Adjustable elongated medical device handle

Abstract

The catheter placement system includes a stylet disposed within a lumen of the catheter. The stylet includes an optical fiber configured for shape sensing. A device handle is selectively coupled to the stylet and selectively locked to the stylet to fix the position of the device handle along the stylet. A system module is operably coupled to the stylet, and system logic determines the shape of the stylet and depicts the shape on a display. The device handle is coupled to the stylet such that the optical fiber detects the position of the device handle along the stylet, and the logic depicts a device handle icon along with the stylet shape. According to a temperature difference detected by the optical fiber, the logic determines the position of an insertion site along the stylet. The logic further depicts an insertion site icon along with the stylet shape.

Description

[Technical Field]

[0001] SUMMARY The present disclosure relates to a medical device handle that is attached to a stylet used to place a catheter within a patient. [Background technology]

[0002] Placing a catheter, such as a central catheter, within a patient requires careful manipulation of the catheter. Often, a stiffening stylet is inserted within the catheter's lumen to assist the clinician in inserting the catheter. In some instances, a handle may be attached to the stylet to help the clinician grasp the stylet. A guide system also assists the clinician in guiding the catheter along the vasculature and further assists the clinician in positioning the stylet's distal tip at a desired location, such as within the superior vena cava. In some instances, the length of the catheter may be specifically defined, such as by trimming, so that the position of the catheter's outer components relative to the insertion site can indicate the location of the catheter's distal tip during and after placement. In some instances, it may be advantageous to position the stylet's distal tip adjacent to the catheter's distal tip. However, maintaining the stylet's distal tip adjacent to the catheter's distal tip during insertion can be difficult. Furthermore, if mispositioned, it can be difficult to reposition the stylet's distal tip adjacent to the catheter's distal tip after the insertion process has begun. Therefore, it may be advantageous to monitor the position of the stylet relative to the catheter via the guidance system. Additionally, it may be advantageous to monitor the position of the stylet relative to the insertion site.

[0003] Disclosed herein are catheter placement systems, devices, and methods that address the above. Summary of the Invention

[0004] Disclosed herein is a catheter placement system, according to some embodiments, including an elongated medical device disposed within a lumen of a catheter, the catheter being inserted into a patient's vasculature. The elongated medical device includes a multi-core optical fiber extending along the elongated medical device, the multi-core optical fiber including a plurality of fiber optic Bragg gratings disposed along the multi-core optical fiber, the fiber optic Bragg gratings configured to enable shape sensing of the elongated medical device. The system further includes (i) a device handle coupled to the elongated medical device at a location along the elongated medical device, and (ii) a system module operably coupled to the elongated medical device, the system module including a processor and a memory having stored thereon logic that, when executed by the processor, performs operations of the system. The operations include determining a three-dimensional shape of the elongated medical device and rendering an image on a display of the system, the image including (i) the three-dimensional shape and a device handle icon positioned along the three-dimensional shape. In some embodiments, the fiber optic Bragg grating is configured to determine the location of the device handle along the elongated medical device.

[0005] In some embodiments, the device handle includes a locking mechanism configured to selectively transition between an unlocked state in which the device handle is positionable along the elongate medical device and a locked state in which the location of the device handle along the elongate medical device is fixed.

[0006] In some embodiments, the device handle defines a positioning shape for the elongate medical device when the locking mechanism is transitioned to a locked state, and the operation includes determining a location of the device handle along the elongate medical device based on the positioning shape.

[0007] In some embodiments, the device handle is rotatable about the elongate medical device in the unlocked state, and the device handle is rotatably fixed to the elongate medical device in the locked state.

[0008] In some embodiments, the operation includes determining a rotational position of a device handle icon around the elongated medical device based on the positioning shape, and the image includes an orientation of the device handle relative to the three-dimensional shape based on the rotational position of the device handle around the elongated medical device.

[0009] In some embodiments, the fiber optic Bragg grating is configured to enable sensing of multiple local temperatures along the elongated medical device. The local temperatures include a first local temperature at a first point along the elongated medical device, the first point located outside the patient adjacent an insertion site of the patient. The local temperatures further include a second local temperature at a second point along the elongated medical device, the second point located inside the patient adjacent the insertion site. In such embodiments, the operations include determining a location of the insertion site along the elongated medical device based on the first and second local temperatures, and the image includes an insertion site icon at a position along the three-dimensional shape corresponding to the location of the insertion site along the elongated medical device.

[0010] Also disclosed herein are medical devices, according to some embodiments, including a device handle configured to selectively attach to an elongate medical device, the device handle including a housing having a passageway extending therethrough, the passageway configured to receive the elongate medical device therethrough. The elongate medical device includes a multi-core optical fiber extending along the elongate medical device, the multi-core optical fiber including a plurality of fiber optic Bragg gratings disposed along the multi-core optical fiber, and the device handle configured to enable the fiber optic Bragg gratings to detect a position of the device handle along the elongate medical device.

[0011] In some embodiments of the device, the housing transitions between an open state and a closed state, in which the elongate medical device is laterally constrained within the passageway, and in the open state, the elongate medical device is laterally displaceable in and out of the passageway.

[0012] In some embodiments of the device, the device handle includes a locking mechanism configured to selectively transition between an unlocked state in which the device handle is positionable along the elongated medical device and a locked state in which the location of the device handle is fixed along the elongated medical device.

[0013] In some embodiments of the device, transitioning the housing from an open state to a closed state transitions the locking mechanism from an unlocked state to a locked state. In some embodiments of the device, the device handle is rotatable about the elongate medical device in the unlocked state, and the device handle is rotatably fixed to the elongate medical device in the locked state.

[0014] In some embodiments of the device, the device handle includes an actuator configured for manual actuation by a clinician, the actuator configured to transition the locking mechanism between a locked state and an unlocked state.

[0015] In some embodiments of the device, the locking mechanism includes an engagement surface configured to establish a frictional force between the engagement surface and the elongate medical device when the locking mechanism is transitioned to a locked state.

[0016] In some embodiments of the device, the locking mechanism includes a cam member including an engagement surface, the cam member being rotatable between a first angular position and a second angular position, in such embodiments, the engagement surface is displaced away from the elongate medical device to define an unlocked state in the first angular position, and the engagement surface is disposed in frictional contact with the elongate medical device to define a locked state in the second angular position.

[0017] In some embodiments of the device, the housing is rotatable about the elongate medical device between a first orientation and a second orientation, the second orientation being inverted relative to the first orientation. In such embodiments, when the housing is disposed in the first orientation, gravity rotates the cam member toward the first angular position, and when the housing is disposed in the second orientation, gravity rotates the cam member toward the second angular position.

[0018] In some embodiments of the device, the locking mechanism forms a positioning feature for the elongated medical device when the locking mechanism is transitioned to a locked state, and the positioning feature enables the fiber optic Bragg grating to detect the position of the device handle along the elongated medical device.

[0019] Also disclosed herein are methods, according to some embodiments, that include providing a stylet including a multi-core optical fiber extending along the stylet. The multi-core optical fiber includes a plurality of fiber optic Bragg gratings disposed along the multi-core optical fiber, the fiber optic Bragg gratings configured to enable shape sensing of the stylet, the stylet being operably coupled to a system module that (i) determines a three-dimensional shape of the stylet and (ii) depicts the three-dimensional shape on a display of the system module. The method further includes (i) inserting the stylet into a lumen of a catheter, which in some embodiments includes positioning a distal end of the stylet adjacent to the distal end of the catheter, (ii) coupling a stylet handle to the stylet, (iii) positioning the stylet handle adjacent an extension leg connector of the catheter, and (iv) locking the stylet handle to the stylet to fix a position of the stylet handle along the stylet, wherein locking the stylet handle forms a positioning shape of the stylet. According to the method, the system module detects the positioning shape and depicts a handle icon on the display at a location along the three-dimensional shape that corresponds to the position of the stylet handle along the stylet. The method further includes inserting the stylet, along with the catheter, into the patient using the stylet handle to manipulate the stylet.

[0020] In some embodiments, the method further includes visually monitoring a three-dimensional shape in relation to the stylet handle icon to enable guiding the distal end of the stylet to a desired insertion location within the patient.

[0021] In some embodiments of the method, the fiber optic Bragg grating is configured to enable sensing of multiple local temperatures along the stylet. The local temperatures include (i) a first local temperature at a first point along the stylet located outside the patient adjacent an insertion site of the patient, and (ii) a second local temperature at a second point along the stylet located inside the patient adjacent the insertion site. In such embodiments, the system module determines a location of the insertion site along the stylet based on the first and second local temperatures and depicts an insertion site icon on the display at a location along the three-dimensional shape, the location along the three-dimensional shape corresponding to the location of the insertion site along the stylet. In such embodiments, the method further includes monitoring a location of the stylet handle icon relative to the insertion site icon.

[0022] These and other features of the concepts provided herein will become more apparent to those skilled in the art upon review of the following description and accompanying drawings that describe in more detail certain embodiments of such concepts. [Brief explanation of the drawings]

[0023] [Figure 1] 1 illustrates a catheter placement system in use on a patient, according to some embodiments. [Figure 2] 2 shows a detailed side view of an elongated medical device handle of the system of FIG. 1 according to some embodiments. [Figure 3] FIG. 10 shows an end view of a second embodiment of an elongated medical device handle, according to some embodiments. [Figure 4A] FIG. 10 shows a cross-sectional side view of a third embodiment of an elongated medical device handle in an unlocked state, according to some embodiments. [Figure 4B] 4B shows a cross-sectional side view of the elongated medical device handle of FIG. 4A in a locked state, according to some embodiments. [Figure 5A] FIG. 10 shows a cross-sectional side view of a fourth embodiment of an elongated medical device handle in an unlocked state, according to some embodiments. [Figure 5B] 5B shows a cross-sectional side view of the elongated medical device handle of FIG. 5A in a locked state, according to some embodiments. [Figure 6] 1 shows a flowchart of an exemplary method for placing a catheter in a patient, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0024] 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 a specific embodiment disclosed herein may have features that are readily separable from the specific embodiment and that can be combined or substituted in any way with features of any of the numerous other embodiments disclosed herein.

[0025] Regarding the terms used herein, it should also be understood that these terms are intended to describe 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 within a group of features or steps and do not provide sequential or numerical limitations. For example, "first," "second," and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Designations such as "left," "right," "up," "down," "front," and "rear" are used for convenience and do not imply, for example, a specific fixed location, orientation, or direction. Instead, such designations are used to reflect, for example, a relative location, orientation, or direction. The singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0026] The phrases "connected," "coupled," and "in communication with" refer to any form of interaction between two or more entities, including, but not limited to, mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interactions. Two components can be coupled to each other even if they are not in direct contact with each other. For example, two components can be coupled to each other by an intermediate component.

[0027] The terms "proximal" and "distal" refer to the opposite ends of a medical device, including the devices disclosed herein. As used herein, the proximal portion of a medical device is the portion closest to the practitioner during use, while the distal portion is the portion at the opposite end. For example, the proximal end of an ultrasound probe is defined as the end closest to the practitioner during use of the ultrasound probe. The distal end is the end along the length of the ultrasound probe opposite the proximal end.

[0028] The term "logic" may refer to hardware, firmware, or software configured to perform one or more functions. As hardware, the term logic may refer to or include circuitry having data processing and / or storage capabilities. Examples of such circuitry may include, but are not limited to or restricted to, a hardware processor (e.g., a microprocessor, one or more processor cores, a digital signal processor, a programmable gate array, a microcontroller, an application-specific integrated circuit "ASIC," etc.), semiconductor memory, or combinational elements.

[0029] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. Similar references are made throughout this specification, such as by use of the term "substantially." For each such reference, it is understood that in some embodiments, the value, feature, or characteristic may be specified without the similar. For example, when modifiers such as "about" and "approximately" are used, these terms include within their scope the modified word without the modifier. For example, when the term "substantially linear" is described with respect to a feature, it is understood that in further embodiments, the feature may be in a strictly linear configuration.

[0030] Any method disclosed herein includes one or more steps or actions for implementing the described method. Method steps and / or actions may be interchangeable with one another. In other words, unless a specific order of steps or actions is required for proper operation of an embodiment, the order and / or use of specific steps and / or actions may be modified. Furthermore, only subroutines or portions of methods described herein may be separate methods within the scope of the present disclosure. In other words, some methods may include only a portion of the steps described in a more detailed method. Additionally, all embodiments disclosed herein are combinable and / or interchangeable unless otherwise stated or unless such combination or interchange would contradict the described operability of any embodiment.

[0031] 1 shows a catheter placement system (system) 100 being used on a patient 50. A catheter 120 (e.g., a PICC in the illustrated example) is advanced along the vascular system of the patient 50. An elongate medical device 130 is inserted into the lumen of the catheter 120 via an extension leg connector 121 of the catheter 120. In some embodiments, a distal end 132 of the elongate medical device 130 is positioned adjacent to the distal end 122 of the catheter 120. The elongate medical device 130 includes an optical fiber 140 extending along the elongate medical device 130. The optical fiber 140 is operably coupled to a system module 110. The system module 110 includes a display 111 and a console 115.

[0032] The system 100 may (i) assist a clinician during advancement of the catheter 120 along the vasculature and (ii) assist a clinician during placement of the distal end 122 of the catheter 120 within the vasculature, such as within the superior vena cava. The catheter 120 may include a central catheter, such as a central venous catheter (CVC) or a peripherally inserted center catheter (PICC). The elongate medical device 130 may have a length sufficient to extend between the distal end 122 of the catheter 120 and the extension leg connector 121 of the catheter 120. The elongate medical device 130 may include a stylet, a guidewire, or any other elongate device suitable for insertion into the vasculature of the patient 50 and / or the lumen of the catheter 120.

[0033] The elongated medical device 130 includes an optical fiber 140 extending along the elongated medical device 130. The optical fiber 140 is a multi-core optical fiber including a plurality (e.g., 5, 10, 20, 50, 100, or more) of fiber optic Bragg gratings 141 disposed along the length of the optical fiber 140. The optical fiber 140 is configured to enable shape sensing of the elongated medical device 130 based on reflected optical signals emitted from (i.e., reflected by) the fiber optic Bragg gratings 141. In the illustrated embodiment, the fiber optic Bragg gratings 141 may be disposed along the length (e.g., the entire length) of the elongated medical device 130. U.S. Patent Application Publication No. 2022-0034733, entitled "BRAGG GRATED FIBER-OPTIC FLUCTUATION SENSING AND MONITORING SYSTEM," which shows and describes fiber optic shape sensing systems and methods, is incorporated herein by reference in its entirety.

[0034] In some embodiments, the fiber optic Bragg grating 141 may be configured to detect a condition of the optical fiber 140, such as the temperature of the optical fiber 140, the movement of the optical fiber 140, or the displacement of a fluid adjacent to the optical fiber 140, for example, via the Doppler effect. In the illustrated embodiment, the optical fiber 140 extends away from the elongated medical device 130 such that the optical fiber 140 may be optically coupled to the system module 110, such as, for example, via an optical connecting member (not shown).

[0035] The system module 110 is operably coupled to the elongate medical device 130. More specifically, the system module 110 is optically coupled to (i) an optical fiber 140. The system module 110 includes a console 115 having a processor and logic stored in a memory (e.g., a non-transitory computer-readable medium). The logic, when executed by the processor, governs the operation of the system module 110. The console 115 further includes a light source and an optical receiver operably coupled to the optical fiber 140.

[0036] The system module 110 is configured to (i) determine a three-dimensional shape 130A of the optical fiber 140 based on the reflected optical signal emitted from the fiber optic Bragg grating 141, where the three-dimensional shape 130A represents the shape of the elongated medical device 130 and the catheter 120, and (ii) depict the three-dimensional shape 130A on the display 111. In other words, the logic is configured to depict an image on the display 111, where the image includes at least the three-dimensional shape 130A. In some embodiments, the system module 110 may depict the three-dimensional shape 130A in real time during advancement of the catheter 120 along the vasculature to assist a clinician in placing / guiding the catheter 120.

[0037] The system 100 further includes a device handle (e.g., a stylet handle) 150 for the elongate medical device 130. The device handle 150 includes a passageway 151 within which, during use, the elongate medical device 130 is disposed. In some use cases, the device handle 150 can be coupled to the elongate medical device 130 adjacent the extension leg connector 121. In some embodiments, the device handle 150 can be configured for slidable displacement along the elongate medical device 130. In further embodiments, the device handle 150 can be frictionally coupled to the elongate medical device 130 such that the longitudinal position of the device handle 150 is generally fixed in the absence of intentional displacement action by the clinician.

[0038] In some embodiments, the fiber optic Bragg grating 141 is configured to enable detection of multiple localized temperatures along the elongated medical device 130. For example, the fiber optic Bragg grating 141 may enable detection of a first localized temperature 55A (e.g., room temperature) at a first point 135A along the elongated medical device 130, the first point 135A being located outside the patient 50 adjacent to an insertion site 52 of the patient 50. Additionally, the fiber optic Bragg grating 141 may enable detection of a second localized temperature 55B (e.g., body temperature) at a second point 135B along the elongated medical device 130, the second point 135B being located inside the patient 50 adjacent to the insertion site 52 of the patient 50. Thus, the logic may determine the location of the insertion site 52 along the elongated medical device 130. After determining the location of the insertion site 52, the logic may include an insertion site icon 52 in the image at a position along the three-dimensional shape 130A that corresponds to the location of the insertion site along the elongated medical device 130. In some embodiments, the system module 110 may depict the insertion site icon 52 along the three-dimensional shape 130A in real time during advancement of the catheter through the vasculature to assist the clinician in placing / guiding the catheter 120. Thus, the clinician can monitor the position of the insertion site icon 52A along the three-dimensional shape 130A during advancement of the stylet 130 through the vasculature.

[0039] In the illustrated embodiment, the device handle 150 may include a locking mechanism 155 configured to selectively transition between an unlocked state and a locked state. In the unlocked state, the device handle 150 may be displaced along the elongate medical device 130. Conversely, in the locked state, the device handle 150 may be attached to the elongate medical device 130 such that its longitudinal position is fixed, i.e., such that the device handle 150 is generally immovable along the elongate medical device 130. Thus, a clinician can manipulate the device handle 150 to longitudinally displace the elongate medical device 130.

[0040] In some embodiments, the device handle 150 is rotatable about the elongate medical device 130 in the unlocked state, and the device handle 150 is rotatably fixed to the elongate medical device 130 in the locked state. In such embodiments, a clinician can manipulate the device handle 150 to rotate the elongate medical device 130 during use.

[0041] The device handle 150 includes a housing 152 that generally defines the structure of the device handle 150. The housing 152 may be formed of any suitable material that is rigid enough to allow the device handle 150 to function. In some embodiments, the housing 152 may be formed of a plastic material, such as, for example, a thermoplastic material. In some embodiments, the housing 152 may be formed by a plastic injection molding process.

[0042] The housing 152 may include geometric shapes to assist the clinician in gripping the device handle 150. In some embodiments, the housing 152 may include finger indentations and / or raised portions. In some embodiments, the housing 152 may include dimples, protrusions, ribs, grooves, roughened surfaces, or any combination thereof. In some embodiments, the geometry of the housing 152 may be symmetrical. In some embodiments, the geometry may indicate the orientation of the device handle 150. For example, one side of the housing 152 may include a feature that indicates that side is the top side of the device handle 150.

[0043] 2 shows a detailed cutaway view of the device handle 150 including the elongated medical device 130 extending through the passageway 151. The locking mechanism 155 may be configured to define a positioning feature 233 for the elongated medical device 130 within the device handle 150. The fiber optic Bragg grating 141 enables sensing of the positioning feature 233. The logic can recognize the positioning feature 233 separately from other three-dimensional shapes of the elongated medical device 130 during use. Thus, the logic can determine that the device handle 150 is locked onto the elongated medical device 130 at the location of the positioning feature 233 along the elongated medical device 130. After determining the location of the positioning feature 233, the logic can depict the device-handle icon 150A at a position along the three-dimensional shape 130A that coincides with the location of the positioning feature 233 along the elongated medical device 130.

[0044] In some embodiments, the logic can determine a rotational orientation of the elongate medical device 130 about the longitudinal axis 236 of the elongate medical device 130 based on the positioning feature 233. For example, the logic can associate a first lateral side 234A of the elongate medical device 130 with a first side 254A of the device handle 150. Similarly, the logic can associate a second lateral side 234B of the elongate medical device 130 with a second side 254B of the device handle 150, the second lateral side 234B being opposite the first lateral side 234A and the second side 254B being opposite the first side 254A. Although not shown, the device-handle icon 150A can include a first side 254A and a second side 254B such that the device-handle icon 150A indicates a rotational orientation of the three-dimensional shape 130A.

[0045] It should be noted that the positioning feature 233 is just one exemplary mechanism for enabling the fiber optic Bragg grating 141 to sense the location of the device handle 150 along the elongated medical device 130. Other mechanisms may be employed for enabling the fiber optic Bragg grating 141 to sense the location of the device handle 150 along the elongated medical device 130, such as, for example, an optically reflective surface. Accordingly, any and all other mechanisms as may be contemplated by one of ordinary skill in the art are included in the present disclosure.

[0046] 3 is an end view of a second embodiment of a device handle 350 that may be similar to certain features and functions of device handle 150. Device handle 350 includes first and second housing halves 352A and 352B coupled to one another via a hinge 356. Hinge 356 allows device handle 350 to transition between an open position (as shown) and a closed position. Device handle 350 may include a latch 353 configured to secure device handle 350 in the closed position. In the open position, device handle 350 allows for lateral placement of elongate medical device 130 (FIG. 1) into and out of passageway 351. In the closed position, device handle 350 prevents lateral removal of elongate medical device 130 from passageway 351.

[0047] In some embodiments, transitioning the device handle 350 toward the closed state with the elongate medical device 130 positioned within the passageway 351 can define an unlocked state for the device handle 350, i.e., the device handle 350 can be slidably displaced along the elongate medical device 130 when the device handle 350 is transitioned to the closed state. In other embodiments, transitioning the device handle 350 toward the closed state with the elongate medical device 130 positioned within the passageway 351 can define a locked state for the device handle 350, i.e., can prevent slidable displacement of the device handle 350 along the elongate medical device 130 when the device handle 350 is transitioned to the closed state. In some embodiments, transitioning the device handle 350 toward the closed state with the elongate medical device 130 positioned within the passageway 351 can define a positioning feature 233 (see FIG. 2 ) for the elongate medical device 130.

[0048] 4A and 4B illustrate a third embodiment of a device handle 450 that may resemble certain features and functionality of the device handle 150. The exemplary locking mechanism 455 is generally configured to transition between an unlocked state and a locked state as a result of manipulation by a clinician. A housing 452 (in cross section) and a passageway 451 through which an elongate medical device 130 passes are shown. FIG. 4A illustrates the locking mechanism 455 in an unlocked state, and FIG. 4B illustrates the locking mechanism 455 in a locked state. The locking mechanism 455 includes an actuator 461 and a cam member 462. The actuator 461 is positionable by the clinician between an unlocked position 461A and a locked position 461B. The cam member 462 is pivotable about a pivot point 463 between an unclamped position 462A and a clamped position 462B. In the clamping position 462B, the cam member 462 sandwiches the elongate medical device 130 between the cam member 462 and a wall 464 of the housing 452, defining a frictional force between the device handle 450 and the elongate medical device 130. The frictional force prevents longitudinal displacement and / or rotation of the device handle 450 relative to the elongate medical device 130. In some embodiments, sandwiching the elongate medical device 130 between the cam member 462 and the wall 464 defines a positioning feature 433 for the elongate medical device 130. The actuator 461 engages the cam member 462 such that (i) when the actuator 461 is in the unlocked position 461A, the cam member 462 is disposed in the unclamping position 462A, and (ii) when the actuator 461 is in the locked position 461B, the cam member 462 is pivoted to the clamping position 462B.

[0049] In use, a clinician can displace the device handle 450 to a desired location along the elongate medical device 130. The clinician can then slide the actuator 461 away from the unlocked position 461A to the locked position 461B to secure the location of the device handle 450 on the elongate medical device 130. In some examples, the clinician can slide the actuator away from the locked position 461B to the unlocked position 461A to adjust the location of the device handle 450 on the elongate medical device 130. The clinician can then slide the actuator away from the unlocked position 461A to the locked position 461B to secure the location of the device handle 450 on the elongate medical device 130 again.

[0050] 5A and 5B illustrate a fourth embodiment of a device handle 550 that may resemble certain features and functionality of device handle 150. Another exemplary locking mechanism 555 is generally configured to transition between an unlocked state and a locked state as a result of a clinician's rotation of device handle 550 about elongate medical device 130. A housing 552 (in cross section) and a passageway 551 through which elongate medical device 130 passes are shown. FIG. 5A illustrates locking mechanism 555 in the unlocked state, while FIG. 5B illustrates locking mechanism 555 in the locked state. Locking mechanism 555 includes a gravity-activated cam member 562 that is pivotable about pivot point 563. In the unlocked state of FIG. 5A, device handle 450 is positioned in a first orientation with first side 554A facing upward and second side 554B facing downward. In the first orientation, gravity causes the cam member 562 to rotate toward the unclamped position 562A, displacing the cam surface 565 away from the elongate medical device 130. Similarly, in the locked state of FIG. 5B , the device handle 450 is disposed in a second orientation (inverted relative to the first orientation) with the first side 554A facing downward and the second side 554B facing upward. In the second orientation, gravity causes the cam member 562 to rotate toward the clamped position 562B, and the cam member 562 pinches the elongate medical device 130 between the cam surface 565 and the wall 564, defining a frictional force between the device handle 550 and the elongate medical device 130. The frictional force prevents longitudinal displacement and / or rotation of the device handle 550 relative to the elongate medical device 130. In some embodiments, sandwiching the elongated medical device 130 between the cam surface 565 and the wall 564 can define a positioning geometry (not shown, see FIG. 2) of the elongated medical device 130.

[0051] In use, a clinician can rotate the device handle 550 in a first orientation to allow the device handle 550 to slide to a desired location along the elongated medical device 130. The clinician can then rotate the device handle 550 in a second orientation to fix the location of the device handle 550 on the elongated medical device 130.

[0052] It should be noted that locking mechanisms 455 and 555 are merely two exemplary locking mechanisms of many that may be contemplated by one of ordinary skill in the art. Accordingly, any and all other locking mechanisms suitable for selectively locking and unlocking device handle 150 relative to elongate medical device 130 as may be contemplated by one of ordinary skill in the art are included within the present disclosure.

[0053] FIG. 6 shows a flowchart of an exemplary method for placing a central catheter within a patient, which may include all or any subset of the following steps, actions, or processes. The method 600 may include providing a stylet (block 610). The stylet includes a multi-core optical fiber having a plurality of fiber optic Bragg gratings disposed along the multi-core optical fiber, the fiber optic Bragg gratings configured to enable shape sensing of the stylet. The stylet is operably coupled to a system module that (i) determines a three-dimensional shape of the stylet and (ii) depicts the three-dimensional shape on a display of the system module. The method 600 may further include inserting the stylet into a lumen of the catheter (block 620). In some embodiments, inserting the stylet may include positioning a distal end of the stylet adjacent to the distal end of the catheter. The method 600 may further include coupling a stylet handle to the stylet (block 630). In some embodiments, coupling the stylet handle to the stylet includes positioning the stylet handle adjacent to an extension leg connector of the catheter. The method 600 may further include locking the stylet handle to the stylet (block 640) to fix the position of the stylet handle along the stylet. In some embodiments, locking the stylet handle to the stylet forms a positioning shape for the stylet. According to such an embodiment, the system module detects the positioning shape and depicts a handle icon on the display at a location along the three-dimensional shape that corresponds to the position of the stylet handle along the stylet. The method 600 may further include inserting the stylet into the patient (block 650). In some embodiments, the stylet is inserted into the patient along with the catheter using the stylet handle to manipulate the stylet.

[0054] The method 600 may further include visually monitoring the three-dimensional shape on the display (block 660) to enable guiding the distal end of the stylet to a desired insertion location within the patient. In some embodiments, the three-dimensional shape is specifically monitored in relation to a handle icon.

[0055] In some embodiments of the method 600, the fiber optic Bragg grating is configured to enable sensing of multiple local temperatures along the stylet. The local temperatures include (i) a first local temperature at a first point along the stylet located outside the patient adjacent an insertion site of the patient, and (ii) a second local temperature at a second point along the stylet located inside the patient adjacent the insertion site. In such embodiments, the system module determines a location of the insertion site along the stylet based on the first and second local temperatures and depicts an insertion site icon on the display at a location along the three-dimensional shape, the location along the three-dimensional shape corresponding to the location of the insertion site along the stylet. In such embodiments, the method 600 may further include visually monitoring the location of the stylet handle icon relative to the insertion site icon (block 670).

[0056] Although some specific embodiments are disclosed herein, and the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be apparent to those skilled in the art, and the broader aspects also encompass these adaptations and / or modifications. Thus, departures can be made from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. 1. A catheter placement system, comprising: an elongated medical device disposed within a lumen of a catheter inserted into the vascular system of a patient; the elongated medical device includes a multi-core optical fiber extending along the elongated medical device; the multi-core optical fiber includes a plurality of optical fiber Bragg gratings disposed along the multi-core optical fiber; the fiber optic Bragg grating is configured to enable shape sensing of the elongated medical device; The catheter placement system further comprises: a device handle coupled to the elongated medical device at a location along the elongated medical device; a system module operably coupled to the elongate medical device, the system module including a processor and a memory having stored thereon logic that, when executed by the processor, performs operations of the system; and the operation includes: determining a three-dimensional shape of an elongated medical device; Rendering an image on the system's display; The image includes Three-dimensional shape, Device handle icons positioned along the 3D shape and A catheter placement system comprising:

2. The catheter placement system according to claim 1, A catheter placement system, wherein the fiber optic Bragg grating is configured to determine the location of a device handle along an elongated medical device.

3. The catheter placement system according to claim 1 or 2, A catheter placement system, wherein the device handle includes a locking mechanism configured to selectively transition between an unlocked state in which the device handle is positionable along the elongate medical device and a locked state in which the location of the device handle along the elongate medical device is fixed.

4. The catheter placement system according to claim 3, the device handle defines a positioning geometry for the elongated medical device when the locking mechanism is transitioned to a locked state; A catheter placement system, the operations of which include determining a location of a device handle along an elongate medical device based on a positioning geometry.

5. The catheter placement system according to claim 3, the device handle is rotatable about the elongate medical device in the unlocked state; A catheter placement system, wherein the device handle is rotatably secured to the elongate medical device in the locked state.

6. The catheter placement system according to claim 5, The operations include determining a rotational position of the device handle about a longitudinal axis of the elongate medical device based on the positioning geometry; A catheter placement system, wherein the image includes an orientation of a device handle icon relative to a three-dimensional shape based on a rotational position of the device handle about a longitudinal axis of the elongated medical device.

7. The catheter placement system according to any one of claims 1 to 6, the fiber optic Bragg grating is configured to enable sensing of multiple localized temperatures along the elongated medical device; the localized temperature includes a first localized temperature at a first point along the elongate medical device, the first point being located outside the patient adjacent an insertion site of the patient; the localized temperature further includes a second localized temperature at a second point along the elongate medical device, the second point located inside the patient adjacent the insertion site; The operations include determining a location of an insertion site along the elongate medical device based on the first and second local temperatures; The image includes an insertion site at a position along a three-dimensional shape corresponding to the location of the insertion site along the elongated medical device.

8. A medical device comprising: a device handle configured to selectively attach to an elongate medical device, the device handle including a housing having a passageway extending therethrough, the passageway configured to receive the elongate medical device; the elongated medical device includes a multi-core optical fiber extending along the elongated medical device; the multi-core optical fiber includes a plurality of optical fiber Bragg gratings disposed along the multi-core optical fiber; A medical device, wherein the device handle is configured with a fiber optic Bragg grating capable of detecting the position of the device handle along the elongated medical device.

9. 9. The medical device of claim 8, the housing transitions between an open state and a closed state; In the closed state, the elongated medical device is laterally constrained within the passageway; A medical device wherein in the open state, the elongate medical device is laterally displaceable into and out of the passageway.

10. 10. The medical device according to claim 8 or 9, A medical device, wherein the device handle includes a locking mechanism configured to selectively transition between an unlocked state in which the device handle is positionable along the elongated medical device and a locked state in which the location of the device handle is fixed along the elongated medical device.

11. 11. The medical device of claim 10, A medical device in which transitioning the housing from an open state to a closed state transitions the locking mechanism from an unlocked state to a locked state.

12. 11. The medical device of claim 10, the device handle is rotatable about the elongate medical device in the unlocked state; A medical device, wherein the device handle is rotatably secured to the elongated medical device in the locked state.

13. 11. The medical device of claim 10, the device handle includes an actuator configured to be manually actuated by a clinician; The medical device, wherein the actuator is configured to transition the locking mechanism between a locked state and an unlocked state.

14. 11. The medical device of claim 10, The locking mechanism includes an engagement surface; The medical device, wherein the engagement surface is configured to establish a frictional force between the engagement surface and the elongate medical device when the locking mechanism is transitioned to the locked state.

15. 15. The medical device of claim 14, The locking mechanism includes a cam member including an engagement surface; the cam member is rotatable between a first angular position and a second angular position; the engagement surface is displaced away from the elongate medical device to define an unlocked state at a first angular position; The engagement surface is positioned in frictional contact with the elongate medical device to define a locked state in the second angular position.

16. 16. The medical device of claim 15, the housing is rotatable about the elongate medical device between a first orientation and a second orientation that is inverted relative to the first orientation; In the first orientation, gravity rotates the cam member toward the first angular position; In the second orientation, gravity rotates the cam member toward the second angular position.

17. 11. The medical device of claim 10, the locking mechanism forms a positioning feature for the elongated medical device when the locking mechanism is transitioned to a locked state; A medical device, wherein the positioning feature enables a fiber optic Bragg grating to identify the location of the device handle along the elongated medical device.

Images