Optical and electrical diagnostic systems and methods

Abstract

Optical and electrical medical systems and methods thereof are disclosed. Such medical systems may include a console, an optical shape sensing ("OSS") medical device including a fiber optic stylet, one or more electrical medical devices, and a relay module for establishing one or more optical or electrical relay connections between the relay module and the remainder of the medical system, including the console. The console may be configured to convert a reflected optical signal from the fiber optic stylet into its shape for display. The relay module may include a primary receptacle configured to receive a medical barrier puncture plug of the OSS medical device and establish a barrier-through optical connection therebetween. The relay module may also include one or more secondary receptacles configured to receive a corresponding number of electrical plugs of one or more electrical medical devices and establish one or more barrier-under electrical connections therebetween.

Description

[0001] priority

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 002,041, filed on March 30, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present invention relates to the field of medical devices, and more particularly to optical and electrical diagnostic systems and methods thereof. Background Art

[0004] Sometimes, the tip of a peripherally inserted central catheter ("PICC") or central venous catheter ("CVC") may move and be displaced from its ideal position in the patient's superior vena cava ("SVC"). Clinicians who believe that such a PICC or CVC has moved typically check for displacement via chest X-ray and replace the PICC or CVC if necessary. Because X-rays expose patients to ionizing radiation, medical devices (such as PICCs and CVCs) are being developed with integrated fiber optic stylets that allow clinicians to easily and safely check for displacement. However, in order for clinicians to check for displacement, the sterile-provided PICC or CVC needs to be at least optically connected to a non-sterile asset device without compromising sterile conditions. Therefore, there is a need for an optical medical system that allows disposable medical devices (such as the aforementioned PICCs and CVCs) to be at least optically connected to a non-sterile asset device without compromising sterile conditions. Disclosed herein are optical and electrical medical systems and methods thereof. Summary of the Invention

[0005] Disclosed herein is a relay module, which in some embodiments includes: a housing; a main receptacle arranged in the housing; one or more secondary receptacles arranged in the housing; and one or more cables extending from the housing. The main receptacle is configured to receive the insertion of a barrier-piercing plug associated with an optical shape sensing ("OSS") medical device and establish a barrier-through connection (through-barrier connection) between the relay module and the OSS medical device. The barrier-through connection is selected from a barrier-through optical connection and a barrier-through optical and electrical connection. The one or more secondary receptacles are configured to receive the insertion of a corresponding number of electrical plugs associated with one or more electrical medical devices and establish a corresponding number of under-barrier electrical connections between the relay module and the one or more electrical medical devices. The one or more cables include a corresponding number of relay module plugs for establishing one or more relay connections between the relay module and the rest of the medical system, the relay module plug being configured to receive optical and electrical signals from the relay module. The one or more relay connections are selected from a relay optical connection, a relay optical and electrical connection, and a relay electrical connection, provided that at least a relay optical connection or a relay optical and electrical connection is selected.

[0006] In some embodiments, the relay module further includes an optical fiber having one or more optical fiber cores, the optical fiber extending from the primary receptacle through a primary cable in the one or more cables to a corresponding primary plug in a number of relay module plugs. The optical fiber is configured to transmit an input optical signal from the optical interrogator of the medical system to the optical fiber stylet of the OSS medical device once a barrier-through connection is established. The optical fiber is also configured to transmit a reflected optical signal from the optical fiber stylet to the optical interrogator when the barrier-through connection is established.

[0007] In some embodiments, the relay module further includes one or more electrical leads extending from a number of receiving receptacles, including a primary receiving receptacle and one or more secondary receiving receptacles, through any of the one or more cables to their corresponding relay module plugs. The one or more electrical leads are configured to transmit electrical signals from the relay module to the medical system.

[0008] In some embodiments, the relay module further includes one or more sensors selected from the group consisting of a gyroscope, an accelerometer, and a magnetometer disposed within the housing. The one or more sensors are configured to provide sensor data for determining a reference plane for shape sensing using the OSS medical device.

[0009] In some embodiments, the relay module further includes a light emitting diode ("LED") disposed in the housing adjacent to the primary receptacle. The LED is configured to illuminate when a relay optical and electrical connection or any of a number of relay electrical connections is established, for locating the primary receptacle when the relay module is under a medical barrier.

[0010] In some embodiments, the relay module can be high-level disinfected or sterilized.

[0011] In some embodiments, the housing includes a patient-facing surface configured to be adhered to the patient, thereby enabling the relay module to be secured to the patient.

[0012] Disclosed herein is a medical system that, in some embodiments, includes: a console; an OSS medical device configured for shape sensing; one or more electrical medical devices; and a relay module. The console includes a memory and one or more processors for converting a reflected optical signal from a fiber optic stylet into its shape for display. The console further includes an integrated optical interrogator for converting the reflected optical signal into the shape of the fiber optic stylet. Alternatively, the console is communicatively coupled to a separate optical interrogator configured to convert the reflected optical signal into the shape of the fiber optic stylet. The OSS medical device includes a fiber optic stylet and a barrier piercing plug. Each of the one or more electrical medical devices includes at least one electrical plug. The relay module includes a housing, a primary receptacle disposed in the housing, one or more secondary receptacles disposed in the housing, and one or more cables extending from the housing. The primary receptacle is configured to receive a barrier piercing plug associated with the OSS medical device and establish a barrier-piercing connection between the relay module and the OSS medical device. The barrier-piercing connection is selected from a barrier-piercing optical connection and a barrier-piercing optical and electrical connection. The one or more secondary receptacles are configured to receive at least one electrical plug from each of the one or more electrical medical devices and establish a corresponding number of below-the-barrier electrical connections between the relay module and the one or more electrical medical devices. The one or more cables include a corresponding number of relay module plugs for establishing one or more relay connections between the relay module and the console, or between the relay module and a combination of the console and the standalone optical interrogator. The one or more relay connections are selected from the group consisting of a relay optical connection, a relay optical and electrical connection, and a relay electrical connection, provided that at least the relay optical connection or the relay optical and electrical connection is selected.

[0013] In some embodiments, the relay module further includes an optical fiber having one or more optical fiber cores, the optical fiber extending from the primary receptacle through a primary cable in the one or more cables to a corresponding primary plug in a number of relay module plugs. The optical fiber is configured to transmit an input optical signal from the integrated optical interrogator or the standalone optical interrogator to the optical fiber stylet of the OSS medical device once a barrier penetration connection is established. The optical fiber is also configured to transmit a reflected optical signal from the optical fiber stylet to the integrated optical interrogator or the standalone optical interrogator when the barrier penetration connection is established.

[0014] In some embodiments, the relay module further includes one or more electrical leads extending from a number of receptacles, including a primary receptacle and one or more secondary receptacles, through any of the one or more cables to their corresponding relay module plugs. The one or more electrical leads are configured to transmit electrical signals from the relay module to the console.

[0015] In some embodiments, the relay module further includes one or more relay module-based sensors selected from the group consisting of a gyroscope, an accelerometer, and a magnetometer disposed within the housing. The one or more relay module-based sensors are configured to provide relay module-based sensor data for determining a reference plane for shape sensing using the OSS medical device.

[0016] In some embodiments, the relay module further includes an LED disposed in the housing adjacent to the primary receptacle, the LED being configured to illuminate when an electrical connection in one or more relay connections is established, for locating the primary receptacle when the relay module is under the medical barrier.

[0017] In some embodiments, the relay module can be high-level disinfected or sterilized.

[0018] In some embodiments, the housing includes a patient-facing surface configured to be adhered to the patient, thereby enabling the relay module to be secured to the patient.

[0019] In some embodiments, the one or more electrical medical devices include one or more electrocardiogram ("ECG") patches.

[0020] In some embodiments, the one or more electrical medical devices include an armband. The armband has one or more armband-based sensors selected from an armband-based gyroscope, an accelerometer, and a magnetometer. The one or more armband-based sensors are configured to provide armband-based sensor data for determining a reference plane for shape sensing using the OSS medical device.

[0021] Also disclosed herein is a method for a medical system. In some embodiments, the method includes a relay module placement step, an electrical plug insertion step, a medical drape placement step, and a barrier piercing plug insertion step. The relay module placement step includes placing the relay module on a surface. The electrical plug insertion step includes inserting one or more electrical plugs corresponding to one or more electrical medical devices into a corresponding number of secondary receptacles of the relay module. The electrical plug insertion step establishes one or more below-barrier electrical connections between the one or more electrical devices and the relay module. The medical drape placement step includes placing a medical barrier above the relay module. The medical drape placement step establishes a sterile field above the relay module. The barrier piercing plug insertion step includes inserting a barrier piercing plug of an OSS medical device through the medical barrier and into the primary receptacle of the relay module. The barrier piercing plug insertion step establishes a barrier-through optical connection or a barrier-through optical and electrical connection between the OSS medical device in the sterile field and the relay module in the non-sterile field.

[0022] In some embodiments, the relay module placement step includes placing the relay module on the patient's chest.The relay module placement step establishes a reference plane for shape sensing using the OSS medical device.

[0023] In some embodiments, the method further includes an identification step and a palpation step. The identification step includes identifying an illuminated LED disposed in the housing of the relay module adjacent to the primary receptacle. The palpation step includes palpating the primary receptacle beneath the medical barrier. Both the identification step and the palpation step occur before the barrier piercing plug insertion step.

[0024] In some embodiments, the method further includes establishing one or more relay connections between the relay module and the rest of the medical system for relaying optical and electrical signals from the relay module. The one or more relay connections are selected from the group consisting of a relay optical connection, a relay optical and electrical connection, and a relay electrical connection, provided that at least the relay optical connection or the relay optical and electrical connection is selected.

[0025] These and other features of the concepts provided herein will become more readily apparent to those skilled in the art in view of the accompanying drawings and the following description, which more particularly depict specific embodiments of the concepts. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 is a block diagram of a first medical system according to some embodiments.

[0027] Figure 2 is a block diagram of a second medical system according to some embodiments.

[0028] Figure 3A second medical system is presented according to some embodiments.

[0029] Figure 4 A cross-section of a catheter tubing of an OSS medical device is shown, according to some embodiments.

[0030] Figure 5 A barrier piercing plug of an extension tube of an OSS medical device for establishing an optical or optical and electrical connection is shown, according to some embodiments.

[0031] Figure 6 Shown is a detailed view of a relay module with a primary receptacle for establishing an optical or optical and electrical connection, according to some embodiments.

[0032] Figure 7 Establishing a barrier-through optical connection or a barrier-through optical and electrical connection between an OSS medical device and a relay module according to some embodiments is demonstrated.

[0033] Figure 8 A second medical system is shown for use during patient surgery, according to some embodiments.

[0034] Figure 9 A second medical system having a medical barrier for use during patient surgery is shown, according to some embodiments.

[0035] Figure 10 An optical connector of an extension tube of an OSS medical device is shown, according to some embodiments.

[0036] Figure 11 An alternative relay module having an optical connector for establishing an optical connection across a medical barrier is presented in accordance with some embodiments. DETAILED DESCRIPTION

[0037] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiments and can optionally be combined or substituted with the features of any one of the multiple other embodiments disclosed herein.

[0038] About the terms used in this article, it should also be understood that these terms are for the purpose of describing some specific embodiments, and these terms do not limit the scope of the concept provided herein. Ordinal numbers (for example, first, second, third, etc.) are generally used to distinguish or identify the different features or different steps in a set of features or a set of steps, and do not provide sequence or numerical restrictions. For example, "first", "second" and "third" features or steps do not necessarily need to appear in order, and the specific embodiment including such features or steps does not necessarily need to be limited to these three features or steps. Labels such as "left", "right", "top", "bottom", "front", "back" are used for convenience and are not intended to imply such as any specific fixed position, orientation or direction. On the contrary, such labels are used to reflect such as relative position, orientation or direction. The singular forms "a", "one" and "the" include plural references unless the context clearly indicates otherwise.

[0039] For example, with respect to the "proximal side," "proximal portion," or "proximal end portion" of a catheter disclosed herein, includes the portion of the catheter that is expected to be near a clinician when the catheter is used on a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter that is expected to be near a clinician when the catheter is used on a patient. For example, the "proximal end" of a catheter includes the end of the catheter that is expected to be near a clinician when the catheter is used on a patient. The proximal portion, proximal portion, or proximal length of a catheter can include the proximal end of the catheter; however, the proximal portion, proximal portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless the context indicates otherwise, the proximal portion, proximal portion, or proximal length of a catheter is not the terminal portion or terminal length of a catheter.

[0040] For example, with respect to the "distal side" of the catheter disclosed herein, "distal portion" or "distal section" includes the portion of the catheter that is expected to be near the patient or in the patient when the catheter is used on the patient. Similarly, for example, the "distal length" of the catheter includes the length of the catheter that is expected to be near the patient or in the patient when the catheter is used on the patient. For example, the "distal end" of the catheter includes an end of the catheter that is expected to be near the patient or in the patient when the catheter is used on the patient. The distal portion, distal portion or distal length of the catheter can include the distal end of the catheter; however, the distal portion, distal portion or distal length of the catheter does not need to include the distal end of the catheter. That is, unless the context indicates otherwise, the distal portion, distal portion or distal length of the catheter is not the terminal portion or terminal length of the catheter.

[0041] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art.

[0042] As noted above, there is a need for an optical medical system that allows single-use medical devices, such as the aforementioned PICCs and CVCs, to be at least optically connected to non-sterile asset equipment without compromising sterility.Disclosed herein are optical and electrical medical systems and methods thereof.

[0043] Features of the optical and electrical medical system ("medical system") provided herein will become more apparent with reference to the accompanying drawings and the following description, which provide specific embodiments of the medical system in greater detail. For context, the medical system will be described first, followed by a description of the medical device and relay module of the medical system and methods of the foregoing.

[0044] Medical system

[0045] Figure 1 is a block diagram of a first medical system 100 according to some embodiments. Figure 2 is a block diagram of a second medical system 200 according to some embodiments. Figure 3 A second medical system 200 is shown, according to some embodiments. Figure 8 A second medical system 200 is shown for use during patient surgery, according to some embodiments. Figure 9 A second medical system 200 is shown having a medical barrier 703 for use during patient surgery, according to some embodiments.

[0046] As shown, the medical system 100 or 200 includes an OSS medical device 110, one or more electrical medical devices, a console 130 or 230, and a relay module 120. The relay module 120 is configured to connect the OSS medical device 110 and the one or more electrical medical devices to the rest of the medical system 100 or 200 (e.g., the console 230). The OSS medical device 110 is typically used in a sterile field, while the one or more electrical medical devices, the relay module 120, and the console 130 or 230 are typically used in a non-sterile field defined by at least a medical barrier 703 (e.g., a sterile drape).

[0047] The OSS medical device 110 includes at least an integrated fiber optic stylet and a barrier piercing plug. The fiber optic stylet is a probe comprising one or more optical fiber cores, wherein each of the one or more optical fiber cores has a number of fiber Bragg grating ("FBG") sensors along its length, thereby enabling shape sensing using the medical system 100 or 200 (for an embodiment of the fiber optic stylet of the OSS medical device 110, see Figure 4 The barrier-piercing plug is configured to establish at least a barrier-piercing optical connection between the OSS medical device 110 and the relay module 120 (see for an embodiment of a barrier-piercing plug of the OSS medical device 110). Figure 3 10). However, OSS medical device 110 may also include electrical components such as an electrocardiogram ("ECG") stylet and one or more electrical leads supporting the ECG stylet. Thus, in some embodiments of OSS medical device 110, the barrier-piercing plug may be configured to establish a barrier-piercing optical and electrical connection between OSS medical device 110 and relay module 120.

[0048] Certain features of the OSS medical device 110 will be described in more detail below with respect to specific embodiments of the OSS medical device 110 (e.g., the PICC 310). That is, some features described below with respect to one or more embodiments of the OSS medical device 110 (e.g., the fiber optic stylet, the ECG stylet, etc.) may be shared between two or more embodiments of the OSS medical device 110. Thus, when necessary for ease of description, "OSS medical device 110" is used herein to generally refer to more than one embodiment of the OSS medical device 110. Although certain features have been described with respect to specific embodiments of the OSS medical device 110 (e.g., the PICC 310),

[0049] The one or more electrical medical devices may include, but are not limited to, an electrocardiogram ("ECG") patch 112 (e.g., ECG patch 112a configured as a right arm ECG patch, ECG patch 112b configured as a left leg ECG patch, ..., and ECG patch 112n), a companion armband 114, or both the ECG patch 112 and the armband 114. Each of the one or more electrical medical devices includes at least one electrical plug configured to establish an electrical connection between the electrical device and the relay module 120.

[0050] The armband 114 may include one or more sensors selected from at least a gyroscope, an accelerometer, and a magnetometer disposed within the armband 114. The one or more sensors are configured to provide sensor data to the console 130 or 230 via the relay module 120 for determining a reference plane for shape sensing using the fiber optic stylet of the OSS medical device 110.

[0051] Although only console 230 is shown, each of consoles 130 and 230 includes a memory 236 and one or more processors 234 configured to convert at least a reflected optical signal from a fiber optic stylet of the OSS medical device 110 into a displayable shape of the OSS medical device 110. The displayable shape of the OSS medical device 110 can be displayed on an integrated display screen integrated into console 130 or 230, or on a display screen of a separate monitor coupled to console 130 or 230. Each of consoles 130 and 230 can be further configured to convert electrical signals from one or more electrical devices into displayable information for the one or more electrical devices. For example, for any of the optional ECG stylets or ECG patches 112, console 130 or 230 can be configured to convert the electrical signals therefrom into an ECG trace for display. Such an ECG trace, in conjunction with the displayable shape of the OSS medical device 110, can be useful for determining whether the OSS medical device 110 has been displaced from its ideal position.

[0052] Medical system 100 further includes a standalone optical interrogator 140 communicatively coupled to console 130, while medical system 200 further includes an integrated optical interrogator 232 integrated into console 230. Optical interrogator 140 or 232 is configured to transmit an input optical signal into the fiber optic stylet of OSS medical device 110 via relay module 120, and to receive a reflected optical signal from the fiber optic stylet via relay module 120. Optical interrogator 140 or 232 may be further configured to provide data corresponding to the received reflected optical signal to console 130 or 230 for converting the reflected optical signal from the fiber optic stylet of OSS medical device 110 into a displayable shape of OSS medical device 110.

[0053] The relay module 120 includes a housing 324, a cable 326 extending from the housing 324, one or more optical fiber cores 628 ("optical fibers 628") extending through the housing 324 and along the cable 326, and one or more electrical leads extending through the housing 324 and along the cable 326 or another cable (see, for details regarding the optical fibers 628). Figure 6 ).

[0054] The relay module 120 is configured to establish at least an optical connection (eg, a barrier-through optical connection) between the fiber optic stylet of the OSS medical device 110 and the optical fiber 628 of the relay module 120 (see Figure 1 and 2326, wherein each connection comprises at least an optical connection). The relay module 120 is further configured with a plug 330 at the end of the cable 326 to establish at least another optical connection between the optical fiber 628 of the relay module 120 and a standalone optical interrogator 140 or a console 230 including an integrated optical interrogator 232 (see Figure 1 The connection b1 and Figure 2 , wherein each connection comprises at least an optical connection.) The optical fiber 628 of the relay module 120 is configured to transmit the input optical signal from the optical interrogator 140 or 232 to the optical fiber stylet of the OSS medical device 110, and to transmit the reflected optical signal from the optical fiber stylet to the optical interrogator 140 or 232.

[0055] The relay module 120 may also be configured to establish an electrical connection (e.g., a barrier-through electrical connection) between any electrical component of the OSS medical device 110 and one or more electrical leads of the relay module 120, which may be established simultaneously with the optical connection in the electrical and optical connection (see Figure 1 and 2 2. The optical interrogator 232 may be connected to the console 230 (e.g., a console 230 including an integrated optical interrogator 232) and the one or more electrical leads of the relay module 120. Such an electrical connection may be established simultaneously with the optical connection to the console 230 (e.g., a console 230 including an integrated optical interrogator 232) in another electrical and optical connection. Figure 2 Alternatively, another plug at the end of another cable of the relay module 120 may be configured to establish other electrical connections between one or more electrical leads of the relay module 120 and the console 130 or 230 (see Figure 1 The connection b2′ and Figure 2 b′ in , wherein each connection comprises at least an electrical connection). The one or more electrical leads of the relay module 120 are configured to transmit electrical signals from any electrical component of the OSS medical device 110 to the console 130 or 230 .

[0056] In addition to the electrical connection between any electrical component of the OSS medical device 110 and one or more electrical leads of the relay module 120, the relay module 120 can be configured to establish an electrical connection (e.g., an under-barrier electrical connection) between any of the one or more electrical medical devices (e.g., any of the ECG patches 112, the armband 114, etc.) and one or more electrical leads of the relay module 120 (see Figure 1 and 2', c2', and c3', each of which includes at least an electrical connection). As described above, the plug 330 at the end of the cable 326 can be configured to establish other electrical connections between one or more electrical leads of the relay module 120 and the console 230 (i.e., the console 230 including the integrated optical interrogator 232). Such electrical connections can be established simultaneously with the optical connection to the console 230, among other electrical and optical connections (see Figure 2 Alternatively, other plugs at the ends of other cables of the relay module 120 may be configured to establish other electrical connections between one or more electrical leads of the relay module 120 and the console 130 or 230 (see Figure 1 The connection b2′ and Figure 2 b′ in , wherein each connection comprises at least an electrical connection). The one or more electrical leads of the relay module 120 are configured to transmit electrical signals from the one or more electrical devices to the console 130 or 230 .

[0057] From the foregoing, it should be understood that a type A connection or barrier is a through connection between the OSS medical device 110 and the relay module 120, a type B connection or relay connection is between the relay module 120 and the rest of the medical system 100 or 200 (e.g., a combination of the console 130 and a standalone optical interrogator 140 or a console 230 with an integrated optical interrogator 232), and a type C connection or barrier is a down connection between one or more electrical medical devices and the relay module 120. The subscript numbers associated with any of the types of connections in the a, b, and c types numerically identify a specific connection in a number of a, b, or c type connections. Finally, a type A, B, or C connection without a single prime ("'") or double prime ("") indicates an optical connection, a type A, B, or C connection with a single prime (e.g., "a'") indicates an electrical connection, and a type A, B, or C connection with a double prime (e.g., "a") indicates both an optical and an electrical connection.

[0058] The relay module 120 may further include one or more sensors 222 selected from at least a gyroscope, an accelerometer, and a magnetometer disposed within a housing 324. The one or more sensors 222 are configured to sense the sensor data via one or more electrical leads and cables 326 (or the like) within the housing 324. Figure 1 The connection b2′ and Figure 2 The other cables described in b′ in FIG. 1 ) provide sensor data to the console 130 or 230 to determine a reference plane for shape sensing using the fiber optic stylet of the OSS medical device 110 .

[0059] Certain features of the relay module 120 will be described in more detail below with respect to specific embodiments of the relay module 120. That is, some features described below with respect to one or more embodiments of the relay module 120 are shared between two or more embodiments of the relay module 120 (e.g., the relay module 1120). Thus, when necessary for ease of description, "relay module 120" is used herein to generally refer to more than one embodiment of the relay module 120. Although certain features have been described with respect to specific embodiments of the relay module 120,

[0060] medical devices

[0061] Figure 3 Also shown is a PICC 310 as the OSS medical device 110 according to some embodiments. Figure 4 A cross-section of a catheter tube 312 of a PICC 310 including an integrated fiber optic stylet 424 is shown, according to some embodiments. Figure 5 Shown is a barrier piercing plug 322 of an extension tube or cable 320 of a PICC 310 for establishing an optical or optical and electrical connection, according to some embodiments.

[0062] As shown, PICC 310 comprises catheter tubing 312, bifurcated sleeve 314, two extension legs 316 and two Luer connectors 318, and they are operably connected with aforementioned order.Catheter tubing 312 comprises two catheter tubing inner chambers 413 and optical fiber stylet 424, and optical fiber stylet 424 is arranged in the longitudinal seam (longitudinal bead) of catheter tubing 312, such as between two catheter tubing inner chambers 413 of extrusion.Optionally, in the identical or different longitudinal seam of catheter tubing 312, PICC 310 can further comprise ECG stylet.Bifurcation sleeve 314 has two liner lumens, and its fluid is connected to two catheter tubing inner chambers 413 correspondingly.Each extension leg in two extension legs 316 has an extension leg lumen that is connected with the liner lumen fluid in two liner lumens. The PICC 310 further includes an extension tube 320 that extends from or is communicatively coupled to the bifurcated hub 314. When extending from the bifurcated hub 314, the extension tube 320 can be a cut portion of the catheter tubing 312 that includes the fiber optic stylet 424 and, if an ECG stylet is present, can terminate in a plug 322 for establishing an optical connection, as well as any electrical connections, between the fiber optic stylet 424 of the PICC 310 and the optical fiber 628 of the relay module 120. The cut portion of the catheter tubing 312 can be disposed within another tube that, in combination, forms the extension tube 320, which terminates in a plug 322 for establishing the aforementioned optical and electrical connections.

[0063] Although the PICC 310 is provided as a specific embodiment of the OSS medical device 110 of the medical system 100 or 200, it should be understood that any of a number of medical devices including a catheter (e.g., a CVC) can include at least a fiber optic stylet and optionally electrical components (e.g., an ECG stylet and one or more electrical leads supporting it, which terminate in a plug) for establishing an optical or optical and electrical connection between the medical device and the relay module 120.

[0064] Relay module

[0065] Figure 6 Shown is a detailed view of a relay module 120 having a primary receptacle 632 for establishing an optical or optical and electrical connection, according to some embodiments. Figure 7 Establishing a barrier-through optical or optical and electrical connection between the OSS medical device 110 and the relay module 120 is illustrated according to some embodiments. Figure 9 A second medical system 200 is shown having a medical barrier 703 for use during patient surgery, according to some embodiments.

[0066] As shown, the relay module 120 includes a housing 324, a primary receptacle 632 disposed in the housing 324, one or more secondary receptacles (such as secondary receptacle 634) disposed in the housing 324, one or more cables extending from the housing including a primary cable (such as cable 326 extending from the housing 324), and optical fibers 628 extending through the housing 324 and along the cable 326. Again, the relay module 120 may include one or more electrical leads extending through the housing 324 and along the cable 326 or another cable (e.g., a secondary cable) of the one or more cables.

[0067] The primary receptacle 632 includes an optical receiver configured to receive insertion of optical terminals of a plug of the OSS medical device 110 (e.g., plug 322 of the PICC 310) when the plug is inserted into the primary receptacle 632, thereby establishing an optical connection (e.g., a barrier-through optical connection) between the relay module 120 and a fiber optic stylet (e.g., fiber optic stylet 424 of the PICC 310) of the OSS medical device 110. The primary receptacle 632 may also include one or more electrical contacts configured to, when present, contact electrical terminals of the plug of the OSS medical device 110 (e.g., metal tabs of the plug 322 of the PICC 310 corresponding to the barrier-piercing elements 523 of the plug 322) when the plug is inserted into the primary receptacle 632, thereby establishing an electrical connection between the relay module 120 and one or more electrical leads of the OSS medical device 110, simultaneously with the optical connection in the optical and electrical connection (e.g., a barrier-through optical and electrical connection).

[0068] One or more secondary receptacles (e.g., secondary receptacles 634) are configured to receive a corresponding number of electrical plugs associated with one or more electrical medical devices (e.g., ECG patch 112, armband 114, etc.) and establish a corresponding number of electrical connections (e.g., under-barrier electrical connections) between the relay module 120 and the one or more electrical medical devices. Figure 1 and 2 The relay module 120 includes at least three secondary receiving sockets to receive the insertion of three electrical plugs associated with the ECG patch 112a (e.g., right arm ECG patch), the ECG patch 112b (e.g., left leg ECG patch), and optionally the armband 114, and establish three electrical connections (e.g., under-barrier electrical connections) between the relay module 120 and the aforementioned electrical medical devices.

[0069] The one or more cables include one or more corresponding plugs for establishing one or more connections between the relay module 120 and the rest of the medical system 100 or 200, which is configured to receive optical and electrical signals from the relay module 120. For example, a main cable (e.g., cable 326) of the one or more cables includes a main plug (e.g., plug 330) for establishing an optical connection (e.g., between the relay module 120 and a console 230 (i.e., a console 230 including an integrated optical interrogator 232). Figure 2 The main plug is also used to establish an electrical connection between the relay module 120 and the console 230 (e.g., Figure 2 In order to generate at least an ECG trace using the ECG stylet, in addition to the aforementioned electrical connections (ie, Figure 2 In addition to the connection b″ in FIG, the one or more cables may include, for example, a secondary cable having a secondary plug for establishing one or more electrical connections (for example, Figure 2 1 ) in order to generate an ECG trace using the ECG patch 112, determine a reference frame using the armband 114, or both. However, in some embodiments, only the main cable and plug are required to establish all such optical and electrical connections (see Figure 2 Connection b″).

[0070] An optical fiber 628 extends from a primary receptacle 632 through a primary cable (e.g., cable 326) to a primary plug (e.g., plug 330). The optical fiber 628 is configured to transmit an input optical signal from the optical interrogator 140 or 232 to a fiber optic stylet of the OSS medical device 110 (e.g., fiber optic stylet 424 of the PICC 310), and to transmit a reflected optical signal from the fiber optic stylet to the optical interrogator 140 or 232.

[0071] As described above, the relay module 120 may further include one or more sensors 222 selected from a gyroscope, an accelerometer, and a magnetometer disposed within the housing 324. The one or more sensors 222 are configured to provide sensor data for determining a reference plane for shape sensing using a fiber optic stylet of the OSS medical device 110 (e.g., the fiber optic stylet 424 of the PICC 310).

[0072] The relay module 120 may further include an LED 636 disposed in the housing 324 adjacent to the primary receptacle 632. The LED 636 is configured to provide a sense of the presence of an optical or electrical connection (e.g., Figure 2 connection b″) or another electrical connection (e.g. Figure 2 When illuminated, LED 636 is useful for finding the primary docking station 632 (when the relay module 120 is under the medical barrier 703).

[0073] The relay module 120 further includes one or more electrical leads extending from any number of docking stations (including the primary docking station 632 and one or more secondary docking stations), one or more sensors 222 (if present), and an LED 636 (if present) via any one of one or more cables (e.g., cable 326) and its corresponding plug (e.g., plug 330). In addition to any power required by the ECG stylet, one or more electrical medical devices connected to the secondary docking stations, one or more sensors 222, LED 636, etc., the one or more electrical leads are configured to transmit input electrical signals from the console 130 or 230 to the ECG stylet, one or more electrical medical devices connected to the secondary docking stations, one or more sensors 222, LED 636, etc. The one or more electrical leads are also configured to transmit any output electrical signals from the ECG stylet, one or more electrical medical devices connected to the secondary docking stations, one or more sensors 222, LED 636, etc. to the console 130 or 230.

[0074] The relay module 120 is configured to be positioned on or next to the patient P (e.g., on the patient's chest) below the medical barrier 703. As such, the relay module 120 does not need to be disinfected or sterilized. However, if the relay module 120 needs to be disinfected or sterilized, the relay module 120 can be configured to be disinfected or sterilized. For example, the housing 324 of the relay module 120 can be non-porous or resistant to chemical oxidants. The relay module 120 can be configured for use with Becton, Dickinson and Company (Franklin Lakes, NJ). The product can be manually sterilized, or the relay module 120 can be configured for use with a Nanosonics Inc. (Indianapolis, IN) Automated high-level disinfection or sterilization using vaporized H2O2.

[0075] Although not shown, the housing 324 of the relay module 120 may include a loop extending from the housing 324, a tether point integrated into the housing 324, or a ball-lock-pin receiver integrated into the housing 324 configured for attaching a neck strap to the relay module 120. The loop, tether point, or ball-lock-pin receiver enables the relay module 120 to be secured to the neck of the patient P when positioned on the patient's chest. Additionally or alternatively, the housing 324 includes a patient-facing surface (e.g., the back of the relay module 120) configured to adhere to the patient's chest. The patient-facing surface enables the relay module 120 to be secured to the patient when positioned on or next to the patient's chest, regardless of whether the relay module 120 is also secured to the patient's neck.

[0076] Again, primary receptacle 632 includes an optical receiver configured to receive insertion of optical terminals of a plug of OSS medical device 110 (e.g., plug 322 of PICC 310) and form an optical connection when the plug is inserted into primary receptacle 632. Primary receptacle 632 may also include one or more electrical contacts configured to, when present, contact electrical terminals of the plug of OSS medical device 110 (e.g., metal tabs of plug 322 corresponding to barrier piercing elements 523 of plug 322) when the plug is inserted into primary receptacle 632, thereby establishing an electrical connection between relay module 120 and one or more electrical leads of OSS medical device 110. However, such optical and electrical connections are formed using relay module 120 with medical barrier 703 between relay module 120 and OSS medical device 110. The receiving receptacle 632 and the plug of the medical device 110 enable such a connection from a sterile area including the OSS medical device 110 (e.g., PICC 310) (e.g., when the sterile drape is above the medical barrier 703) to a non-sterile area including the relay module 120 (e.g., when the sterile drape is below the medical barrier 703).

[0077] Other implementation plans

[0078] Figure 10 The optical connector 1022 of the extension tube 320 of the OSS medical device 110 is shown, according to some embodiments. Figure 11 An alternative relay module 1120 is shown having an optical connector 1122 for establishing an optical connection across a medical barrier 1103, according to some embodiments.

[0079] As described above, the extension tube 320 can include one or more optical fiber cores extending from the optical fiber stylet 424 along the length of the extension tube 320. The one or more optical fibers can extend to optical terminals in the mating surface of the optical connector 1022.

[0080] The optical connector 1022 includes one or more alignment magnets 1026 disposed in a mating surface of the optical connector 1022 around the end of the optical terminal or fiber stylet 424 .

[0081] As described above, the relay module 120 can be configured to relay optical signals to its receiver (e.g., the console 230 of the medical system 200). When the relay module 1120 is so configured, the relay module 1120 includes one or more optical fiber cores within the housing 1124 and the optical connector 1122 of the relay module 1120. It should be understood that, similar to the relay module 120, the relay module 1120 can be further configured to relay electrical signals from one or more electrical devices (e.g., the ECG patch 112a, the ECG patch 112b, the armband 114, etc.) to the console 230 of the medical system 200.

[0082] The optical connector 1122 includes one or more alignment magnets 1126 arranged in a mating surface of the optical connector 1122 around the optical receiver 1132 .

[0083] The optical connector 1022 and the optical connector 1122 are configured to mate across the transparent window 1104 of the medical barrier 1103 (e.g., a drape) and establish an optical connection between the optical terminal of the optical connector 1022 in the sterile area and the optical receiver of the optical connector 1122 in the non-sterile area.

[0084] The shape of each of optical connectors 1022 and 1122 can be configured to achieve a specific orientation of optical connector 1022 and optical connector 1122 when mated across transparent window 1104 of medical barrier 1103. For example, Figure 11 Each of the illustrated optical connectors 1022 and 1122 is rectangular or longer than it is wide, thereby achieving two of the four most reasonable orientations for a rectangular connector.

[0085] The magnetic poles of the one or more alignment magnets 1026 and 1126 of each of the optical connector 1022 and the optical connector 1122 can be additionally or alternatively configured to achieve a specific orientation of the optical connector 1022 and the optical connector 1122 when mated across the transparent window 1104 of the medical barrier 1103. For example, a first side of the optical connector 1022 can include a first pair of alignment magnets 1026 having the same magnetic pole orientation (e.g., N). A second side of the optical connector 1022 can include a second pair of alignment magnets 1026 having the same magnetic pole orientation (e.g., S) but different from the first side of the extension tube connector. The optical connector 1122 can be similarly configured such that similar sides of the optical connector 1022 and the optical connector 1122 repel each other when brought close together, and dissimilar sides of the optical connector 1022 and the optical connector 1122 attract each other when brought close together. In this way, two of the four most reasonable orientations of, for example, a square connector can be achieved. However, if the optical connector 1022 and the optical connector 1122 are as Figure 11 While shown as rectangular, both the shape and the poles as configured in the embodiment can achieve a single orientation.

[0086] Nevertheless, the shape of each of the optical connectors 1022 and 1122 can be rotationally symmetrical. Such a configuration allows for multiple rotationally equivalent orientations of the optical connectors 1022 and 1122 when mated across the transparent window 1104 of the medical barrier 1103. For example, all of the magnetic poles of the one or more alignment magnets 1026 of the optical connector 1022 can have the same magnetic pole orientation, but opposite to all of the magnetic poles of the one or more alignment magnets 1126 of the optical connector 1122, so as to complement all of the magnetic poles of the one or more alignment magnets 1126 of the optical connector 1122. In effect, such a configuration allows for multiple rotationally equivalent orientations of the optical connectors 1022 and 1122 when mated across the transparent window 1104 of the medical barrier 1103.

[0087] method

[0088] Figure 9 A second medical system 200 is shown having a medical barrier 703 for use during patient surgery, according to some embodiments.

[0089] Methods for use with medical system 100 or 200 may include methods used during a medical procedure. For example, a method for using medical system 200 during such a medical procedure may include a relay module placement step, an electrical plug insertion step, a medical drape placement step, and a barrier piercing plug insertion step.

[0090] The relay module placement step includes placing the relay module 120 on a surface (e.g., a relatively flat surface such as the chest of the patient P, a table next to the patient P, etc.), which establishes a reference plane for shape sensing using the OSS medical device 110. Before the relay module placement step, the method may further include a disinfection or sterilization step: disinfecting or sterilizing the relay module 120 before placing it on or next to the patient P.

[0091] The electrical plug insertion step includes inserting one or more electrical plugs corresponding to the one or more electrical medical devices into a corresponding number of secondary receptacles (e.g., secondary receptacles 634) of the relay module 120. The electrical plug insertion step establishes one or more under-barrier electrical connections (or soon-to-be one or more under-barrier electrical connections) between the one or more electrical devices and the relay module 120.

[0092] The medical drape placement step includes placing the medical barrier 703 on the relay module 120 and any one of the one or more electrical medical devices, if connected to the relay module 120. The medical drape placement step establishes a sterile field on the relay module 120 and any one of the one or more electrical devices connected thereto.

[0093] The barrier piercing plug insertion step includes inserting the barrier piercing plug 322 of the OSS medical device (e.g., PICC 310) through the medical barrier 703 and into the primary receptacle 632 of the relay module 120. The barrier piercing plug insertion step establishes a through-barrier optical connection or a through-barrier optical and electrical connection between the OSS medical device 110 in the sterile field and the relay module 120 in the non-sterile field.

[0094] The method may further include an identification step, a palpation step, or both. The identification step includes identifying an LED 636 disposed within the housing 324 of the relay module 120 adjacent to the primary receptacle 632. The identification step occurs after the setup step described below, which illuminates the LED 636. The palpation step includes palpating the primary receptacle 632 beneath the medical barrier 703. Both the identification step and the palpation step occur before the barrier piercing plug insertion step.

[0095] The method may further include establishing one or more connections between the relay module 120 and the rest of the medical system 200 (e.g., the console 230) for relaying optical and electrical signals from the relay module 120. The one or more connections are selected from an optical connection, an optical and electrical connection, and an electrical connection. At least an optical and electrical connection as another electrical connection between the relay module 120 and the console 230 is required (e.g., Figure 2connection b″) or electrical connection (e.g. Figure 2 Connection b') in provides power to LED 636 for lighting thereof for the identification step.

[0096] Although certain specific embodiments have been disclosed herein, and although some details of specific embodiments have been disclosed, these specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be apparent to those of ordinary skill in the art, and in broader aspects, these adaptations and / or modifications are also encompassed. Therefore, departures from the specific embodiments disclosed herein may be made without departing from the scope of the concepts provided herein.

Claims

1. A relay module, characterized in that: include: case; a primary receptacle disposed in the housing and configured to receive insertion of a barrier-piercing plug associated with an optical shape sensing OSS medical device and establish a barrier-piercing connection between the relay module and the OSS medical device, the barrier-piercing connection being selected from a barrier-piercing optical connection and a barrier-piercing optical and electrical connection; one or more secondary receptacles disposed in the housing and configured to receive insertion of a corresponding number of electrical plugs associated with one or more electrical medical devices and establish a corresponding number of below-the-barrier electrical connections between the relay module and the one or more electrical medical devices; and One or more cables extending from the housing, the one or more cables including a corresponding number of relay module plugs, the relay module plugs being used to establish one or more relay connections between the relay module and the rest of the medical system, the medical system being configured to receive optical and electrical signals from the relay module, the one or more relay connections being selected from the group consisting of a relay optical connection, a relay optical and electrical connection, and a relay electrical connection, provided that at least the relay optical connection or the relay optical and electrical connection is selected.

2. The relay module according to claim 1, wherein: Further comprising an optical fiber having one or more optical fiber cores, the optical fiber extending from the main receiving seat through a main cable of the one or more cables to a corresponding main plug of the number of relay module plugs, the optical fiber being configured to transmit an input optical signal from the optical interrogator of the medical system to the optical fiber stylet of the OSS medical device when the barrier penetration connection is established, and to transmit a reflected optical signal from the optical fiber stylet to the optical interrogator.

3. The relay module according to claim 1, wherein: Further comprising one or more electrical leads extending from a number of receiving sockets including the primary receiving socket and the one or more secondary receiving sockets, through any of the one or more cables to their corresponding relay module plugs, the one or more electrical leads being configured to transmit electrical signals from the relay module to the medical system.

4. The relay module according to claim 1, wherein: Further comprising one or more sensors disposed within the housing, the one or more sensors being selected from a gyroscope, an accelerometer, and a magnetometer and configured to provide sensor data for determining a reference plane for shape sensing using the OSS medical device.

5. The relay module according to claim 1, wherein: Further comprising a light emitting diode arranged in the housing adjacent to the main receiving seat, the light emitting diode being configured to light up when the relay optical and electrical connection or any relay electrical connection among the number of relay electrical connections is established, for finding the main receiving seat when the relay module is under a medical barrier. The relay module according to claim 1 , wherein: The relay module can be disinfected or sterilized at a high level.

7. The relay module according to claim 1, wherein: The housing includes a patient-facing surface configured to be adhered to a patient, thereby enabling the relay module to be secured to the patient.

8. A medical system, characterized in that: include: a console comprising a memory and one or more processors for converting a reflected optical signal from a fiber optic stylet into a shape thereof for display, said console further comprising an integrated optical interrogator or communicatively coupled to a separate optical interrogator for converting said reflected optical signal into a shape of said fiber optic stylet; An optical shape sensing OSS medical device for shape sensing, the OSS medical device comprising the optical fiber stylet and a barrier puncture plug; one or more electrical medical devices, each electrical medical device comprising at least one electrical plug; and A relay module, the relay module comprising: case; a primary receptacle disposed in the housing and configured to receive insertion of the barrier-piercing plug and establish a barrier-piercing connection between the relay module and the OSS medical device, the barrier-piercing connection being selected from a barrier-piercing optical connection and a barrier-piercing optical and electrical connection; one or more secondary receptacles disposed in the housing and configured to receive insertion of the at least one electrical plug of each of the one or more electrical medical devices and establish a corresponding number of below-the-barrier electrical connections between the relay module and the one or more electrical medical devices; and one or more cables extending from the housing, the one or more cables including a corresponding number of relay module plugs for establishing one or more relay connections between the relay module and the console or between the relay module and a combination of the console and the stand-alone optical interrogator, the one or more relay connections being selected from the group consisting of a relay optical connection, a relay optical and electrical connection, and a relay electrical connection, provided that at least the relay optical connection or the relay optical and electrical connection is selected.

9. The medical system according to claim 8, characterized in that The relay module further includes an optical fiber having one or more optical fiber cores, the optical fiber extending from the main receiving seat through a main cable among the one or more cables to a corresponding main plug among the number of relay module plugs, the optical fiber being configured to transmit an input optical signal from the integrated optical interrogator or the independent optical interrogator to the optical fiber stylet of the OSS medical device when the barrier penetration connection is established, and to transmit a reflected optical signal from the optical fiber stylet to the integrated optical interrogator or the independent optical interrogator.

10. The medical system according to claim 8, wherein: The relay module further includes one or more electrical leads extending from a number of receiving sockets including the main receiving socket and the one or more secondary receiving sockets, through any of the one or more cables to their corresponding relay module plugs, the one or more electrical leads being configured to transmit electrical signals from the relay module to the console.

11. The medical system according to claim 8, wherein: The relay module further includes one or more relay module-based sensors disposed within the housing, the one or more relay module-based sensors being selected from a relay module-based gyroscope, an accelerometer, and a magnetometer, and configured to provide relay module-based sensor data for determining a reference plane for shape sensing using the OSS medical device.

12. The medical system according to claim 8, wherein: The relay module further includes a light emitting diode arranged in the housing adjacent to the main receiving seat, the light emitting diode being configured to illuminate when an electrical connection in the one or more relay connections is established, for finding the main receiving seat when the relay module is under a medical barrier.

13. The medical system according to claim 8, wherein: The relay module can be disinfected or sterilized at a high level.

14. The medical system according to claim 8, wherein: The housing of the relay module includes a patient-facing surface configured to be adhered to a patient, thereby enabling the relay module to be secured to the patient.

15. The medical system according to claim 8, wherein The one or more electrical medical devices include one or more electrocardiogram (ECG) patches.

16. The medical system according to claim 8, wherein: The one or more electrical medical devices include an armband having one or more armband-based sensors selected from an armband-based gyroscope, an accelerometer, and a magnetometer, wherein the one or more armband-based sensors are configured to provide armband-based sensor data for reference plane determination for shape sensing using the OSS medical device.

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