Optical fiber viable stylet

Abstract

Disclosed herein is a catheter placement system including a catheter placement device having an elongate body configured for insertion into a catheter lumen, where the elongate body includes a body lumen. A compartment at the proximal end of the body is in fluid communication with the body lumen. An aqueous saline solution disposed within the compartment and the body lumen defines an electrical path along the elongated body and an electrode at the distal end of the elongated body. A stylet extends along the elongate body, where the stylet includes a multi-core optical fiber extending along the stylet, and where the multi-core optical fiber includes a plurality of fiber Bragg gratings arranged along the optical fiber to enable shape sensing of the optical fiber. A system module optically and electrically coupled to the catheter placement device displays the shape and ECG waveform of the elongate body.

Description

[0001] Priority

[0002] This application claims the benefit of priority of U.S. Patent Application No. 18 / 075,280, filed Dec. 5, 2022, the entire disclosure of which is incorporated herein by reference. Background Art

[0003] In the past, certain intravascular guidance of medical devices, such as guidewires and catheters, has used fluoroscopic methods to track the tip of the medical device and determine whether the distal tip is properly positioned within its target anatomy. However, such fluoroscopic methods expose the patient and their attending clinician to harmful X-ray radiation. Additionally, in some cases, the patient is exposed to potentially harmful contrast agents required for the fluoroscopic method.

[0004] More recently, electromagnetic tracking systems involving stylets have been used. Generally speaking, electromagnetic tracking systems are characterized by three components: a field generator, a sensor unit, and a control unit. The field generator uses multiple coils to generate a magnetic field with a changing position, which is used to establish a coordinate space. The sensor unit is attached to the stylet, such as near the distal end (far end) of the stylet. The sensor unit includes small coils in which a current is induced via the magnetic field. Based on the electrical properties of each coil, the position and orientation of the medical device within the coordinate space can be determined. The control unit controls the field generator and captures data from the sensor unit.

[0005] Although electromagnetic tracking systems avoid the line-of-sight dependence of tracking the tip of the stylet while avoiding the radiation exposure and potentially harmful contrast agents associated with fluoroscopic methods, electromagnetic tracking systems are susceptible to interference. More specifically, since electromagnetic tracking systems rely on the measurement of the magnetic field generated by the field generator, these systems are vulnerable to electromagnetic field interference, which may be caused by the presence of many different types of consumer electronics, such as cellular phones. Additionally, electromagnetic tracking systems are susceptible to signal loss, rely on external sensors, and are limited to a finite depth range. U.S. Publication No. 2022 / 0034733, entitled "BRAGG GRATED FIBER OPTIC FLUCTUATION SENSING AND MONITORING SYSTEM", shows and describes a fiber optic shape sensing system and method, the entire disclosure of which is incorporated herein by reference.

[0006] Disclosed herein is a catheter placement system that utilizes fiber optic shape sensing and electrical signal monitoring to assist in the placement of a catheter and the specific placement of the tip of the catheter. Summary of the Invention

[0007] According to some embodiments, a catheter placement system is disclosed herein that includes a catheter placement device. The catheter placement device includes an elongate body configured to be inserted into a catheter lumen, where the elongate body includes a body lumen extending between a proximal end of the body and a distal end of the body. The catheter placement device also includes a compartment coupled to the elongate body at the proximal end of the body, where the compartment is in fluid communication with the body lumen. A saline solution is disposed within the compartment and the body lumen. A stylet extends along the elongate body, and the stylet includes a multi-core optical fiber extending along the stylet, where the multi-core optical fiber includes a plurality of fiber Bragg gratings disposed along the length of the multi-core optical fiber.

[0008] In some embodiments, the catheter placement device is optically coupled to a system module.

[0009] In some embodiments, a distal portion of the stylet is disposed within the body lumen.

[0010] In some embodiments, the stylet includes an elongate opening extending along the distal portion, where the opening defines an additional cross-sectional area of the body lumen.

[0011] In some embodiments, the system module is configured to determine the shape of the stylet based on reflected optical signals emitted from the fiber Bragg gratings.

[0012] In some embodiments, the system module is further configured to display an image acquired by the optical fiber.

[0013] In some embodiments, the system module is further configured to determine one or more of the following based on reflected optical signals emitted from the fiber Bragg gratings: the temperature of the optical fiber, the movement of the optical fiber, or the displacement of fluid adjacent to the optical fiber.

[0014] In some embodiments, the saline solution is electrically coupled to the system module.

[0015] In some embodiments, the stylet extends through the compartment, and a proximal portion of the stylet extends proximally away from the compartment.

[0016] In some embodiments, the proximal portion of the stylet: (i) is conductive; (ii) is electrically coupled to the saline within the compartment; and (iii) is electrically coupled to the system module.

[0017] In some embodiments, the saline solution is electrically coupled to the system module via a wire, and in some embodiments, the wire extends from a sterile environment through a sterile barrier to a non-sterile environment.

[0018] In some embodiments, the catheter placement device further includes a fluid delivery device that houses the saline solution, where the fluid delivery device is fluidly coupled to the compartment. In some embodiments, the compartment includes a side port, and the fluid delivery device is fluidly coupled to the compartment via the side port.

[0019] In some embodiments, the system module is configured to display an electrocardiogram waveform. In some embodiments, the system module is configured to determine the placement location of the distal end of the body within the patient based on the electrocardiogram waveform.

[0020] According to some embodiments, a method is also disclosed herein, which includes inserting the elongate body of a catheter placement device into the lumen of a central catheter, wherein the catheter placement device includes: (i) a body lumen that extends along the elongate body; (ii) a compartment that is coupled to the elongate body at the proximal end of the elongate body, wherein the compartment is in fluid communication with the body lumen; (iii) a saline solution that is disposed within the compartment and the body lumen, wherein the saline solution defines an electrical circuit path along the elongate body; and (iv) a stylet that extends along the elongate body, wherein the stylet includes a multi-core optical fiber that extends along the stylet, and wherein the multi-core optical fiber includes a plurality of fiber Bragg gratings disposed along the length of the multi-core optical fiber. In such embodiments, the catheter placement device is optically and electrically coupled to a catheter placement system module. The method further includes: (i) advancing the central catheter along the patient's vasculature; (ii) determining the position of the central catheter within the patient's vasculature based on the shape of the multi-core optical fiber, wherein the shape is determined by optical reflection signals from the fiber Bragg gratings; and (iii) determining the position of the distal end of the elongate body within the superior vena cava of the vasculature based on an electrocardiogram signal obtained from the patient via an electrode located at the distal end.

[0021] In some embodiments of the method, the saline solution adjacent the distal end within the body lumen defines an electrode.

[0022] In some embodiments of the method, the stylet is disposed within the body lumen.

[0023] In some embodiments of the method, a syringe containing the saline solution is fluidly coupled to the compartment.

[0024] In some embodiments of the method, the saline is electrically coupled to the catheter placement system module via a wire, and the wire extends through a sterile barrier between a sterile environment and a non-sterile environment.

[0025] In view of the drawings and the following description, these and other features of the concepts provided herein will become more apparent to those skilled in the art, and the drawings and the following description more particularly describe specific embodiments of such concepts. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 A catheter placement system is shown in accordance with some embodiments.

[0027] Figure 2 Shown in accordance with some embodiments Figure 1End view of a catheter placement device of a system.

[0028] Figure 3A Shows a catheter placement system for a patient according to some embodiments. Figure 1 of the catheter placement system.

[0029] Figure 3B Shows a detailed view of the distal portion of a catheter placement device inserted into the superior vena cava of a patient according to some embodiments. Figure 1 of the catheter placement device.

[0030] Figure 4 Shows a flowchart of an exemplary method for placing a catheter in a patient according to some embodiments. Detailed Description

[0031] Before more particularly disclosing some specific embodiments, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein can have features that can be readily separated from the specific embodiments and that these features can optionally be combined with or replace the features of any one of many other embodiments disclosed herein.

[0032] Regarding the terms used herein, it should also be understood that these terms are for the purpose of describing some specific embodiments and that these terms do not 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 provide a sequence or numerical limitation. For example, the "first", "second", and "third" features or steps do not necessarily occur in that order, and a particular embodiment including such features or steps is not necessarily limited to these three features or steps. For convenience, labels such as "left", "right", "top", "bottom", "front", "rear", etc. are used, and these labels are not intended to imply, for example, any particular fixed position, orientation, or direction. Instead, such labels are used to reflect, for example, relative position, orientation, or direction. The singular forms "a", "an", and "the" include plural references unless the context clearly dictates otherwise.

[0033] The phrases "connected to", "coupled with", 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 do not directly contact each other. For example, two components can be coupled to each other through an intermediate component.

[0034] 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 catheter placement device is the portion that is closest to the practitioner during use, while the distal portion is the portion at the opposite end. For example, the distal end of a catheter placement device is defined as the end that is closest to the patient during utilization of the catheter placement device. The proximal end is the end opposite the distal end.

[0035] The term "logic" can represent hardware, firmware, or software configured to perform one or more functions. As hardware, the term "logic" can refer to or include a circuit having data processing and / or storage capabilities. Examples of such circuits can 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.), a semiconductor memory, or a combination of elements.

[0036] 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. Throughout the specification, approximations are referred to, such as by using the term "substantially". For each such reference, it should be understood that in some embodiments, a value, feature, or characteristic can be specified without approximation. For example, in cases where qualifiers such as "about" and "substantially" are used, these terms include within their scope the case where the qualified word is without its qualifier. For example, in the case of reciting the term "substantially straight" with respect to a feature, it should be understood that in other embodiments, the feature can have an exactly straight configuration.

[0037] Any method disclosed herein includes one or more steps or actions for performing the described method. These method steps and / or actions can be interchanged with each other. In other words, unless the proper operation of an embodiment requires a specific order of steps or actions, the order and / or use of specific steps and / or actions can be modified.

[0038] Figure 1 A catheter placement system is shown, which is generally configured to assist a clinician during placement of a catheter within a patient's vasculature. More specifically, the catheter placement system (system) 100 can: (i) assist the clinician during advancement of the catheter along the vasculature; and (ii) assist the clinician during placement of the distal end of the catheter within the vasculature (such as placement within, for example, the superior vena cava). System 100 generally includes a catheter placement device 120, which is coupled to a system module 110 that includes a display 111.

[0039] In some cases, system 100 may be deployed in combination with a sterile environment. Accordingly, portions of system 100 (e.g., catheter placement device 120) may be deployed within sterile environment 51, while other portions (e.g., system module 110) may be deployed within a non-sterile environment 52, i.e., outside of sterile environment 51. In some cases, a sterile barrier 50 may separate sterile environment 51 from non-sterile environment 52. In some cases, sterile barrier 50 may include a fabric sheet, such as a drape, and multiple components of system 100 may extend through sterile barrier 50.

[0040] Catheter placement device 120 includes an elongate body 125 configured to be placed within a catheter lumen, such as a central catheter (e.g., the lumen of a central venous catheter (CVC) or a peripherally inserted central catheter (PICC)). Elongate body 125 may have a sufficient length to extend between a distal end of the catheter and an extension leg bushing of the catheter. Stated another way, during use, proximal body end 125A may be disposed proximal to the extension leg bushing of the catheter, while distal body end 125B is disposed near the distal end of the catheter. Elongate body 125 includes a body lumen 124 extending along the length of elongate body 125.

[0041] Catheter placement device 120 further includes a compartment 126 coupled to the elongate body at proximal body end 125A such that compartment 126 is in fluid communication with body lumen 124. A saline solution 140 is disposed within compartment 126 and body lumen 124. The saline solution 140 within body lumen 124 defines an electrical path 141 extending between distal body end 125B and compartment 126. Body lumen 124 opens at distal body end 125B such that saline solution 140 may make direct electrical contact with a patient. More specifically, the saline solution 140 adjacent distal body end 125B defines a saline electrode 142, where saline electrode 152 is configured to acquire an electrical signal from the patient, e.g., an electrocardiogram signal.

[0042] Catheter placement device 120 includes a fluid delivery device 150, such as a syringe. Fluid delivery device 150 houses saline solution 140. Fluid delivery device 150 is fluidly coupled to compartment 126. In some embodiments, fluid delivery device 150 may be coupled to compartment 126 via a tube 155 coupled to a side port 127 of compartment 126. During use, fluid delivery device 150 may be set to have saline solution 140 therein. Then, fluid delivery device 150 may be coupled to compartment 126, and fluid delivery device 150 may dispense saline solution 140 into compartment 126 and along body lumen 124.

[0043] The catheter placement device 120 also includes a stylet 130 extending along the elongate body 125. In the illustrated embodiment, the stylet 130 is disposed within the body lumen 124. However, in other embodiments, the stylet 130 may extend along the exterior of the elongate body 125 and the stylet 130 may be disposed within a different lumen (not shown). The stylet 130 defines: (i) a proximal portion 130C extending between the proximal end 130A of the stylet and the compartment 126; and (ii) a distal portion 130D extending between the compartment 126 and the distal end 130B of the stylet. In some embodiments, the distal end 130B of the stylet may be disposed near the distal end 125B of the body. In the illustrated embodiment, the stylet 130 is generally non-conductive. Thus, the stylet 130 may be formed of a non-conductive polymeric material. In some embodiments, the distal portion 130D may include a greater stiffness than the proximal portion 130C. Since the distal portion 130 extends along the elongate body 125 and the catheter, the greater stiffness of the distal portion 130D may assist the clinician during advancement of the catheter along the vasculature. Since the proximal portion 130C is generally disposed outside the elongate body 125, the greater flexibility may allow the clinician to more easily manipulate the catheter during advancement.

[0044] The stylet 130 extends through the end wall 126A of the compartment 126. In the illustrated embodiment, the compartment 126 includes a coupling member 128 configured to sealably couple the stylet 130 to the compartment 126. The coupling member 128 includes an opening 128A through which the stylet 130 is disposed. In some embodiments, the coupling member 128 may couple the stylet 130 to the compartment 126 such that longitudinal displacement of the stylet 130 relative to the compartment 126 (including the elongate body 125) is prevented. In other embodiments, the coupling member 128 may couple the stylet 130 to the compartment 126 such that slidable displacement of the stylet 130 relative to the compartment 126 is allowed. In some embodiments, the coupling member 128 may include an elastomeric septum and the opening 128A may be a slit extending through the septum.

[0045] In the illustrated embodiment, the catheter placement device 120 includes a wire 145 extending between the compartment 126 and the system module 110. A wire electrode 146 electrically couples the wire 145 to the saline solution 140 within the compartment 126. In summary, during use, the anatomy of the patient adjacent to the distal end 125B of the body is electrically coupled to the system module 110 via the saline electrode 142, the saline solution 140 along the body lumen 124, the saline solution 140 within the compartment 126, the wire electrode 146, and the wire 145. In some cases, the wire 145 may extend through the sterile barrier 50.

[0046] The stylet includes an optical fiber 135 extending along the stylet 130. The optical fiber 135 is a multi-core optical fiber and includes a plurality of fiber Bragg gratings 136 arranged along the length of the optical fiber 135. The optical fiber 135 is configured to achieve shape sensing of the optical fiber 135 based on reflected optical signals emitted from (i.e., reflected by) the fiber Bragg gratings 136. When the optical fiber 135 extends along the stylet 130, when the stylet 130 extends along the elongate body 125, and when the elongate body 125 is disposed within the lumen of the catheter, the optical fiber 135 achieves shape sensing of the catheter.

[0047] In some embodiments, the fiber Bragg gratings 136 may be configured to define an optical reflection signal based on a condition of the optical fiber 135 (such as the temperature of the optical fiber 135, the movement of the optical fiber 135, or the displacement of a fluid adjacent to the optical fiber 135), such as via, for example, the Doppler effect. Although not shown, in some embodiments, the optical fiber 135 may extend distally beyond the distal end 130B of the stylet.

[0048] In some embodiments, the optical fiber 135 may be configured to project illumination light away from the distal end 130B of the stylet and receive imaging light entering the optical fiber 135 at the distal end 130B of the stylet. Thus, the optical fiber 135 may obtain an image of anatomical elements of a patient adjacent to the distal end 130B of the stylet during use.

[0049] In the illustrated embodiment, the optical fiber 135 extends away from the proximal portion 130C of the stylet 130 such that the optical fiber 135 may be optically coupled to the system module 110 via, for example, an optical connection member (not shown). In some cases, the optical fiber 135 or the optical connection member may extend through the sterile barrier 50.

[0050] The system module 110 is operatively coupled to the catheter placement device 120. More specifically, the system module 110 (i) is optically coupled to the optical fiber 135 and (ii) is electrically coupled to the saline solution 140. In the illustrated embodiment, the system module 110 is configured to provide information to a clinician regarding the placement of the catheter, such as displaying information and / or images (i.e., depicting an image or information on the display 111). The system module 110 may include a console having a plurality of processors and logic stored in a memory (e.g., a non-transitory computer-readable medium). The logic manages the operation of the system module 110 when executed by the processors. The system module 110 also includes a light source and an optical receiver.

[0051] The system module 110 is configured to: (i) determine the shape 115 of the optical fiber 135 based on the reflected optical signal emitted from the fiber Bragg grating 136, where the shape 115 represents the shape of the catheter; and (ii) display the shape 115, i.e., present an image of the shape 115 on the display 111. In some embodiments, the system module 110 can display the shape 115 in real time during the advancement of the catheter along the vasculature to assist the clinician in placing the catheter.

[0052] The system module 110 is configured to receive an electrical signal from the catheter placement device 120, where in some cases, the electrical signal is emitted from the patient, such as an electrocardiogram (ECG) signal. In some embodiments, the system module 110 can display the ECG waveform 116. In some cases, the ECG waveform 116 can vary according to the position of the distal end 125B of the body within the vasculature (such as within the superior vena cava, for example). In some embodiments, the logic can compare the ECG waveform 116 with the ECG waveforms stored in the memory, where the ECG waveforms stored in the memory are consistent with the placement of the distal end 125B of the body within the lower third of the superior vena cava. As a result of the comparison, the logic can determine that the distal end 125B of the body is located within the lower third of the superior vena cava. Generally, the system module 110 can be configured to determine the placement position of the distal end 125B of the body (and, by association, the distal end of the catheter) within the patient's vasculature based on the electrocardiogram signal.

[0053] According to another embodiment, the proximal portion 130C of the stylet 130 can be conductive, thereby defining a circuit path that replaces the wire 145 and the wire electrode 146. In such embodiments, the optical fiber 135 and / or the optical connection member can include a conductive element 137 extending therealong. The conductive element 137 can be electrically coupled to the proximal portion 130C and extend between the proximal portion 130C and the system module 110. In summary, during use, the anatomy of the patient adjacent to the distal end 125B of the body is electrically coupled to the system module 110 via the saline electrode 142, the saline solution 140 along the body lumen 124, the saline solution 140 within the compartment 126, the proximal portion 130C, and the conductive element 137.

[0054] Figure 2 is a distal view of the elongated body 125, including an end view of the distal portion 130D of the stylet 130. To maximize the cross-sectional area of the body lumen, the distal portion 130D can include an elongated opening 131 (i.e., a slot or groove) extending along the distal portion 130D. Thus, the cross-sectional area of the elongated opening 131 increases the annular cross-sectional area of the lumen 124.

[0055] Figure 3ASystem 100 for patient 300 is shown. Catheter 360 (e.g., PICC in the illustrated example) is advanced along the vasculature of patient 300. The elongate body 125 of catheter placement device 120 is inserted into the lumen of catheter 360 via the bushing 362 of the extension leg of catheter 360. The distal body end 125B is disposed near the distal end 361 of catheter 360. Fluid delivery device 150 holds saline solution 140, and saline solution 140 is dispensed into compartment 126 and along lumen 124 ( Figure 1 ). Sterile barrier 50 is disposed between system module 110 and catheter placement device 120, and optical fiber 135 and wire 145 pass through sterile barrier 50. System module 110 presents an image of shape 115 on display 111.

[0056] Now referring to Figure 3B , according to some embodiments, a detailed view of the distal portion of elongate body 125 is shown, where distal body end 125B and distal end 361 of catheter 360 are disposed within the superior vena cava 304. System module 110 including display 111 is also shown. Figure 3B A detailed perspective view of the vasculature near heart 303 of patient 300 and the anatomy of heart 303 is shown. Saline electrode 142 is located within the superior vena cava 304 to obtain an ECG signal from heart 303. The waveform 116 of the ECG signal is depicted on display 111.

[0057] Figure 4 A flowchart of an exemplary method for placing a central catheter within a patient is shown. The method may include all or any subset of the following steps, actions, or processes. Method 400 may include inserting the elongate body of a catheter placement device into the lumen of a central catheter (block 410). The catheter placement device is optically and electrically coupled to a catheter placement system module.

[0058] According to method 400, the catheter placement device includes a body lumen extending along the elongate body and a compartment coupled to the elongate body at the proximal end of the elongate body, where the compartment is in fluid communication with the body lumen. Saline solution is disposed within the compartment and the body lumen such that the saline solution defines an electrical circuit path along the elongate body. In some embodiments of method 400, a syringe holding saline solution is fluidly coupled to the compartment. In some embodiments of method 400, the saline solution within the body lumen adjacent the distal end defines an electrode. In some embodiments of method 400, the saline solution is electrically coupled to the system module via a wire, and the wire extends through a sterile barrier between a sterile environment and a non-sterile environment.

[0059] The stylet extends along the elongated body, wherein the stylet includes a multi-core optical fiber extending along the stylet, and wherein the multi-core optical fiber includes a plurality of fiber Bragg gratings arranged along the length of the multi-core optical fiber. In some embodiments of method 400, the stylet is disposed within the lumen of the body.

[0060] Method 400 further includes advancing a central catheter along a patient's vasculature (block 420). Method 400 may further include determining the position of the central catheter within the patient's vasculature based on the shape of the multi-core optical fiber (block 430), wherein the shape is determined from the optical reflection signals emitted from the fiber Bragg gratings. Method 400 may further include determining the position of the distal end of the elongated body within the superior vena cava based on an electrocardiogram signal obtained from the patient via saline electrodes located at the distal end (block 440).

[0061] Although some specific embodiments have been disclosed herein and although these specific embodiments have been disclosed in considerable detail, these specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may occur to those of ordinary skill in the art, and in a broader sense, these adaptations and / or modifications are also encompassed. Accordingly, changes may be made to the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A catheter placement system, comprising: A catheter placement device, the catheter placement device comprising: An elongate body configured to be inserted into a catheter lumen, the elongate body including a body lumen extending between a proximal end of the body and a distal end of the body; A compartment coupled to the elongate body at the proximal end of the body, the compartment being in fluid communication with the body lumen; A saline solution disposed within the compartment and the body lumen; and A stylet extending along the elongate body, the stylet including a multi-core optical fiber extending along the stylet, the multi-core optical fiber including a plurality of fiber Bragg gratings disposed along the length of the multi-core optical fiber.

2. The system according to claim 1, wherein a distal portion of the stylet is disposed within the body lumen.

3. The system according to claim 2, wherein the stylet includes an elongate opening extending along the distal portion, the opening defining an additional cross-sectional area of the body lumen.

4. The system according to any one of the preceding claims, wherein the catheter placement device is optically coupled to a system module.

5. The system according to claim 4, wherein the system module is configured to determine the shape of the stylet based on reflected optical signals emitted from the fiber Bragg gratings.

6. The system according to claim 5, wherein the system module is configured to display the shape.

7. The system according to claim 4, wherein the system module is further configured to display an image acquired by the optical fiber.

8. The system according to claim 4, wherein the system module is further configured to determine one or more of the following based on the reflected optical signals emitted from the fiber Bragg gratings: The temperature of the optical fiber, The movement of the optical fiber, or The displacement of fluid adjacent to the optical fiber.

9. The system according to claim 4, wherein the saline solution is electrically coupled to the system module and the patient.

10. The system according to claim 9, wherein the saline solution is electrically coupled to the system module via a wire.

11. The system according to claim 10, wherein the wire extends through a sterile barrier between a sterile environment and a non-sterile environment.

12. The system according to claim 9, wherein the system module is configured to determine an electrocardiogram signal of the patient and display an electrocardiogram waveform.

13. The system according to claim 12, wherein the system module is configured to determine the placement position of the distal end of the body within the patient's vasculature based on the electrocardiogram signal.

14. The system according to any one of the preceding claims, wherein: The stylet extends through the compartment, and A proximal portion of the stylet extends proximally away from the fluid compartment.

15. The system according to claim 14, wherein the proximal portion of the stylet: Is conductive, Is electrically coupled to the saline solution within the compartment, and Is electrically coupled to the system module.

16. The system according to any one of the preceding claims, wherein the catheter placement device further comprises a fluid delivery device for containing the saline solution, and the fluid delivery device is fluidly coupled to the compartment.

17. The system according to claim 16, wherein: the compartment includes a side port, and the fluid delivery device is fluidly coupled to the compartment via the side port.

18. A method of placing a central catheter in a patient, comprising: inserting an elongate body of a catheter placement device into the lumen of the central catheter, the catheter placement device comprising: a body lumen extending along the elongate body; a compartment coupled to the elongate body at a proximal end of the elongate body, the compartment being in fluid communication with the body lumen; a saline solution disposed within the compartment and the body lumen, the saline solution defining an electrical path along the elongate body; and a stylet extending along the elongate body, the stylet comprising a multi-core optical fiber extending along the stylet, the multi-core optical fiber including a plurality of fiber Bragg gratings disposed along a length of the multi-core optical fiber, wherein the catheter placement device is optically and electrically coupled to a catheter placement system module; advancing the central catheter along the patient's vasculature; determining a position of the central catheter within the vasculature based on a shape of the multi-core optical fiber, the shape being determined by an optical reflection signal emitted from the fiber Bragg gratings; and determining a position of a distal end of the elongate body within the superior vena cava of the vasculature based on an electrocardiogram signal obtained from the patient via an electrode located at the distal end.

19. The method according to claim 18, wherein the saline solution adjacent the distal end within the body lumen defines the electrode.

20. The method according to claim 18 or 19, wherein the stylet is disposed within the body lumen.

21. The method according to any one of claims 18 to 20, wherein the catheter placement device includes a syringe for containing the saline solution, and the syringe is fluidly coupled to the compartment.

22. The method according to any one of claims 18 to 21, wherein: the saline is electrically coupled to the catheter placement system module via a wire, and the wire extends through a sterile barrier between a sterile environment and a non-sterile environment.

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