Optical connection system and method thereof

Abstract

Optical connection systems including electrical and optical connection systems and methods thereof are disclosed. An electrical and optical connection system can include an extension tube having a plug and a relay module having a receptacle. The plug can be formed of a metal piece that surrounds an electrical wire that in turn surrounds an optical fiber core that extends along a length of the extension tube. The plug can be configured to pierce at least one sterile barrier. The relay module can include the electrical wire and the optical fiber core within a housing of the relay module and the receptacle disposed in the housing. The receptacle can be configured to establish electrical and optical connections between the plug and the receptacle from a sterile field to a non-sterile field while accepting insertion of the plug therein, the sterile field and the non-sterile field established by the sterile barrier. Shape sensing systems including the optical connection systems are also disclosed.

Description

[0001] Priority

[0002] This application claims priority to U.S. Provisional Application No. 62 / 983,402, filed February 28, 2020, the entirety of which is incorporated by reference into this application. BACKGROUND

[0003] Sometimes, the tip of a peripherally inserted central catheter (“PICC”) or central venous catheter (“CVC”) can move, shifting from an ideal position in a superior vena cava (“SVC”) of a patient. A clinician who believes that such a PICC or CVC has shifted will typically check for the shift via chest X-ray and replace the PICC or CVC if necessary. Since X-rays expose patients to ionizing radiation, medical devices such as PICCs and CVCs are being developed with integrated fiber optic probes that enable clinicians to conveniently and safely check for shifts thereof. However, in order for a clinician to check for a shift, a sterile PICC or CVC provided needs to be at least optically connected to a non-sterile capital device without compromising the sterile condition. Thus, there is a need for a relay module that allows a single-use medical device such as the aforementioned PICC and CVC to be at least optically connected to a non-sterile capital device without compromising the sterile condition.

[0004] Disclosed herein are optical connection systems including electrical and optical connection systems and methods thereof. SUMMARY

[0005] Disclosed herein is an electrical and optical connection system, in some embodiments, the system includes an extension tube having a plug and a relay module having a receptacle. The extension tube includes one or more optical fiber cores extending along a length of the extension tube, one or more electrical wires extending along the length of the extension tube over the one or more optical fibers, and the plug. The plug is formed of a metal piece surrounding the one or more electrical wires. The plug is configured for piercing at least one sterile barrier. The relay module is configured to relay electrical and optical signals to its receiver. The relay module includes one or more optical fiber cores within a housing of the relay module, one or more electrical wires within the housing of the relay module, and the receptacle disposed in the housing. The receptacle is configured to establish electrical and optical connections from a sterile zone to a non-sterile zone between the plug and the receptacle while accepting the plug inserted therein.

[0006] In some embodiments, the metal piece is fixedly coupled to the one or more electrical wires of the extension tube by a conductive adhesive.

[0007] In some embodiments, the metal piece is crimped onto the one or more wires of the extension tube, fixedly coupling the metal piece thereto.

[0008] In some embodiments, the receptacle comprises one or more electrical contacts configured to form the electrical connection with the metal piece when the plug is inserted into the receptacle, with the sterile barrier positioned therebetween when the plug is inserted into the receptacle. This configuration enables the electrical connection from the sterile field to the non-sterile field.

[0009] In some embodiments, the receptacle comprises an optical receiver configured to accept insertion of an optical terminal of the plug, and form the optical connection when the plug is inserted into the receptacle, with the sterile barrier positioned therebetween when the plug is inserted into the receptacle. This configuration enables the optical connection from the sterile field to the non-sterile field.

[0010] In some embodiments, the electrical and optical connection system further comprises a plug insertion device configured to be removably attached to a surface of the relay module.

[0011] The plug insertion device comprises a plug holder configured to hold the extension tube or the plug. The plug insertion device is configured to insert the plug into the receptacle when the plug holder holds the plug and the plug insertion device is actuated to insert the plug into the receptacle while the plug insertion device is attached to the relay module.

[0012] In some embodiments, the plug insertion device comprises a lever as an actuator for inserting the plug into the receptacle. The lever is configured to insert the plug into the receptacle when the lever is moved through a sector towards the plug holder.

[0013] In some embodiments, the relay module is configured to be placed on or next to a patient below the sterile barrier.

[0014] In some embodiments, the housing comprises a surface facing the patient, the surface being configured to be affixed to the patient. This configuration enables the relay module to be fastened to the patient while establishing the electrical and optical connections between the plug and the relay module.

[0015] Also disclosed herein is an optical connection system, in some embodiments, comprising an extension tube having an extension tube connector and a relay module having a relay module connector. The extension tube comprises one or more optical fiber cores extending along a length of the extension tube and the extension tube connector. The extension tube connector comprises an optical terminal disposed in a mating surface of the extension tube connector. The relay module is configured to relay optical signals to its receiver. The relay module comprises one or more optical fiber cores located within a housing of the relay module and the relay module connector. The relay module connector comprises an optical receiver disposed in a mating surface of the relay module connector. The extension tube connector and the relay module connector are configured to mate across a transparent window of a sterile barrier and establish an optical connection between the optical terminal in a sterile area and the optical receiver in a non-sterile area.

[0016] In some embodiments, the extension tube connector comprises one or more alignment magnets disposed in the mating surface of the extension tube connector around the optical terminal. Also, the relay module connector comprises one or more alignment magnets disposed in the mating surface of the relay module connector around the optical receiver.

[0017] In some embodiments, the shape of each of the extension tube connector and the relay module connector forces the extension tube connector and the relay module connector to adopt a particular orientation when mated across the transparent window.

[0018] In some embodiments, the poles of the one or more alignment magnets of each of the extension tube connector and the relay module connector force the extension tube connector and the relay module connector to adopt a particular orientation when mated across the transparent window.

[0019] In some embodiments, the shape of each of the extension tube connector and the relay module connector is rotationally symmetric. This configuration allows for multiple rotationally equivalent orientations of the extension tube connector and the relay module connector when mated across the transparent window.

[0020] In some embodiments, all the poles of the one or more alignment magnets of the extension tube connector have the same orientation but are opposite to all the poles of the one or more alignment magnets of the relay module connector. This configuration allows for multiple rotationally equivalent orientations of the extension tube connector and the relay module connector when mated across the transparent window.

[0021] In some embodiments, the relay module is configured to be placed on or beside a patient below the sterile barrier.

[0022] In some embodiments, the housing includes a patient-facing surface configured to be affixed to the patient. This configuration enables the relay module to be secured to the patient while the electrical and optical connections are established between the plug and the relay module.

[0023] Also disclosed herein is a method of an electrical and optical connection system. In some embodiments, the method includes a relay module placement step, a sterile barrier placement step, and a first plug insertion step. The relay module placement step includes placing a relay module on or near a patient. The sterile barrier placement step includes placing a sterile barrier on the patient. This step establishes a sterile field above the sterile barrier and a non-sterile field below the sterile barrier. The first plug insertion step includes inserting a plug of an extension tube in communication with a medical device in the sterile field into a receptacle of the relay module in the non-sterile field. The first plug insertion step simultaneously establishes an electrical connection and an optical connection between the medical device and the relay module across the sterile barrier.

[0024] In some embodiments, the relay module placement step occurs before the sterile barrier placement step.

[0025] In some embodiments, the method further includes a mounting step and a second plug insertion step. The mounting step includes mounting a plug insertion device on a surface of the relay module. The second plug insertion step includes inserting the plug into a plug holder of the plug insertion device.

[0026] In some embodiments, the method further includes an actuation step of actuating a lever of the plug insertion device to insert the plug into the receptacle.

[0027] Also disclosed herein is a method of an optical connection system. In some embodiments, the method includes a relay module placement step, a sterile barrier placement step, and a mating step. The relay module placement step includes placing a relay module on or near a patient. The sterile barrier placement step includes placing a sterile barrier having a transparent window on the patient. This step establishes a sterile field above the sterile barrier and a non-sterile field below the sterile barrier. The mating step includes mating an extension tube connector of an extension tube in communication with a medical device in the sterile field with a relay module connector of the relay module in the non-sterile field, wherein the transparent window is positioned between the extension tube connector and the relay module connector. The mating step establishes the optical connection between the medical device and the relay module across the sterile barrier.

[0028] In some embodiments, the relay module placement step occurs before the sterile barrier placement step.

[0029] In some embodiments, the mating step includes orienting the extension tube connector such that its shape matches the shape of the relay module connector.

[0030] In some embodiments, the mating step includes orienting the extension tube connector such that the poles of its one or more alignment magnets are complementary to the poles of the one or more alignment magnets of the relay module connector.

[0031] These and other features of the concepts provided herein will become more apparent from the following description in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0032] Figure 1 is a block diagram of a first shape sensing system in accordance with some embodiments.

[0033] Figure 2 is a block diagram of a second shape sensing system in accordance with some embodiments.

[0034] Figure 3 shows a second shape sensing system in accordance with some embodiments.

[0035] Figure 4 shows a cross-section of a catheter tube of a medical device in accordance with some embodiments.

[0036] Figure 5 shows a plug of an extension tube of a medical device for establishing optical and electrical connections in accordance with some embodiments.

[0037] Figure 6 shows a detailed view of a relay module with a socket for establishing optical or optical and electrical connections in accordance with some embodiments.

[0038] Figure 7 shows a plug insertion device in accordance with some embodiments.

[0039] Figure 8 shows a second shape sensing system used during a surgery of a patient in accordance with some embodiments.

[0040] Figure 9 shows a second shape sensing system used with a sterile barrier during a surgery of a patient in accordance with some embodiments.

[0041] Figure 10 shows an extension tube optical connector of an extension tube of a medical device in accordance with some embodiments.

[0042] Figure 11 A relay module with a relay module optical connector for establishing an optical connection is shown in accordance with some embodiments. DETAILED DESCRIPTION

[0043] Before certain specific embodiments are provided in more detail, it should be understood that the certain specific embodiments provided herein do not limit the scope of the concepts disclosed herein. It should also be understood that the features of the certain specific embodiments disclosed herein can be readily separated from the certain specific embodiments and optionally combined with features of any one of the various embodiments disclosed herein or substituted for like features of other embodiments without departing from the scope of the concepts disclosed herein.

[0044] With respect to the terms used herein, it should also be understood that the terms are used herein for the purpose of describing certain specific embodiments and are not intended to limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps and do not supply a serial or numerical limitation. For example, "first," "second," and "third" features or steps need not necessarily appear in that order and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as "left," "right," "top," "bottom," "front," "back," and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. On the contrary, such labels are used herein for the convenience of the reader to reflect, for example, relative positions, orientations, or directions. Singular forms of "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0045] For example, a "proximal," "proximal portion," or "proximal end portion" of a catheter disclosed herein includes a portion of the catheter that should be closer to a clinician when the catheter is used on a patient. Likewise, for example, a "proximal length" of a catheter includes a length of the catheter that should be closer to a clinician when the catheter is used on a patient. For example, a "proximal end" of a catheter includes an end of the catheter that should be closer to a clinician when the catheter is used on a patient. A proximal portion, proximal end portion, or proximal length of a catheter can include a proximal end of the catheter; however, a proximal portion, proximal end portion, or proximal length of a catheter need not include a proximal end of the catheter. That is, unless the context indicates otherwise, a proximal portion, proximal end portion, or proximal length of a catheter is not a distal portion or a distal length of the catheter.

[0046] For example, a "distal," "distal portion," or "distal end portion" of a catheter disclosed herein includes a portion of the catheter that should be proximate to or within a patient when the catheter is used on the patient. Likewise, for example, a "distal length" of a catheter includes a length of the catheter that should be proximate to or within a patient when the catheter is used on the patient. For example, a "distal end" of a catheter includes an end of the catheter that should be proximate to or within a patient when the catheter is used on the patient. A distal portion, distal end portion, or distal length of a catheter can include a distal end of the catheter; however, a distal portion, distal end portion, or distal length of a catheter need not include a distal end of the catheter. That is, unless context dictates otherwise, a distal portion, distal end portion, or distal length of a catheter is not a terminal portion or length of the catheter.

[0047] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of ordinary skill in the art to which this disclosure belongs.

[0048] As described above, there is a need for a relay module that allows a single-use medical device (e.g., the aforementioned PICC and CVC) to be at least optically connected to a non-sterile capital device without compromising the sterile condition. Disclosed herein are optical connection systems including electrical and optical connection systems and methods thereof.

[0049] The features of the optical connection systems provided herein will become more apparent from the drawings and the following description, in which specific embodiments of the optical connection systems are described in more detail. Insofar as context permits, the optical connection systems are first described in the context of a shape sensing system, then in the context of a medical device and a relay module of the shape sensing system, and then in the context of the aforementioned methods. The optical connection systems, as well as the electrical and optical connection systems, are described in the context of a combination of the shape sensing system, the medical device, and the relay module.

[0050] Shape sensing system

[0051] Figure 1 is a block diagram of a first shape sensing system 100 according to some embodiments. Figure 2 is a block diagram of a second shape sensing system 200 according to some embodiments. Figure 3 A second shape sensing system 200 according to some embodiments is shown. Figure 8 A second shape sensing system 200 according to some embodiments used during a surgical procedure on a patient is shown. Figure 9 A second shape sensing system 200 according to some embodiments used during a surgical procedure on a patient with a sterile barrier 903 is shown.

[0052] As shown, in some embodiments, shape sensing system 100 or 200 includes a medical device 110, a console 130 or 230, and a relay module 120 configured to connect the medical device 110 to the rest of the shape sensing system 100 or 200, e.g., the console 230. The medical device 110 is typically used in a sterile field, while the relay module 120 and the console 130 or 230 are typically used in a non-sterile field, the sterile field and the non-sterile field being defined at least by a sterile barrier 903 (e.g., a sterile drape) that is one of several possible sterile barriers (e.g., a sterile drape, a plastic tent, a sheath, etc.).

[0053] The medical device 110 includes at least one integrated fiber optic probe that includes one or more fiber optic cores, each core in turn having a plurality of fiber Bragg grating ("FBG") sensors along its length for shape sensing with the shape sensing system 100 or 200. (See, e.g., the integrated fiber optic probe 424 in Figure 4 However, the medical device 110 can also include electrical components, e.g., an electrocardiogram ("ECG") probe and one or more electrical wires to support the ECG probe.

[0054] Certain features of the medical device 110 will be set forth in greater detail below with respect to particular embodiments of the medical device 110, e.g., the PICC 310. That is, some features set forth below with respect to one or more embodiments of the medical device 110, e.g., the PICC 310 (e.g., fiber optic probe, ECG probe, etc.) can be shared between two or more embodiments of the medical device 110. As such, "medical device 110" is used herein to refer generally to more than one embodiment of the medical device 110 when needed for ease of illustration. Although certain features have been described with respect to particular embodiments of the medical device 110, e.g., the PICC 310.

[0055] Although shown only with respect to the console 230, each of the consoles 130 and 230 includes a memory 236 and one or more processors 234 for converting the reflected optical signals from the fiber optic probe of the medical device 110 into a displayable shape of the medical device 110. The displayable shape of the medical device 110 can be displayed on an integrated display screen integrated into the console 130 or 230, or on a display screen of a separate monitor coupled to the console 130 or 230.

[0056] The shape sensing system 100 further includes a standalone optical interrogator 140 communicatively coupled to the console 130, while the shape sensing system 200 further includes an integrated optical interrogator 232 integrated into the console 230. The optical interrogator 140 or 232 is configured to send input optical signals into the fiber probe of the medical device 110 through the relay module 120 and receive reflected optical signals from the fiber probe through the relay module 120.

[0057] The relay module 120 includes a housing 324, a cable 326 extending from the housing 324, and one or more optical fiber cores 628 ("optical fibers 628") extending through the housing 324 and along the cable 326. (See Figure 6 .) The relay module 120 is configured to establish an optical connection at least between the fiber probe of the medical device 110 and the optical fibers 628 of the relay module 120. The relay module 120 is also configured with a plug 330 at the end of the cable 326 to establish at least another optical connection between the optical fibers 628 of the relay module 120 and the optical interrogator 140 or 232. The optical fibers 628 of the relay module 120 are configured to carry input optical signals from the optical interrogator 140 or 232 to the fiber probe of the medical device 110 and to carry reflected optical signals from the fiber probe to the optical interrogator 140 or 232.

[0058] The relay module 120 can also be configured to establish an electrical connection between the medical device 110 and the relay module 120, between the relay module 120 and the console 103 or 230, or both, as set out in more detail below. To support such electrical connections, the relay module 120 can include one or more electrical wires that, like the optical fibers 628, extend through the housing 324 and along the cable 326.

[0059] The relay module 120 can further include one or more sensors 222 disposed within the housing 324, selected from at least a gyroscope, an accelerometer, and a magnetometer. The one or more sensors 222 are configured to provide sensor data through the one or more electrical wires within the housing 324 and the cable 326 to the console 130 or 230 for determining a reference plane for shape sensing with the fiber probe of the medical device 110.

[0060] Certain features of the relay module 120 will be set forth in greater detail below with respect to particular embodiments of the relay module 120. That is, some features set forth 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. As such, "relay module 120" is used herein to generically refer to more than one embodiment of the relay module 120 when needed for convenience of explanation. Although certain features have been described with respect to particular embodiments of the relay module 120.

[0061] Medical device

[0062] Figure 3 A PICC 310 as a medical device 110 is also shown in accordance with some embodiments. Figure 4 A cross-section of a catheter tube 312 of the PICC 310 including an integrated optical fiber probe 424 is shown in accordance with some embodiments. Figure 5 A plug 322 of the extension tube or cable 320 of the medical device 110 for establishing optical and electrical connections is shown in accordance with some embodiments.

[0063] As shown, the PICC 310 includes a catheter tube 312, a bifurcated hub 314, two extension legs 316, and two luer connectors 318, which are operatively connected in the aforementioned order. The catheter tube 312 includes two catheter lumens 413 and an optical fiber probe 424, which is disposed in a longitudinal bead of the catheter tube 312, e.g., between the two extruded catheter lumens 413. Optionally, in the same or different longitudinal bead of the catheter tube 312, the PICC 310 can further include an ECG probe. The bifurcated hub 314 has two hub lumens, which are respectively fluidically connected to the two catheter lumens 413. Each of the two extension legs 316 has an extension leg lumen fluidically connected to one of the two hub lumens. The PICC 310 further includes an extension tube 320, which either extends from the bifurcated hub 314 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 tube 312, including the optical fiber probe 424 and (if present) the ECG probe, which can terminate at a plug 322 for establishing optical and any electrical connections between the optical fiber probe 424 of the PICC 310 and the optical fiber 628 of the relay module 120. The cut portion of the catheter tube 312 can be disposed in another tube, which, in combination, forms the extension tube 320, which terminates at the plug 322 for establishing the aforementioned optical and electrical connections.

[0064] While the PICC 310 is provided as a particular implementation of the medical device 110 of the shape sensing 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 one optical fiber probe, and optionally one or more electrical components, such as an ECG probe and one or more wires supporting the same, terminating in a plug for establishing an optical connection or an optical and electrical connection between the medical device and the relay module 120.

[0065] relay module

[0066] Figure 6 A detailed view of the relay module 120 is shown, according to some embodiments, having a receptacle 632 for establishing an optical connection or an optical and electrical connection. Figure 9 A second shape sensing system 200 is shown, according to some embodiments, for use with a sterile barrier 903 during a surgical procedure on a patient.

[0067] As shown, the relay module 120 includes a housing 324, a receptacle 632 disposed in the housing 324, a cable 326 extending from the housing 324, and at least the optical fiber 628 within the housing 324 and the cable 326. Also, in some embodiments, similar to the optical fiber 628, the relay module 120 can include one or more electrical wires extending through the housing 324 and along the cable 326.

[0068] The receptacle 632 includes an optical receptacle configured to receive insertion of an optical terminal of a plug of the medical device 110 (e.g., the plug 322 of the PICC 310) for establishing an optical connection between the relay module 120 and the optical fiber probe of the medical device 110 (e.g., the optical fiber probe 424 of the PICC 310) when the plug is inserted into the receptacle 632. The receptacle 632 can also include one or more electrical contacts, when present, configured to contact an electrical terminal of the plug of the medical device 110 (e.g., the metal piece of the plug 322 of the PICC 310) for establishing an electrical connection between the relay module 120 and the one or more electrical wires of the medical device 110 when the plug is inserted into the receptacle 632.

[0069] In some embodiments, the cable 326 includes a plug 330 for establishing an optical connection between the relay module 120 and the optical interrogator 232 of the console 230, and an electrical connection between the relay module 120 and the console 230.

[0070] Optical fiber 628 extends from the receptacle 632 to the plug 330 through the cable 326. The optical fiber 628 is configured to transmit input optical signals from the optical interrogator 232 to a fiber optic probe of the medical device 110 (e.g., the fiber optic probe 424 of the PICC 310) and to transmit reflected optical signals from the fiber optic probe to the optical interrogator 232.

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

[0072] Like the optical fiber 628, when present in the relay module 120, the one or more electrical wires extend from the one or more sensors 222 (if present), the receptacle 632, or both the one or more sensors 222 and the receptacle 632, to the plug 330 through the cable 326. In addition to any required power, when present in the relay module 120, the one or more electrical wires are configured to transmit input electrical signals from the control console 230 to the one or more sensors 222. The one or more electrical wires are also configured to transmit any output electrical signals from the one or more sensors 222, the ECG probe (if present in the medical device 110), or both the one or more sensors 222 and the ECG probe, to the control console 230.

[0073] The relay module 120 is configured to be positioned below the sterile barrier 903, on or next to the patient P, for example, on the patient's chest. In this way, the relay module 120 does not need to be sterilized or disinfected. However, if the relay module 120 needs to be sterilized or disinfected, the relay module 120 can be configured to withstand sterilization or disinfection. For example, the housing 324 of the relay module 120 can be non-porous or resistant to chemical oxidizers. The relay module 120 can be configured to be manually sterilized with the STERRAD® product by Becton, Dickinson and Company (Franklin Lakes, NJ), or the relay module 120 can be configured to be automatically high-level disinfected or sterilized with the SONEX® product by Nanosonics, Inc. (Indianapolis, IN) using vaporized H2O2.

[0074] ​​Although not shown, the housing 324 of the relay module 120 can 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 enable the relay module 120 to be secured to the neck of the patient P when positioned on the chest of the patient. Additionally or alternatively, the housing 324 includes a patient-facing surface (e.g., the back of the relay module 120) configured to be affixed to the chest of the patient. The patient-facing surface enables the relay module 120 to be secured to the patient when positioned on or near the patient, regardless of whether the relay module 120 is also secured to the neck of the patient.

[0075] Likewise, the receptacle 632 includes an optical receiver configured to accept insertion of an optical terminal of a plug of the medical device 110 (e.g., the plug 322 of the PICC 310) and form an optical connection when the plug is inserted into the receptacle 632. The receptacle 632 can also include one or more electrical contacts, when present, configured to contact electrical terminals of a plug of the medical device 110 (e.g., the metal pieces of the plug 322 of the PICC 310) for establishing an electrical connection between the relay module 120 and one or more electrical wires of the medical device 110 when the plug is inserted into the receptacle 632. However, for the relay module 120, such optical and electrical connections are formed in the presence of the sterile barrier 903 between the relay module 120 and the medical device 110. The receptacle 632 and plug of the medical device 110 enable such connections from a sterile field (e.g., above the sterile barrier 903) including the medical device 110 (e.g., the PICC 310) to a non-sterile field (e.g., below the sterile barrier 903) including the relay module 120.

[0076] Connection system

[0077] Figure 5 A plug 322 of an extension tube 320 of a medical device 110 for establishing optical and electrical connections is shown, according to some embodiments. Figure 6 A detailed view of a relay module 120 having a receptacle 632 for establishing optical or optical and electrical connections is shown, according to some embodiments.

[0078] As shown, an electrical and optical connection system can include an extension tube 320 having a plug 322 and a relay module 120 having a receptacle 632.

[0079] As described above, the extension tube 320 can include one or more optical fiber cores extending from the optical fiber probe 424 along the length of the extension tube 320, one or more electrical wires (e.g., one or more electrical wires 525) extending along the length of the extension tube 320 over the one or more optical fiber cores, for example, woven over the one or more optical fiber cores, and the plug 322.

[0080] The plug 322 is formed from a metal piece (e.g., a metal ferrule) that surrounds the one or more electrical wires, which in turn are located over the one or more optical fiber cores. The metal piece can be fixedly coupled to the one or more electrical wires of the extension tube 320 by a conductive adhesive (e.g., a conductive epoxy), crimped onto the one or more electrical wires of the extension tube 320, or a combination thereof. The plug 322, or the metal piece thereof, is tapered enough such that it is configured for piercing at least one aseptic barrier, for example, the aseptic barrier 903.

[0081] As described above, the relay module 120 can be configured to relay the optical and electrical signals to its receiver, for example, the console 230 of the shape sensing system 200. When so configured, the relay module 120 includes the one or more optical fiber cores within the housing 324 of the relay module 120, the one or more electrical wires within the housing 324, and the receptacle 632 disposed in the housing 324.

[0082] The receptacle 632 is configured to establish the electrical and optical connections between the plug 322 and the receptacle 632 from the aseptic zone to the non-aseptic zone while accepting the plug 322 inserted therein. For the optical connection, the receptacle 632 includes the optical receiver described above configured to accept the insertion of the optical terminal of the plug 322 and form the optical connection with the aseptic barrier 903 in between when the plug 322 is inserted into the receptacle 632. This configuration enables the optical connection from the aseptic zone to the non-aseptic zone. For the electrical connection, the receptacle 632 includes the one or more electrical contacts set forth herein configured to form the electrical connection with the metal piece with the aseptic barrier 903 in between when the plug 322 is inserted into the receptacle 632. This configuration enables the electrical connection from the aseptic zone to the non-aseptic zone.

[0083] Figure 7 A plug insertion device 700 according to some embodiments is shown.

[0084] As shown, the electrical and optical connection system described above can further include the plug insertion device 700. The plug insertion device 700 is configured to be removably attached to the surface of the relay module 120 through the aseptic barrier 903 between the plug insertion device 700 and the relay module 120, as Figure 7 shown, for inserting the plug 322 into the receptacle 632 of the relay module 120.

[0085] The plug insertion device 700 includes a plug holder 702 and a lever 704. The plug holder 702 is configured to hold the extension tube 320 or the plug 322. The lever 704 is an actuator configured to insert the plug 322 into the receptacle 632 of the relay module 120 as the lever 704 is moved toward the plug holder 702 through a sector, as shown. Figure 7 In practice, the plug insertion device 700 is configured to insert the plug 322 into the receptacle 632 when the plug insertion device 700 is attached to the relay module 120, the plug holder 702 holds the plug 322, and the plug insertion device 700 is actuated by the lever 704 to insert the plug 322 into the receptacle 632.

[0086] Figure 10 An extension tube optical connector 1022 of the extension tube 320 of the medical device 110 is shown in accordance with some embodiments. Figure 11 A relay module 1120 is shown in accordance with some embodiments having a relay module optical connector 1122 for establishing an optical connection across the sterile barrier 1103.

[0087] As shown, the optical connection system can include the extension tube 320 having the extension tube connector 1022 and the relay module 1120 having the relay module connector 1122.

[0088] As described above, the extension tube 320 can include one or more optical fiber cores extending from the fiber optic probe 424 along the length of the extension tube 320. The one or more optical fibers can extend to an optical termination in the mating surface of the extension tube connector 1022.

[0089] The extension tube connector 1022 includes one or more alignment magnets 1026 disposed in the mating surface of the extension tube connector 1022 around the end of the optical termination or the fiber optic probe 424.

[0090] As described above, the relay module 120 can be configured to relay the optical signal to its receiver, such as the console 230 of the shape sensing 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 of the relay module 1120 and the relay module connector 1122.

[0091] The relay module connector 1122 includes one or more alignment magnets 1126 disposed in the mating surface of the relay module connector 1122 around the optical receiver 1132.

[0092] The extension tube connector 1022 and the relay module connector 1122 are configured to mate across the transparent window 1104 of the sterile barrier 1103 (e.g., a drape) and establish an optical connection between an optical terminal of the extension tube connector 1022 in the sterile area and an optical receiver of the relay module connector 1122 in the non-sterile area.

[0093] The shape of each of the extension tube connector 1022 and the relay module connector 1122 can be configured to force the extension tube connector 1022 and the relay module connector 1122 to adopt a particular orientation when mated across the transparent window 1104 of the sterile barrier 1103. For example, Figure 11 Each of the extension tube connector 1022 and the relay module connector 1122 shown in the middle is rectangular or longer than it is wide, forcing adoption of two of the four most reasonable orientations of the rectangular connector.

[0094] The poles of one or more alignment magnets 1026 and 1126 of each of the extension tube connector 1022 and the relay module connector 1122 can additionally or alternatively be configured to force the extension tube connector 1022 and the relay module connector 1122 to adopt a particular orientation when mated across the transparent window 1104 of the sterile barrier 1103. For example, a first side of the extension tube connector 1022 can include a first pair of alignment magnets 1026 having the same pole orientation (e.g., N). A second side of the extension tube connector 1022 can include a second pair of alignment magnets 1026 having the same pole orientation (e.g., S), but different from the first side of the extension tube connector. The relay module connector 1122 likewise can be configured such that similar sides of the extension tube connector 1022 and the relay module connector 1122 repel each other when brought close to each other, and dissimilar sides of the extension tube connector 1022 and the relay module connector 1122 attract each other when brought close to each other. In this way, two of the four most reasonable orientations of a square connector can be forced, for example. However, if the extension tube connector 1022 and the relay module connector 1122 are rectangular as shown in the bottom, Figure 11 both the shape and the poles as configured in this example can force adoption of a single orientation if the extension tube connector 1022 and the relay module connector 1122 are rectangular as shown in the bottom.

[0095] Notwithstanding, the shape of each of the extension tube connector 1022 and the relay module connector 1122 can be rotationally symmetric. This configuration allows for multiple rotationally equivalent orientations of the extension tube connector 102 and the relay module connector 1122 when mated across the transparent window 1104 of the sterile barrier 1103. For example, all of the magnetic poles of the one or more alignment magnets 1026 of the extension tube connector 1022 can have the same magnetic pole orientation, but opposite to, and complementary to, all of the magnetic poles of the one or more alignment magnets 1126 of the relay module connector 1122. In effect, this configuration allows for multiple rotationally equivalent orientations of the extension tube connector 1022 and the relay module connector 1122 when mated across the transparent window 1104 of the sterile barrier 1103.

[0096] Method

[0097] Figure 9 A second shape sensing system 200 for use with a sterile barrier 903 during a surgical procedure on a patient is shown in accordance with some embodiments.

[0098] The method of the electrical and optical connection system can be part of the method of the shape sensing system 100 or 200. Such a method can include a relay module placement step, a sterile barrier placement step, and a first plug insertion step.

[0099] The relay module placement step includes placing the relay module 1120 on or next to the patient P, for example on the patient’s chest. Prior to the relay module placement step, the method can further include a sterilization or disinfection step of sterilizing or disinfecting the relay module 1120 prior to placing the relay module 1120 on or next to the patient.

[0100] The sterile barrier placement step includes placing the sterile barrier 903 on the patient. Such a step establishes a sterile zone above the sterile barrier 903 and a non-sterile zone below the sterile barrier 903, and can occur after the relay module placement step.

[0101] The first plug insertion step includes inserting the plug 322 of the extension tube 320 that is communicatively connected with the medical device 110 (e.g., the PICC 310) in the sterile zone into the receptacle 632 of the relay module 120 in the non-sterile zone. The first plug insertion step simultaneously establishes an electrical connection and an optical connection between the medical device 110 (e.g., the PICC 310) and the relay module 120 across the sterile barrier 903.

[0102] Prior to the first plug insertion step, the method can further include a mounting step and a second plug insertion step. The mounting step includes mounting the plug insertion device 700 on a surface of the relay module 120. The second plug insertion step includes inserting the plug 322 into the plug holder 702 of the plug insertion device 700 used for the first plug insertion step.

[0103] After the mounting and second plug insertion steps, the method can further include an actuation step, i.e., during the first plug insertion step, actuating the lever 704 of the plug insertion device 700 to insert the plug 322 into the receptacle 632.

[0104] The method of the optical connection system can also be part of the method of the shape sensing system 100 or 200. Such a method can include a relay module placement step, a sterile barrier placement step, and a mating step.

[0105] The relay module placement step includes placing the relay module 1120 on or next to the patient P, e.g., on the patient’s chest. Prior to the relay module placement step, the method can further include a sterilization or disinfection step of sterilizing or disinfecting the relay module 1120 prior to placing the relay module 1120 on or next to the patient.

[0106] The sterile barrier placement step includes placing the sterile barrier 1103 having the transparent window 1104 on the patient. Such a step establishes a sterile zone above the sterile barrier 1103, a non-sterile zone below the sterile barrier 1103, and can occur after the relay module placement step.

[0107] The mating step includes mating the extension tube connector 1022 in the sterile zone that is communicatively connected to the extension tube 320 of the medical device 110 (e.g., the PICC 310) with the relay module connector 1122 in the non-sterile zone of the relay module 1120, with the transparent window 1104 positioned between the extension tube connector 1022 and the relay module connector 1122. The mating step establishes the optical connection between the medical device 110 and the relay module 1120 across the sterile barrier 1103.

[0108] The mating step includes orienting the extension tube connector 1022 such that its shape matches the shape of the relay module connector 1122. The mating step can also include orienting the extension tube connector 1022 such that the poles of the one or more alignment magnets 1026 complement the poles of the one or more alignment magnets 1126 of the relay module connector 1122.

[0109] While some specific embodiments have been disclosed herein, and while the particular embodiments have been disclosed with some specificity, these specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications of the specific embodiments disclosed herein can occur to persons skilled in the art, and such adaptations and / or modifications are included within the scope of the concepts provided herein. Therefore, it is contemplated that the specific embodiments provided herein will be subject to modifications and / or substitutions by those of ordinary skill in the art.

Claims

1. An electrical and optical connection system for establishing both electrical and optical connections across a sterile barrier, comprising: an extension tube comprising: one or more optical fiber cores extending along a length of the extension tube; one or more electrical wires extending along the length of the extension tube and woven over the one or more optical fiber cores; and a plug formed from a metal piece surrounding the one or more electrical wires, the plug configured for piercing the sterile barrier; and a relay module configured to relay electrical and optical signals to its receivers, the relay module comprising: one or more optical fiber cores within a housing of the relay module; one or more electrical wires within the housing of the relay module; and a receptacle disposed in the housing, the receptacle configured to establish both electrical and optical connections across the sterile barrier between the plug and the receptacle while accepting insertion of the plug therein.

2. The electrical and optical connection system of claim 1, wherein the metal piece is fixedly coupled to the one or more electrical wires of the extension tube by a conductive adhesive.

3. The electrical and optical connection system of claim 1, wherein the metal piece is crimped onto the one or more electrical wires of the extension tube, fixedly coupling the metal piece thereto.

4. The electrical and optical connection system of claim 1, wherein the receptacle comprises one or more electrical contacts configured to form the electrical connection with the metal piece when the plug is inserted into the receptacle, thereby enabling electrical connection across the sterile barrier, with the sterile barrier positioned therebetween when the plug is inserted into the receptacle.

5. The electrical and optical connection system of claim 1, wherein the receptacle comprises an optical receiver configured to accept insertion of an optical terminal of the plug and form the optical connection when the plug is inserted into the receptacle, thereby enabling optical connection across the sterile barrier, with the sterile barrier positioned therebetween when the plug is inserted into the receptacle.

6. The electrical and optical connection system of claim 1, further comprising a plug insertion device configured to be removably attached to a surface of the relay module, the plug insertion device comprising a plug holder configured to hold the extension tube or the plug, and to insert the plug into the receptacle when the plug insertion device is attached to the relay module, the plug holder holds the plug, and the plug insertion device is actuated to insert the plug into the receptacle.

7. The electrical and optical connection system of claim 6, wherein the plug insertion device comprises a lever as an actuator for inserting the plug into the receptacle, the lever configured to insert the plug into the receptacle when the lever is moved through a sector toward the plug holder.

8. The electrical and optical connection system of claim 1, wherein the relay module is configured to be placed on or next to a patient below the sterile barrier, wherein the housing includes a patient-facing surface configured to be affixed to the patient such that the relay module can be secured to the patient when both the electrical and optical connections are established between the plug and the relay module.

9. A method of the electrical and optical connection system of claim 1, comprising: placing a relay module on or next to a patient; placing a sterile barrier on the patient, thereby establishing a sterile field above the sterile barrier and a non-sterile field below the sterile barrier; inserting a plug of an extension tube in communication with a medical device in the sterile field into a receptacle of the relay module in the non-sterile field, the insertion simultaneously establishing both an electrical and an optical connection between the medical device and the relay module across the sterile barrier.

10. The method of claim 9, wherein placing the relay module on or next to the patient occurs before placing the sterile barrier on the patient.

11. The method of claim 9, further comprising: installing a plug insertion device on a surface of the relay module; and inserting the plug into a plug holder of the plug insertion device.

12. The method of claim 11, further comprising actuating a lever of the plug insertion device to insert the plug into the receptacle. ​

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