Tumor access devices with integrated sensors

Abstract

Tumor access devices with integrated sensors are described. An example device includes a reservoir element defining a reservoir therein and an elongate shaft defining a lumen. The elongate shaft extends between a proximal opening at a proximal end portion of the elongate shaft and a distal end portion of the elongate shaft, and the lumen is in fluid communication with the reservoir via the proximal opening. The distal end portion of the sidewall includes a distal opening. One or more sensors disposed at the distal end portion of the elongate shaft, and one or more leads are coupled to the sensor(s) and extending between the reservoir and the sensors. An electronics assembly is coupled to the leads and configured to obtain sensor data.

Description

TUMOR ACCESS DEVICES WITH INTEGRATED SENSORSCROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] The present application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 677,743, filed July 31, 2024, which is incorporated by reference herein in its entirety.TECHNICAL FIELD

[0002] The present technology relates to implantable devices for accessing and monitoring tumors.BACKGROUND

[0003] Glioblastoma multiforme (GBM) is an aggressive form of brain cancer with a five-year survival rate of less than 5%. For several decades, few advancements have been made in the treatment of this condition, in large part due to the difficulties in assessing treatment efficacy and progression of the disease. Current imaging modalities are unable to distinguish tumor growth from treatment effects, such as pseudo-progression. The most effective way to assess a tumor is through direct tissue biopsy, but this is typically done only once in each patient due to the invasiveness of the procedure. As a result, temporal data on GBM progression is extremely limited, making it difficult to develop novel therapies to treat the condition.

[0004] Presently, methods such as liquid biopsy and MR spectroscopy have been investigated as minimally invasive ways to measure biomarkers associated with tumor growth as a means to assess disease progression. However, these methods also come with significant limitations. The blood brain barrier heavily restricts material passing through, meaning that any biomarkers indicative of GBM progression would be significantly diluted in the bloodstream. As a result, these methods risk failing to detect GBM progression or distorting the data they are able to collect.

[0005] Accordingly, there is a need for a reliable and accurate method for monitoring GBM progression and tracking various associated biomarkers to improve understanding of GBM and to develop more effective therapies.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on illustrating clearly the principles of the present disclosure.

[0007] FIG. 1 A is a block diagram of an example monitoring system in accordance with aspects of the present technology.

[0008] FIG. IB is a schematic diagram of a patient utilizing the monitoring system shown in FIG. 1 A.

[0009] FIG. 2A is a side view of an example implantable monitoring device in accordance with aspects of the present technology.

[0010] FIG. 2B is an enlarged detail view of a distal portion of the implantable monitoring device shown in FIG. 2A.

[0011] FIG. 2C is a cross-sectional view of the distal portion of the implantable monitoring device shown in FIG. 2B.

[0012] FIG. 2D is an exploded view of the implantable monitoring device shown in FIGS. 2A-2C.

[0013] FIGS. 3 and 4 are flowcharts of example methods of using an implantable monitoring device in accordance with aspects of the present technology.DETAILED DESCRIPTIONI. Overview

[0014] The present technology relates to implantable medical devices for accessing a target site within a patient's body and / or monitoring biomarkers of the target site. Some embodiments of the present technology, for example, are directed to implantable devices for accessing and monitoring tumors, specifically glioblastomas. Specific details of several embodiments of the technology are described below with reference to FIGS. 1 A-4.

[0015] Targeted therapies are becoming increasingly widespread in the field of cancer treatment due to their increased efficacy and safety over prior methods. However, different types of cancers have distinct characteristics, making it difficult to apply treatment methods successful in one type of cancer to another. Tumor prognosis can also vary between different patients afflicted by the same cancer. Accordingly, the study of unique tumor characteristicsand microenvironments is vital to the development of targeted therapies that will be effective for unique forms of cancer and patients.

[0016] Some forms of cancer, glioblastoma multiforme (GME) in particular, are difficult to characterize. The location of GME within the brain makes it difficult to access the tumor consistently in order to obtain sufficient data to better understand the prognosis of GME, and to allow clinicians to develop effective treatment plans for patients. Moreover liquid biopsy approaches may not be able to detect or characterize GME, since cancer cells, DNA, proteins, or exomes from the GME may not pass the blood-brain barrier to be detected in circulating blood. Various examples of the present technology enable the monitoring, assessment, and / or treatment of GME and other conditions.

[0017] As described in more detail below, some aspects of the present technology relate to implantable monitoring devices and related systems and methods. In various implementations, an implantable monitoring device can include an elongate access shaft coupled to a reservoir, with the device configured for the access shaft to be inserted into a patient’s body (e.g., through a burr hole in the patient’s skull) and a distal end thereof advanced to a target site. The reservoir, which can be coupled to a proximal end portion of the access shaft, may be positioned at or above the patient’s skin, thereby enabling clinician access without requiring removal of the monitoring device. Optionally, the access shaft of the monitoring device can include one or more inlet openings configured to receive biological material (e.g., cells, fluid, etc.) therethrough, which may move through the access shaft and into the reservoir. Optionally, this movement can be facilitated by the presence of a nanofiber film or other structure that promotes migration of cells along the access shaft toward the reservoir. In the example case of a tumor at a target site in the brain, the implantable monitoring device can be inserted into the patient’s body such that the access shaft extends into the brain with a distal portion contacting or penetrating the tumor. Tumor cells can enter into the shaft lumen via the inlet holes, after which the cells migrate towards the reservoir along a nanofiber film disposed within the lumen. A clinician may sample the collected cells via the reservoir for analysis (e.g., either removing a lid to the reservoir or using a needle or other sampling device to collect cells through the reservoir lid).

[0018] In various implementations, the monitoring device can include one or more sensors configured to obtain sensor data indicative of one or more physiological parameters at the target site. The sensor(s) can be positioned at any suitable location along the device, such as at a distal end portion (e.g., adjacent the inlet hole(s)), along an intermediate portion of theaccess shaft, and / or at a proximal portion in or adjacent to the reservoir. The sensor(s) can be configured to obtain sensor data along an exterior surface of the access shaft, an interior surface of the access shaft (e.g., in contact with the lumen), or at any other suitable location within the access shaft. Among examples, the sensors can be configured to measure characteristics of the target site (e.g., temperature, fluid pressure, pH, etc.). Additionally or alternatively, the sensors can be configured to detect the presence of various biomarkers (e.g., particular cell types, target molecules, etc.). In some instances, the sensor data can be indicative of the presence of, or characteristic of the development of, a tumor or other diseased tissue at the target site. The sensor data may be collected via the monitoring device continuously, periodically, according to a predetermined schedule, in response to user inputs, or in any other suitable fashion.

[0019] The monitoring device can additionally include integrated electronics configured to facilitate collection, transmission, and / or analysis of the sensor data. In some implementations, the sensor data can be collected and stored via the implantable monitoring device, and then transmitted to one or more external monitoring devices for storage and / or analysis. Such transmission can occur via a wired or wireless connection. The external monitoring device(s) may take the form of local devices (e.g., a portable computing device such as a smartphone, tablet, or laptop, or any other suitable computing device that can communicate with the implantable monitoring device over a local data connection (e.g., Bluetooth, NFC, local area network, etc.)). In some instances, the external monitoring device(s) can include remote devices (e.g., computing devices that can communicate with the implantable monitoring device over a wide area network connection, such as servers associated with a healthcare provider, medical analytics provider, insurance company, or any other suitable entity). The collected sensor data can be analyzed via any one or more suitable external monitoring devices. Analysis of the sensor data may indicate, for instance, whether a particular pathology is present, the development or progression of a particular pathology, whether a particular pathology is responding to interventions (e.g., medication or radiation), or any other suitable parameter.II. Example Monitoring Systems and DevicesA. Monitoring System Overview

[0020] The following discussion provides a brief, general description of a suitable environment in which the present technology may be implemented. Although not required, aspects of the technology are described in the general context of computer-executableinstructions, such as routines executed by a general -purpose computer. Aspects of the technology can be embodied in a special purpose computer or data processor that is specifically programmed, configured, or constructed to perform one or more of the computer-executable instructions explained in detail herein. Aspects of the technology can also be practiced in distributed computing environments where tasks or modules are performed by remote processing devices, which are linked through a communication network (e.g., a wireless communication network, a wired communication network, a cellular communication network, the Internet, a short-range radio network (e.g., via Bluetooth)). In a distributed computing environment, program modules may be located in both local and remote memory storage devices.

[0021] Computer-implemented instructions, data structures, screen displays, and other data under aspects of the technology may be stored or distributed on computer-readable storage media, including magnetically or optically readable computer disks, as microcode on semiconductor memory, nanotechnology memory, organic or optical memory, or other portable and / or non-transitory data storage media. In some embodiments, aspects of the technology may be distributed over the Internet or over other networks (e.g. a Bluetooth network) on a propagated signal on a propagation medium (e.g., an electromagnetic wave(s), a sound wave) over a period of time, or may be provided on any analog or digital network (packet switched, circuit switched, or other scheme).

[0022] FIG. 1A is a schematic diagram of monitoring system 100 configured in accordance with an embodiment of the disclosed technology. Although the system 100 is shown with certain devices for purposes of explanation, in various examples any one or more of the devices shown in FIG. 1 A can be omitted. Similarly, although the devices shown in FIG. 1 A are illustrated as including certain components, in various examples any one or more of the particular components within these devices can be omitted (e.g., the monitoring device 110 may omit the reservoir 113, the nanofiber structure 117, etc.). Moreover, any of the devices can include additional components not specifically shown herein.

[0023] In the illustrated embodiment, the monitoring device 110 comprises an elongate access shaft 111, a reservoir 113 coupled to the access shaft 111, one or more sensors 115, a nanofiber structure 117 coupled to the access shaft 111, and an electronics assembly 120. The electronics assembly 120 can include a power source 119, a communications link 121, a controller 123, and a memory 125. The monitoring device 110 is configured to be coupled to a patient (e.g., implanted at least partially within a patient’s body) for monitoring physiologicalcharacteristics at a target site. In some instances, the monitoring device 110 also facilitates extraction of tissue or cells from the target site for analysis.

[0024] The sensor(s) 115 can include a number of different sensors and / or types of sensors. For example, the sensors 115 can include any one or more of electrodes, biosensors, optical sensors, pH sensors, accelerometers, pressure sensors, temperature sensors, hygrometers, altimeters, gyroscopes, magnetometers, hall effect sensors, or any other suitable sensor(s) for monitoring physiological characteristics of the target site. These particular sensors are exemplary, and in various embodiments the sensors employed can vary. In some embodiments, the monitoring device 110 omits the sensors 115 altogether.

[0025] The sensors 115 may be configured to track a variety of biomarkers, chemical compounds, and features of the tumor microenvironment. In some embodiments, these markers may be indicative of tumor growth, shrinkage, and / or response to a therapeutic agent or other treatment (e.g., radiation therapy, ablation therapy, etc.). In some embodiments, the sensors 115 comprise electrodes that include an electrically conductive material such as a metal, metal alloy, conductive polymer, etc. In one example, the electrodes can be made of platinum, optionally with an additional coating such as iridium oxide. In some embodiments, the sensors are configured to facilitate ultrasound, and / or optical imaging.

[0026] In some embodiments, the sensors 115 include a coating of enzymes, antibodies, and / or other bioactive agents, such that the sensors 115 are configured to detect certain target cells, molecules, chemical compositions, etc. For instance, in various examples, the sensors 115 are configured to detect glucose, lactate, metal ions, and / or other molecules. In some embodiments, the sensors 115 are configured to detect interleukins (IL), tumor necrosis factor (TNF-a), interferons (IFNs), immunoglobulins (Ig), other cytokines, and / or other immunological biomarkers. In some implementations, a substance (e.g., contrast agent, dye, enzyme, tagged antibody and / or antibody fragment, etc.) may be delivered to the target site to assist with detection of target cells, molecules, compositions, and / or other biomarkers via the sensors 115.

[0027] In some embodiments, the power source 119 can be rechargeable, for example using inductive charging or other wireless charging techniques, by using energy harvesting techniques, or other suitable approaches. Such rechargeability can facilitate long-term placement of the monitoring device 110 on or within a patient.

[0028] In various embodiments, the memory 125 can take the form of one or more computer readable storage modules configured to store information (e.g., signal data, subject information or profiles, environmental data, treatment regimes, data collected from one or more sensing components, media files) and / or executable instructions that can be executed by the controller 123. The memory 125 can include, for example, instructions for causing the sensors 115 to be activated, collecting and / or analyzing sensor data to evaluate the patient’s health status, etc. In some embodiments, the memory 125 stores data (e.g., sensor data acquired from the sensor(s) 115) used in the analysis techniques disclosed herein.

[0029] The communications link 121 enables the monitoring device 110 to transmit to and / or receive data from external devices (e.g., external device 150 or external computing devices 180). The communications link 121 can include transceiver such as a wired communication link and / or a wireless communication link (e.g., Bluetooth, Near-Field Communications, LTE, 5G, Wi-Fi, infrared and / or another wireless radio transmission network). Additionally or alternatively, the communications link 121 can facilitate wired connection to the external device 150 (e.g., via USB cable or other suitable connection).

[0030] The controller 123 can include, for example, a suitable processor or central processing unit (“CPU”) that controls operation of the monitoring device 110 in accordance with computer-readable instructions stored on the memory 125. The controller 123 may be any logic processing unit, such as one or more CPUs, digital signal processors (DSPs), applicationspecific integrated circuits (ASICs), etc. The controller 123 may be a single processing unit or multiple processing units in a device or distributed across multiple devices. The controller 123 is connected to the memory 125 and may be coupled to other hardware devices, for example, with the use of a bus (e.g., a PCI Express or Serial ATA bus). The memory 125 can include read-only memory (ROM) and random access memory (RAM) or other storage devices, such as disk drives or SSDs, that store the executable applications, test software, databases and other software required to, for example, implement the various routines described herein, control device components, communicate and exchange data and information with remote computers and other devices, etc.

[0031] The controller 123 can also include drive circuitry configured to control operation of the sensor(s) 115 of the monitoring device 110. For example, the drive circuitry can be configured to deliver waveforms having predetermined and controllable parameters to the sensor(s) 115, for instance to initiate data collection via one or more sensor(s) 115. Forexample, the sensor(s) 115 of the monitoring device 110 can be prompted to detect physiological data from the target site (e.g., temperature, pH, biomarker detection, etc.).

[0032] The monitoring device 110 can be communicatively coupled to an external device 150, for example, via a wireless connection. In some embodiments, the external device 150 can be a mobile device (e.g., a smartphone, tablet, smartwatch, etc.) or other computing device with which the patient, clinician, or other user can interact. In operation, the monitoring device 110 may receive input from and / or can be controlled by instructions from the external device 150. For example, the external device 150 can cause the monitoring device 110 to initiate or cease data collection via the sensors 115, and / or provide other control instructions to the monitoring device 110. Additionally or alternatively, the external device 150 may output user prompts which can be synchronized with data collection via the monitoring device 110. For example, the external device 150 may instruct the patient to perform certain actions (e.g., cognitive assessment tasks), and the monitoring device 110 may record physiological data (e.g., via sensors 115) while the patient performs the requested actions. Moreover, the external device 150 may itself analyze the patient (e.g., the patient’s activity or condition in response to such prompts), for example using a camera to detect eye movement or facial expression, using a microphone to detect speech patterns, or to detect any other indicia of health conditions. In some embodiments, such indicia can be compared against baseline inputs (e.g., a stored baseline facial image or voice print with baseline speech recording).

[0033] The monitoring device 110 and / or the external device 150 can also be communicatively coupled with one or more external computing devices 180 (e.g., over network 170). In some examples, the external computing devices 180 can take the form of servers, personal computers, tablet computers or other computing devices associated with one or more healthcare providers (e.g., hospitals, medical data analytics companies, device manufacturers, etc.). These external computing devices 180 can collect data recorded by the monitoring device 110 and / or the external device 150. In some embodiments, such data can be anonymized and aggregated to perform large-scale analysis (e.g., using machine-learning techniques or other suitable data analysis techniques) to develop and improve treatments using data collected by a large number of monitoring devices 110. Additionally, the external computing devices 180 may transmit data to the external device 150 and / or the monitoring device 110. For example, an updated protocol for treating one or more health conditions may be developed by the external computing devices 180 (e.g., using machine learning or other techniques) and thenprovided to the monitoring device 110 and / or the external device 150 via the network (e.g., as an over-the-air update), and installed on the monitoring device 110 and / or external device 150.

[0034] In some embodiments, the system 100 can also include additional devices, for example implantable neuromodulation devices, ventricular drainage catheters, cardiac monitors, an implantable pacemaker, an implantable cardiac defibrillator, a cardiac resynchronization therapy (CRT) device (e.g., CRT-D defibrillator or CRT-P pacemaker), a neurostimulator, a deep-brain stimulation device, a nerve stimulator, a drug pump (e.g., an insulin pump), a glucose monitor, a fitness monitor, a nutrition device, etc. Such additional devices may be communicatively coupled to the monitoring device 110, external device 150, and / or the external computing devices 180.

[0035] In some implementations, the monitoring device 110 is configured to calculate physiological characteristics relating to one or more signals received from the sensors 115. For example, the monitoring device 110 may be configured to algorithmically determine the presence or absence of a pathological condition such as a malignant tumor, to assess the progression or recession of a tumor, or other such determination. In certain embodiments, the monitoring device 110 initiates transmission of data signals in response to sensor data (e.g., upon detecting certain pH levels or other such parameter). In some embodiments, the sensing performed via the sensors 115 can be modified in response to event detection, for example with an increased sampling rate or other modification.

[0036] As noted above, in some embodiments, the monitoring device 110 may also communicate with an external device 150. The external device 150 can be, for example, a smartwatch, smartphone, laptop, tablet, desktop PC, or any other suitable computing device and can include one or more features, applications and / or other elements commonly found in such devices. For example, the external device 150 can include display 151, a communications link 153 (e.g., a wireless transceiver that may include one or more antennas for wirelessly communicating with, for example, other devices, websites, and the monitoring device 110). Communication between the external device 150 and other devices can be performed via, e.g., a network 170 (which can include the Internet, public and private intranet, a local or extended Wi-Fi network, cell towers, the plain old telephone system (POTS), etc.), direct wireless communication, etc. The external device 150 can additionally include well-known input components 155 and output components 157, including, for example, a touch screen, a keypad, speakers, a camera, etc.

[0037] In operation, a patient or clinician may receive output or instructions from the external device 150 that are based at least in part on data received at the external device 150 from the monitoring device 110. For example, the monitoring device 110 may generate an alert based on analysis of data collected via sensors 115. The monitoring device 110 may then instruct the external device 150 to output an alert to the user (e.g., via display 151 and / or output 157) or another entity. In some embodiments, the alert can both be displayed to the user (e.g., via display 151 of the external device) and can also be transmitted to an appropriate emergency medical response service (e.g., a 9-1-1 call may be placed with location data from the external device 150 used to direct responders to locate the user), and / or to other healthcare provider entities or individuals (e.g. a hospital, emergency room, or physician). In some embodiments, embedded circuitry that provides location data (e.g., a GPS unit) can be included within the electronics assembly 120 of the monitoring device 110.

[0038] As noted previously, the external computing device(s) 180 can take the form of servers or other computing devices associated with healthcare providers or other entities. The external devices can include a communications link 181 (e.g., components to facilitate wired or wireless communication with other devices either directly or via the network 170), a memory 183, and processing circuitry 185. These external computing devices 180 can collect data recorded by the monitoring device 110 and / or the external device 150. In some embodiments, such data can be anonymized and aggregated to perform large-scale analysis (e.g., using machine-learning techniques or other suitable data analysis techniques) to develop and improve treatment regimens using data collected by a large number of monitoring devices 110 associated with a large population of patients. Additionally, the external computing devices 180 may transmit data to the external device 150 and / or the monitoring device 110. For example, an updated sensing or analysis algorithm for evaluating conditions may be developed by the external computing devices 180 (e.g., using machine learning or other techniques) and then provided to the monitoring device 110 and / or the external device 150 via the network 170, and installed on the recipient monitoring device 110 or the external device 150.

[0039] FIG. IB illustrates an example implementation in which the system 100 shown in FIG. 1 A is used to monitor a target site within the brain of a patient 190. As illustrated in FIG. IB, the implantable monitoring device 110 is disposed such that the reservoir 113 sits over the skull of the patient 190. The access shaft 111 extends into the skull (e.g., through a burr hole) such that a distal end portion of the access shaft 111 penetrates a tumor at a target site 192. One or more sensors 115 carried by or integrated within the monitoring device 110 can detectphysiological parameters at the target site 192 (e.g., characterizing the tumor and / or the surrounding microenvironment). This sensor data can be transmitted (e.g., using electronics assembly 120 as described above) to a local external device 150 (e.g., a user’s smartphone or other suitable computing device) and / or to one or more remote external computing devices 180 (e.g., computing devices associated with a clinician, hospital, medical data analytics providers, etc.) In the case of a local external device 150, such communication with the implantable monitoring device 110 can be direct wired or wireless communication, or can be carried out via a network 170 (e.g., a local area network, wide area network, etc.).

[0040] While the specific configuration illustrated in FIG. IB relates to use to monitor a target site 192 within a patient’s brain, in various implementations the monitoring device 110 can be configured for use in other locations, and may be implanted within or disposed over a patient’s body at various other locations. For example, the monitoring device 110 may be implanted at any site within a patient's body, and the sensor(s) 115 may be configured to detect any suitable biomarker, chemical compound, or environmental feature within or adjacent to the target site.B. Example Monitoring Devices

[0041] FIG. 2A shows a side schematic view of an embodiment of an implantable monitoring device 110. FIG. 2B shows an enlarged detail view of a distal portion of the monitoring device 110, FIG. 2C shows a cross-sectional view of the distal portion of the monitoring device 110, and FIG. 2D shows an exploded side view of the monitoring device 110. With reference to FIGS. 2A-2D together, the device 110 generally comprises an elongate access shaft 111 defining an internal lumen 116 extending between a proximal end portion I l la and a distal end portion 111b of the access shaft 111. In various implementations, the access shaft 111 can take the form of a tubular member such as a catheter, hypotube, etc., and can be formed of or coated with a biocompatible material suitable for long-term implantation within a patient’s body. The distal end portion 111b of the access shaft 111 can optionally terminate in a closed, atraumatic distal tip (e.g., a rounded tip). In other implementations, the distal tip can be open or assume other shapes or configurations.

[0042] The monitoring device 110 can additionally include a reservoir 113 mounted on the proximal end portion 11 la of the access shaft 111. A removable cap 108 can be disposed over the reservoir 113. The reservoir 113 and the cap 108 can define an internal volume in which at least a portion of the electronics assembly 120 is disposed. In some embodiments, theelectronics assembly 120 may comprise a hollow disk, annulus, or "donut" shape to enable extracorporeal access of the access shaft 111 from the cap 108 when the device 110 is implanted within a patient 190. As noted previously, the electronics assembly 120 can include a power component (e.g., battery), a communications link component (e.g., a wireless transceiver), a controller (e.g., a microprocessor or other suitable circuitry), and / or a memory component configured to storage data thereon. The electronics assembly 120 can be in electrical communication with one or more sensors 115 coupled to or carried by the monitoring device 110.

[0043] One or more inlet openings 106 can be disposed at the distal end portion 11 lb of the access shaft 111. These inlet opening(s) 106 can be configured to permit fluid or tissue from the target site to enter into the lumen 116 for movement toward to the reservoir 113. Optionally, as shown in FIG. 2D, the device 110 includes a nanofiber structure 117 extending within the lumen 116 of the access shaft 111. The nanofiber structure 117 can be configured to promote migration of tumor cells and / or other bioactive agents away from the target site and towards the reservoir 113 at the proximal end of the device. The nanofiber structure 117 can extend along the length of the access shaft 111 and may assume a U-shaped according to some embodiments. Further embodiments and configurations of the nanofiber structure 117 and other aspects of an implantable tumor access device are described in detail in U.S. Patent 10,493,233, which is incorporated herein by reference in its entirety. The sensors 115 and other aspects described herein can be combined with any feature or combination of features of the tumor access devices described in U.S. Patent No. 10,492,233. Promoting migration of bioactive agents from the target site to the extracorporeal portion of the device 110 may enable clinicians to perform regular tumor biopsies without the need for repeated invasive surgical procedures.

[0044] In some embodiments, the cap 108 is removably attached to the proximal portion 11 la of the device 110. In some embodiments, removing the cap 108 may allow a user to access the internal components of the device 110. The cap 108 may be configured to allow a user to extract tumor cells and / or other materials collected by the device 110. In some embodiments, the cap 108 comprises a silicone cover. In some embodiments, the cap 108 may comprise a diameter of at least about 10 mm, 15 mm, 20 mm, 25 mm, 28 mm, 30 mm, 40 mm, or 50 mm.

[0045] As noted previously, in various embodiments the monitoring device 110 includes one or more sensors 115 configured to obtain physiological measurements of the target site and / or cells extracted from the target site. In some implementations, one or more sensors 115are located on an exterior portion of the access shaft 111 such that they are in contact with the tumor microenvironment when the device 110 is positioned within the target site. Additionally or alternatively, one or more sensors 115 can be disposed within or exposed to the central lumen 116 of the access shaft 111, such that the sensors can come into contact with cells or tissue within the central lumen 116. In some implementations, the sensors 115 can be disposed within the reservoir 113.

[0046] As best shown in FIG. 2B, some embodiments of the device 110 may comprise a plurality of radially spaced sensors 115 located internally at a distal portion 11 lb of the access shaft 111. Material from the target site enters the device 110 through the inlet openings 106 to contact the sensors 115. After data is collected by the sensors 115, the data can be carried by internal leads 112 extending through the length of the access shaft 111 to be transmitted to a memory component of the electronics assembly 120 disposed within the cap 108. However, it should be appreciated that this is an exemplary embodiment of the present technology and that other configurations of the sensor 115 are possible. For instance, the sensors 115 may be located on the exterior of the access shaft 111 and / or the sensors 115 may be located at a proximal and / or intermediate position along the length of the access shaft 111. Moreover, communication of data from the sensors to the electronics assembly 120 can be carried out via wired or wireless connections.

[0047] FIG. 2C shows a cross-sectional view of an embodiment of the access shaft 111 of the device 110. The access shaft 111 comprises a central lumen 116 that may optionally be configured to house the nanofiber structure 117 (not shown in FIG. 2C), the internal leads 112, and / or other structures. In some embodiments, the nanofiber structure 117 may be omitted. In some embodiments, the central lumen 116 may be configured to deliver therapeutic compositions, drugs, contrast agents, and / or other materials to the target site. In some embodiments, the access shaft 111 may comprise an additional lumen to transport such materials. In some embodiments, such as the embodiment shown in FIG. 2C, the internal leads 112 may be embedded within the walls of the access shaft 111. The access shaft 111 may comprise longitudinal holes to house the internal leads 112. The internal leads 112 may be radially spaced about the access shaft 111. In some embodiments, the internal leads 112 are radially spaced about the access shaft 111 by intervals of about 45, 90, or 180 degrees.

[0048] In the example shown in FIGS. 2B and 2C, the sensors 115 are substantially evenly radially spaced around the shaft 111. However, the spacing may be uneven, with some sensors 115 closer together along the circumferential direction. Additionally, the axial positionof the sensors 115 can vary. In the configuration shown in FIG. 2B, each of the sensors 115 is disposed at a different axial position. In other variations, some or all of the sensors 115 are aligned at the same axial positions, while being spaced apart radially from one another. Other arrangements and configurations are possible.

[0049] As noted previously, the sensors 115 may be configured to track a variety of biomarkers, chemical compounds, and / or features of the tumor microenvironment. In some embodiments, these markers may be indicative of pathological conditions of or a treatment or disease progression, for instance indicating tumor growth, shrinkage, and / or response to a therapeutic agent. For instance, in some examples, the sensors 115 are configured to detect glucose, lactate, metal ions, and / or other molecules that could provide information about disease prognosis. Given the increasing interest in studying specialized immune responses to certain diseases, and cancer in particular, it may be useful to track biomarkers indicative of immune activity. Accordingly, in some embodiments, the sensors 115 are configured to detect interleukins (IL), tumor necrosis factor (TNF-a), interferons (IFNs), immunoglobulins (Ig), other cytokines, and / or other immunological biomarkers. The sensors 115 may be configured to detect molecules present within the tumor microenvironment and / or molecules adhered to the surfaces of cells. In some aspects, a substance (e.g., contrast agent, dye, enzyme, tagged antibody and / or antibody fragment, etc.) may be delivered to the target site to assist with detection of target cells, molecules, compositions, and / or other biomarkers via imaging modalities described previously. In some embodiments, the target cells may comprise tumor cells, T cells, B cells, natural killer cells, macrophages, dendritic cells, neutrophils, innate lymphoid cells, myeloid-derived suppressor cells, other immune cells, etc.

[0050] Accordingly, various embodiments of the sensors 115 include suitable structures to facilitate detection of the parameters as previously described. In some embodiments, the sensors 115 comprise electrodes that may be constructed from an electrically conductive material such as metals, metal alloys, conductive polymers, etc. In one example, the electrodes can be made of platinum, optionally with an additional coating such as iridium oxide. In some embodiments, the sensors can be made from copper, silver, titanium, brass, graphite and / or other metals or conductive alloys. In some embodiments, the electrodes may have a coating comprising mineral silicates, oxides, fluorides, carbonates, hydrocarbons, and / or metal alloys. In some embodiments, the sensors comprise probes configured to perform ultrasound, and / or optical imaging. In some embodiments, the sensors 115 may comprise a coating of enzymes, antibodies, and / or other bioactive agents, such that the sensors 115 are configured to detectcertain target cells, molecules, chemical compositions, etc. The sensors 115 can include an outer porous layer to control the size of the substrates contacting the sensors 115. In some implementations, the sensors 115 include a bioactive layer treated with enzymes, antibodies, etc. that is positioned over an electrode layer to bind specified substrate(s) and generate quantitative and / or qualitative data.

[0051] In operation, the monitoring device 110 may be used at a variety of target sites to monitor and / or treat various conditions. In some embodiments, the device 110 is configured to continuously access tumors, particularly tumors that typically require invasive surgical procedures to access. In various examples, the target site may comprise a tumor such as a glioma, a glioblastoma multiforme, a neuroblastoma, a medulloblastoma, a meningioma, a neurofibrosarcoma, a fibrosarcoma, a liposarcoma, a chondrosarcoma, an osteosarcoma, a chordoma, a fibrous histiocytoma, a lymphoma, a mesothelioma, an angiosarcoma, a lymphangiosarcoma, a cystosarcoma phylloides, a parathyroid carcinoma, a medullary carcinoma, a bronchial carcinoid, a pheochromocytoma, an islet cell carcinoma, a carcinoid, a paraganglioma, a leiomyosarcoma, a rhabdomyosarcoma, an adenocarcinoma, a hepatoma, a renal cell carcinoma, a choriocarcinoma, a seminoma, a dysgerminoma, etc. In some embodiments, the device 110 may be positioned within the body of a patient 190 such that various biomarkers, chemical compound, molecules, etc. may be detected within the blood. Positioning the device 110 such that it continuously accesses the bloodstream may enable the detection and / or treatment of conditions including but not limited to: various cancers such as leukemia, kidney diseases such as chronic kidney disease, polycystic kidney disease, pyelonephritis, etc., infections such as sepsis, etc.

[0052] In some implementations, the elongate access shaft 111 comprises a longitudinal hole or plurality of longitudinal holes configured to house the internal leads 112. Optionally, the elongate shaft 111 includes internal leads 112 prefabricated into its walls. In some embodiments, the internal leads 112 extend the length of the access shaft 111, for instance connecting respective sensors 115 disposed at a distal end portion 111b and the electronics assembly 120 disposed at or proximal to a proximal end portion I l la. The access shaft 111 may comprise a length of at least about 20 mm, 40 mm, 60 mm, 80 mm, 100 mm, 120 mm, 140 mm, 160 mm, or 200 mm. The access shaft 111 may comprise an outer diameter of at least about 1 mm, 2 mm, 4 mm, 6mm, or 8 mm. In some embodiments, the access shaft 111 may comprise an inner diameter defining a central lumen, the inner diameter being at least about 0.2 mm, 0.4 mm, 0.6 mm, 0.8 mm, 1 mm, 2 mm, 2.75 mm, or 4 mm. The longitudinal holesconfigured to house the internal leads 112 may comprise diameters of at least about 0.01 mm, 0.02 mm, 0.03 mm, 0.04 mm, 0.05 mm, or 0.1 mm. In some embodiments, one or multiple of the cross-sectional dimensions described herein may vary along the length of the access shaft 111.

[0053] In implementations in which the sensors 115 are housed within an interior portion of the device 110, inlet openings 106 may facilitate contact between the sensors 115 and material from the target site. In some embodiments, the device 110 comprises a single inlet opening 106 or a plurality of inlet openings 106. These inlet openings 106 may comprise an elliptical shape with a long radius of at least about 1 mm, 1.5 mm, 1.65 mm, 1.75 mm, or 2 mm, and a short radius of at least about 0.5 mm, 0.7 mm, 0.85 mm, 1 mm, or 1.5 mm. In some embodiments, the device 110 comprises 1, 2, 4, 8, or more inlet openings 106. In some embodiments, the inlet openings 106 are radially spaced at intervals of about 45, 90, or 180 degrees around a distal portion of the access shaft 111. In some embodiments, the inlet openings 106 may be axially spaced along the access shaft 111. In some embodiments, the inlet openings 106 may be located at a portion of the device 110 other than the distalmost portion 11 lb such as the proximal end portion I l la and / or an intermediate portion therebetween.

[0054] FIG. 2D shows an exploded view of the device 110 to better illustrate the electrical components of the device. The sensors 115 of the intracorporeal portion of the device 110 can be placed in electrical communication with the electronics assembly 120, which are disposed within the cap 108 at the proximal, extracorporeal portion of the device 110. This electrical communication can be achieved via the internal leads 112 as described above. In some embodiments, the cap 108 of the device 110 may extend over and enclose the reservoir 113.

[0055] In some embodiments, the reservoir 113 is configured to be extracorporeally accessible without requiring surgery. In some embodiments, material may be introduced into or removed from the reservoir 113 by a clinician. For instance, bioactive agents carried away from the target site by the nanofiber structure 117 may be collected within the reservoir 113. In some embodiments, the reservoir 113 is configured to receive drugs and / or therapeutic agents and diffuse them distally along the elongate shaft 111 to the target site. In some embodiments, the reservoir 113 is constructed from a rigid material such as polymethylmethacrylate (PMMA), polycarbonates, other acrylics, etc. In various examples, the reservoir 113 is configured to be removably joined to the cap 108, and comprises a diameter of at least about 5 mm, 7 mm, 10 mm, 15 mm, 20 mm, 25 mm, 26 mm, 30 mm, or 40 mm.III. Example Methods of Use

[0056] Example methods of use for various embodiments of a monitoring device will now be described. While these methods are described in regards to specific applications and embodiments of the device, they -may also be applicable to other uses not explicitly disclosed herein. In some embodiments, the target site may be a tumor and / or other abnormality located anywhere within a patient's body. In some embodiments, the patient can be a human or an animal.

[0057] FIG. 3 is a flowchart illustrating an example method 300 for monitoring a target site using an implantable monitoring device. As illustrated, the method 300 begins in block 302 with advancing a monitoring device to a target site. For instance, following identification of a target site by MRI, CT, ultrasound, and / or other imaging modality, an implantable device can be implanted within a patient's body through a surgical procedure. In some embodiments, the surgical procedure comprises a craniotomy and / or tissue biopsy. In some embodiments, the device cap can be secured to the cranium and / or another exterior portion of a patient's body. The device is implanted such that a distal portion of the device comprising inlet openings is disposed within or adjacent to a target site.

[0058] The method 300 continues in block 304 with uptaking biomaterials into the monitoring device. For instance, the device can receive material from the target site microenvironment through the inlet openings and into its interior lumen and / or the reservoir. In various implementations, this receipt can facilitate interaction of the sensor(s) with the biomaterials, for instance placing one or more sensors into direct contact with the biomaterials.

[0059] Next, in block 306, data characterizing one or more physiological parameter(s) is detected via the one or more sensor(s). As noted above, the type, arrangement, and configuration of the sensor(s) and the corresponding physiological parameter(s) being measured can vary. Moreover, a combination of different types of sensors can be provided that are configured to detect different physiological parameters.

[0060] As part of the data collection, signals generated by the sensors can be transmitted through a lead or plurality of leads to the electronics assembly. The data may then be stored within a memory component of the electronics assembly, and optionally signal processing and / or analysis of these signals and / or data can be performed locally on the device itself.

[0061] In block 308, the data can be transmitted to one or more external monitoring devices for analysis. For instance, sensor data can be uploaded to the external monitoringsystem at specified intervals, on a continuous basis, in response to a user request, or according to other parameters. This collected data may then be evaluated by a patient, clinician, or other user. In some embodiments in which the sensors are located on an exterior portion of the device, step 304 can be omitted, and data from the tumor environment may be collected without biomaterials first being introduced into the device (e.g., through inlet openings).

[0062] FIG. 4 illustrates an example method 400 for collecting data sensors of an implantable monitoring device. Beginning with block 402, the controller within electronics assembly switches on at a specified time, supplying power to the microprocessor. At block 404, a lead corresponding to a particular sensor can be selected, and the controller can read a signal from the selected lead (e.g., an open circuit voltage from a selected lead). This signal reflects “raw” sensor data, which can be filtered, amplified, and otherwise processed in block 406.

[0063] This processed signal can then be stored in memory in block 408, after which the analog switch changes channels to the next internal lead to collect data from the next sensor (block 410) as shown by step 640. As illustrated by FIG. 4, steps 404-410 may be repeated in a cycle and the device will continue to collect data from each of the sensors until the specified data collection interval is complete, at which point the method 400 proceeds to block 412 and controller switches off power from the power source and halts data collection until the beginning of the next specified data collection interval, at which point the cycle will repeat beginning with step 402.IV. Conclusion

[0064] Although many of the embodiments are described above with respect to systems, devices, and methods for minimally invasive tumor monitoring, the technology is applicable to other applications and / or other approaches, such as applications in target sites in various regions of a patient's body, veterinary applications, etc. Moreover, other embodiments in addition to those described herein are within the scope of the technology. Additionally, several other embodiments of the technology can have different configurations, components, or procedures than those described herein. A person of ordinary skill in the art, therefore, will accordingly understand that the technology can have other embodiments with additional elements, or the technology can have other embodiments without several of the features shown and described above with reference to FIGS. 1 A-4.

[0065] The descriptions of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise form disclosed above. Where the contextpermits, singular or plural terms may also include the plural or singular term, respectively. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology, as those skilled in the relevant art will recognize. For example, while steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0066] As used herein, the terms “generally,” “substantially,” “about,” and similar terms are used as terms of approximation and not as terms of degree, and are intended to account for the inherent variations in measured or calculated values that would be recognized by those of ordinary skill in the art.

[0067] Moreover, unless the word “or” is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of “or” in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Additionally, the term "comprising" is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and / or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with certain embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.

[0068] Various examples of aspects of the subject technology are described as numbered examples (1, 2, 3, etc.) for convenience. These are provided as examples and do not limit the subject technology.

[0069] Example 1. A device, comprising: a reservoir element defining a reservoir therein; an elongate shaft comprising a tubular sidewall defining a lumen, the elongate shaft extending between a proximal opening at a proximal end portion of the elongate shaft and a distal end portion of the elongate shaft, wherein the lumen is in fluid communication with the reservoir via the proximal opening, and wherein the distal end portion of the sidewall includes a distalopening; a nanofiber structure disposed within the lumen of the elongate shaft and having a distal region disposed adjacent the distal opening and a proximal region disposed within the reservoir, the nanofiber structure configured to promote migration of tumor cells from the distal region toward the reservoir; one or more sensors disposed at the distal end portion of the elongate shaft; one or more leads coupled to the sensor(s) and extending between the reservoir and the sensors; and an electronics assembly coupled to the leads and configured to obtain sensor data.

[0070] Example 2. The device of Example 1, further comprising a plurality of sensors spaced apart from one another radially about the elongate shaft.

[0071] Example 3. The device of Example 2, wherein the plurality of sensors are radially spaced at about 45 degrees from one another.

[0072] Example 4. The device of Example 2, wherein the plurality of sensors are radially spaced at about 90 degrees from one another.

[0073] Example 5. The device of any one of the preceding Examples, further comprising a plurality of sensors spaced apart from one another axially about the elongate shaft.

[0074] Example 6. The device of any one of the preceding Examples, wherein the sensors are exposed on an outer radial surface.

[0075] Example 7. The device of any one of the preceding Examples, wherein the leads are embedded within the elongate shaft wall.

[0076] Example 8. The device of any one of the preceding Examples, wherein the elongate shaft comprises a nanofiber film configured to promote migration of biological agents.

[0077] Example 9. The device of any one of the preceding Examples, wherein the sensors are configured to characterize a tumor adjacent to the distal region of the elongate shaft.

[0078] Example 10. The device of any one of the preceding Examples, wherein the device is configured to detect and / or evaluate tumor growth.

[0079] Example 11. The device of any one of the preceding Examples, wherein the device is configured to detect and / or evaluate tumor shrinkage.

[0080] Example 12. The device of any one of the preceding Examples, wherein the device is configured to detect and / or evaluate tumor response to a drug.

[0081] Example 13. The device of any one of the preceding Examples, wherein the device is configured to collect tissue samples.

[0082] Example 14. The device of any one of the preceding Examples, wherein the device is configured to administer therapeutic agents.

[0083] Example 15. The device of any one of the preceding Examples, wherein the sensors are configured to detect the presence of anti-tumor drugs.

[0084] Example 16. The device of any one of the preceding Examples, wherein the sensors are configured to detect biomarkers associated with the tumor.

[0085] Example 17. The device of any one of the preceding Examples, wherein the sensors are configured to detect pH level.

[0086] Example 18. The device of any one of the preceding Examples, wherein the electronics assembly comprises a power regulator.

[0087] Example 19. The device of Example 18, wherein the power regulator is configured to turn the device on and / or off on a predetermined schedule.

[0088] Example 20. The device of any one of the preceding Examples, wherein the electronics assembly comprises a wireless transceiver.

[0089] Example 21. The device of Example 20, wherein the wireless transceiver operates using Bluetooth, near-field communication (NFC), Wifi, or 5G.

[0090] Example 22. The device of any one of the preceding Examples, wherein the electronics assembly comprises an inductively re-chargeable power source.

[0091] Example 23. The device of any one of the preceding Examples, further comprising one or more sensors configured to extend beyond the body.

[0092] Example 24. A device, comprising: a reservoir element defining a reservoir therein; an elongate shaft comprising a tubular sidewall defining a lumen, the elongate shaft extending between a proximal opening at a proximal end portion of the elongate shaft and a distal end portion of the elongate shaft, wherein the lumen is in fluid communication with the reservoir via the proximal opening, and wherein the distal end portion of the sidewall includes a distal opening; a nanofiber structure disposed within the lumen of the elongate shaft and having a distal region disposed adjacent the distal opening and a proximal region disposed within the reservoir, the nanofiber structure configured to promote migration of tumor cellsfrom the distal region toward the reservoir; a cap disposed at the proximal end of the elongate shaft, configured to engage the body of the patient at the insertion site, and configured to extend outside the patient's body; and a sensor assembly comprising one or more sensors disposed at the distal end portion of the elongate shaft, the sensor assembly configured to collect data and transmit the data to an external device.

[0093] Example 25. The device of Example 24, wherein the cap further comprises a printed circuit board.

[0094] Example 26. The device of Example 25, wherein the printed circuit board further comprises an analog switch.

[0095] Example 27. The device of any one of Examples 24-26, further comprising a plurality of sensors spaced apart from one another radially about the elongate shaft.

[0096] Example 28. The device of Example 27, wherein the plurality of sensors are radially spaced at about 45 degrees from one another.

[0097] Example 29. The device of Example 27, wherein the plurality of sensors are radially spaced at about 90 degrees from one another.

[0098] Example 30. The device of any one of Examples 24-29, further comprising a plurality of sensors spaced apart from one another axially about the elongate shaft.

[0099] Example 31. The device of any one of Examples 24-30, wherein the sensors are exposed on an outer radial surface.

[0100] Example 32. The device of any one of Examples 24-31, wherein the leads are embedded within the elongate shaft wall.

[0101] Example 33. The device of any one of Examples 24-32, wherein the elongate shaft comprises a nanofiber film configured to promote migration of biological agents.

[0102] Example 34. The device of any one of Examples 24-33, wherein the sensors are configured to characterize a tumor adjacent to the distal region of the elongate shaft.

[0103] Example 35. The device of any one of Examples 24-34, wherein the device is configured to detect and / or evaluate tumor growth.

[0104] Example 36. The device of any one of Examples 24-35, wherein the device is configured to detect and / or evaluate tumor shrinkage.

[0105] Example 37. The device of any one of Examples 24-36, wherein the device is configured to detect and / or evaluate tumor response to a drug.

[0106] Example 38. The device of any one of Examples 24-37, wherein the device is configured to collect tissue samples.

[0107] Example 39. The device of any one of Examples 24-38, wherein the device is configured to administer therapeutic agents.

[0108] Example 40. The device of any one of Examples 24-39, wherein the sensors are configured to detect the presence of anti-tumor drugs.

[0109] Example 41. The device of any one of Examples 24-40, wherein the sensors are configured to detect biomarkers associated with the tumor.

[0110] Example 42. The device of any one of Examples 24-41, wherein the sensors are configured to detect pH level.

[0111] Example 43. The device of any one of Examples 24-42, wherein the electronics assembly comprises a power regulator.

[0112] Example 44. The device of Example 43, wherein the power regulator is configured to turn the device on and / or off on a predetermined schedule.

[0113] Example 45. The device of any one of Examples 24-44, wherein the electronics assembly comprises a wireless transceiver.

[0114] Example 46. The device of Example 45, wherein the wireless transceiver operates using Bluetooth, NFC, Wifi, 5G, or similar technology.

[0115] Example 47. The device of any one of Examples 24-46, wherein the electronics assembly comprises an inductively re-chargeable power source.

[0116] Example 48. The device of any one of Examples 24-47, further comprising one or more sensors configured to extend beyond the body.

[0117] Example 49. A method, comprising: inserting an elongate shaft having openings such that a distal end portion of the elongate shaft is disposed adjacent a target site; migrating tumor cells along a lumen of the elongate shaft towards an extracorporeal reservoir; collecting sensor data via one or more sensors disposed at a distal region of the elongate shaft; and based on the sensor data, evaluating tumor development at the target site.

[0118] Example 50. The method of Example 49, wherein the elongate shaft comprises a plurality of sensors spaced apart from one another radially about the elongate shaft.

[0119] Example 51. The method of Example 50, wherein the plurality of sensors are radially spaced at about 45 degrees from one another.

[0120] Example 52. The method of Example 50, wherein the plurality of sensors are radially spaced at about 90 degrees from one another.

[0121] Example 53. The method of any one of Examples 49-52, wherein the elongate shaft comprises a plurality of sensors spaced apart from one another axially about the elongate shaft.

[0122] Example 54. The method of any one of Examples 49-53, wherein the sensors are exposed on an outer radial surface.

[0123] Example 55. The method of any one of Examples 49-54, wherein a plurality of leads are embedded within the elongate shaft wall.

[0124] Example 56. The method of any one of Examples 49-55, wherein the elongate shaft comprises a nanofiber film configured to promote migration of biological agents.

[0125] Example 57. The method of any one of Examples 49-56, wherein the sensors are configured to characterize a tumor adjacent to the distal region of the elongate shaft.

[0126] Example 58. The method of any one of Examples 49-57, further comprising detecting and / or evaluating tumor growth.

[0127] Example 59. The method of any one of Examples 49-58, further comprising detecting and / or evaluating tumor shrinkage.

[0128] Example 60. The method of any one of Examples 49-59, further comprising detecting and / or evaluating tumor response to a drug.

[0129] Example 61. The method of any one of Examples 49-60, further comprising collecting a tissue sample.

[0130] Example 62. The method of any one of Examples 49-61, further comprising administering a therapeutic agent.

[0131] Example 63. The method of any one of Examples 49-62, further comprising detecting the presence of anti-tumor drugs.

[0132] Example 64. The method of any one of Examples 49-63, further comprising detecting biomarkers associated with a tumor.

[0133] Example 65. The method of any one of Examples 49-64, further comprising detecting pH level.

[0134] Example 66. The method of any one of Examples 49-65, wherein the elongate shaft coupled to an extracorporeal cap is left in place to allow for continuous data collection.

[0135] Example 67. A method, comprising: inserting an elongate shaft having openings such that a distal end portion of the elongate shaft is disposed adjacent a target site; collecting sensor data via one or more sensors disposed at a distal region of the elongate shaft; storing the data within a memory component; transmitting the data to an external system; and based on the sensor data, evaluating tumor development at the target site.

[0136] Example 68. The method of Example 67, wherein the data is collected at specified intervals.

[0137] Example 69. The method of Example 68, wherein the intervals of data collection are controlled by a microprocessor.

[0138] Example 70. The method of any one of Examples 67-69, wherein the elongate shaft further comprises a cap comprising a printed circuit board.

[0139] Example 71. The method of Example 70, wherein the printed circuit board further comprises an analog switch.

[0140] Example 72. The method of any one of Examples 67-71, wherein the elongate shaft comprises a plurality of sensors spaced apart from one another radially about the elongate shaft.

[0141] Example 73. The method of Example 72, wherein the plurality of sensors are radially spaced at about 45 degrees from one another.

[0142] Example 74. The method of Example 72, wherein the plurality of sensors are radially spaced at about 90 degrees from one another.

[0143] Example 75. The method of any one of Examples 67-74, wherein the elongate shaft comprises a plurality of sensors spaced apart from one another axially about the elongate shaft.

[0144] Example 76. The method of any one of Examples 67-75, wherein the sensors are exposed on an outer radial surface.

[0145] Example 77. The method of any one of Examples 67-76, wherein a plurality of leads are embedded within the elongate shaft wall.

[0146] Example 78. The method of any one of Examples 67-77, wherein the elongate shaft comprises a nanofiber film configured to promote migration of biological agents.

[0147] Example 79. The method of any one of Examples 67-78, wherein the sensors are configured to characterize a tumor adjacent to the distal region of the elongate shaft.

[0148] Example 80. The method of any one of Examples 67-79, further comprising detecting and / or evaluating tumor growth.

[0149] Example 81. The method of any one of Examples 67-80, further comprising detecting and / or evaluating tumor shrinkage.

[0150] Example 82. The method of any one of Examples 67-81, further comprising detecting and / or evaluating tumor response to a drug.

[0151] Example 83. The method of any one of Examples 67-82, further comprising collecting a tissue sample.

[0152] Example 84. The method of any one of Examples 67-83, further comprising administering a therapeutic agent.

[0153] Example 85. The method of any one of Examples 67-84, further comprising detecting the presence of anti-tumor drugs.

[0154] Example 86. The method of any one of Examples 67-85, further comprising detecting biomarkers associated with a tumor.

[0155] Example 87. The method of any one of Examples 67-86, further comprising detecting pH level.

[0156] Example 88. The method of any one of Examples 67-87, wherein the elongate shaft coupled to an extracorporeal cap is left in place to allow for continuous data collection.

[0157] Example 89. The method of any one of Examples 67-88, wherein the elongate shaft comprises an electronics assembly comprising a power regulator.

[0158] Example 90. The method of Example 89, wherein the power regulator is configured to turn the device on and / or off on a predetermined schedule.

[0159] Example 91. The method of any one of Examples 67-90, wherein the electronics assembly comprises a wireless transceiver.

[0160] Example 92. The method of any one of Examples 67-91, wherein the data is transmitted to the external system using Bluetooth, NFC, Wifi, 5G, or similar technology.

[0161] Example 93. The method of any one of Examples 67-92, wherein the electronics assembly comprises an inductively re-chargeable power source.

[0162] Example 94. A system, comprising: a treatment device, comprising: a reservoir element defining a reservoir therein; an elongate shaft comprising a tubular sidewall defining a lumen, the elongate shaft extending between a proximal opening at a proximal end portion of the elongate shaft and a distal end portion of the elongate shaft, wherein the lumen is in fluid communication with the reservoir via the proximal opening, and wherein the distal end portion of the sidewall includes a distal opening; a nanofiber structure disposed within the lumen of the elongate shaft and having a distal region disposed adjacent the distal opening and a proximal region disposed within the reservoir, the nanofiber structure configured to promote migration of tumor cells from the distal region toward the reservoir; a cap disposed at the proximal end of the elongate shaft, configured to engage the body of the patient at the insertion site, and configured to extend outside the patient's body; one or more sensors disposed at the distal end portion of the elongate shaft; one or more leads coupled to the sensor(s) and extending between the reservoir and the sensors; and an electronics assembly coupled to the leads and configured to obtain sensor data; an external monitoring system configured to receive data collected by the device; and wherein the treatment system is configured to perform operations comprising: collecting sensor data via the one or more sensors disposed at a distal region of the elongate shaft; storing the data within a memory component; transmitting the data to the external monitoring system; and based on the sensor data, evaluating tumor development at the target site.

[0163] Example 95. A system, comprising: a treatment device, comprising: a reservoir element defining a reservoir therein; an elongate shaft comprising a tubular sidewall defining a lumen, the elongate shaft extending between a proximal opening at a proximal end portion of the elongate shaft and a distal end portion of the elongate shaft, wherein the lumen is in fluid communication with the reservoir via the proximal opening, and wherein the distal end portionof the sidewall includes a distal opening; one or more sensors disposed at the distal end portion of the elongate shaft; and an electronics assembly configured to obtain sensor data; an external monitoring system configured to receive data collected by the device; and wherein the treatment system is configured to perform operations comprising: collecting sensor data via the one or more sensors disposed at a distal region of the elongate shaft; storing the data within a memory component; transmitting the data to the external monitoring system; and based on the sensor data, evaluating tumor development at the target site.

[0164] Example 96. A system, comprising: a treatment device, comprising: a reservoir element defining a reservoir therein; an elongate shaft comprising a tubular sidewall defining a lumen, the elongate shaft extending between a proximal opening at a proximal end portion of the elongate shaft and a distal end portion of the elongate shaft, wherein the lumen is in fluid communication with the reservoir via the proximal opening, and wherein the distal end portion of the sidewall includes a distal opening; one or more sensors disposed at the distal end portion of the elongate shaft; an electronics assembly configured to obtain sensor data; and an external monitoring system configured to receive and analyze data collected by the device.

[0165] Example 97. The system of claim any one of Examples 94-96, wherein the electronics assembly is configured to store sensor data.

[0166] Example 98. The system of any one of Examples 94-96, wherein the external monitoring system comprises a graphical user interface.

[0167] Example 99. The system of any one of Examples 94-96, wherein the external monitoring system comprises a software program.

[0168] Example 100. The system of any one of Examples 94-96, wherein the external monitoring system comprises a smartphone application.

Claims

CLAIMS1. A device, comprising: a reservoir element defining a reservoir therein; an elongate shaft comprising a tubular sidewall defining a lumen, the elongate shaft extending between a proximal opening at a proximal end portion of the elongate shaft and a distal end portion of the elongate shaft, wherein the lumen is in fluid communication with the reservoir via the proximal opening, and wherein the distal end portion of the sidewall includes a distal opening; a nanofiber structure disposed within the lumen of the elongate shaft and having a distal region disposed adjacent the distal opening and a proximal region disposed within the reservoir, the nanofiber structure configured to promote migration of tumor cells from the distal region toward the reservoir; one or more sensors disposed at the distal end portion of the elongate shaft; one or more leads coupled to the sensor(s) and extending between the reservoir and the sensors; and an electronics assembly coupled to the leads and configured to obtain sensor data.

2. The device of claim 1, further comprising a plurality of sensors spaced apart from one another radially about the elongate shaft.

3. The device of claim 2, wherein the plurality of sensors are radially spaced at about 45 degrees from one another.

4. The device of claim 2 or claim 3, wherein the plurality of sensors are radially spaced at about 90 degrees from one another.

5. The device of any one of claims 1-4, further comprising a plurality of sensors spaced apart from one another axially about the elongate shaft.

6. The device of any one of claims 1-5, wherein the sensors are exposed on an outer radial surface.

7. The device of any one of claims 1-6, wherein the leads are embedded within the elongate shaft wall.

8. The device of any one of claims 1-7, wherein the elongate shaft comprises a nanofiber film configured to promote migration of biological agents.

9. The device of any one of claims 1-8, wherein the sensors are configured to characterize a tumor adjacent to the distal region of the elongate shaft.

10. The device of any one of claims 1-9, wherein the device is configured to detect and / or evaluate tumor growth.

11. The device of any one of claims 1-10, wherein the device is configured to detect and / or evaluate tumor shrinkage.

12. The device of any one of claims 1-11, wherein the device is configured to detect and / or evaluate tumor response to a drug.

13. The device of any one of claims 1-12, wherein the device is configured to collect tissue samples.

14. The device of any one of claims 1-13, wherein the device is configured to administer therapeutic agents.

15. The device of any one of claims 1-14, wherein the sensors are configured to detect the presence of anti-tumor drugs.

16. The device of any one of claims 1-15, wherein the sensors are configured to detect biomarkers associated with the tumor.

17. The device of any one of claims 1-16, wherein the sensors are configured to detect pH level.

18. The device of any one of claims 1-17, wherein the electronics assembly comprises a power regulator.

19. The device of claim 18, wherein the power regulator is configured to turn the device on and / or off on a predetermined schedule.

20. The device of any one of claims 1-19, wherein the electronics assembly comprises a wireless transceiver.

21. The device of claim 20, wherein the wireless transceiver operates using Bluetooth, near-field communication (NFC), Wifi, or 5G.

22. The device of any one of claims 1-21, wherein the electronics assembly comprises an inductively re-chargeable power source.

23. The device of any one of claims 1-22, further comprising one or more sensors configured to extend beyond the body.

24. A device, comprising: a reservoir element defining a reservoir therein; an elongate shaft comprising a tubular sidewall defining a lumen, the elongate shaft extending between a proximal opening at a proximal end portion of the elongate shaft and a distal end portion of the elongate shaft, wherein the lumen is in fluid communication with the reservoir via the proximal opening, and wherein the distal end portion of the sidewall includes a distal opening; a nanofiber structure disposed within the lumen of the elongate shaft and having a distal region disposed adjacent the distal opening and a proximal region disposed within the reservoir, the nanofiber structure configured to promote migration of tumor cells from the distal region toward the reservoir; a cap disposed at the proximal end of the elongate shaft, configured to engage the body of the patient at the insertion site, and configured to extend outside the patient's body; anda sensor assembly comprising one or more sensors disposed at the distal end portion of the elongate shaft, the sensor assembly configured to collect data and transmit the data to an external device.

25. The device of claim 24, wherein the cap further comprises a printed circuit board.

26. The device of claim 25, wherein the printed circuit board further comprises an analog switch.

27. The device of any one of claims 24-26, further comprising a plurality of sensors spaced apart from one another radially about the elongate shaft.

28. The device of claim 27, wherein the plurality of sensors are radially spaced at about 45 degrees from one another.

29. The device of claim 27 or claim 28, wherein the plurality of sensors are radially spaced at about 90 degrees from one another.

30. The device of any one of claims 24-29, further comprising a plurality of sensors spaced apart from one another axially about the elongate shaft.

31. The device of any one of claims 24-30, wherein the sensors are exposed on an outer radial surface.

32. The device of any one of claims 24-31, wherein the leads are embedded within the elongate shaft wall.

33. The device of any one of claims 24-32, wherein the elongate shaft comprises a nanofiber film configured to promote migration of biological agents.

34. The device of any one of claims 24-33, wherein the sensors are configured to characterize a tumor adjacent to the distal region of the elongate shaft.

35. The device of any one of claims 24-34, wherein the device is configured to detect and / or evaluate tumor growth.

36. The device of any one of claims 24-35, wherein the device is configured to detect and / or evaluate tumor shrinkage.

37. The device of any one of claims 24-36, wherein the device is configured to detect and / or evaluate tumor response to a drug.

38. The device of any one of claims 24-37, wherein the device is configured to collect tissue samples.

39. The device of any one of claims 24-38, wherein the device is configured to administer therapeutic agents.

40. The device of any one of claims 24-39, wherein the sensors are configured to detect the presence of anti-tumor drugs.

41. The device of any one of claims 24-40, wherein the sensors are configured to detect biomarkers associated with the tumor.

42. The device of any one of claims 24-41, wherein the sensors are configured to detect pH level.

43. The device of any one of claims 24-42, wherein the electronics assembly comprises a power regulator.

44. The device of claim 43, wherein the power regulator is configured to turn the device on and / or off on a predetermined schedule.

45. The device of any one of claims 24-44, wherein the electronics assembly comprises a wireless transceiver.

46. The device of claim 45, wherein the wireless transceiver operates using Bluetooth, NFC, Wifi, 5G, or similar technology.

47. The device of any one of claims 24-46, wherein the electronics assembly comprises an inductively re-chargeable power source.

48. The device of any one of claims 24-47, further comprising one or more sensors configured to extend beyond the body.

49. A method, comprising: inserting an elongate shaft having openings such that a distal end portion of the elongate shaft is disposed adjacent a target site; migrating tumor cells along a lumen of the elongate shaft towards an extracorporeal reservoir; collecting sensor data via one or more sensors disposed at a distal region of the elongate shaft; and based on the sensor data, evaluating tumor development at the target site.

50. The method of claim 49, wherein the elongate shaft comprises a plurality of sensors spaced apart from one another radially about the elongate shaft.

51. The method of claim 50, wherein the plurality of sensors are radially spaced at about 45 degrees from one another.

52. The method of claim 50 or claim 51, wherein the plurality of sensors are radially spaced at about 90 degrees from one another.

53. The method of any one of claims 49-52, wherein the elongate shaft comprises a plurality of sensors spaced apart from one another axially about the elongate shaft.

54. The method of any one of claims 49-53, wherein the sensors are exposed on an outer radial surface.

55. The method of any one of claims 49-54, wherein a plurality of leads are embedded within the elongate shaft wall.

56. The method of any one of claims 49-55, wherein the elongate shaft comprises a nanofiber film configured to promote migration of biological agents.

57. The method of any one of claims 49-56, wherein the sensors are configured to characterize a tumor adjacent to the distal region of the elongate shaft.

58. The method of any one of claims 49-57, further comprising detecting and / or evaluating tumor growth.

59. The method of any one of claims 49-58, further comprising detecting and / or evaluating tumor shrinkage.

60. The method of any one of claims 49-59, further comprising detecting and / or evaluating tumor response to a drug.

61. The method of any one of claims 49-60, further comprising collecting a tissue sample.

62. The method of any one of claims 49-61, further comprising administering a therapeutic agent.

63. The method of any one of claims 49-62, further comprising detecting the presence of anti-tumor drugs.

64. The method of any one of claims 49-63, further comprising detecting biomarkers associated with a tumor.

65. The method of any one of claims 49-64, further comprising detecting pH level.

66. The method of any one of claims 49-65, wherein the elongate shaft coupled to an extracorporeal cap is left in place to allow for continuous data collection.

67. A method, comprising: inserting an elongate shaft having openings such that a distal end portion of the elongate shaft is disposed adjacent a target site; collecting sensor data via one or more sensors disposed at a distal region of the elongate shaft; storing the data within a memory component; transmitting the data to an external system; and based on the sensor data, evaluating tumor development at the target site.

68. The method of claim 67, wherein the data is collected at specified intervals.

69. The method of claim 68, wherein the intervals of data collection are controlled by a microprocessor.

70. The method of any one of claims 67-69, wherein the elongate shaft further comprises a cap comprising a printed circuit board.

71. The method of claim 70, wherein the printed circuit board further comprises an analog switch.

72. The method of any one of claims 67-71, wherein the elongate shaft comprises a plurality of sensors spaced apart from one another radially about the elongate shaft.

73. The method of claim 72, wherein the plurality of sensors are radially spaced at about 45 degrees from one another.

74. The method of claim 72 or claim 73, wherein the plurality of sensors are radially spaced at about 90 degrees from one another.

75. The method of any one of claims 67-74, wherein the elongate shaft comprises a plurality of sensors spaced apart from one another axially about the elongate shaft.

76. The method of any one of claims 67-75, wherein the sensors are exposed on an outer radial surface.

77. The method of any one of claims 67-76, wherein a plurality of leads are embedded within the elongate shaft wall.

78. The method of any one of claims 67-77, wherein the elongate shaft comprises a nanofiber film configured to promote migration of biological agents.

79. The method of any one of claims 67-78, wherein the sensors are configured to characterize a tumor adjacent to the distal region of the elongate shaft.

80. The method of any one of claims 67-79, further comprising detecting and / or evaluating tumor growth.

81. The method of any one of claims 67-80, further comprising detecting and / or evaluating tumor shrinkage.

82. The method of any one of claims 67-81, further comprising detecting and / or evaluating tumor response to a drug.

83. The method of any one of claims 67-82, further comprising collecting a tissue sample.

84. The method of any one of claims 67-83, further comprising administering a therapeutic agent.

85. The method of any one of claims 67-84, further comprising detecting the presence of anti-tumor drugs.

86. The method of any one of claims 67-85, further comprising detecting biomarkers associated with a tumor.

87. The method of any one of claims 67-86, further comprising detecting pH level.

88. The method of any one of claims 67-87, wherein the elongate shaft coupled to an extracorporeal cap is left in place to allow for continuous data collection.

89. The method of any one of claims 67-88, wherein the elongate shaft comprises an electronics assembly comprising a power regulator.

90. The method of claim 89, wherein the power regulator is configured to turn the device on and / or off on a predetermined schedule.

91. The method of claim 89 or claim 90, wherein the electronics assembly comprises a wireless transceiver.

92. The method of any one of claims 67-91, wherein the data is transmitted to the external system using Bluetooth, NFC, Wifi, 5G, or similar technology.

93. The method of any one of claims 89-92, wherein the electronics assembly comprises an inductively re-chargeable power source.

94. A system, comprising: a treatment device, comprising: a reservoir element defining a reservoir therein; an elongate shaft comprising a tubular sidewall defining a lumen, the elongate shaft extending between a proximal opening at a proximal end portion of the elongate shaft and a distal end portion of the elongate shaft, wherein the lumen is in fluid communication with the reservoir via the proximal opening, and wherein the distal end portion of the sidewall includes a distal opening;a nanofiber structure disposed within the lumen of the elongate shaft and having a distal region disposed adjacent the distal opening and a proximal region disposed within the reservoir, the nanofiber structure configured to promote migration of tumor cells from the distal region toward the reservoir; a cap disposed at the proximal end of the elongate shaft, configured to engage the body of the patient at the insertion site, and configured to extend outside the patient's body; one or more sensors disposed at the distal end portion of the elongate shaft; one or more leads coupled to the sensor(s) and extending between the reservoir and the sensors; and an electronics assembly coupled to the leads and configured to obtain sensor data; and an external monitoring system configured to receive data collected by the device, wherein the treatment system is configured to perform operations comprising: collecting sensor data via the one or more sensors disposed at a distal region of the elongate shaft; storing the data within a memory component; transmitting the data to the external monitoring system; and based on the sensor data, evaluating tumor development at the target site.

95. A system, comprising: a treatment device, comprising: a reservoir element defining a reservoir therein; an elongate shaft comprising a tubular sidewall defining a lumen, the elongate shaft extending between a proximal opening at a proximal end portion of the elongate shaft and a distal end portion of the elongate shaft, wherein the lumen is in fluid communication with the reservoir via the proximal opening, and wherein the distal end portion of the sidewall includes a distal opening; one or more sensors disposed at the distal end portion of the elongate shaft; and an electronics assembly configured to obtain sensor data; and an external monitoring system configured to receive data collected by the device, wherein the treatment system is configured to perform operations comprising:collecting sensor data via the one or more sensors disposed at a distal region of the elongate shaft; storing the data within a memory component; transmitting the data to the external monitoring system; and based on the sensor data, evaluating tumor development at the target site.

96. A system, comprising: a treatment device, comprising: a reservoir element defining a reservoir therein; an elongate shaft comprising a tubular sidewall defining a lumen, the elongate shaft extending between a proximal opening at a proximal end portion of the elongate shaft and a distal end portion of the elongate shaft, wherein the lumen is in fluid communication with the reservoir via the proximal opening, and wherein the distal end portion of the sidewall includes a distal opening; one or more sensors disposed at the distal end portion of the elongate shaft; an electronics assembly configured to obtain sensor data; and an external monitoring system configured to receive and analyze data collected by the device.

97. The system of claim any one of claims 94-96, wherein the electronics assembly is configured to store sensor data.

98. The system of any one of claims 94-97, wherein the external monitoring system comprises a graphical user interface.

99. The system of any one of claims 94-98, wherein the external monitoring system comprises a software program.

100. The system of any one of claims 94-99, wherein the external monitoring system comprises a smartphone application.

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