Patent Description:
At times, a tip of a peripherally inserted central catheter ("PICC") or central venous catheter ("CVC") can move becoming displaced from an ideal position in a patient's superior vena cava ("SVC"). A clinician believing such a PICC or CVC has displaced typically checks for displacement by chest X-ray and replaces 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 optical-fiber stylets for clinicians to easily and safely check for displacement thereof. However, in order for the clinicians to check for displacement, the PICCs or CVCs, which are sterile as provided, need to be at least optically connected to non-sterile capital equipment without compromising sterile conditions. Therefore, there is a need for a relay module that allows for single-use medical devices such as the foregoing PICCs and CVCs to be at least optically connected to non-sterile capital equipment without compromising sterile conditions. <CIT> discloses a cable connector including a plurality of electrical contacts and one or more optical fibers. <CIT> discloses surgical tray comprising a top surface configured to be used in a sterile field and a reusable non-sterile module.

Disclosed herein are optical connection systems including electrical-and-optical connection systems and methods thereof.

According to a first aspect, there is provided an electrical-and-optical connection system according to claim <NUM>.

In some embodiments, the metal piece is fixedly coupled to the one or more electrical wires of the extension tube by an electrically conductive adhesive.

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

In some embodiments, the receptacle includes 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 therebetween. Such a configuration enables the electrical connection from the sterile field to the non-sterile field.

In some embodiments, the receptacle includes 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 therebetween. Such a configuration enables the optical connection from the sterile field to the non-sterile field.

In some embodiments, the electrical-and-optical connection system further includes a plug-inserting device configured to removably attach to a surface of the relay module.

The plug-inserting device includes a plug holder configured to hold the extension tube or the plug. The plug-inserting device is configured to insert the plug into the receptacle when the plug-inserting device is attached to the relay module, the plug holder is holding the plug, and the plug-inserting device is actuated to insert the plug into the receptacle.

In some embodiments, the plug-inserting device includes 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 circular sector toward the plug holder.

In some embodiments, the relay module is configured to sit on or alongside a patient beneath the sterile barrier.

In some embodiments, the housing includes a patient-facing surface configured to be adhered to the patient. Such a configuration enables the relay module to be secured to the patient while establishing both the electrical and optical connections between the plug and the relay module.

According to a second aspect, there is provided a method of an electrical-and-optical connection system according to claim <NUM>.

In some embodiments, the relay-module placing step occurs before the sterile-barrier placing step.

In some embodiments, the method further includes a mounting step and second plug-inserting step. The mounting step includes mounting a plug-inserting device over a surface of the relay module. The second plug-inserting step includes inserting the plug into a plug holder of the plug-inserting device.

In some embodiments, the method further includes an actuating step of actuating a lever of the plug-inserting device for inserting the plug into the receptacle.

Also disclosed herein is a method of an optical connection system. The method includes, in some embodiments, a relay-module placing step, a sterile-barrier placing step, and a mating step. The relay-module placing step includes placing a relay module on or alongside a patient. The sterile-barrier placing step includes placing a sterile barrier having a transparent window over the patient. Such a step establishes a sterile field over the sterile barrier and a non-sterile field under the sterile barrier. The mating step includes mating an extension-tube connector of an extension tube communicatively connected to a medical device in the sterile field with a relay-module connector of the relay module in the non-sterile field with the transparent window 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.

In some embodiments, the mating step includes orientating the extension-tube connector such that its shape matches a shape of the relay-module connector.

In some embodiments, the mating step includes orientating the extension-tube connector such that magnetic poles of its one or more alignment magnets complement magnetic poles of one or more alignment magnets of the relay-module connector.

With respect to "proximal," a "proximal portion" or a "proximal end portion" of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near a clinician when the catheter is used on a patient. Likewise, a "proximal length" of, for example, the catheter includes a length of the catheter intended to be near the clinician when the catheter is used on the patient. A "proximal end" of, for example, the catheter includes an end of the catheter intended to be near the clinician when the catheter is used on the patient. The proximal portion, the proximal end portion, or the proximal length of the catheter can include the proximal end of the catheter; however, the proximal portion, the proximal end portion, or the proximal length of the catheter need not include the proximal end of the catheter. That is, unless context suggests otherwise, the proximal portion, the proximal end portion, or the proximal length of the catheter is not a terminal portion or terminal length of the catheter.

With respect to "distal," a "distal portion" or a "distal end portion" of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near or in a patient when the catheter is used on the patient. Likewise, a "distal length" of, for example, the catheter includes a length of the catheter intended to be near or in the patient when the catheter is used on the patient. A "distal end" of, for example, the catheter includes an end of the catheter intended to be near or in the patient when the catheter is used on the patient. The distal portion, the distal end portion, or the distal length of the catheter can include the distal end of the catheter; however, the distal portion, the distal end portion, or the distal length of the catheter need not include the distal end of the catheter. That is, unless context suggests otherwise, the distal portion, the distal end portion, or the distal length of the catheter is not a terminal portion or terminal length of the catheter.

As set forth above, there is a need for a relay module that allows for single-use medical devices such as the foregoing PICCs and CVCs to be at least optically connected to non-sterile capital equipment without compromising sterile conditions. Disclosed herein are optical connection systems including electrical-and-optical connection systems and methods thereof.

Features of the optical connection systems provided herein will become more apparent with reference to the accompanying drawings and the following description, which provide particular embodiments of the optical connection systems in greater detail. For context, shape-sensing systems are described first followed by medical devices and relay modules of the shape-sensing systems, as well as methods of the foregoing. The optical connection systems and the electrical-and-optical connection systems are described among a combination of the shape-sensing systems, the medical devices, and the relay modules.

<FIG> is a block diagram of a first shape-sensing system <NUM> in accordance with some embodiments. <FIG> is a block diagram of a second shape-sensing system <NUM> in accordance with some embodiments. <FIG> illustrates the second shape-sensing system <NUM> in accordance with some embodiments. <FIG> illustrates the second shape-sensing system <NUM> in use during a patient procedure in accordance with some embodiments. <FIG> illustrates the second shape-sensing system <NUM> in use during a patient procedure with a sterile barrier <NUM> in accordance with some embodiments.

As shown, the shape-sensing system <NUM> or <NUM> includes, in some embodiments, a medical device <NUM>, a console <NUM> or <NUM>, and relay module <NUM> configured for connecting the medical device <NUM> to a remainder of the shape-sensing system <NUM> or <NUM> such as the console <NUM>. The medical device <NUM> is typically used in a sterile field while the relay module <NUM> and the console <NUM> or <NUM> are typically used in a non-sterile field as defined by at least the sterile barrier <NUM> (e.g., drape) as one of several possible sterile barriers (e.g., drape, plastic holder, sheath, etc.).

The medical device <NUM> includes at least an integrated optical-fiber stylet including one or more optical-fiber cores, each core, in turn, having a number of fiber Bragg grating ("FBG") sensors along a length thereof for shape sensing with the shape-sensing system <NUM> or <NUM>. (See integrated optical-fiber stylet <NUM> in <FIG> for an example of the optical-fiber stylet of the medical device <NUM>. ) However, the medical device <NUM> can also include electrical componentry such as an electrocardiogram ("ECG") stylet and one or more electrical wires in support of the ECG stylet.

Certain features of the medical device <NUM> are set forth in more detail below with respect to particular embodiments of the medical device <NUM> such as the PICC <NUM>. That said, some features (e.g., the optical fiber stylet, the ECG stylet, etc.) set forth below with respect to one or more embodiments of the medical device <NUM> such as the PICC <NUM> can be shared among two or more embodiments of the medical device <NUM>. As such, "medical device <NUM>" is used herein to generically refer to more than one embodiment of the medical device <NUM> when needed for expository expediency. This is despite certain features having been described with respect to particular embodiments of the medical device <NUM> such as the PICC <NUM>.

While only shown for the console <NUM>, each console of the consoles <NUM> and <NUM> includes memory <NUM> and one or more processors <NUM> for converting reflected optical signals from the optical-fiber stylet of the medical device <NUM> into displayable shapes for the medical device <NUM>. The displayable shapes for the medical device <NUM> can be displayed on an integrated display screen integrated into the console <NUM> or <NUM> or a display screen of a stand-alone monitor coupled to the console <NUM> or <NUM>.

The shape-sensing system <NUM> further includes a stand-alone optical interrogator <NUM> communicatively coupled to the console <NUM>, whereas the shape-sensing system <NUM> further includes an integrated optical interrogator <NUM> integrated into the console <NUM>. The optical interrogator <NUM> or <NUM> is configured to send input optical signals into the optical-fiber stylet of the medical device <NUM> by way of the relay module <NUM> and receive reflected optical signals from the optical-fiber stylet by way of the relay module <NUM>.

The relay module <NUM> includes a housing <NUM>, a cable <NUM> extending from the housing <NUM>, and one or more optical-fiber cores <NUM> ("optical fiber <NUM>") extending through the housing <NUM> and along the cable <NUM>. (For the optical fiber <NUM>, see <FIG>. ) The relay module <NUM> is configured to establish at least an optical connection between the optical-fiber stylet of the medical device <NUM> and the optical fiber <NUM> of the relay module <NUM>. The relay module <NUM> is also configured with a plug <NUM> at a terminus of the cable <NUM> to establish at least another optical connection between the optical fiber <NUM> of the relay module <NUM> and the optical interrogator <NUM> or <NUM>. The optical fiber <NUM> of the relay module <NUM> is configured to convey the input optical signals from the optical interrogator <NUM> or <NUM> to the optical-fiber stylet of the medical device <NUM> and the reflected optical signals from the optical-fiber stylet to the optical interrogator <NUM> or <NUM>.

The relay module <NUM> can also be configured to establish an electrical connection between the medical device <NUM> and the relay module <NUM>, an electrical connection between the relay module <NUM> and the console <NUM> or <NUM>, or both as set forth in more detail below. In support of such electrical connections, the relay module <NUM> can include one or more electricals wires extending through the housing <NUM> and along the cable <NUM> like the optical fiber <NUM>.

The relay module <NUM> can further include one or more sensors <NUM> selected from at least a gyroscope, an accelerometer, and a magnetometer disposed within the housing <NUM>. The one or more sensors <NUM> are configured to provide sensor data to the console <NUM> or <NUM> by way of the one or more electrical wires within the housing <NUM> and the cable <NUM> for determining a reference plane for shape sensing with the optical-fiber stylet of the medical device <NUM>.

Certain features of the relay module <NUM> are set forth in more detail below with respect to particular embodiments of the relay module <NUM>. That said, some features set forth below with respect to one or more embodiments of the relay module <NUM> are shared among two or more embodiments of the relay module <NUM>. As such, "relay module <NUM>" is used herein to generically refer to more than one embodiment of the relay module <NUM> when needed for expository expediency. This is despite certain features having been described with respect to particular embodiments of the relay module <NUM>.

<FIG> also illustrates a PICC <NUM> as the medical device <NUM> in accordance with some embodiments. <FIG> illustrates a cross-section of a catheter tube <NUM> of the PICC <NUM> including an integrated optical-fiber stylet <NUM> in accordance with some embodiments. <FIG> illustrates a plug <NUM> of an extension tube or cable <NUM> of the medical device <NUM> for establishing both optical and electrical connections in accordance with some embodiments.

As shown, the PICC <NUM> includes the catheter tube <NUM>, a bifurcated hub <NUM>, two extension legs <NUM>, and two Luer connectors <NUM> operably connected in the foregoing order. The catheter tube <NUM> includes two catheter-tube lumens <NUM> and the optical-fiber stylet <NUM> disposed in a longitudinal bead of the catheter tube <NUM> such as between the two catheter-tube lumens <NUM>, as extruded. Optionally, in a same or different longitudinal bead of the catheter tube <NUM>, the PICC <NUM> can further include the ECG stylet. The bifurcated hub <NUM> has two hub lumens correspondingly fluidly connected to the two catheter-tube lumens <NUM>. Each extension leg of the two extension legs <NUM> has an extension-leg lumen fluidly connected to a hub lumen of the two hub lumens. The PICC <NUM> further includes the extension tube <NUM> either extending from the bifurcated hub <NUM> or communicatively coupled to the bifurcated hub <NUM>. When extending from the bifurcated hub <NUM>, the extension tube <NUM> can be a skived portion of the catheter tube <NUM> including the optical-fiber stylet <NUM> and, if present, the ECG stylet, which extension tube <NUM> can terminate in the plug <NUM> for establishing an optical connection between the optical-fiber stylet <NUM> of the PICC <NUM> and the optical fiber <NUM> of the relay module <NUM>, as well as any electrical connections. The skived portion of the catheter tube <NUM> can be disposed in another tube, which, in combination, forms the extension tube <NUM> terminating in the plug <NUM> for establishing the foregoing optical and electrical connections.

While the PICC <NUM> is provided as a particular embodiment of the medical device <NUM> of the shape-sensing system <NUM> or <NUM>, it should be understood that any of a number of medical devices including catheters such as a CVC can include at least an optical-fiber stylet and, optionally, electrical componentry such as the ECG stylet and the one or more wires in support thereof, terminating in a plug for establishing an optical connection or both optical and electrical connections between the medical device and the relay module <NUM>.

<FIG> illustrates a detailed view of the relay module <NUM> with a receptacle <NUM> for establishing optical connections or both optical and electrical connections in accordance with some embodiments. <FIG> illustrates the second shape-sensing system <NUM> in use during a patient procedure with the sterile barrier <NUM> in accordance with some embodiments.

As shown, the relay module <NUM> includes the housing <NUM>, the receptacle <NUM> disposed in the housing <NUM>, the cable <NUM> extending from the housing <NUM>, and at least the optical fiber <NUM> within the housing <NUM> and the cable <NUM>. Again, the relay module <NUM> can include one or more electricals wires extending through the housing <NUM> and along the cable <NUM> similar to the optical fiber <NUM> in some embodiments.

The receptacle <NUM> includes an optical receiver configured to accept insertion of an optical terminal of a plug of the medical device <NUM> (e.g., the plug <NUM> of the PICC <NUM>) for establishing an optical connection between the relay module <NUM> and the optical-fiber stylet of the medical device <NUM> (e.g., the optical-fiber stylet <NUM> of the PICC <NUM>) when the plug is inserted into the receptacle <NUM>. The receptacle <NUM> can also include one or more electrical contacts configured to contact an electrical terminal (e.g., the metal piece of the plug <NUM>) of the plug of the medical device <NUM> (e.g., the plug <NUM> of the PICC <NUM>), when present, for establishing an electrical connection between the relay module <NUM> and the one or more electrical wires of the medical device <NUM> when the plug is inserted into the receptacle <NUM>.

The cable <NUM> includes the plug <NUM> for establishing an optical connection between the relay module <NUM> and the optical interrogator <NUM> of the console <NUM>, as well as an electrical connection between the relay module <NUM> and the console <NUM> in some embodiments.

The optical fiber <NUM> extends from the receptacle <NUM> through the cable <NUM> to the plug <NUM>. The optical fiber <NUM> is configured to convey the input optical signals from the optical interrogator <NUM> to the optical-fiber stylet of the medical device <NUM> (e.g., the optical-fiber stylet <NUM> of the PICC <NUM>) and the reflected optical signals from the optical-fiber stylet to the optical interrogator <NUM>.

As set forth above, the relay module <NUM> can further include the one or more sensors <NUM> selected from the gyroscope, the accelerometer, and the magnetometer disposed within the housing <NUM>. The one or more sensors <NUM> are configured to provide sensor data for determining a reference plane for shape sensing with the optical-fiber stylet of the medical device <NUM> (e.g., the optical-fiber stylet <NUM> of the PICC <NUM>).

As with the optical fiber <NUM>, the one or more electrical wires, when present in the relay module <NUM>, extend from the one or more sensors <NUM>, if present, the receptacle <NUM>, or both the one or more sensors <NUM> and the receptacle <NUM> through the cable <NUM> to the plug <NUM>. In addition to any needed electrical power, the one or more electrical wires are configured to convey input electrical signals from the console <NUM> to the one or more sensors <NUM>, when present in the relay module <NUM>. The one or more electrical wire are also configured to convey any output electrical signals from the one or more sensors <NUM>, the ECG stylet, if present in the medical device <NUM>, or both the one or more sensors <NUM> and the ECG stylet to the console <NUM>.

The relay module <NUM> is configured to sit beneath the sterile barrier <NUM> on or alongside a patient P such as on a chest of the patient. As such, the relay module <NUM> need not require disinfection or sterilization. However, should the relay module <NUM> require disinfection or sterilization, the relay module <NUM> can be configured to be amenable to disinfection or sterilization. For example, the housing <NUM> of the relay module <NUM> can be non-porous or chemically resistant to oxidants. The relay module <NUM> can be configured for manual disinfection with a ChloraPrep® product by Becton, Dickinson and Company (Franklin Lakes, NJ), or the relay module <NUM> can be configured for automatic high-level disinfection or sterilization with vaporized H<NUM>O<NUM> by way of Trophon® by Nanosonics Inc. (Indianapolis, IN).

While not shown, the housing <NUM> of the relay module <NUM> can include a loop extending from the housing <NUM>, a tether point integrated into the housing <NUM>, or a ball-lock-pin receiver integrated into the housing <NUM> configured for attaching a neck strap to the relay module <NUM>. The loop, the tether point, or the ball-lock-pin receiver enables the relay module <NUM> to be secured to a neck of the patient P while sitting on the patient's chest. Additionally or alternatively, the housing <NUM> includes a patient-facing surface (e.g., a back of the relay module <NUM>) configured to be adhered to the patient's chest. The patient-facing surface enables the relay module <NUM> to be secured to the patient while sitting on or alongside the patient whether or not the relay module <NUM> is also secured to the patient's neck.

Again, the receptacle <NUM> includes the optical receiver configured to accept insertion of the optical terminal of the plug of the medical device <NUM> (e.g., the plug <NUM> of the PICC <NUM>) and form an optical connection when the plug is inserted into the receptacle <NUM>. The receptacle <NUM> can also include one or more electrical contacts configured to contact the electrical terminal (e.g., the metal piece of the plug <NUM>) of the plug of the medical device <NUM> (e.g., the plug <NUM> of the PICC <NUM>), when present, for establishing an electrical connection between the relay module <NUM> and the one or more electrical wires of the medical device <NUM> when the plug is inserted into the receptacle <NUM>. However, with the relay module <NUM>, such optical and electrical connections are formed with the sterile barrier <NUM> between the relay module <NUM> and the medical device <NUM>. The receptacle <NUM> and the plug of the medical device <NUM> enable such connections from a sterile field (e.g., above the sterile barrier <NUM>) including the medical device <NUM> such as the PICC <NUM> to a non-sterile field (e.g., beneath the sterile barrier <NUM>) including the relay module <NUM>.

<FIG> illustrates the plug <NUM> of the extension tube <NUM> of the medical device <NUM> for establishing both optical and electrical connections in accordance with some embodiments. <FIG> illustrates a detailed view of the relay module <NUM> with the receptacle <NUM> for establishing optical connections or both optical and electrical connections in accordance with some embodiments.

As shown, an electrical-and-optical connection system can include the extension tube <NUM> having the plug <NUM> and the relay module <NUM> having the receptacle <NUM>.

As set forth above, the extension tube <NUM> includes one or more optical-fiber cores extending from the optical-fiber stylet <NUM> along a length of the extension tube <NUM>, one or more electrical wires (e.g., one or more electrical wires <NUM>) extending along the length of the extension tube <NUM> over the one or more optical fibers being braided over the one or more optical fibers, and the plug <NUM>.

The plug <NUM> is formed of a metal piece (e.g., a metal ferrule) around the one or more electrical wires, which, in turn, are 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 <NUM> by an electrically conductive adhesive (e.g., electrically conductive epoxy), crimped onto the one or more electrical wires of the extension tube <NUM>, or a combination thereof. The plug <NUM> or the metal piece thereof is sufficiently tapered such that it is configured to pierce through at least a sterile barrier such as the sterile barrier <NUM>.

As set forth above, the relay module <NUM> can be configured to relay both optical signals and electrical signals to a receiver thereof such as the console <NUM> of the shape-sensing system <NUM>. When so configured, the relay module <NUM> includes one or more optical-fiber cores within the housing <NUM> of the relay module <NUM>, one or more electrical wires within the housing <NUM>, and the receptacle <NUM> disposed in the housing <NUM>.

The receptacle <NUM> is configured to simultaneously accept insertion of the plug <NUM> therein and establish both electrical and optical connections between the plug <NUM> and the receptacle <NUM> from a sterile field to a non-sterile field. For the optical connection, the receptacle <NUM> includes the optical receiver set forth above configured to accept insertion of the optical terminal of the plug <NUM> and form the optical connection when the plug <NUM> is inserted into the receptacle <NUM> with the sterile barrier <NUM> therebetween. Such a configuration enables the optical connection from the sterile field to the non-sterile field. For the electrical connection, the receptacle <NUM> includes the one or more electrical contacts set forth herein configured to form the electrical connection with the metal piece when the plug <NUM> is inserted into the receptacle <NUM> with the sterile barrier <NUM> therebetween. Such a configuration enables the electrical connection from the sterile field to the non-sterile field.

<FIG> illustrates a plug-inserting device <NUM> in accordance with some embodiments.

As shown, the electrical-and-optical connection system set forth above can further include the plug-inserting device <NUM>. The plug-inserting device <NUM> is configured to removably attach to a surface of the relay module <NUM> with the sterile barrier <NUM> between the plug-inserting device <NUM> and the relay module <NUM> as shown in <FIG> for inserting the plug <NUM> into the receptacle <NUM> of the relay module <NUM>.

The plug-inserting device <NUM> includes a plug holder <NUM> and a lever <NUM>. The plug holder <NUM> is configured to hold the extension tube <NUM> or the plug <NUM>. The lever <NUM> is an actuator configured to insert the plug <NUM> into the receptacle <NUM> of the relay module <NUM> when the lever <NUM> is moved through a circular sector toward the plug holder <NUM> as shown in <FIG>. Indeed, the plug-inserting device <NUM> is configured to insert the plug <NUM> into the receptacle <NUM> when the plug-inserting device <NUM> is attached to the relay module <NUM>, the plug holder <NUM> is holding the plug <NUM>, and the plug-inserting device <NUM> is actuated by the lever <NUM> to insert the plug <NUM> into the receptacle <NUM>.

<FIG> illustrates an extension-tube optical connector <NUM> of the extension tube <NUM> of the medical device <NUM> in accordance with some embodiments. <FIG> illustrates a relay module <NUM> with a relay-module optical connector <NUM> for establishing optical connections across a sterile barrier <NUM> in accordance with some embodiments.

As shown, an optical connection system can include the extension tube <NUM> having the extension-tube connector <NUM> and the relay module <NUM> having the relay-module connector <NUM>.

As set forth above, the extension tube <NUM> can include one or more optical-fiber cores extending from the optical-fiber stylet <NUM> along a length of the extension tube <NUM>. The one or more optical-fibers can extend to an optical terminal in a mating surface of the extension-tube connector <NUM>.

The extension-tube connector <NUM> includes one or more alignment magnets <NUM> disposed in the mating surface of the extension-tube connector <NUM> around the optical terminal or an end portion of the optical-fiber stylet <NUM>.

As set forth above, the relay module <NUM> can be configured to relay optical signals to a receiver thereof such as the console <NUM> of the shape-sensing system <NUM>. When the relay module <NUM> is so configured, the relay module <NUM> includes one or more optical-fiber cores within a housing <NUM> of the relay module <NUM> and the relay-module connector <NUM>.

The relay-module connector <NUM> includes one or more alignment magnets <NUM> disposed in a mating surface of the relay-module connector <NUM> around an optical receiver <NUM>.

The extension-tube connector <NUM> and the relay-module connector <NUM> are configured to mate across a transparent window <NUM> of the sterile barrier <NUM> (e.g., drape) and establish an optical connection between the optical terminal of the extension-tube connector <NUM> in a sterile field and the optical receiver of the relay-module connector <NUM> in a non-sterile field.

A shape of each connector of the extension-tube connector <NUM> and the relay-module connector <NUM> can be configured to enforce a particular orientation of the extension-tube connector <NUM> and the relay-module connector <NUM> when mated across the transparent window <NUM> of the sterile barrier <NUM>. For example, each connector of the extension-tube connector <NUM> and the relay-module connector <NUM> shown in <FIG> is rectangular or longer than it is wide, thereby enforcing two of the four most reasonable orientations for rectangular connectors.

Magnetic poles of the one or more alignment magnets <NUM> and <NUM> of each connector of the extension-tube connector <NUM> and the relay-module connector <NUM> can additionally or alternatively be configured to enforce a particular orientation of the extension-tube connector <NUM> and the relay-module connector <NUM> when mated across the transparent window <NUM> of the sterile barrier <NUM>. For example, a first side of the extension-tube connector <NUM> can include a first pair of the alignment magnets <NUM> having a same magnetic pole orientation (e.g., N). A second side of the extension-tube connector <NUM> can include a second pair of the alignment magnets <NUM> having a same magnetic pole orientation (e.g., S) but different than the first side of the extension-tube connector. The relay-module connector <NUM> can be likewise configured such that similar sides of the extension-tube connector <NUM> and the relay-module connector <NUM> repel each other when brought close to each other and dissimilar sides of the extension-tube connector <NUM> and the relay-module connector <NUM> attract each other when brought close to each other. In this way, two of the four most reasonable orientations of, for example, square-shaped connectors can be enforced. However, if the extension-tube connector <NUM> and the relay-module connector <NUM> are rectangular as shown in <FIG>, both the shape and the magnetic poles configured as in the example can enforce a single orientation.

Notwithstanding the foregoing, a shape of each connector of the extension-tube connector <NUM> and the relay-module connector <NUM> can be rotationally symmetric. Such a configuration allows a number of rotationally equivalent orientations of the extension-tube connector <NUM> and the relay-module connector <NUM> when mated across the transparent window <NUM> of the sterile barrier <NUM>. For example, all the magnetic poles of the one or more alignment magnets <NUM> of the extension-tube connector <NUM> can be of a same magnetic pole orientation but opposite all the magnetic poles of the one or more alignment magnets <NUM> of the relay-module connector <NUM> to complement all the magnetic poles of the one or more alignment magnets <NUM> of the relay-module connector <NUM>. Indeed, such a configuration allows a number of rotationally equivalent orientations of the extension-tube connector <NUM> and the relay-module connector <NUM> when mated across the transparent window <NUM> of the sterile barrier <NUM>.

<FIG> illustrates the second shape-sensing system <NUM> in use during a patient procedure with the sterile barrier <NUM> in accordance with some embodiments.

A method of an electrical-and-optical connection system can be a part of a method of the shape-sensing system <NUM> or <NUM>. Such a method can include a relay-module placing step, a sterile-barrier placing step, and a first plug-inserting step.

The relay-module placing step includes placing the relay module <NUM> on or alongside the patient P such as on the chest of the patient. Prior to the relay-module placing step, the method can further include a disinfecting or sterilizing step of disinfecting or sterilizing the relay module <NUM> before placing the relay module <NUM> on or alongside the patient.

The sterile-barrier placing step includes placing the sterile barrier <NUM> over the patient. Such a step establishes a sterile field over the sterile barrier <NUM> and a non-sterile field under the sterile barrier <NUM> and can occur after the relay-module placing step.

The first plug-inserting step includes inserting the plug <NUM> of the extension tube <NUM> communicatively connected to the medical device <NUM> (e.g., the PICC <NUM>) in the sterile field into the receptacle <NUM> of the relay module <NUM> in the non-sterile field. The first plug-inserting step simultaneously establishes both electrical and optical connections between the medical device <NUM> (e.g. the PICC <NUM>) and the relay module <NUM> across the sterile barrier <NUM>.

Before the first plug-inserting step, the method can further include a mounting step and second plug-inserting step. The mounting step includes mounting the plug-inserting device <NUM> over the surface of the relay module <NUM>. The second plug-inserting step includes inserting the plug <NUM> into the plug holder <NUM> of the plug-inserting device <NUM> for the first plug-inserting step.

Following on the mounting and second plug-inserting steps, the method can further include an actuating step of actuating the lever <NUM> of the plug-inserting device <NUM> for inserting the plug <NUM> into the receptacle <NUM> during the first plug-inserting step.

A method of an optical connection system can also be a part of a method of the shape-sensing system <NUM> or <NUM>. Such a method can include a relay-module placing step, a sterile-barrier placing step, and a mating step.

The sterile-barrier placing step includes placing the sterile barrier <NUM> having the transparent window <NUM> over the patient. Such a step establishes a sterile field over the sterile barrier <NUM> and a non-sterile field under the sterile barrier <NUM> and can occur after the relay-module placing step.

The mating step includes mating the extension-tube connector <NUM> of the extension tube <NUM> communicatively connected to the medical device <NUM> (e.g., the PICC <NUM>) in the sterile field with the relay-module connector <NUM> of the relay module <NUM> in the non-sterile field with the transparent window <NUM> between the extension-tube connector <NUM> and the relay-module connector <NUM>. The mating step establishes the optical connection between the medical device <NUM> and the relay module <NUM> across the sterile barrier <NUM>.

The mating step includes orientating the extension-tube connector <NUM> such that its shape matches the shape of the relay-module connector <NUM>. The mating step can also include orientating the extension-tube connector <NUM> such that the magnetic poles of the one or more alignment magnets <NUM> complement the magnetic poles of the one or more alignment magnets <NUM> of the relay-module connector <NUM>.

Claim 1:
An electrical-and-optical connection system for establishing both electrical and optical connections across a sterile barrier, comprising:
an extension tube (<NUM>) including:
one or more optical-fiber cores (<NUM>) extending along a length of the extension tube;
one or more electrical wires (<NUM>) extending along the length of the extension tube and braided over the one or more optical-fiber cores; and
a plug (<NUM>) formed of a metal piece around the one or more electrical wires, the plug configured to pierce through the sterile barrier; and
a relay module (<NUM>) configured to relay electrical and optical signals to a receiver thereof, the relay module including:
one or more optical-fiber cores within a housing (<NUM>) of the relay module;
one or more electrical wires within the housing of the relay module; and
a receptacle (<NUM>) disposed in the housing, the receptacle configured to simultaneously accept insertion of the plug therein and establish both electrical and optical connections between the plug and the receptacle across the sterile barrier.