HK40090036A - Dual purpose inductors for implantable medical devices and associated systems and methods - Google Patents

Description

Dual-purpose inductors for implantable medical devices and related systems and methods

Cross-references to related applications

This application claims the benefit of U.S. Provisional Application No. 63/093,073, filed on October 16, 2020, the disclosure of which is incorporated herein by reference in its entirety.

Technical Field

This technology generally relates to implantable medical devices, and in particular, to implantable systems with dual-purpose inductors.

Background Technology

Implantable medical devices that can be selectively activated or otherwise actuated typically require a particular type of power management system. For example, some medical devices include onboard electronics for wirelessly receiving energy and/or charging or recharging implantable energy storage devices (e.g., batteries or capacitors). Onboard electronics may include inductors incorporated into various circuits to generate energy in response to exposure to electric or magnetic fields. To maximize the inductance of the inductors, coils are typically constructed with closely spaced, concentrically stacked coils to achieve maximum coupling efficiency.

Attached Figure Description

Figure 1 is a schematic diagram of an atrial device implanted in the heart and constructed according to a selected embodiment of the present technology.

Figure 2A is a schematic diagram of an inductor constructed according to a selected embodiment of the present technology.

Figures 2B to 2D show another inductor constructed according to a selected embodiment of the present technology.

Figures 3A and 3B illustrate various aspects of an implantable medical device constructed according to a selected embodiment of the present technology.

Figure 4 is a schematic diagram of a circuit constructed according to the selected implementation scheme of this technology.

Detailed Implementation

This technology relates to implantable medical devices including circuitry for powering one or more active components of the device, such as actuators, motors, microcontrollers, or sensors. The circuitry may include one or more inductors having one or more receiving leads that generate current in response to exposure to an electromagnetic field. As described in detail throughout this specific embodiment, inductors constructed according to embodiments of this technology are designed to generate sufficient energy/power upon exposure to an electromagnetic field, even in embodiments where the inductor is implanted relatively deep within the patient's body (e.g., in an organ deep within the body, such as the heart). The current generated by the receiving leads can be used to power one or more active components, directly or indirectly. Compared to conventional inductors, the receiving leads may also be non-concentrically arranged such that, in addition to generating current for powering the device, the receiving leads also anchor or stabilize a portion of the device when implanted in the patient's body. For example, the receiving leads may be at least partially constructed of a hyperelastic material, causing them to exhibit hyperelastic properties at body temperature. As discussed further below, the advantage of this construction is that the use of catheter-based implantation devices makes it easier to deliver and deploy ultra-elastic leads, resulting in numerous device functional and patient safety benefits.

Conventional medical devices with active components powered via inductive coupling typically have discrete (i.e., separate) inductive elements (e.g., coils) and anchoring elements. The inductive and anchoring elements are each optimized for their respective functions. For example, inductive elements are typically constructed of highly conductive materials and have a concentrically stacked coil orientation to maximize the inductance of the element. Anchoring elements can take a variety of shapes and sizes, but are typically constructed of rigid, semi-rigid, or hyperelastic materials with a surface area suitable for stabilizing the device by engaging patient tissue. It should be noted that the optimal composition and construction of an inductor differs from that of an anchor. Therefore, in most conventional devices, the inductor does not act as an anchor, and vice versa. In contrast to this conventional arrangement, this technology provides inductive elements that also function as anchoring or stabilizing elements (referred to herein as "wires" or "windings").

Another challenge with many conventional inductor devices is that they are unsuitable for use with medical devices that are implanted relatively deep within the patient's body (e.g., in the patient's heart, rather than subcutaneously). For example, if implanted relatively deep within the patient's body, many conventional inductors will not be able to generate sufficient energy/power unless the patient is exposed to unsafe levels of electromagnetic energy. Furthermore, many conventional inductors are relatively large to ensure sufficient charging capacity, making them unsuitable for transvascular delivery and/or placement within confined cavities. In contrast, and without being constrained by theory, implantable medical devices with inductors constructed according to this technology are designed to address one or more of the aforementioned challenges. For example, this technology includes an inductor that (1) can be delivered via minimally invasive techniques (e.g., transvascular delivery via a catheter), (2) can be fitted into a relatively small cavity (e.g., one or more atria of a patient's heart), and (3) can generate a large amount of energy/power when exposed to electromagnetic fields within acceptable exposure limits.

As described above, the inductors described herein enable the charging of energy storage devices that are relatively deeply implanted in the human body and/or in relatively constrained spaces. For example, in one embodiment, the inductor is implemented in heart failure devices such as interventricular shunts or implantable pressure sensors, wherein the inductor resides in one or more atria and/or across a septal wall. The shunt can be configured to shunt fluid between a first body region (e.g., the left atrium) and a second body region (e.g., the right atrium) of a patient. An exemplary system includes a shunt element having a lumen extending therethrough, the lumen being configured to fluidly connect the first and second body regions when the shunt element is implanted in the patient. The system may also include an actuating element (e.g., a shape memory actuating element) configured to adjust the geometry of the lumen to alter the flow of fluid passing through it. Examples of actuating elements for modifying shunts are described in U.S. Patent Applications 16/840,108 and 17/016,192, the entire contents of which are incorporated herein by reference for all purposes. The exemplary system may also include circuitry for supplying power to the actuating element (e.g., for energizing it to induce resistive heating in the actuating element). This circuitry may include one or more inductive wires configured to generate a current upon receiving energy (e.g., when positioned in an electromagnetic field). In various embodiments, the inductive wires are configured as antennas and anchors. For example, the wires may induce current to power the actuating element and may also anchor and/or stabilize the device (e.g., a shunt element) upon implantation. In various embodiments, the wires may be at least partially constructed of a hyperelastic material, causing them to exhibit hyperelastic properties at body temperature.

The terminology used in the description presented below is intended to be interpreted in its broadest and most reasonable manner, even as it is used in the detailed description of certain specific embodiments of the present technology. Certain terms may even be emphasized below; however, any term intended to be interpreted in any limited manner will be disclosed and specifically defined in this Detailed Description section. Additionally, the present technology may also include other embodiments within the scope of the examples but not described in detail in Figures 1 through 4.

Throughout this specification, the phrase "in one embodiment" or "in an embodiment" means that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment of the present invention. Therefore, the phrases "in one embodiment" or "in an embodiment" appearing in various places throughout the specification do not necessarily refer to the same embodiment. Furthermore, a particular feature or characteristic may be combined in any suitable manner in one or more embodiments.

Relative terms used throughout this specification, such as “generally,” “about,” and “approximately,” are used herein to indicate stated values ±10%.

Figure 1 is a schematic diagram of an exemplary system utilizing elements for receiving energy and/or anchoring implantable medical devices in the body. The exemplary system includes an adjustable shunt system 100 (“System 100”) constructed according to embodiments of the present technology. The exemplary system 100 includes a shunt element 102 defining a lumen 104 passing through it. In the illustrated embodiment, the shunt element 102 is implanted across a septal wall S in a patient's heart; however, the shunt element 102 can be implanted in other areas of the body to fluidly connect any two body areas. When implanted across the septal wall S, the system 100 can fluidly connect the left atrium LA and the right atrium RA via the lumen 104. Thus, when the shunt element 102 is implanted in the septal wall 3 of some patients, blood can flow from the left atrium LA to the right atrium RA via the lumen 104 (as indicated by arrow F). The system 100 may also include one or more active components 106 that can be coupled to the shunt element 102. The active components 106 may include any features implanted with the shunt element 102 that require energy or power to operate. For example, the active component 106 may include one or more actuating elements (e.g., for adjusting the geometry or other characteristics of the shunt element 102), a motor, a microcontroller, or a sensor (e.g., for measuring one or more physiological parameters and/or one or more parameters of the system 100). The shunt element 102 may include additional features not shown in FIG1, such as a frame, diaphragm, etc.

System 100 may also include an energy delivery device 122 for delivering energy (e.g., power) to an implanted component of system 100 (e.g., active component 106, inductor 110, and/or other electrical component 114 described below). Energy delivery device 122 may include any device or system external to the implant capable of wirelessly delivering energy to the implanted component. For example, energy delivery device 122 may include a handheld or portable transmitter, a fixed transmitter (e.g., a pad configured to be placed under a patient's mattress or another suitable location, as further described in U.S. Provisional Patent Application No. 63/217,081, the entire disclosure of which is incorporated herein by reference), or other suitable means. Based on techniques known to those skilled in the art, energy delivery device 122 may be configured to deliver radio frequency (RF) energy, microwave frequency energy, other forms of electromagnetic energy, ultrasonic energy, thermal energy, or other types of energy. In some embodiments, the energy delivery device 122 may deliver frequencies in the range of about 1 MHz to about 1 GHz, such as between about 1 MHz and about 15 MHz (e.g., 1 MHz, 2 MHz, 3 MHz, 4 MHz, 5 MHz, 6 MHz, etc.), but other frequencies are possible. In some embodiments, the energy delivery device 122 may generate an electromagnetic field directed toward the implantation aspect of the system 100. For example, the energy delivery device 122 may generate a substantially uniform electromagnetic field surrounding the system 100. Optionally, the energy delivery device 122 may include one or more devices configured to be positioned at least temporarily within the patient's body (e.g., an energy delivery catheter configured to be navigated to the system 100 during surgery).

System 100 may also include onboard electronics, including one or more inductors 110 and other electrical components 114 (e.g., capacitors, resistors, etc.) electrically coupled together to form a circuit (e.g., an RLC resonant circuit, as described below with respect to FIG3). Inductors 110 may include one or more receiving leads 112 (also referred to herein as "inductor element", "inductor coil", or "inductor wire") capable of receiving energy (e.g., power) from energy transfer device 122. For example, in some embodiments, inductor wire 112 generates energy in response to exposure to an electromagnetic field generated by energy transfer device 122. The generated energy can be used to power active component 106, as described below with respect to FIG2. The lead 112 may have a circular cross-sectional shape, a rectangular cross-sectional shape, or any other suitable cross-sectional shape.

As described in more detail with reference to Figures 2A through 2C, one or more conductors 112 may form multiple loops, lobes, etc. However, unlike conventional inductors, the conductors 112 typically have a non-concentric construction, such that the multiple loops or lobes do not have a "stacked" construction in which the center point of the first coil is axially aligned with the center point of the second coil. In some embodiments, the inductor 110 is formed from a single continuous conductor 112. In other embodiments, the inductor 110 is formed from multiple conductors 112 connected in series (e.g., welded together end-to-end or otherwise linked together). Regardless of whether the inductor 110 consists of a single conductor 112 or multiple conductors 112, the conductors 112 form an electrically continuous inductor structure with a considerable inductance over its entire length. As described in further detail below with reference to Figures 2A through 2C, this is expected to provide several advantages over systems incorporating multiple discrete inductors and/or inductors having sections separated by segments with relatively low inductance and relatively high resistance. The conductor 112 is also arranged such that the current flows in the same sense (e.g., direction). Furthermore, although the conductor 112 is shown as being located in a first region of the system 100 (e.g., in the left atrium LA), in some embodiments, such as those described with reference to Figures 2B and 2C, the conductor 112 may be configured to extend across the septal wall S such that a portion of the inductor 110 is located in a second, opposite region of the system (e.g., in the right atrium RA).

In addition to generating energy to power various aspects of system 100, conductor 112 may also be configured to anchor and/or stabilize shunt element 102 or another aspect of system 100 in a desired location (therefore, inductor 110 and/or conductor 112 may also be referred to herein as "anchoring components"). In one embodiment, for example, individual conductor 112 may engage with patient tissue (e.g., septum S as shown in FIG. 1) to secure shunt element 102 in place. For example, as shown in FIG. 1, inductor conductor 112 may be arranged non-concentrically to form a plurality of spaced-apart individual coils, loops, lobes, etc. This arrangement is comparable to conventional inductor constructions, in which inductor conductors are wound in a closely spaced, concentrically stacked configuration. Therefore, the contact area of conductor 112 is increased compared to a single coil with multiple overlapping turns.

The inductor lead 112 may have components that further enhance the stability provided by the lead. In some embodiments, the inductor lead 112 may be at least partially made of a hyperelastic material (e.g., nitinol), such that it exhibits an elastic response to applied stress at body temperature. For example, the lead 112 may have a highly conductive (e.g., silver) core surrounded by a hyperelastic (e.g., nitinol) sheath or coating. As another example, the lead 112 may have a hyperelastic core (e.g., with relatively high resistivity) with a highly conductive sheath or coating (e.g., with relatively low resistivity and/or that is stretchable). As yet another example, the lead 112 may include a highly conductive lead coupled to the hyperelastic lead, or another suitable arrangement. The hyperelastic properties of the lead 112 enable it to resist plastic mechanical deformation and, therefore, provide a substantially stable anchoring mechanism for the shunt element 102 or other aspects of the system 100, while its conductive properties enable it to be used as a high-quality factor inductor. In some implementations, an insulating material (e.g., a biocompatible polymer, such as polyurethane, polytetrafluoroethylene, etc.) may be positioned around the conductor 112 to reduce the effects of proximity effects relative to a coil made of more closely spaced conductors.

As those skilled in the art will understand from the description herein, the lead 112 may be formed of materials other than hyperelastic materials. A variety of materials are suitable for the lead 112, including but not limited to elastomers, metals, and alloys, among others. The shape and configuration of the lead 112 may be determined based on material properties, delivery techniques, and/or application requirements. In various embodiments, the lead 112 is configured for surgical or minimally invasive delivery (e.g., mini-thoracotomy). In various embodiments, the lead 112 is configured for percutaneous delivery via a catheter. The materials and configurations of certain embodiments of the lead 112 will be described in more detail below.

In addition to one or more aspects of the stabilization/anchoring system 100, the lead wire 112 can also be used to position the electrical component 114 or other components of the system 100 in a desired location during deployment of the system 100. For example, the electrical component 114 may be housed within a housing or canister 118 mechanically coupled to the lead wire 112. During delivery, the lead wire 112 may be compressed, coiled, or otherwise deformed to be placed within the catheter. When deployed from the catheter at the target implantation site, the hyperelastic properties of one or more lead wires 112 will cause one or more lead wires 112 to unfold into their deployment configuration, as shown in FIG1. Because the lead wire 112 is mechanically coupled to the housing 118, the housing 118 will be guided to the predetermined location when the lead wire 112 unfolds into its deployment configuration.

Figure 2A illustrates additional details of a first embodiment of an inductor 110 constructed according to a preferred embodiment of the present technology. As shown, in some embodiments, the inductor 110 includes conductors 112 forming a plurality of conductor loops 112 (four shown as conductor loops 112a to 112d). The conductor loops 112a to 112d are oriented in a petal or cloverleaf configuration (as opposed to conventional concentric stacking/spiral configurations) such that the center points of the conductor loops 112a to 112d generally do not overlap. The conductor loops 112a to 112d may extend from or otherwise surround the shunt element 102 (e.g., as best shown in Figure 1). For example, the conductors 112 may define a core region 113 that may be coupled to or otherwise surround the shunt element 102 or other components of the system 100. Thus, the conductor loops 112a to 112d may provide an anchoring mechanism for the shunt element 102, wherein each conductor loop 112a to 112d contacts a different portion of the spacer wall S.

Although shown as a single conductor with four conductor loops 112a to 112d, those skilled in the art will understand that inductor 110 may have any number of conductors, any number of loops or lobes formed by the conductors, and may be arranged in any suitable configuration to anchor shunt element 102 while maintaining sufficient inductance for receiving and/or generating energy. For example, inductor 110 may include one, two, three, four, five, six, seven, eight, nine, ten, or more conductors coupled in series in an end-to-end configuration. As another example, each conductor loop 112a to 112d of inductor 110 may include more than a single receiving conductor (e.g., loop 112a may include two or more stacked conductors of similar shape, loop 112b may include two or more stacked conductors of similar shape, etc.). As yet another example, system 100 may include multiple inductors 110 (two, three, four, five, six, seven, eight, or more inductors) coupled in series in the same circuit.

Figures 2B to 2D illustrate another embodiment of the inductor 110 constructed according to a preferred embodiment of the present technology. As shown in Figures 2B and 2C, the inductor 110 may be formed from a single continuous conductor 112 woven into a twisted or loop shape, having a central hole 213 extending therethrough. The inductor 110 may have a first end region 224 and a second end region 226, in which the conductor 112 forms a plurality of first lobes or loops 225, and in which the conductor 112 forms a plurality of second lobes or loops 227. The first lobes 225 and the second lobes 227 may be connected by a connecting segment 229 extending between the first end region 224 and the second end region 226. As best shown in Figure 2C, the first lobes 225 and the second lobes 227 may be spaced apart by a gap 228. In operation, tissue (e.g., a spacer wall) may be received within gap 228, and first lobe 225 and second lobe 227 may apply a slightly inward pressure (e.g., by means of the hyperelasticity of wire 112) relative to gap 228 to stabilize or secure inductor 110 and one or more components of system 100 (FIG. 1) to the tissue. For example, FIG. 2D is a front view of inductor 110 deployed across spacer wall S, showing first lobe 225 of first end region 224 engaging spacer wall S and defining an aperture 213 extending therethrough. In the illustrated embodiment, inductor 110 stabilizes shunt element 102 across spacer wall S; however, in other embodiments, shunt element 102 may be omitted and inductor 110 may stabilize other components (e.g., sensors).

Referring back to Figures 2B through 2D, the conductor 112 may have a woven, mesh, or braided pattern or construction in which segments of the conductor 112 “cross” or “overlap” with each other. For example, as best shown in the enlarged portion of Figure 2D, the conductor 112 forms a plurality of intersection points 231 at which segments of adjacent lobes of a plurality of first lobes 225 cross each other. It should be noted that in some embodiments, the conductor 112 is configured such that the segments of the conductor 112 forming the intersection points 231 are formed at an angle θ between about 30 degrees and about 150 degrees, between about 45 degrees and about 135 degrees, between about 70 degrees and 110 degrees, between about 80 degrees and about 100 degrees, or about 90 degrees. In some embodiments, the overlapping segments of the connection portions 229 of the conductor 112 (FIG. 2C) are also formed at an angle θ of about 30 degrees to about 150 degrees, about 45 degrees to about 135 degrees, about 70 degrees to 110 degrees, about 80 degrees to about 100 degrees, or about 90 degrees. This is the opposite of an inductor in which the overlapping segments are parallel or have an angle θ of less than about 30 degrees. Without being theoretically constrained, it is expected that an inductor 110 with normal or substantially normal overlapping segments (e.g., overlapping segments with an angle θ between about 30 degrees and about 150 degrees) will advantageously exhibit (1) a reduced self-capacitance and/or (2) a reduced proximity effect that would adversely increase the resistance of the inductor 110 compared to an inductor 110 with parallel or substantially parallel overlapping segments (e.g., overlapping segments with an angle θ of less than about 30 degrees). Therefore, inductor 110 can have a relatively higher number of wire turns, coils, loops, etc., while maintaining low resistance and a self-resonant frequency substantially greater than the power delivery frequency. Both lower resistance and a higher self-resonant frequency increase the voltage generated across the inductor. In some embodiments, wire 112 may include an insulating material (e.g., a biocompatible polymer) at least at intersection 231 to further reduce the effects of proximity effects.

Although primarily described as a single continuous conductor 112, in some embodiments, the inductor 110 may be composed of multiple conductors 112 connected end-to-end by welding or otherwise linking together, as previously described. However, even in embodiments where the inductor 110 is formed by multiple conductors 112 connected end-to-end, the inductor 110 is a single electrically continuous inductor structure with a considerable inductance over its entire length (e.g., the inductor 110 is designed to eliminate or at least minimize conductor paths across the conductors 112 that increase resistance without significantly increasing inductance). Without being bound by theory, this is expected to ensure that the ratio between inductance and resistance remains within a suitable range and/or above a suitable threshold that enables the inductor 110 to generate current when exposed to an electromagnetic field. For example, in some embodiments, the value of 2 × π × f × L/R is preferably in the range of 40 to 100, where L is the inductance of the inductor in henries, R is the resistance of the inductor in ohms, and f is the power delivery frequency in Hz. It is also anticipated that the inductance will be distributed throughout the inductor 110 to minimize inductance variation that may occur due to mechanical deformation of the inductor 110 caused by anatomical changes and movement (e.g., pulsating motion) at the deployment site.

Without being bound by theory, an inductor 110 having receiving wires 112 configured with a non-concentric stacking orientation as described with reference to Figures 1 to 2D can have a smaller inductance than when the same receiving wires are arranged in a conventional concentric stacking coiled configuration. For example, the non-overlapping wires typically have an inductance of 1/N compared to the same wires in a concentric stacking configuration, where N is the number of non-overlapping wire loops (e.g., if two non-overlapping wire loops are present, then N = 2, in which case the inductance is half that of the two wire loops in a concentric stacking configuration). Therefore, the non-concentric stacked wires 112 can have an inductance that is about 5%, about 10%, about 15%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, or about 90% smaller than that of the same wires coiled in a conventional stacking configuration. However, the conductor 112 generates sufficient energy in response to the electromagnetic field to power one or more active components 106. For example, without theoretical constraints, the energy transfer device 122 generates a substantially uniform electromagnetic field that enables the inductor conductor 112 to generate sufficient energy in a resonant RLC circuit to power one or more active components 106. Furthermore, the conductor 112 is designed to generate sufficient energy in response to an electromagnetic field within acceptable (e.g., clinically acceptable) exposure limits. Acceptable exposure limits are typically expressed as a range of the magnetic field-frequency product, for example, in the range of 2 μT·MHz to 20 μT·MHz. In one embodiment, a representative exposure limit could be 0.3 μT to 3 μT at 6.78 MHz.

Figures 3A and 3B illustrate selectable aspects of an implantable medical device 300 constructed according to embodiments of the present technology. Specifically, Figure 3A shows a view of the device 300 in a deployment configuration, and Figure 3B shows a view of the device 300 in a delivery configuration. Referring first to Figure 3A, the device 300 includes an inductive element 310 comprising one or more receiving or inductive leads 312 (which may be a single continuous inductive lead or multiple inductive leads coupled in series, and may also be referred to as a "coil" or "receiving lead"). The inductive leads 312 may be made of any of the materials described herein, such as composite materials having hyperelasticity and high conductivity. In the deployment configuration, the inductive leads 312 have a surface area sufficient to engage patient tissue to anchor/stabilize the device 300 in a desired location. The device 300 also includes a housing or canister 320 configured to receive one or more electrical components of the device 300. The device 300 may also include body elements, such as the shunt element 102 described with respect to Figure 1.

Unlike the embodiments described with reference to Figures 1 and 2, the inductor wires 312 can be "stacked," allowing multiple wire segments to overlap. However, the inductor wires 312 have a larger perimeter (e.g., 25%, 50%, 100%, etc.) compared to conventional inductor coils. In some embodiments, such as the one shown, the inductor wires 312 also have a non-circular and/or non-elliptical shape in the deployment configuration. For example, the inductor wires 312 may have a height (parallel to the major axis A) greater than their width (perpendicular to the major axis A). In other embodiments, the inductor wires 312 may have a width greater than their height. The ratio between the height and width of the inductor wire can be approximately 2:1, 1.9:1, 1.8:1, 1.7:1, 1.6:1, 1.5:1, 1.4:1, 1.3:1, 1.2:1, 1.1:1, 1:1, 0.9:1, 0.8:1, 0.7:1, 0.6:1, 0.5:1, 0.4:1, 0.3:1, or 0.2:1. The desired size/ratio can be selected based on the location where the implanted device 300 will be placed. For example, in an embodiment where the device 300 includes a septal shunt and the inductor wire 312 will abut against the septal wall anchoring system, the inductor wire 312 may have a height of approximately 40 mm and a width of approximately 30 mm. Therefore, the non-circular geometry allows the inductor wire 312 to engage a larger surface area of the patient tissue, which is expected to maximize power delivery and improve the stability provided by the inductor wire 312.

The inductor wire 312 may also form folded elements, such as small pieces or protrusions 314. Small pieces 314 may be oriented about the long axis A of the device 300 to facilitate collapsing the device (e.g., using less force) into a delivery configuration that can be fitted within the conduit 350, as shown in FIG. 3B. Small pieces 314 may also facilitate deployment of the device 300 from the conduit 350 (e.g., using less force). Small pieces 314 may also alter the stress and/or strain distribution within the wire 312, which may facilitate its collapse into a delivery configuration (e.g., as shown in FIG. 3B). In particular, small pieces 314 may have a size D1 smaller than the inner diameter D2 of the conduit 350, such that when collapsed, the system fits within the conduit 350. Although shown as having a single small piece 314, the device 300 may optionally include multiple small pieces 314, such as a second small piece oriented along the long axis A (e.g., positioned at the bottom portion of the device 300).

Due to the non-circular geometry of the inductor 312, it can also act as a positioning element during deployment of the device 300. For example, various components of the device 300 (e.g., canister 320) can be oriented along the long axis A of the inductor 312. Therefore, a physician can adjust the orientation of the inductor 312 to adjust the orientation of components aligned with its long axis A. This is expected to be particularly advantageous in embodiments where the physician can see the inductor 312 without seeing other components (e.g., if the device 300 is implanted across the septum and the inductor 312 is in the right atrium, the physician can see the inductor 312 via a camera mounted on the catheter, without seeing other components of the system in the left atrium).

As provided above, and in addition to forming an anchor, the inductive elements described herein (e.g., inductor leads 112 of system 100 and inductor leads 312 of device 300) are integrated into a circuit for powering one or more active components 306. For example, FIG. 4 is a circuit diagram of an exemplary resonant RLC circuit 400 formed using inductor leads 410 (which may be the same as inductor leads 112 or 312), electrical components 114 (which may include capacitor C in FIG. 4), and active components (shown in FIG. 4 as actuation element 406) according to an embodiment of the present technology. In embodiments where the actuation element 406 is made of shape memory material, the actuation element 406 can be powered by resistance heating and does not require a specific energy waveform as many conventional motors or engines. Therefore, the actuation element 406 can be directly incorporated into the resonant RLC circuit 400. For example, in the illustrated embodiment, the actuation element 406 is coupled in series with other electrical components of the resonant RLC circuit 400. When the resonant RLC circuit 400 is activated (e.g., via an external power transfer device 122 – FIG. 1), current flows through the actuating element 406, thereby resistively heating the actuating element 406. In an embodiment where the actuating element 406 is made of a shape memory material, this resistive heating can heat the shape memory actuating element above its transition temperature and induce a material phase transition, which causes a change in the geometry of the cavity 104, as described above in detail with respect to FIG. 1. Additional details of an exemplary resonant RLC circuit incorporating an actuating element and usable with the inductor described herein are described in International Patent Application No. PCT/US21/53836, filed October 6, 2021, the entire disclosure of which is incorporated herein by reference.

Those skilled in the art will understand from the disclosure herein that inductor 410 can be incorporated into circuits other than those shown in FIG. 4. For example, inductor 410 can be incorporated into a conventional RLC circuit that supplies power to an energy storage device (e.g., a supercapacitor, battery, etc.), which can then release the stored energy to power active components (e.g., motors, sensors, etc.). As those skilled in the art will further understand, the power/energy generated by the inductor described herein can vary based on several factors, including the strength of electromagnetic fields or other energy sources, the duration of exposure, etc. For example, in some embodiments, the inductor described herein is configured to receive power between about 5 mW and about 500 mW during daily/weekly/monthly maintenance charging. In some embodiments, the inductor may also be configured to receive power between about 5 W and about 20 W to perform certain tasks requiring more energy (e.g., adjusting a shunt during a medical visit).

Compared to currently available technologies, the combination of inductive and anchoring elements in the same components as described herein offers several advantages. As previously mentioned, conventional systems utilize coiled inductive and anchoring/stabilizing components that are separate and independent from each other. This increases system complexity and overall size and weight, which may be unsuitable for certain constrained anatomical locations, such as within one or more atria of a patient's heart. In contrast, devices incorporating this technology can be relatively smaller in size, which benefits the patient by leaving more space around the implant (e.g., more space on the septal wall) to allow for future surgeries (e.g., pulmonary vein ablation, mitral valve surgery, left atrial appendage closure, etc.). Furthermore, devices constructed according to currently disclosed technologies are expected to be more robust in responding to failures.

Traditional coil systems also complicate the delivery of implants and components. For example, cardiovascular implants are typically delivered via small catheters. Relatively soft and malleable conventional coil materials (e.g., silver, copper, gold, etc.) can collapse into the catheter for delivery, but may be difficult to reshape into a suitable coil shape after delivery. Leads (e.g., coils) made of hyperelastic materials (e.g., nitinol manufactured to be in an austenitic state at body temperature) are easier to deliver because they “self-deploy” when withdrawn; however, the electrical properties of such materials can make these leads inefficient and/or unsuitable for use as energy-receiving coils for implanted devices (e.g., acting as coils in a system to drive actuators). The use of leads made of composite materials (e.g., nitinol leads coated with a more conductive silver layer) allows for a balance between electrical performance and mechanical delivery practicality. As currently disclosed, the use of leads made of composite materials allows the lead component to act as both a self-deployment anchor and an energy-receiving component, enabling smaller implants and therefore smaller catheter delivery sizes, which improves patient safety. In fact, one of the intended advantages of this technology is that the system described herein can be delivered and deployed using standard 24Fr (or smaller) conduits.

Those skilled in the art will understand from the disclosure herein that various components of the system described above may be omitted without departing from the scope of this technology. Similarly, additional components not explicitly described above may be added to the system without departing from the scope of this technology. Furthermore, the circuitry described herein can be incorporated into other types of implantable medical devices besides cardiac shunts. Therefore, this technology is not limited to the construction explicitly indicated herein, but covers variations and modifications of the described system.

Example

Several aspects of this technology are illustrated in the following embodiments:

1. A system for diverting fluid between a first body region and a second body region, the system comprising:

The shunt element has an inner lumen extending through the shunt element and is configured such that when the shunt element is implanted in the patient's body, the inner lumen fluidly connects the first body region and the second body region.

An actuating element configured to adjust the geometry of the cavity; and

A circuit for supplying power to the actuating element, the circuit including wires configured as a...

It generates current when exposed to an electromagnetic field, and

When the shunt element is implanted in the patient, it is anchored at the target location.

2. The system according to Embodiment 1, wherein the circuit is a resonant RLC circuit.

3. The system according to embodiment 1 or 2, wherein the conductor is configured to (1) form at least a first loop or lobe in the first body region, (2) form a second loop or lobe in the second body region, and (3) receive tissue between the at least first loop or lobe and the at least second loop or lobe to anchor the system at the target location.

4. The system according to Embodiment 3, wherein the conductor is a single conductor.

5. The system according to embodiment 3, wherein the conductor comprises a plurality of conductors arranged in series.

6. The system according to any one of embodiments 1 to 5, wherein the wire forms a plurality of non-overlapping loops.

7. The system according to any one of embodiments 1 to 5, wherein the conductor includes stacked conductor segments having a non-circular shape.

8. The system according to embodiment 7, wherein the stacked conductor segment has a non-elliptical shape.

9. The system according to any one of Examples 1 to 8, wherein the wire is made of a hyperelastic material and a highly conductive material.

10. The system according to Example 9, wherein the superelastic material is nitinol and the highly conductive material is silver.

11. The system according to embodiment 9, wherein the conductor includes a hyperelastic core and an inductive outer layer.

12. The system according to embodiment 9, wherein the conductor includes an inductive core and a superelastic outer layer.

13. The system according to any one of embodiments 1 to 12, wherein the wire is used as the sole anchoring element in the anatomical region.

14. A circuit for use with an implantable medical device, the circuit comprising:

An inductor coupled to the implantable medical device, wherein the inductor includes a wire that, when deployed across the patient's tissue wall, forms at least one first loop or flap on a first side of the tissue wall and at least one second loop or flap on a second side of the tissue wall.

The conductor is constructed as a

It generates current when exposed to an electromagnetic field, and

When the device is implanted in a patient, it receives a portion of the tissue wall between the first ring or flap and the second ring or flap to anchor the device in the target location.

15. The circuit according to embodiment 14, wherein the circuit is a resonant RLC circuit.

16. The circuit according to embodiment 14 or 15, wherein the wire is a single wire.

17. The circuit according to embodiment 14 or 15, wherein the conductor comprises a plurality of conductors arranged in series.

18. The circuit according to any one of embodiments 14 to 17, wherein the wire forms a plurality of non-overlapping loops.

19. The circuit according to any one of embodiments 14 to 17, wherein the conductor includes stacked conductor segments having a non-circular shape.

20. The circuit according to embodiment 19, wherein the stacked conductor segments have a non-elliptical shape.

21. The circuit according to any one of embodiments 14 to 20, wherein the wire is made of a hyperelastic material and a highly conductive material.

22. The circuit according to Example 21, wherein the superelastic material is nitinol and the highly conductive material is silver.

23. The circuit according to embodiment 21, wherein the conductor includes a hyperelastic core and an inductive outer layer.

24. The circuit according to embodiment 21, wherein the conductor includes an inductor core and a superelastic outer layer.

25. The circuit according to any one of embodiments 14 to 24, wherein the at least one first ring or lobe includes a first first lobe and a second first lobe, both the first first lobe and the second first lobe being configured to reside on the first side of the tissue wall, the first first lobe and the second first lobe having an overlapping section formed at an angle between about 30 degrees and about 150 degrees.

26. The circuit according to any one of embodiments 14 to 25, wherein the wire serves as the sole anchoring element in the anatomical region.

27. An inductor for use with an implantable medical device configured to be implanted across a tissue wall separating a first body region and a second body region, the inductor comprising:

One or more conductors, the conductors being made of a composite material comprising a highly conductive material and a superelastic material, wherein the conductors form a single electrically continuous inductor structure having a first plurality of rings or lobes, a second plurality of rings or lobes at least partially spaced apart from the first plurality of rings or lobes by gaps, and a plurality of connecting segments extending between the first plurality of rings or lobes and the second plurality of rings or lobes.

When the inductor is implanted in a patient, a first end region is configured to reside in a first body region, a second end region is configured to reside in a second body region, and the gap is configured to receive a portion of the tissue wall.

28. The inductor according to embodiment 27, wherein the individual first rings or lobes of the first plurality of rings or lobes do not overlap.

29. The inductor according to embodiment 27, wherein the individual first rings or lobes of the first plurality of rings or lobes overlap.

30. The inductor according to embodiment 29, wherein the individual first ring or lobe has a height and a width, and wherein the height is greater than the width.

31. The inductor according to any one of embodiments 27 to 30, wherein the one or more conductors form a folded element or block for compressing the one or more conductors into a delivery configuration.

32. The inductor according to any one of embodiments 27 to 31, wherein the conductor serves as the sole anchoring element in the anatomical region.

33. A method for treating a patient, the method comprising:

The catheter carrying a heart failure treatment device is passed through the patient's vascular system and advanced toward the patient's heart. The heart failure treatment device includes an anchoring assembly formed by a continuous inductive structure having one or more wires.

The heart failure treatment device is deployed from the catheter at the target location in the patient's heart.

Upon deployment from the catheter, the continuous inductive structure automatically extends to the deployment position and stabilizes the heart failure treatment device at the target location; and

One or more energy storage components on the heart failure treatment device are charged by generating an electromagnetic field, wherein the continuous inductor structure generates current in response to exposure to the electromagnetic field.

34. The method according to embodiment 33, wherein the continuous inductor structure is formed by a single conductor.

35. The method according to embodiment 33 or 34, wherein the continuous inductor structure includes a superelastic core and an inductor exterior.

36. The method according to any one of embodiments 33 to 35, wherein once deployed, the one or more conductors form one or more overlapping segments, wherein each overlapping segment is formed at an angle between about 30 degrees and about 150 degrees.

37. The method according to any one of Examples 33 to 36, wherein the heart failure treatment device includes a sensor.

38. The method according to any one of Examples 33 to 36, wherein the heart failure treatment device includes an atrial shunt.

in conclusion

Embodiments of this disclosure may include some or all of the following components: a battery, supercapacitor, or other suitable power source; a microcontroller, FPGA, ASIC, or other programmable component or system capable of storing and performing software and/or firmware that drives the implant; a memory such as RAM or ROM for storing data and/or software/firmware associated with the implant and/or its operation; wireless communication hardware, such as an antenna system configured to transmit via Bluetooth, WiFi, or other protocols known in the art; and energy harvesting devices, such as coils or antennas capable of receiving and/or reading externally provided signals that can be used to power the device, charge the battery, initiate readouts from sensors, or for other purposes. Embodiments may also include one or more sensors, such as pressure sensors, impedance sensors, accelerometers, force/strain sensors, temperature sensors, flow sensors, optical sensors, cameras, microphones or other acoustic sensors, ultrasound sensors, ECG or other heart rhythm sensors, SpO2 and other sensors suitable for measuring tissue and/or blood gas levels, blood volume sensors, and other sensors known to those skilled in the art. Implementations may include radiopaque and/or ultrasound-reflective components to facilitate image-guided implantation or image-guided surgery using techniques such as fluoroscopy, ultrasound, or other imaging methods. System implementations may include dedicated delivery catheters/systems adapted for delivering implants and/or performing surgery. The system may include components such as guidewires, sheaths, dilators, and multiple delivery catheters. Components may be interchangeable via in-line, quick-change, combination, or other methods.

The above detailed description of embodiments of this technology is not intended to be exhaustive or to limit the technology to the precise forms disclosed above. Although specific embodiments and examples of this technology have been described above for illustrative purposes, those skilled in the art will recognize that various equivalent modifications can be made within the scope of this technology. For example, although the steps are given in a given order, alternative embodiments may perform the steps in a different order. Various embodiments described herein may also be combined to provide other embodiments. For example, although this disclosure has been prepared to describe means generally described as being for forming a fluid communication path between the left and right atria, it should be understood that similar embodiments may also be used for shunts between other chambers of the heart or for shunts in other regions of the body.

Unless the context explicitly requires otherwise, throughout the specification and embodiments, the terms "comprising," "including," etc., shall be interpreted in the sense of inclusion, as opposed to exclusion or exhaustive; that is, in the sense of "including but not limited to." As used herein, the terms "connection," "link," or any variation thereof mean any direct or indirect connection or link between two or more elements; the coupling or connection between elements may be physical, logical, or a combination thereof. Additionally, when used in this application, the terms "this article," "above," "below," and similar terms shall refer to the application as a whole and not any particular part thereof. Where the context permits, singular or plural terms used in the above specific embodiments may also include plural or singular, respectively. As used herein, the phrase "and/or" in "A and/or B" refers to A alone, B alone, and A and B. Furthermore, the term "comprising" throughout means at least including the mentioned features, thus not excluding any further number of the same features and/or features of other types. It should also be understood that specific embodiments have been described herein for illustrative purposes, but various modifications may be made without departing from the present invention. Furthermore, while advantages associated with certain embodiments of the present invention have been described in the context of these embodiments, other embodiments may also exhibit such advantages, and not all embodiments must exhibit such advantages to fall within the scope of the present invention. Therefore, this disclosure and related technologies may include other embodiments not expressly shown or described herein.

Claims (38)

1. A system for diverting fluid between a first body region and a second body region, the system comprising: A shunt element having an inner lumen extending through the shunt element and configured such that, when the shunt element is implanted in a patient, the inner lumen fluidly connects the first body region and the second body region. An actuating element configured to adjust the geometry of the cavity; and A circuit for supplying power to the actuating element, the circuit including wires configured as a... It generates current when exposed to an electromagnetic field, and When the shunt element is implanted in the patient, the shunt element is anchored at the target location. 2. The system according to claim 1, wherein the circuit is a resonant RLC circuit. 3. The system of claim 1, wherein the wire is configured to (1) form at least a first loop or lobe in the first body region, (2) form a second loop or lobe in the second body region, and (3) receive tissue between the at least first loop or lobe and the at least second loop or lobe to anchor the system at the target location. 4. The system of claim 3, wherein the conductor is a single conductor. 5. The system of claim 3, wherein the conductor comprises a plurality of conductors arranged in series. 6. The system of claim 1, wherein the wires form a plurality of non-overlapping loops. 7. The system of claim 1, wherein the conductor comprises stacked conductor segments having a non-circular shape. 8. The system of claim 7, wherein the stacked conductor segments have a non-elliptical shape. 9. The system of claim 1, wherein the conductor is composed of a hyperelastic material and a highly conductive material. 10. The system of claim 9, wherein the superelastic material is nitinol and the highly conductive material is silver. 11. The system of claim 9, wherein the conductor comprises a hyperelastic core and an inductive outer layer. 12. The system of claim 9, wherein the conductor comprises an inductive core and a superelastic outer layer. 13. The system of claim 1, wherein the wire serves as the sole anchoring element in the anatomical region. 14. A circuit for use with an implantable medical device, the circuit comprising: An inductor coupled to the implantable medical device, wherein the inductor includes a wire that, when deployed across the patient's tissue wall, forms at least one first loop or flap on a first side of the tissue wall and at least one second loop or flap on a second side of the tissue wall. The wire is constructed as a It generates current when exposed to an electromagnetic field, and When the device is implanted in a patient, a portion of the tissue wall is received between the first ring or flap and the second ring or flap to anchor the device in a target location. 15. The circuit according to claim 14, wherein the circuit is a resonant RLC circuit. 16. The circuit of claim 14, wherein the wire is a single wire. 17. The circuit of claim 14, wherein the conductor comprises a plurality of conductors arranged in series. 18. The circuit of claim 14, wherein the wires form a plurality of non-overlapping loops. 19. The circuit of claim 14, wherein the conductor comprises stacked conductor segments having a non-circular shape. 20. The circuit of claim 19, wherein the stacked conductor segments have a non-elliptical shape. 21. The circuit of claim 14, wherein the conductor is made of a hyperelastic material and a highly conductive material. 22. The circuit of claim 21, wherein the superelastic material is nitinol and the highly conductive material is silver. 23. The circuit of claim 21, wherein the conductor comprises a hyperelastic core and an inductive outer layer. 24. The circuit of claim 21, wherein the conductor comprises an inductor core and a superelastic outer layer. 25. The circuit of claim 14, wherein the at least one first ring or lobe comprises a first first lobe and a second first lobe, both the first first lobe and the second first lobe being configured to reside on the first side of the tissue wall, the first first lobe and the second first lobe having an overlapping section formed at an angle between about 30 degrees and about 150 degrees. 26. The circuit of claim 14, wherein the wire serves as the sole anchoring element in the anatomical region. 27. An inductor for use with an implantable medical device configured to be implanted across a tissue wall separating a first body region and a second body region, the inductor comprising: One or more conductors, said one or more conductors being made of a composite material comprising a highly conductive material and a superelastic material, wherein said one or more conductors form a single electrically continuous inductor structure, said single electrically continuous inductor structure having a first plurality of rings or lobes, a second plurality of rings or lobes at least partially spaced apart from the first plurality of rings or lobes by gaps, and a plurality of connecting segments extending between the first plurality of rings or lobes and the second plurality of rings or lobes. When the inductor is implanted in a patient, a first end region is configured to reside in a first body region, a second end region is configured to reside in a second body region, and the gap is configured to receive a portion of the tissue wall. 28. The inductor of claim 27, wherein the individual first rings or lobes of the first plurality of rings or lobes do not overlap. 29. The inductor of claim 27, wherein the individual first rings or lobes of the first plurality of rings or lobes overlap. 30. The inductor of claim 29, wherein the individual first ring or lobe has a height and a width, and wherein the height is greater than the width. 31. The inductor of claim 27, wherein the one or more conductors form folded elements or blocks for compressing the one or more conductors into a delivery configuration. 32. The inductor of claim 27, wherein the wire serves as the sole anchoring element in the anatomical region. 33. A method of treating a patient, the method comprising: A catheter carrying a heart failure treatment device is passed through the patient's vascular system and advanced toward the patient's heart. The heart failure treatment device includes an anchoring assembly formed by a continuous inductive structure having one or more wires. The heart failure treatment device is deployed from the catheter at a target location in the patient's heart. Upon deployment from the catheter, the continuous inductive structure automatically extends to the deployment position and stabilizes the heart failure treatment device at the target position; and One or more energy storage components on the heart failure treatment device are charged by generating an electromagnetic field, wherein the continuous inductor structure generates current in response to exposure to the electromagnetic field. 34. The method of claim 33, wherein the continuous inductor structure is formed by a single conductor. 35. The method of claim 33, wherein the continuous inductor structure comprises a superelastic core and an inductor exterior. 36. The method of claim 33, wherein once deployed, the one or more conductors form one or more overlapping segments, wherein each overlapping segment is formed at an angle between about 30 degrees and about 150 degrees. 37. The method of claim 33, wherein the heart failure treatment device includes a sensor. 38. The method of claim 33, wherein the heart failure treatment device comprises an atrial shunt.