WO2025006701A1

WO2025006701A1 - Systems and methods for selectively adjusting and/or calibrating implantable shunting systems

Info

Publication number: WO2025006701A1
Application number: PCT/US2024/035748
Authority: WO
Inventors: Anthony Pantages; Greg YEH; Ian BARANOWSKI; Brian Fahey; Peter ANDRIOLA; Jace Valls; Virgilina Tan PAPASIN
Original assignee: Shifamed Holdings LLC
Current assignee: Shifamed Holdings LLC
Priority date: 2023-06-29
Filing date: 2024-06-27
Publication date: 2025-01-02
Anticipated expiration: 2025-12-29

Abstract

The present technology generally relates to implantable medical devices and, in particular, to systems and methods for selectively adjusting and/or calibrating implantable shunting systems, including opening and/or closing the shunting systems after implantation within a patient. In some embodiments, a system for selectively adjusting and/or calibrating an implantable shunting system includes an energy transmission device configured to be positioned at least proximate to the implantable shunting system. The energy transmission device can be configured to transmit energy to the adjustable shunting element to change a dimension of the adjustable shunting element. In at least some embodiments, for example, the adjustable shunting element can define a lumen having a diameter, and the energy transmitted by the energy transmission device can cause a decrease to the diameter of the lumen.

Description

SYSTEMS AND METHODS FOR SELECTIVELY ADJUSTING AND/OR CALIBRATING IMPLANTABLE SHUNTING SYSTEMS

CROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] The present application claims priority to U.S. Provisional App. No. 63/511.145, filed June 29, 2023, and U.S. Provisional App. No. 63/582,785, filed September 14, 2023. Both of the above-identified applications are hereby incorporated by reference in their entireties.

TECHNICAL FIELD

[0002] The present technology generally relates to implantable medical devices and, in particular, to systems and methods for selectively adjusting and/or calibrating implantable shunting systems, including opening and/or closing the shunting systems after implantation.

BACKGROUND

[0003] Shunting systems have been widely proposed for treating various disorders associated with fluid build-up or pressure in a particular body region. For example, interatrial shunting systems that shunt blood from the left atrium of the heart to the right atrium of the heart have been proposed as a treatment for heart failure in general, and heart failure with preserved ejection fraction in particular. Proposed shunting systems range in complexity from simple tube shunts to more sophisticated systems having on-board electronics, adjustable lumens, or the like. Despite the advancement of shunting system technology, designing shunting systems that can be reliably and relatively non-invasively delivered and deployed across a target structure, as well as adjusting and/or calibrating these systems after deployment, remains a challenge.

BRIEF DESCRIPTION OF THE DRAWINGS

[0004] FIG. 1 is a schematic illustration of a shunting element implanted in a heart and an adjustment and/or calibration catheter, each configured in accordance with select embodiments of the present technology.

[0005] FIG. 2A is a perspective view of an adjustment and/or calibration catheter configured in accordance with select embodiments of the present technology.

[0006] FIG. 2B is a side view of the catheter of FIG. 2A with an energy transmission device carried by the catheter deployed from within an energy transmission device lumen of the catheter. [0007] FIG. 2C is a side view the energy⁷ transmission device of FIG. 2B deployed in a coaxially-aligned configuration.

[0008] FIG. 2D is a side view of the catheter of FIG. 2A with an expandable component carried by the catheter deployed from within an expandable component lumen of the catheter.

[0009] FIG. 2E is a side view of the expandable component of FIG. 2D.

[0010] FIGS. 3A-3G illustrate select steps in a process for adjusting and/or calibrating a shunting element using an adjustment and/or calibration catheter, in accordance with embodiments of the present technology.

[0011] FIGS. 4A-4C illustrate select steps in another process for adjusting and/or calibrating a shunting element using a catheter in accordance with embodiments of the present technology⁷.

[0012] FIG. 5 illustrates a step in a process for adjusting and/or calibrating a shunting element using an adjustment and/or calibration catheter with an energy⁷ transmission device deployed in a coaxially-aligned configuration, in accordance with embodiments of the present technology.

[0013] FIG. 6A is a side view of another adjustment and/or calibration catheter configured in accordance with select embodiments of the present technology.

[0014] FIG. 6B is a cross-sectional view of the adjustment and/or calibration catheter taken along section line A-A in FIG. 6A.

[0015] FIG. 7 is a perspective view of another adjustment and/or calibration catheter configured in accordance with select embodiments of the present technology.

DETAILED DESCRIPTION

[0016] The present technology is generally directed to systems and methods for selectively- adjusting and/or calibrating implantable shunting systems. In at least some embodiments, the present technology includes an adjustment and/or calibration catheter carrying an expandable component (e.g., a balloon) and an energy⁷ transmission device (e.g., a coil). The expandable component can be positioned within a lumen of a shunting element and expanded to increase a diameter of the shunting element, thereby decreasing a resistance to fluid flow through the shunting element. The energy transmission device can transmit energy to the shunting system to cause a decrease to the diameter of the shunting element, thereby increasing a resistance to fluid flow through the shunting element.

[0017] The terminology used in the description presented below is intended to be interpreted in its broadest reasonable manner, even though it is being used in conjunction with a detailed description of certain specific embodiments of the present technology. Certain terms may even be emphasized below; however, any terminology intended to be interpreted in any restricted manner will be overtly and specifically defined as such in this Detailed Description section. Additionally, the present technology can include other embodiments that are within the scope of the examples but are not described in detail with respect to FIGS. 1-7.

[0018] Reference throughout this specification to “one embodiment’⁷ or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present technology . Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features or characteristics may be combined in any suitable manner in one or more embodiments.

[0019] Reference throughout this specification to relative terms such as, for example, “generally,” “approximately,” and “about” are used herein to mean the stated value plus or minus 10%.

[0020] As used herein, the terms “interatrial device,” “interatrial shunt device,” “IAD,” “IASD,” “interatrial shunt,” and “shunt” are used interchangeably to refer to a device that, in at least one configuration, includes a shunting element that provides a blood flow between a first region (e g., a left atrium of a heart) and a second region (e.g., a right atrium or coronary sinus of the heart) of a patient. Although described in terms of a shunt between the atria, namely the left and right atria, one will appreciate that the technology may be applied equally to devices positioned between other chambers and passages of the heart, or between other parts of the cardiovascular system. For example, any of the shunts described herein, including those referred to as “interatrial,” may be nevertheless used and/or modified to shunt blood between the left atrium (“LA”) and the coronary sinus, or between the right pulmonary vein and the superior vena cava. Moreover, while the disclosure herein primarily describes shunting blood from the LA to the right atrium (“RA”). the present technology can be readily adapted to shunt blood from the RA to the LA to treat certain conditions, such as pulmonary hypertension. For example, mirror images of embodiments, or in some cases identical embodiments, used to shunt blood from the LA to the RA can be used to shunt blood from the RA to the LA in certain patients. Moreover, while certain embodiments herein are described in the context of heart failure treatment, any of the embodiments herein, including those referred to as interatrial shunts, may nevertheless be used and/or modified to treat other diseases or conditions, including other diseases or conditions of other body regions. For example, the systems described herein can be used to treat diseases characterized by increased pressure and/or fluid build-up. including but not limited to glaucoma, pulmonary failure, renal failure, hydrocephalus, and the like.

[0021] Although certain aspects of the present technology are described with reference to adjusting and/or calibrating an implantable device-based interatrial shunt, a person of ordinary skill in the art will appreciate that the present technology can be used to adjust and/or calibrate other shunts and/or shunting systems. For example, at least some embodiments of the present technology can be used to adjust and/or calibrate procedure-based interatrial shunts, and/or other suitable interatrial shunts.

[0022] FIG. 1 is a schematic illustration of an interatrial shunting system 100 ('‘system 100”) including a shunting element 102 implanted in a heart of a patient, and an adjustment and/or calibration catheter 112 (“catheter 112”), both configured in accordance with select embodiments of the present technology. The shunting element 102 can include an actuation element 104, an inductor 106, a power source 108. and one or more first sensors 110. The shunting element 102 can define a lumen 103 that fluidly connects the RA and the LA. The shunting element 102 can include additional features not shown in FIG. 1 , such as a frame, anchors, membrane, or the like. For example, the shunting element 102 can include features such as those described in International Patent Application No. PCT/US2020/049996. the disclosure of which is incorporated by reference in its entirety.

[0023] The actuation element 104 can be configured to change (e.g., decrease) a size/diameter of the lumen 103 to produce a corresponding change (e.g., decrease) in fluid flow through the system 100. More specifically, the actuation element 104 can be configured to selectively change a geometry (size, shape, etc.) and/or other characteristic of the shunting element 102 to selectively modulate (e.g., increase or decrease) the flow of fluid through the lumen 103. For example, the actuation element 104 can be configured to adjust the shape and/or geometry of the lumen 103 so that fluid flow through the lumen 103 is at least partially or fully prevented, for example, by selectively decreasing a diameter of the lumen 103 and/or otherwise reducing an intemal cross-sectional area defined by the lumen 103. In some embodiments, at least a portion of the actuation element 104 comprises a shape memory material, such as a shape memory metal or alloy (e.g., Nitinol, including Nitinol-based alloys), a shape memory polymer, or apH-based shape memory material. For embodiments in which the actuation element 104 is composed of a shape memory material (which may be referred to herein as a “shape memory actuation element”), the shape memory actuation element can be configured to change in geometry (e.g., transform between a first configuration and a second configuration) in response to a stimulus (e.g., heat or mechanical loading). The movement of the actuation element 104 can adjust the geometry of the lumen 103, as described above. Additional aspects of adjusting an interatrial shunt using shape memory actuation elements, including various adjustable interatrial shunts incorporating shape memory actuation elements, are described in International Application No. PCT/US2020/049996, previously incorporated by reference herein.

[0024] The inductor 106 can be operably coupled to the actuation element 104. e.g.. to provide the stimulus that causes the actuation element 104 to change (e g., decrease) the size/ diameter the lumen 103. The power source 108 can provide power to one or more components of the shunting element 102, such as the one or more first sensors 110, the actuation element 104, etc. Individual ones of the first sensors 110 can be configured to detect a pressure in the RA and/or the LA.

[0025] The catheter 112 can include an expandable component 114, an energy transmission device 116, and/or one or more second sensors 118. The expandable component 1 14 can be configured to change (e.g., increase) the size/diameter of the lumen, e.g., to produce a corresponding change (e.g., increase) in fluid flow through the system 100. For example, as described in greater detail with reference to FIGS. 2A-4C, the expandable component 114 can be positioned within the lumen 103 and transitioned to an expanded state to increase the size/diameter of the lumen 103, e.g., to reduce a resistance to fluid flow through the shunting element 102. The energy transmission device 116 can be configured to transmit energy (e.g., heat) to the inductor 106 and, in turn, cause the actuation element 104 to change the size/diameter of the lumen 103, e.g., to increase and/or decrease the size/diameter ofthe lumen 103. Additionally, or alternatively, the energy transmission device 116 can be configured to transmit energy to charge the power source 108, e.g., while causing the actuation element 104 to change the size/diameter of the lumen 103. In these and/or other embodiments, the energy transmission device 116 can be configured to act as a data communication antenna that can send and/or receive information from components (e.g., a sensor, a microcontroller, etc.) of the shunting element 102. Individual ones of the second sensors 118 can be configured to detect a pressure in the RA and/or the LA. In some embodiments, the expandable component 114 and/or the second sensors 118 can be omitted from the catheter 112 and/or included in another device. Although the catheter 112 is positioned in the RA in the embodiment shown in FIG. 1, in other embodiments all, or at least a portion, of the catheter 112 can be positioned in the LA and operated in an at least generally similar or identical manner. For example, at least a portion of the energy transmission device 116 can be positioned in the LA and transmit energy to the inductor 106, as described in greater detail below with reference to at least FIGS. 4A-4C

[0026] FIG. 2A is a perspective view of an adjustment and/or calibration catheter 212 (‘’catheter 212”) configured in accordance with select embodiments of the present technology. One or more features of the catheter 212 can be at least generally similar or identical in structure and/or function to the catheter 112 of FIG. 1. Additionally, the catheter 212 can define a first or expandable component lumen 220, a pressure sensing port 222. a third or energy transmission device lumen 224, and/or a fourth or guidewire lumen 226. An expandable component 214 (e.g., generally similar to or the same as the expandable component 114 of FIG. 1) can be positioned within and/or deployed from the expandable component lumen 220. An energy transmission device 216 (e.g.. generally similar to or the same as the energy transmission device 116) can be positioned within and/or deployed from the energy transmission device lumen 224. The energy transmission device 216 can be operably coupled to a console 228 configured to control the operation of the energy transmission device 216. In at least some embodiments, for example, the energy transmission device 216 can be operably coupled to the console 228 via a coaxial cable, such as an RG178 cable or another suitable coaxial cable. The coaxial cable can be covered with a braided sheath and/or other structure configured to stiffen the coaxial cable and, accordingly, increase the pushability and/or navigability of the energy' transmission device 216. At least a tip portion 213 of the catheter 212 can be steerable. The catheter 212 can further include a first port 223 coupled to the pressure sensing port 222 and/or a second or flush port 225 to flush individual lumens 220-226 of the catheter 212.

[0027] FIG. 2B is a side view of the catheter of FIG. 2A with an energy transmission device 216 deployed from within the energy transmission device lumen 224 (FIG. 2 A). The energy transmission device 216 can be at least generally similar in structure and/or function to the energy' transmission device 116 of FIG. 1. In the illustrated embodiment, the energy transmission device 216 includes a coil 230 formed at the end of a wire 232. In some embodiments the coil 230 comprises a conductive (e.g., highly electrically conductive) material (e.g., silver, gold, or platinum), a superelastic material (e.g., Nitinol, including Nitinol-based alloys), or a combination thereof (e.g.. a Silver -NiTi construction). For example, at least a portion of the coil 230 can include an arrangement in which a superelastic material covers (e.g., is clad around) a more strongly conductive material (e.g., core). In some embodiments, at least a portion of the coil 230 can include an arrangement in which a strongly conductive material (e.g., cladding) can cover a superelastic material (e.g.. core), such that the more strongly conductive material is positioned externally on (at a surface of) the coil 230. In these and/or other embodiments, thermal and/or electrical insulation (e.g., polytetrafluoroethylene, polyurethane, thermoplastic polyurethane, etc.) can be placed around all, or at least a portion, of the wire 232. The insulation can at least partially prevent heat generated by the wire 232 from elevating temperatures in nearby tissues (e.g., blood) when, e.g., the coil 230 is being used to transmit energy. Insulation can also provides a secondarybenefit of physically separating portions of the wire 232 from one another, reducing electrical interference and/or other proximity effects. Without wishing to be bound by theory-, it is believed that this separation may allow for induction efficiencies in the system. The wire 232 can be operably (e.g., electrically) connected to the console 228 (FIG. 2A) via, e.g., a coaxial cable, as described previously with reference to FIG. 2A. In at least some embodiments, for example, the wire 232 can be soldered to the coaxial cable and this connection point between the wire 232 and the coaxial cable can be covered with a polymer, including any of the polymers described herein.

[0028] FIG. 2C is a side view of the energy' transmission device 216 deployed in a coaxially - aligned configuration. In the configuration shown in FIG. 2C, the generally loop-shaped coil 230 is substantially orthogonal to the longitudinal length of the wire 232 (see also FIG. 4). A central axis 234 of the coil 230 can be coaxial with, or at least generally coaxial with, a portion of a longitudinal axis of the wire 232. For example, the wire 232 can be shape-set to the coaxially- aligned configuration, and/or can be otherwise configured to bend from (i) a first configuration in which a plane of the coil 230 is parallel to the wire 232 toward and/or to (ii) a second configuration in which the plane of the coil is perpendicular to all or a portion of the wire 232.

[0029] In some embodiments, the wire 232 can have one or more segments or sections 233 (individually identified as a first section 233a, a second section 233b, and a third section 233c). The second section 233b can be positioned between the first section 233a and the third section 233c. The third section 233c can include the coil 230 and, e.g., define at least a portion of the energy transmission device 216. In the illustrated embodiment, the second section 233b is at a first angle Al relative to the first section 233a. The first angle Al can be between about 1 degree and about 180 degrees, such as an angle of at least 5 degrees, 10 degrees, 15 degrees, 20 degrees. 30 degrees, 45 degrees, 90 degrees, 135 degrees, or one or more other suitable angles. Additionally, or alternatively, the third section 233c can be at a second angle A2 relative to the second section 233b. The second angle A2 can be between about 1 degree and about 90 degrees, such as an angle of at least 5 degrees, 10 degrees, 15 degrees, 20 degrees, 30 degrees, 45 degrees, or one or more other suitable angles. In at least some embodiments, the wire 232 can include a shape-memory material that is, e.g., shape-set and/or otherwise configured to assume the configuration with the angles Al, A2 shown in FIG. 2C, or with one or more of the other values for these angles Al, A2 described previously herein.

[0030] The wire 232 can be advanced distally from within the catheter 212 to deploy the coil 230 and/or retracted proximally within the catheter 212 to resheathe the coil 230. Additionally, or alternatively, the wire 232 can be positioned within a deployment sheath 235 that can be retracted proximally over the wire 232 to deploy the coil 230 and/or advanced distally over the wire 232 to resheathe the coil 230 within the deployment sheath 235. In some embodiments, a covering or sleeve 237 can be placed around at least a portion of the wire 232, such as the coil 230, to at least partially prevent the wire 232 from catching on patient anatomy and/or one or more implanted objects (e.g., an adjustable shunting element) during a procedure. The sleeve 237 can be formed from one or more electromagnet! cally transparent materials, such as expanded polytetrafluoroethylene (ePTFE) and/or one or more other suitable materials. In some embodiments, the sleeve 237 includes and/or is used in addition to the insulation described previously with reference to FIG. 2B.

[0031] FIG. 2D is a side view of the catheter of FIG. 2A with an expandable component 214 carried by the catheter deployed from within the expandable component lumen 220 (FIG. 2A). The expandable component can be at least generally similar in structure and/or function to the expandable component 114 of FIG. 1. In the illustrated embodiment, the expandable component 214 includes an inflatable balloon 236 carried by a delivery⁷ catheter or shaft 238.

[0032] FIG. 2E is a side view of the expandable component 214 of FIG. 2D. One or more second sensors 218a, 218b can be carried by the delivery shaft 238. The second sensors 218a, 218b can be at least generally similar or identical in structure and/or function to the second sensors 118 of FIG. 1. The illustrated embodiment includes an RA sensor 218a positioned on a first side of the balloon 236 and an LA sensor 218b positioned on a second side of the balloon 236, opposite the first side, although in other embodiments, one or both of the second sensors 218a, 218b can be omited. Although described as an RA sensor 218a and an LA sensor 218b, both sensors can be operably utilized to measure pressures in numerous anatomical locations.

[0033] FIGS. 3A-3G illustrate select steps in a process for adjusting and/or calibrating a shunting element using a catheter, in accordance with embodiments of the present technology. FIG. 3 A shows an adjustable shunting element 302 defining a lumen having a first diameter DI . FIGS. 3B and 3C show the coil 230 being used to transmit energy to decrease the diameter of the lumen 303 from the first diameter DI (FIG. 3B) to a second diameter D2 (FIG. 3C). The coil 230 can (while, e.g.. transmiting the energy) be positioned at least proximate to the adjustable shunting element 302, such as within a distance of 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3 cm, 2 cm, 1 cm, 0.5 cm, 0.1 cm, 0.01 cm, another suitable distance, or in contact with the adjustable shunting element 302. Accordingly, although the coil 230 is spaced apart from the adjustable shunting element 302 in the embodiments shown in FIGS. 3B and 3C. in other embodiments the coil 230 can be placed in contact with the adjustable shunting element 302, e.g.. when transmiting energy to change the diameter of the lumen 303. Placing the coil 230 in contact with the adjustable shunting element 302 is expected to help align the coil 230 with the adjustable shunting element 302, e.g., to improve energy transmission. In some embodiments, the coil 230 can be closed around at least a portion of the adjustable shunting element 302 to, e.g., decrease the diameter of the lumen 303.

[0034] Before using the coil 230 to transmit energy to the adjustable shunting element 302, the user may confirm that the coil 230 is positioned at least proximate to the adjustable shunting element 302 and/or an inductor thereof (e.g., the inductor 106 of FIG. 1). In at least some embodiments, for example, the coil 230 and/or the adjustable shunting element 302 can be visible using fluoroscopy and/or one or more other suitable visualization techniques, and the user can confirm that the coil 230 is positioned at least proximate to the adjustable shunting element 302 using one or more images and/or videos obtained using fluoroscopy and/or the one or more other suitable visualization techniques.

[0035] Additionally, or alternatively, the user may confirm that the coil 230 is positioned at least proximate to the adjustable shunting element 302 based, at least in part, on feedback associated with a position of the coil 230 relative to the adjustable shunting element 302. In at least some embodiments, for example, the feedback includes a return loss or Si l parameter associated with an electrical signal transmited from the coil 230 to the adjustable shunting element 302. The user can, while moving the coil 230 relative to the adjustable shunting element 302 or holding the coil 230 in a static position, transmit the electrical signal at a single frequency or sweep the electrical signal through one or more frequencies ranges (e.g.. from about 5 MHz to about 20 MHz, such as from about 6.5 MHz to about 7 MHz and/or from about 13 MHz to about 14 MHz). A decrease or reduction in the return loss or Si l parameter at a given frequency can indicate that, for transmission to the adjustable shunting element 302 at the given frequency, the coil 230 is positioned at least proximate to the adjustable shunting element 302. A greater decrease or reduction in the return loss or S I 1 parameter can indicate that, for the given frequency, the coil 230 is better-positioned to transmit to the adjustable shunting element 302 at the given frequency than one or more other frequencies associated with higher return losses and/or Si l parameters. Accordingly, a local or absolute minimum in the return loss or S 11 parameter at a given frequency can indicate that the coil 230 is positioned optimally relative to the adjustable shunting element 302 for energy transmission at the given frequency. In at least some embodiments, the return loss or S 11 parameter can be used to determine both an optimal charging frequency (expected to be from about 6.5 MHz to about 7 MHz) and/or position of the coil 230 and an optimal actuation frequency (expected to be from about 13 MHz to about 14 MHz) and/or position of the coil 230. To reduce or minimize heat build-up within the adjustable shunting element 302, the electrical signal can include one or more short (e.g., up to 1-3 second) bursts at one or more of the frequencies described herein. A relatively shorter burst can have a higher power than a relatively longer burst while still reducing or minimizing the heat build-up.

[0036] In some embodiments, the coil 230 can be used to transmit data/telemetry and/or otherwise communicate with the adjustable shunting element 302. For example, the coil 230 can be configured to transmit energy at a first frequency and transmit data/telemetry at a second frequency different than the first frequency. The first frequency and the second frequency can be selected based, at least in part, on an overall length of the wire 232 and/or a size (e.g., diameter) of the coil 230. Additionally, or alternatively, the first frequency and the second frequency can be above a range that may lead to interference with other implantable devices, e.g., pacemakers and/or other cardiac rhythm management devices. In some embodiments, the size (e g., diameter) of the coil 230 could be adjustable (e.g., in vivo) to enhance/optimize transmissions/receptions at the first frequency and/or the second frequency. A switching circuit can be included to facilitate transmission at the first and second frequencies and/or reduce or prevent interference. In other embodiments, a second coil may be used to transmit data/telemetry before, during, and/or after the coil 230 is used to adjust the adjustable shunting element 302. In some embodiments, the coil 230 may take other geometric configurations that are not generally circular or ovular in shape. [0037] FIGS. 3D and 3E show the balloon 236 positioned within the lumen 303 and being inflated to increase the diameter of the lumen 303 from a third diameter D3 (FIG. 3D) to a fourth diameter D4 (FIG. 3E). In some embodiments, the balloon 236 can be used to expand, or aid in the shape-memory expansion of, the adjustable shunting element 302, e.g., during implantation and/or before adjusting and/or calibrating the adjustable shunting element 302. FIG. 3F shows the balloon 236 being deflated for removal from the adjustable shunting element 302. During and/or after deflation of the balloon 236, the lumen 303 can retain or approximately retain the fourth diameter D4. In some embodiments, during and/or after the deflation of the balloon 236, the lumen 303 can experience a modest degree of recoil and stabilize with a diameter slightly smaller than the fourth diameter D4. FIG. 3G shows the delivery shaft inserted through the adjustable shunting element 302 to position the RA sensor 218a in the RA and the LA sensor 218b in the LA. Data from one or more of these sensors can be used to calibrate one or more first sensors 310a, 310b (e.g., at least generally similar to the first sensors 110 of FIG. 1) implanted along with the adjustable shunting element 302.

[0038] FIGS. 4A-4C illustrate select steps in another process for adjusting and/or calibrating a shunting element using a catheter in accordance with embodiments of the present technology. FIG. 4A, for example, shows the adjustable shunting element 302 deployed between the RA and the LA of the patient. The balloon 236 is positioned within and/or through the lumen 303 of the adjustable shunting element 302. The coil 230 is deployed in the LA, distally of the balloon 236. In alternative implementations, the coil 230 is deployed in alternate locations (e.g., proximally) relative to the balloon 236. FIG. 4B shows the adjustable shunting element 302 after the coil 230 has transmitted energy to the adjustable shunting element 302. e.g., to close the adjustable shunting element 302 around the balloon 236 and decrease a size of lumen 303. FIG. 4C shows the adjustable shunting element after the balloon 236 and the coil 230 (FIGS. 4A and 4B) have been removed from the lumen 303. The lumen 303 can retain approximately the same size that was set in FIG. 4B. Compared to the adjustment/calibration process described with reference to FIGS. 3A-3G, the process described with reference to FIGS. 4A-4C can involve fewer steps, e.g., because the balloon 236 is used to control (e.g., stop) the reduction in size of the lumen 303 rather than being used to expand the lumen 303 after the lumen’s size has been reduced via the coil 230.

[0039] FIG. 5 illustrates a step in a process for adjusting and/or calibrating a shunting element using a catheter with an energy transmission device deployed in a coaxially-aligned configuration, in accordance with embodiments of the present technology. For example, the coil 230 can be used to decrease a diameter of the lumen 303 as described previously with reference to FIGS. 3B and 3C, but the coil can be in the coaxially-aligned configuration described previously with reference to FIG. 2B. This is expected to make it easier to align the coil 230 with the adjustable shunting element 302 and/or improve energy transmission efficiency. A guidewire 505 can be inserted through the lumen 303 to aid in positioning the coil 230 relative to the adjustable shunting element 302. For example, the guidewire 505 can pass through a center or central region of the coil 230 and be used to center the coil 230 relative to the adjustable shunting element 302.

[0040] FIG. 6 A is a side view of another adjustment and/or calibration catheter 612 (‘’catheter 612”) configured in accordance with select embodiments of the present technology. One or more features of the catheter 612 can be at least generally similar or identical in structure and/or function to the catheter 112 of FIG. 1 and/or the catheter 212 of FIGS. 2A-2E. For example, referring to FIG. 6B, which is a cross-sectional view taken along section line A-A in FIG. 6A, the catheter 612 defines a first or expandable component lumen 620, a pressure sensing port 622, a third or energy transmission device lumen 624, and/or a fourth or guidewire lumen 626. The catheter 212 can further include a first port 623 coupled to the pressure sensing portion 622 and/or a second or flush port 625. Returning to FIG. 6A, an expandable component 614 (e.g., generally similar to or the same as the expandable component 114 of FIG. 1 and/or the expandable component 214 of FIGS. 2B and 2C) can be positioned within and/or deployed from the expandable component lumen 620. An energy' transmission device 616 (e.g., generally similar to or the same as the energy transmission device 116 of FIG. 1 and/or the energy transmission device 216 of FIGS. 2D and 2E) can be positioned within and/or deployed from the energy transmission device lumen 624 (FIG. 6B).

[0041] FIG. 7 is a perspective view of another adjustment and/or calibration catheter 712 (‘’catheter 712”) configured in accordance with select embodiments of the present technology. One or more features of the catheter 712 can be at least generally similar or identical in structure and/or function to the catheter 112 of FIG. 1, the catheter 212 of FIGS. 2A-2E, and/or the catheter 612 of FIG. 6. For example, the catheter 712 defines the guidewire lumen 226 and includes an energy transmission device 716 that can be at least generally similar or identical to the energy transmission device 116 of FIG. 1 and/or the energy transmission device 216 of FIGS. 2A-2C. The energy' transmission device 716 can include the coil 230 and/or the wire 232, e.g., described previously with reference to FIGS. 2A-2C. The wire 232 can be received within one or more lumens 740 (individually identified as a first lumen 740a and a second lumen 740b) defined by the catheter 712. In the illustrated embodiment, for example, the energy transmission device 716 includes a loop of the wire 232 that exits the catheter 212 via one of the lumens 740a-b. forms the coil 230, and returns within the catheter 212 via the other of the lumens 740a-b. The wire 232 can be advanced distally from within one or both of the lumens 740a-b to deploy the coil 230 and/or retracted proximally within one or both of the lumens 740a-b to resheathe the coil 230 within the catheter 712, as described previously with reference to FIG. 2C.

[0042] When deployed from within the catheter 712, e.g., as shown in FIG. 7, the wire 232 can include a joint portion 742 between the second section 233b and the third section 233c. The joint portion 742 can define a third angle A3 at which the wire 232 curves to transition to the coil 230. In the illustrated embodiment the third angle A3 is about 90 degrees. In other embodiments, the third angle A3 can be betw een about 45 degrees and about 135 degrees, such as an angle of at least 50 degrees, 60 degrees, 70 degrees, 80 degrees, 100 degrees, 110 degrees, 120 degrees, 130 degrees, or one or more other suitable angles. Increasing the third angle A3 can reduce the force/stress on the wire 232 at the joint portion 742, e.g.. when the coil 230 is deployed. The guidewire lumen 226 can be centered relative to the coil 230, e.g., when the coil 230 is deployed, which can aid in positioning the coil relative to a shunt (e.g., as described previously with reference to FIG. 4).

[0043] In some embodiments, one or more of the sections 233 of the wire 232 can be twisted or helical. For example, in the embodiment shown in FIG. 7, the second section 233b of the wire 232 is helical. The helical arrangement of the wire 232 can help to ensure that, when deployed from the catheter 212, the wire 232 assumes the correct shape (e.g., the shape-set shape) and/or increase a stiffness of the overall energy transmission device 216 when deployed, e.g., to counteract possible deformations when deployed in vivo. The wire spacing in the second section 233b (e.g.. the number of turns in the helical section) can correspond to an amount of heat generated during energy delivery. The wire spacing in the second section 233b can be increased to reduce heat build-up and/or increase passive cooling of the wire via heat transfer to ambient fluids within the patient. Additionally, or alternatively, one or more active cooling methods can be used to reduce or prevent heat build-up along the wire 232. For example, the wire 232 and/or one or more of the sections 233 thereof can be flushed with saline and/or one or more other fluids to reduce or prevent heat build-up. Examples

[0044] Several aspects of the present technology are described with reference to the following examples:

1 . A method of adjusting and/or calibrating an adjustable shunting element implanted within a heart of a patient, the method comprising: deploying, from an adjustment catheter, an energy transmission device within the heart of the patient at least proximate to the adjustable shunting element, wherein deploying the energy transmission device includes causing a wire extending through a lumen of the adjustment catheter to transition from a first configuration, in which a portion of the wire defining the energy transmission device is at least generally parallel with one or more adjacent portions of the wire, toward a second configuration, in which the portion of the wire defining the energy transmission device is angled relative to the one or more adjacent portions of the wire; aligning the energy’ transmission device with at least a portion of the adjustable shunting element; and transmitting energy to the adjustable shunting element via the energy transmission device to change a size of a lumen of the adjustable shunting element.

2. The method of example 1 wherein aligning the energy transmission device includes centering the energy transmission device relative to the adjustable shunting element.

3. The method of example 1 or 2 wherein transmitting energy to the adjustable shunting element includes decreasing the size of the lumen.

4. The method of any of examples 1-3 wherein the energy' transmission device includes a shape memory' material having a shape-set configuration, and wherein deploying the energy transmission device includes allowing the energy' transmission device to transition toward the shape-set configuration.

5. The method of any of examples 1-4 wherein deploying the energy' transmission device includes deploy ing at least a portion of the energy' transmission device within a left atria or a right atria of the heart of the patient. 6. The method of any of examples 1-5 wherein deploying the energy' transmission device includes extending the portion of the wire defining the energy transmission device distally beyond the adjustment catheter.

7. The method of any of examples 1-6 wherein deploying the energy' transmission device includes advancing the portion of the wire defining the energy transmission device distally through the lumen of the adjustment catheter.

8. The method of any of examples 1-7, further comprising: positioning an expandable component within the lumen of the adjustable shunting element; and expanding the expandable component within the lumen.

9. The method of example 8 wherein transmitting energy to the adjustable shunting element via the energy transmission device to change the size of the lumen includes decreasing the size of the lumen, and wherein expanding the expandable component within the lumen includes increasing a size of the lumen.

10. The method of example 8 or example 9 wherein, when expanded, the expandable component has a diameter, and wherein transmitting energy to the adjustable shunting element via the energy transmission device to change the size of the lumen includes decreasing the size of the lumen to match the diameter of the expandable component.

11. The method of any of examples 1-10 wherein aligning the energy transmission device with at least a portion of the adjustable shunting element includes visually confirming that the energy transmission device is aligned with at least the portion of the adjustable shunting element.

12. The method of example 11 wherein visually confirming includes visually confirming, via fluoroscopy, that the energy transmission device is aligned with at least the portion of the adjustable shunting element. 13. The method of any of examples 1-12 wherein aligning the energy transmission device with at least a portion of the adjustable shunting element includes confirming, based at least in part on electrical feedback, that the energy transmission device is aligned with at least the portion of the adjustable shunting element.

14. The method of example 13 wherein the electrical feedback includes a return loss or an S 11 parameter.

15. A system for adjusting and/or calibrating an adjustable shunting element implanted within a heart of a patient, the system comprising: a catheter defining a lumen; and a wire slidably positioned within the lumen, wherein the wire includes a first section, a second section distal of the first section, and a third section distal of the second section, wherein, when deployed from within the lumen, the second section is at a first angle relative to the first section and the third section is at a second angle relative to the second section, and wherein the third section of the wire defines an energy' transmission device configured to transmit energy to adjust a dimension of the adjustable shunting element.

16. The system of example 15 wherein the energy transmission device includes a coil.

17. The system of example 15 or example 16 wherein: the lumen is a wire lumen; the catheter further defines a guidewire lumen configured to receive a guidewire; and when the energy transmission device is deployed from within the lumen, the guidewire lumen is positioned to center the guidewire relative to the energy’ transmission device.

18. The system of any of examples 15-17, further comprising an expandable component configured to expand and adjust the adjustable shunting element, wherein the lumen is a wire lumen, and wherein the catheter further defines an expandable component lumen configured to receive the expandable component. 19. The system of example 18 wherein the expandable component includes a deliver}' shaft and an inflatable balloon earned by the delivery shaft.

20. The system of example 19 wherein the deliver ' shaft includes a first pressure sensor positioned proximally from the inflatable balloon and a second pressure sensor positioned distally of the inflatable balloon.

21. The system of any of examples 15-20 wherein the first angle is between about 1 degree and about 180 degrees.

22. The system of any of examples 15-21 wherein the first angle is about 135 degrees.

23. The system of any of examples 15-22 wherein the second angle is between about 1 degree and about 90 degrees.

24. The system of any of examples 15-23 wherein the second angle is about 45 degrees.

25. The system of any of examples 15-24 wherein, when deployed from within the lumen, the energy transmission device defines a plane perpendicular, or at least generally perpendicular, to the first section of the wire.

26. A system for addressing heart failure in a patient, the system comprising: an adjustable shunting element configured to be implanted in a heart of the patient, wherein the adjustable shunting element defines a lumen configured to direct fluid flow between a left atrium of the heart and a right atrium of the heart; an energy transmission device configured to be positioned at least proximate to the adjustable shunting element when the adjustable shunting element is implanted in the heart and operable to adjust a dimension of the lumen, wherein the energy transmission device includes — a wire, and a coil formed in the wire; and a console operably coupled to the energy transmission device, wherein the console is configured to cause the energy transmission device to transmit energy, via the coil, to the adjustable shunting element to adjust the dimension of the lumen.

27. The system of example 26 wherein the wire includes a first section, a second section distal of the first section, and a third section distal of the second section, and wherein: the second section has a first shape-set configuration at a first angle relative to the first section; and the third section has a second shape-set configuration to form the coil at a second angle relative to the second section.

28. The system of example 27 wherein the first section of the wire defines a longitudinal axis, wherein the coil defines a central axis, and wherein the first angle and/or the second angle are selected to orient the central axis at least generally parallel to the longitudinal axis.

29. The system of example 27 or example 28, further comprising a delivery catheter, wherein: the wire is slidably positioned within the delivery catheter; and the second section and/or the third section are configured to assume their respective first and second shape-set configurations after being extended outwardly from within a delivery catheter.

30. The system of example 29 wherein: the delivery' catheter defines a first wire lumen and a second wire lumen; and the wire includes a loop portion that (i) extends outwardly from the delivery catheter via the first wire lumen, (ii) forms the coil, and (iii) extends into the delivery catheter via the second wire lumen.

31. The system of any of examples 26-30 wherein the console is configured to cause the energy transmission device to transmit energy, via the coil, to the adjustable shunting element to decrease a diameter of the lumen, and wherein the system further comprises an expandable component configured to be positioned within the lumen and operable to increase the diameter of the lumen.

32. The system of example 31 wherein the expandable component includes an inflatable balloon.

33. The system of any of examples 26-32 wherein the console is configured to transmit first energy to the coil and thereby cause the coil to transmit second energy to the adjustable shunting element.

34. The system of example 33 wherein the first energy is electrical energy and wherein the second energy is heat energy.

Conclusion

[0045] As one of skill in the art will appreciate from the disclosure herein, various components of the adjustment and/or calibration catheters described above can be omitted without deviating from the scope of the present technology. Likewise, additional components not explicitly described above may be added to the adjustment and/or calibration catheters without deviating from the scope of the present technology. Accordingly, the present technology is not limited to the configurations expressly identified herein, but rather encompasses variations and alterations of the described systems.

[0046] Embodiments of the present disclosure may include some or all of the following components: a battery, supercapacitor, or other suitable power source; a microcontroller, FPGA, ASIC, or other programmable component or system capable of storing and executing software and/or firmware that drives operation of an implant; memory such as RAM or ROM to store data and/or software/firmware associated with an implant and/or its operation; wireless communication hardware such as an antenna system configured to transmit via Bluetooth, WiFi, or other protocols known in the art; energy harvesting means, for example a coil or antenna which is capable of receiving and/or reading an externally-provided signal which may be used to power the device, charge a battery, initiate a reading from a sensor, or for other purposes. Embodiments may also include one or more sensors, such as pressure sensors, impedance sensors, accelerometers, force/strain sensors, temperature sensors, flow sensors, optical sensors, cameras, microphones or other acoustic sensors, ultrasonic sensors, ECG or other cardiac rhythm sensors, SpO2 and other sensors adapted to measure tissue and/or blood gas levels, blood volume sensors, and other sensors known to those who are skilled in the art. Embodiments may include portions that are radiopaque and/or ultrasonically reflective to facilitate image-guided implantation or image guided procedures using techniques such as fluoroscopy, ultrasonography, or other imaging methods. Embodiments of the system may include specialized deliver}' catheters/sy stems that are adapted to deliver an implant and/or cany’ out a procedure. Systems may include components such as guidewires, sheaths, dilators, and multiple delivery catheters. Components may be exchanged via over-the-wire, rapid exchange, combination, or other approaches.

[0047] The above detailed description of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise forms disclosed above. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology as those skilled in the relevant art will recognize. For example, although steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments. For example, although this disclosure has been written to describe devices that are generally described as being used to create a path of fluid communication between the LA and RA, the LV and the right ventricle (RV), or the LA and the coronary sinus, it should be appreciated that similar embodiments could be utilized for shunts between other chambers of heart or for shunts in other regions of the body.

[0048] Unless the context clearly requires otherwise, throughout the description and the examples, the words “comprise,” “comprising,” and the like are to be construed in an inclusive sense, as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to.” As used herein, the terms “connected,” “coupled,” or any variant thereof, means any connection or coupling, either direct or indirect, between two or more elements; the coupling of connection between the elements can be physical, logical, or a combination thereof. Additionally, the words “herein.” “above,” “below,” and words of similar import, when used in this application, shall refer to this application as a whole and not to any particular portions of this application. Where the context permits, words in the above Detailed Description using the singular or plural number may also include the plural or singular number respectively. As used herein, the phrase “and/or” as in “A and/or B” refers to A alone, B alone, and A and B. Additionally, the term “comprising” is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and/or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with some embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.

Claims

CLAIMS I/'W e claim:

1. A method of adjusting and/or calibrating an adjustable shunting element implanted within a heart of a patient, the method comprising: deploying, from an adjustment catheter, an energy transmission device within the heart of the patient at least proximate to the adjustable shunting element, wherein deploying the energy transmission device includes causing a wire extending through a lumen of the adjustment catheter to transition from a first configuration, in which a portion of the wire defining the energy transmission device is at least generally parallel with one or more adjacent portions of the wire, toward a second configuration, in which the portion of the wire defining the energy transmission device is angled relative to the one or more adjacent portions of the wire; aligning the energy transmission device with at least a portion of the adjustable shunting element; and transmitting energy to the adjustable shunting element via the energy transmission device to change a size of a lumen of the adjustable shunting element.

2. The method of claim 1 wherein aligning the energy transmission device includes centering the energy transmission device relative to the adjustable shunting element.

3. The method of claim 1 wherein transmitting energy to the adjustable shunting element includes decreasing the size of the lumen.

4. The method of claim 1 wherein the energy transmission device includes a shape memory material having a shape-set configuration, and wherein deploying the energy transmission device includes allowing the energy transmission device to transition toward the shape-set configuration.

5. The method of claim 1 wherein deploying the energy transmission device includes deploying at least a portion of the energy transmission device within a left atria or a right atria of the heart of the patient.

6. The method of claim 1 wherein deploying the energy' transmission device includes extending the portion of the wire defining the energy transmission device distally beyond the adjustment catheter.

7. The method of claim 1 wherein deploying the energy' transmission device includes advancing the portion of the wire defining the energy transmission device distally through the lumen of the adjustment catheter.

8. The method of claim 1, further comprising: positioning an expandable component within the lumen of the adjustable shunting element; and expanding the expandable component within the lumen.

9. The method of claim 8 wherein transmitting energy to the adjustable shunting element via the energy transmission device to change the size of the lumen includes decreasing the size of the lumen, and wherein expanding the expandable component within the lumen includes increasing a size of the lumen.

10. The method of claim 8 wherein, when expanded, the expandable component has a diameter, and wherein transmitting energy to the adjustable shunting element via the energy transmission device to change the size of the lumen includes decreasing the size of the lumen to match the diameter of the expandable component.

11. The method of claim 1 wherein aligning the energy transmission device with at least a portion of the adjustable shunting element includes visually confirming that the energy' transmission device is aligned with at least the portion of the adjustable shunting element.

12. The method of claim 11 wherein visually' confirming includes visually' confirming, via fluoroscopy, that the energy' transmission device is aligned with at least the portion of the adjustable shunting element.

13. The method of claim 1 wherein aligning the energy transmission device with at least a portion of the adjustable shunting element includes confirming, based at least in part on electrical feedback, that the energy' transmission device is aligned with at least the portion of the adjustable shunting element.

14. The method of claim 13 wherein the electrical feedback includes a return loss or an S 11 parameter.

15. A system for adjusting and/or calibrating an adjustable shunting element implanted within a heart of a patient, the system comprising: a catheter defining a lumen; and a wire slidably positioned within the lumen, wherein the wire includes a first section, a second section distal of the first section, and a third section distal of the second section, wherein, when deployed from within the lumen, the second section is at a first angle relative to the first section and the third section is at a second angle relative to the second section, and wherein the third section of the wire defines an energy transmission device configured to transmit energy' to adjust a dimension of the adjustable shunting element.

16. The system of claim 15 wherein the energy transmission device includes a coil.

17. The system of claim 15 wherein: the lumen is a wire lumen; the catheter further defines a guidewire lumen configured to receive a guidewire; and when the energy transmission device is deployed from within the lumen, the guidewire lumen is positioned to center the guidewire relative to the energy' transmission device.

18. The system of claim 15, further comprising an expandable component configured to expand and adjust the adjustable shunting element, wherein the lumen is a wire lumen, and wherein the catheter further defines an expandable component lumen configured to receive the expandable component.

19. The system of claim 18 wherein the expandable component includes a deliver}' shaft and an inflatable balloon earned by the delivery shaft.

20. The system of claim 19 wherein the delivery' shaft includes a first pressure sensor positioned proximally from the inflatable balloon and a second pressure sensor positioned distally of the inflatable balloon.

21. The system of claim 15 wherein the first angle is between about 1 degree and about 180 degrees.

22. The system of claim 15 wherein the first angle is about 135 degrees.

23. The system of claim 15 wherein the second angle is between about 1 degree and about 90 degrees.

24. The system of claim 15 wherein the second angle is about 45 degrees.

25. The system of claim 15 wherein, when deployed from within the lumen, the energy transmission device defines a plane perpendicular, or at least generally perpendicular, to the first section of the wire.

27. The system of claim 26 wherein the wire includes a first section, a second section distal of the first section, and a third section distal of the second section, and wherein: the second section has a first shape-set configuration at a first angle relative to the first section; and the third section has a second shape-set configuration to form the coil at a second angle relative to the second section.

28. The system of claim 27 wherein the first section of the wire defines a longitudinal axis, wherein the coil defines a central axis, and wherein the first angle and/or the second angle are selected to orient the central axis at least generally parallel to the longitudinal axis.

29. The system of claim 27, further comprising a delivery catheter, wherein: the wire is slidably positioned within the delivery catheter; and the second section and/or the third section are configured to assume their respective first and second shape-set configurations after being extended outwardly from within a delivery catheter.

30. The system of claim 29 wherein: the delivery catheter defines a first wire lumen and a second wire lumen; and the wire includes a loop portion that (i) extends outwardly from the delivery catheter via the first wire lumen, (ii) forms the coil, and (iii) extends into the delivery catheter via the second wire lumen.

31. The system of claim 26 wherein the console is configured to cause the energy transmission device to transmit energy, via the coil, to the adjustable shunting element to decrease a diameter of the lumen, and wherein the system further comprises an expandable component configured to be positioned within the lumen and operable to increase the diameter of the lumen.

32. The system of claim 31 wherein the expandable component includes an inflatable balloon.

33. The system of claim 26 wherein the console is configured to transmit first energy to the coil and thereby cause the coil to transmit second energy to the adjustable shunting element.

34. The system of claim 33 wherein the first energy is electrical energy and wherein the second energy is heat energy.