Obstruction device with detection function
Patent Information
- Application Number
- JP2023513323
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2021-07-01
- Filing Date
- 2021-08-24
- Publication Date
- 2024-12-16
- Estimated Expiration
- Not applicable · inactive patent
AI Technical Summary
Monitoring the progress of aneurysms, particularly those located within the brain, is difficult after treatment procedures such as coil embolization, leading to increased medical costs and potential complications like compaction at the aneurysm neck, with no reliable mechanism for continuous monitoring.
Implantable sensor systems with sensors and antennas that detect physiological parameters, transmit data wirelessly, and include anchor structures to stabilize the sensor within the vascular structure, allowing for continuous or intermittent monitoring and data transmission.
Enables reliable, continuous monitoring of aneurysms, reducing the need for frequent follow-up visits and minimizing complications by providing real-time data on blood flow, clotting, and other parameters, thus improving patient care and reducing costs.
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Abstract
Description
[Technical Field]
[0001] The present disclosure relates generally to medical devices with sensors, systems including such medical devices, methods for using such devices and systems and data generated therefrom, and devices and methods for solving problems associated with implanted medical devices with sensors.
[0002] [Incorporation by reference of priority application] Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet filed with this application are incorporated by reference and made a part hereof. [Background technology]
[0003] After treating internal injuries or other internal defects, it can be difficult to monitor a patient's progress. For example, an aneurysm occurs when a patient's arterial wall weakens, causing the weakened area to bulge. Aneurysms can occur throughout the body (e.g., in the aorta, brain, or elsewhere). Patients with aneurysms often experience no symptoms until the aneurysm ruptures, which can result in internal bleeding and stroke, which can be fatal.
[0004] Not all of the subject matter described in the Background Art section is necessarily prior art, and should not be considered to be prior art solely as a result of the description of prior art in the Background Art section. Along these lines, any recognition of a problem in the prior art described in the Background Art section or related to such subject matter should not be treated as prior art absent an explicit description of the prior art. Instead, the description of any subject matter in the Background Art section should be treated as part of the inventor's approach to a particular problem, which may also be inventive in its own right and in its own right. Summary of the Invention
[0005] This Summary is provided to introduce certain concepts in a simplified form that are more fully described in the Detailed Description. Unless expressly specified otherwise, this Summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter.
[0006] The details of one or more embodiments are set forth in the following description. Features shown or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Thus, any of the various embodiments described herein may be combined with each other to provide further embodiments. Where necessary to employ concepts from the various patents, applications, and publications cited herein, aspects of the embodiments may be modified to provide yet further embodiments. Other features, objects, and advantages will become apparent from the description, drawings, and claims.
[0007] One method of treating aneurysms is coil embolization. During this procedure, a physician implants a structure, such as a metal coil, into the aneurysm to close or isolate it and reduce the risk of bleeding. After the procedure, it is difficult to monitor the progress of the aneurysm, especially if the aneurysm is located in the brain. This can result in multiple follow-up visits to the physician, thereby increasing the patient's medical expenses. Additionally, compaction can occur at the aneurysm neck (i.e., the transition between the parent artery and the aneurysm). Currently, there is no reliable mechanism for monitoring aneurysms after treatment.
[0008] Certain aspects of the present invention relate to an implantable sensor system that can be implanted within any vasculature, such as an aneurysm. The sensor system may include one or more sensors and / or antennas. The antenna may be in electrical communication with the sensors. The sensors may continuously or intermittently sense one or more physiological parameters of the patient to generate sensor data. The antenna may continuously or intermittently transmit the sensor data related to the one or more physiological parameters of the patient to a receiver, which may be located inside or outside the patient. The antenna may be capable of stabilizing the position of the sensor within the vasculature.
[0009] The sensor system described above may include one or more of the following features: The antenna may be compressible around the sensor for loading into the delivery system and expandable upon release from the delivery system. The antenna may at least partially or completely surround the sensor. The antenna may extend across one or more surfaces of the sensor. For example, the antenna may form a uniaxial loop, a biaxial loop, or a spherical loop around the sensor. The antenna may transmit and / or receive RF signals. The signals received by the antenna may adjust the operation of the sensor system, e.g., the frequency or type of physiological parameter being monitored, or the power management of the sensor system. In some embodiments, the sensor may perform a function only upon receiving a command from outside the patient's body. The antenna may include platinum, a platinum / iridium alloy, and / or nitinol. The antenna may include an implantable material capable of functioning at radio frequencies. The antenna may be coated with a parylene film, a gold material, and / or a platinum material.
[0010] The sensor may further include a radiopaque marker to locate the sensor within the patient. The sensor may be a blood flow sensor, a blood pressure sensor, a metabolic sensor, a glucose sensor, an oxygen sensor, or other sensor. The sensor may generate sensor data based on analyte materials, analyte components, or by-products resulting from certain cellular or blood interactions or exchanges in the blood, and / or kinetic information. For example, the sensor may be capable of detecting oxygen, carbon dioxide, potassium, iron, and / or glucose in the patient's blood.
[0011] The sensor system may include a sealing layer that hermetically seals the sensor assembly or individual components of the sensor assembly. The sensor system may further include a dissolving membrane layer that dissolves upon contact with the patient's blood. The dissolving membrane layer may release the clotting enhancer as the dissolving membrane layer dissolves.
[0012] The sensor system may include a power source, such as a battery or supercapacitor, located within the sensor system. Alternatively, the sensor may be powered by a power source located external to the patient's body. In some configurations, the sensor may be an inductive sensor. The power source may be rechargeable. The sensor system may include a memory device for storing sensor data or computer-executable instructions to be executed by a processor of the sensor system. The processor may be integrated into the sensor or may be separate from the sensor.
[0013] The sensor system may be implantable within the aneurysm and may detect one or more physiological parameters indicative of blood flow into or out of the aneurysm and / or the level of blood clotting within the aneurysm.
[0014] The sensor may be capable of providing a first output indicative of a first level of blood flow and a second output indicative of a second level of blood flow. The first output may be an indication that no blood clot has formed within the vasculature. In response to the first output, a clinician may select to deliver an occlusion device or a procoagulant. The second output may be an indication that a blood clot has formed within the vasculature. In some forms, the sensor may be a conductivity switch.
[0015] Certain aspects of the present invention relate to an implantable sensor system including a sensor assembly having any of the features described herein. The implantable sensor system may include an anchor structure that maintains the position of the sensor within the vasculature. The sensor assembly may be disposed within an interior space defined by the anchor structure. The anchor structure may be a separate component from the sensor. The antenna of the sensor assembly may contact the anchor structure upon implantation. This contact may facilitate data transmission from the sensor. In other configurations, the sensor assembly may be directly or indirectly coupled to the anchor structure. For example, the antenna and / or sensor may be directly or indirectly coupled to the anchor structure.
[0016] The anchor structure can occlude the vascular structure. The anchor structure can include one or more coils. The anchor structure can include a mesh or woven structure. The anchor structure can include a basket structure, a tubular structure, a lumenless structure, or other structure.
[0017] In some embodiments, the anchor structure can act as an anchor alone or in combination with a separate antenna. The anchor structure may be made of the same material as the antenna. In some embodiments, the anchor structure may form part of the sensor assembly. For example, the anchor structure may be made of a material that allows it to be part of a stacked configuration of the sensor assembly.
[0018] The anchor structure may be coated on its interior or exterior with a complex chemical compound that carries or releases a healing promoting substance that aids in blood clotting and sealing of the aneurysm, or an inhibitor that prevents biological attachment to the sensor system within the aneurysm in order to maintain the duration of its ability to detect and respond to blood clotting within the aneurysm.
[0019] The sensor assembly and / or anchoring structure may be capable of eluting a drug to promote occlusion. The drug may be eluted at the time of implantation or at a predetermined time after implantation. The drug may be eluted in response to data collected from the sensor.
[0020] Any of the sensor assemblies or systems described herein may carry a drug (e.g., a clotting agent) capable of treating a patient's vasculature. The drug may be applied to the sensor assembly or anchor structure or stored within a cavity in the sensor assembly or anchor structure. The sensor system may include a memory device that stores computer-executable instructions. The sensor system may include a processor in communication with the memory device. The computer-executable instructions, when executed by the processor, may cause the processor to release the drug from the sensor system or anchor structure. The computer-executable instructions, when executed by the processor, may operate a switch, which causes the switch to release the drug carried by the implantable sensor system. The processor may include a wireless receiver as part of the antenna or separate from the antenna. The processor may execute the computer-executable instructions upon receiving a wireless transmission from outside the patient. The processor may execute the computer-executable instructions a predetermined time following implantation of the implantable sensor system.
[0021] Any of the sensors or sensor assemblies described herein may be capable of wireless communication with an electronic device (e.g., a base station or other computing device) using Bluetooth™, Wi-Fi, ZigBee, cellular, Medical Implant Communication Service (“MICS”), Medical Device Radio Communication Service (“MedRadio”), or other protocols. The electronic device may include a memory device and a processor. The memory device may be configured to store an application. The processor may execute the application to perform any of the functions described herein. For example, the processor may be in wireless communication with a sensor assembly implanted within a vasculature. The processor may calculate values of one or more physiological parameters that are indicative of blood flow. The processor may output values that are displayable on a display and provide to a user. The values may provide a metric that is indicative of the degree of obstruction of the vasculature. The processor may execute the application to communicate the values to a computing system via a communications network. The processor may execute the application to send setting adjustment commands to the sensor assembly to adjust settings for monitoring one or more physiological parameters, such as the timing of data collection. Additionally or alternatively, the setpoint adjustment commands may adjust different operations of the sensor assembly, such as power management, hi some embodiments, the sensor assembly may collect data only in response to commands received from the processor.
[0022] Certain aspects of the present invention relate to kits including an implantable sensor assembly and / or anchor structure having any of the features described herein. The kit may further include a delivery system capable of releasing the implantable sensor assembly and / or anchor structure into a vasculature. The sensor assembly and anchor structure may be delivered using the same or different delivery systems. Optionally, the kit may include an electronic device as described herein.
[0023] A particular aspect of the present invention relates to a method of monitoring a vasculature using any of the sensor assemblies described herein. The vasculature may include a neurovascular or cardiovascular structure, including, but not limited to, an arterial aneurysm in a patient's posterior circulation, a basilar aneurysm, a bifurcation aneurysm, a sidewall aneurysm, a ductus arteriosus, a carotid artery, or a venous structure. The method may include continuously or intermittently sensing one or more physiological parameters in the vasculature using an implantable sensor assembly. The method may include continuously or intermittently transmitting sensor data related to the one or more physiological parameters to a remote location located within or outside the patient's body.
[0024] The above-described method may include one or more of the following steps: The method may include occluding the vascular structure with an anchor structure; The sensor assembly may include a blood flow sensor, a blood pressure sensor, a metabolic sensor, a glucose sensor, an oxygen sensor, or other sensor; The method may include generating sensor data based on analyte materials, analyte components, or by-products resulting from certain cellular or blood interactions or exchanges in the blood, and / or motion information; The sensor assembly may detect one or more physiological parameters, including, but not limited to, oxygen, carbon dioxide, potassium, iron, and / or glucose in the patient's blood; The method may include charging the sensor assembly; The method may include charging the sensor assembly.
[0025] A particular aspect of the present invention relates to a method of implanting any of the sensor assemblies into a patient's vasculature. The method may include percutaneously advancing a delivery system carrying the sensor system to the vasculature and releasing the sensor assembly into the vasculature. The method may include advancing the delivery system over a guidewire or through a guiding catheter. The delivery system may include a pusher that pushes the sensor assembly out of the delivery system. The method may further include simultaneously or separately releasing an anchor structure into the vasculature. The step of releasing the anchor structure may include positioning the anchor structure around the sensor assembly. Alternatively, the sensor assembly may be released into an interior space within the anchor structure. The anchor structure may occlude the vasculature.
[0026] Certain aspects of the present invention relate to a delivery system for delivering any of the sensor assemblies and / or systems described herein to a vasculature. The delivery system may include a handle, a distal tip, and a shaft therebetween. The distal tip may be actively or passively deflectable. In actively deflectable embodiments, the distal tip may be steered using mechanical and / or electronic controls. The distal tip may have a load chamber that carries the sensor assembly. The handle may include one or more user-operable mechanisms for releasing the sensor assembly and / or sensor system, controlling the distal tip, and / or stabilizing the delivery system. The shaft may include one or more lumens, such as a guidewire lumen, a fluid delivery lumen, a steering lumen, and / or a lumen for carrying a pusher. In some configurations, the delivery system includes a delivery sleeve that fits over the shaft. The delivery sleeve may directly or indirectly cause deflection of the distal tip.
[0027] Certain aspects of the present invention relate to an implantable sensor system that can be implanted within an aneurysm or other vascular structure. The sensor system may include a sensor assembly that is implantable within the aneurysm and capable of measuring physiological parameters. The sensor assembly may include one or more sensors, including, but not limited to, a blood flow sensor, a blood pressure sensor, a metabolic sensor, a glucose sensor, an oxygen sensor, a conductivity switch, or a motion sensor. The sensor assembly may include a processor that at least partially processes data collected by the one or more sensors. The processor may be hermetically sealed to protect the processor from bodily fluids. The sensor assembly may include a memory device that stores sensor data. The outer surface of the sensor assembly may be shaped, treated, or otherwise modified to reduce endothelialization. For example, the outer surface of the sensor assembly may have peaks and valleys. The sensor system may include a battery or supercapacitor that powers the sensor assembly. The sensor system may include an antenna in electrical communication with the sensor assembly. The sensor assembly may be positioned between the antenna and the anchor structure.
[0028] The sensor system may include an anchor structure that maintains the position of the sensor assembly within the aneurysm. The anchor structure may be bonded to the sensor assembly or may be separate from the sensor assembly. In some configurations, the anchor structure may be bonded while being positioned between the sensor assembly and the battery or supercapacitor. The anchor structure may extend radially outward from the contour of the sensor assembly. The anchor structure may extend outward to contact the wall of the aneurysm. The anchor structure may have multiple anchor portions, which may be loop-shaped, coil-shaped, or otherwise extend outward from the contour of the sensor assembly. The multiple anchor portions may be circumferentially spaced apart from one another. Each of the multiple anchor portions may have an atraumatic end portion that contacts the wall of the aneurysm. In some embodiments, the anchor structure may be coated with a drug.
[0029] Certain aspects of the present invention relate to delivery systems for deploying any of the sensor systems described herein. The delivery system may include a handle portion. The delivery system may include a delivery sheath or catheter through which the inner shaft may be inserted. The delivery system may include a retention wire passing through the inner shaft. The retention wire may retain the sensor system within the space between the outer wall of the inner shaft and the inner wall of the delivery sheath, or within the inner shaft. The distal portion of the inner shaft may be deflectable or steerable.
[0030] In some embodiments, the inner shaft can have a plurality of openings in the shaft wall. The openings can be axially spaced apart along the shaft wall. In some configurations, the openings are rotationally aligned. In other configurations, at least one of the openings is rotationally offset from another of the openings. The retention wire can form one or more loops to hold the sensor system against the outer or inner wall of the inner shaft. For example, the retention wire can extend from a first opening in the shaft wall into the space between the inner shaft and the delivery sheath, through a second opening in the shaft wall, and back into the lumen of the inner shaft, thereby forming one of the one or more loops. As another example, the retention wire can extend from a first opening in the shaft wall into the space between the inner shaft and the delivery sheath, and through a first opening in the shaft wall, and back into the lumen of the inner shaft, thereby forming one of the one or more loops.
[0031] One particular aspect of the present invention relates to a method of deploying a sensor system within an aneurysm. The method may include advancing a delivery system carrying the sensor system to a parent artery. The sensor system may be carried by an inner shaft of the delivery system. The method may include retracting the sensor system from a sheath and deploying the sensor system within the aneurysm. The method may include steering a distal tip of the inner shaft into the aneurysm prior to deployment of the sensor system within the aneurysm, or positioning the sensor system against the neck of the aneurysm prior to deployment of the sensor system within the aneurysm.
[0032] To deploy the sensor system, the method may include withdrawing the retention wire to release the sensor system into the aneurysm. Withdrawing the retention wire releases the retention wire from the anchoring structure of the sensor system. Deploying the sensor system expands the anchoring structure of the sensor system to stabilize the position of the sensor system within the aneurysm. Once deployed, the sensor of the sensor system is positioned away from the wall of the aneurysm. After deploying the sensor system within the aneurysm, a treatment device may be deployed within the aneurysm, for example around the sensor. Deploying the sensor system may include releasing communication circuitry of the sensor system into the aneurysm before releasing the anchoring structure of the sensor system.
[0033]
[0013] Exemplary features of the present invention, its nature and various advantages will become apparent from the accompanying drawings and the following detailed description of various embodiments. Non-limiting and non-exhaustive embodiments are described with reference to the accompanying drawings, in which like labels or reference characters refer to like parts throughout the various views unless otherwise specified. The dimensions and relative positions of elements in the drawings are not necessarily drawn to scale. For example, the shapes of various elements may be selected, enlarged, and positioned to improve drawing clarity. The particular shapes of the depicted elements have been selected for ease of recognition in the drawings.
[0014] One or more embodiments are described below with reference to the accompanying drawings. [Brief explanation of the drawings]
[0034] [Figure 1] 1 illustrates an exemplary sensor-utilizing environment in accordance with certain aspects of the present invention; [Figure 2] 2A and 2B illustrate an exemplary sensor assembly implanted within an aneurysm in accordance with certain aspects of the present invention. [Figure 3] 3A, 3B, and 3C illustrate different exemplary sensor systems implanted within an aneurysm in accordance with certain aspects of the present invention. [Figure 4] 1 illustrates an exemplary sensor implanted within an aneurysm in accordance with certain aspects of the present invention. [Figure 5] 5A, 5B, 5C, and 5D are schematic diagrams of exemplary sensor assemblies according to certain aspects of the present invention. [Figure 6] 2 is a detailed view of the surface of an exemplary sensor according to certain aspects of the present invention. [Figure 7A] 2 is a schematic plan view of certain components of an exemplary sensor assembly according to certain aspects of the present invention; [Figure 7B] FIG. 7B is a cross-sectional view of the sensor assembly shown in FIG. 7A. [Figure 7C] FIG. 7B is a cross-sectional view of the sensor assembly shown in FIG. 7A. [Figure 7D] FIG. 7B is a cross-sectional view of the sensor assembly shown in FIG. 7A. [Figure 8A] 2A and 2B are plan views of certain components of an exemplary sensor assembly in accordance with certain aspects of the present invention. [Figure 8B] FIG. 8B is a cross-sectional view of the sensor assembly shown in FIG. 8A. [Figure 8C] FIG. 8C is a diagram showing another form of the cross section shown in FIG. 8B. [Figure 9A] 3 is a schematic diagram of certain components of an exemplary sensor assembly in accordance with certain aspects of the present invention. [Figure 9B] 4 is a schematic diagram of certain components of another exemplary sensor assembly. [Figure 10A] 1A-1C illustrate different wearable devices that can interact with the disclosed sensor assembly. [Figure 10B] 1A-1C illustrate different wearable devices that can interact with the disclosed sensor assembly. [Figure 11] 3 is a flow diagram of an exemplary method of implanting an exemplary sensor system within a patient's body in accordance with certain aspects of the present invention. [Figure 12] 3 is a flow diagram of an exemplary method of implanting an exemplary sensor system within a patient's body in accordance with certain aspects of the present invention. [Figure 13] FIG. 1 illustrates a delivery system according to certain aspects of the present invention. [Figure 14] FIG. 1 illustrates another delivery system according to certain aspects of the present invention. [Figure 15A] FIG. 1 illustrates a sensor system. [Figure 15B] FIG. 1 illustrates components of a sensor system within an aneurysm. [Figure 15C] FIG. 1 illustrates components of a sensor system within an aneurysm. [Figure 15D] FIG. 15B illustrates a tethering or anchoring structure for the sensor system shown in FIG. 15A. [Figure 15E] 15B is a schematic diagram of a portion of the sensor system shown in FIG. 15A. [Figure 15F] FIG. 10 shows the surface contour of the sensor assembly. [Figure 16A]FIG. 10 illustrates another delivery system for deploying the sensor system. [Figure 16B] FIG. 16B shows the proximal portion of the delivery system shown in FIG. 16A. [Figure 16C] FIG. 16C shows the main body portion of the handle shown in FIG. 16B. [Figure 16D] FIG. 16B shows the distal portion of the delivery system shown in FIG. 16A. [Figure 16E] FIG. 1 is a diagram illustrating a deployment state of a sensor system. [Figure 16F] FIG. 1 is a diagram illustrating a deployment state of a sensor system. [Figure 17A] FIG. 10 illustrates another delivery system for deploying the sensor system. [Figure 17B] FIG. 17B is an enlarged view of the distal portion of the delivery system shown in FIG. 17A. DETAILED DESCRIPTION OF THE INVENTION
[0035] The present disclosure may be readily understood by reference to the following detailed description of exemplary embodiments of a "sensor assembly" or "sensor system" included herein. The following description, together with the accompanying drawings, sets forth certain specific details to provide a thorough understanding of various disclosed embodiments. However, those skilled in the art will recognize that the disclosed embodiments may be practiced without one or more of these specific details, or in various combinations using other methods, other components or parts, devices, materials, and the like. In other cases, well-known structures or components associated with the present invention's environment, including, but not limited to, communication systems and networks, are not shown or described in order to avoid unnecessarily obscuring the description of the embodiments. Additionally, various embodiments may be methods, systems, media, or devices. Thus, various embodiments may be entirely hardware embodiments, entirely software embodiments, entirely firmware embodiments, or embodiments that are combinations or subcombinations of software, firmware, and hardware aspects.
[0036] Before describing the invention in detail, it may be helpful to an understanding of the invention to provide definitions of certain terms used herein. Additional definitions are provided throughout this disclosure. In the original specification, "include" (often translated as "including") and "comprise" (often translated as "having") and variations thereof mean open-ended inclusion. As used herein, "or" is inclusive and means "and / or." As used herein, "in connection with" and "in connection with" and variations thereof may mean including, contained within, interconnected with, containing, contained within, connected to, coupled with, communicateable with, cooperate with, interleaved with, juxtaposed with, located near, linked to, having, having the property of, etc. The terms "controller" or "processor," as used herein, mean any device, system, or portion thereof that controls at least one operation; such a device may be embodied in hardware (e.g., electronic circuitry), firmware, or software, or a combination of at least two of these. The functionality associated with any particular controller may be centralized or distributed, whether locally or remotely. Other definitions of certain terms and phrases may be provided throughout this document. Those skilled in the art will appreciate that in many, if not most, cases, such definitions apply to conventional and future uses of the defined terms and phrases.
[0037] As used in this disclosure, an "intelligent medical device" is an implantable or pre-implanted medical device that, if desired, replaces or functionally supplements a subject's natural body part. The intelligent medical device may include one of the disclosed sensor assemblies and / or an anchoring structure (e.g., a metal coil or basket). The sensor assembly includes or is associated with a controller or processor, also referred to as an implantable reporting processor ("IRP"). In one form, the intelligent medical device is an implantable or pre-implanted medical device that includes a sensor assembly with an IRP arranged to perform the functions described herein. The sensor assembly may perform one or more of the following example actions to characterize the post-implant condition of the intelligent medical device: identify the intelligent medical device or a portion of the intelligent medical device (e.g., by recognizing one or more unique identification codes associated with the sensor assembly or the intelligent medical device or portion of the intelligent medical device); detect, sense, and / or measure parameters (sometimes collectively referred to as "monitoring parameters") to collect operational, physiological, kinematic, or other data associated with the intelligent medical device or portion of the intelligent prosthesis (e.g., the sensor assembly), and enable such data to be collected, optionally as a function of time; store the collected data within the intelligent medical device or portion of the intelligent medical device (e.g., the sensor assembly); and communicate the collected and / or stored data wirelessly from the intelligent medical device or portion of the intelligent medical device (e.g., the sensor assembly) to an external computing device. The external computing device may have at least one data storage location found, for example, on a personal computer, a base station, a computer network, a cloud-based storage system, or another computing device with access to such storage, or may otherwise have access to such at least one data storage location.A non-limiting and non-exhaustive list of forms of intelligent medical devices includes metal coils configured to be implanted within an aneurysm.
[0038] As used herein, the phrase "monitoring data" includes, individually or collectively, some or all data associated with a particular implantable sensor assembly and available for communication outside of a particular implantable sensor system. For example, the monitoring data can include raw data from one or more sensors of a sensor assembly. The one or more sensors may be configured to detect an analyte (e.g., glucose), an analyte component (e.g., oxygen or carbon dioxide), etc. in the blood, which generates data related to one or more physiological parameters of the patient. For example, the one or more physiological parameters of the patient may be related to the patient's aneurysm after the aneurysm has been treated, such as by coil embolization. The monitoring data can also include processed data from one or more sensors, status data, operational data, control data, fault data, time data, scheduling data, event data, log data, etc., associated with a particular sensor assembly. In some cases, high-resolution monitoring data includes monitoring data from one, many, or all of the sensors of a sensor assembly, where such monitoring data is collected from more sensors, in greater volume, at higher resolution, more frequently, etc.
[0039] A "sensor" refers to a device that can be used to detect, measure, and / or monitor one or more distinct aspects of body tissue (e.g., anatomical structure, physiological characteristics, metabolism, and / or function) and / or one or more aspects of a smart medical instrument or sensor system. Representative examples of sensors suitable for use in the present invention include, for example, oxygen sensors, fluid pressure sensors, fluid volume sensors, contact sensors, position sensors, pulse pressure sensors, blood volume sensors, blood flow sensors, chemical sensors (e.g., blood and / or other fluid-directed), metabolic sensors (e.g., blood and / or other fluid-directed), accelerometers, mechanical stress sensors, and temperature sensors. Within certain embodiments, the sensors may be wireless sensors, or within other embodiments, sensors connected to a wireless microprocessor. Within other embodiments, one or more (including all) of the sensors may have a unique sensor identification number ("USI") that specifically identifies the sensor.
[0040] A "sensor assembly" may refer to one or more components. For example, a "sensor assembly" may be a single-piece sensor with processing and wireless transmission implemented on the sensor. In other examples, a "sensor assembly" may be multiple components including sensors and other components that perform one or more functions described herein.
[0041] To further understand the various aspects of the invention provided herein, the following sections are provided: I. Overview, II. Sensor Assembly, A. Antenna, B. Sensor, C. Processor / Controller, D. Power Supply, E. Sensor Assembly Configuration, III. Method of Using the Sensor System, IV. Kit, V. Delivery System, VI. Additional Embodiments and Terminology, and VII. Implementation.
[0042] I. Overview The devices, systems, and methods disclosed herein can be used to treat vascular structures within a patient's vasculature. Exemplary vascular structures include neurovascular or cardiovascular structures, including, but not limited to, aneurysms, carotid arteries, venous structures, the ductus arteriosus, or other vascular structures. Exemplary aneurysms include aneurysms of arteries in the patient's posterior circulation, basilar aneurysms, bifurcation aneurysms, intracranial aneurysms, and sidewall aneurysms. Monitoring the treatment status of aneurysms, particularly intracranial aneurysms, can be difficult. Thus, it would be beneficial to implant an intelligent medical device with an implant (e.g., a metal coil) and / or a sensor system within the aneurysm to monitor the treatment status.
[0043] FIG. 1 illustrates an exemplary sensor-utilizing environment 10. In the environment 10, one or more sensor assemblies 100a, 100b may be implanted in a patient 1 by a healthcare professional 2. The sensor assemblies 100a, 100b may include an associated implantable reporting processor (“IRP”) that may be positioned and configured to collect data including, for example, medical and health data associated with the patient 1 associated with the sensor assemblies 100a, 100b, as well as operational data for the sensor assemblies 100a, 100b themselves. The sensor assemblies 100a, 100b may communicate with one or more base stations 4 or one or more computing devices 3 during various stages of monitoring the patient 1. The sensor assemblies 100a, 100b may also communicate with a barcode scanner 5 while implanted in the patient's body 1, such that the barcode scanner 5 can identify the particular assemblies 100a, 100b implanted in the patient 1. The barcode scanner 5 and / or base station 4 may communicate with one or more computing devices 3 .
[0044] For example, sensor assemblies 100a, 100b may be implanted within a patient's body 1 in connection with a medical procedure. Sensor assemblies 100a, 100b may communicate with a base station 4 located in an operating room. While patient 1 is at home and has sufficiently recovered from the medical procedure, sensor assemblies 100a, 100b may be configured to communicate with a home base station (not shown) and / or a clinic base station (not shown). Sensor assemblies 100a, 100b may communicate with each base station via a short-range network protocol, such as Medical Implant Communication Service ("MICS"), Medical Device Radio Communication Service ("MedRadio"), or other wireless communication protocol suitable for use with sensor assemblies 100a, 100b.
[0045] The sensor assemblies 100a, 100b may be stand-alone medical devices or may be components within a larger system, preferably including an anchor structure, such as a metal coil or basket, that can collect and provide patient medical data, device operational data, or other useful data in the field.
[0046] The sensor assemblies 100a, 100b may include one or more measurement units, e.g., sensors, capable of collecting information and data, including medical and health data associated with the patient 1 to which the sensor assemblies 100a, 100b are associated, as well as operational data of the sensor assemblies 100a, 100b themselves.
[0047] The sensor assemblies 100a, 100b can collect data at various different times and at various different rates during the patient 1 monitoring process. In some forms, the sensor assemblies 100a, 100b can operate in multiple different phases throughout the patient monitoring process. For example, the sensor assemblies 100a, 100b may collect relatively more data immediately after the sensor assemblies 100a, 100b are implanted in the patient 1 and collect relatively less data as the patient 1 heals and thereafter. The amount and type of data collected by the sensor assemblies 100a, 100b may vary from patient to patient, and the amount and type of data collected may also vary within a single patient. For example, a medical professional studying data collected by the sensor assemblies 100a, 100b for a particular patient can adjust or otherwise control how much future data the sensor assemblies 100a, 100b collect. The amount and type of data collected by sensor assemblies 100a, 100b may vary for different body parts, different types of patient conditions, different patient demographics, or other differences. Alternatively or additionally, the amount and type of data collected may change over time based on other factors, such as how the patient is healing or feeling, how long the monitoring process is estimated to last, how much battery power is remaining and how much should be saved, the type of exercise being monitored, the part of the body being monitored, etc. In some cases, the collected data can be supplemented with personal descriptive information provided by the patient, such as subjective pain data, quality of life metrics, co-morbidities, patient perceptions or expectations related to sensor assemblies 100a, 100b, etc.
[0048] Implantation of the sensor assemblies 100a, 100b into the patient 1 may occur in an operating room, as shown in FIG. 2 . As used herein, an operating room includes any clinic, room, building, or facility in which the sensor assemblies 100a, 100b may be implanted into a patient. For example, the operating room may be a typical operating room in a hospital, a surgical clinic or doctor's office, any other operating room, interventional lab, intensive care unit, emergency room, etc., where the sensor assemblies 100a, 100b are implanted into the patient. The operating room base station 4 may be utilized to configure and initialize the sensor assemblies 100a, 100b when they are implanted into the patient 1. For example, a communication relationship may be established between the sensor assemblies 100a, 100b and the operating room base station 4 based on polling signals transmitted by the operating room base station 4 and response signals transmitted by the sensor assemblies 100a, 100b.
[0049] Upon establishing a communication relationship, which often occurs prior to implantation of the sensor assemblies 100a, 100b, the operating room base station 4 may transmit initialization information to the sensor assemblies 100a, 100b, including, but not limited to, a time stamp, a date stamp, identification of the type and placement of the sensor assembly 100a, 100b, information regarding other implants associated with the sensor assembly 100a, 100b, information regarding the surgeon, patient identification, operating room information, etc.
[0050] In some configurations, the initialization information may flow unidirectionally. In some embodiments, the initialization information may flow bidirectionally. The initialization information may define at least one parameter associated with data collection by the sensor assemblies 100a, 100b. For example, the initialization information may specify settings for one or more sensors of the sensor assemblies 100a, 100b for each of one or more operating modes. The initialization information may also include other control information, such as the initial operating mode of the sensor assemblies 100a, 100b, specific events that trigger a change in operating mode, radio settings, data collection information (e.g., how frequently the sensor assemblies 100a, 100b wake up to collect data, how long the sensor assemblies collect data, and how much data they collect), home base station (not shown), computing device 3, and connected personal assistant identification information, as well as other control information associated with the implantation or operation of the sensor assemblies 100a, 100b. Examples of connected personal assistants, also known as smart speakers, include Amazon Echo®, Amazon Dot®, Google Home®, Philips® patient monitors, Comcast health tracking speakers, and Apple HomePod®. In some configurations, initial configuration information may be pre-stored on the operating room base station 4 or on an associated computing device 3. In other configurations, a surgeon, surgical technician, or some other medical personnel 2 may input control information and other parameters into the operating room base station 4 so that they can be transmitted to the sensor assemblies 100a, 100b. In at least one such configuration, the operating room base station 4 may be in communication with a operating room setup computing device 3. The operating room setup computing device 3 may include an application having a graphical user interface that allows medical personnel to input configuration information for the sensor assemblies 100a, 100b.In various embodiments, an application running on the operating room configuration computing device 3 may default to some of the configuration information, which may or may not be adjustable by medical personnel 2. The operating room configuration computing device 3 may transmit the configuration information to the operating room base station 4 as shown in FIG. 1 via a wired or wireless network connection (e.g., via a USB connection, a Bluetooth™ connection, a Bluetooth™ Low Energy (“BTLE”) connection, or a Wi-Fi connection) that can communicate the configuration information to the sensor areas 100a, 100b.
[0051] The operating room setup computing device 3 may also display information regarding the sensor assemblies 100a, 100b or the operating room base station 4 to the surgeon, surgical technician, or other medical personnel 2. For example, the operating room setup computing device 3 may display error information if the sensor assemblies 100a, 100b are unable to store or access setup information, if the sensor assemblies 100a, 100b are unresponsive, if the sensor assemblies 100a, 100b identify a problem with the sensors or radios during an initial self-test, if the operating room base station 4 is unresponsive or malfunctioning, or for other reasons. While the operating room base station 4 and the operating room setup computing device 3 are described as separate devices, embodiments are not limited thereto, and the functionality of the operating room setup computing device 3 and the operating room base station 4 may alternatively be included in a single computing device or, as shown, in separate devices. Thus, in one embodiment, medical personnel 2 may be able to input setup information directly into the operating room base station 4.
[0052] 1, once the sensor assemblies 100a, 100b are implanted in a patient and the patient returns home, a home base station, a computing or smart device (e.g., the patient's smartphone), a connected personal assistant, or two or more of the home base station, computing or smart device, and connected personal assistant can communicate with the sensor assemblies 100a, 100b. The sensor assemblies 100a, 100b can collect data at a set rate and time, a variable rate and time, or a controllable rate and time. Data collection can begin when the sensor assemblies 100a, 100b are initialized in the operating room, when directed by medical personnel 2, or at some later point. At least some data collected by sensor assemblies 100a, 100b can be transmitted to a home base station directly, directly to the smart device, directly to the connected personal assistant, via one or both of the smart device and the connected personal assistant to the base station, via one or both of the base station and the connected personal assistant to the smart device, or via one or both of the smart device and the base station to the connected personal assistant. As used herein, the phrase "one or both" means by one item only, by both items sequentially, or in parallel. For example, data collected by sensor assemblies 100a, 100b can be transmitted to a home base station by the smart device alone, by the connected personal assistant alone, sequentially by the smart device and the connected personal assistant, sequentially by the connected personal assistant and the smart device, and directly by both the smart device and the connected personal assistant, possibly simultaneously. Similarly, data collected by sensor assemblies 100a, 100b can be transmitted to the smart device by the home base station alone, by the connected personal assistant alone, continuously by the home base station and the connected personal assistant, continuously by the connected personal assistant and the home base station, and directly by both the home base station and the connected personal assistant, in some cases simultaneously.Further, by way of example, data collected by sensor assemblies 100a, 100b can be transmitted to the connected personal assistant by the smart device alone, by the home base station alone, continuously by the smart device and home base station, continuously by the home base station and smart device, and directly by both the smart device and home base station, or in some cases simultaneously. In various embodiments, one or more of the home base station, the smart device, and the connected personal assistant can ping sensor assemblies 100a, 100b at regular, predetermined, or other times to determine whether sensor assemblies 100a, 100b are within communication range of one or more of the home base station, the smart device, and the connected personal assistant. Based on the response from the sensor assemblies 100a, 100b, one or more of the home base station, the smart device, and the connected personal assistant may verify that the sensor assemblies 100a, 100b are within communication range and may issue a request, command, or otherwise instruct the sensor assemblies 100a, 100b to transmit data collected by the sensor assemblies to one or more of the home base station, the smart device, and the connected personal assistant.
[0053] One or more of the home base station, smart device, and connected personal assistant may each, in some cases, have a respective optional user interface. The user interface may be configured as a multimedia interface for one-way or two-way streaming of one or more types of multimedia information (e.g., video, audio, tactile, etc.). The respective user interface of one or more of the home base station, smart device, and connected personal assistant may allow patient 1 or a person connected to patient 1 (not shown in FIG. 1 ) to input other data to supplement the data collected by sensor assemblies 100 a, 100 b. For example, a user may input personal descriptive information (e.g., age change, weight change), changes in medical condition, comorbidities, pain level, quality of life, or other subjective metric data, a personalized message for a healthcare professional, etc. In these configurations, the personal descriptive information may be input via a keyboard, mouse, touchscreen, microphone, wired or wireless computing interface, or some other input means. If personal descriptive information is collected, the personal descriptive information may include or be otherwise associated with one or more identifiers that associate the information with the sensor assembly 100a, 100b, the patient, an associated medical professional, an associated medical facility, etc. The personal descriptive information may include or be otherwise associated with one or more identifiers that associate the information with a unique identifier.
[0054] For some of these cases, any user interface of one or more of the home base station, the smart device, and the connected personal assistant or device may also be configured to transmit information associated with the sensor assembly 100a, 100b to a user, for example, from a healthcare professional 2. In these cases, the information transmitted to the user may be transmitted via a video screen, an audio output device, a tactile transducer, a wired or wireless computing interface, or some other similar means.
[0055] One or more of the home base station, the smart device, and the connected personal assistant comprise a user interface, which may include an internal user interface configured to be communicatively coupled to a patient portal device, which may be a smartphone, a tablet, a body-worn device, a weight or other health measurement device (e.g., a thermometer, a weight scale, etc.), or some other computing device capable of wired or wireless communication, where the user may be able to input personal descriptive information and may also be able to obtain information associated with the sensor assemblies 100a, 100b.
[0056] The home base station can utilize the patient's home network to transmit collected data to the cloud. The home network, which may be a local area network, allows access from the patient's home to a wide area network, e.g., the Internet. In some configurations, the home base station can utilize a Wi-Fi connection to connect to the home network and access the Internet. In other embodiments, the home base station can connect to the patient's home computer (not shown), e.g., via a USB connection that is itself connected to the home network. The smart device can communicate directly with the sensor assemblies 100a, 100b, e.g., via Bluetooth®-compatible signals, and can utilize the patient's home network to send collected data to the cloud, or can communicate directly with the cloud, e.g., via a cellular network. Alternatively, the smart device can be configured to communicate directly with one or both of the base station and the connected personal assistant, e.g., via Bluetooth®-compatible signals, but not with the sensor assemblies 100a, 100b.
[0057] Additionally, the connected personal assistant may communicate directly with the sensor assemblies 100a, 100b, e.g., via Bluetooth®-compliant signals, and may send collected data to the cloud using the patient's home network, or may communicate directly with the cloud, e.g., via a modem / internet connection or a cellular network. Alternatively, the connected personal assistant may be configured to communicate directly with one or both of the base station and the smart device, e.g., via Bluetooth®-compliant signals, but not with the sensor assemblies 100a, 100b.
[0058] In addition to sending collected data to the cloud, one or more of the home base station, the smart device, and the connected personal assistant can also obtain data, instructions, or other information from the cloud directly or via the home network. One or more of the home base station, the smart device, and the connected personal assistant can provide some or all of the received data, instructions, or other information to the sensor assemblies 100a, 100b. Examples of such information include, but are not limited to, updated configuration information, diagnostic requests to determine whether the sensor assemblies 100a, 100b are functioning properly, data collection requests, and other information.
[0059] The cloud may include one or more server computers or databases for integrating data collected from sensor assemblies 100a, 100b, and in some cases, personal descriptive information collected from the patient, with data collected from other intelligent implantable devices, and in some cases, personal descriptive information collected from other patients. In this manner, the cloud may generate a wide variety of metrics regarding the collected data from each of multiple intelligent implantable devices implanted in different patients. This information may be useful in determining whether the intelligent implantable devices are functioning properly. The collected information may also be useful for other purposes, such as determining which particular device is not functioning properly, determining whether a procedure or condition associated with the intelligent implantable device is benefiting the patient (e.g., whether a sensor system including sensor assemblies 100a, 100b is operating properly), and determining other medical information.
[0060] At various points throughout the monitoring process, the patient may be required to visit a medical professional to schedule a follow-up appointment. This medical professional may be the surgeon who implanted the sensor assemblies 100a, 100b in the patient, or another medical professional overseeing the monitoring process, physical therapy, and patient recovery. For various reasons, the medical professional may want to collect real-time data from the sensor assemblies 100a, 100b in a controlled environment. In some cases, the request to visit a medical professional may be sent through an optional interactive user interface of each of one or more of the home base station, the smart device, and the connected personal assistant.
[0061] A medical professional can use a clinic base station in communication with the sensor assemblies 100a, 100b to communicate additional data between the clinic base station and the sensor assemblies 100a, 100b. Alternatively or additionally, the medical professional can use the clinic base station to communicate commands to the sensor assemblies 100a, 100b. In some forms, the clinic base station can instruct the sensor assemblies 100a, 100b to enter a high-resolution mode to temporarily increase the rate or type of data collected for a short period of time. The high-resolution mode instructs the sensor assemblies 100a, 100b to collect a different (e.g., greater) amount of data during an activity in which the medical professional is also monitoring the patient.
[0062] In some embodiments, the clinic base station may allow a medical professional to input event markers and synchronize such event markers with the high-resolution data collected by the sensor assemblies 100a, 100b. For example, assume that the sensor assemblies 100a, 100b are components of a sensor system that is implanted in an intracranial aneurysm. During a follow-up visit, the medical professional may place the sensor assemblies 100a, 100b in high-resolution mode. The medical professional may review the sensor data from the sensor assemblies 100a, 100b to determine whether a blood clot has formed within the aneurysm. If the sensor data indicates that a blood clot does not appear to have formed within the aneurysm, the medical professional may administer medication to the patient. The medical professional may administer a beta-blocker and / or a calcium channel blocker to lower the patient's blood pressure and relax the patient's blood vessels. Alternatively, the healthcare professional may administer an antifibrinolytic drug (e.g., aprotinin, tranexamic acid, epsilon-aminocaproic acid) that promotes blood clotting. After the healthcare professional administers the drug to the patient, the healthcare professional can click an event marker button on the clinic base station to mark the administration of the drug. The clinic base station records the marker and the time the marker was entered. When the timing of this marker matches the timing of collected high-resolution data, the healthcare professional can analyze the data to confirm the effectiveness of the drug. In another embodiment, the clinic base station can provide updated configuration information to the sensor assemblies 100a, 100b. The sensor assemblies 100a, 100b can store this updated configuration information, which can be used to adjust parameters associated with data collection. For example, if the patient is doing well, the healthcare professional can instruct the sensor assemblies 100a, 100b to collect data less frequently. Conversely, if the defect or injury has not healed (e.g., no blood clotting has occurred within the aneurysm), the medical professional may instruct the sensor assemblies 100a, 100b to collect additional data over a predetermined period of time (e.g., several days).The medical practitioner may use the additional data to diagnose and address specific problems. In some cases, the additional data may include personal descriptive information provided by the patient after the patient has left the medical practitioner and is no longer within communication range of the clinic base station. In these cases, the personal descriptive information may be collected and sent by one or more of the home base station, the smart device, and the connected personal assistant. Firmware within the sensor assembly 100a, 100b and / or the base station may provide safeguards to limit the duration of such enhanced monitoring so that the battery retains enough power to last the lifecycle of the implant. Additionally or alternatively, the sensor assembly 100a, 100b may include a conductivity switch that helps limit the monitoring of the sensor assembly 100a, 100b, as described further below.
[0063] In various embodiments, the clinic base station may communicate with a clinic-configured computing device. The clinic-configured computing device may include an application with a graphical user interface that allows a medical professional to input commands and data. Some or all of the commands, data, and other information may then be transmitted to the sensor assemblies 100a, 100b via the clinic base station. For example, in some embodiments, a medical professional may use the graphical user interface to instruct the sensor assemblies 100a, 100b to enter their high-resolution mode. In other embodiments, a medical professional may use the graphical user interface to input or change configuration information for the sensor assemblies 100a, 100b. The clinic-based computing device can transmit information (e.g., commands, data, or other information) to a clinic base station via a wired or wireless network connection (e.g., via a USB connection, a Bluetooth® connection, or a Wi-Fi connection), which can transmit some or all of the information to the sensor assemblies 100a, 100b.
[0064] The clinic-set computing device can also display information about the sensor assemblies 100a, 100b, other information about the patient (e.g., personal descriptive information), or other information about the clinic base station to the healthcare professional. For example, the clinic-set computing device can display high-resolution data collected by the sensor assemblies 100a, 100b and transmitted to the clinic base station. The clinic-set computing device can also display error information if the sensor assemblies 100a, 100b are unable to store or access configuration information, if the sensor assemblies 100a, 100b are unresponsive, if the sensor assemblies 100a, 100b identify a problem with one of the sensors or radios, if the clinic base station is unresponsive or malfunctioning, or for other reasons. In some forms, the clinic-set computing device can access a cloud. In at least one embodiment, a healthcare professional can utilize a clinic-based computing device to access data stored in the cloud, such data having previously been collected by the sensor assemblies 100a, 100b and transmitted to the cloud via one or both of a home base station and a smart device. Similarly, the clinic-based computing device can transmit high-resolution data obtained from the sensor assemblies 100a, 100b to the cloud via the clinic base station. In some embodiments, the clinic base station may have internet access, thereby enabling the high-resolution data to be transmitted directly to the cloud without the use of a clinic-based computing device.
[0065] In various embodiments, a healthcare professional can update the configuration information of the sensor assemblies 100a, 100b when the patient is not in the healthcare professional's clinic. In these cases, the healthcare professional can use a clinic configuration computing device to transmit the updated configuration information to the sensor assemblies 100a, 100b via the cloud. One or more of the home base station, the smart device, and the connected personal assistant can obtain the updated configuration information from the cloud and communicate the updated configuration information to the cloud. This allows the healthcare professional to remotely adjust the operation of the sensor assemblies 100a, 100b without the patient needing to visit the healthcare professional's clinic. This also allows the healthcare professional to send messages to the patient, for example, in response to personal description information provided by the patient and sent to the clinic base station by one or more of the home base station, the smart device, and the connected personal assistant.
[0066] Although the clinic base station and clinic setting computing device are described as separate devices, the configuration is not so limited; instead, the functions of the clinic setting computing device and the clinic base station can be included in a single computing device or in separate devices (as shown). Thus, in one form, a medical professional can enter setting information or markers directly into the clinic base station and review high resolution data (and synchronized marker information) from a display on the clinic base station.
[0067] Still referring to FIG. 1 , alternative configurations are contemplated. For example, each of the base station, smart device, and connected personal assistant may be configured to communicate with one or both of the sensor assemblies 100a, 100b and the cloud via another one or two of the base station, smart device, and connected personal assistant. Furthermore, a smart device may be temporarily contracted as an interface to the sensor assemblies 100a, 100b, and such a smart device may be any suitable device other than a smartphone, such as a smart watch, a smart patch, or any IoT device, such as a coffee pot, that can serve as an interface to the sensor assemblies 100a, 100b. Additionally, one or more of the base station, smart device, and connected personal assistant may serve as a communication hub for multiple sensor assemblies 100a, 100b implanted in one or more patients. Additionally, one or more of the base station, smart device, and connected personal assistant may automatically order or reorder prescriptions or medical supplies (e.g., calcium channel blockers) in response to patient input or sensor assembly 100a, 100b input (e.g., pain level, blood clotting level), provided that a medical professional and insurance company have pre-authorized such ordering or reordering; alternatively, one or more of the base station, smart device, and connected personal assistant may be configured to request authorization from a medical professional or insurance company to place an order or reorder. Additionally, one or more of the base station, smart device, and connected personal assistant may include a personal assistant, such as Alexa® or Siri®.
[0068] II. Sensor Assembly Figures 2A and 2B illustrate various types of aneurysms. Figure 2A illustrates a bifurcation aneurysm 20a. The neck 21a of the bifurcation aneurysm 20a is located at the bifurcation between the parent artery 23a and two daughter branches 22a. Bifurcation aneurysms 20a can be particularly dangerous because the bifurcation creates significant pressure on the aneurysm. Figure 2B illustrates a sidewall aneurysm 20b. The sidewall aneurysm 20b has a neck 21b located at or near the transition between the parent artery 23b and the sidewall aneurysm 20b. The sensor assembly 100 described herein can be implanted in any vascular structure, including aneurysms of the type illustrated in Figures 2A and 2B.
[0069] As shown in FIGS. 3A-3C , the sensor assembly 100 may include one or more sensors 102 and / or one or more antennas 112. The one or more sensors 102 may monitor one or more physiological parameters. The one or more physiological parameters may be indicative of blood flow through the patient's vascular system or other conditions of the patient. For example, the one or more sensors 102 may monitor the one or more physiological parameters continuously, intermittently at regular intervals, or upon command. The one or more antennas 112 may transmit sensor data to a receiver located outside the patient's body. For example, the one or more antennas 112 may transmit sensor data continuously, intermittently, intermittently at regular intervals, or upon command.
[0070] The sensor assembly 100 can monitor one or more physiological parameters indicative of blood flow through a vascular structure, such as an aneurysm 20 as shown in Figures 3A-3C. The sensor assembly 100 may include one or more sensors for monitoring other conditions of the patient, such as movement. For example, the sensor assembly 100 may include an accelerometer for monitoring whether the patient is standing or lying down.
[0071] The sensor assembly 100 may be incorporated into a sensor system 150, which may further include a tethering or anchoring structure 106. For example, FIG. 3A shows the sensor system 150 being implanted in an aneurysm 20 by a delivery system 300. The anchoring structure 106a may be positioned between the sensor assembly 100 and the wall of the aneurysm 20. The anchoring structure 106a may take the form of one or more framing coils or other structural members to maintain the aneurysm entrance and / or stabilize the aneurysm. For example, the anchoring structure 106a may at least partially surround the sensor assembly 100 and contact the wall of the aneurysm 20. Alternatively, the sensor assembly 100 may be disposed within an interior space defined by the anchoring structure 106a. The anchoring structure 106a may contact the sensor assembly 100 directly or indirectly. For example, the anchor structure 106a may contact the antenna 112 and / or the sensor 102. In some forms, the anchor structure 106a may be directly or indirectly coupled to the sensor assembly 100. In other forms, the anchor structure 106a may not contact the sensor assembly 100 at all.
[0072] The anchor structure can take a variety of forms. For example, FIG. 3B shows a sensor system 150 implanted in an aneurysm 20. The anchor structure 106b can be in the form of a mesh or woven structure, such as a basket. The anchor structure 106b can also be in the form of multiple loops extending from the sensor system, such as two, three, or more loops. Optionally, the multiple loops lie in a single plane. Optionally, the multiple loops are each the same size. The anchor structure 106b can contact the wall of the aneurysm 20. FIG. 3C shows the sensor system 150 after it has been implanted in a bifurcated aneurysm 20 by an anchor structure 106c. The anchor structure 106c can include one or more coils to promote occlusion. After the sensor system 150 is implanted in the aneurysm 20, blood can flow from the parent vessel 23 into the associated daughter vessel 22 (as indicated by the arrows). The sensor system 150 can stop blood from flowing into the aneurysm 20, thereby reducing the risk of the aneurysm 20 growing.
[0073] FIG. 4 illustrates possible positioning of a sensor 102 or sensor assembly 100 within an aneurysm 20. As shown in FIG. 4, the aneurysm 20 may have a neck 21, which is located adjacent to a parent artery 23. The aneurysm 20 may have a height H, which may have a width W. The sensor 102 may be positioned at or near the middle of the height H of the aneurysm 20 and at or near the middle of the width W of the neck 21. The positioning of one or more sensors 102 or sensor assembly 100 is important. For example, if the sensor 102 is positioned too far from the parent vessel 23, the sensor 102 may not be able to detect blood flow. If the sensor 102 is positioned too close to the neck 21, the sensor 102 may cause undesirable blockages and other problems during treatment. Furthermore, the sensor 102 may be accidentally flushed out of the aneurysm 20 by, for example, blood flow in the parent vessel 23.
[0074] A. antenna As described above, the sensor assembly 100 may include one or more antennas 112. The antenna 112 may be in electrical communication with one or more other components of the sensor assembly 100, such as the sensor 102. The antenna 112 may transmit sensor data or other data associated with the sensor assembly 100 to a receiver (e.g., a hub within the body and / or base station, or another computing device located outside the body). For example, the antenna 112 may transmit sensor data continuously upon receiving a command or transmit sensor data intermittently at predetermined time intervals. The antenna 112 may be configured to receive data from an external transmitter (e.g., a hub within the body and / or base station, or another computing device located outside the body). The antenna 112 may include or function as an RF transceiver, which may be a conventional transceiver configured to enable the sensor assembly 100 to communicate with a base station (not shown in FIGS. 5A-5C ) configured for use with the sensor assembly 100. For example, antenna 112 may be any suitable type of transceiver (e.g., Bluetooth, Bluetooth Low Energy (BTLE), and Wi-Fi), may be configured to operate according to any suitable protocol (e.g., MICS, ISM, Bluetooth, Bluetooth Low Energy (BTLE), Zigbee, and Wi-Fi), and may be configured to operate in a frequency band ranging from 1 MHz to 5.4 GHz, or any other suitable range.
[0075] Antenna 112 may include a filter (not shown). The filter may be any suitable bandpass filter, such as a surface acoustic wave ("SAW") filter or a bulk acoustic wave ("BAW") filter. Antenna 112 may be suitable for the frequency bands at which the RF transceiver and / or antenna 112 generates signals transmittable by antenna 112 and at which the base station generates signals receiveable by antenna 112.
[0076] The antenna 112 may be constructed from one or more materials (e.g., pure or alloy materials). For example, the antenna 112 may be constructed from one or more of the following materials: platinum-iridium, platinum, or coated shape memory wire. The coated shape memory wire may include an inner nitinol wire that is coated and / or plated with an electrical / RF signal conductive material capable of operating at frequencies between 2 MHz and 500 MHz. The one or more materials may have a conductivity between 1.0 and 6.0×10 6 The material may have a conductivity of S / M. The one or more materials may be configured to interact with the sensor 102 or be neutral to the sensor 102 as it interacts with the treatment zone.
[0077] The antenna 112 may be sufficiently flexible, pliable, and / or conformable to allow the sensor assembly 100 to transition between the compressed and expanded configurations. For example, the antenna 112 may include a flex-type Parylene antenna. One or more antennas 112 may be compressed into the compressed configuration and loaded into a delivery system. Furthermore, once the antenna 112 is implanted within a patient, the antenna 112 may expand to the expanded configuration to temporarily anchor or secure the sensor assembly 100 within the patient (e.g., within or near a treatment zone). In the expanded configuration, the antenna 112 may be sized and configured to conform to an interior surface at or near a treatment zone (e.g., an interior surface of an aneurysm).
[0078] The antenna 112 can form an anchoring structure for the sensor system 150. The antenna 112 can include a uniaxial loop, a biaxial loop, or a spherical loop to enhance contact with vascular structures or other anchoring structures. The antenna can position the sensor assembly 100 within the patient (e.g., at a location around the entrance to the aneurysm neck). Once the sensor assembly 100 is implanted within the patient, the antenna 112 can act as an anchoring contact with the aneurysm, for example, to interact with the aneurysm wall and maintain the position of the sensor assembly 100 to enable proper monitoring of fluid exchange between the aneurysm and an associated parent artery. For example, the antenna 112 can have one or more prongs and / or prong extensions that can interact with the inner wall of the aneurysm. The one or more prongs and / or prong extensions can have rounded ends so that the prongs and / or prong extensions are atraumatic. Alternatively, a separate tethering structure 106 may be added to support the sensor assembly 100 within the patient's body. In these configurations, the separate tethering structure 106 may be in direct or indirect contact with or coupled to the antenna 112. The antenna 112 may be positioned such that the antenna does not interfere with the implantation of the separate tethering structure 106. The separate tethering structure 106 may conform to an interior surface at or near the treatment zone.
[0079] The antenna 112 or other components of the sensor assembly 100 can be fabricated to carry materials that complement or inhibit a desired therapeutic interaction, as described further below with respect to one or more sensors. For example, the antenna 112 can be coated on the exterior or interior of the antenna 112 with a degradable substance that can release a portion of the substance, or other by-products of its degradation, to the treatment site. For example, the release of such substances or other by-products can be based on a conductivity switch, which is described further below with reference to the sensor system. The antenna 112 acts as a coil implant for the sensor 102 and can act as a coil or spherical implant to fill the aneurysm zone or to obstruct flow through and around the aneurysm zone.
[0080] 5A-5D illustrate various configurations of the sensor assembly 100. The antenna 112 may be in electrical communication with the sensor 102. The antenna 112 may be located on the same chip as the sensor 102 or on a different chip from the sensor 102. As discussed above, the sensor assembly 100 may be capable of transitioning between a compressed configuration and an expanded configuration. For example, one or more antennas 112 may be compressed around the sensor 102 and / or carrier 104 for loadability into a delivery system and expand upon release from the delivery system. In this expanded configuration, the antenna 112 may perform a stabilizing or anchoring function.
[0081] As shown in FIG. 5A , the sensor assembly 100c may include one or more sensors 102, a carrier 104, and / or one or more antennas 112a, 112b. The one or more antennas 112a, 112b may be flexible so that the antennas 112a, 112b can be compressed around the sensor 102 and / or carrier 104. The one or more antennas 112a, 112b may at least partially surround the one or more sensors 102 and / or carrier 104. As shown, the sensor 102 may be disposed on a first side of the carrier 104, and the antennas 112a, 112b may be disposed on an opposite side of the carrier 104. Together, the sensor 102 and antennas 112a, 112b substantially surround the carrier 104.
[0082] 5B, the sensor assembly 100d may include one or more antennas 112a, 112b at least partially surrounding the sensor 102. For example, the sensor 102 may be positioned between a first antenna 112a and a second antenna 112b. The first antenna 112a may be located on a first side of the sensor 102, and the second antenna 112b may be located on an opposite side of the sensor 102.
[0083] As shown in FIG. 5C, the sensor assembly 100e may include one or more sensors 102a, 102b supported by a carrier 104. For example, the carrier 104 may be positioned between the sensors 102a, 102b. The first sensor 102a may be provided on a first side of the carrier 104. The second sensor 102b may be provided on an opposite side of the carrier 104. One or more antennas 112a, 112b may at least partially surround the one or more sensors 102a, 102b and / or the carrier 104. The first antenna 112a may be provided on a first side of the carrier 104. The second antenna 112b may be provided on an opposite side of the carrier 104. Each sensor 102a, 102b may be positioned between the carrier 104 and the antenna 112a, 112b.
[0084] 5D, the sensor assembly 100f may include one or more antennas 112a-112e that form a spherical structure that at least partially surrounds the one or more sensors 102. The antennas 112a-112e may be wrapped around the one or more sensors 102. The one or more antennas 112a-112e may be coupled to each other at each end.
[0085] In some embodiments, the size of the antenna 112 may limit the transmission distance. The sensor system 150 may include an additional transceiver, either inside or outside the patient's body, to extend the transmission distance. For example, the transceiver may be integrated into a wearable device or garment. As shown in FIGS. 10A and 10B , the sensor assembly 100 may be adapted to communicate with an external transceiver 402. The external transceiver 402 may be attached to a user interface of a continuous positive airway pressure (“CPAP”) machine, a headband 400 a, a cap 400 b, or other wearable device. The external transceiver 402 may be adapted to receive one or more signals (e.g., RF signals) from the sensor assembly 100. The external transceiver 402 may include an internal battery or a battery with a capacitor. The external transceiver 402 may be adapted to communicate with a receiving platform, such as a base station or other computing device. For example, the external transceiver 402 may be indirectly or directly connected to a base station to download and transmit the generated information to the cloud.
[0086] B. Sensor 5A, 5B, 5C, and 5D, as discussed above, the sensor assembly 100 may include one or more sensors 102. A "sensor" refers to a device that can be utilized to detect, measure, and / or monitor one or more various aspects of body tissue (e.g., anatomical structure, physiological characteristics, metabolism, and function), one or more aspects of the state or function of the body or body segment (e.g., blood clotting in an aneurysm), and / or one or more aspects of the sensor assembly 100.
[0087] Representative examples of sensors suitable for use in the sensor assembly 100 include, for example, fluid pressure sensors, fluid volume sensors, contact sensors, position sensors, pulse pressure sensors, blood volume sensors, blood flow sensors, chemical sensors (e.g., blood and / or other fluid-oriented), metabolic sensors (e.g., blood and / or other fluid-oriented), impedance sensors, electrodes, accelerometers, gyroscopes, mechanical stress sensors, and temperature sensors. Within certain embodiments, at least one sensor of the one or more sensors 102 may be a wireless sensor, or within other embodiments, may be connected to a wireless microprocessor. Within some embodiments, at least one sensor of the one or more sensors 102 may have a unique sensor identification number (“USI”) that specifically identifies the sensor.
[0088] The one or more sensors 102 may be configured to detect, measure, and / or monitor information regarding the state of the sensor assembly 100 after implantation, including the health of the sensor assembly 100, the movement of the sensor assembly 100, the forces applied to the sensor assembly 100, and other information regarding the sensor assembly 100 in its implanted state.
[0089] The one or more sensors 102 may be configured to detect, measure, and / or monitor information about body tissue (e.g., one or more physiological parameters of the patient) after implantation of the sensor assembly 100. The body tissue monitoring may include blood pressure, pH level in the patient's blood, oxygen, carbon dioxide, potassium, iron, and / or glucose. The one or more sensors 102 may include a fluid pressure sensor, a fluid volume sensor, a pulse pressure sensor, a blood volume sensor, a blood flow sensor, a chemical sensor (e.g., for blood and / or other fluids), a metabolic sensor (e.g., for blood and / or other fluids).
[0090] Radiopaque or other types of markers may be incorporated into one or more of the sensors 102. The radiopaque markers allow the location of the one or more sensors 102 to be tracked within the vasculature using standard fluoroscopy.
[0091] As shown in FIG. 6, at least one of the one or more sensors 102 may include a detection mechanism utilizing a chemical reaction (CR). For example, the sensor 102 may have an outer membrane 103 containing specific chemical equivalents and analyte perfusion rates sufficient to govern the chemical reaction (CR) on the sensor 102 and the resulting output interaction on a platinum surface, e.g., an antenna 112, which generates a signal for transmitting and monitoring the zone. The antenna 112 may extend from the sensor 102. Using a broken containment technique, such as those used in treating aneurysm closure therapy, cancer, embolic therapy, embolic vascular closure therapy (arterial or venous), the signal may determine whether the chemical reaction (CR) is in a decremental or incremental mode of action of the biological propagation of blood from the parent artery to the aneurysm, i.e., void.
[0092] The duration of the chemical reaction CR can be one day or more and / or 360 days or less. For example, the duration can be one day or more and / or 180 days or less. The duration can be one day or more and / or about 90 days or less. The duration can be one day or more and / or about 30 days or less. The duration can be one day or more and / or about 10 days or less. The data output variability of the chemical reaction CR can range from as little as a 1% deviation to as much as over 99% based on a metric of chemical reaction CR presence or absence. For example, a conductivity switch or sensor can be used, as further described below. Based on the chemical interaction, the sensor 102 can detect a resulting biological response, which can be used to determine a measurement of biological flow reduction / restriction, biological flow impaction, and / or biological sealing. Signal degradation and / or non-degradation can be a determining factor in the functionality of the treatment in the region / zone in which the sensor assembly 100 and / or sensor system 150 is located.
[0093] C. Processor / Controller The sensor assembly 100 may include a processor in electrical communication with the one or more sensors 102 and / or the antenna 112. The one or more sensors 102 and the processor may be implemented on a printed circuit board. Alternatively, some or all of the one or more sensors 102 may be located in or on another structure of the sensor assembly 100 separate from the printed circuit board. The processor may be any suitable microcontroller or microprocessor and may be configured to control the settings and operation of one or more of the other components of the sensor assembly 100. For example, the processor may be configured to control the one or more sensors 102 to detect associated measurement data or physiological parameters, store the measurement data generated by the one or more sensors in a memory, generate messages including the stored data as a payload, packetize the messages, and provide the message packets to the antenna 112 for transmission to a receiver (e.g., a hub within the patient's body or a base station or other computing device located outside the patient's body). The processor may be configured to execute instructions received from the base station or other computing device via the antenna 112. For example, the processor may be configured to receive configuration data from a base station and provide the configuration data to components of the sensor assembly 100 for which the base station has directed the configuration data. If the base station directs the configuration data to the processor, the processor may configure itself in response to the configuration data.
[0094] The processor enables one or more sensors 102 to measure, detect, and determine whether a measurement is appropriate or valid, store data representing the valid measurement, and then transmit the stored data to a base station or other source external to the sensor assembly 100. In response to being polled by the base station or another device external to the sensor assembly 100, the processor can create a conventional message including a payload and a header. The scan of the payload contains stored samples of signals produced by one or more sensors 102. The header may include sample delimiters in the payload, a timestamp indicating the time the sensor 102 acquired the sample, an identifier for the sensor assembly 100 (e.g., a serial number), and / or an identifier for the patient (e.g., a number or name). The processor can generate data packets containing the message according to a conventional data packetization protocol. Each packet may further include a packet header, which may include, for example, a packet sequence number, thereby enabling a receiving device to properly order the packets even if they are sent or received out of order. The processor may encrypt some or all portions of each of the data packets, e.g., according to a conventional encryption algorithm, and then error code the encrypted data packets. For example, the processor may encrypt at least the sensor assembly 100 and the patient identifier to make the data packets compliant with the Health Insurance Portability and Accountability Act (“HIPAA”). The processor may provide the encrypted and error coded data packets to antenna 112, which transmits the data packets via a filter to a destination, e.g., base station 4 (shown in FIG. 1) or a receiver located external to sensor system 150. Antenna 112 may transmit the data packets according to any suitable data packet transmission protocol.
[0095] Other configurations of sensor assembly 100 and / or sensor system 150 are contemplated. For example, antenna 112 can perform encryption or error coding in place of or in addition to a processor. Additionally, sensor assembly 100 and sensor system 150 can have components other than those described herein, and can omit one or more of the components described herein.
[0096] The sensor assembly 100 may include a memory circuit (not shown), which may be any suitable non-volatile memory circuit, such as an EEPROM or flash memory. The memory may be in electrical communication with the processor, the antenna 112, and / or one or more sensors 102. The memory may be configured to store data written by, for example, the processor or the antenna 112, and to provide this data in response to a read command from the processor.
[0097] D. power supply The sensor assembly 100 may include one or more power sources. For example, the sensor assembly may include one or more batteries and / or supercapacitors. The power source may be sized to fit within the vasculature along with the rest of the sensor assembly 100. In other forms, the sensor assembly 100 may be powered by a power source located remote from the vasculature, either inside or outside the patient's body.
[0098] The power source may be any suitable battery, such as a lithium carbon monofluoride (LiCFx) battery or solid-state battery, or other storage cell (e.g., a supercapacitor) capable of storing energy to power the processor for the expected lifetime (e.g., at least one month or at least six months) of the sensor assembly 100. The power source may receive enough energy from the sensor reaction by-products to maintain a minimum power capacity capable of sustaining a sleep mode of the microcontroller's memory, real-time clock, and / or SRAM.
[0099] Replacing a power source implanted within a patient's body is often undesirable, at least because it can be relatively expensive and involves an invasive procedure that can cause side effects, such as infection and pain. Thus, the power source may be rechargeable. For example, the power source may be charged using an integrated circuit implemented on an ASIC chip. As another example, the battery may be inductively rechargeable. The wearable garment shown in Figures 10A and 10B, or other wearable medical devices (e.g., CPAP devices), may be configured to facilitate inductive charging.
[0100] E. Sensor Assembly Configuration Figures 7A, 7B, 7C, 7D, 8A, 8B, 8C, 9A, and 9B illustrate various configurations of sensor assemblies that can be used in any of the systems and methods described herein. Although the following examples describe specific types of sensors, the sensor configurations described below can be used for other chemical interactions or other types of sensors.
[0101] Figure 7A is a schematic plan view of sensor assembly 200. Figures 7B, 7C, and 7D are schematic cross-sectional views of sensor assembly 200 shown in Figure 7A. The cross-sections are taken along the lines shown in Figure 7A. Sensor assembly 200 may have a length and / or width of about 1.5 mm or less, or about 1.0 mm or less. Sensor assembly 200 may have a thickness of 500 microns or less, or 300 microns or less.
[0102] The sensor assembly 200 may include a substrate layer 210, such as a silicon substrate, for mounting components, which may be stacked on a power source 220 (see Figures 7B and 7C).
[0103] The sensor assembly 200 may include one or more antennas 212 and one or more sensors 202 (e.g., glucose sensors, oxygen sensors, metabolic sensors, motion sensors, or other sensors described herein). As shown, the sensors 202 and / or antennas 212 may comprise platinum, platinum alloys, gold, silver, or other suitable materials (see FIG. 7B). Optionally, the sensor assembly 200 may include a reference electrode or balancer 222 to clean the signal. The reference electrode 222 may comprise a noble metal, such as silver or silver oxide. A region 205 of the substrate layer 210 may be kept clean for die-attaching of additional devices.
[0104] The sensor assembly 200 may include one or more contact pads 206 for component coupling. The contact pads 206 may be supported by an insulating layer 207 (see FIG. 7C). The sensor assembly 200 may include one or more ground pads 208 for circuit conduit and switch interaction. The ground pads 208 may be supported by a power source 220 (see FIG. 7D). As shown, the contact pads 206 may be positioned between the ground pads 208 and the sensor 102.
[0105] 7B, 7C, and 7D, the sensor assembly 200 may include a power source 220. For example, the power source 220 may include one or more batteries and / or supercapacitors. Each battery or supercapacitor may have a thickness of about 150 μm or less.
[0106] 8A is a schematic plan view of sensor assembly 200a. FIG. 8B shows a cross-section of sensor assembly 200a. Sensor assembly 200a can include any of the features described above with reference to sensor assembly 200.
[0107] The sensor assembly 200a may include two sensors 202a, 202b. For example, the first sensor 202a may be a glucose sensor and the second sensor 202b may be an oxygen sensor. The glucose sensor 202a may include a platinum or platinum alloy pad. The glucose sensor 202a may be 0.5 mm 2 The oxygen sensor 202b may have a pad with an oxygen-based oxidase. The glucose sensor pad 202a may have a larger surface area than the oxygen sensor pad 202b. For example, the surface area of the glucose sensor pad 202a may be at least two times or at least three times the surface area of the oxygen sensor pad 202b. The surface area of the glucose sensor pad 202a may be at least five times or at least ten times the surface area of the reference electrode 222.
[0108] The sensor assembly 200a may include one or more contact pads 206 and / or one or more ground pads 208. Unlike the sensor assembly 200, the one or more contact pads 206 may be disposed along one dimension of the sensor assembly 200a, and the one or more ground pads 208 may be disposed along another dimension of the sensor assembly 200a. For example, the reference electrode 222 may be positioned between the sensors 202a, 202b and the one or more contact pads 206.
[0109] 8B and 8C are schematic cross-sectional views of the sensor assembly 200a. As shown in FIG. 8B, the sensor assembly 200b may include a topological platform 221 stacked on at least one power supply 220. The topological platform 221 may include a stacked topography connected by metal fusion. For example, the topological platform 221 may include a substrate layer 210, a second substrate layer 214, and a signal processing chip 234 and / or a capacitor 232 located between the substrate layers. The substrate layer 210 may support one or more contact pads 206. The second substrate layer 214 may support the sensor 202 and / or the reference electrode 222. The second substrate layer 214 may include at least one channel 228, 230, e.g., formed by etching. For example, the second substrate layer 214 may include at least one channel 228, 230 on each side of the sensor 202. At least one channel 228 may be disposed between the sensor 202 and the reference electrode 222. The channels 228, 230 may receive or engage a polymer membrane to form a seal around the sensor 202.
[0110] The sensor assembly 200b shown in FIG. 8C may include all of the features of the sensor assembly 200a, except for the features described below. As shown in FIG. 8C, the second substrate layer 214 forms a cap around the signal processing chip 234. The second substrate layer 214 may be bonded to the substrate layer 210 to provide a hermetic seal. For example, the second substrate layer 214 may be bonded to the substrate layer 210 using metallized bond zones 216 for eutectic bonding. In addition to or instead of the one or more channels 228, 230, the sensor assembly 200b may include one or more raised edges 227 extending from a surface of the sensor assembly 200b to engage the polymer membrane and form a seal around the sensor 202.
[0111] In addition to or instead of the antenna 112 described herein, the interior of the channels 228, 230 may include one or more antennas (not shown). For example, the channels 228, 230 may house an Antenna in a Package ("AIP") type antenna in the form of a platform for supplementing or receiving external communications for the processing system. Positioning the antenna within the channels 228, 230 increases the surface area available for the sensor 202. The length of the antenna within the channels 228, 230 may be 10 mm or less, or 7 mm or less. The thickness of the antenna within the channels 228, 230 may be 5 microns or less, or 3 microns or less.
[0112] The stacked configuration shown in Figures 8B and 8C increases the surface area available for the active sensing region. The stacked configuration hermetically seals certain processing components of the sensor assembly (e.g., signal processing chip 234 and capacitor 232) without the use of external polymer packaging. Advantageously, the stacked configuration can reduce component volume in the final assembly of the sensor assembly. Although the sensor assembly shown in Figures 8B and 8C is shown in a stacked configuration, the sensor assembly may be in any suitable configuration.
[0113] 9A is a schematic plan view of sensor assembly 200c, which may include any of the features of the sensor assemblies described above.
[0114] The sensor assembly 200c may include one or more sensors 202c, 202d. For example, the sensor assembly 200c may include a working sensor or electrode 202c, e.g., a glucose sensor, and a counter sensor or electrode 202d, e.g., an oxygen sensor. The glucose sensor may have a platinum or platinum alloy base. The glucose sensor may have a top permeable membrane for chemical reactions (e.g., oxidase-based for blood fluid extraction of glucose and oxygen). The oxygen sensor may generate a signal by chemical reactions to support fluid exchange detection. Optionally, the sensor assembly 200c may include the reference electrode 222 described above. The reference electrode 222 may be a complementary balancer, eliminating noise in the CPU signal. The surface area ratio of the working electrode 202c to the counter electrode 202d may be between 1:1 and 1:10. The surface area ratio of the combination of working electrode 202c to counter electrode 202d and reference electrode 222 may be 1:10 to 1:15, for example 1:11 or 1:13. If the counter electrode is large, the reference electrode 222 may be small to fit the overall ratio, or vice versa.
[0115] The sensor assembly 200c may include a conductivity switch. For example, the conductivity switch may include one or more pads 244, such as a ground conduit pad and a balance conduit pad. When the fluid in the fluid-rich environment increases to a threshold amount, the signal between the two pads 244 increases. When the fluid amount decreases, the signal decreases to a negligible level. The conductivity switch can identify fluid propagation from the parent artery through the aneurysm neck and into the aneurysm. The conductivity switch may be the sensor assembly's sole means of identifying fluid flow, or the conductivity switch may be used in combination with another sensor described herein. If the clinician continues to observe a signal over an extended period of time, this may be an indication that the blood in the aneurysm has not clotted. Based on this information, the clinician may choose to deliver a drug or additional medical device to facilitate embolization.
[0116] In some configurations, the sensor assembly 200c may only perform certain functions when the conductivity switch is in contact with the fluid. For example, the sensors 202c and 202d may operate only when the signal exceeds a threshold amount. As another example, the sensor assembly 200c may release a drug when the signal exceeds a threshold amount. Depending on the ratio of working and reference electrodes, it may be possible to eliminate the counter electrode. In these sensor configurations, the voltage level may be low enough that a counter electrode is not necessary to filter noise. By omitting the counter electrode, a compact sensor assembly may be deployed. For example, FIG. 9B shows a sensor assembly 200d that includes a reference electrode 222 and a working electrode 202c, which may be a glucose sensor, but does not include a counter electrode. The sensor assembly 200d may include one or more electrical pads 244 that can be connected to other circuit components of the sensor assembly 200d. If a counter electrode is not provided, the X or Y dimension of the sensor assembly 200d may be about 1.5 mm or less, or about 1.0 mm or less. The ratio of the surface area of the working electrode 202c to the reference electrode 222 may be 1:1.
[0117] 15A, another exemplary embodiment of sensor system 1050 is shown. Sensor system 1050 is similar in many respects to the previously described sensor system 150. Accordingly, the reference numerals used to identify features of sensor system 150 are often incremented from hundreds to thousands to identify identical features of sensor system 1050.
[0118] One or more sensor systems 1050 can be deployed within the aneurysm to measure one or more physiological parameters. In some embodiments, a single sensor system 1050 can include one or more sensors to measure one or more physiological parameters. In other embodiments, multiple sensor systems 1050 can be deployed within the aneurysm, with each sensor system 1050 measuring a different physiological parameter.
[0119] As shown in FIG. 15A , the sensor system 1050 may include a sensor assembly 1000 with one or more sensors, such as any one of the sensors 102 and 202 described above. The sensor assembly 1000 may include any of the features of the sensor assemblies 100, 200, and 200a-200d described above. The sensor assembly 1000 may collect data continuously, intermittently, and / or on demand. The sensor system 1050 may include an anchoring or tethering structure 1006 configured to stabilize the position of the sensor assembly 1000 within the interior space of the aneurysm. The sensor system 1050 may include a power source 1020, such as one or more batteries or supercapacitors. The tethering structure 1006 may be positioned between the sensor assembly 1000 and the power source 1020, although other configurations in which the tethering structure 1006, sensor assembly 1000, and power source 1020 are joined together are possible, such as where the sensor assembly 1000 is positioned between the tethering structure 1006 and the power source 1020. The sensor assembly 1000 and / or power source 1020 may include a stacked configuration similar to the sensor assembly 200a shown in FIG. 8C or other layouts described herein. Alternatively, a space for the tethering structure 1006 may be provided between the sensor assembly 1000 and the power source 1020, as shown in FIG. 15E. The combined sensor assembly 1000 and its power source 1020 may have a height of about 1 mm or less, or about 0.75 mm or less.
[0120] The sensor system 1050 may include communication circuitry for wireless communication with a remote electronic device. The communication circuitry may include one or more antennas 1012, which may have any of the characteristics of the antenna 112. The antenna may comprise an implantable material capable of functioning at radio frequencies. The antenna 1012 may transmit sensor data collected by the one or more sensors 1002 to another location within the body or to a location outside the body. The sensor data may be raw sensor data, data that has been partially processed (e.g., signal filtering or signal conditioning) into a parameter state by a processor within the sensor assembly 1000, or data that has been fully processed into a parameter state. The one or more antennas 1012 may be separate components from the sensor assembly 1000 or the tethering structure 1006, or may be separate components fixed to the sensor assembly 1000 or the tethering structure 1006. If the sensor system 1050 is a single component, the entire sensor system 1050 may be deployed with a single delivery system.
[0121] As shown in FIG. 15B , the antenna 1012 may be positioned against the apex or innermost wall of the aneurysm 20. The antenna 1012 may be positioned between the sensor assembly 1000 and the apex or innermost wall of the aneurysm 20. Alternatively or additionally, the antenna 1012 may be positioned at the neck 21 of the aneurysm 20 to perform a secondary function as an occluder or to maintain the sensor assembly 1000 within the aneurysm 20. Optionally, one or more therapeutic devices, such as coils, may be positioned in the space between the antenna 1012 and the sensor assembly 1000 or the space between the sensor assembly 1000 and the aneurysm wall (see, e.g., FIG. 3C ). While the antenna 1012 is shown schematically as a separate component, it may be secured to the sensor assembly 1000 and / or the anchoring structure 1006. The tethering structure 1006 may be bonded to the sensor assembly 1000. The tethering structure 1006 may be chemically and / or mechanically bonded to the sensor assembly 1000. For example, the tethering structure 1006 may include a body portion 1009 for bonding the tethering structure 1006 to the sensor assembly 1000. The body portion 1009 may be fused or mechanically clipped to the sensor assembly 1000. In one example, the body portion 1009 may be a sacrificial wafer comprising the same material as the substrate of the sensor assembly 1000 for fusion bonding the tethering structure 1006 to the sensor assembly 1000.
[0122] The tethering structure 1006 may be a resilient structure that can collapse or bend into a configuration that can be loaded into a delivery catheter. The tethering structure 1006 may transition to an expanded configuration upon release. Upon deployment, the tethering structure 1006 may provide opposing forces within the aneurysm 20 to stabilize the sensor system 1050 at least until a therapeutic device can be deployed within the aneurysm 20. As shown in FIGS. 15B and 15C , the tethering structure 1006 maintains the position of the sensor assembly 1000 (not shown) within the interior space and away from the aneurysm wall so as not to interfere with placement of the therapeutic device. The tethering structure 1006 may be atraumatic to avoid puncturing or tearing the wall of the aneurysm 20. The tethering structure 1006 may stabilize the position of the one or more sensors 1002 within the aneurysm 20 without anchoring the sensor system 1050 to the aneurysm wall.
[0123] 15D, the anchor structure 1006 can have one or more anchor portions 1006'. There can be at least two anchor portions 1006' and / or up to ten anchor portions 1006', e.g., three, four, five, or six anchor portions 1006'. The one or more anchor portions 1006' can be circumferentially spaced apart such that the one or more anchor portions 1006' contact the aneurysm wall at one or more locations around the aneurysm 20.
[0124] The anchor portions 1006' may be arms extending from the rest of the sensor system 1050. As shown, the anchor portions 1006' may be in the form of a wire loop defining an open space within each anchor portion 1006', although in other configurations, the anchor portions 1006' may be coils, prongs, extensions, or other anchor shapes. The anchor portions 1006' may be integrally formed with or bonded to the body portion 1009. Such a loop configuration allows one or more treatment devices to pass through the open space in the anchor portions 1006'. Each anchor portion 1006' may have rounded edges to provide atraumatic contact with the aneurysm wall. Each anchor portion 1006' may have a substantially identical shape, although they may vary in size. As shown in Figure 15D, the two anchor portions 1006' along the X-axis are larger than the two anchor portions 1006' along the Y-axis. The anchor portions 1006' can be shaped to a desired configuration. For example, the anchor portions 1006' can include nitinol, platinum, iridium, or any material that can be shaped to a desired configuration.
[0125] As shown, the body portion 1009 may be centered within the anchor structure 1006. However, in other embodiments, the body portion 1009 may be off-center relative to the overall anchor structure 1006. The anchor structure 1006 may extend across a single plane, such as a plane containing the X and Y axes shown in FIG. 15D. In other configurations, at least one anchor portion 1006′ may be positioned in a different plane than one or more other anchor portions 1006′. For example, different anchor portions 1006′ may lie in different, but parallel, planes. As another example, at least one anchor portion 1006′ may extend in a direction perpendicular to one or more other anchor portions 1006′, such as out of the plane of the paper depicted in FIG. 15D.
[0126] The tethering structure 1006 may be symmetrical about the X-axis and / or Y-axis shown in FIG. 15D . For example, the anchor portions 1006′ may be evenly spaced around the circumference of the sensor assembly 1000. The length of the tethering structure 1006 along the X-axis may be the same as the length of the tethering structure 1006 along the Y-axis, although the lengths of the individual anchor portions 1006′ may be the same or different depending on the dimensions of the body portion 1009. The length of the sensor assembly 1000 along the X-axis and / or Y-axis may be at least about 4 mm and / or not more than about 10 mm, e.g., about 8 mm. Depending on the size and shape of the aneurysm, the length of the tethering structure 1006 along the Y-axis may be different from the length along the X-axis.
[0127] Each anchor portion 1006' can be narrower near the body portion 1009 than at locations spaced further from the body portion 1009. Each anchor portion 1006' can span an angle greater than 0° and / or less than or equal to about 90°, e.g., between about 15° and 75°, or between 30° and 60°, e.g., about 45°. When the anchor portions 1006' are coplanar, the angle between the central axis of a first anchor portion 1006' and a circumferentially adjacent second anchor portion 1006' can be less than or equal to about 90° and / or greater than or equal to about 45°, e.g., between about 45° and about 60°, between about 60° and about 75°, or between about 75° and about 90°. When the anchor portions 1006' are in different planes, the angle between the central axis of the first anchor portion 1006' and the circumferentially adjacent second anchor portion 1006' may be less than about 60° or 45° and / or greater than about 0°, for example, between about 0° and about 15°, between about 15° and about 30°, and between about 30° and about 45°.
[0128] For loading into a delivery catheter, the individual anchor portions 1006' may bend or fold inward to form a more elongated shape. The anchor portions 1006' may also bend toward each other to form a more elongated configuration for loading into a delivery catheter. For example, two anchor portions 1006' along the X-axis may bend or fold toward the anchor portion 1006' along the Y-axis to form a more elongated profile, or circumferentially adjacent anchor portions 1006' may bend or fold toward each other to form a more elongated profile.
[0129] FIG. 15F shows the contour of the outer surface 1000a of the sensor assembly 1000. The outer surface 1000a may be shaped or modified to inhibit endothelialization of cells. Endothelialization prevents or inhibits interaction of the sensor assembly 1000 with the surrounding fluid. The surface contour shown in FIG. 15F extends the functional life of the sensor assembly 1000.
[0130] As shown, the outer surface 1000a can have a series of peaks and valleys. The peaks and valleys inhibit endothelialization of cells. The wave height h can be greater than or equal to about 20 μm and / or less than or equal to about 500 μm, e.g., less than or equal to about 100 μm or less than or equal to about 40 μm. The distance between peaks can be greater than or equal to about 20 μm and / or less than or equal to about 500 μm, e.g., less than or equal to about 100 μm or less than or equal to about 40 μm.
[0131] During the chip manufacturing process, the substrate initially deposited may have a profile with peaks and valleys. The peaks and valleys of the substrate may be created by etching, roughening, or otherwise modifying the surface of the substrate. Each layer deposited on top of the substrate level, and ultimately the outer layer 1000a of the sensor assembly, has a similar surface profile with peaks and valleys.
[0132] In other embodiments, the sensor assembly 1000 may be coated with a drug to inhibit endothelialization. While this surface contour is described with respect to the sensor assembly 1000, it may also be utilized with any of the sensor assemblies 100, 200, 200a-200d described above.
[0133] III. How to use the sensor system Any of the implantable sensor assemblies 100 and / or implantable sensor systems 150 described herein can be implanted within a patient to monitor any anatomical structure of the patient. For example, sensor assembly 100 and / or implantable sensor system 150 can be implanted within an aneurysm to monitor blood flow into the aneurysm. Low blood flow indicates clotting of blood within the aneurysm, while high blood flow indicates non-clotting of blood within the aneurysm. While the following description relates to sensor assembly 100 and sensor system 150, the method can be used with any of the sensor assemblies described herein, including sensor assemblies 200, 200a-d, 1000, and sensor system 1050.
[0134] The implantable sensor assembly 100 and / or the implantable sensor system 150 can be implanted in a patient via a delivery system. FIG. 11 illustrates an exemplary method 500 for supporting or delivering the sensor assembly 100 and / or the sensor system 150 in an anatomical structure of interest (e.g., an aneurysm). While the method 500 is described with respect to an aneurysm, the method can be used to deliver the sensor assembly 100 to other vascular structures. Using imaging techniques, a clinician can identify the anatomical structure of interest within a patient. In block 502, the clinician can advance a guide structure, such as a guidewire or guiding catheter, to the target site. Optionally, in block 504, the clinician can frame the aneurysm with one or more framing coils to control orientation and aneurysm access. In block 506, the clinician can position the distal end of the delivery system through the aneurysm neck. For example, the clinician can position the distal end of the delivery system approximately midway through the neck. In block 508, the clinician may position the sensor assembly 100 within the aneurysm, for example, at or near the middle of the aneurysm or away from the wall and neck of the aneurysm, so that the sensor assembly 100 can detect blood flow into the aneurysm. In block 510, the clinician may deploy an anchoring structure 106 (e.g., a metal coil or basket) around the sensor assembly 100 or between the sensor assembly 100 and the wall of the vasculature. In block 512, once the sensor system 150 is implanted within the aneurysm, the clinician may start the sensor system 150 and link it to a receiver to receive sensor data from the sensor system 150.
[0135] 12 illustrates another exemplary method 600 for delivering the sensor assembly 100 and / or sensor system 150 to an anatomical structure of interest in a patient, such as an aneurysm. While the method 600 is described with respect to an aneurysm, the method can be used to deliver the sensor assembly 100 to other vascular structures. In block 602, a delivery or deployment system can be removed and placed in a sterile location. In block 604, a clinician can verify the steering and control of the delivery system shaft and the deflection state of the distal section of the shaft. In block 606, a clinician can verify whether the sensor assembly 100 is loaded into the distal tip of the delivery system. If the delivery system is not preloaded with the sensor assembly 100, the clinician can load the sensor assembly 100 into the distal tip. At block 608, a medical professional may flush the primed delivery system to ensure that the conductivity switch (if provided) of the sensor assembly 100 is functional and that the sensor assembly 100 is able to connect to an external transceiver. At block 610, a medical professional may insert a guidewire or guiding catheter to a position near the entrance or neck of the aneurysm. Optionally, at block 612, a clinician may deliver one or more framing coils to the aneurysm. At block 614, a clinician may deliver the delivery system to the aneurysm by deflecting the distal section of the shaft as needed using the catheter handle. At block 616, a medical professional may deliver the sensor assembly 100 into the aneurysm. Once the sensor assembly 100 is implanted within the aneurysm, the clinician can retract the catheter from the patient's body and implant an anchoring structure 106, such as a framing coil or filler coil, around the sensor assembly 100 or between the sensor assembly 100 and the wall of the vasculature, in block 618. Once the sensor system 150 is implanted within the aneurysm, the clinician can start the sensor assembly 150 and link it to a receiver to receive sensor data from the sensor system 150.
[0136] Once the sensor system 150 is implanted within a patient and initially configured, the sensor system 150 can begin to generate sensor data associated with one or more physiological parameters of the patient, either continuously or intermittently. For example, when a conductivity sensor switch of the sensor system 150 is exposed to the patient's blood, the sensor system 150 may turn on a switch that begins detecting the one or more physiological parameters of the patient. The sensor system 150 may transmit the sensor data continuously, intermittently at regular or irregular time intervals, or on demand to a receiver, which may be, for example, a base station, a smart device, a computing device, or an external transceiver 402.
[0137] IV. kit Any of the implantable sensor assemblies and / or anchoring structures described herein may be included in a kit along with one or more delivery systems. The same delivery system may be used to deliver the sensor assembly and anchoring structure. Alternatively, the kit may include separate delivery systems for the sensor assembly and anchoring structure.
[0138] The delivery system can be preloaded with the sensor assembly prior to packaging, or the delivery system can be included in the kit separately from the sensor assembly. If provided separately, the delivery system may be loaded with the sensor assembly by the clinician.
[0139] The delivery system may include a loading chamber that supports the sensor assembly. For example, the loading chamber may be located within a lumen of the delivery system. The lumen may support an ejection mechanism, such as a pusher, for ejecting the sensor assembly from the delivery system. The loading chamber may be located within the same lumen as the guidewire or within a different lumen. The loading chamber may be separate from the guidewire lumen and / or the fluid delivery lumen.
[0140] The delivery system may include a deflectable distal tip. The deflectable tip may include radiopaque markers for tracking the location of the delivery system within the vasculature using standard fluoroscopic techniques. The deflectable distal tip may be actively and / or passively deflected to steer the sensor assembly to the target site. In an actively deflectable delivery system, the delivery system may include a handle capable of mechanically and / or electrically steering the deflectable distal tip. For example, the handle may directly cause deflection of the deflectable distal tip via one or more cables, wires, or other connections between the handle and the deflectable distal tip. As another example, the handle may indirectly cause deflection of the deflectable distal tip by deflecting an outer sleeve, thereby forcibly causing deflection of the deflectable distal tip.
[0141] The delivery system may include an adapter for connection to a robotic surgical system, which allows a clinician to actively steer the delivery system to a target site. Robotic surgical systems, teleoperated surgical systems, and the like, can be used or configured to connect to the delivery system of the present invention to deliver and implant the implantable detection or sensor assembly of the present invention into a patient's body, and such robotic surgical systems, teleoperated surgical systems, and the like are commercially available from several companies. One example of such a teleoperated, computer-assisted surgical system (e.g., a robotic system providing telepresence) with which embodiments of the present invention can be used is the Da Vinci Surgical System manufactured by Intuitive Surgical, Inc. In this regard, for example, U.S. Patent Nos. 9,358,074, 9,295,524, and 8,852,208, U.S. Patent Application Publication Nos. 20140128886, 20200253678, 20190192132, 20190254763, and 20180318020, See the specifications of US Patent Nos. 20170312047, 20170172671, 20170172674, 20170000575, 20170172670, 20130204271, and 20120209305, as well as International Publication No. WO2020150165. Each of these patent documents is incorporated herein by reference, and the contents thereof are incorporated herein by reference. Another example is the Digital Surgery and Surgical Robotics divisions of Medtronic, Inc. (Minneapolis, Minnesota, USA, and affiliated companies such as Covidien LP, Mansfield, Massachusetts, USA, and Medtronic Navigation, Inc., Louisville, Colorado, USA), which commercializes various robotic-assisted surgery (RAS) solutions.See, for example, U.S. Patent Application Publication Nos. 20200222127, 20190365477, 20190214126, 20190069964, and 20130289439. Each of these patent documents is incorporated by reference herein. Yet another example is Auris Health, Inc. (Redwood City, California, USA; Auris Health, Inc. is a division of Johnson & Johnson Medical Devices Companies; Auris Health, Inc. was formerly known as Auris Surgical Robotics, Inc.), which has commercialized the Monarch platform. See, for example, U.S. Patent Application Publication Nos. 20200198147, 20200100845, 20200100853, 20200100855, 20200093554, 20200060516, 20200046434, 20200000537, 20190365209, and 20190365486. Each of these patent documents is incorporated herein by reference. Additionally, Stryker Corp. (Kalamazoo, Michigan, USA) has disclosed robotic surgical systems, for example, in U.S. Patent Application Publication Nos. 260374770 and 20140276949, both of which are incorporated by reference herein.For further information, see, e.g., U.S. Patent Application Publication Nos. 20200046978, 20200001053, 20200197111, 20190262084, 20190231447, and 20190090957, as well as International Publication Nos. WO2019195841 and WO2019082224, each of which is incorporated herein by reference. In one embodiment, the handle of the delivery system of the present invention is configured to dock with the arm of a robotic surgical system. In one embodiment, the delivery system of the present invention is integrated with a robotic surgical system to enable robot-assisted delivery and implantation of the implantable detection or sensor assembly of the present invention into a patient's body. In one embodiment, the present invention provides a method for advancing any of the implantable sensor assemblies and / or systems described herein into a patient's vascular system using robotic assistance.
[0142] V. Delivery System FIG. 13 illustrates a delivery system 700 for advancing any of the implantable sensor assemblies and / or systems described herein into the vascular system. The delivery system 700 may include a deflectable distal tip 702, a handle 706, and a shaft 704 located between the distal tip and the handle. In some technical contexts, the delivery system 700 may be sufficiently sized to be advanced into the neurovasculature. For example, the outer diameter of the shaft 704 may be 1 mm or less. The relative terms "proximal" and "distal" used herein are defined relative to the delivery system. Thus, proximal refers to the control end of the delivery system, and distal refers to the distal tip.
[0143] The deflectable distal tip 702 can support a sensor assembly. For example, the deflectable distal tip 702 can be pre-loaded with the sensor assembly, which is then introduced into the patient. The sensor assembly can be pre-loaded in a loading chamber separate from the guidewire lumen or fluid delivery lumen. The sensor assembly can be attached to the loading chamber or can reside free in the loading chamber. The sensor assembly can be sterilized prior to loading or can be sterilized along with the delivery system 700. In another delivery method, the sensor assembly can be advanced into the deflectable distal tip 702 after the delivery system 700 has been advanced to the target site.
[0144] The handle 706 can be used to actively deflect the deflectable tip 702 to facilitate accurate placement of the sensor assembly. For example, the deflectable tip 702 can be mechanically deflected using a user-actuable mechanism within the handle 706. The user-actuable mechanism can control one or more cables or wires that pass through the wall of the shaft 704 or along the interior and / or exterior surfaces of the shaft 704 to steer the deflectable distal tip 702. Additionally or alternatively, the deflectable distal tip 702 can be sufficiently flexible to be passively deflected. The deflectable distal tip 702 can include one or more markers to monitor the position and / or orientation of the deflectable distal tip.
[0145] The deflectable distal tip 702 may be constructed from one or more polymeric materials, such as Pebax® polyethylene, polyethylene terephthalate, or other polymeric materials. The deflectable distal tip 702 may or may not be supported by a braided material.
[0146] The shaft 704 can have one or more internal lumens. For example, the shaft 704 can have a guidewire lumen for tracking the delivery system 700 to the target site. The guidewire lumen can extend from a guidewire lumen port 714 in the handle 706 and through the deflectable distal tip 702. The shaft 704 can have a fluid delivery lumen for delivering fluids to the delivery site.
[0147] The shaft 704 may be made of one or more polymeric materials, such as Pebax® polyethylene, tetrafluoroethylene, polytetrafluoroethylene, or other polymeric materials. The shaft 704 may be reinforced with a braided material to facilitate pushability and / or torque management. The shaft 704 may be co-extruded with a first polymeric material and a liner and / or outer layer. The liner and / or outer layer may comprise tetrafluoroethylene or polytetrafluoroethylene.
[0148] The handle 706 can have one or more user-actuable mechanisms that control different functions of the delivery system 700. For example, the handle 706 can have a first user-actuable mechanism 710 that can release the sensor assembly from the delivery system 700. The handle 706 can have a second user-actuable mechanism 708 that can steer the shaft 704 and / or the deflectable distal tip 702. As used herein, the terms "first" and "second" user-actuable mechanism can be used interchangeably. For example, a "first" user-actuable mechanism can refer to any control feature described herein.
[0149] The first user-actuable mechanism 710 can push the sensor assembly out of the distal tip 702 of the delivery system 700. For example, the first user-actuable mechanism 710 can control a pusher that extends through a lumen in the shaft 704. In another form, the first user-actuable mechanism 710 can retract the distal tip 702 relative to the sensor assembly to eject the sensor assembly. As shown, the first user-actuable mechanism 710 can be an axial slider, although in other forms the first user-actuable mechanism 710 can be a button, switch, lever, rotatable knob, rotatable dial, etc.
[0150] The second user-actuable mechanism 708 can steer the shaft 704 and / or the deflectable distal tip 702. As shown, the second user-actuable mechanism 708 can be a rotation knob that can control the direction of the flexible shaft 704 and / or the distal tip 702. The rotation knob can rotate about the longitudinal axis of the handle 706. In other forms, the second user-actuable mechanism 710 can rotate in different directions.
[0151] 13, the first user-actuable mechanism 710 may be positioned proximal to the second user-actuable mechanism 708. In other forms, the second user-actuable mechanism 708 may be positioned proximal to the first user-actuable mechanism 710 or elsewhere.
[0152] The handle 706 may further include one or more ports. For example, the handle 706 may include a flush port 712 for introducing fluid into the delivery system 700. The handle 706 may include a separate guidewire lumen port 714. As shown, the one or more ports are located proximal to the user-actuable mechanism, but may be located anywhere along the delivery system 702. The handle 706 may be molded from a polymeric material, such as ABS, polypropylene, Pebax®, or other materials.
[0153] Optionally, the delivery system 700 may include a delivery sheath 716 that fits over the shaft 704. The delivery sheath 716 may act as an introducer. The delivery sheath 716 may include one or more seals to prevent fluids from passing from the patient through the space between the delivery sheath 716 and the shaft 704. For example, the delivery sheath 716 may include a seal located near the proximal side of the delivery sheath 716. The delivery sheath 716 may include a separate port 718 to flush the delivery sheath 716 or to facilitate interaction between the delivery sheath 716 and the shaft 704. In some forms, the delivery sheath 716 may enhance steering and tracking of the delivery system 700 through the vasculature. For example, the delivery sheath 716 may be coupled to the deflectable distal tip 702 to allow steering of the deflectable distal tip 702. As another example, the delivery sheath 716 may not engage the deflectable distal tip 702, and bending the delivery sheath 716 causes deflection of the distal tip 702.
[0154] The delivery sheath 716 can be constructed of the same or a different material as the deflectable distal tip 702. For example, the delivery sheath 716 can be constructed of a polymeric material, such as Pebax® polyethylene, polyethylene terephthalate, or other polymeric material. The delivery sheath 716 may or may not be supported by a braided material.
[0155] 14 illustrates another delivery system 800 for advancing any of the implantable sensor assemblies or systems described herein into the vasculature. Delivery system 800 may include any of the features described above with respect to delivery system 700. Delivery system 800 may include a deflectable distal tip 802, a handle 806, and a shaft 804 positioned between the distal tip and a sheath.
[0156] The deflectable distal tip 802 can include a load chamber that supports the sensor assembly. The load chamber can be separate from any guidewire lumen, fluid delivery lumen, and / or other lumens that extend through the deflectable distal tip 802.
[0157] The deflectable distal tip 802 can comprise a molded or thermally reshaped polymer. For example, the deflectable distal tip 802 can comprise one or more polymeric materials, such as Pebax® polyethylene, tetrafluoroethylene, polytetrafluoroethylene, or other polymeric materials. The deflectable distal tip 802 can be supported by a braided material or can be unsupported. For example, the deflectable distal tip 802 can comprise a braided structure that is lined and / or coated or overmolded with a separate polymer layer, such as tetrafluoroethylene or polytetrafluoroethylene.
[0158] The shaft 804 may have one or more internal lumens. For example, the shaft 804 may have a guidewire lumen for tracking the delivery system 800 to the target site. The guidewire lumen may extend from a guidewire lumen port 814 in the handle 806 and through the deflectable distal tip 802. The shaft 804 may have a fluid delivery lumen for delivering fluids to the delivery site. The shaft 804 may comprise one or more polymeric materials, such as Pebax® polyethylene, tetrafluoroethylene, polytetrafluoroethylene, or other polymeric materials.
[0159] The handle 806 may include one or more user-actuable mechanisms that control various functions of the delivery system 800. For example, the handle 806 may include a first user-actuable mechanism 810 that can release the sensor assembly from the delivery system 800. The handle 806 may include a second user-actuable mechanism 808 that can steer the shaft 804 and / or the deflectable distal tip 802. The second user-actuable mechanism 808 may be a rotatable knob, although in other forms the second user-actuable mechanism 808 may be a button, switch, lever, slider, rotatable dial, etc. The handle 806 may include a third user-actuable mechanism 820 to stabilize the orientation of the shaft 804 and / or the deflectable distal tip 802. For example, the third user-actuable mechanism 820 may be a toggle lock. As used herein, the terms "first," "second," and "third" user-actuatable mechanism may be used interchangeably. For example, a "first" user-actuatable mechanism may refer to any control feature described herein. The user-actuatable mechanisms may be positioned in an order that corresponds to their use during a procedure.
[0160] The handle 806 can include controls 822 for steering the deflectable tip 802 and / or shaft 804. For example, the handle 806 can include mechanical and / or electrical control mechanisms for steering the deflectable distal tip 802 and / or shaft 804. For example, the delivery system 800 can include a slider or carriage assembly with one or more wires or cables. The delivery system 800 can include voltage controls for actuating the deflection mechanism. The wires or cables can electrically transmit energy to steer the deflectable distal tip 802 and / or shaft 804. Additionally or alternatively, the mechanical and / or electrical control mechanisms can be utilized in a delivery sheath that fits over the shaft 804.
[0161] 16A illustrates another delivery system 1100 that can include any of the features of delivery systems 700 and 800. Accordingly, the reference numerals used to identify features of delivery systems 700 and 800 are incremented to 1100 numbers to identify identical features of delivery system 1100. Delivery system 1100 is described below in conjunction with sensor system 1050, which may be used in combination with any of the sensor systems or sensor assemblies described herein.
[0162] The delivery system 1100 can include a proximal portion 1106 (shown in FIG. 16B) and a distal portion 1102 (shown in FIG. 16D). As shown in FIG. 16B, the proximal portion 1106 has a handle body 1107. A delivery sheath 1116 extends distally from the handle body 1107. A shaft 1104 extends through a lumen in the delivery sheath 1116. FIG. 16C shows a cross section of the handle body 1107. The handle body 1107 can have a lumen 1109 through which a retention wire 1130 can extend.
[0163] As shown in FIG. 16D, the retention wire 1130 can extend through the shaft 1104. The retention wire 1130 can extend out of openings 1132a, 1132c in the sidewall of the shaft 1104 and back into different openings 1132b, 1132d in the sidewall of the shaft 1104, thereby forming one or more loop portions 1130′, such as two loop portions (see FIG. 16D) or four loop portions (see FIG. 17B). The loop portions 1130′ can be positioned within 10 cm of the distal tip of the shaft 1104, within 5 cm of the distal tip of the shaft 1104, within 2 cm of the distal tip of the shaft 1104, or within 1 cm of the distal tip of the shaft 1104. As shown in FIG. 16D, the retention wire 1130 can extend out of the shaft 1104 through a first opening 1132a in the sidewall of the shaft 1104 and back into the shaft 1104 through an adjacent second opening 1132b. The retention wire 1130 can extend out of the shaft 1104 through a third opening 1132c near the distal tip of the shaft 1104 and back into the shaft 1104 through an adjacent fourth opening 1132d. The distal end of the retention wire 1130 can extend out of the distal tip of the shaft 1104. The loop portions 1130′ can be axially spaced apart from one another but rotationally aligned along the shaft 1104. In other embodiments, adjacent loop portions can be rotationally offset (see FIG. 17B).
[0164] Each loop portion 1130′ is configured to retain one or more anchor portions 1006′ of the sensor system 1050. The loop portions 1130′ retain the sensor system 1050 on the exterior of the shaft 1104. For example, the sensor system 1050 can be retained within the space between the outer wall of the shaft 1104 and the inner wall of the delivery sheath 1116. In other embodiments, the retention wire 1130 can extend through the space between the delivery sheath 1116 and the shaft 1104 and into and out of the shaft 1104, thereby forming a loop portion 1130′ within the shaft 1104, thereby retaining the sensor system 1050 within the shaft 1104.
[0165] 16E, each loop portion 1130' can be configured to retain two anchor portions 1006'. As the retention wire 1130 extends out of the shaft 1104 through a first opening 1132a, the retention wire 1130 can be threaded through one or more looped anchor portions 1006' and then extend back into the shaft 1104 through a second adjacent opening 1132b, thereby capturing the anchor portions 1006' within the loop portion 1130'. The retention wire 1130 can extend out of the shaft 1104 through a third opening 1132c, return, pass through one or more additional looped anchor portions 1006', and extend back into the shaft 1104 through a fourth adjacent opening 1132d, thereby capturing the additional anchor portions 1006' within the loop portion 1130'. In this configuration, the sensor assembly's anchoring structure 1006 may be held within the delivery system 1100 and against the shaft 1104 in an elongated, compact configuration.
[0166] The loop portions 1130' can be sequentially released to deploy the sensor system 1050. As the retention wire 1130 is withdrawn proximally, the distal end of the retention wire 1130 is withdrawn through the openings 1132a-1132d, thereby releasing the loop portion 1130' and corresponding anchor portion 1006'. In FIG. 16F, the retention wire 1130 has been withdrawn through the third and fourth openings 1132c, 1132d to release the distal-most loop portion 1130' and corresponding anchor portion 1006'. Continuing to withdraw the retention wire 1130 releases the remaining anchor portions 1006'. Once released into the aneurysm, the anchor portions 1006' retain the sensor system 1050 within the aneurysm, as shown in FIG. 15B.
[0167] To release the sensor system 1050 into the aneurysm 20, the distal portion 1102 of the delivery system 1100 can be positioned within the parent artery and adjacent to the aneurysm neck 21. The sensor assembly 1050 can be exposed to the aneurysm neck 21 by advancing the distal portion of the shaft 1104 distally of the distal end of the sheath 1116 or by withdrawing the sheath 1116 proximally to expose the sensor assembly 1050. The openings 1132a-d at the distal portion of the shaft 1104 can be positioned against the aneurysm neck 21 so that the sensor system 1050 is deployed within the aneurysm 20 when the retention wire 1130 is released from the openings 1132a-d. Alternatively, the distal portion of the shaft 1104 can extend into the aneurysm 20 to release the sensor system 1050 into the aneurysm 20. As mentioned in the previous embodiment, the distal portion of the shaft 1104 may be steerable so that the distal end of the shaft 1104 can be guided into the aneurysm 20. A separate delivery system may then be used to deliver the therapeutic device. FIG. 17A shows another delivery system 1200 that may include any of the features of the delivery system 1100. The delivery system 1200 is similar to the delivery system 1100, except for the features described below. The features of the delivery systems 1100 and 1200 are interchangeable.
[0168] Unlike delivery system 1100, delivery system 1200 includes loop portions 1230′ for each anchor portion 1006′. For example, for sensor system 1050 with four anchor portions 1006′, delivery system 1200 may include four corresponding loop portions 1230′. Furthermore, each loop portion 1230′ may be formed by extending from shaft 1204 and back into shaft 1204 through the same opening. As shown in FIG. 17B, each opening 1232a-d may be an elongated opening that receives loop portion 1230′. Openings 1232a-d may be axially spaced apart from one another. At least one of openings 1232c may be rotationally offset from adjacent openings 1232d, 1232b.
[0169] As the retention wire 1230 extends out of the shaft 1204 through the first opening 1232a, it can be threaded through the looped anchor portion 1006′ and then extend back into the shaft 1204 through the same first opening 1232a, thereby capturing the anchor portion 1006′ within the looped portion 1230′. The retention wire 1230 can extend out of the shaft 1204 through the second opening 1232b, return through another looped anchor portion 1006′, and then return into the shaft 1204 through the same second opening 1232b, thereby capturing the additional anchor portion 1006′ within the looped portion 1230′. In this configuration, the anchoring structure 1006 of the sensor assembly can be retained within the delivery system 1200 and against the shaft 1204 in an elongated, compact configuration.
[0170] Similar to delivery system 1100, loop portions 1230' can be sequentially released to release sensor system 1050. As retention wire 1230 is withdrawn proximally, the distal end of retention wire 1230 is pulled out of openings 1232a-1232d, thereby releasing loop portions 1230' and corresponding anchor portions 1006'.
[0171] VI. Additional Embodiments and Terminology All U.S. patents, U.S. patent application publications, U.S. patent applications, foreign patents, foreign patent applications, and non-patent literature referenced herein and / or listed in the Application Data Sheet are hereby incorporated by reference and incorporated herein in their entireties. Such patent and non-patent literature is incorporated by reference and incorporated herein in its entirety for the purpose of describing and disclosing, for example, the materials and methodology described therein that may be used in connection with the present disclosure. The publications listed above and throughout this text are provided solely for their disclosure prior to the filing date of the present application. Nothing herein should be construed as an admission that the inventors have no antedate right by virtue of prior filing to any publication cited as a reference.
[0172] While certain methods have been described herein with respect to aneurysms, the methods described herein can be utilized with any vascular structure, for example, the ductus arteriosus. While certain embodiments and examples have been described herein, those skilled in the art will recognize that many aspects of the sensor assemblies shown and described in this disclosure can be combined and / or modified in various ways to create still further embodiments or acceptable examples. All such modifications and variations are intended to be within the scope of the present invention. A wide variety of designs and approaches can be employed. No feature, structure, or step disclosed herein is essential or essential.
[0173] For purposes of this disclosure, certain aspects, certain advantages, and novel features have been described herein. It is to be understood that not necessarily all such advantages can be achieved in accordance with any particular embodiment. Thus, for example, one skilled in the art will recognize that the invention can be embodied or carried out in a way that achieves one advantage or group of advantages as taught herein, without necessarily achieving other advantages as taught or suggested herein.
[0174] Furthermore, while exemplary embodiments have been described herein, the scope of any and all embodiments, including equivalent elements, modifications, omissions, combinations (e.g., combining aspects shown throughout various embodiments), adaptations, and / or variations, will be understood by those of ordinary skill in the art based on this disclosure. Any limitations in the claims should be construed broadly based on the language employed in the claims, and not limited to the examples described herein or during the prosecution of this application, such examples being construed in a non-exclusive manner. Furthermore, the acts or steps of the disclosed processes and methods may be modified in any manner, including by changing the order of acts and / or adding additional acts and / or deleting acts. Accordingly, the specification and examples should be considered as illustrative only, with the true scope and spirit to be determined by the appended claims, along with their full scope of equivalents.
[0175] As used herein, "nearly," "about," and "substantially" refer to an amount close to the stated amount that still performs or achieves the desired function. For example, the terms "nearly," "about," and "substantially" can refer to an amount that is within 10%, within 5%, within 1%, within 0.1%, and within 0.01% of the stated amount.
[0176] As used in the specification, conditional words such as "can," "might," "may," and "eg," among others, are generally intended to mean that, unless expressly stated otherwise or understood otherwise within the context in which they are used, some embodiments may include a particular feature, element, and / or condition, and other embodiments may not include a particular feature, element, and / or condition. Thus, such conditional words are generally not intended to imply that a feature, element, block, and / or condition is in any manner necessary for one or more embodiments, or that one or more embodiments necessarily include logic, with or without author input or prompting, for determining whether or not those features, elements, and / or conditions are included in or should be implemented in any particular embodiment.
[0177] While the methods disclosed herein may include certain actions taken by a clinician, the methods may further include, explicitly or implicitly, any third-party command of such actions. For example, the action "release the sensor assembly" includes "command the release of the sensor assembly."
[0178] The various illustrative logic blocks, modules, routines, and algorithm steps described in connection with the embodiments disclosed herein can be embodied as electronic hardware, computer software, or a combination of both. To clearly illustrate this interchangeability of hardware and software, the various illustrative components, blocks, modules, and steps have been described above generally in terms of their functionality. Whether such functionality is embodied as hardware or software depends on the particular application and design constraints imposed on the overall system. The described functionality may be embodied in various ways for each particular application, and such implementation decisions should not be interpreted as causing a departure from the scope of the present disclosure.
[0179] Furthermore, the various illustrative logic blocks and modules described in connection with the embodiments disclosed herein may be embodied or performed by a machine designed to perform the functions described herein, such as a general-purpose processor device, a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof. A general-purpose processor device may be a microprocessor, although in alternative embodiments, such a processor device may be a controller, microcontroller, or state machine, combinations thereof, or the like. A processor device may include electrical circuitry configured to process computer-executable instructions. In another embodiment, a processor device includes an FPGA or other programmable device that performs logical operations without processing computer-executable instructions. A processor device may also be embodied as a combination of computing devices, such as a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors in combination with a DSP core, or any other such form. While a processor device has been described herein primarily with respect to digital technology, a processor device may also include primarily analog components. For example, some or all of the signal processing algorithms described herein may be implemented in analog circuitry or mixed analog-digital circuitry. The computing environment may include any type of computer system, including, but not limited to, a computer system utilizing a computational engine in a microprocessor, mainframe computer, digital signal processor, portable computing device, device controller, or appliance, to name a few.Elements of the methods, processes, routines, or algorithms described in connection with the embodiments disclosed herein may be embodied directly in hardware, in software modules executed by a processor device, or in a combination of the two. The software modules may reside in RAM memory, flash and ROM memory, EPROM memory, EEPROM memory, registers, a hard disk, a removable disk, a CD-ROM, or any other form of non-transitory computer-readable storage medium. An exemplary storage medium may be coupled to the processor device such that the processor device can read information from, and write information to, the storage medium. In an alternative, the storage medium may be integral to the processor device. The processor device and the storage medium may be incorporated in an ASIC. The ASIC may be incorporated in a user terminal. In an alternative, the processor device and the storage medium may reside as separate components in a user terminal.
[0180] VII. Implementation The following embodiments identify some possible permutations of the combinations of features disclosed herein, although other permutations of the combinations of features are also possible. [Embodiment 1] 1. An implantable sensor system, comprising: the sensor is capable of detecting one or more physiological parameters of the patient to generate sensor data; An implantable sensor system including an antenna in electrical communication with the sensor, the antenna transmitting sensor data related to the one or more physiological parameters of the patient to a receiver, the antenna being compressible around the sensor so as to be loadable into a delivery system and expandable upon release from the delivery system. [Embodiment 2] 2. The implantable sensor system of embodiment 1, wherein the antenna continuously transmits sensor data. [Embodiment 3] 2. The implantable sensor system according to embodiment 1, wherein the antenna transmits sensor data intermittently. [Embodiment 4] 2. The implantable sensor system of embodiment 1, wherein the sensor continuously detects the one or more physiological parameters. [Embodiment 5] 2. The implantable sensor system of embodiment 1, wherein the sensor intermittently detects the one or more physiological parameters. [Embodiment 6] An implantable sensor system according to any one of the first to third embodiments, wherein the sensor is implantable within the vasculature of the patient. [Embodiment 7] 7. The implantable sensor system according to embodiment 6, wherein the vascular structure is an aneurysm. [Embodiment 8] The implantable sensor system according to any one of the first to seventh embodiments, wherein the antenna at least partially surrounds the sensor. [Embodiment Item 9] 9. The implantable sensor system of embodiment 8, wherein the antenna extends at least partially across the first surface of the sensor. [Embodiment 10] The implantable sensor system of embodiment 9, wherein the antenna extends at least partially across a second surface of the sensor, the second surface being located opposite the first surface. [Embodiment 11] The implantable sensor system according to any one of the first to tenth embodiments, wherein the antenna is a single-axis loop, a double-axis loop, or a spherical loop. [Embodiment 12] 12. The implantable sensor system according to any one of the first to eleventh embodiments, wherein the antenna is made of platinum, a platinum / iridium alloy, and / or nitinol. [Embodiment 13] 13. The implantable sensor system according to any one of embodiments 1 to 12, wherein the antenna is coated with a parylene film, a gold material, and / or a platinum material. [Embodiment 14] 14. The implantable sensor system according to any one of the first to thirteenth embodiments, wherein the antenna is capable of stabilizing the position of the sensor within the aneurysm. [Embodiment 15] 15. The implantable sensor system of any one of embodiments 1-14, further comprising a radiopaque marker for locating the position of the implantable sensor assembly within the patient. [Embodiment 16] An implantable sensor system according to any one of embodiments 1 to 15, wherein the sensor generates the sensor data based on analyte materials, analyte components, and / or by-products resulting from certain cellular interactions or exchanges in the blood or blood interactions or exchanges. [Embodiment 17] The implantable sensor system according to any one of the first to sixteenth embodiments, wherein the sensor comprises a blood flow sensor, a blood pressure sensor, a metabolic sensor, a glucose sensor, an oxygen sensor or a pressure sensor. [Embodiment 18] 18. The implantable sensor system of any one of embodiments 1 to 17, wherein the one or more physiological parameters include oxygen, carbon dioxide, potassium, iron, and / or glucose in the patient's blood. [Embodiment 19] The implantable sensor system according to any one of the first to seventeenth embodiments, wherein the one or more physiological parameters include motion information. [Embodiment 20] The implantable sensor system according to any one of the first to nineteenth embodiments, wherein the antenna transmits and receives RF signals. [Embodiment 21] The implantable sensor system according to any one of embodiments 1 to 20, further comprising a sealing layer that hermetically seals the sensor assembly. [Embodiment 22] 22. The implantable sensor system according to any one of the first to twenty-first embodiments, further comprising a dissolving membrane layer that dissolves upon contact with the patient's blood. [Embodiment 23] 23. The implantable sensor system of embodiment 22, wherein the dissolving membrane layer releases the clotting enhancer when the dissolving membrane layer dissolves. [Embodiment 24] The implantable sensor system according to any one of the first to twenty-third embodiments, further comprising a power source for supplying power to the sensor. [Embodiment 25] 25. The implantable sensor system of embodiment 24, wherein the power source is rechargeable. [Embodiment 26] 24. The implantable sensor system of any one of embodiments 1 to 23, wherein the sensor is powerable by a power source located external to the patient. [Embodiment 27] The implantable sensor system according to any one of the first to twenty-third embodiments, wherein the sensor is an inductive sensor. [Embodiment 28] The implantable sensor system of any one of embodiments 1 to 23, further comprising a supercapacitor. [Embodiment 29] The implantable sensor system according to any one of embodiments 1 to 28, further comprising a memory device for storing sensor data. [Embodiment 30] The implantable sensor system according to any one of embodiments 1 to 29, further comprising a second sensor capable of detecting a physiological parameter different from that of the first sensor. [Embodiment 31] A kit comprising: The implantable sensor system according to any one of the first to thirteenth embodiments, and a delivery system capable of releasing the implantable sensor assembly into the vasculature. [Embodiment 32] 1. An implantable sensor system, comprising: the sensor is capable of sensing one or more physiological parameters of the patient to generate sensor data; an antenna in electrical communication with the sensor, the antenna capable of transmitting the sensor data associated with the one or more physiological parameters of the patient to a receiver; An implantable sensor system including an anchor structure that maintains the position of the sensor within a vasculature, the sensor being disposed within a space defined by the anchor structure. [Embodiment 33] 33. The implantable sensor system of claim 32, wherein the anchor structure is separate from the sensor, and the anchor structure contacts the sensor upon implantation. [Embodiment 34] 33. The implantable sensor system of embodiment 32, wherein the anchor structure is directly or indirectly coupled to the sensor and / or the antenna. [Embodiment 35] The implantable sensor system according to any one of embodiments 32 to 34, wherein the antenna continuously transmits the sensor data. [Embodiment 36] The implantable sensor system according to any one of embodiments 32 to 34, wherein the antenna transmits sensor data intermittently. [Embodiment 37] 37. The implantable sensor system according to any one of embodiments 32 to 36, wherein the sensor continuously senses the one or more physiological parameters. [Embodiment 38] 37. The implantable sensor system according to any one of embodiments 32 to 36, wherein the sensor intermittently senses the one or more physiological parameters. [Embodiment 39] An implantable sensor system according to any one of embodiments 32 to 38, wherein the sensor generates the sensor data based on analyte materials, analyte components, and / or by-products resulting from certain cellular interactions or exchanges in the blood or blood interactions or exchanges. [Embodiment 40] 40. The implantable sensor system according to any one of embodiments 32 to 39, wherein the sensor comprises a blood flow sensor, a blood pressure sensor, a metabolic sensor, a glucose sensor, an oxygen sensor, or a pressure sensor.
[0181] [Embodiment 41] 41. The implantable sensor system according to any one of embodiments 32 to 40, wherein the one or more physiological parameters include oxygen, carbon dioxide, potassium, iron, and / or glucose in the patient's blood. [Embodiment 42] The implantable sensor system according to any one of embodiments 32 to 40, wherein the one or more physiological parameters include motion information. [Embodiment 43] 43. The implantable sensor system of any one of embodiments 32-42, further comprising a radiopaque marker for locating the implantable sensor system within the patient. [Embodiment 44] The implantable sensor system according to any one of embodiments 32 to 43, wherein the vascular structure is an aneurysm. [Embodiment 45] 45. The implantable sensor system of embodiment 44, wherein the one or more physiological parameters are indicative of blood flow into the aneurysm. [Embodiment 46] 45. The implantable sensor system of embodiment 44, wherein the one or more physiological parameters are indicative of blood flow from the aneurysm. [Embodiment 47] The implantable sensor system according to any one of embodiments 32 to 46, wherein the antenna transmits and receives RF signals. [Embodiment 48] The implantable sensor system according to any one of embodiments 32 to 47, wherein the anchor structure comprises one or more coils. [Embodiment 49] 48. The implantable sensor system according to any one of embodiments 32 to 47, wherein the anchor structure is made of a mesh or woven structure. [Embodiment 50] 48. The implantable sensor system according to any one of embodiments 32 to 47, wherein the anchor structure comprises a basket. [Embodiment 51] The implantable sensor system according to any one of embodiments 32 to 50, wherein the anchor structure is capable of occluding the flow of blood through the vascular structure. [Embodiment 52] The implantable sensor system according to any one of embodiments 32 to 51, further comprising a drug. [Embodiment 53] 53. The implantable sensor system of embodiment 52, wherein the anchor structure carries the drug. [Embodiment 54] 54. The implantable sensor system according to embodiment 52 or 53, wherein the drug is a coagulant. [Embodiment 55] The implantable sensor system according to any one of embodiments 32 to 54, further comprising a power source for supplying power to the sensor. [Embodiment 56] 56. The implantable sensor system of embodiment 55, wherein the power source is rechargeable. [Embodiment 57] 55. The implantable sensor system according to any one of embodiments 32 to 54, wherein the sensor is powerable by a power source located external to the patient. [Embodiment 58] The implantable sensor system according to any one of embodiments 32 to 54, wherein the sensor is an inductive sensor. [Embodiment 59] The implantable sensor system of any one of embodiments 32 to 54, further comprising a supercapacitor. [Embodiment 60] The implantable sensor system according to any one of embodiments 32 to 59, further comprising a memory device for storing sensor data. [Embodiment 61] The implantable sensor system according to any one of embodiments 32 to 60, further comprising a second sensor capable of detecting a physiological parameter different from that of the first sensor. [Embodiment 62] A kit comprising: The implantable sensor system according to any one of embodiments 32 to 61; and one or more delivery systems capable of releasing the implantable sensor system into a vascular structure. [Embodiment 63] 1. An implantable sensor assembly comprising: a conductivity switch responsive to blood flow, the conductivity switch capable of providing a first output indicative of a first level of blood flow and a second output indicative of a second level of blood flow; The implantable sensor assembly includes an antenna in electrical communication with the conductivity switch, the antenna capable of transmitting the first output and the second output to a receiver. [Embodiment 64] 64. The implantable sensor system of embodiment 63, wherein the second output indicates that substantially no blood flow is occurring. [Embodiment 65] 1. An implantable sensor system, comprising: an agent capable of treating a vasculature within a patient's body; a memory device configured to store computer-executable instructions; an implantable sensor system comprising: a processor in communication with the memory device, the computer-executable instructions, when executed by the processor, causing the processor to release the agent from the implantable sensor system; [Embodiment 66] The implantable sensor system of embodiment 65 further comprises a switch, wherein the computer-executable instructions, when executed by the processor, operate the switch, causing the release of the drug carried by the implantable sensor system. [Embodiment 67] An implantable sensor system as described in embodiment 65 or 66, further comprising a wireless receiver capable of receiving transmissions from outside the patient, wherein receiving the transmissions causes the processor to execute the computer-executable instructions. [Embodiment 68] 67. The implantable sensor system of embodiment 65 or 66, wherein the processor executes the computer-executable instructions a predetermined time following implantation of the implantable sensor system. [Embodiment 69] 69. The implantable sensor system according to any one of embodiments 65 to 68, wherein the drug is a coagulant. [Embodiment 70] 1. An electronic device for monitoring blood flow through a vasculature, the electronic device comprising: a memory device configured to store an application; a processor configured to execute the application, the processor thereby: in wireless communication with a sensor assembly implanted within the vasculature, the sensor assembly capable of monitoring one or more physiological parameters indicative of blood flow through the vasculature; determining a value of one or more of the physiological parameters indicative of blood flow; An electronic device adapted to output said value displayably and provideable to a user on a display. [Embodiment 71] 71. The electronic device of embodiment 70, wherein said value provides a metric that is indicative of the degree of obstruction of said vascular structure. [Embodiment 72] 72. The electronic device of claim 70 or 71, wherein the processor is configured to execute the application and communicate the value to a computing system via a communications network. [Embodiment 73] An electronic device described in any one of embodiments 70 to 72, wherein the processor is configured to execute the application and send setting value adjustment commands to the sensor assembly to adjust setting values for monitoring the one or more physiological parameters. [Embodiment 74] An electronic device described in any one of embodiments 70 to 73, wherein the processor is configured to wirelessly communicate with the sensor assembly via Bluetooth (trademark) protocol, Wi-Fi, ZigBee, Medical Implant Communication Service ("MICS"), Medical Device Radio Communication Service ("MedRadio"), or cellular. [Embodiment 75] The electronic device according to any one of embodiments 70 to 74, used in combination with the sensor assembly. [Embodiment 76] 1. A method for monitoring the outcome vasculature of a patient, the method comprising: sensing one or more physiological parameters of the vasculature with an implantable sensor assembly; and transmitting sensor data associated with the one or more physiological parameters to a remote location. [Embodiment Item 77] 77. The method of embodiment 76, further comprising the step of occluding the vascular structure with an anchor structure. [Embodiment 78] 78. The method of embodiment 77, further comprising the step of releasing a drug from the anchor structure to treat the vascular structure. [Embodiment 79] The method of any one of embodiments 76-78, further comprising the step of releasing a drug from the implantable sensor assembly to treat the vascular structure. [Embodiment 80] 80. The method of any one of embodiments 76-79, wherein the one or more physiological parameters include oxygen, carbon dioxide, potassium, iron, and / or glucose in the patient's blood.
[0182] [Embodiment 81] 80. The method of any one of embodiments 76 to 79, wherein the one or more physiological parameters include exercise information. [Embodiment 82] 82. The method of any one of embodiments 76 to 81, wherein the implantable sensor assembly includes a blood flow sensor, a blood pressure sensor, a metabolic sensor, a glucose sensor, or an oxygen sensor. [Embodiment 83] 83. The method of any one of embodiments 76 to 82, wherein said step of sensing one or more physiological parameters comprises the step of intermittently sensing said one or more physiological parameters. [Embodiment 84] The method of any one of embodiments 76 to 82, wherein said step of detecting one or more physiological parameters comprises the step of continuously detecting said one or more physiological parameters. [Embodiment 85] The method of any one of embodiments 76 to 84, further comprising the step of charging a power source of the sensor assembly. [Embodiment 86] 86. The method of any one of embodiments 76 to 85, wherein said vascular structure comprises a neurovascular structure. [Embodiment 87] 86. The method of any one of embodiments 76 to 85, wherein said vascular structure comprises a cardiovascular structure. [Embodiment Item 88] 86. The method of any one of embodiments 76 to 85, wherein the vascular structure is located within an aneurysm in the patient's posterior circulation. [Embodiment 89] 86. The method of any one of embodiments 76 to 85, wherein the vascular structure comprises a basilar artery aneurysm. [Embodiment Item 90] 86. The method of any one of embodiments 76 to 85, wherein the vascular structure comprises a bifurcated aneurysm. [Embodiment Item 91] 86. The method of any one of embodiments 76 to 85, wherein the vascular structure comprises a sidewall aneurysm. [Embodiment Item 92] 86. The method of any one of embodiments 76 to 85, wherein said vascular structure comprises the ductus arteriosus. [Embodiment Item 93] 86. The method of any one of embodiments 76 to 85, wherein the vascular structure includes a carotid artery. [Embodiment Item 94] 86. The method of any one of embodiments 76 to 85, wherein the vascular structure includes a venous structure. [Embodiment Item 95] The method of any one of embodiments 76 to 94, further comprising the step of delivering a flow diverter based on the sensor data. [Embodiment Item 96] The method of any one of embodiments 76 to 95, further comprising the step of delivering a coagulant based on the sensor data. [Embodiment Item 97] 1. A method of implanting a sensor system in a vasculature of a patient, the method comprising: advancing a delivery system carrying a sensor system to the vascular structure, the sensor system including a sensor assembly and an anchor structure; releasing the sensor assembly into the vasculature; and releasing the anchor structure into the vasculature. [Embodiment Item 98] The method of embodiment 97, further comprising the step of occluding the vascular structure with the anchor structure. [Embodiment Item 99] The method of any one of embodiments 97-98, further comprising the step of percutaneously introducing the delivery system. [Embodiment 100] The method of any one of paragraphs 97 to 99, further comprising the step of advancing the delivery system over and along a guidewire. [Embodiment 101] The method of any one of paragraphs 97-99, further comprising the step of advancing the delivery system into a guide catheter. [Embodiment 102] The method of any one of embodiments 97 to 101, further comprising the step of positioning the anchor structure around the sensor. [Embodiment 103] The method of any one of embodiments 97-101, further comprising the step of positioning the sensor within the anchor structure. [Embodiment 104] The method of any one of embodiments 97 to 101, further comprising the step of simultaneously releasing said sensor and said anchoring structure. [Embodiment 105] The method of any one of embodiments 97-104, further comprising detecting one or more physiological parameters within said vasculature. [Embodiment 106] The method of embodiment 105, further comprising the step of transmitting sensor data associated with the one or more physiological parameters to a remote location. [Embodiment 107] The method of any one of embodiments 97 to 106, further comprising the step of charging the sensor assembly. [Embodiment 108] The method of any one of embodiments 97 to 107, wherein the vascular structure comprises an aneurysm of an artery in the patient's posterior circulation. [Embodiment 109] 108. The method of any one of embodiments 97 to 107, wherein said vascular structure comprises a neurovascular structure. [Embodiment 110] 108. The method of any one of embodiments 97 to 107, wherein said vascular structure comprises a cardiovascular structure. [Embodiment 111] The method of any one of embodiments 97 to 107, wherein the vascular structure comprises a basilar artery aneurysm. [Embodiment 112] 108. The method of any one of embodiments 97 to 107, wherein the vascular structure comprises a bifurcated aneurysm. [Embodiment 113] The method of any one of embodiments 97 to 107, wherein the vascular structure comprises a sidewall aneurysm. [Embodiment 114] 108. The method according to any one of embodiments 97 to 107, wherein said vascular structure comprises the ductus arteriosus. [Embodiment 115] 1. A delivery system capable of delivering a sensor assembly into a patient's vasculature, the delivery system comprising: a shaft having a lumen; a deflectable distal tip capable of carrying the sensor assembly, the lumen extending through the deflectable distal tip; a handle, the handle comprising: a first user-operable mechanism that ejects the sensor assembly from the deflectable distal tip; and a second user-operable system for steering the deflectable distal tip. [Embodiment 116] The delivery system of embodiment 115, wherein the shaft has a guidewire lumen. [Embodiment Item 117] The delivery system of embodiment 115 or 116, wherein the second user-operable system mechanically controls steering of the deflectable distal tip. [Embodiment Item 118] The delivery system of embodiment 117, wherein the second user-operable mechanism electrically controls steering of the deflectable distal tip. [Embodiment 119] The delivery system according to any one of embodiments 115 to 118, further comprising a delivery sleeve fitted over the shaft. [Embodiment 120] The delivery system of embodiment 119, wherein the delivery sleeve enables steering of the deflectable distal tip.
[0183] [Embodiment Item 121] The delivery system of any one of embodiments 115 to 120, further comprising a fluid port for flushing said delivery system. [Embodiment 122] The delivery system of any one of embodiments 115 to 121, wherein the flexible shaft has a second lumen configured to enable steering of the deflectable distal tip. [Embodiment 123] A delivery system according to any one of embodiments 115 to 122, wherein the deflectable distal tip has a loading chamber separate from the lumen, the loading chamber carrying the sensor assembly. [Embodiment Item 124] The delivery system according to any one of paragraphs 115 to 123, wherein the shaft is made of a polymer material. [Embodiment Item 125] A delivery system according to any one of embodiments 115 to 124, wherein the handle further comprises a third user-operable mechanism for stabilizing the position of the deflectable distal tip. [Embodiment 126] 1. An implantable sensor system, comprising: a sensor assembly implantable within the aneurysm for measuring a physiological parameter; an anchor structure for maintaining the position of the sensor assembly within the aneurysm, the anchor structure being joined to the sensor assembly; An implantable sensor system including an antenna in electrical communication with the sensor assembly. [Embodiment Item 127] The implantable sensor system of embodiment 126, wherein the sensor assembly includes a glucose sensor. [Embodiment Item 128] The implantable sensor system of embodiment 126 or 127, wherein the sensor assembly includes a conductivity switch. [Embodiment 129] An implantable sensor system according to any one of embodiments 126 to 128, wherein the sensor assembly includes a processor that at least partially processes data collected by the sensor. [Embodiment 130] An implantable sensor system as described in embodiment 129, wherein the processor is hermetically sealed. [Embodiment Item 131] The implantable sensor system according to any one of embodiments 126 to 130, wherein the outer surface of the sensor assembly has peaks and valleys. [Embodiment 132] The implantable sensor system of any one of embodiments 126 to 131, further comprising a supercapacitor for powering the sensor assembly. [Embodiment 133] The implantable sensor system of embodiment 132, wherein the supercapacitor is bonded to the anchor structure. [Embodiment 134] The implantable sensor system of embodiment 133, wherein the anchor structure is positioned between the sensor assembly and the supercapacitor. [Embodiment 135] An implantable sensor system according to any one of embodiments 126 to 134, wherein the sensor assembly is positioned between the antenna and the anchor structure. [Embodiment 136] The implantable sensor system of any one of embodiments 126 to 135, wherein the anchor structure extends radially outward from the sensor assembly to contact the wall of the aneurysm. [Embodiment Item 137] 137. The implantable sensor system according to any one of embodiments 126 to 136, wherein the anchor structure has a plurality of loop-shaped anchor portions. [Embodiment Item 138] The implantable sensor system of embodiment 137, wherein the plurality of anchor portions are positioned circumferentially around the sensor assembly. [Embodiment 139] The implantable sensor system of embodiment 137 or 138, wherein each of the plurality of anchor portions includes an atraumatic end portion that contacts the wall of the aneurysm. [Embodiment Item 140] 140. The implantable sensor system according to any one of embodiments 126 to 139, wherein the anchor structure is coated with a drug. [Embodiment 141] An implantable sensor system according to any one of embodiments 126 to 141, wherein the sensor assembly includes a memory device for storing the sensor data. [Embodiment 142] 1. A delivery system for deploying a sensor system within a vasculature, the delivery system comprising: Including the handle, a delivery sheath extending distally from the handle portion; an inner shaft extending through the delivery sheath, the inner shaft having a shaft wall defining a lumen; A delivery system including a retention wire extending through the inner shaft, the retention wire configured to retain the sensor system within a space between an outer wall of the inner shaft and an inner wall of the delivery sheath. [Embodiment Item 143] The delivery system of embodiment 142, wherein the inner shaft has a plurality of openings in the shaft wall. [Embodiment Item 144] The delivery system of embodiment 143, wherein the plurality of openings are axially spaced apart along the shaft wall. [Embodiment Item 145] The delivery system of any one of embodiments 143 to 144, wherein each of the plurality of openings is rotationally aligned. [Embodiment 146] The delivery system of embodiment 143 or 144, wherein at least one of the plurality of openings is rotationally offset from another one of the plurality of openings. [Embodiment Item 147] The delivery system of any one of embodiments 142 to 146, wherein the retention wire forms one or more loop portions to hold the sensor system against the inner shaft. [Embodiment Item 148] A delivery system as described in embodiment 147, wherein the retention wire extends from a first opening in the shaft wall into the space between the inner shaft and the delivery sheath, and returns into the lumen of the inner shaft through a second opening in the shaft wall, thereby forming one of the one or more loop portions. [Embodiment Item 149] A delivery system as described in embodiment 147, wherein the retention wire extends from a first opening in the shaft wall into the space between the inner shaft and the delivery sheath, and returns through the first opening in the shaft wall into the lumen of the inner shaft, thereby forming one of the one or more loop portions. [Embodiment Item 150] The delivery system of any one of paragraphs 142 to 149, wherein the distal portion of the inner shaft is deflectable. [Embodiment Item 151] A delivery system according to any one of embodiments 142 to 150, wherein the distal portion of the inner shaft is steerable to deflect the distal portion of the inner shaft into the vasculature. [Embodiment Item 152] 1. A method of deploying a sensor system within an aneurysm, the method comprising: advancing a delivery system carrying a sensor system into a parent artery, the sensor system being carried by an inner shaft of the delivery system; unplugging the sensor system; The method includes deploying the sensor system within the aneurysm. [Embodiment Item 153] The method of embodiment 152, wherein the step of deploying the sensor system includes the step of withdrawing a retention wire to release the sensor system into the aneurysm. [Embodiment Item 154] The method of embodiment 153, wherein the retention wire is released from the anchor structure of the sensor system by pulling out the retention wire. [Embodiment Item 155] A method according to any one of embodiments 152 to 154, wherein deploying the sensor system causes an anchor structure of the sensor system to expand and stabilize the position of the sensor system within the aneurysm. [Embodiment Item 156] The method of any one of embodiments 152 to 155, wherein the sensor system is deployed within the aneurysm such that the sensor of the sensor system is positioned away from the wall of the aneurysm. [Embodiment Item 157] The method of any one of embodiments 152 to 156, further comprising the step of deploying a treatment device within the aneurysm after deploying the sensor system within the aneurysm. [Embodiment Item 158] The method of any one of embodiments 152 to 157, wherein the step of deploying the treatment device includes deploying the treatment device around the sensor. [Embodiment Item 159] A method according to any one of embodiments 152 to 158, wherein the step of deploying the sensor system includes a step of releasing the communication circuitry of the sensor system into the aneurysm before releasing the anchor structure of the sensor system. [Embodiment 160] The method of any one of embodiments 152 to 159, further comprising steering the distal tip of the inner shaft into the aneurysm before deploying the sensor system within the aneurysm. [Embodiment Item 161] The method of any one of embodiments 152 to 159, further comprising the step of positioning the sensor system against the neck of the aneurysm before deploying the sensor system within the aneurysm.
[0184] All documents cited in this specification, including patent and non-patent documents, are incorporated by reference in their entirety as if each were individually incorporated herein.
[0185] It is to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting of the invention. Further, unless otherwise specified, it is to be understood that the terms used herein are to be given their traditional meanings as known in the relevant art.
[0186] Throughout this specification, the references to "one embodiment" or "an embodiment" and variations thereof mean that a particular feature, structure, or characteristic described in connection with the embodiments is included in at least one embodiment. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification do not necessarily all refer to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
[0187] As used in the original specification and claims, the singular forms "a," "an," and "the" include the plural, i.e., one or more, unless expressly stated otherwise. It should also be noted that the conjunctions "and" and "or" are generally employed broadly to include "and / or" unless the text expressly indicates otherwise, as the case may be, inclusive or exclusive. Thus, the use of alternative language (e.g., "or") should be understood to mean either one, both, or any combination thereof. Additionally, when "and / or" is used herein, the "and" and "or" construction is intended to include embodiments including all of the associated items or ideas, as well as one or more other alternative embodiments that include fewer than all of the associated items or ideas.
[0188] Unless the context requires otherwise, throughout the specification and the claims that follow, the term "comprise" (often translated as "having") and its synonyms and variants, such as "have" (often translated as "having" or "comprising") and "include," as well as "comprises" and "comprising," are to be construed in an open-ended, inclusive sense, e.g., "including, but not limited to." The expression "consisting essentially of" limits the claim to the specified materials or steps or to materials or steps that do not significantly affect the basic and novel characteristics of the claimed invention.
[0189] The headings used herein are merely utilized to facilitate the reader's consideration and should not be construed as limiting the scope or meaning of the present disclosure, the present invention, or the claimed invention in any way. Thus, the headings and "abstract" provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.
[0190] Where a range of values is described herein, it is understood that, unless expressly stated otherwise, each value between the upper and lower limits of that range, down to one-tenth of the unit of the lower limit, and any other stated or intervening value within that stated range, is encompassed within this disclosure, the invention, or claims. The upper and lower limits of any narrower range that may be independently included in a narrower range are also encompassed within this disclosure, subject to any specifically excluded limit in that stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also encompassed within this disclosure.
[0191] For example, any concentration range, percentage range, ratio range, or integer range described herein should be understood to include any integer value within the described range and fractions thereof, where applicable (e.g., 1 / 10 and 1 / 100 of an integer), unless otherwise specified. Also, any numerical range described herein for a physical characteristic, such as a polymer subunit, dimension, or thickness, should be understood to include any integer within the described range, unless otherwise specified. As used herein, "about" means ±20% of the indicated range, value, or structure, unless otherwise specified.
[0192] All U.S. patents, U.S. patent application publications, U.S. patent applications, foreign patents, foreign patent applications, and non-patent literature referenced herein and / or listed in the Application Data Sheet are hereby incorporated by reference and incorporated herein in their entireties. Such patent and non-patent literature is incorporated by reference and incorporated herein in its entirety for the purpose of describing and disclosing, for example, the materials and methodology described therein that may be used in connection with the present disclosure. The publications listed above and throughout this text are provided solely for their disclosure prior to the filing date of the present application. Nothing herein should be construed as an admission that the inventors have no antedate right by virtue of prior filing to any publication cited as a reference.
[0193] All patent documents, publications, scientific articles, websites, and other documents and articles cited or referred to herein represent the common general knowledge of those skilled in the art to which this invention pertains, and each such cited document and article is hereby incorporated by reference to the same extent as if it were individually or entirely set forth. Applicant reserves the right to physically incorporate into this specification any and all articles and information from any such patent documents, publications, scientific articles, websites, electronically available information, and other researched articles or documents.
[0194] In general, in the following claims, the terms used should not be construed to limit the claim content to the specific embodiments disclosed in the specification and claims, but should be construed to include all possible embodiments of such claim content, along with all equivalents thereof. Accordingly, the scope of the claimed invention is not limited by the disclosure.
[0195] Furthermore, the written portion of this application includes all claims. Moreover, all claims, including all original claims and any and all claims from any priority document, are incorporated by reference in their entirety and made part of the written portion of this specification, and Applicant reserves the right to physically incorporate any and all such claims into the written portion of this application or any other portion. Thus, for example, in no event will a patent be construed as failing to provide written portion for a claim based upon an allegation that the precise terms of the claim are not recited in those words in the written portion of the patent.
[0196] The content of the claims will be interpreted in accordance with law. However, and notwithstanding any alleged or perceived ease or difficulty in interpreting any claim or any portion thereof, in no event shall any adjustment or amendment of a claim or any portion thereof during the prosecution of this application or applications resulting in a patent be construed as forfeiting any and all equivalents thereof that do not form part of the prior art. Other non-limiting embodiments are within the scope of the following claims. The patent shall not be construed as limited to the particular examples or non-limiting embodiments or methods specifically and / or explicitly disclosed herein. In no event shall the patent be construed as limited by any statement made by any examiner or any other officer or employee of the Patent and Trademark Office, provided that such statement is specific and, without qualification or reservation, is not expressly adopted in the applicant's reply brief.
Claims
1. 1. An implantable sensor system, comprising: an implantable sensor in the aneurysm, the sensor capable of sensing one or more physiological parameters of the patient to generate sensor data; an antenna in electrical communication with the sensor, the antenna capable of transmitting the sensor data associated with the one or more physiological parameters of the patient to a receiver; An implantable sensor system including an anchor structure that maintains the position of the sensor in the aneurysm.
2. The implantable sensor system of claim 1 , wherein the anchor structure is separate from the sensor, and the anchor structure contacts the sensor when implanted.
3. The implantable sensor system of claim 1 , wherein the anchor structure is directly or indirectly coupled to the sensor and / or the antenna.
4. The implantable sensor system of claim 1 , wherein the antenna transmits the sensor data continuously.
5. The implantable sensor system of claim 1 , wherein the antenna transmits sensor data intermittently.
6. The implantable sensor system of claim 1 , wherein the sensor senses the one or more physiological parameters continuously.
7. The implantable sensor system of claim 1 , wherein the sensor senses the one or more physiological parameters intermittently.
8. The implantable sensor system of claim 1 , wherein the sensor generates the sensor data based on analyte materials, analyte components, and / or by-products resulting from certain cellular or blood interactions or exchanges in blood.
9. The implantable sensor system of claim 1 , wherein the sensor comprises a blood flow sensor, a blood pressure sensor, a metabolic sensor, a glucose sensor, or an oxygen sensor.
10. The implantable sensor system of claim 1 , wherein the one or more physiological parameters include oxygen, carbon dioxide, potassium, iron, and / or glucose in the patient's blood.
11. The implantable sensor system of claim 1 , wherein the sensor is a pressure sensor.
12. The implantable sensor system of claim 1 , wherein the one or more physiological parameters include motion information.
13. The implantable sensor system of claim 1 , further comprising a radiopaque marker for locating a position of the implantable sensor system within the patient's body.
14. The implantable sensor system of claim 1 , wherein the anchor structure has a body portion fused to the sensor.
15. The implantable sensor system of claim 14 , wherein the one or more physiological parameters are indicative of blood flow into the aneurysm.
16. The implantable sensor system of claim 14 , wherein the one or more physiological parameters are indicative of blood flow from the aneurysm.
17. The implantable sensor system of claim 1 , wherein the antenna transmits and receives RF signals.
18. The implantable sensor system of claim 1 , wherein the anchor structure comprises one or more coils.
19. The implantable sensor system of claim 1 , wherein the anchor structure comprises a mesh or woven structure.
20. The implantable sensor system of claim 1 , wherein the anchor structure comprises a basket.
21. The implantable sensor system of claim 1 , wherein the anchor structure is capable of occluding blood flow through the vasculature.
22. The implantable sensor system of claim 1 , further comprising a drug coating.
23. The implantable sensor system of claim 22 , wherein the anchor structure carries the agent.
24. The implantable sensor system of claim 22 , wherein the agent is a coagulant.
25. The implantable sensor system of claim 1 , further comprising a power source for providing power to the sensor.
26. 26. The implantable sensor system of claim 25, wherein the power source is rechargeable.
27. The implantable sensor system of claim 1 , wherein the sensor is powerable by a power source located external to the patient.
28. 30. The implantable sensor system of claim 29, wherein the sensor is an inductive sensor.
29. The implantable sensor system of claim 1 , further comprising a supercapacitor for powering the sensor.
30. The implantable sensor system of claim 1 , further comprising a memory device for storing the sensor data.
31. The implantable sensor system of claim 1 , further comprising a second sensor capable of sensing a different physiological parameter than that of the first sensor.
32. A kit comprising: The implantable sensor system of claim 1 ; and one or more delivery systems capable of releasing the implantable sensor system into a vascular structure.
33. 1. An implantable sensor system, comprising: a sensor assembly implantable within the aneurysm for measuring a physiological parameter; an anchor structure for maintaining a position of the sensor assembly within the aneurysm, the anchor structure being joined to the sensor assembly; An implantable sensor system including an antenna in electrical communication with the sensor assembly.
34. 34. The implantable sensor system of claim 33, wherein the sensor assembly includes a glucose sensor.
35. 34. The implantable sensor system of claim 33, wherein the sensor assembly includes a conductivity switch.
36. 34. The implantable sensor system of claim 33, wherein the sensor assembly includes a processor that at least partially processes data collected by the sensor.
37. 37. The implantable sensor system of claim 36, wherein the processor is hermetically sealed.
38. 34. The implantable sensor system of claim 33, wherein an outer surface of the sensor assembly has peaks and valleys.
39. 34. The implantable sensor system of claim 33, further comprising a supercapacitor for powering the sensor assembly.
40. 40. The implantable sensor system of claim 39, wherein the supercapacitor is bonded to the anchor structure.
41. 40. The implantable sensor system of claim 39, wherein the anchor structure is positioned between the sensor assembly and the supercapacitor.
42. The implantable sensor system of claim 33 , wherein the sensor assembly is positioned between the antenna and the anchor structure.
43. 34. The implantable sensor system of claim 33, wherein the anchor structure extends radially outward from the sensor assembly to contact a wall of the aneurysm.
44. 34. The implantable sensor system of claim 33, wherein the anchor structure comprises a plurality of loop-shaped anchor portions.
45. 45. The implantable sensor system of claim 44, wherein the plurality of anchor portions are circumferentially positioned about the sensor assembly.
46. 45. The implantable sensor system of claim 44, wherein each of the plurality of anchor portions includes an atraumatic end portion that contacts a wall of the aneurysm.
47. 34. The implantable sensor system of claim 33, wherein the anchor structure is coated with a drug.
48. 34. The implantable sensor system of claim 33, wherein the sensor assembly includes a memory device that stores the sensor data.
