Systems and methods for controlling operability of multiple medical devices

Abstract

An apparatus arrangement characterized by: a housing; an input / output (I / O) interface; and one or more control logic units disposed to operate within the housing and communicatively coupled to the I / O interface. Each of the one or more control logic units can be configured to: (i) control operation of at least one medical device controlled by a control logic unit of the one or more control logic units when the medical device is communicatively coupled to the I / O interface; and (ii) collect a subset of data acquired at least during placement of a vascular access device within a vasculature of a patient.

Description

[0001] priority

[0002] This application claims priority to U.S. Provisional Application No. 62 / 991,782, filed March 19, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This application relates to the field of medical devices, and more specifically to systems and methods for controlling the operability of multiple medical devices. Background Technology

[0004] Over the years, various techniques have been developed for use with devices such as catheters to guide blood vessels. The selection of the correct type of endovascular guidance technique is based at least in part on an assessment of the patient's needs, venous anatomy, health and medical history, and consideration of treatment recommendations for suspected diagnoses. In emergency situations, where time is of the essence, it is crucial for healthcare facilities (e.g., hospitals, emergency rooms, etc.) to provide clinicians with a wide range of available endovascular guidance techniques. Given that most of these endovascular guidance techniques are deployed as standalone systems, healthcare facilities are forced to purchase different types of endovascular guidance devices to provide an acceptable standard of care. Purchasing these systems imposes significant financial costs on healthcare facilities. Furthermore, these systems occupy valuable building space within these facilities.

[0005] This paper discloses a data acquisition module that operates in conjunction with a central computing platform and provides connectivity to different types of medical devices, especially those involving different types of intravascular guidance technologies. Summary of the Invention

[0006] In short, one embodiment of the disclosed content relates to a customizable medical device monitoring system. In this document, the medical device monitoring system is characterized by a data acquisition module including a first input / output (I / O) interface and a second I / O interface. The data acquisition module operates as an intermediary between a central computing platform (communically coupled to the first I / O interface) and one or more medical devices responsible for intravascular guidance (hereinafter referred to as "medical devices (one or more)", communicatively coupled to the second I / O interface). For example, the second I / O interface may be adapted to receive (i) a connector located proximally at each medical device (e.g., a connector located proximally at the medical device, proximally at an interconnect associated with the medical device, etc.) or (ii) a connector serving as an intermediary between the second I / O interface and a connector associated with a selected medical device. For example, the intermediary connector may be a connector integrated within a sterile drape (e.g., a penetration barrier / window (fiber optic) connector) that can provide a communicative connection (e.g., mechanical, optical, and / or electrical connection) to the medical device located on the sterile side of the drape. Alternatively, the data acquisition module can be configured to reside in a sterile environment (e.g., on the sterile side of a cover) using a through-barrier / window (fiber optic) connection, which can be assisted by through-barrier palpation, illumination, and / or a magnetic indicator / assist.

[0007] In some implementations, the medical device (one or more) may be accompanied by a vascular access device inserted into the patient's vascular system (e.g., one or more blood vessels) or may be positioned outside the patient's body. When accompanied by a vascular access device within the patient's vascular system (e.g., with a catheter), the medical device is configured to acquire a subset of data during and after placement of the vascular access device. As an illustrative example, the acquired data may include, but is not limited to: (i) vascularization data, which are associated with the structure and / or contents of the patient's vascular system; (ii) intravascular guidance data, which are associated with the physical state of the medical device (e.g., length, shape, form, and / or orientation) for guidance during placement of the vascular access device; and / or (iii) data associated with monitored systems or organs within the patient. Of course, when the medical device is positioned outside the patient's body, the acquired data may focus on the intravascular guidance of the vascular access device rather than the medical device itself, while also acquiring vascularization data and monitoring data.

[0008] The central computing platform is connected to the first I / O interface of the data acquisition module via a wired or wireless interconnect. The central computing platform can be configured to analyze acquired data received from the data acquisition module, wherein the analysis results can be transmitted to a remote positioning device for viewing or displayed on a screen (integrated into or separate from the central computing platform) for clinicians to view. I / O selection logic can control the selection of which medical devices are operable. Examples of device selection may include, but are not limited to, the following: (i) automatic device selection based on connectivity to the data acquisition module (e.g., which medical devices(one or more) in operation are connected to the second I / O interface); (ii) manual device selection based on a user interface located on the housing of the data acquisition module (or computing platform) and accessible to the clinician for manually selecting which medical devices or which medical devices are operable; or similar methods.

[0009] Another embodiment of the disclosed text relates to a central computing platform adapted to one or more connectors to establish operational communication with different data acquisition modules, each suited for a different intravascular guidance technique. In this embodiment, the central computing platform includes components enabling analysis of data provided by any of the data acquisition modules, and each of these data acquisition modules is customized to include components supporting communication necessary for a specific type of intravascular guidance technique provided by a medical device (or multiple medical devices) connected to that data acquisition module. The data acquisition modules are configured to acquire data used to determine the placement and / or physical state of the vascular access device and can be used as reference points for planar markers / orientations (for spatial analysis) or centerline markers and misalignment markers associated with fiber optic shape sensing via an internal sensor inscribed with one or more core fibers (which receive reflected light signals that, based on their phase changes, can determine misalignment).

[0010] Furthermore, each of these data acquisition modules is removably coupled to the central computing platform, allowing for the removal and addition of any module to enhance the functionality of the medical device monitoring system or to replace another module. This system architecture enables the central computing platform to support multiple types of medical devices that can be interchanged based on patient needs. Interchangeability offers a significant cost advantage, as different clinicians can use the same central computing platform and expand its functionality by purchasing additional data acquisition modules. Interchangeability also provides a significant advantage for patient health, as clinicians can immediately deploy different vascular access devices in emergency situations when a patient's condition changes.

[0011] As an illustrative example, the first data acquisition module may include a first connector for establishing communication with and potentially receiving power from a central computing platform. The first data acquisition module may further include a second connector supporting connectivity to a subset of medical devices supported by the central computing platform, such as a single endovascular access device supporting specific intravascular guidance technologies (e.g., fiber optic, electrical, ultrasound, spatial, and / or magnetic) or multiple endovascular access devices with complementary operability (e.g., fiber optic and electrical providing optical three-dimensional shape sensing). Alternatively, instead of the second connector, the medical device may be hardwired to the first data acquisition module.

[0012] These and other features of the invention will become clearer from the following description and appended claims, or may be learned by practicing the embodiments of the invention listed below. Attached Figure Description

[0013] A more specific description of the disclosure will be presented with reference to specific embodiments shown in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and are therefore not intended to limit the scope of the invention. Exemplary embodiments of the invention will be described and explained by way of additional features and details in the drawings, using the accompanying drawings:

[0014] Figure 1 This is a first illustrative embodiment of a medical device monitoring system including a media data acquisition module that provides interconnectivity between a central computing platform and one or more medical devices;

[0015] Figure 2 It is deployed in Figure 1 An exemplary implementation of a component within a data acquisition module provides connectivity between one or more medical devices and a centralized computing platform;

[0016] Figure 3AThis is an exemplary implementation of a fiber control logic unit deployed in... Figure 2 Within the data acquisition module, operational communication with functional medical devices, including fiber-optic-based devices, is enabled;

[0017] Figure 3B This is an exemplary implementation of an ultrasonic control logic unit, which is deployed in... Figure 2 Within the data acquisition module, operational communication with the ultrasound probe is enabled;

[0018] Figure 3C This is an exemplary implementation of a space control logic unit, which is deployed in... Figure 2 Within the data acquisition module, operational communication with medical devices, including those with spatial assessment functions, is enabled;

[0019] Figure 3D This is an exemplary implementation of a sensor control logic unit, which is deployed in... Figure 2 Within the data acquisition module, operational communication with medical devices, including magnetic sensors, is enabled;

[0020] Figure 3E This is an exemplary implementation of an electrical control logic unit deployed in... Figure 2 Within the data acquisition module, operational communication with functional medical devices, including those based on electrical signals, is enabled;

[0021] Figure 4A This is a second illustrative embodiment of a medical device monitoring system, which includes a central computing platform and one or more data acquisition modules that support connectivity with one or more medical devices;

[0022] Figure 4B This is a perspective view of the first surface of a computing platform, including an exemplary embodiment of a first input / output (I / O) interface of the computing platform;

[0023] Figure 4C This is a perspective view of the second surface of a computing platform, including an exemplary embodiment of a second I / O interface of the computing platform;

[0024] Figure 4D It can be communicatively connected to Figure 4A A perspective view of the data acquisition module of the computing platform;

[0025] Figure 4EThis is an exemplary implementation of a medical device monitoring system that includes a data acquisition module, which is stacked and communicatively connected to a second I / O interface of a computing platform;

[0026] Figure 4F This is an exemplary implementation of a medical device monitoring system that includes a data acquisition module, which is communicatively connected to each of a first I / O interface and a second I / O interface of a computing platform;

[0027] Figure 5A This is the third illustrative implementation scheme for a medical device monitoring system;

[0028] Figure 5B It involves the use of with Figure 5A A perspective view of the first surface of an exemplary embodiment of a data acquisition module that communicates with a computing platform;

[0029] Figure 5C This is a perspective view of the second surface of an exemplary embodiment of a data acquisition module for communicatively connecting with another data acquisition module;

[0030] Figure 5D This is an exemplary implementation of a medical device monitoring system that includes multiple data acquisition modules serially connected to a computing platform. Detailed Implementation

[0031] Referring now to the accompanying drawings, in which the same structures will have the same reference numerals. It should be understood that the drawings are illustrations and schematic representations of exemplary embodiments of the invention, and are neither limiting nor necessarily drawn to scale.

[0032] Regarding the terminology used herein, it should be understood that these terms are for the purpose of describing certain specific embodiments and do not limit the scope of the concepts presented herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different components or different operations and do not provide for a sequence or numerical limitation. For example, the components or operations “first,” “second,” and “third” do not necessarily appear in this order, and a particular embodiment including such components or operations is not necessarily limited to these three components or operations. Similarly, labels such as “left,” “side,” “right,” “up,” “down,” “front,” and “rear” are used for convenience and are not intended to imply, for example, any particular fixed position, orientation, or direction. Rather, such labels are used to reflect, for example, relative position, orientation, or direction. The singular forms “a,” “an,” and “the” include plural references unless the context clearly indicates otherwise.

[0033] The terms “logic,” “logic unit,” and “component” represent hardware and / or software configured to perform one or more functions. As hardware, logic (or logic unit or component) can include circuit systems with data processing and / or storage capabilities. Examples of such circuit systems may include, but are not limited to, processors, programmable gate arrays, microcontrollers, application-specific integrated circuits (ASICs), combinational circuit systems, etc. Alternatively or in combination with the hardware circuit systems described above, logic (or logic unit or component) can be software in the form of one or more software modules that can be configured to operate as their corresponding circuit systems. Software modules can include, for example, executable applications, daemon applications, application programming interfaces (APIs), subroutines, functions, procedures, routines, source code, or even one or more instructions. Software modules (one or more) can be stored in any type of suitable non-transitory storage medium, such as programmable circuits, semiconductor memories, non-persistent memories such as volatile memories (e.g., any type of random access memory “RAM”), persistent memories such as non-volatile memories (e.g., read-only memories “ROM,” powered RAM, flash memory, phase-change memory, etc.), solid-state drives, hard disk drives, optical disk drives, or portable storage devices.

[0034] The term "interconnect" can be interpreted as a physical or logical communication path between two or more components or devices including such components. For example, a physical communication path can include wired or wireless transmission media. Examples of wired and wireless transmission media include wires, optical fibers, cables, bus traces, radio units supporting radio frequency (RF) signaling, or any other conventional wired / wireless signaling transmission mechanism. A logical communication path can include any mechanism that allows the exchange of content between different logics or different components. Similarly, the term "signaling" or "signal" generally refers to data in a prescribed format (such as analog or digital formats for electrical signaling, light pulses for optical signaling, etc.). Data associated with signaling can be propagated over interconnects supporting a specific type of signaling according to appropriate transmission protocols.

[0035] For clarity, it should be understood that the term "distal" refers to the direction relatively closer to the patient (as described herein, on which the medical device will be used), while the term "proximal" refers to the direction relatively farther from the patient. Furthermore, the terms "comprising," "having," and "with" as used herein (including the claims) should have the same meaning as the term "including."

[0036] Finally, in the following description, the terms “or” and “and / or” as used herein will be interpreted as inclusive or meaning any one or any combination thereof. For example, “A, B or C” or “A, B and / or C” means “any one of the following: A; B; C; A and B; A and C; B and C; A, B and C”. Exceptions to this definition occur only when the combination of elements, components, functions, steps, or actions is inherently mutually exclusive in some way.

[0037] refer to Figure 1 An illustrative embodiment of a medical device monitoring system 100 is shown. The medical device monitoring system 100 generally includes a computing platform 110 and a data acquisition module 120, which is communicatively connected to the computing platform 110 and one or more medical devices 1301-130. N (N≥1; for this embodiment, N=5). According to one embodiment of the disclosed text, the data acquisition module 120 may be configured to operate as a vascular access data interpretation / transmission module (i.e., interface) configured to support the propagation of data from multiple (e.g., two or more) medical devices 1301-1305 (e.g., N=5) to the computing platform 110, the data being associated with at least the placement and / or physical state (e.g., length, shape, form, and / or orientation) of the vascular access device. Each medical device 1301...or 1305 is characterized by the following logic: providing data to the data acquisition module 120 to identify the at least placement and / or physical state (e.g., length, shape, form, and / or orientation) of the vascular access device within the patient's vascular system. Examples of types of vascular access devices may include, but are not limited to, catheters.

[0038] As shown, the data acquisition module 120 can be configured to be physically separate from the computing platform 110 (e.g., an external module) and includes logic capable of acquiring at least a subset of data from different sources (e.g., medical devices 1301-1305) without analyzing (e.g., calculating / description) the acquired data. The data acquisition module 120 supports communication with different types of medical devices that rely on various intravascular guidance technologies. For example, medical devices 1301-1305 can return data acquired using technologies such as optical (e.g., fiber optics), ultrasound (e.g., ultrasound probes), spatial (e.g., multiple electrodes relying on magnetic field effects), magnetic (e.g., multiple sensors), and / or electrical (e.g., electrical interconnections).

[0039] Specifically, according to one embodiment of the published text, the data acquisition module 120 may be configured to acquire data from one or more medical devices 1301-1305, wherein the type of data acquired provides information about the placement and / or physical state of a vascular access device being monitored by the medical device. For example, when the medical device 1301 is accompanied by a vascular access device, the acquired data may include, but is not limited to, the following: (i) vascularization data, which is associated with the structure and / or contents of the vascular system of the patient to whom the medical device 1301 is inserted; (ii) intravascular guidance data, which is associated with the physical state (e.g., length, shape, form, and / or orientation) of the medical device 1301 for guiding and / or determining the placement of the medical device 1301 within the vascular system; and / or (iii) monitoring data, which is associated with a specific system or organ within the patient, and so on. When the medical device 1301 is positioned outside the patient, although vascularization data and monitoring data may be acquired as described below, the acquired data may focus on intravascular guidance.

[0040] Still referencing Figure 1 The computing platform 110 is operatively connected to the data acquisition module 120 via an interconnect 140 (e.g., a wired interconnect 142 or a wireless interconnect 144). Through this interconnect 140, the computing platform 110 is configured to receive data from the medical device(s) 1301-130 via the data acquisition module 120. N The collected data can be analyzed by the computing platform 110 to produce analytical results, such as a three-dimensional (3-D) representation of the monitored vascular access device or a 3-D representation of a medical device that may be accompanied by a vascular access device. The 3-D representation is provided to enable clinicians to monitor the location and / or physical state of the vascular access device. When the computing platform 110 is operating as a console, the analytical results can be displayed on a display 150 integrated into the computing platform 110. Alternatively, the computing platform 110 can be configured to analyze the collected data and transmit the analytical results to (i) a display separate from the computing platform 110 or (ii) a networked device remotely located relative to the computing platform 110, which generates and / or provides results (e.g., visual or auditory presentations) for clinicians to review. Illustrative examples of certain components that may be deployed within the computing platform 110 are described in U.S. Patent No. 10,159,531, the entire contents of which are incorporated herein by reference.

[0041] As an illustrative example, computing platform 110 may include processor 112, memory 114, port 116, and power connector 118. Processor 112, which has access to memory 114 (e.g., non-volatile memory), is configured to control the functionality of system 100 and thus operates as a control processor. Port 116 is provided for communicative coupling to data acquisition module 110 and optional peripheral devices (e.g., printers, storage media, keyboards, etc.). In one embodiment, port 116 may include a Universal Serial Bus (USB) port, but another port type or combination of port types may be used. Power connector 118 is included with computing platform 110 to enable operative connection to an external power supply, but an internal power source (e.g., a backup battery) may also be used, with or without an external power supply. Power connector 118 may be further configured to regulate power usage and power distribution, wherein the I / O selection logic and power supply described for data acquisition module 120 are employed within computing platform 110.

[0042] Still referencing Figure 1 According to one embodiment of the published text, the data acquisition module 120 includes: a first I / O interface 160, which supports communication with the computing platform 110 via interconnect 140; and a second I / O interface 165, which supports communication via corresponding interconnects 1751-1752. N With medical device 1301-130 N Communication. Specifically, the first I / O interface 160 can be deployed as a physical or logical connector 162 to receive signal transmissions via a wired interconnect 142. Alternatively, the first I / O interface 160 can be deployed as a wireless transceiver (e.g., a wireless chipset including a wireless receiver and transmitter) to support communication with the computing platform 110 via a wireless interconnect 144. The second I / O interface 165 can be deployed as one or more connectors, each configured to support communication with medical devices 1301-130. N Communication. For example, each of one or more connectors can support communication with medical devices 1301-130. N A physical connection to another connector is achieved at the proximal end of one of the connectors. As another example, each or more connectors can be communicatively coupled to medical device 1301-130. N The communication connection can be between individual physical connectors, or between a connector associated with the data acquisition module 120 and the medical device 1301-130. N Hardwired connection between one or more of them or enabling data acquisition module 120 to connect with medical device 1301 to 130 N Any other type of connection that allows communication between one or more of them.

[0043] More specifically, according to one embodiment of the published text, the second I / O interface 165 may include a plurality of I / O connectors 1701-170. N Each I / O connector is 1701-170. N Configured to connect to connectors 1751-175 respectively N (and its corresponding medical device 1301-130) N (Associated) mating. The mating can be removable or permanent (hardwired). It is worth noting that each of the mating pairs of connectors 1701&1751, 1702&1752, 1703&1753, 1704&1754 and 1705&1755 can correspond to: (1) individual physical connectors connected together; (2) two different interfaces having hardwired connections (or activators / magnetizers) between one or more internal components of the data acquisition module 120 and the corresponding medical device 1301, and so on.

[0044] For example, as an illustrative example, the second I / O interface 165 may include an I / O connector 1701 configured to mate with an optical connector 1751 located at the proximal end of a multi-core optical fiber that operates at least as part of a medical device 1301 (e.g., a three-dimensional sensing needle). Alternatively or additionally, the second I / O interface 165 may include: (i) an I / O connector 1702 for mates with a connector 1752 (e.g., a connector 1752 located on or on an interconnect associated with the second medical device 1302) associated with the second medical device 1302, such as an ultrasound probe; and (ii) an I / O connector 1703 for mates with a connector 1753 (e.g., a connector 1753 located on or on an interconnect associated with the third medical device 1302) associated with the third medical device 1303, such as a multi-electrode, depending on which the multi-electrode is used around the patient's body. The difference between the transmitted and received magnetic field measurements at different locations is used for imaging; (iii) an I / O connector 1704 for mating with connector 1754, which is located on or on an interconnect associated with fourth medical device 1304, such as a magnetic sensor for tip positioning navigation; and / or (iv) an I / O connector 1705 for mating with connector 1755, which is associated with fifth medical device 1305, such as a sensor (e.g., an electrical sensor deployed at the distal end of fifth medical device 1305 to provide an electrocardiogram “ECG” signal), for receiving at least signal transmissions from a target source within the patient.

[0045] In this document, data acquisition module 120 (or each of the different data acquisition modules 450 / 550 described below) can be used as a reference point for: planar markings / orientations, centerline markings, and misalignment markings associated with a medical device (e.g., a needle including fiber optic 1301). Similarly, the data acquisition module (or each of the different data acquisition modules 450 / 550 described below) can exist as an in-the-bed module deployed beneath a sterile drape with a through barrier / window, and therefore, one or more media I / O connectors may be required to connect the computing platform 110 to the data acquisition module (or... Figure 4A / Figure 5A Establish a communication connection between modules 450 / 550.

[0046] Now for reference Figure 2 An exemplary embodiment of a data acquisition module 120 and its internal components deployed therein is shown. According to this embodiment, the data acquisition module 120 is characterized by a housing 200, which is wholly or partially made of a rigid material (e.g., hardened plastic, metal, glass, composite material, or any combination thereof). The housing 200 provides connectors 162 associated with a first I / O interface 160 and connectors 1701-170 associated with a second I / O interface 165. N The housing 200 provides access to the internal components 210 while protecting them from environmental conditions. As shown, a first I / O interface 160 may be located in a first region 202 of the housing 200, while a second I / O interface 165 may be located in a second region 204 of the housing 200. In this document, the first region 202 may be located on a side of the housing 200 opposite to the second region 204. Alternatively, one of the first region 202 or the second region 204 may be located on a front or rear surface of the housing 200, while the other may be located on a lateral surface (or side surface) of the housing 200.

[0047] As in Figure 2 As illustrated, as an illustrative example, the internal components 210 of the data acquisition module 120 are characterized by a power supply 220 (e.g., a power connector / regulator for an external power supply, or an internal power supply such as a backup battery), I / O selection logic 230, and multiple control logic units 2401-240. N Control logic unit 2401-240 N In terms of quantity (N), it can correspond to I / O connectors 1701-170. N The quantity or corresponding to medical devices 1301-130 supported by data acquisition module 120. NThe number. For this implementation in the publicly available text, multiple control logic units 2401-240 N The device may include a first (optical) control logic unit 2401, a second (ultrasound) control logic unit 2402, a third (spatial) control logic unit 2403, a fourth (sensor) logic unit 2404, and a fifth (electrical) control logic unit 2405. The control logic units 2401-2405, connected to connectors 1701-1705, respectively correspond to components that at least partially control the operability of medical devices 1301-1305.

[0048] According to one embodiment of the published text, I / O selection logic 230 is configured to select one or more of medical devices 1301-1305 for power supply and operation. Based on the connectivity of any of the medical devices 1301-1305 to their assigned data acquisition module 120 connectors 1701-1705, the selection of which medical device or medical device 1301-1305 is powered and operated can be automatically controlled (without user intervention). In other words, I / O selection logic 230 will detect the connection of any medical device 1301,..., or 1305 to its corresponding connector 1701,..., or 1705, and as a result, I / O selection logic 230 will allow power to be supplied from power supply 220 to one or more control logic units 2401,..., and / or 2405 via power interconnects 2501-2505. For example, I / O selection logic 230 can be configured to detect a connection of a first medical device 1301 (e.g., a multi-core fiber optic core) to the first connector 1701, which would allow power to be supplied from power supply 220 to the first (optical) control logic unit 2401. This detection can be performed via a sensing line (not shown) that can be used to detect whether the first medical device 1301 is connected to the first connector 1701.

[0049] Alternatively, I / O selection logic 230 is configured to allow a clinician to manually select which of the medical devices 1301-1305(if any) currently connected to the data acquisition module 120 will be powered and operated. According to one embodiment of the disclosed text, I / O selection logic 230 may include: switch logic 260 (e.g., one or more switches, cross switches, etc.) actuated by one or more physical components (e.g., buttons, knobs, toggle switches, etc.); or logic component optional elements on a display (e.g., LEDs (light-emitting diodes), LCDs (liquid crystal displays), etc.) accessible on the housing 200 (or located on a computing platform 110 having signal transmissions directed to I / O selection logic 230). For this embodiment of the disclosed text, the switch logic 260, accessible via the housing 200, allows the clinician to select any combination of operations for one or more of the medical devices 1301-1305. Upon selection, control logic units 2401-2405 corresponding to the selected medical device(s) 1301, ..., and / or 1305 are powered by power supply 220. Based on triggering events such as activation of physical actuators (e.g., movement of a pressable button, rotary knob, toggle switch) and / or activation of virtual actuators (e.g., optional elements on a graphical user interface), clinicians can select one or more of the control logic units 2401-2405 (and consequently one or more of the medical devices 1301-1305) to be powered and can be used to identify the placement and / or physical state of the vascular access device (or medical device accompanied by a vascular access device).

[0050] Alternatively, with the I / O selection logic 230 and power supply 220 deployed within the computing platform 110 as described above, the data acquisition module 120 will still include any combination of multiple control logic units 2401-2405, which can be powered from the computing platform 110 via the first I / O interface 160.

[0051] As further illustrated, the plurality of control logic units 2401-2405 include a first (optical) control logic unit 2401, a second (ultrasound) control logic unit 2402, a third (spatial) control logic unit 2403, a fourth (sensor) control logic unit 2404, and a fifth (electrical) control logic unit 2405. These control logic units 2401-2405 can be configured to acquire data from at least medical devices 1301-1305, wherein such data may relate to the placement of a vascular access device (e.g., a catheter, etc.) within a patient's vascular system. Some of these medical devices 1301, 1304, and / or 1305 can generate data suitable for placing a vascular access device when accompanied by a vascular access device within the patient, while other medical devices 1302 and / or 1303 can generate data suitable for placing a vascular access device when positioned close to and outside the patient. Data acquired can be received via data interconnect 270 (e.g., interconnects 2701-2705), where such data can be converted into digital signals for transmission to the first I / O interface 160 via data interconnect 280 (e.g., interconnects 2801-2805).

[0052] As an illustrative example, upon activation, the first (optical) control logic unit 2401 is powered to initiate incident light to a medical device 1301, which can be inserted into a catheter's Luer connector and reflects the incident light for reception by the first control logic unit 2401 via data interconnect 2701. Within the first control logic unit 2401, the reflected light can be converted into an electrical signal for transmission to a computing platform 110 for analysis via data interconnect 2801 and a first I / O interface 160. As another illustrative example, the third (spatial) control logic unit 2403 is powered to provide electrical signal transmission to multiple electrodes 1303 positioned on different sides of the patient to monitor the movement and subsequent placement of a vascular access device within the patient's vascular system based on measured magnetic field differences. The magnetic field differences are transmitted back to the third control logic unit 2403 as an electrical signal via data interconnect 2703. Within the third control logic unit 2403, these measurement results are forwarded to the computing platform 110 for analysis via the data interconnect 2803 and the first I / O interface 160.

[0053] refer to Figures 3A-3E , showed Figure 2 Exemplary implementations of the control logic units 2401-2405. In this document, as... Figure 3AThe illustration shows an illustrative embodiment of a first (optical) control logic unit 2401 configured to monitor the physical state and placement of an optical fiber 300 (e.g., a multi-core optical fiber). Specifically, the optical fiber 300 may be part of a medical device (cardiogram) 1301, for example, the medical device 1301 being inserted into a vascular access device 310 (such as an extension leg of a catheter). As a result, the physical state and placement of the vascular access device 310 can be inferred from the physical state and placement of the optical fiber 300. Electronics deployed within the first control logic unit 2401 are designed to relocate components associated with supporting the operability of the optical fiber 300 from the computing platform 110 into… Figure 1-2 The data acquisition module 120. According to one embodiment of the published text, the first control logic unit 2401 may be configured to include at least a light source 320 and a light-to-digital converter 322, but other components that support the transmission and reception of optical signals may also be deployed within the first control logic unit 2401 for subsequent analysis by the computing platform 110.

[0054] Specifically, according to this embodiment of the published text, the first control logic unit 2401 can be configured to receive a signal transmission from the computing platform 110 that triggers the light source 320 to emit an optical signal 324 to the optical connector 1701 of the data acquisition module 120 for transmission via the optical fiber 300. The optical signal 324 can operate as incident light, where the characteristics of the incident light signal (e.g., phase, etc.) can be used as a reference related to the characteristics of the reflected light, which returns to the optical connector 1701 from a sensor (e.g., an internal sensor such as a fiber Bragg grating (FBG) sensor) distributed along one or more core fibers maintained within the optical fiber 300. An optical-to-digital converter 322, which receives the reflected light 326 from the optical connector 1701, is responsible for converting the reflected light signal into an electrical signal 328 that can be analyzed by the computing platform 100, since changes in the characteristics of the reflected signal can identify the physical location and orientation of the optical fiber 300 for presentation on a display 150 associated with the computing platform 110.

[0055] Now for reference Figure 3BAn illustrative embodiment of a second (ultrasound) control logic unit 2402 is shown. Herein, the second control logic unit 2402 includes beamformer logic 330 and a transceiver 335 communicatively coupled to I / O connector 1702. Herein, beamformer logic 330 includes a transmitting beamformer 332 and a receiving beamformer 334. Specifically, the transmitting beamformer 332 is configured to transmit signal transmissions (e.g., electrical signals), wherein the phase and / or relative amplitude of the signal transmissions are controlled such that phase and / or amplitude changes can be detected by the receiving beamformer 334. Phase and / or amplitude changes can represent interference patterns, wherein such interference can be used to discern the shape and / or location of a vascular access device within the patient's vascular system.

[0056] Specifically, the transmitting beamformer 332, when activated, is configured to transmit a signal transmission (e.g., a specified current) with controlled phase and / or amplitude. The signal transmission is propagated from the transmitting beamformer 332 to the medical device (e.g., an ultrasound probe) 1302 via transceiver 335 and mating connectors 1702 and 1752. According to one embodiment of the disclosed text, transceiver 335 may perform certain signal transmission adjustments (e.g., filtering or other waveform shaping) before reception by the ultrasound probe 1302. Transceiver 335 may also operate as a switch to control the routing of the signal transmission from the transmitting beamformer 332 to connector 1702 and from connector 1702 to the receiving beamformer 334. Alternatively, transceiver 335 may be removed, wherein connector 1702 is characterized by a separate connector port dedicated to the communication paths of the transmitting (TX) and receiving (RX) ultrasound probes 1302.

[0057] An ultrasound probe 1302, operating as a transducer, typically includes an array of quartz crystals, each configured to transmit ultrasound waves into the patient when a signal transmission from a beamformer 332 is provided. When the ultrasound probe 1302 is placed directly on the patient's body and moved over the area to be observed, ultrasound echoes (e.g., ultrasound waves bouncing off objects within the patient's body, such as tissue blocks, vascular access devices, etc.) are detected by the quartz crystals within the ultrasound probe 1302. The crystals generate an electrical signal in response to the ultrasound echoes, which is returned to the beamformer receiver 334 via an I / O connector 1702 (and optionally a transceiver 335). Changes in the returned electrical signal transmission produce contrast on an acoustic waveform presented by a computing platform 110. The acoustic waveform can be used to provide a visible representation of the placement and / or physical state of a vascular access device within the patient.

[0058] refer to Figure 3CAn illustrative embodiment of a third (spatial) control logic unit 2403 is shown, which controls the generation of one or more magnetic fields to detect the placement and / or physical state of a vascular access device. In this document, the third control logic unit 2403 includes a signal source 340, an amplifier 342, and a transceiver 344. Upon a trigger event from the computing platform 110, the signal source 340 of the spatial control logic unit 2403 generates a signal transmission, which is amplified by the amplifier 342 and may undergo waveform shaping by the transceiver 344 before transmission via the third I / O connector 1703. The amplified signal transmission is provided to the medical device 1303 as a reference signal to the first electrode 3461 of a plurality of electrodes 346.

[0059] Specifically, according to one embodiment of the published text, the first electrode 3461 is configured to transmit a signal transmission 3491 that generates a magnetic field 348 detected by a second electrode 3462 among a plurality of electrodes 346. The second electrode 3462 can be positioned at different locations within the patient's body to establish a magnetic field 348 between the electrodes 346 to capture images of objects within the patient's body (e.g., tissue blocks, vascular access devices, etc.) between the electrodes 346. The second electrode 3462 receives a signal transmission 3492 (e.g., an electrical signal) associated with the magnetic field 348 and provides the detected signal transmission to a transceiver 344 via a third I / O connector 1703. The detected signal transmission 3492 can be returned to the computing platform 110. Considering that the reference signal can be relatively static in nature and that the data associated with the reference signal is pre-stored, the computing platform 110 is configured to determine the measurement difference between the reference signal and the detected signal transmission 3492, and the computing platform is capable of generating imaging information that can be sent and provided to a clinician for review.

[0060] Now for reference Figure 3DAn illustrative embodiment of the fourth (sensor) logic unit 2404 is shown. The fourth control logic unit 2404 includes a tip positioning navigation system (TLS) 350 operatively coupled to a fourth I / O connector 1704. Herein, the fourth control logic unit 2404 is responsible for generating signal transmissions for tip positioning of a medical device 1304 being inserted through the patient's vascular system to properly place the medical device for monitoring the patient's health. For example, according to one embodiment, the TLS 350 of the fourth control logic unit 2404 can be used to control the placement of an appropriate catheter near the patient's heart to return ECG signals to the computing platform 110 via a fifth control logic unit 2405. Thus, the fourth control logic unit 2404 can operate in conjunction with other control logic units such as the fifth control logic unit 2405 to control wire placement, thereby recovering electrical signal transmissions related to cardiac operability. Alternatively, TLS functionality can be deployed within any of the control logic units 2401-3, 5 to provide additional TLS functionality.

[0061] Now for reference Figure 3E An illustrative embodiment of a fifth (electrical) logic unit 2405 is shown. The fifth control logic unit 2405 is configured to receive at least electrical signals (e.g., ECG signals, etc.) from the medical device 1305 for subsequent analysis by the computing platform 110. Additionally, the fifth control logic unit 2405 can be configured to transmit electrical signals to the medical device 1305 to initiate the propagation of the received electrical signals described above. In one embodiment of the disclosed text, the fifth control logic unit 2405 includes analog-to-digital conversion logic 360 communicatively coupled to a fifth I / O connector 1705. According to another embodiment of the disclosed text, the fifth control logic unit 2405 includes analog-to-digital conversion logic 360, digital-to-analog conversion logic 362, and a transceiver 364 communicatively coupled to the fifth I / O connector 1705.

[0062] In this document, the fifth control logic unit 2405 can be configured to receive an electrical signal 368 as a reference signal, which is converted from digital to analog format by analog-to-digital conversion logic 362 before being transmitted to the medical device 1305 via the fifth I / O connector 1705. A transceiver 364 can be configured to operate as a switch to control the transmission of the reference signal and receive signal transmissions from the medical device 1305 for transmission to the analog-to-digital conversion logic 360. The analog-to-digital conversion logic 360 converts the received analog signal into a digital result 368 for transmission to the computing platform 110 for analysis of the digital result 368 associated with the returned digital signal, thereby presenting the results of these analyses (e.g., determined pulses representing the rate, rhythm, and intensity of the monitored heart, based on the amplitude and periodicity of the analog signal).

[0063] Figure 4A This illustrates a computing platform 400 and one or more data acquisition modules 4501-450. N A second illustrative embodiment of the medical device monitoring system 100 includes one or more data acquisition modules 4501-450. N Supports one or more medical devices 1301-130 N Connectivity. Although computing platform 400 may include similar connectivity as described above. Figure 1 The internal components of the computing platform 110, but used to establish data acquisition modules 4501-450. N The communication connections rely on different I / O. For example, medical devices 1301-130... N One or more of them can be hardwired to their corresponding data acquisition modules 4501-450. N (For example, Figure 4E-4F Connectors 475 and 1751 can represent the logical interface between these two separate components, or medical devices 1301-130. N One or more of them can be removably connected to data acquisition modules 4501-450. N (For example, Figure 4E-4F Connectors 475 and 1751 can refer to the physical connectors used to connect these two separate components. Similarly, instead of... Figure 1 Single data acquisition module 120, data acquisition module 4501-450 N Each of them is configured to support medical devices 1301-130. N Utilizing specific types of intravascular guidance technologies (e.g., fiber optic, ultrasound, spatial, magnetic sensing, or electrical), and thus, data acquisition modules 4501-450 NEach of these can be configured to include control logic units 2401-240 respectively. N Related components (see) Figures 3A-3E ).

[0064] In this paper, when the computing platform 400 is characterized by the dual I / O interface architecture shown, the data acquisition modules 4501-450... N It can be communicatively connected to at least a first I / O interface 410 or alternatively a second I / O interface 420. The communicative connection can correspond to an electrical and mechanical (electromechanical) connection, an optical and mechanical (optical-mechanical) connection, or any other type of connection that allows the computing platform 400 to transmit and / or receive data between a specific data acquisition module 450i (where 1 ≤ i ≤ N). In this document, interface 410 or 420 is associated with data acquisition module 450i. i The electromechanical connection between the two is achieved by sliding the data acquisition module 450 along the first I / O interface 410 until the data acquisition module 450 is in position. i It is set into the fastened position. A snap lock or tab can be used at certain locations along interface 410 / 420.

[0065] As shown in 4A and 4B, the computing platform 400 is characterized by a housing 430, which is configured to allow data acquisition modules 4501-450 to be installed. N It is communicatively connected to at least a first I / O interface 410. According to one embodiment of the disclosed text, the housing 430 is wholly or partially made of a rigid material such as hardened plastic or any insulating composite material. Similarly, the first I / O interface 410 is characterized by a first channel 432 formed along a first surface 434 of the housing 430, having a first interconnect 436 positioned along an inner concave surface 438 of the first channel 432. Alternatively, instead of this channel connectivity, the computing platform 400 may be configured with different ports at predetermined locations for use with different data acquisition modules 4501... or 450... N Communication connection.

[0066] As shown, the first surface 434 may form a sidewall of the housing 430, wherein the first channel 432 is formed longitudinally (e.g., in a generally vertical direction) along the sidewall 434. The length of the first channel 432 may extend longitudinally along a portion of the sidewall 434 (e.g., ranging from 25% to 50%, 25% to 75%, 50% to 95%, etc.) or along the entire sidewall 434, as shown. A first interconnect 436 positioned along the inner concave surface 438 of the first channel 432 enables communication with data acquisition modules 4501-450 to be coupled to the first I / O interface 410 (particularly the first interconnect 436). N Either of them transmits and / or receives signals. In other words, the first interconnect 436 is connected to... Figure 1 The interconnect 142 operates in a similar manner, as both interconnects are intercalated between components of the computing platform and the corresponding data acquisition modules (one or more).

[0067] In addition, as in Figure 4A and 4C Optional features are shown, and the computing platform 400 may include a second I / O interface 420 characterized by an architecture that is the same as or at least substantially similar to that of the first I / O interface 410. Hereinafter, the second I / O interface 420 may be configured with a second channel 442 formed along a second surface 444 of the housing 430, and a second interconnect 446 positioned along an inner concave surface 448 of the second channel 442. As shown, the second surface 444 may constitute a second sidewall of the housing 430, which is positioned on the opposite side of the housing 430. Alternatively, although not shown, the second surface 444 may constitute a surface orthogonal to the first surface 434 (e.g., a sidewall in the case where the first surface 434 is a front or rear surface of the housing; a front or rear surface in the case where the first surface 434 is a sidewall of the housing 430).

[0068] refer to Figure 4C The second channel 442 is formed longitudinally (e.g., generally vertically) along the sidewall 444. The length of the second channel 442 may extend along a portion of the sidewall 444 (e.g., ranging from 25% to 50%, 25% to 75%, 50% to 95%, etc.) or longitudinally along the entire sidewall 444 as shown. A second interconnect 446 positioned along the inner concave surface 448 of the second channel 442 enables data acquisition modules 4501-450 to be communicatively coupled to the second interconnect 446 of the second I / O interface 420. N Any one of them transmits and / or receives signals.

[0069] refer to Figure 4A and 4D Data acquisition module 4501-450N Each of them (e.g., data acquisition module 450) i The data acquisition module 4501 is configured with a housing 460. The housing 460 is characterized by a first surface 462, which includes a protruding member 464 having an external convex surface 466. The convex surface 466 is complementary to the concave surfaces 438 of the first channel 432 and the second channel 442 of the computing platform 400. As shown, surface 462 forms the front surface of the data acquisition module 4501, wherein the rear surface 470 of the housing 460 includes support for a corresponding medical device 130. i I / O connector 475 for communication connection. As an illustrative example, for the first data acquisition module 4501, I / O connector 475 can correspond to any I / O connector 170. i (1≤i≤N), such as I / O connector 1701 configured to establish a communication connection (e.g., an optomechanical connection) with I / O connector 1751 of medical device 1301.

[0070] A third interconnect 468, positioned along at least a portion of the convex surface 466 of the protruding member 464, is oriented to establish a communication connection with either the first interconnect 436 of the first I / O interface 410 or the second interconnect 446 of the second I / O interface 420. As a result, when communicatively connected to the first I / O interface 410, the data acquisition module 450... i Oriented to make I / O connector 475 accessible, this allows clinicians to communicatively connect the I / O connectors of medical devices to I / O connector 475. This connection enables clinicians to utilize medical device 130 i A device for monitoring blood vessel entry, as described above.

[0071] As in Figure 4E As shown, one or more data acquisition modules 4501-450 N (For example, data acquisition module 4501) can be communicatively connected to the first I / O interface 410, while at least one other data acquisition module (e.g., data acquisition module 4502) can be communicatively connected to the second I / O interface 420. As shown, different types of data acquisition modules (e.g., optical and ultrasonic, optical and spatial, electrical and ultrasonic, etc.) can be located at different I / O interfaces, but the computing platform 400 can be configured to support the same type of data acquisition modules (e.g., two optional data acquisition modules 4501) communicatively connected to different I / O interfaces 410 and 420. Additionally or alternatively, as in Figure 4F As shown, two or more data acquisition modules 4501-450 NThey can be communicatively coupled to a single I / O interface (e.g., first I / O interface 410) and arranged in a stacked configuration. As before, data acquisition modules 4501-450 N It can involve different types of intravascular guidance techniques or the same specific type of intravascular guidance technique.

[0072] As an alternative implementation, although not shown, the first I / O interface 410 and / or the second I / O interface 420 of the computing platform 400 may be deployed with protruding (convex) interfaces (architecturally similar to interface members 462-468 for the data acquisition module 4501), while the data acquisition module 4501 may include concave interfaces (architecturally similar to interface members 432-438 of the first I / O interface 410 and / or interface members 442-448 of the second I / O interface 420). Other types of interfaces (e.g., any male-convex type adapter / concave type adapter, etc.) can be used. The above description and... Figures 4A-4F as well as Figures 5A-5D The I / O interface configurations shown are provided for illustrative purposes.

[0073] Figure 5A This is a third illustrated embodiment of a medical device monitoring system 100, which includes a computing platform 500 and supports communication with one or more medical devices 1301-130. N One or more data acquisition modules 5501-550 with connectivity N Data acquisition module 5501-550 N Operable equivalent to Figures 4A-4F Data acquisition module 4501-450 N However, its housing construction and I / O connector layout differ. In this paper, when the computing platform 500 is characterized by a dual I / O interface architecture, the data acquisition modules 5501-550... N It can be communicatively connected to at least the first I / O interface 510, or alternatively to the second I / O interface (not shown).

[0074] In this article, as in Figure 5A and 5D As shown, the computing platform 500 is characterized by a housing 530, which is shaped to allow data acquisition modules 5501-550 to be acquired. NIt is communicatively connected to the first I / O interface 510. As described above, the housing 530 may be made entirely or partially of a rigid material such as hardened plastic or any insulating composite material. Similarly, the first I / O interface 510 is characterized by a first channel 532 formed along a first surface 534 of the housing 530, and a first interconnect 536 positioned along an inner concave surface 538 of the first channel 532. As previously described, instead of this channel connectivity, the computing platform 500 may be configured with different ports at predetermined locations to connect with different data acquisition modules 5501... or 550... N Communication connection.

[0075] As shown, the first surface 534 may form a sidewall of the housing 530, wherein a first channel 532 is formed along a portion or the entire length of the sidewall 534 longitudinally. Depending on the stacking orientation, a first interconnect 536 positioned along the concave surface 538 of the first channel 532 enables connection to data acquisition modules 5501-550. N One or more of them are used for transmitting and / or receiving signals. In other words, the first interconnect 536 is configured to connect with stackable data acquisition modules 5501-550. N One or more of them (e.g., data acquisition module 5501) establish a direct communication connection, but each data acquisition module further includes an interconnect that serves as a medium for the communication connection to the first interconnect 536.

[0076] More precisely, as in Figures 5A-5C As shown, the data acquisition module 5501-550 N Each of them (e.g., data acquisition module 550) i The device is configured with a housing 560. The housing 560 is characterized by a first surface 562, which includes a protruding member 564 having an interconnect 566 positioned on an external concave surface 568 for establishing a communicative connection with a first interconnect 536 of the computing platform 500. Additionally, data acquisition modules 5501-550... N Each of them (e.g., data acquisition module 550) i The second surface 570 is further characterized by a channel 572 formed along the second surface 574 of the housing 560, and a third interconnect 576 positioned along the inner concave surface 578 of the channel 572. Herein, the convex surface 568 of the protruding member 564 is complementary to the concave surface 538 of the first channel 532 of the computing platform 500 and the concave surface 578 of the channel 572 of any other data acquisition module.

[0077] According to one embodiment of the published text, the second surface 570 may be formed on the side of the housing 530 opposite to the first surface 562 or on a side generally orthogonal to the first surface 562. Therefore, when the first surface 562 constitutes the data acquisition module 550... i When the first side surface 562 forms the front side surface, the second surface 570 can constitute the front side surface, rear side surface, or opposite side wall of the housing 560. Similarly, when the first side surface 562 forms the side wall of the housing 560, the second surface 570 can constitute the opposite side wall, front side surface, or rear side surface of the housing 530. As a result, the data acquisition module 550 i Oriented such that the I / O connector 580 (e.g., Figure 1 Any I / O connector 170 i or Figure 4A The I / O connector 475 may be accessible on a surface of housing 530 other than the first surface 562 or the second surface 570, which allows clinicians to connect medical device 130. i The communication ground is connected to I / O connector 580. For example, a medical device (e.g., medical device 130) i It can be hardwired to its corresponding data acquisition module 5501 or medical device 130. i It can be removably connected to the data acquisition module 5501 (see...) Figure 5D This connection enables clinicians to utilize medical devices 130 i A device for monitoring blood vessel entry, as described above.

[0078] More precisely, as in Figure 5D As shown, along the data acquisition module 550 i (For example,) a second interconnect 566, located on at least a portion of the convex surface 568 of the protruding member 564 of the data acquisition module 5501, is oriented to establish a direct communication connection with the first interconnect 536 of the first I / O interface 510 of the computing platform 500. Additionally, a third interconnect 576 is located at the first interconnect 536 of the computing platform 500 and connects to another data acquisition module 550. i+1 An indirect communication connection (e.g., an electrical connection) is provided between the second interconnects of data acquisition modules 5501-550 (e.g., data acquisition module 5502). This enables data acquisition modules 5501-550... N They can be stacked and connected in a serial (horizontal) manner.

[0079] Embodiments of the present invention may be implemented in other specific forms without departing from the spirit of the disclosure. The described embodiments should be considered in all respects as illustrative rather than restrictive. Therefore, the scope of the embodiments is indicated by the appended claims rather than the foregoing description. All variations within the meaning and scope of the equivalents of the claims are included within the scope of these claims.

Claims

1. An apparatus comprising: case; interface; and One or more control logic units are deployed within the housing and communicatively coupled to the interface, each of the one or more control logic units being configured to: Controlling the operation of medical devices, and A subset of data is acquired by the medical device at least during the placement of the vascular access device within the patient's vascular system. The one or more control logic units include (i) a first control logic unit comprising at least a light source and a photo-to-digital converter, the first control logic unit being configured to emit incident light through the core fiber of a multi-core optical fiber corresponding to a three-dimensional sensing needle of a first medical device among a plurality of medical devices, and to receive reflected light as the data subset; and (ii) a second control logic unit comprising a beamformer and a transceiver, the second control logic unit being configured to provide signal transmission to an ultrasound probe and to receive signal transmission corresponding to the data subset acquired from the ultrasound probe, thereby providing guidance for placing the vascular access device within the patient.

2. The apparatus of claim 1, wherein when the medical device is hardwired to the interface, the medical device is communicatively connected to the interface.

3. The apparatus of claim 1, wherein the subset of data includes vascularization data associated with the structure or contents of the patient's vascular system.

4. The device according to claim 1, wherein the data subset includes intravascular guidance data associated with the physical state of the vascular access device for guiding and determining the placement of the vascular access device within the patient's vascular system.

5. The device of claim 1, wherein the subset of data includes intravascular guidance data, the intravascular guidance data being associated with the physical state of the medical device accompanied by the vascular entry device inserted into the vascular system of the patient, the physical state of the medical device including the shape, form, and orientation of the medical device.

6. The device according to claim 1, wherein the interface includes a connector for communicatively connecting to the medical device corresponding to the three-dimensional sensing needle, the three-dimensional sensing needle including a multi-core optical fiber, wherein the proximal end of the multi-core optical fiber includes a connector for communicatively connecting to the connector of the interface.

7. The device according to claim 4, wherein the interface is a second interface, the device further comprising a first interface and a computing platform, the first interface being communicatively connected to the computing platform, the computing platform analyzing at least a portion of the data subset to determine the physical state of the vascular access device or the medical device.

8. The apparatus of claim 7, wherein the computing platform includes an integrated display for presenting the analysis.

9. The apparatus of claim 7, wherein the subset of data acquired by the computing platform is used to generate analysis results, the analysis results including data to present a three-dimensional representation of the monitored vascular access device or a three-dimensional representation of the medical device accompanied by the vascular access device.

10. The device according to claim 1, wherein the interface is implemented within the housing, which is inserted between the one or more control logic units and the medical device.

11. The device apparatus of claim 1, wherein the interface is implemented to be exposed along the surface of the housing and physically coupled to a portion of the medical device.

12. The device according to claim 1, wherein the device is a data acquisition module. The data acquisition module includes an interface connection member formed on a first surface of the housing. The interface connection member includes interconnects configured for communicative connection with an interconnection of a computing platform. The one or more control logic units are interposed between the medical device and the computing platform, and provide at least a subset of the data to the computing platform during the placement of the vascular access device within the patient's vascular system.

13. A medical device monitoring system, comprising: A computing platform, which includes a processor and memory; and The data acquisition module includes: case, The first input / output interface is configured to establish a first communication connection with the computing platform. One or more control logic units are deployed within the housing and communicatively coupled to a second input / output interface, each of the one or more control logic units being configured to: (a) control the operation of a medical device, which is communicatively coupled to and controlled by the one or more control logic units; and (b) acquire a subset of data, which is acquired by the medical device at least during the placement of a vascular access device within a patient's vascular system. The one or more control logic units include (i) a first control logic unit, which includes at least a light source and a light-to-digital converter, the first control logic unit being configured to emit incident light through the core fiber of a multi-core optical fiber corresponding to the three-dimensional sensing needle of the first medical device, and to receive reflected light as the data subset. (ii) a second control logic unit, comprising a beamformer and a transceiver, the second control logic unit being configured to provide signal transmission to an ultrasound probe and to receive signal transmission corresponding to a subset of data acquired from the ultrasound probe, thereby providing guidance for placing the vasculature access device within the patient.

14. The medical device monitoring system of claim 13, wherein when the medical device is hardwired to the second input / output interface, the medical device is communicatively connected to the second input / output interface.

15. The medical device monitoring system of claim 13, wherein the subset of data acquired by the data acquisition module includes vascularization data associated with the structure or contents of the patient's vascular system.

16. The medical device monitoring system of claim 13, wherein the subset of data acquired by the data acquisition module includes intravascular guidance data, the intravascular guidance data being associated with the physical state of the vascular entry device for guiding and determining the placement of the vascular entry device within the patient's vascular system.

17. The medical device monitoring system of claim 13, wherein the subset of data acquired by the data acquisition module includes intravascular guidance data, the intravascular guidance data being associated with the physical state of the medical device accompanied by a vascular entry device inserted into the vascular system of the patient, the physical state of the medical device including the shape, form, or orientation of the medical device.

18. The medical device monitoring system of claim 13, wherein the second input / output interface of the data acquisition module is communicatively connected to the medical device corresponding to the three-dimensional sensing core, the three-dimensional sensing core comprising a multi-core optical fiber, wherein the proximal end of the multi-core optical fiber is communicatively connected to the second input / output interface.

19. The medical device monitoring system of claim 18, wherein the medical device is communicatively connected to the second input / output interface by hard-wired interconnects that are part of the medical device.

20. The medical device monitoring system of claim 13, wherein the computing platform analyzes at least a portion of the data subset from any one of the one or more control logic units to determine the physical state of the vascular access device or the medical device.

21. The medical device monitoring system of claim 20, wherein the computing platform includes an integrated display for presenting the analysis.

22. The medical device monitoring system of claim 20, wherein the subset of data acquired by the computing platform is used to generate analysis results, the analysis results including data to present a three-dimensional representation of the monitored vascular access device or a three-dimensional representation of the medical device accompanied by the vascular access device.

23. The medical device monitoring system of claim 13, wherein the vascular access device is a catheter.

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