Implantable medical devices with hermetic canisters enclosed within a slip membrane

Abstract

The present technology generally relates to a sensor assembly for an implantable medical device. In some embodiments, the sensor assembly includes a housing, a sensor, and a slip membrane. The sensor can be positioned at least partially inside the housing, and can be configured to measure one or more physiological parameters of a patient. For example, the sensor can be configured to measure a left atrial pressure and / or a right atrial pressure of the patient. The slip membrane can at least partially enclose the housing and the sensor. The slip membrane can be configured to protect the housing without adhering and / or sticking to an outer surface of the housing. In some embodiments, the slip membrane is composed of ePTFE. The slip membrane is also expected to reduce noise in and / or attenuation of signals received by the sensor.

Description

IMPLANTABLE MEDICAL DEVICES WITH HERMETIC CANISTERSENCLOSED WITHIN A SLIP MEMBRANECROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] The present application claims the benefit of U.S. Provisional Patent Application No. 63 / 554,364, filed February 16, 2024, the disclosure of which is incorporated herein by reference in its entirety.TECHNICAL FIELD

[0002] The present technology generally relates to implantable medical devices and / or medical systems and, in particular, to sensors for implantable medical devices and / or systems.BACKGROUND

[0003] Implantable devices and systems are utilized in modem medicine to provide a host of diagnostic and / or therapeutic benefits. For example, implantable shunting systems are widely used to treat a variety of patient conditions by shunting fluid from a first body region / cavity to a second body region / cavity. The flow of fluid through the shunting systems is primarily controlled by the pressure gradient across the shunt lumen and the geometry (e.g., size) of the shunt lumen. One challenge with conventional shunting systems is selecting the appropriate geometry of the shunt lumen for a particular patient. A lumen that is too small may not provide enough therapy to the patient, while a lumen that is too large may create new issues in the patient. Despite this, most conventional shunts cannot be adjusted once they have been implanted. Accordingly, once the system is implanted, the therapy provided by the shunting system cannot be adjusted or titrated to meet the patient’s individual needs.

[0004] Some implantable medical systems use sensors to measure physiological parameters (e.g., a shunt device that includes sensors to measure parameters in the first bodyregion and / or the second body region). Oftentimes, electrical components of sensors must be fluidically-isolated from anatomical regions in order to remain functional or accurate, and as such can be integrated into sealed (e.g., hermetically-sealed) housings, casings, and the like. For housings associated with pressure sensors, the housings generally can have a pressure responsive element at or near a surface that is affixed to the housing in a manner that is impermeable to fluid ingress. This pressure responsive element can be. for example, a diaphragm whosedefl ection profile changes in response to changes in local physiological pressure. If the pressure responsive element is comprised of a material with suitable mechanical properties (e.g., flexural rigidity), it will sufficiently transfer pressure signals from outside of the housing to the interior of the housing without meaningful artifact (e.g., damping).

[0005] Challenges associated with systems described in the prior art can be related to manufacturing of appropriate sensor housings and related components. These challenges can include, for example, ensuring adequate coupling of a signal from outside of a housing to the electrical and / or mechanical components located internal to the housing that are sensitive to the signal (i.e., the '‘measurement component(s)" of the sensor apparatus). These challenges can also include, for example, ensuring adequate protection of the electrical and / or mechanical components located internal to the housing from the external environment, which can include fluid, particulates, tissue growth, etc. that may damage and / or interference with operation of the electrical and / or mechanical components.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] Many aspects of the present technology can be better understood with reference to the following drawings. The components in the drawings are not necessarily drawn to scale. Instead, emphasis is placed on illustrating clearly the principles of the present technology’. Furthermore, components can be shown as transparent in certain views for clarity of illustration only and not to indicate that the component is necessarily^ transparent. Components may also be shown schematically.

[0007] FIG. 1 is a schematic illustration of an interatrial shunting system including one or more sensors configured in accordance with select embodiments of the present technology.

[0008] FIG. 2 is a partially schematic, cross-sectional side view of a sensor assembly’ configured in accordance with select embodiments of the present technology.

[0009] FIG. 3 is a top view of an interatrial shunting system including a sensor assembly configured in accordance with select embodiments of the present technology.

[0010] FIG. 4 is a flowchart illustrating a method of manufacturing a sensor assembly in accordance with select embodiments of the present technology.DETAILED DESCRIPTION

[0011] The present technology7is generally directed to medical systems including one or more sensors covered with a slip membrane. In some embodiments, for example, the system includes a shunting element implantable into a patient at or adjacent to a septal wall. The shunting element, for example, can fluidly connect a left atrium and a right atrium of the patient to facilitate blood flow therebetween. In some embodiments, a size and / or shape of the shunting element is adjustable to alter the flow through the shunt. In some embodiments, the shunting system can be configured to adjust the size and / or shape of the shunting element in response to a sensed (e.g., measured, detected, etc.) physiological parameter. For example, the system can include one or more sensors configured to sense a physiological parameter (e.g., temperature, pressure, etc.) in a first body chamber (e.g., the left atrium) and / or in a second body chamber (e.g., the right atrium), and the shunting element can be adjusted at least in part based on the sensed physiological parameter. In some embodiments, the sensors can include one or more capacitive sensors, piezoelectric sensors, piezoresistive sensors, Micro-electromechanical System (“MEMS”) sensors, and / or any other suitable sensor.

[0012] In some embodiments, a sensor assembly includes a hermetic housing or canister that is substantially impermeable to fluid. The housing can at least partially enclose one or more sensors, and a slip membrane can enclose the housing without adhering or sticking to the housing. The slip membrane can protect the housing and the sensors by insulating or isolating the housing and the sensors from an anatomical region of the patient, while still allowing the sensors to measure one or more physiological parameters (e.g., pressure, temperature, etc.). As explained in detail below, the slip membrane is also expected to improve long-term performance of the sensors by providing a barrier between the sensors and tissue growth external to the sensor assembly, which may exert pulling forces on the sensor assembly and interfere with operation of the sensors.

[0013] 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. 1-4.

[0014] Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present technology. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features or characteristics may be combined in any suitable manner in one or more embodiments.

[0015] Reference throughout this specification to relative terms such as, for example, “substantially,” “approximately,” and “about” are used herein to mean the stated value plus or minus 10%.

[0016] 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 chamber (e.g., a left atrium of a heart) and a second chamber (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, between other parts of the cardiovascular system, or between other parts of the body. For example, any of the shunts described herein, including those referred to as “interatrial,” may nevertheless be used and / or modified to shunt between the left atria and the coronary sinus, or between the right pulmonary vein and the superior vena cava. Moreover, while the disclosure herein primarily describes medical devices for shunting blood in the heart, the present technology' can be readily adapted for medical devices used to shunt other fluids — for example, devices used for aqueous shunting or cerebrospinal fluid shunting. The present technology may also be adapted to a variety of implanted medical devices in addition to shunts. The headings provided herein are for convenience only and do not interpret the scope or meaning of the claimed present technology.A. Medical Systems Including Sensor(s)

[0017] FIG. 1 is a schematic illustration of an interatrial shunting system 100 (“system 100”) configured in accordance with embodiments of the present technology. The system 100 includes a shunting element 102 defining a lumen 104 therethrough. The shunting element 102 can include a first end portion 103a positioned in a left atrium LA of a patient and a second end portion 103b positioned in a right atrium RA of the patient. Accordingly, when implanted in theseptal wall S. the system 100 fluidly connects the left atrium LA and the right atrium RA via the lumen 104. When the system 100 is implanted within the patient to treat heart failure, blood generally flows through the lumen 104 in flow direction F (i.e., from the left atrium LA to the right atrium RA).

[0018] The system 100 can also include one or more sensors 140. For example, the system 100 can include a first sensor 140a positionable within the left atrium LA and a second sensor 140b positionable within the right atrium RA (collectively referred to as sensors 140). Further details regarding sensors configured for use with the system 100 or other medical systems are provided below with reference to FIGS. 2 and 3. The sensors 140 can measure one or more physiologic parameters related to the system 100 or the environment proximate to the sensors 140. For example, the first sensor 140a can be configured to measure left atrium LA pressure and the second sensor 140b can be configured to measure right atrium RA pressure. In some embodiments, the system 100 can further include a processor (not shown) configured to calculate a pressure differential between the left atrium LA and the right atrium RA, or other calculated parameters, based on the information measured by the sensor(s) 140. As described below, the system 100 may be adjusted based on the parameters measured by the sensor(s) 140 and / or the pressure differential calculated by the processor. Additional features of some embodiments of the sensors 140 useful in the system described herein are disclosed in International Patent Application No. PCT / US20 / 63360, the disclosure of which is incorporated herein by reference in its entirety.

[0019] The system 100 also includes a flow control mechanism 150 (e.g., an actuation mechanism). The flow control mechanism 150 is configured to change a size, shape, or other characteristic of the shunting element 102 to change the flow of fluid through the lumen 104. In some embodiments, the flow control mechanism 150 can selectively change a size and / or shape of the lumen 104 to change the flow through the lumen 104. For example, the flow control mechanism 150 can be configured to selectively increase a diameter of the lumen 104 and / or selectively decrease a diameter of the lumen 104 in response to an input. In other embodiments, the flow control mechanism 150 is configured to otherwise affect a shape of the lumen 104. Accordingly, the flow control mechanism 150 can be coupled to the shunting element 102 and / or can be included within the shunting element 102. For example, in some embodiments the flow control mechanism 150 is part of the shunting element 102 and at least partially defines the lumen 104. In other embodiments, the flow control mechanism 150 is spaced apart from but operably coupled to the shunting element 102.

[0020] In some embodiments, at least a portion of the flow control mechanism 150 can comprise a shape memory material. The shape memory portion can include Nitinol. a shape memory polymer, a pH-based shape memory material, or any other suitable material configured to move or otherwise adjust as would be understood by one of skill from the description herein. The shape memory portion can be characterized by a curve that defines the amount of deformation the portion undergoes in response to a particular input (e.g., an applied stress). For example, the flow control mechanism 150 can include a Nitinol element that is configured to change shape in response to exposure to energy, such as light and / or heat. In such embodiments, the flow control mechanism 150 can be selectively actuated by applying energy directly or indirectly to the Nitinol element. Additional embodiments of flow control mechanisms suitable for use with the present technology are described in International Patent Application No. PCT / US20 / 38549, the disclosure of which is incorporated herein by reference in its entirety, and International Patent Application No. PCT / US20 / 63360, the disclosure of which was previously incorporated by reference.

[0021] In some embodiments, the flow control mechanism 150 is operably coupled to a processor (not shown) that calculates the pressure differential between the left atrium and right atrium based, at least in part, on the measurements taken by the sensors 140. If the calculated pressure differential falls outside of a predetermined range, the processor can direct the flow control mechanism 150 to change the flow through the shunting element 102.

[0022] FIG. 2 is a partially schematic, cross-sectional side view of a sensor assembly 200 (“assembly 200”) configured in accordance with select embodiments of the present technology'. The assembly 200 can be part of a stand-alone sensing system, part of an interatrial shunting system such as the system 100 of FIG. 1, or part of other suitable systems configured for implantation within a patient. In some embodiments, for example, the assembly 200 can be generally similar to, the same as, or included in (e.g., a component of) the first sensor 140a and / or the second sensor 140b of FIG. 1, and can measure one or more physiologic parameters related to the environment proximate and / or external to the assembly 200.

[0023] The assembly 200 includes ahousing 210, one or more sensors 220 at least partially- enclosed within the housing 210, and a slip membrane 250 (also referred to as a sleeve or sock) enclosing the housing 210 and the sensor(s) 220. In some embodiments, the housing 210 can have a generally cylindrical shape with a hemispherical end 212. In other embodiments, however, the housing 210 can have other suitable shapes. The housing 210 can be formed froma material such as metal (e.g., titanium), a composite, polymer, a combination thereof, and / or any other suitable material. The housing 210 can be hermetically sealed (or substantially impermeable to fluid) to prevent fluid from leaking into the housing 210 and potentially damaging the sensor(s) 220 (and / or other components not shown but enclosed inside the housing 210, such as a battery' or circuitry), and / or affecting measurements taken by the sensor(s) 220.

[0024] In some embodiments, the sensor(s) 220 can be positioned and configured to measure one or more physiological parameters from a surrounding environment external to the assembly 200, such as an anatomical region inside of a patient in which the assembly 200 is implanted. For example, the sensors can be configured to measure pressure (e.g., a left atrial pressure and / or a right atrial pressure of the patient), temperature, etc. The sensor(s) 220 can include one or more capacitive sensors, piezoelectric sensors, piezoresistive sensors, MEMS sensors, and / or any other suitable sensor. In some embodiments, the housing 210 includes an aperture 214 through which the sensor(s) 220 can be directly exposed to an inner surface of the slip membrane 250. The slip membrane 250 can be semi-permeable or permeable. In such embodiments, the sensor(s) 220 may be able to measure the physiological parameters (e.g., pressure) more accurately than if the sensor(s) 220 were fully enclosed within the housing 210. Moreover, the sensor(s) 220 can include components (e.g., O-rings. sealants) and / or a design (e.g., interference fit) that provides a hermetic seal for the housing 210 notwithstanding the aperture 214. In some embodiments, a portion of the slip membrane 250 at the aperture 214 is configured to conform to a shape of the sensor 220. For example, if the sensor 220 includes a coupling element and / or a moving membrane to transmit pressure, the slip membrane 250 may extend partially into the aperture 214 and conform to the shape of the coupling element and / or the moving membrane. Additional details regarding sensors and, in particular, sensors suitable for use with the slip membrane 250 are provided in PCT International Application No. XX, filed February XX, 2025 [Attny Docket No. 134181.8055. WO00], the disclosure of which is incorporated herein by reference in its entirety.

[0025] The slip membrane 250 can enclose the housing 210 and the sensor(s) 220 to protect the housing 210 and the sensor(s) 220 from the surrounding environment external to the assembly 200. For example, the slip membrane 250 can provide an additional hermetic sealing layer to the housing 210. The slip membrane 250 can also still allow the sensor(s) 220 to accurately measure the physiological parameters. For example, in embodiments in which the sensor(s) 220 comprise pressure sensors, the slip membrane 250 can comprise a very thin, flexible membrane that can convey any force or pressure from the surrounding environment tothe sensor(s) 220. In embodiments in which the sensor(s) 220 comprise temperature sensors, the slip membrane 250 can comprise a very thin membrane with high thermal conductivity such that the slip membrane 250 can quickly convey the temperature of the surrounding environment to the sensor(s) 220.

[0026] The slip membrane 250 can be composed of a material such as expanded polytetrafluoroethylene (ePTFE), polytetrafluoroethylene (PTFE), polyethylene (PE), polyurethane (PU), silicone, polyether ether ketone (PEEK), polypropylene, polycarbonate, a combination thereof, and / or any other suitable material. For example, the slip membrane 250 can be formed from other materials that are biocompatible, chemically inert, flexible, durable, low-friction, and / or non-sticky.

[0027] In the illustrated embodiment, the assembly 200 also includes a connector 230 operably coupled to the sensor(s) 220 (wired or wirelessly) and extending external to the housing 210. More specifically, the connector 230 can extend out from the hemispherical end 212 as shown. The other end of the connector 230 can be operably coupled to a processor, a power source, an actuator (e.g., the flow control mechanism 150 of FIG. 1), and / or another component. In operation, the connector 230 can deliver power to the sensor(s) 220 and / or other components enclosed in the housing 210, transfer data from the sensor(s) 220, etc. In some embodiments, the slip membrane 250 can be coupled to a portion of the connector 230 to form a hermetic seal around the housing 210. For example, the assembly 200 cam further include a sealing component 240 that couples the slip membrane 250 to the connector 230. The sealing component 240 can include a medical-grade elastic band, adhesives, fasteners, or other suitable sealing or coupling mechanisms.

[0028] In some embodiments, while the slip membrane 250 encloses the housing 210, the slip membrane 250 does not adhere to (e.g.. stick to) the outer surface of the housing 210. The non-stick properties of the slip membrane 250 is expected to improve long-term performance of the sensor(s) 220. In particular, if the assembly 200 is implanted inside of a patient (e.g., in the patient's heart), tissue may grow at least partially around the assembly 200 and generate forces (e.g., pulling forces) on the slip membrane 250. In fact, in some embodiments, the slip membrane 250 can include a porous structure adapted to promote tissue growth for enhancing biocompatibility of the assembly 200. If the slip membrane 250 were to adhere to the outer surface of the housing 210, the slip membrane 250 may convey the forces from the tissue growth (e.g., tissue ingrowth in the slip membrane) to the housing 210 and interfere with operation ofthe sensor(s) 220 (e.g., pressure sensors that rely on measuring external force or pressure) and / or other components enclosed in the housing 210. Furthermore, if the assembly 200 were not to include any slip membrane, the tissue growth may directly interfere with operation of the sensor(s) 220 and / or the other components enclosed in the housing 210.

[0029] The slip membrane 250 configured in accordance with the present technology, however, does not adhere to the outer surface of the housing 210, and accordingly does not convey (or at least convey less of) the forces resulting from tissue growth to the housing 210. For example, as the tissue growth exerts forces on the slip membrane 250, the slip membrane 250 can stretch, fold, or otherwise deform instead of transferring such forces to the housing 210. Thus, the impact of the forces from the tissue growth on the sensor(s) 220 and / or other components in the housing 210 is expected to be minimal or at least reduced compared to if the slip membrane were to adhere to the outer surface of the housing 210. Also, in some embodiments, the slip membrane 250 is expected to reduce noise in and / or attenuation of signals received by the sensor(s) 220. As mentioned above, ePTFE, which has nonstick and low-friction properties while also being biocompatible, flexible, and chemically resistant, is an example material that can be used to form the slip membrane 250.

[0030] FIG. 3 is a top view of an interatrial shunting system 301 including a sensor assembly 300 (‘"assembly 300”) configured in accordance with select embodiments of the present technology. In the illustrated embodiment, the assembly 300 is operably coupled to a shunting element 302 of the interatrial shunting system 301 via a connector 330. It will be appreciated that the interatrial shunting system 301 can be an example of the interatrial shunting system 100, the shunting element 302 can be an example of the shunting element 102 of FIG. 1, the assembly 300 can be an example of the assembly 200 of FIG. 2, and similarly labeled components can be identical or similar in structure and / or function.

[0031] The assembly 300 can include a slip membrane 350 enclosing a housing 310 and one or more sensors 320 (obscured from view underneath the slip membrane 350). As discussed previously with reference to FIG. 2, the slip membrane 350 can enclose and protect the housing 310 and the sensor(s) 320 without adhering to the outer surface of the housing 310 or materially- interfering with operation of the sensor(s) 320. The slip membrane 350 is shown coupled to a portion of the connector 330 by an elastic band 340, thereby forming a seal (e.g., a hermetic seal) around the housing 310 and the sensor(s) 320. One of ordinary skill in the art will appreciate that the elastic band 340 can be replaced or co-implemented with other sealing components ormechanisms. The data from the sensor(s) 320 can be transferred via the connector 330 to a processor (not shown) and / or the shunting element 302, which can include an adjustable shunt lumen 304 and anchors 306. The sensor data can be used to adjust (e.g., in real-time) the size of the adjustable shunt lumen 304, which can be mounted at a desired implantation site (e.g., a septal wall inside a patient’s heart, as illustrated in FIG. 1) by the anchors 306.

[0032] As discussed previously with reference to FIG. 2, by not adhering or sticking to the housing 310, the slip membrane 350 is expected to improve long-term performance of the sensor(s) 320 and / or other components in the housing 310 by not conveying (or conveying less of) any forces generated by, for example, tissue growth around the assembly 300 to the sensor(s) 320. For example, in embodiments in which the sensors 320 include pressure sensors that rely on measuring any external forces or pressure, the slip membrane 350 is expected to protect the housing 310 while preventing tissue growth from materially affecting performance of the pressure sensors (or at least reducing the effect to an acceptable level).C. Methods of Manufacturing Sensor Assemblies

[0033] FIG. 4 is a flowchart illustrating a method 400 of manufacturing a sensor assembly. The method 400 can be used to manufacture the assembly 200, the assembly 300, or other sensor assemblies. The sensor assembly manufactured via the method 400 can be part of a stand-alone sensing system, part of an interatrial shunting system, or part of other suitable systems configured for implantation within a patient.

[0034] The method 400 can include providing a housing (e.g., the housing 210, 310) and a sensor (e.g., the sensors 220, 320) positioned at least partially inside the housing (process portion 402). In some embodiments, the sensor can be configured to measure one or more physiological parameters from a surrounding environment external to the sensor assembly, such as pressure (e.g.. a left atrial pressure and / or a right atrial pressure of a patient), temperature, etc. In some embodiments, the sensor is at least partially exposed to an environment external to the sensor assembly via an aperture (e.g., the aperture 214) of the housing.

[0035] The method 400 can also include at least partially enclosing the housing and the sensor in a slip membrane (e.g., the slip membrane 250, 350). The slip membrane can protect the housing without adhering or sticking to an outer surface of the housing (process portion 404). The slip membrane can be formed from a material such as expanded polytetrafluoroethylene (ePTFE), polytetrafluoroethylene (PTFE), polyethylene (PE), polyurethane (PU), silicone, polyether ether ketone (PEEK), polypropylene, polycarbonate, a combination thereof, and / orany other suitable material. In some embodiments, the slip membrane can be configured to deform upon tissue growth external to the sensor assembly exerting forces on the sensor assembly, thereby reducing the forces exerted on the housing and the sensor. As discussed in further detail above, reducing such forces can improve long-term performance of the sensor.

[0036] In some embodiments, the method 400 can further include coupling the slip membrane to a portion of a connector (e.g., the connector 230, 330) operably coupled to the sensor and extending out of the housing, thereby forming a seal (e.g., a hermetic seal) around the housing. For example, a medical-grade elastic band, adhesives, fasteners, or other sealing mechanisms can be used to couple the slip membrane to the portion of the connector to form the seal around the housing.

[0037] Sensor assemblies including slip membranes configured in accordance with embodiments of the present technology are expected to exhibit improved long-term performance compared to sensor assemblies without slip membranes or with slip membranes that adhere to the housings of the sensor assemblies. The slip membranes offer a low-cost (e.g.. relative to the overall sensor assembly), low-footprint, and safe solution to ensuring long-term sensor performance notwithstanding any tissue growth external to the sensor assembly, which may exert pulling forces on the sensor assembly as discussed previously.C. ExamplesThe present technology is illustrated, for example, according to various aspects described below as numbered examples (1 , 2, 3, etc.) for convenience. These are provided as examples and do not limit the present technology. It is noted that any of the dependent examples may be combined in any combination, and placed into a respective independent example. The other examples can be presented in a similar manner.1. A sensor assembly for an implantable medical device, the sensor assembly comprising: a housing; a sensor positioned at least partially inside the housing, wherein the sensor is configured to measure one or more physiological parameters of a patient; anda slip membrane at least partially enclosing the housing and the sensor, wherein the slip membrane is configured to protect the housing without adhering to an outer surface of the housing.2. The sensor assembly of example 1 wherein the slip membrane is configured to reduce noise in and / or attenuation of signals received by the sensor.3. The sensor assembly of example 1 or example 2 wherein the slip membrane is configured to deform upon tissue grow th external to the sensor assembly exerting forces on the sensor assembly, thereby reducing the forces exerted on the housing and the sensor.4. The sensor assembly of any of examples 1-3 1 wherein the slip membrane is composed of expanded polytetrafluoroethylene (ePTFE).5. The sensor assembly of any of examples 1-4 wherein the slip membrane comprises at least one of polyethylene (PE), polyurethane (PU), silicone, polyether ether ketone (PEEK), polypropylene, or polycarbonate.6. The sensor assembly of any of examples 1-5 wherein the slip membrane fully encloses the housing and the sensor.7. The sensor assembly of any of examples 1-6 wherein the sensor is at least partially exposed to an environment external to the sensor assembly via an aperture of the housing.8. The sensor assembly of example 7 wherein a portion of the slip membrane at the aperture is configured to conform to a shape of the sensor.9. The sensor assembly of any of examples 1-8 wherein the sensor is configured to measure a left atrial pressure and / or a right atrial pressure of the patient.10. The sensor assembly of any of examples 1-9 wherein the medical device comprises an interatrial shunt configured to be implanted within a heart of the patient.11. The sensor assembly of any of examples 1-10 wherein the sensor includes aMEMS sensor.12. The sensor assembly of any of examples 1-11, further comprising a connector operably coupled to the sensor and extending external to the housing, wherein the slip membrane is sealed around a portion of the connector to hermetically seal the housing and the sensor.13. A method of manufacturing a sensor assembly for an implantable medical device, the method comprising: providing a housing and a sensor positioned at least partially within the housing; and at least partially enclosing the housing and the sensor in a slip membrane, wherein the slip membrane is configured to protect the housing without adhering to an outer surface of the housing.14. The method of example 13 wherein the slip membrane is configured to reduce noise in and / or attenuation of signals received by the sensor.15. The method of example 13 or example 14 wherein the slip membrane is configured to deform upon tissue growth external to the sensor assembly exerting forces on the sensor assembly, thereby reducing the forces exerted on the housing and the sensor.16. The method of any of examples 13-1 wherein the slip membrane is composed of expanded polytetrafluoroethylene (ePTFE).17. The method of any of examples 13-16, further comprising coupling the slip membrane to a portion of a connector operably coupled to the sensor and extending out of the housing, thereby forming a hermetic seal around the housing and the sensor.18. A sensor assembly, comprising: a sensor configured to measure a left atrial pressure and / or a right atrial pressure of a patient; a housing at least partially enclosing the sensor; anda slip membrane at least partially enclosing the sensor and the housing, wherein the slip membrane is configured to protect the housing without sticking to the housing.19. The sensor assembly of example 18 wherein the slip membrane is composed of expanded polytetrafluoroethylene (ePTFE).20. The sensor assembly of example 18 or example 19 wherein the slip membrane is permeable.Conclusion

[0038] 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, SpCh and other sensors adapted to measure tissue and / or blood gas levels, blood volume sensors, and other sensors known to those who are skilled in the art. Embodiments may include portions that are radiopaque and / or ultrasonically reflective to facilitate image-guided implantation or image guided procedures using techniques such as fluoroscopy, ultrasonography, or other imaging methods. Embodiments of the system may' include specialized delivery catheters / sy stems that are adapted to deliver an implant and / or carry out a procedure. Systems may include components such as guidewires, sheaths, dilators, and multiple delivery’ catheters. Components may be exchanged via over-the-wire. rapid exchange, combination, or other approaches.

[0039] 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. Althoughspecific 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 left atrium and right atrium, the left ventricle and the right ventricle, or the left atrium 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.

[0040] To the extent any material incorporated herein by reference conflicts with the present disclosure, the present disclosure controls. From the foregoing, it will be appreciated that specific embodiments of the technology have been described herein for purposes of illustration, but well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. Where the context permits, singular or plural terms may also include the plural or singular term, respectively.

[0041] 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 ty pes 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 ofthe 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

CLAIMSI / W e claim:

1. A sensor assembly for an implantable medical device, the sensor assemblycomprising: a housing; a sensor positioned at least partially inside the housing, wherein the sensor is configured to measure one or more physiological parameters of a patient; and a slip membrane at least partially enclosing the housing and the sensor, wherein the slip membrane is configured to protect the housing without adhering to an outer surface of the housing.

2. The sensor assembly of claim 1 wherein the slip membrane is configured to reduce noise in and / or attenuation of signals received by the sensor.

3. The sensor assembly of claim 1 wherein the slip membrane is configured to deform upon tissue growth external to the sensor assembly exerting forces on the sensor assembly, thereby reducing the forces exerted on the housing and the sensor.

4. The sensor assembly of claim 1 wherein the slip membrane is composed of expanded polytetrafluoroethylene (ePTFE).

5. The sensor assembly of claim 1 wherein the slip membrane comprises at least one of polyethylene (PE), polyurethane (PU), silicone, polyether ether ketone (PEEK), polypropylene, or polycarbonate.

6. The sensor assembly of claim 1 wherein the slip membrane fully encloses the housing and the sensor.

7. The sensor assembly of claim 1 wherein the sensor is at least partially exposed to an environment external to the sensor assembly via an aperture of the housing.

8. The sensor assembly of claim 7 wherein a portion of the slip membrane at the aperture is configured to conform to a shape of the sensor.

9. The sensor assembly of claim 1 wherein the sensor is configured to measure a left atrial pressure and / or a right atrial pressure of the patient.

10. The sensor assembly of claim 1 wherein the medical device comprises an interatrial shunt configured to be implanted within a heart of the patient.

11. The sensor assembly of claim 1 wherein the sensor includes a MEMS sensor.

12. The sensor assembly of claim 1, further comprising a connector operably coupled to the sensor and extending external to the housing, wherein the slip membrane is sealed around a portion of the connector to hermetically seal the housing and the sensor.

13. A method of manufacturing a sensor assembly for an implantable medical device, the method comprising: providing a housing and a sensor positioned at least partially within the housing; and at least partially enclosing the housing and the sensor in a slip membrane, wherein the slip membrane is configured to protect the housing without adhering to an outer surface of the housing.

14. The method of claim 13 wherein the slip membrane is configured to reduce noise in and / or attenuation of signals received by the sensor.

15. The method of claim 13 wherein the slip membrane is configured to deform upon tissue growth external to the sensor assembly exerting forces on the sensor assembly, thereby reducing the forces exerted on the housing and the sensor.

16. The method of claim 13 wherein the slip membrane is composed of expanded polytetrafluoroethylene (ePTFE).

17. The method of claim 13, further comprising coupling the slip membrane to a portion of a connector operably coupled to the sensor and extending out of the housing, thereby forming a hermetic seal around the housing and the sensor.

18. A sensor assembly, comprising: a sensor configured to measure a left atrial pressure and / or a right atrial pressure of a patient; a housing at least partially enclosing the sensor; and a slip membrane at least partially enclosing the sensor and the housing, wherein the slip membrane is configured to protect the housing without sticking to the housing.

19. The sensor assembly of claim 18 wherein the slip membrane is composed of expanded polytetrafluoroethylene (ePTFE).

20. The sensor assembly of claim 18 wherein the slip membrane is permeable.

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