EP4654919A1

EP4654919A1 - Thromboembolic event detection and imaging device

Info

Publication number: EP4654919A1
Application number: EP24747890.2A
Authority: EP
Inventors: Basil P. ALIAS
Original assignee: Texas A&M University System
Current assignee: Texas A&M University System
Priority date: 2023-01-27
Filing date: 2024-01-26
Publication date: 2025-12-03
Also published as: WO2024159146A1

Abstract

A thromboembolic event detection and imaging device may include an inferior vena cava sensing filter, signal circuitry, a processing unit, and a power source. Also, a method of monitoring for a thromboembolic event may include providing a thromboembolic event detection and imaging device, which may include an inferior vena cava sensing filter, signal circuitry, a processing unit, and a power source. The method may also include placing the inferior vena cava sensing filter within an inferior vena cava of a patient.

Description

THROMBOEMBOLIC EVENT DETECTION AND IMAGING DEVICE

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application 63/441 ,539 entitled “Thromboembolic Event Detection and Imaging Device (TEDID)” filed January 27, 2023, which is incorporated herein by reference in its entirety.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

[0002] Not applicable.

TECHNICAL FIELD

[0003] The present disclosure relates generally to a thromboembolic event detection and imaging device (referred to herein as a “TEDID”).

BACKGROUND

[0004] Venous thromboembolic diseases are diseases characterized by a systemic increase in blood clots that are formed within a vein. Serious complications often occur as a result of clots dislodging and blocking blood flow, including illness, disability, and death. Thromboembolic diseases can lead to outcomes such as deep vein thrombosis (DVT) and pulmonary embolism (PE) that affect 1 in 1000 adults annually 1. The normal course oftreatment for thromboembolic diseases includes anticoagulants, which reduce the formation of blood clots. As the average population age increases, more patients are being placed on anticoagulant therapies for thrombotic prophylaxis, however the use of anticoagulation therapies is associated with adverse outcomes following bleeding incidents, including risks such as uncontrolled bleeding. Patients with DVT treated with warfarin were found to suffer from bleeding events at a rate of 1.31 per 100 person- years, and warfarin-associated bleeding events on average range from 10.8 - 50.9% increase in healthcare cost over non-warfarin-associated bleeding events. These adverse outcomes present a clear need for alternatives to anticoagulant therapies, especially in patients with high-risk factors such as advanced age, diabetes, and hypertension.

[0005] There are currently no smart vena cava filters that are able to not only detect when an embolism is caught within the filter but also to image the clot and to provide that information to a healthcare provider, all without the need for a doctor’s appointment or a visit to a hospital with those imaging capabilities. BRIEF SUMMARY OF THE DISCLOSURE

[0006] Disclosed herein are one or more embodiments of a thromboembolic event detection and imaging device may comprise an inferior vena cava sensing filter, signal circuitry, a processing unit, and a power source. In some embodiments, the thromboembolic event detection and imaging device may be configured to detect an embolism when deployed in a patient. Also, in some embodiments, the thromboembolic event detection and imaging device may be configured to image an embolism when deployed in a patient. Also, in some embodiments, the thromboembolic event detection and imaging device may be configured to use electrical impedance tomography to generate an image of an embolism based on an impedance differential between the embolism and blood.

[0007] Also disclosed herein are one or more embodiments of monitoring for a thromboembolic event. The method may comprise providing a thromboembolic event detection and imaging device. The thromboembolic event detection and imaging device may comprise an inferior vena cava sensing filter, signal circuitry, a processing unit, and a power source. The method may also comprise placing the inferior vena cava sensing filter within an inferior vena cava of a patient. Also, in some embodiments, the method may further comprise capturing an embolism in the inferior vena cava sensing filter. Also, in some embodiments, the method may further comprise detecting the embolism captured in the inferior vena cava sensing filter. Also, in some embodiments, the method may further comprise determining a size of the embolism captured in the inferior vena cava sensing filter. Also, in some embodiments, determining the size of the embolism may further comprise utilizing electrical impedance tomography to generate an image of the embolism. In some embodiments, detecting the embolism captured in the inferior vena cava sensing filter may comprises generating a stimulation current, delivering the stimulation current via at least one of a plurality of electrodes of the inferior vena cava sensing filter, collecting a resultant impedance signal via two or more other electrodes of the inferior vena cava sensing filter, and evaluating the resultant impedance signal. In some embodiments, the method may further comprise communicating a signal indicative of the embolism captured in inferior vena cava sensing filter to an external device. In some embodiments, the method may further comprise communicating a signal indicative of the inferior vena cava sensing filter becoming dislodged. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] For a detailed description of exemplary embodiments of the disclosure, reference will now be made to the accompanying drawings in which:

[0009] Figure 1 is a schematic view of an embodiment of a TEDID according to one or more embodiments disclosed herein.

[0010] Figure 2 is an example of a tomographic image as may be generated via operation of the TEDID.

[0011] Figure 3 is an example of an embodiment of a TEDID according to one or more embodiments disclosed herein.

DETAILED DESCRIPTION OF THE DISCLOSED EMBODIMENTS

[0012] The following discussion is directed to various exemplary embodiments. However, one skilled in the art will understand that the examples disclosed herein have broad application, and that the discussion of any embodiment is meant only to be exemplary of that embodiment, and not intended to suggest that the scope of the disclosure, including the claims, is limited to that embodiment.

[0013] Certain terms are used throughout the following description and claims to refer to particular features or components. As one skilled in the art will appreciate, different persons may refer to the same feature or component by different names. This document does not intend to distinguish between components or features that differ in name but not function. The drawing figures are not necessarily to scale. Certain features and components herein may be shown exaggerated in scale or in somewhat schematic form and some details of conventional elements may not be shown in interest of clarity and conciseness.

[0014] In the following discussion and in the claims, the terms "including" and "comprising" are used in an open-ended fashion, and thus should be interpreted to mean "including, but not limited to...” Also, the term "couple" or "couples" is intended to mean either an indirect or direct connection. Thus, if a first device couples to a second device, that connection may be through a direct connection, or through an indirect connection via other devices, components, and connections. In addition, as used herein, the terms "axial" and "axially" generally mean along or parallel to a central axis (e.g., the central axis of a body or a port), while the terms "radial" and "radially" generally mean perpendicular to the central axis. For instance, an axial distance refers to a distance measured along or parallel to the central axis, and a radial distance means a distance measured perpendicular to the central axis.

[0015] Disclosed herein are various embodiments of a TEDID. Generally, the TEDID may be configured to utilize electrical impedance to determine the occurrence of a thrombolytic event, such as the presence of an embolism or clot. Electrical impedance tomography (EIT) is an imaging technique that relies upon the differences in impedance measurements between multiple electrodes circumferentially disposed in a plane to identify differences in tissue components based on differential impedance. For example, and not intending to be bound by theory, the impedance exhibited by an embolism or clot may be sufficiently greater than impedance exhibited by blood as to allow for distinguishing between blood and an embolism or clot on the basis of impedance differential.

[0016] The TEDID is a multiple-component device that uses a sensor that is configured to function as an inferior vena cava filter and also to function as an imaging electrode array. For example, the vena cava sensing filter may function as a physical net that stops embolisms or clots from migrating to the heart or lungs. Once an embolism or clot is caught, the device can notify the patient as well as their healthcare provider. The user and/or provider can then request the device to create an image of the crosssection of the sensor and can show the approximate dimensions of the embolism. Additionally, the TEDID can perform very other functions and analysis, for example, so as to determine approximate stenosis of the vein and/or to determine if the device has become dislodged.

[0017] In various embodiments, the TEDID includes an inferior vena cava sensing filter that is configured to function as a sensor, for example, as an imaging electrode array. More particularly, the vena cava sensing filter may be configured to provide a physical obstacle, for example, a “net,” that captures an embolism(s) and/or clot(s) and thereby impedes migration of the embolism or clot to the heart or lungs. Once an embolism or clot is captured, the TEDID may be configured to provide, for example, to the patient and/or a healthcare provider, an indication of the embolism or clot. Additionally, the TEDID may further be configured to provide an image representative of a crosssection of the sensor and, for example, which may show information, such as the approximate dimensions, of the embolism. Additionally, the TEDID may further be configured to provide further information about the operation of the TEDID, the environment in which the TEDID is employed, an embolism or clot captured by the TEDID, or combinations thereof. For example, in some embodiments the TEDID may be configured to determine the presence and/or position in which the inferior vena cava sensing filter is deployed and/or to monitor for dislodgement of the inferior vena cava sensing filter (for example, movement of the inferior vena cava sensing filter.) [0018] Referring now to Figure 1 , an embodiment of a TEDID 100 is shown schematically. In the embodiment of Figure 1 , the TEDID 100 generally comprises an inferior vena cava sensing filter 110, signal circuitry 120, a processing unit 130, and a power source 140.

[0019] In some embodiments, the inferior vena cava sensing filter 110 may comprise a medical-grade and/or biocompatible electrically-conductive material, for example, medical-grade and/or biocompatible metal. Generally, the term “medical-grade” may refer to a material that is not toxic or injurious with respect to biological tissue. In some embodiments, the medically-su itable material, for example, a medically-suitable metal may be or comprise those electrically-conductive materials as may be employed in conventional inferior vena cava filters, examples of which may include metals such as copper and copper alloys, titanium and titanium alloys, magnesium and magnesium alloys, gold and gold alloys, silver and silver alloys, iridium and iridium alloys, tantalum and tantalum alloys, nickel-titanium alloys (e.g., nitinol), cobalt-chromium alloys, medical and/or implant-grade stainless steel (316L), and combinations thereof. Additionally, at least a portion of the inferior vena cava sensing filter 110 may a medical-grade and/or biocompatible material, for example, a polymer. Examples of suitable polymers may include, but are not limited to, synthetic polymers such as polymers polyvinyl alcohol, polyethylene glycerol, poly-vinyl pyrrolidone (PVP), polyolefins, fluoropolymers, hydropolymers of vinyl esters, vinyl ethers, carboxy vinyl monomers, meth(acrylic) acid, acrylamide, N-vinyl pyrrolidone, acylamidoptopanem, acylamdiopropane, polyal koxylated alcohols, alkyl or dialkyl polyglycerol compounds, polyethyloxylated alcohols, homopolymers and copolymers of acrylamide (e.g. N-(2- hydroxypropyl)methacrylamide (HPMA), silicone, polyether block amides, polyetherpolyester block polymers, polyurethanes, and combinations thereof.

[0020] In various embodiments, the inferior vena cava sensing filter 110 may be configured for placement within the inferior vena cava of a patient and to capture, catch, filter, and/or retain a clot or embolism (a pulmonary embolism) so as to impede movement of the clot or embolism to impede migration of the embolism or clot to the heart or lungs while also allowing sustained blood-flow through the vena cava. For example, the inferior vena cava sensing filter 110 may generally comprise a plurality of members collectively defining a framework, for example, a mesh, network, grid, web, or other suitably-configured assemblage. For example, in some embodiments, one or more of the members of the framework may characterized as plurality of wires or filaments. The framework may also define a plurality of open spaces, for example, between the various members of the framework, thereby allowing for blood-flow therethrough while being sufficiently small as to capture the clot or embolism.

[0021] Also, in various embodiments, the inferior vena cava sensing filter 110 may be configured to configured to apply a stimulation or injection current, for example, an electrical signal such as an alternating current (A/C) or a direct current (D/C), and to collect impedance data that may be employed to generate a tomographic image, as will be disclosed herein. For example, in some embodiments, two or more of the plurality of members that collectively form the framework may be configured as an electrode 112. More particularly, as will be disclosed herein, at least one of the plurality of members may be configured to apply the stimulation current, for example, electrical signal such as an A/C or a D/C, and one or more other of the plurality of members may be configured to collect the impedance signal, for example, to collect impedance data such as current and/or voltage that can be used to calculate the impedance. For example, the members configured as electrodes 112 comprise, for example, be formed from, a suitable electrically-conductive material.

[0022] Referring again to Figure 1 , the signal circuitry 120 may generally be configured to generate and deliver the stimulation current to be applied via at least one electrode and to sense an impedance signal via one or more other electrodes. In various embodiments, a plurality electrical leads connected to the inferior vena cava sensing filter 110, for example, in electrical communication with each of the one or more electrodes, may provide signal communication to the signal circuitry 120. In various embodiments, the electrical leads may comprise or be made from a suitable signalconducting material, for example, MP-35N and/or MP-35N with titanium, platinum, or platinum-iridium alloys.

[0023] In various embodiments, the signal circuitry may comprise any components as suitable to yield the desired functionality, for example, integrated circuits, transistors, multiplexors, LEDs, copper wires, tin-lead solder, EFTE coating, or combinations thereof.

[0024] For example, generally, the signal circuitry 120 may be in electrical communication with the one or more electrodes. The signal circuitry 120 may be configured to generate one or more stimulation currents, for example, electrical signal such as an A/C signal or a D/C signal. In some embodiments, the signal circuitry 120 may be in electrical communication with the power source 140 so as to generate the stimulation current utilizing power from the power source 140. Additionally, the signal circuitry 120 may include one or more capacitors, which may be charged via the power source 140, to generate the stimulation current. In some embodiments, the signal circuitry 120 may be configured to selectively connect one or more of the electrodes, for example, via a suitable configuration of switches of the like, such that the one or more electrodes that deliver the impedance is selectable. Additionally, in some embodiments, the signal circuitry 120 may be configured to monitor and control various parameters associated with the generated stimulation current, for example, current, voltage, waveform, and the like. For example, in some embodiments, the signal circuitry 120 may be configured to generate a A/C stimulation current having a frequency from about 1 hertz (Hz) to about 10 kHz, or from about 50 Hz to about 500 Hz, and a peak-to-peak voltage (Vpp) from about 3 volts (V) to about 9V, or from about 4V to about 8V. Additionally or alternatively, the signal circuitry 120 may be configured to generate a D/C stimulation current about 3 volts (V) to about 9V, or from about 4V to about 8V. Also, in various embodiments, the stimulation current may be characterized as exhibiting any suitable signal propagation parameters and/or reconstruction qualities. In various embodiments, the stimulation current may also be characterized exhibiting a suitable waveform, for example, a sinusoidal wave, a square wave, a triangular wave, or a complex wave. Additionally, in some embodiments, the signal circuitry 120 may also comprise an oscillator (for example, to provide for generation of a sinusoidal output signal) and/or one or more digital to analog converters (DAC) (for example, to provide a controllable output signal in a desired form).

[0025] Also for example, the signal circuitry 120 may be configured to sense the one or more aspects of an impedance signal. In some embodiments, the signal circuitry 120 may receive, via two or more of the electrodes, the resulting impedance, for example, so as to provide electrical signals (i.e., data) indicative of the presence or absence of an embolism or clot. The signal circuitry 120 may also be configured to be adjustable with respect to various parameters associated with impedance sensing, for example, sampling rate, frequency band, slew rate, sensitivity, and/or dynamic range. In some embodiments, the signal circuitry 120 may include one or more analog-to- digital converter sub-circuits and/or sample/hold circuitry for use in sampling the sensed signal and converting the sensed signal to a form that can be processed via the processing unit 130. Although the signal circuitry 120 and processing unit 130 may be disclosed as distinct, in some embodiments, the signal circuitry 120 and processing unit 130, as will be disclosed herein, may be integrated.

[0026] The processing unit 130 may be configured to control the operation of the TEDID, for example, so as to detect the presence of an embolism or clot captured by the inferior vena cava sensing filter 110. Generally, the processing unit 130 may be configured to detect the presence of an embolism or clot captured by the inferior vena cava sensing filter 110 may by causing the TEDID to implement processes for the generation, delivery, sensing and evaluation of an impedance signal, for example, based on an impedance differential between an embolism or clot and blood.

[0027] Generally, in various embodiments, the processing unit 130 may comprise a microcontroller or microprocessors, suitable memory, and wireless communications modules (e.g., microchips or circuits), for example, suitable for communication via a desired communication interface. Additionally or alternatively, in some embodiments, the processing unit 130 may comprise one or more integrated circuits comprising a suitable arrangement of transistors, LEDs, copper wires, tin-lead solder, EFTE coatings, or combinations thereof.

[0028] In some embodiments, the processing unit 130 may be configured to carry out a desired functionality. For example, the processing unit 130 may execute instructions stored in memory. The memory can include computer system readable media in the form of volatile memory, such as random-access memory (RAM) and/or cache memory. The memory may further include other removable/non-removable, volatile/non-volatile computer system storage media. As will be further depicted and described below, the memory may include at least one application configured to carry out the disclosed functionalities, for example, evaluation of an impedance signal and/or communication with an external device. For example, an application may be stored in the memory and may include a set of application program modules (e.g. software). In some cases, the application may also include an operating system and program data. According to various embodiments, the application program modules may be assembler instructions, instruction-set-architecture (ISA) instructions, machine instructions, machine dependent instructions, microcode, firmware instructions, statesetting data, or either source code or object code written in any combination of one or more programming languages, including an object oriented programming language such as Smalltalk, C++ or the like, and conventional procedural programming languages, such as the “C” programming language or similar programming languages. [0029] Additionally, in some embodiments, the processing unit may 130 may be configured for communication with an external device such as a mobile device (e.g., a smart-phone), a tablet, or a computer. For example, in various embodiments, the processing unit 130 may comprise one or more communication modules configured to provide communication via wireless connection such as radiofrequency (RF) signals (Bluetooth, Wi-Fi, for example), inductive coupling, optical signaling, acoustic signaling, conducted communication signals, and/or any other signals suitable for communication.

[0030] In some embodiments, the external device may comprise a user interface that allows a user to control and monitor the TEDID via the communication over the wireless connection. For example, the user interface may comprise a graphical user interface (GUI) that is displayed on a mobile device, tablet, or computer. In some embodiments, the user interface may be modifiable to meet the needs of different users or medical professionals. For example, the user interface may include different languages or font sizes to accommodate users with different backgrounds or visual impairments. The user interface may also include different modes or profiles for different types of functions or different users. The user interface may also include security features, such as passwords or biometric authentication, to ensure that only authorized users can access the device. Additionally, the user interface may allow a user to monitor the TEDID, to adjust settings, and to view real-time data from the TEDID. The user interface may also provide alerts or notifications when the TEDID requires attention, such as a low battery alarm, or when certain conditions are met, such as when an embolism or clot is detected.

[0031] In some embodiments, the processing unit may 130 may be configured to cause a stimulation current to be generated and delivered. For example, the processing unit 130 may include instructions that cause the signal circuitry 120 to generate the stimulation current and to cause the inferior vena cava sensing filter 110 to deliver the stimulation current. More particularly, in some embodiments, the processing unit 130 may include instructions that cause one or more of the electrodes to deliver the stimulation current. Additionally, the processing unit 130 may include instructions that cause the stimulation current to exhibit a desired parameter, for example, a A/C stimulation current having a frequency from about 1 hertz (Hz) to about 10 kHz, or from about 50 Hz to about 500 Hz, and a peak-to-peak voltage (Vpp) from about 3 volts (V) to about 9V, or from about 4V to about 8V or a D/C stimulation current about 3 volts (V) to about 9V, or from about 4V to about 8V.

[0032] In some embodiments, the processing unit 130 may include instructions that cause the stimulation current to be generated and delivered, for example, via the signal circuitry 120 and inferior vena cava sensing filter 110, at a predetermined interval, for example, about once every 10 minutes, alternatively, about every 30 minutes, alternatively, about every 60 minutes, alternatively, about every 2 hours, alternatively, about every 4 hours, alternatively, about every 8 hours, alternatively, about every 12 hours, alternatively, about every 24 hours, alternatively, about every 36 hours or, alternatively, about every 48 hours, Additionally or alternatively, the processing unit 130 may cause the stimulation current to be generated and delivered upon receipt of a prompt, such as from the external device via the wireless communication. For example, the processing unit 130 may be configured to receive one or more inputs, such as via the user interface, to control the operation of the TEDID 100. In various embodiments, the processing unit 130 may receive an indication of the frequency with which the stimulation current is generated and deliver to the inferior vena cava sensing filter 110.

[0033] Additionally, the processing unit may 130 may be configured to cause an impedance signal, for example, including impedance data such as current and/or voltage that can be used to calculate the impedance, to be collected and to evaluate the impedance data, for example, to determine presence of an embolism or clot captured by the inferior vena cava sensing filter 110. For example, the processing unit 130 may receive, via the inferior vena cava sensing filter 110 and the signal circuitry 120, one or more impedance signals resultant from the stimulation current delivered via the one or more electrodes. Additionally, the processing unit may evaluate the one or more resultant impedance signals, for example, based upon differential impedance, more particularly, based on an impedance differential between the embolism and blood, to determine if an embolism or clot is present, that is, to determine if an embolism or clot has been captured by the inferior vena cava sensing filter 110.

[0034] Additionally, in some embodiments, where the processing unit 130 determines that an embolism or clot has been captured by the inferior vena cava sensing filter 110, the processing unit 130 may further generate a tomographic image representative of the embolism or clot, for example, based on an impedance differential between the embolism and blood. Generally, the tomographic image may include or indicate various characteristics associated with the embolism or clot, for example, its size or position. In some embodiments, the processing unit 130 may generate the tomographic image via a suitable software, an example of which is publicly available as Electrical Impedance Tomography and Diffuse Optical Tomography Reconstruction Software (EIDORS). An example of a tomographic image 200 is illustrated with respect to Figure 2.

[0035] Also, in various embodiments, the processing unit 130 may be configured to communicate various electrical impedance data to the external device. For example, in some embodiments, the processing unit 130 may be configured to communicate the results and/or an indication of the results of the evaluation of impedance data to the external device. For example, upon determining the presence or absence of an embolism of clot, the processing unit 130 may be configured to communicate an indication of the result of such determination to the external device; for example, a visual, tactile, and/or audible alert may be sent to the external device. Additionally or alternatively, upon generating a tomographic image indicative of the embolism or clot, the processing unit 130 may be configured to communication the tomographic image to the external device.

[0036] Additionally or alternatively, in some embodiments, the processing unit 130 may be configured to communicate the one or more impedance signals resultant from the stimulation current delivered via the one or more electrodes, for example received via the signal circuitry 120 and inferior vena cava sensing filter 110, to the external device. For example, while in some embodiments the impedance signals received from the signal circuitry 120 and inferior vena cava sensing filter 110 may be processed (e.g., evaluated) by the processing unit 130 to determine the presence of an embolism or clot, additionally or alternatively, in some embodiments the impedance signals may be communicated to the external device and the external device may evaluate the impedance signals to likewise determine the presence or absence of an embolism or clot. Also, while in some embodiments the impedance signals received from the signal circuitry 120 and inferior vena cava sensing filter 110 may be processed (e.g., evaluated) by the processing unit 130 to generate a tomographic image indicative of an embolism or clot, additionally or alternatively, in some embodiments the impedance signals may be communicated to the external device and the external device may evaluate the impedance signals to likewise generate a tomographic image.

[0037] In some embodiments, the power source 140 may generally be configured to provide power for the operation of the TEDID 100. For example, the power source 140 may comprise a battery and/or a battery management system. Examples of suitable batteries may include a rechargeable battery, such as a lithium ion battery.

[0038] Referring to Figure 3, an embodiment of a TEDID 300 is illustrated, including an inferior vena cava sensing filter 310, an implantable control unit 340, and a plurality of leads 320 extending between the inferior vena cava sensing filter 310 and the implantable control unit 340.

[0039] In the embodiment of Figure 3, an example of a suitable configuration for an inferior vena cava sensing filter 310. In the embodiment of Figure 3, the inferior vena cava sensing filter 310 generally comprises a plurality of frame members 312, each of which extends generally axially outward so as to collectively form the inferior vena cava sensing filter. Also in the embodiment of Figure 3, any suitable number (e.g., all) of the frame members may be configured as electrodes, for example, such that the frame members may deliver the stimulation signal and/or sense the impedance signal. [0040] Also in the embodiment of Figure 3, the implantable control unit 340 may generally be configured to house various components of the TEDID 300. For example, the implantable control unit 340 may, in some embodiments, house the signal circuitry 120, the processing unit 130, and/or the power source 140 as disclosed with respect to Figure 1. As will be disclosed herein, the implantable control unit 340 may be configured to be implanted within a patient.

[0041] In some embodiments, a TEDID as disclosed herein, for example, the TEDID 300 of Figure 3, may be utilized in a procedure to monitor a patient, for example, who may be characterized as having or at risk for developing a venous thromboembolic disease, for example, such that the patient is an increased risk for developing embolisms or clots.

[0042] In some embodiments, the TEDID 300 may be implanted within the patient according to a placement procedure. Generally, a procedure for the placement of the TEDID 300 may include pre-procedural imaging, such as MRI or CT angiography, to determine an intended deployment site.

[0043] In some embodiments, the procedure comprises accessing the venous system through peripheral tributary veins via a needle, followed by the insertion of a series of guidewires and catheters, until the intended site in the inferior vena cava is reached and the final catheter size for insertion of the filter is achieved. The inferior vena cava sensing filter 310 may then be attached to the leads 320. The length of the leads 320 may be confirmed via the preoperative imaging, such that the leads 320 of sufficient length to extend between the intended site of deployment for the inferior vena cava sensing filter 310 and the subcutaneous pocket where the implantable control unit 340 will be disposed. After ensuring the inferior vena cava sensing filter 310 functions correctly and that the electrical connections to the leads 320 are correct, the inferior vena cava sensing filter 310 may be inserted and deployed at the implantation site by following the length of the catheter, with live or intermittent imaging used during placement. In some embodiments, further imaging may be performed to confirm the placement and orientation of the inferior vena cava sensing filter 310. The catheter may them be removed from the axillary port and pressure is maintained held on the insertion site.

[0044] In some embodiments, following placement of the, the inferior vena cava sensing filter 310, with the leads 320 connected thereto, the leads 320 may be connected to the implantable control unit 340, thereby providing signal communication between the inferior vena cava sensing filter 310 and the signal circuitry 120 and the processing unit 130, as disclosed with respect to Figure 1. The processing unit 130 may then be programmed and tested to confirm signal communication with the inferior vena cava sensing filter 310.

[0045] In some embodiments, the inferior vena cava sensing filter's placement within the vein may be adjustable to accommodate patient-specific anatomical variance, prior surgical history, comorbidities, and preference for control unit placement. For example, generally, the spatial configuration of the filter relative to the implantable control unit may dictate the connection protocol. When the implantable control unit is superior to the inferior vena cava, the sensing filter and leads may be affixed at a connection point with locking and alignment capabilities for the wires and electrodes. For example, this junction may facilitate an integrated test and deployment of the sensing apparatus and leads. Also for example, if the control unit is positioned inferiorly or laterally to the inferior vena cava, an alternative sensing filter design may be utilized, which features an inferiorly located connection point at the filter's apex. This juncture can be established pre- or post-filter deployment. In various embodiments, any suitable connection mechanism may be employed. For example, the connection may employ weak magnetic forces for alignment and securing, and/or may utilize a hook-based approach. Post-deployment, the leads may be connected to the inferior vena cava sensing filter via a superior or inferior connection point, routed through tributary veins, and exiting through the venous wall. The procedural initiation, involving venous dilation for lead placement coupled with the venous system's low-pressure attribute, may serve to mitigate the probability of excessive hemorrhage from the procedure. Next, the implantable control unit 340 may be implanted under the skin, for example, similar to placement of a pacemaker, such as within the patient’s chest. Not intending to be bound by theory, placement within the patient’s chest area may provide ease of access for future maintenance and may provide relatively little discomfort for the patient. Alternatively, in some embodiments the implantable control unit 340 may be implanted submuscularly.

[0046] Following placement of the implantable control unit 340, local anesthetic may be placed around the insertion site and the patient may be held in the hospital for at least 24 hours postoperatively. The patient may also be imaged again, for example, to confirm placement of the implant control unit 340 and/or to confirm placement and functionality (e.g., connections) of the inferior vena cava sensing filter 310.

[0047] Once the TEDID 300 has been implanted, the TEDID 300 may monitor for the presence of an embolism or clot within the inferior vena cava sensing filter 310. For example, as disclosed herein, the TEDID 300 may function both to capture an embolism or clot and, also to detect, image, and monitor embolisms or clots in patients, that is, capture by the inferior vena cava sensing filter 310. For example, as also disclosed herein, the TEDID 300 as disclosed herein may also send real-time information and imaging to the physician when an embolism or clot is detected.

[0048] In some embodiments, the TEDID 300 may be advantageously used as a replacement for conventional inferior vena cava filters. The capability to image the embolism or clot according to disclosure, notably, does not use radiation for imaging and the initial imaging can be completed in under one second, cutting down on radiation exposure for patients. Additionally, in some embodiments the TEDID 300 can also be configured to detect dislodging of the inferior vena cava sensing filter 310, thereby enabling early detection of life-threatening events. Finally, the TEDID 300 as disclosed herein can also help reduce the use of lifetime anticoagulant therapy and reduce the risk of hemorrhages and drug interferences. These all lead to reduced healthcare costs to insurers, Medicare/Medicaid, hospitals, and patients. [0049] In various additional embodiments, a similar device may be configured for implantation in various other large veins, such as the superior vena cava or hepatic portal vein.

[0050] Certain additional embodiments of the subject matter disclosed herein are set forth herein below.

[0051] Embodiment 1 is a thromboembolic event detection and imaging device comprising an inferior vena cava sensing filter; signal circuitry; a processing unit; and a power source.

[0052] Embodiment 2 is the thromboembolic event detection and imaging device of Embodiment 1 , wherein the inferior vena cava sensing filter is made of a medically- suitable metal.

[0053] Embodiment 3 is the thromboembolic event detection and imaging device of Embodiment 2, wherein the medically-suitable metal comprises nitinol, stainless steel, a cobalt-chromium alloy, or combinations thereof.

[0054] Embodiment 4 is the thromboembolic event detection and imaging device of Embodiment 1 , wherein the inferior vena cava sensing filter comprises a plurality leads connected to the inferior vena cava sensing filter.

[0055] Embodiment 5 is the thromboembolic event detection and imaging device of Embodiment 4, wherein the plurality of leads are made of MP-35N or MP-35N including titanium, platinum, or a platinum-iridium alloy.

[0056] Embodiment 6 is the thromboembolic event detection and imaging device of Embodiment 1 , wherein the processing unit comprises a microcontroller and a wireless communications module.

[0057] Embodiment 7 is the thromboembolic event detection and imaging device of Embodiment 1 , wherein the power source comprises a lithium-ion battery and a battery management system.

[0058] Embodiment 8 is the thromboembolic event detection and imaging device of any one of Embodiments 1-7, wherein the thromboembolic event detection and imaging device is configured to detect an embolism when deployed in a patient.

[0059] Embodiment 9 is the thromboembolic event detection and imaging device of any one of Embodiments 1-8, wherein the thromboembolic event detection and imaging device is configured to image an embolism when deployed in a patient.

[0060] Embodiment 10 is the thromboembolic event detection and imaging device of any one of Embodiments 1-9, wherein the thromboembolic event detection and imaging device is configured to use electrical impedance tomography to generate an image of an embolism based on an impedance differential between the embolism and blood.

[0061] Embodiment 11 is a method of monitoring for a thromboembolic event, the method comprising providing a thromboembolic event detection and imaging device, wherein the thromboembolic event detection and imaging device comprises an inferior vena cava sensing filter; signal circuitry; a processing unit; and a power source; and placing the inferior vena cava sensing filter within an inferior vena cava of a patient.

[0062] Embodiment 12 is the method of Embodiment 11 , wherein the inferior vena cava sensing filter is made of a medically-suitable metal.

[0063] Embodiment 13 is the method of Embodiment 12, wherein the medically- suitable metal comprises nitinol, stainless steel, a cobalt-chromium alloy, or combinations thereof.

[0064] Embodiment 14 is the method of Embodiment 11 , wherein the inferior vena cava sensing filter comprises a plurality leads connected to the inferior vena cava sensing filter.

[0065] Embodiment 15 is the method of Embodiment 14, wherein the plurality of leads are made of MP-35N or MP-35N including titanium, platinum, or a platinum-iridium alloy.

[0066] Embodiment 16 is the method of Embodiment 14, wherein the processing unit comprises a microcontroller and a wireless communications module.

[0067] Embodiment 17 is the method of Embodiment 14, wherein the power source comprises a lithium-ion battery and a battery management system.

[0068] Embodiment 18 is the method of any one of Embodiment 11-17, wherein the thromboembolic event detection and imaging device is configured to detect an embolism when deployed in a patient.

[0069] Embodiment 19 is the method of any one of Embodiment 11-18, wherein the thromboembolic event detection and imaging device is configured to image an embolism when deployed in a patient.

[0070] Embodiment 20 is the method of any one of Embodiment 11-19, wherein the thromboembolic event detection and imaging device is configured to use electrical impedance tomography to generate an image of an embolism based on an impedance differential between the embolism and blood.

[0071] Embodiment 21 is the method of any one of Embodiment 11-20, further comprising capturing an embolism in the inferior vena cava sensing filter.

[0072] Embodiment 22 is the method of Embodiment 21 , further comprising detecting the embolism captured in the inferior vena cava sensing filter.

[0073] Embodiment 23 is the method of one of Embodiments 21-22, further comprising determining a size of the embolism captured in the inferior vena cava sensing filter.

[0074] Embodiment 24 is the method of Embodiment 23, wherein determining the size of the embolism comprises utilizing electrical impedance tomography to generate an image of the embolism.

[0075] Embodiment 25 is the method of one of Embodiments 21-24, wherein detecting the embolism captured in the inferior vena cava sensing filter comprises generating a stimulation current; and delivering the stimulation current via at least one of a plurality of electrodes of the inferior vena cava sensing filter.

[0076] Embodiment 26 is the method of Embodiment 25, wherein detecting the embolism captured in the inferior vena cava sensing filter further comprises collecting a resultant impedance signal via two or more other electrodes of the inferior vena cava sensing filter; and evaluating the resultant impedance signal.

[0077] Embodiment 27 is the method of one of Embodiments 21-26, further comprising communicating a signal indicative of the embolism captured in inferior vena cava sensing filter to an external device.

[0078] Embodiment 28 is the method of any one of Embodiments 11-27, further comprising communicating a signal indicative of the inferior vena cava sensing filter becoming dislodged.

[0079] While embodiments of the disclosure have been shown and described, modifications thereof can be made by one skilled in the art without departing from the scope or teachings herein. The embodiments described herein are exemplary only and are not limiting. Many variations and modifications of the systems, apparatus, and processes described herein are possible and are within the scope of the disclosure. For example, the relative dimensions of various parts, the materials from which the various parts are made, and other parameters can be varied. Accordingly, the scope of protection is not limited to the embodiments described herein, but is only limited by the claims that follow, the scope of which shall include all equivalents of the subject matter of the claims. Unless expressly stated otherwise, the steps in a method claim may be performed in any order. The recitation of identifiers such as (a), (b), (c) or (1 ), (2), (3) before steps in a method claim are not intended to and do not specify a particular order to the steps, but rather are used to simplify subsequent reference to such steps.

Claims

CLAIMS What is claimed is:

1 . A thromboembolic event detection and imaging device comprising: an inferior vena cava sensing filter; signal circuitry; a processing unit; and a power source.

2. The thromboembolic event detection and imaging device of claim 1 , wherein the inferior vena cava sensing filter is made of a medically-suitable metal.

3. The thromboembolic event detection and imaging device of claim 2, wherein the medically-suitable metal comprises nitinol, stainless steel, a cobalt-chromium alloy, or combinations thereof.

4. The thromboembolic event detection and imaging device of claim 1 , wherein the inferior vena cava sensing filter comprises a plurality leads connected to the inferior vena cava sensing filter.

5. The thromboembolic event detection and imaging device of claim 4, wherein the plurality of leads are made of MP-35N or MP-35N including titanium, platinum, or a platinum-iridium alloy.

6. The thromboembolic event detection and imaging device of claim 1 , wherein the processing unit comprises a microcontroller and a wireless communications module.

7. The thromboembolic event detection and imaging device of claim 1 , wherein the power source comprises a lithium-ion battery and a battery management system.

8. The thromboembolic event detection and imaging device of any one of claims 1-7, wherein the thromboembolic event detection and imaging device is configured to detect an embolism when deployed in a patient.

9. The thromboembolic event detection and imaging device of any one of claims 1-8, wherein the thromboembolic event detection and imaging device is configured to image an embolism when deployed in a patient.

10. The thromboembolic event detection and imaging device of any one of claims 1-9, wherein the thromboembolic event detection and imaging device is configured to use electrical impedance tomography to generate an image of an embolism based on an impedance differential between the embolism and blood.

11. A method of monitoring for a thromboembolic event, the method comprising: providing a thromboembolic event detection and imaging device, wherein the thromboembolic event detection and imaging device comprises: an inferior vena cava sensing filter; signal circuitry; a processing unit; and a power source; and placing the inferior vena cava sensing filter within an inferior vena cava of a patient.

12. The method of claim 11 , wherein the inferior vena cava sensing filter is made of a medically-suitable metal.

13. The method of claim 12, wherein the medically-suitable metal comprises nitinol, stainless steel, a cobalt-chromium alloy, or combinations thereof.

14. The method of claim 11 , wherein the inferior vena cava sensing filter comprises a plurality leads connected to the inferior vena cava sensing filter.

15. The method of claim 14, wherein the plurality of leads are made of MP-35N or MP-35N including titanium, platinum, or a platinum-iridium alloy.

16. The method of claim 14, wherein the processing unit comprises a microcontroller and a wireless communications module.

17. The method of claim 14, wherein the power source comprises a lithium-ion battery and a battery management system.

18. The method of any one of claims 11-17, wherein the thromboembolic event detection and imaging device is configured to detect an embolism when deployed in a patient.

19. The method of any one of claims 11-18, wherein the thromboembolic event detection and imaging device is configured to image an embolism when deployed in a patient.

20. The method of any one of claims 11-19, wherein the thromboembolic event detection and imaging device is configured to use electrical impedance tomography to generate an image of an embolism based on an impedance differential between the embolism and blood.

21. The method of any one of claims 11-20, further comprising capturing an embolism in the inferior vena cava sensing filter.

22. The method of claim 21 , further comprising detecting the embolism captured in the inferior vena cava sensing filter.

23. The method of one of claims 21 -22, further comprising determining a size of the embolism captured in the inferior vena cava sensing filter.

24. The method of claim 23, wherein determining the size of the embolism comprises utilizing electrical impedance tomography to generate an image of the embolism.

25. The method of one of claims 21-24, wherein detecting the embolism captured in the inferior vena cava sensing filter comprises: generating a stimulation current; and delivering the stimulation current via at least one of a plurality of electrodes of the inferior vena cava sensing filter.

26. The method of claim 25, wherein detecting the embolism captured in the inferior vena cava sensing filter further comprises: collecting a resultant impedance signal via two or more other electrodes of the inferior vena cava sensing filter; and evaluating the resultant impedance signal.

27. The method of one of claims 21-26, further comprising communicating a signal indicative of the embolism captured in inferior vena cava sensing filter to an external device.

28. The method of any one of claims 11-27, further comprising communicating a signal indicative of the inferior vena cava sensing filter becoming dislodged.