, 20, 30, 40, or 90 days, or other period).

[0072] In some embodiments, the local monitoring device 42 can function as an intermediate communication device between the implanted device 30 and the remote monitor 46. The local monitoring device 42 can be a dedicated external unit designed to communicate with the implanted device 30. For example, the local monitoring device 42 can be a wearable communication device or other device that can be easily disposed in close proximity to the patient 44 and the implanted device 30. The local monitoring device 42 can be configured to continuously, periodically, or sporadically interrogate the implanted device 30 to extract or request sensor-based information from the implanted device 30. In certain embodiments, the local monitor 42 includes a user interface that allows a user to view sensor data, request sensor data, or otherwise interact with the local monitoring system 42 and / or the implanted device 30.

[0073] The system 40 may include a secondary local monitor 47, which may be, for example, a desktop computer or other computing device configured to provide a monitoring station or interface for viewing and / or interacting with the monitored cardiac pressure data. In one example, the local monitor 42 may be a wearable device or other device or system configured to be placed in physical proximity to the patient and / or implanted device 30, where the local monitor 42 is primarily designed to transmit signals to and / or receive signals from the implanted device 30 and provide such signals to the secondary local monitor 47 for viewing, processing, and / or manipulation. The external local monitor system 42 may be configured to receive and / or process certain metadata, such as device ID or the like, from or associated with the implanted device 30, which may also be provided via a data link from the implanted device 30.

[0074] The remote monitoring subsystem 46 may be any type of computing device or collection of computing devices configured to receive, process, and / or present monitoring data received over the network 49 from the local monitoring device 42, from the secondary local monitor 47, and / or from the embedded device 30. For example, the remote monitoring subsystem 46 may be advantageously operated and / or controlled by a medical entity, such as a hospital, physician, or other care entity associated with the patient 44. While certain examples disclosed herein describe communication from the embedded device to the remote monitoring subsystem 46 indirectly through the local monitoring device 42, in certain embodiments, the embedded device 30 may include a transmitter that may communicate over the network 49 to the remote monitoring subsystem 46 without having to relay information through the local monitoring device 42.

[0075] As discussed above, shunts and / or other implanted devices / structures may be integrated with sensors, antennas / transceivers, and / or other components to facilitate in vivo monitoring of pressure and / or other physiological parameters. A sensor apparatus according to examples of the present disclosure may be integrated with a cardiac shunt structure / device or other implanted device using any suitable or desired attachment or integration mechanism or configuration.

[0076] 9A, 9B, 9C, and 9D show perspective, side, and axial views, respectively, of a shunt sensor embedding device 80, according to one or more embodiments. FIGURE 10 shows an exemplary sensor device / assembly 70 that may be used in a sensor embedding device, such as the sensor embedding device 80 shown in Figures 9A-9D, according to one or more embodiments of the present disclosure.

[0077] The shunt sensor embedding device 80 includes two barrel-forming wings / panels 88a, 88b configured to be curved / bent such that edges 89a, 89b of the device 80 are in contact or close proximity (e.g., within 2 mm) to one another to form a tubular fluid conduit / channel. The device 80 may further include a plurality of anchor arms 86a, 86b that may emanate from diametrically opposed axial ends / sides of the barrel 88 of the device 80. In some embodiments, the sensor device 70 is secured to one or more of the anchor arms 86. The sensor device 70 may be secured to the anchor arms 86 using any suitable means or mechanism. For example, fastening / attachment means / mechanisms that may be suitable for attaching sensor device 70 to either the arms or other structures of shunt device 80 may be any of the mechanisms disclosed in PCT Application No. PCT / US20 / 56746, entitled "Sensor Integration in Cardiac Implant Devices," filed October 22, 2020, the contents of which are expressly incorporated herein by reference in their entirety. For example, arm 86 may include one or more sensor retaining fingers, clamps, wraps, bands, belts, clips, pouches, housings, enclosures, and / or the like configured to secure sensor device 70 to the arms and / or posts or another structural feature of device 80.

[0078] 10, the sensor device / assembly 70 may include a sensor transducer component 75 and an antenna component 71. The sensor transducer component 75 may include any type of sensor transducer as detailed above. In some embodiments, the sensor device 70 may be attached to or integral with an arm member 86a of the shunt device 80 as shown. For example, the arm 86a with which the sensor device 70 is associated may generally be associated with a distal or proximal axial portion / end of the barrel 88. That is, when the shunt device 80 is implanted, one or more arms of the shunt 80 may be associated with an inlet / distal portion of the barrel 88, while one or more other anchor arms may be associated with an outlet / proximal portion of the barrel 88. Although distal and proximal sides / portions are referred to in some capacity herein, it should be understood that the identified distal portions / sides may be the outlet or inlet sides of the associated shunt structure, as well as the identified proximal portions / sides. Additionally, the terms "distal" and "proximal" are used for convenience and may or may not refer to a relative orientation with respect to the delivery system / device used to implant the associated sensor embedding device and / or shunt structure.

[0079] The sensor transducer component 75 includes a sensor element 77, such as a pressure sensor transducer / membrane. With respect to the arm member 86a of the shunt 80, the sensor device 70 may be attached / located at the distal 901, medial 902, or proximal 903 portion or region of the arm / anchor 86a, or any portion therebetween. For example, the illustrated embodiment of FIGS. 9A-9D includes the sensor device 70 located primarily on the medial region 902 and distal region 901 of the arm / anchor 86a. In some embodiments, readings obtained by the sensor device 70 may be used to guide the titration of a drug for the treatment of a patient in whom the implanted device 80 is implanted.

[0080] As described herein, the sensor device 70 may be configured to implement wireless data and / or power transfer. The sensor device 70 may include an antenna component 71 for such purposes. The antenna 71, as well as one or more other components of the sensor device 70, may be at least partially contained within a sensor housing 79, which may further include certain control circuitry 72 disposed therein configured to facilitate wireless data and / or power communication functions. In some embodiments, the antenna member 71 includes one or more conductive coils 73, which may facilitate inductive powering and / or data transmission. In examples including conductive coils, such coils may be at least partially wound / disposed around a magnetic (e.g., ferrite, iron) core 89.

[0081] The sensor device 70 may be associated with either the axial side / end of the shunt device 80 and / or the barrel 88, such that the different axial sides / ends of the shunt device 80 are in contact with the opposing sides (S 1 , S 2 ) will be exposed.

[0082] The sensor device 70 may advantageously be biocompatible. For example, the housing 79 may advantageously be biocompatible, such as a housing including glass or other biocompatible material. However, at least a portion of the sensor transducer element / membrane 77, such as a diaphragm or other component, may be exposed to the external environment in some embodiments to allow pressure readings or other parameter sensing to be implemented. The housing 79 may include an at least partially rigid cylindrical or tubular form, such as a glass cylinder form. In some embodiments, the sensor transducer member 75 / 67 is about 3 mm or less in diameter. The antenna 71 may be about 20 mm or less in length.

[0083] When implanted in the heart or other region of the patient's body, the sensor device 70 may be configured to communicate with an external system. For example, the antenna 71 may wirelessly receive power from and / or communicate sensed data or waveforms to and from the external system. The sensor device 70 may be attached to or integrated with the shunt device 80 in any suitable or desirable manner, such as using mechanical attachment means.

[0084] The sensor element 77 may include a pressure transducer. For example, the pressure transducer may be a microelectromechanical system (MEMS) transducer including a semiconductor diaphragm member. In some embodiments, the transducer may include an at least partially flexible or compressible diaphragm member, such as may be made from silicone or other flexible material. The diaphragm member may be configured to flex or compress in response to changes in environmental pressure. The control circuitry 72 may be configured to process signals generated in response to such flexing / compression to provide a pressure reading. In some embodiments, the diaphragm component is associated with a biocompatible layer on its outer surface, such as silicon nitride (e.g., doped silicon nitride). The diaphragm component and / or other components of the pressure transducer 77 may be advantageously fused or otherwise sealed to / with the housing 79 of the sensor device 70 to provide a hermetic seal of at least a portion of the sensor components.

[0085] The sensor retention mechanism 83 associated with the anchor arm 94 may have any suitable or desired form. For example, the sensor retention mechanism 83 may include one or more sensor retention fingers, or other bands, straps, wraps, coils, wires, adhesives, clamps, clips, apertures, engagement protrusions or forms, locks, or other retention mechanisms. In some embodiments, the anchor arm 86a includes a distal stop mechanism 87a, such as a tab or similar form / structure, configured to limit distal movement of the sensor device 70 beyond the distal end of the shunt arm 86a. For example, the stop mechanism 87a may be a tab that folds over the radial profile of the sensor device 70 in a manner that limits axial movement of the sensor device 70 in at least one direction. In some embodiments, the sensor device 70 is integrated with the arm 86a such that a separate retention mechanism is not required to secure the sensor device 70 to the shunt device 80. For example, the anchor arm 86a may be integrated with the housing 79 of the sensor device 70. As with any embodiment of the shunt device disclosed herein, the barrel / conduit form / body 88 defining the shunt orifice may be at least partially covered internally and / or externally with a fabric or other covering that may provide a seal for the device.

[0086] The sensor device 70 may be advantageously disposed, positioned, secured, oriented, and / or otherwise located in a configuration in which its sensor transducer component 75 is disposed within a channel region of the shunt device 80. The term "channel region" is used herein according to its broad and ordinary meaning and may refer to the three dimensional space defined by the radial boundaries of a fluid conduit and extending from the fluid conduit about the axis of the fluid conduit.

[0087] FIG 9C illustrates an axial view of the implanted device 80 of FIG 9A and FIG 9B in accordance with one or more embodiments of the present disclosure. Specifically, FIG 9C illustrates an axial view corresponding to an axial side of the implanted device 80 associated with the sensor device 70. That is, the sensor component 75 is attached to, integrated with, or otherwise associated with the arm 86a, the side shown facing out of the page in FIG 9C. The side shown facing out of the page in FIG 9C may be the distal side or the proximal side.

[0088] The sensor retention mechanism 83 may circumferentially encapsulate or retain the sensor device 70, or a portion thereof. In some embodiments, the sensor device 70 may be attached to the arm 86a by applying a mechanical force, either through clipping, locking, or otherwise engaging the sensor 70 with the arm 86a, by sliding the sensor 70 through a particular retention mechanism 83, or by applying a pressing or other mechanical force thereto. In some embodiments, the shunt device 80 may include one or more tabs that may be configured to pop up or extend to one or more sides of the sensor device 70 for mechanical fixation. Such tabs may include a shape memory metal (e.g., Nitinol) or other at least partially rigid material. In some embodiments, the sensor device 70 is pre-attached to the arm 86a and / or integrated therewith prior to implantation. In some embodiments, the sensor 70 may be incorporated into or manufactured into the shunt device 80 to form a unitary structure. For example, in some embodiments, the sensor 70 may be attached to or integrated with the arm member 86a of the shunt device 80.

[0089] Figure 9D illustrates another axial view of the implanted device 80 of Figures 9A and 9B, in accordance with one or more embodiments of the present disclosure. Specifically, Figure 9D illustrates an axial view corresponding to the axial side of the implanted device 80 opposite the sensor device 70. The side shown facing out of the page in Figure 9D may be the distal side or the proximal side.

[0090] As mentioned above, the sensor device may be secured to the shunt implantation device and / or its anchoring arms of the present disclosure using any suitable or desired sensor retention means. FIG. 11-1 illustrates a sensor embedding device 120 having a suture-wrapped sensor device 126 associated therewith, according to one or more embodiments. The device 126 includes one or more suture wraps 128 (e.g., PET stitches, fabric strips, etc.) configured to at least partially secure the sensor device 126 to the anchoring arms 124. In some embodiments, the wraps 128 are strand-wrapped circumferentially and / or axially over the sensor cylinder and around the anchoring arms 124. The suture wraps 128 may be wrapped around the cylinder / sensor 126 in a circumferential direction across at least a portion of the length of the sensor 126. In some embodiments, the suture wraps 128 include a sheet-like cover / wrap that is drawn or applied over the sensor 126 and / or anchoring arms 124. For example, sutures or other types of lines or stitches may be wrapped around the cover / wrap to secure the cover / wrap to the sensor 126 and arm 124. The sutures / lines 128 may include ePTFE, PET, etc. It may be desirable to protect the suturing mechanism from tissue ingrowth using a suitable coating, covering, or the like.

[0091] FIG. 11-2 illustrates a sensor embedding device 130 having a sensor retention pouch 138, according to one or more embodiments. The pouch 130 may comprise a membrane sock or wrap type retention means or mechanism configured to at least partially secure the sensor embedding device 130 to the sensor support post / arm. The membrane pouch / wrap may comprise polytetrafluoroethylene (PTFE) and / or polyurethane (PU) (e.g., electrospun or rotary jet spun) membrane. The pouch or sock 138 may be attached to or otherwise associated with the anchor arm 134 or another portion of the shunt structure. For example, the pouch 138 may be a suture-based or fabric-based (e.g., fiber and / or polymer fabric) pouch, wrap, or other retention material and / or form. The pouch 138 may comprise any suitable or desired material, including polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyurethane (PU), etc., and / or a combination of similar materials. Such materials, in some implementations, may be electrospun onto the sensor 136 or applied using rotary jet spinning.

[0092] In some embodiments, the sensor 136 is configured to be slidably disposed within the pouch 138, and tension and / or compression of the pouch 138 serves to hold the sensor 136 in a fixed position within the pouch 138. Although a pouch / wrap encasing at least a portion of the sensor 136 in a sock / tube-like fashion is illustrated in FIG. 11-2, in some embodiments, the pouch 138 includes a band or other non-encircling retaining means. In some embodiments, the sensor 136 may be sewn or otherwise attached or secured to the pouch 138. Additionally, the pouch 138 may be sewn or otherwise secured or secured to the arm members 134 of the shunt structure 139. The pouch 138 may advantageously be open on one or both axial ends thereof to allow fluid contact with the sensor element / transducer 137 associated with the sensor 136. That is, the sensor 136 may be exposed through an open portion on the distal or proximal end of the arm 134 and / or the pouch 138 .

[0093] Although particular examples are disclosed herein in connection with a sensor embedding device including a single sensor device associated with a shunt structure, it should be understood that a shunt sensor embedding device according to aspects of the present disclosure may have any suitable or desirable number of sensor devices associated therewith.

[0094] FIG. 11-3 illustrates a sensor embedding device 140 having a sensor support cup 148, according to one or more embodiments. The cup 148 may include an overmolded support form. The sensor 146 is at least partially nested within the cup form 148. The cup 148 may be rigid or flexible. In some embodiments, the cup 148 is bonded to the sensor 146 and / or the anchor arm 144 via a heat treatment or other process. The sensor 146 may be inserted into the cup form 148, or the cup 148 may be applied over the sensor 146 and anchor arm 144 after placing the sensor 146 on the anchor arm 144. A polymer wrap may be applied over the cup 148 and the sensor 146 to further secure the sensor 146 within the cup 148.

[0095] 12 illustrates a shunt implant device 80 implanted in a coronary sinus tissue wall 21, according to one or more embodiments. Although the shunt implant device 80 is illustrated as including a sensor 70, it should be understood that the shunt device 80 may or may not incorporate a sensor component / function. For sensor-loaded embodiments, the implant device 80 may be implanted in a configuration in which the sensor transducer component 755 is at least partially exposed on the atrial side of the tissue wall 21, as shown.

[0096] The coronary sinus 16 is generally continuous around the left atrium 2, and thus there are a variety of possible acceptable placements for the implant device 80. The target site selected for placement of the implant device 80 may be within an area where the tissue of a particular patient is thin or less dense, as previously determined by non-invasive diagnostic means, such as CT scan or radiography, fluoroscopy or intravascular coronary vasculature echo (IVUS). When the sensor transducer component 75 is positioned within the channel region of the shunt conduit 88, the sensor transducer 65 may be advantageously positioned within an area of ​​relatively high flow, thereby generating sensor readings indicative of the characteristics of the flow through the conduit 88 of the shunt structure 80.

[0097] In some cases, a left-to-right shunt through implantation of a shunt device 80 in the wall 21 between the left atrium 2 and the coronary sinus 16 may be preferable over a shunt through the interatrial septum as shown in FIG. 13. For example, a shunt through the coronary sinus 16 may reduce the risk of thrombus and embolism. The coronary sinus may be less susceptible to thrombus / emboli for several reasons. First, blood exiting the coronary vasculature into the right atrium 5 is essentially filtered blood since it has just passed through the capillaries. Second, the ostium 14 of the coronary sinus in the right atrium is often partially covered by a pseudo-valve called the Thebesian valve (not shown). Although the Thebesian valve is not always present, several studies have shown that it is present in most hearts and may prevent the entry of thrombi or other emboli during spikes in right atrial pressure. Third, the pressure gradient between the coronary sinus and the right atrium where it flows out is generally relatively small, so a thrombus or other embolus in the right atrium is likely to remain there. Fourth, if a thrombus / embolus enters the coronary sinus, there is a much larger gradient between the right atrium and the coronary vasculature than between the right atrium and the left atrium. In most cases, the thrombus / embolus will continue to travel through the coronary vasculature until right atrial pressure returns to normal, after which the embolus will return directly to the right atrium.

[0098] Some additional benefits of placing the shunt structure 80 between the left atrium 2 and the coronary sinus 16 are that this anatomical structure is generally more stable than the atrial septal tissue. By shunting left atrial blood to the coronary sinus, sinus pressure may be increased by a small amount. This may cause blood in the coronary vasculature to move more slowly through the heart, increasing perfusion and oxygen transfer, which may be more efficient and may help the dying myocardium recover. Furthermore, by implanting the shunt device / structure 80 in the wall of the coronary sinus 16, damage to the atrial septum may be prevented. Thus, the atrial septum may be preserved for later transseptal access for alternative therapies.

[0099] 13 illustrates a shunt implant device / structure 80 implanted within the atrial septum 18, according to one or more embodiments. A particular location within the atrial septal wall 18 may be selected or determined to provide a relatively stable anchor location for the shunt implant device 80. Furthermore, the shunt device / structure 80 may be implanted at a desired location to allow for future re-crossing of the septal wall 18 for future interventions. Implantation of the shunt device / structure 73 within the atrial septal wall 18 may advantageously allow for fluid communication between the left atrium 2 and the right atrium 5.

[0100] Although the shunt implant device 80 is shown as including a sensor 70, it should be understood that the shunt device 80 may or may not incorporate a sensor component / function. For sensor-loaded embodiments, the implant device 80 may be implanted in a configuration such that the sensor 70 of the device 80 is exposed to the left atrium 2. Alternatively, the sensor implant device 80 may be implanted in a configuration such that the sensor 70 is exposed to the right atrium 2.

[0101] Figures 14-1, 14-2, 14-3, 14-4, and 14-5 provide a flow diagram illustrating a process 1400 for implanting an adjustable barrel shunt implant device, according to one or more embodiments. Figures 15-1, 15-2, 15-3, 15-4, and 15-5 provide images of cardiac anatomy and specific devices / systems corresponding to the operations of process 1400 of Figures 14-1, 14-2, 14-3, 14-4, and 14-5, according to one or more embodiments.

[0102] At block 1402, the process 1400 includes providing a delivery system 151 having a shunt implantation device 80 disposed therein in a delivery configuration, such as a sensor-equipped shunt implantation device as disclosed in detail herein. Image 1502 in FIG. 15-1 illustrates a partial cross-sectional view of a delivery system 151 for a shunt implantation device 80, according to one or more embodiments of the present disclosure. Image 1502 illustrates the shunt implantation device 80 disposed within an outer sheath 150 of the delivery system 151. Although a particular embodiment of a delivery system is illustrated in FIG. 15-1, it should be understood that an adjustable barrel shunt implantation device according to embodiments of the present disclosure may be delivered and / or implanted using any suitable or desired delivery system and / or delivery system components.

[0103] The illustrated delivery system 151 includes an inner catheter 155, which may be at least partially disposed within the outer sheath 150 during one or more portions of the process 1400. In some embodiments, a shunt structure of the implant device 80 may be at least partially disposed about the inner catheter 155, with the shunt structure being at least partially disposed within the outer sheath 150 during one or more portions of the process 1400. For example, the inner catheter 155 may be disposed within the barrel portion 88 of the shunt 80, as shown.

[0104] In some embodiments, delivery system 151 may be configured such that guidewire 153 may be at least partially disposed therein. For example, guidewire 153 may run within a region of the shaft of sheath 150 and / or inner catheter 155, such as within inner catheter 155 as shown. Delivery system 151 may be configured to be advanced over guidewire 153 to guide delivery system 151 to a target implantation site.

[0105] In some embodiments, the delivery system 51 includes a tapered nose cone feature 152 that may be associated with the sheath 150, the catheter 155, and / or the distal end of the delivery system 51. In some implementations, the nose cone feature 152 may be utilized to enlarge an opening in a tissue wall into which the shunt implantation device 80 is implanted or through which the delivery system is advanced. The nose cone feature 152 may facilitate advancement of the distal end of the delivery system 151 through a tortuous anatomy of a patient and / or within an outer delivery sheath or other conduit / pathway. The nose cone 152 may be a separate component from the catheter 155 or may be integrated with the catheter 155. In some embodiments, the nose cone 152 is adjacent to and / or integrated with the distal end of the catheter 155. In some embodiments, the nose cone 152 may include and / or be formed from multiple flap-type configurations that are urged / spread apart as the shunt implantation device 80 and / or any portion thereof, the inner catheter 155, or other device is advanced therethrough.

[0106] In some embodiments, the shunt implantation device 80 may be disposed within the delivery system 151 with the sensor device 70 attached thereto or otherwise associated therewith, as described in detail herein. In some embodiments, the inner catheter 155 includes one or more cutouts, depressions, recesses, gaps, openings, apertures, holes, slits, or other features configured to accommodate the presence of the sensor device 70 and / or other features or aspects of the implantation device 80. For example, the sensor device 70 may be disposed at least partially within the inner diameter of the shunt structure 80 in a radially compressed delivery configuration as shown in FIG. 15-1. In such a configuration, the sensor assembly components may cause interference with the ability of the shunt structure 80 to be disposed relatively tightly around the inner catheter 155, thereby increasing the profile of the delivery system and / or affecting the ability of the implantation device 80 to be delivered using the delivery system 151. Thus, as shown in FIG. 15-1, the inner catheter 155 may include one or more sensor device adjustment features, such as a sensor cutout or other adjustment feature 157. In some examples, the accommodation feature 157 may include longitudinal and circumferential cutouts in the inner catheter 155. The accommodation feature 157 may advantageously be sized to accommodate the size and / or geometry of the sensor device 70, as shown, and may allow the sensor device 70 to protrude radially into the inner diameter / space of the inner catheter 155.

[0107] The shunt implantation device 80 can be positioned within the delivery system 151 with its first end (i.e., distal anchor arm 86a) disposed distally relative to the barrel 88 of the shunt structure 80. The second end (i.e., proximal anchor arm 86b) is positioned at least partially proximal relative to the barrel 88 of the shunt 80 and / or the sensor device 70.

[0108] The outer sheath 150 may be used to deliver the shunt implantation device 80 to the target implantation site. That is, the shunt implantation device 80 may be advanced to the target implantation site at least partially within the lumen of the outer sheath 50 such that the sensor implantation device 70 is at least partially retained and / or secured within a distal portion of the outer sheath 50.

[0109] As described in detail herein, the barrel 88 of the shunt implantation device 80 may include wings / panels 88a, 88b forming two separate barrels. In the delivery configuration shown in FIG. 15-1, at least one of the barrel wings / panels 88a, 88b may be biased inwardly and / or radially relative to the axis of the barrel 88 such that the wings / panels 88a, 88b at least partially circumferentially overlap one another. The overlap of the barrel wings / panels 88a, 88b may reduce the diameter / profile of the shunt 80 to accommodate placement within an outer sheath 150 that may have a smaller diameter than the expanded diameter of the barrel 80 (see FIG. 15-5). Thus, the adjustability / collapsibility of the barrel 88 enabled by the implementation of the barrel wings / panels 88a, 88b may advantageously enable transport / delivery of the shunt device 80 using relatively / desirably compact equipment / systems. Image 1501 shows an alternative design with an angled / tilted barrel, as detailed above.

[0110] At block 1404, the process 1400 includes accessing the right atrium 5 of the patient's heart using a delivery system 151 having a shunt implant device 80 disposed therein. In some implementations, accessing the cardiac anatomy with the delivery system 151 may be performed according to one or more procedures or steps, including placing a guidewire 53 and / or forming and / or dilating an opening between the left atrium 2 and the coronary sinus 16 of the patient's heart, details of which are omitted for convenience and clarity.

[0111] Image 1504 illustrates various exemplary catheter / sheath type delivery systems 111 that may be used for implantation of a shunt device according to aspects of the disclosure. Delivery system 111 may represent an example of delivery system 151 of image 1502. Delivery system 111 may be steerable and have a relatively small cross-sectional profile to allow for traversal of various blood vessels and heart chambers through which it may be advanced, such as en route to right atrium 5, coronary sinus 16, left atrium 2, or other anatomical structure or chamber. Catheter access to right atrium 5, coronary sinus 16, or left atrium 2 with certain transcatheter solutions may be via inferior vena cava 29 (shown by catheter 111a) or superior vena cava 19 (shown by catheter 111b).

[0112] Although access to the right and / or left atrium is illustrated and described in connection with certain embodiments as via the right atrium and / or inferior vena cava, such as through a transfemoral or other transcatheter procedure, other access routes / methods may be implemented in accordance with embodiments of the present disclosure. For example, other access routes may be employed to the left atrium 2 if septal crossing through the atrial septal wall is not possible. In patients with a weakened and / or damaged atrial septum, further engagement with the septal wall may be undesirable and would result in further injury to the patient. Furthermore, in some patients, the septal wall may be occupied with one or more implanted devices or other therapies, and crossing the septal wall is unsustainable in light of such therapies. As an alternative to transseptal access, transaortic access may be performed, with a delivery catheter passing through the descending aorta 32, the aortic arch 12, the ascending aorta, and the aortic valve 7, and through the mitral valve 6 into the left atrium 2. Alternatively, transapical access may be implemented to access the target anatomy through the apex of the heart, such as using minimally invasive access through the chest wall.

[0113] At block 1406, the process 1400 includes advancing the delivery system 151 into the coronary sinus 16 to a target implantation site adjacent the wall 21 that separates the coronary sinus 16 from the left atrium 2. Access to the target wall 21 and left atrium 2 via the coronary sinus 16 may be achieved using any suitable or desired procedure.

[0114] At block 1408, the process 1400 includes accessing the left atrium 2 through an opening 99 formed in the wall 21. For example, a guidewire 153 may be positioned to run through the opening 99 prior to penetration of the opening 99 by the nosecone 152. The opening 99 may be first formed using a needle (not shown) associated with the delivery system 151 or other delivery system 151 implemented prior to block 1408. In some implementations, the nosecone feature 152 may be used to at least partially dilate the opening 99, although the opening 99 may have previously been dilated using a balloon dilator or other device.

[0115] At block 1410, the process 1400 includes deploying one or more anchor arms 86a, which may be considered distal anchor arms of the shunt implant device 80, on the atrial side of the wall 21. The distal arm 86a may have a sensor device 70 associated with it, such that a sensor transducer 75 of the sensor device 70 is exposed within the left atrium 2 such that the sensor transducer 75 may be used to obtain a signal indicative of a physiological parameter associated with the left atrium 2, such as pressure.

[0116] At block 1412, the process 1400 includes deploying one or more proximal arms 86b of the shunt implant device 80 on the coronary sinus side of the tissue wall 21, thereby sandwiching a portion of the wall 21 between the distal and proximal arms 86 of the shunt structure 80. Once the barrel 88 is positioned within the opening 99, a balloon catheter or other device may be used to expand the barrel wings / panels 88a, 88b to the expanded barrel configuration shown in image 1513 of FIG. 15-5. In some implementations, the expansion of the barrel wings / panels 88a, 88b may be achieved through a shape memory property of the shunt implant 80 that may be pre-formed into an expanded configuration such that release of the barrel 88 from the delivery system 151 automatically causes the barrel wings / panels 88a, 88b to expand to the expanded configuration shown in image 1513. When the barrel wings / panels 88a, 88b are expanded (e.g., by outward / radial deflection) to the point where they no longer overlap, the wings / panels may occupy a common radial area such that mechanical interference between the distal edges 89a, 89b of the wings / panels prevents them from folding / compressing after deployment / expansion, which advantageously allows the desired flow channel through the barrel 88 to be maintained thereafter.

[0117] In block 1414, the process 1400 includes removing the delivery system 151, leaving the shunt implant device 80 implanted in the tissue wall 21, thereby allowing blood flow to be shunted by the implant device 70 from the left atrium 2 to the right side of the heart via the coronary sinus 16.

[0118] Additional aspects and features of a process for delivering a shunt structure that may be integrated with a sensor device / function according to embodiments of the present disclosure for implantation in the wall between the coronary sinus and the left atrium are disclosed in U.S. Patent No. 9,789,294, issued October 15, 2017, entitled "Expandable Cardiac Shunt," the disclosure of which is expressly incorporated herein by reference in its entirety. Although the implant device 80 is shown within the left atrial / coronary sinus wall 21, the implant device 80 may be positioned between other cardiac chambers, such as between the left and right atrium.

[0119] Further description of the embodiment Provided below is a list of examples, each of which may include aspects of any of the other examples disclosed herein. Additionally, aspects of any of the examples described above may be implemented in any of the numbered examples provided below.

[0120] Example 1. A shunt implantation device comprising one or more anchoring arms and first and second barrel wings configured to curve to form a tubular barrel configuration.

[0121] Example 2. The shunt implant device as described in any of the examples herein, particularly example 1, wherein the first and second barrel wings are configured to deflect inwardly such that distal portions of the first and second barrel wings circumferentially overlap.

[0122] Example 3. The shunt implantation device as described in any of the examples herein, particularly Example 1 or Example 2, wherein the distal edges of the first and second barrel wings are curved towards each other and positioned adjacent to each other as the first and second barrel wings form a tubular barrel.

[0123] Example 4. A shunt implantation device as described in any of the embodiments herein, particularly any one of Examples 1-3, wherein the one or more anchor arms and the first and second barrel wings protrude from a backbone support structure of the shunt implantation device.

[0124] Example 5. A shunt implantation device as described in any embodiment herein, particularly any one of embodiments 1-4, wherein in a flat configuration, one or more anchor arms protrude in a first dimension and first and second barrel wings protrude in a second dimension perpendicular to the first dimension.

[0125] Example 6. A shunt implantation device as described in any of the embodiments herein, particularly any one of embodiments 1-5, wherein each barrel wing comprises a plurality of lateral struts separated by one or more lateral slit gaps.

[0126] Example 7. A shunt implantation device as described in any of the embodiments herein, particularly any one of embodiments 1-6, wherein each barrel wing comprises a plurality of vertical struts separated by one or more vertical slit gaps.

[0127] Example 8. A shunt implant device as described in any of the embodiments herein, particularly any one of Examples 1-7, wherein each barrel wing comprises struts forming one or more rows of polygonal cells.

[0128] Example 9. A shunt implantation device as described in any of the embodiments herein, particularly any one of Examples 1-8, wherein the tubular barrel configuration has an axis that is angled relative to a tissue plane associated with the shunt implantation device.

[0129] Example 10. A shunt implantation device as described in any embodiment herein, particularly any one of embodiments 1-9, wherein at least one of the one or more anchor arms includes a sensor retaining means configured to secure the sensor device to the shunt implantation device.

[0130] Example 11. A shunt implantation device as described in any embodiment herein, particularly example 10, further comprising a cylindrical sensor device mechanically coupled to the sensor retaining means.

[0131] Example 12. A shunt implantation device comprising: a shunt barrel formed at least in part by a plurality of arcuate panels arranged in an at least partially cylindrical configuration; a first anchor arm protruding from a first axial side of the shunt barrel and biased radially outward in a first radial direction; and a second anchor arm protruding from a second axial side of the shunt barrel and biased radially outward in the first radial direction.

[0132] Example 13. A shunt implantation device as described in any of the examples herein, particularly example 12, wherein the shunt barrel comprises an axial gap formed between the distal edges of the plurality of arcuate panels.

[0133] Example 14. A shunt implantation device as described in any of the examples herein, particularly example 12 or example 13, wherein a plurality of arcuate panels are connected by a backbone structure diametrically opposed to an axial gap.

[0134] Example 15. A shunt implantation device as described in any embodiment herein, particularly example 14, wherein the backbone structure comprises at least one axial strut.

[0135] Example 16. A shunt implant device as described in any of the examples herein, particularly any one of Examples 12-15, further comprising a pressure sensor device associated with the first anchor arm.

[0136] Example 17. The shunt implant device of any of the embodiments herein, particularly example 16, wherein the pressure sensor is secured to the first anchor arm by a plurality of sensor retaining fingers protruding from the first anchor arm.

[0137] Example 18. The shunt implantation device of any of the embodiments herein, particularly any one of embodiments 12-17, wherein the plurality of arcuate panels are configured to assume a compressed delivery configuration in which a first arcuate panel of the plurality of arcuate panels is biased radially inwardly and circumferentially overlapping a second arcuate panel of the plurality of arcuate panels.

[0138] Example 19. A shunt implantation device as described in any of the embodiments herein, particularly example 18, wherein in the expanded configuration, the first and second arcuate panels of the plurality of arcuate panels are radially aligned.

[0139] Example 20. A shunt implantation device as described in any embodiment herein, particularly example 19, wherein contact between the edges of the plurality of arcuate panels prevents radial compression of the shunt barrel.

[0140] Example 21. A shunt implantation device described in any of the embodiments herein, particularly any one of embodiments 18-20, wherein in a compressed delivery configuration, the shunt barrel has a diameter smaller than the diameter of the shunt barrel in an expanded configuration in which a first and second arcuate panel of the plurality of arcuate panels are radially aligned.

[0141] Example 22. A method of shunting a fluid, comprising: providing a shunt device comprising one or more anchor arms and first and second barrel wings configured to bend to form a tubular barrel configuration; configuring the shunt device into a compressed delivery configuration by deflecting at least one of the first and second barrel wings inwardly to cause the first and second barrel wings to overlap, thereby reducing a diameter of the shunt device; disposing the shunt device in the compressed delivery configuration within a delivery catheter; advancing the shunt device into a target tissue wall within a patient; forming an opening in the target tissue wall; disposing one or more anchor arms on one or more sides of the target tissue wall; deploying the first and second barrel wings within the opening; expanding the first and second barrel wings within the opening to form a tubular barrel configuration; and shunting blood from the tubular barrel configuration.

[0142] Example 23 The method of any of the embodiments herein, particularly Example 22, wherein expanding the first and second barrel wings as described above comprises inflating a balloon catheter within the shunt device.

[0143] Example 24. The method of any of the embodiments herein, particularly Example 22 or Example 23, wherein expanding the first and second barrel wings as described above comprises enabling the shape memory property to automatically expand the first and second barrel wings.

[0144] Depending on the embodiment, certain acts, events, or functions of any of the processes or algorithms described herein may be performed in a differing order, may be added, combined, or omitted entirely, and thus, in a particular embodiment, not all described acts or events may be required to practice a process.

[0145] In particular, conditional language used herein, such as "can," "could," "might," "may," "eg," and the like, unless specifically stated otherwise or understood otherwise within the context in which it is used, is intended to have its ordinary meaning and is generally intended to convey that certain examples include certain features, elements, and / or steps, but other examples do not. Thus, such conditional language is generally not intended to imply that features, elements, and / or steps are in any manner required for one or more examples, or that one or more examples necessarily include logic for determining, with or without author input or prompting, whether those features, elements, and / or steps are included in or should be performed in any particular example. Terms such as "comprising," "including," "having," and the like, are synonymous and used in their ordinary sense and are used in an inclusive, non-limiting manner and do not exclude additional elements, features, acts, operations, and the like. Also, the term "or," for example, when used to connect a list of elements, is used in its inclusive sense (and not its exclusive sense) so that 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" is understood with the context to be used generally to convey that an item, term, element, etc., can be either X, Y, or Z, unless specifically stated otherwise. Thus, such conjunctive language is not generally intended to imply that a particular embodiment requires that at least one of X, at least one of Y, and at least one of Z, respectively, be present.

[0146] In the above description of the embodiments, it should be understood that 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. However, this method of disclosure should not be interpreted as reflecting an intention that any claim requires more features than are expressly recited in that claim. Moreover, any component, feature, or step illustrated and / or described in a particular embodiment herein can be applied to or used with any other embodiment. Moreover, no component, feature, step, or group of components, features, or steps is necessarily required or essential to each embodiment. Thus, it is intended that the scope of the invention herein disclosed and claimed below should not be limited by the particular embodiments described above, but should be determined solely by a fair reading of the following claims.

[0147] It should be understood that certain sequential terms (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply physical characteristics or order. Thus, as used herein, sequential terms (e.g., "first," "second," "third," etc.) used to modify elements, such as structures, components, operations, etc., do not necessarily indicate a priority or order of the element relative to any other elements, but rather may generally distinguish an element from other elements having a similar or identical name (except for the use of sequential terms). In addition, as used herein, the indefinite articles ("a" and "an") may indicate "one or more" rather than "one." Furthermore, an operation performed "based on" a condition or event may also be performed based on one or more other conditions or events not expressly recited.

[0148] Unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as commonly understood by those skilled in the art to which the examples belong. Furthermore, terms such as those defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and are not to be interpreted in an idealized or overly formal sense unless expressly defined herein.

[0149] Spatially relative terms such as "outer", "inner", "upper", "lower", "bottom", "up", "vertical", "horizontal", and similar terms may be used herein for ease of description to describe the relationship between one element or component and another element or component as illustrated in the drawings. It is understood that the spatially relative terms are intended to encompass different orientations of the device during use or operation in addition to the orientation depicted in the drawings. For example, if a device shown in the drawings is turned over, a device that is positioned "below" or "directly below" another device may be positioned "above" another device. Thus, the exemplary term "below" may include both a lower position and an upper position. Devices may also be oriented in other directions, and thus the spatially relative terms may have different interpretations depending on the orientation.

[0150] Unless expressly stated otherwise, comparative and / or quantitative terms such as "less," "more," "greater than," and the like, are intended to encompass equivalent concepts. For example, "less" can mean "less than" as well as "less than" in the strictest mathematical sense.

Claims

1. A shunt implantation device (50; 50a; 50b, 50c; 60) comprising: distal and proximal anchor arms (56; 56a; 56b; 66); a backbone support structure (52, 62) extending between the distal and proximal anchor arms (56; 56a; 56b; 66); first and second barrel wings (58a; 58b; 401a; 401b; 401c; 68a; 68b) configured to protrude from and curve around the backbone support structure (52, 62) to form a tubular barrel configuration (58; 68) defining a central flow channel (96) having a first axis (A1), wherein the distal and proximal anchor arms (56; 56a; 56b; 66) are configured to curl outward from the backbone support structure (52, 62) and radially away from the first axis (A1) of the central flow channel (96); A shunt implant device (50; 50a; 50b, 50c; 60) comprising:

2. 2. The shunt implantation device (50; 50a; 50b, 50c; 60) of claim 1, wherein the first and second barrel wings (58a; 58b; 401a; 401b; 401c; 68a; 68b) are configured to deflect inwardly such that distal portions of the first and second barrel wings (58a; 58b; 401a; 401b; 401c; 68a; 68b) circumferentially overlap.

3. 2. The shunt implantation device (50; 50a; 50b, 50c; 60) of claim 1, wherein distal edges of the first and second barrel wings (58a; 58b; 401a; 401b; 401c; 68a; 68b) curve toward each other and are positioned adjacent to each other when the first and second barrel wings (58a; 58b; 401a; 401b; 401c; 68a; 68b) form the tubular barrel configuration (58; 68).

4. 4. A shunt implantation device (50; 50a; 50b, 50c; 60) according to any one of claims 1 to 3, wherein in a flat configuration, the distal and proximal anchor arms (56; 56a; 56b; 66) protrude in a first dimension and the first and second barrel wings (58a; 58b; 401a; 401b; 401c; 68a; 68b) protrude in a second dimension perpendicular to the first dimension.

5. A shunt implantation device (50; 50a; 50b, 50c; 60) as described in any one of claims 1 to 4, wherein each of the barrel wings (58a; 58b; 401a; 401b; 401c; 68a; 68b) includes a plurality of lateral struts (417; 61) separated by one or more lateral slit gaps (92).

6. 5. The shunt implantation device according to claim 1, wherein each of said barrel wings (58a; 58b; 401a; 401b; 401c; 68a; 68b) comprises a plurality of vertical struts (441; 541) separated by one or more vertical slit gaps (411; 511).

7. A shunt implantation device (50; 50a; 50b, 50c; 60) according to any one of claims 1 to 4, wherein the barrel wings (58a; 58b; 401a; 401b; 401c; 68a; 68b) comprise struts forming one or more rows of polygonal cells.

8. A shunt implantation device (50; 50a; 50b, 50c; 60) as described in any one of claims 1 to 4, wherein the tubular barrel form (58; 68) has an axis that is angled relative to a tissue plane associated with the shunt implantation device (50; 50a; 50b, 50c; 60).

9. A shunt implantation device (50; 50a; 50b, 50c; 60) as described in any one of claims 1 to 8, further comprising a pressure sensor device (70).

10. 10. The shunt implantation device (50; 50a; 50b, 50c; 60) of claim 9, wherein at least one of the distal and proximal anchor arms (56; 56a; 56b; 66) includes a sensor retaining means (83) configured to secure the sensor device (70) to the shunt implantation device (50; 50a; 50b, 50c; 60).

11. A shunt implantation device (50; 50a; 50b, 50c; 60) according to any one of claims 1 to 10, wherein the backbone support structure (52; 62) comprises at least one axial strut.

12. A shunt implantation device (50; 50a; 50b, 50c; 60) as described in claim 1, wherein the first and second barrel wings (58a; 58b; 401a; 401b; 401c; 68a; 68b) include first and second arcuate panels, and in an expanded configuration, the first and second arcuate panels are radially aligned.

13. 13. The shunt implantation device (50; 50a; 50b, 50c; 60) of claim 12, wherein contact between the edges of the first and second arcuate panels prevents radial compression of the tubular barrel form (58; 68).

14. A shunt implantation device (50; 50a; 50b, 50c; 60) as described in any one of claims 1 to 13, wherein the first and second barrel wings (58a; 58b; 401a; 401b; 401c; 68a; 68b) are configured to assume a compressed delivery configuration, in which a first one of the first and second barrel wings (58a; 58b; 401a; 401b; 401c; 68a; 68b) is biased radially inwardly of and circumferentially overlaps a second one of the first and second barrel wings (58a; 58b; 401a; 401b; 401c; 68a; 68b).

15. 15. The shunt implantation device (50; 50a; 50b, 50c; 60) of claim 14, wherein in the compressed delivery configuration, the tubular barrel form (58; 68) has a diameter smaller than the diameter of the tubular barrel form (58; 68) in an expanded configuration in which the first and second barrel wings (58a; 58b; 401a; 401b; 401c; 68a; 68b) are radially aligned.

Images