Patent Publication Number: US-11026630-B2

Title: Connector interface for ECG-based catheter positioning system

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 15/192,561, filed Jun. 24, 2016, now U.S. Pat. No. 10,349,890, which claims the benefit of U.S. Provisional Application No. 62/185,477, filed Jun. 26, 2015, and titled “Interface Connector for ECG-based Catheter Positioning System,” each of which is incorporated herein by reference in its entirety. 
    
    
     BRIEF SUMMARY 
     Briefly summarized, embodiments of the present invention are directed to a connector interface that is configured to enable component interconnection with a location sensor of a catheter placement system. The catheter placement system is configured to assist a clinician in positioning a catheter in a desired location within a body of a patient, such as a lower ⅓ rd  portion of the superior vena cava within the patient&#39;s vasculature. 
     In one embodiment, the location sensor assembly comprises a location sensor body for temporary placement on a portion of the patient body, and a connector interface. The connector interface is configured to removably attach to the location sensor and provide a plurality of electrically conductive pathways between the location sensor and additional components of the catheter placement system to enable the additional components to operably connect with the location sensor. The connector interface further includes a first connector configured to operably connect with a second connector of one of the additional components of the catheter placement system through a sterile barrier, such as a surgical drape, interposed between the first and second connectors. 
     These and other features of embodiments of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of embodiments of the invention as set forth hereinafter. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       A more particular description of the present disclosure will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. Example embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which: 
         FIG. 1  is a block diagram of a catheter placement system according to one embodiment; 
         FIG. 2  is a simplified view of a patient and the catheter placement system of  FIG. 1 ; 
         FIGS. 3A-3C  depict various views of a location sensor of the catheter placement system of  FIGS. 1 and 2 ; 
         FIGS. 4A-4C  depict various views of a connector interface of the location sensor or  FIGS. 3A-3C ; 
         FIG. 5  is an end view of the location sensor of  FIGS. 3A-3C ; 
         FIG. 6  is a perspective view of a stylet of the catheter placement system of  FIGS. 1 and 2 ; 
         FIG. 7  is a perspective view of a tether connector of the stylet of  FIG. 6 ; 
         FIGS. 8A and 8B  depict various views of the connection of the tether connector of  FIG. 6  with the location sensor of  FIGS. 3A-3C ; 
         FIG. 9  is a perspective view of a location sensor according to one embodiment; 
         FIG. 10  is a perspective view of a connector interface for attachment to the location sensor of  FIG. 9 ; 
         FIG. 11  depicts attachment of the connector interface of  FIG. 10  with the location sensor of  FIG. 9 ; 
         FIG. 12  shows a side view of a patient with the location sensor of  FIG. 8B  placed on the patient; and 
         FIG. 13  is an end view of a connector interface according to one embodiment. 
     
    
    
     DETAILED DESCRIPTION OF SELECTED EMBODIMENTS 
     Reference will now be made to figures wherein like structures will be provided with like reference designations. It is understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the present invention, and are neither limiting nor necessarily drawn to scale. 
     For clarity it is to be understood that the word “proximal” refers to a direction relatively closer to a clinician using the device to be described herein, while the word “distal” refers to a direction relatively further from the clinician. For example, the end of a catheter placed within the body of a patient is considered a distal end of the catheter, while the catheter end remaining outside the body is a proximal end of the catheter. Also, the words “including,” “has,” and “having,” as used herein, including the claims, shall have the same meaning as the word “comprising.” 
     Embodiments of the present disclosure are generally directed to a connector interface connector for use in interconnecting various elements of a catheter placement system. Use of the present interface connector enables various components of the catheter placement system to be replaced or interchanged while enabling other components to remain. This in turn reduces system cost and allows for a modular system design. 
       FIGS. 1 and 2  depict various details of a catheter placement system (“system” or “placement system”), generally designated at  10 , which serves as one example environment wherein embodiments of the present disclosure can be practiced. The system  10  is employed to assist a clinician in the placement of a catheter or other medical device within the body of a patient, such as within the vasculature. In one embodiment, the system  10  enables a distal tip of a catheter to be placed within the patient vasculature in desired proximity to the heart using ECG signals produced by the patient&#39;s heart. In one embodiment, the medical device includes a catheter and the intended destination of the catheter within the patient body is such that the distal tip of the catheter is disposed in the lower ⅓ rd  portion of the superior vena cava (“SVC”). The guidance and placement system analyzes the ECG signals of the patient to determine when the catheter has reached its intended destination within the vasculature, then notifies the clinician via a display, for instance. Thus, the system includes an ECG modality for assisting in medical device placement within the patient. 
     In one embodiment, the above-referenced ECG guidance modality of the system  10  is accompanied by an ultrasound (“US”) modality to assist with initial insertion of the medical device into the body, and a magnetic element-based tracking, or tip location system (“TLS”) modality to track the position and orientation of the medical device as it advances toward its intended destination. 
     As mentioned,  FIGS. 1 and 2  depict various components of the system  10  in accordance with one example embodiment. As shown, the system  10  generally includes a console  20 , display  30 , probe  40 , and sensor  50 , each of which is described in further detail below. 
       FIG. 2  shows the general relation of these components to a patient  70  during a procedure to place a catheter  72  into the patient vasculature through a skin insertion site  73 .  FIG. 2  shows that the catheter  72  generally includes a proximal portion  74  that remains exterior to the patient and a distal portion  76  that resides within the patient vasculature after placement is complete. In the present embodiment, the system  10  is employed to ultimately position a distal tip  76 A of the catheter  72  in a desired position within the patient vasculature. In one embodiment, the desired position for the catheter distal tip  76 A is proximate the patient&#39;s heart, such as in the lower one-third (⅓ rd ) portion of the Superior Vena Cava (“SVC”). Of course, the system  10  can be employed to place the catheter distal tip in other locations. The catheter proximal portion  74  further includes a bifurcation hub  74 A that provides fluid communication between the one or more lumens of the catheter  72 , one or more extension tubes  74 B extending proximally from the hub, and corresponding connectors  74 C for enabling connection to the catheter  72 . 
     A processor  22 , including non-volatile memory such as EEPROM for instance, is included in the console  20  for controlling system function during operation of the system  10 , thus acting as a control processor. A digital controller/analog interface  24  is also included with the console  20  and is in communication with both the processor  22  and other system components to govern interfacing between the probe  40 , sensor  50 , and other system components. 
     The system  10  further includes ports  52  for connection with the sensor  50  and optional components  54  including a printer, storage media, keyboard, etc. The ports in one embodiment are USB ports, though other port types or a combination of port types can be used for this and the other interfaces connections described herein. A power connection  56  is included with the console  20  to enable operable connection to an external power supply  58 . An internal battery  60  can also be employed, either with or exclusive of an external power supply. Power management circuitry  59  is included with the digital controller/analog interface  24  of the console to regulate power use and distribution. 
     The display  30  in the present embodiment is integrated into the console  20  and is used to display information to the clinician during the catheter placement procedure. In another embodiment, the display may be separate from the console. As will be seen, the content depicted by the display  30  changes according to which mode the catheter placement system is in: US, TLS, or in other embodiments, ECG tip confirmation. In one embodiment, a console button interface  32  and buttons included on the probe  40  can be used to immediately call up a desired mode to the display  30  by the clinician to assist in the placement procedure. In one embodiment, information from multiple modes, such as TLS and ECG, may be displayed simultaneously. Thus, the single display  30  of the system console  20  can be employed for ultrasound guidance in accessing a patient&#39;s vasculature, TLS guidance during catheter advancement through the vasculature, and (as in later embodiments) ECG-based confirmation of catheter distal tip placement with respect to a node of the patient&#39;s heart. In one embodiment, the display  30  is an LCD device. 
     The probe  40  is employed in connection with the first modality mentioned above, i.e., ultrasound (“US”)-based visualization of a vessel, such as a vein, in preparation for insertion of the catheter  72  into the vasculature. Such visualization gives real time ultrasound guidance for introducing the catheter into the vasculature of the patient and assists in reducing complications typically associated with such introduction, including inadvertent arterial puncture, hematoma, pneumothorax, etc. 
     As such, in one embodiment a clinician employs the first, US, modality to determine a suitable insertion site and establish vascular access, such as with a needle and introducer, then with the catheter. The clinician can then seamlessly switch, via button pushes on the probe button pad, to the second, TLS, modality without having to reach out of the sterile field. The TLS mode can then be used to assist in advancement of the catheter  72  through the vasculature toward an intended destination. 
       FIG. 1  shows that the probe  40  further includes button and memory controller  42  for governing button and probe operation. The button and memory controller  42  can include non-volatile memory, such as EEPROM, in one embodiment. The button and memory controller  42  is in operable communication with a probe interface  44  of the console  20 , which includes a piezo input/output component  44 A for interfacing with the probe piezoelectric array and a button and memory input/output component  44 B for interfacing with the button and memory controller  42 . 
     Note that while a vein is typically depicted on the display  30  during use of the system  10  in the US modality, other body lumens or portions can be imaged in other embodiments. Note that the US mode can be simultaneously depicted on the display  30  with other modes, such as the TLS mode or ECG mode, if desired. In addition to the visual display  30 , aural information, such as beeps, tones, etc., or vibratory/motion-based cues can also be employed by the system  10  to assist the clinician during catheter placement. Moreover, the buttons included on the probe  40  and the console button interface  32  can be configured in a variety of ways, including the use of user input controls in addition to buttons, such as slide switches, toggle switches, electronic or touch-sensitive pads, etc. Additionally, US, TLS, and ECG activities can occur simultaneously or exclusively during use of the system  10 . 
     As just described, the handheld ultrasound probe  40  is employed as part of the integrated catheter placement system  10  to enable US visualization of the peripheral vasculature of a patient in preparation for transcutaneous introduction of the catheter. In the present example embodiment, however, the probe is also employed to control functionality of the TLS portion, or second modality, of the system  10  when navigating the catheter toward its desired destination within the vasculature as described below. Again, as the probe  40  is used within the sterile field of the patient, this feature enables TLS functionality to be controlled entirely from within the sterile field. Thus the probe  40  is a dual-purpose device, enabling convenient control of both US and TLS functionality of the system  10  from the sterile field. In one embodiment, the probe can also be employed to control some or all ECG-related functionality, or third modality, of the catheter placement system  10 , as described further below. 
     The catheter placement system  10  further includes the second modality mentioned above, i.e., the magnetically-based catheter TLS, or tip location system. The TLS enables the clinician to quickly locate and confirm the position and/or orientation of the catheter  72 , such as a peripherally-inserted central catheter (“PICC”), central venous catheter (“CVC”), or other suitable catheter or medical device, during initial placement into and advancement through the vasculature of the patient  70 . Specifically, the TLS modality detects a magnetic field generated by a magnetic element-equipped tip location stylet, which is pre-loaded in one embodiment into a longitudinally defined lumen of the catheter  72 , thus enabling the clinician to ascertain the general location and orientation of the catheter tip within the patient body. In one embodiment, the magnetic assembly can be tracked using the teachings of one or more of the following U.S. Pat. Nos. 5,775,322; 5,879,297; 6,129,668; 6,216,028; and 6,263,230. The contents of the afore-mentioned U.S. patents are incorporated herein by reference in their entireties. The TLS also displays the direction in which the catheter tip is pointing, thus further assisting accurate catheter placement. The TLS further assists the clinician in determining when a malposition of the catheter tip has occurred, such as in the case where the tip has deviated from a desired venous path into another vein. 
     As mentioned, the TLS utilizes a stylet  130  to enable the distal end of the catheter  72  to be tracked during its advancement through the vasculature. In one embodiment and as shown in  FIG. 6 , the stylet  130  includes a proximal end  130 A and a distal end  130 B, with am included handle  136 . A core wire  138  distally extends from the handle  136 , and a tether  134  (for operably connecting the stylet  130  to the placement system  10 ) extends proximally from the handle. A magnetic assembly is disposed distally of the core wire  138 . The magnetic assembly includes one or more magnetic elements disposed adjacent one another proximate the stylet distal end  130 B and encapsulated by tubing. In the present embodiment, a plurality of magnetic elements is included, each element including a solid, cylindrically shaped ferromagnetic stacked end-to-end with the other magnetic elements. An adhesive tip can fill the distal tip of the tubing, distally to the magnetic elements. 
     Note that in other embodiments, the magnetic elements may vary from the design in not only shape, but also composition, number, size, magnetic type, and position in the stylet distal segment. For example, in one embodiment, the plurality of ferromagnetic magnetic elements is replaced with an electromagnetic assembly, such as an electromagnetic coil, which produces a magnetic field for detection by the sensor. Another example of an assembly usable here can be found in U.S. Pat. No. 5,099,845, entitled “Medical Instrument Location Means,” which is incorporated herein by reference in its entirety. Yet other examples of stylets including magnetic elements that can be employed with the TLS modality can be found in U.S. Pat. No. 8,784,336, entitled “Stylet Apparatuses and Methods of Manufacture,” which is incorporated herein by reference in its entirety. These and other variations are therefore contemplated by embodiments of the present invention. It should appreciated herein that “stylet” as used herein can include any one of a variety of devices configured for removable placement within a lumen of the catheter to assist in placing a distal end of the catheter in a desired location within the patient&#39;s vasculature. In one embodiment, the stylet includes a guidewire. As such, it is appreciated that stylets of other forms and configurations can also be acceptably used, in accordance with the present disclosure. 
       FIG. 2  shows disposal of the stylet  130  substantially within a lumen in the catheter  72  such that the proximal portion thereof extends proximally from the catheter lumen, through the bifurcation hub  74 A and out through a selected one of the extension tubes  74 B. So disposed within a lumen of the catheter, the distal end  130 B of the stylet  130  in the present embodiment is substantially co-terminal with the distal catheter end  76 A such that detection by the TLS of the stylet distal end correspondingly indicates the location of the catheter distal end. In other embodiments, other positional relationships between the distal ends of the stylet and catheter or medical device are possible. 
     The TLS sensor  50  (also referred to herein as a “location sensor”) is employed by the system  10  during TLS operation to detect the magnetic field produced by the magnetic elements of the stylet  130 . As seen in  FIG. 2 , the TLS sensor  50  is placed on the chest of the patient during catheter insertion. The TLS sensor  50  is positioned on the chest of the patient in a predetermined location, such as through the use of external body landmarks, to enable the magnetic field of the stylet magnetic elements, disposed in the catheter  72  as described above, to be detected during catheter transit through the patient vasculature. Again, as the magnetic elements of the stylet magnetic assembly are co-terminal with the distal end  76 A of the catheter  72  in one embodiment ( FIG. 2 ), detection by the TLS sensor  50  of the magnetic field of the magnetic elements provides information to the clinician as to the position and orientation of the catheter distal end during its transit. 
     In greater detail, the TLS sensor  50  is operably connected to the console  20  of the system  10  via a connection of a console cable  140  with one or more of the ports  52  of the console, as shown in  FIG. 1 . The console cable  140  attaches to the TLS sensor  50  in a manner to be described further below. Note that other connection schemes between the TLS sensor and the system console can also be used, without limitation. As just described, the magnetic elements are employed in the stylet  130  to enable the position of the catheter distal end  76 A ( FIG. 2 ) to be observable relative to the TLS sensor  50  placed on the patient&#39;s chest. Detection by the TLS sensor  50  of the stylet magnetic elements is graphically displayed on the display  30  of the console  20  during TLS mode. In this way, a clinician placing the catheter is able to generally determine the location of the catheter distal end  76 A within the patient vasculature relative to the TLS sensor  50  and detect when catheter malposition, such as advancement of the catheter along an undesired vein, is occurring. 
     As discussed above, the system  10  includes additional functionality in the present embodiment wherein determination of the proximity of the catheter distal tip  76 A relative to a sino-atrial (“SA”) or other electrical impulse-emitting node of the heart of the patient  70  can be determined, thus providing enhanced ability to accurately place the catheter distal tip in a desired location proximate the node. Also referred to herein as “ECG” or “ECG-based tip confirmation,” this third modality of the system  10  enables detection of ECG signals from the SA node in order to place the catheter distal tip in a desired location within the patient vasculature. Note that the US, TLS, and ECG modalities are seamlessly combined in the present system  10 , but can be employed in concert or individually to assist in catheter placement. In one embodiment, it is understood that the ECG modality as described herein can be included in a stand-alone system without the inclusion of the US and TLS modalities. Thus, the environments in which the embodiments herein are described are understood as merely example environments and are not considered limiting of the present disclosure. 
     As described, the catheter stylet  130  is removably predisposed within the lumen of the catheter  72  being inserted into the patient  70  via the insertion site  73 . The stylet  130 , in addition to including a magnetic assembly for the magnetically-based TLS modality, includes a sensing component, i.e., an internal, intravascular ECG sensor assembly, proximate its distal end and including a portion that is co-terminal with the distal end of the catheter tip for intravascularly sensing ECG signals produced by the SA node, in the present embodiment when the catheter  72  and accompanying stylet  130  are disposed within the patient vasculature. The intravascular ECG sensor assembly is also referred to herein as an internal or “intravascular ECG sensor component,” and the stylet  130  as an “ECG stylet.” 
     As mentioned, the stylet  130  includes the tether  134  extending from its proximal end  130 A that operably connects to the TLS sensor  50  in a manner to be described below, though other connection schemes to the system  10  are contemplated. As will be described in further detail, the stylet tether  134  permits ECG signals detected by the ECG sensor assembly included on a distal portion of the stylet  130  to be conveyed to the TLS sensor  50  during confirmation of the catheter tip location as part of the ECG signal-based tip confirmation modality. 
     External reference and ground ECG electrodes  158  attach to the body of the patient  70  in the present embodiment and are operably attached to the TLS sensor  50  to provide an external baseline ECG signal to the system  10  and to enable the system to filter out high level electrical activity unrelated to the electrical activity of the SA node of the heart, thus enabling the ECG-based tip confirmation functionality. As shown, in the present embodiment, one external electrode  158  is placed on the patient skin proximate the upper right shoulder (“right arm” placement) while another external electrode is placed proximate the lower left abdomen (“left leg” placement). This electrode arrangement provides a lead II configuration according to Einthoven&#39; s triangle of electrocardiography. Operable attachment of the external electrodes  158  with the sensor  50  in a manner to be described below enables the ECG signals detected by the external electrodes to be conveyed to the console  20  of the system  10  or to another suitable destination. As such, the external electrodes  158  serve as one example of an external ECG sensor component. Other external sensors for detecting a baseline ECG signal external to the patient body can also be employed in other embodiments. In addition, other electrode locations are also possible. 
     Together with the external ECG signal received from the external ECG sensor component (i.e., the external ECG electrodes  158  placed on the patient&#39;s skin), an internal, intravascular ECG signal sensed by the internal ECG sensor component (i.e., the stylet ECG sensor assembly of the stylet  130 ), is received by the TLS sensor  50  positioned on the patient&#39;s chest ( FIG. 10 ) or other designated component of the system  10 . The TLS sensor  50  and/or console processor  22  can process the external and internal ECG signal data to produce one or more electrocardiogram traces, including a series of discrete ECG complexes, on the display  30 , as will be described. In the case where the TLS sensor  50  processes the external and internal ECG signal data, a processor is included therein to perform the intended functionality. If the console  20  processes the ECG signal data, the processor  22 , controller  24 , or other processor can be utilized in the console to process the data. 
     Thus, as it is advanced through the patient vasculature, the catheter  72  equipped with the stylet  130  as described above can advance under the TLS sensor  50 , which is positioned on the chest of the patient as shown in  FIG. 10 . This enables the TLS sensor  50  to detect the position of the magnetic assembly of the stylet  130  (described further above), which is substantially co-terminal with the distal tip  76 A of the catheter as located within the patient&#39;s vasculature. The detection by the TLS sensor  50  of the stylet magnetic assembly is depicted on the display  30  during ECG mode. 
     The display  30  can further depict during ECG mode one or more ECG electrocardiogram traces produced as a result of patient heart&#39;s electrical activity as detected by the external and internal ECG sensor components described above. In greater detail, the ECG electrical activity of the SA node, including the P-wave of the trace, is detected by the external and internal sensor components and forwarded to the TLS sensor  50  and console  20 . The ECG electrical activity is then processed for depiction on the display  30 , as will be described further below. 
     A clinician placing the catheter can then observe the ECG data, which assists in determining optimum placement of the distal tip  76 A of the catheter  72 , such as proximate the SA node, for instance. In one embodiment, the console  20  includes the electronic components, such as the processor  22  ( FIG. 1 ), necessary to receive and process the signals detected by the external and internal sensor components. In another embodiment, the TLS sensor  50  can include the necessary electronic components processing the ECG signals. 
     As already discussed, the display  30  is used to display information to the clinician during the catheter placement procedure. The content of the display  30  changes according to which mode the catheter placement system is in: US, TLS, or ECG. Any of the three modes can be immediately called up to the display  30  by the clinician, and in some cases information from multiple modes, such as TLS and ECG, may be displayed simultaneously. In one embodiment, as before, the mode the system is in may be controlled by the control buttons included on the handheld probe  40 , thus eliminating the need for the clinician to reach out of the sterile field (such as touching the button interface  32  of the console  20 ) to change modes. Thus, in the present embodiment the probe  40  is employed to also control some or all ECG-related functionality of the system  10 . Note that the button interface  32  or other input configurations can also be used to control system functionality. Also, in addition to the visual display  30 , aural information, such as beeps, tones, etc., can also be employed by the system to assist the clinician during catheter placement. 
     Note that further details regarding the system  10  can be found in U.S. Pat. No. 8,848,382, issued Sep. 30, 2014, and entitled “Apparatus and Display Methods Relating to Intravascular Placement of a Catheter,” which is incorporated herein by reference in its entirety. It is further noted that the above-described catheter placement system is but example of a variety of placement systems that can benefit from the principles of the embodiments described herein. 
     In view of the above discussion, reference is now made to  FIGS. 3A-3C , which depict various details of the above-described TLS sensor  50 , also referred to herein as a “location sensor.” In particular, the location sensor  50  includes a connector interface (“interface”)  1510  that is configured according to one embodiment. The interface  1510  is configured to enable interconnection of the location sensor  50  with various other catheter placement system components, including the ECG signal-sensing stylet  130  via the tether  134  ( FIG. 6 ), the external ECG electrodes  158  ( FIG. 2 ) via their respective lead wires (“leads”), and the console cable  140  that operably connects the location sensor with the console  20  of the system  10 . 
     As shown, the interface  1510  includes a body  1512  that is configured to removably connect to the location sensor  50  within a pocket  1514  defined on a lower portion of the location sensor  50 , from the perspective shown in  FIG. 3A . The interface body  1512  includes a rail  1518  defined on a fin  1520  that is configured to be slidably received within a corresponding track  1516  defined on an outer surface  50 A of the location sensor  50  proximate the pocket  1514 , as shown in  FIG. 3C . Other connective schemes can be employed in other embodiments. Also, the particular size, shape, and configuration of the interface  1510  can vary. A bottom portion  1520 A of the fin  1520  is configured to be slidably received within a track perimeter  1522  defined about the track  1516  in order to secure the connection between the location sensor  50  and the interface  1510 . 
     The interface body  1512  defines an outer surface  1524  that is shaped and configured so as to match the outer surface  50 A of the location sensor  50  when the interface  1510  is attached to the location sensor. Of course, the particular shape and configuration of both the location sensor and the interface can vary from what is shown and described. Also, the particular connection point of the interface with the location sensor can vary. The interface body  1512  further defines an end surface  1528  that remains externally accessible when the interface  1510  is operably attached to the location sensor ( FIGS. 3A, 3B ), as well as an inner surface  1528  ( FIGS. 3C, 4B, 4C ) that is inaccessible when the interface is attached to the location sensor. As will be described, various connection points are included on both the end surface  1526  and the inner surface  1528  to enable various components of the catheter placement system  10  to operably connect with the location sensor  50 . The size, shape, type, and number of connection points can vary from the below discussion. 
       FIGS. 4A-4C  depict further details regarding the interface  1510 . As shown, the end surface  1526  includes various connection points for enabling interconnection with components of the catheter placement system  10 . Specifically, the end surface  1526  includes a pair of ECG lead connector receptacles  1530  disposed in a recess  1532 . The ECG lead connector receptacles  1530  each include a female contact  1530 A sized and configured to receive therein a male connector end of the leads of the ECG electrodes  158 . In the present embodiment, the recess  1532  is shaped so as to receive a dual connector that includes both male connector ends of the ECG electrodes  158  in a single plug, though other configurations are also possible for the ECG lead connection scheme. 
       FIG. 4A  shows that the fin  1520  includes an ECG stylet wire receptacle  1542 , surrounded by a centering cone  1544 , for removably receiving therein a pin contact  170  ( FIG. 7 ) of a tether connector  132  of the ECG stylet  130  ( FIG. 6 ). Further details regarding connection of the ECG stylet  130  to the interface  1510  and the location sensor  50  are given further below. 
       FIG. 4A  further shows that the console cable  140  is permanently attached so as to extend from the interface  1510 , as shown. The length of the console cable  140  can vary according to need, but is sufficient in the present embodiment to extend between the location sensor  50  and the console  20 , as shown in  FIG. 2 . 
     The inner surface  1528  of the interface  1510  includes various connection points for enabling interconnection of the aforementioned components with the location sensor. As shown, in  FIGS. 4B and 4C , a USB type B plug  1550  of the console cable  140  extends from the interface inner surface  1528  to operably connect with a corresponding USB type B receptacle  1570  ( FIG. 5 ) disposed in the pocket  1514  when the interface  1510  mates with the location sensor  50 . Similarly, a rounded, cylindrical ECG plug  1560  extends from the interface inner surface  1528  to operably connect with a corresponding, cylindrically shaped ECG receptacle  1580  defined in the pocket  1514  when the interface  1510  mates with the location sensor  50 . 
     Specifically, the ECG plug  1560  includes an ECG stylet wire contact  1560 A that is operably connected with the ECG stylet wire receptacle  1542  on the fin  1520 , as well as two ECG lead contacts  1560 B that are operably connected with the ECG lead electrical contacts  1530 A in the ECG lead receptacle  1530  included on the interface end surface  1526 . In the present embodiment, the ECG lead contacts  1560 B are integrally formed with the ECG lead contacts  1530 A and are formed as sleeves so as to receive corresponding ECG lead pins  1580 B disposed in the ECG receptacle  1580 . The ECG receptacle  1580  further includes an ECG stylet pin  1580 A for operably connecting with the sleeve-type ECG stylet wire contact  1560 A of the ECG plug  1560 .  FIGS. 3A, 8A, and 8B  show the manner of attachment of the interface  1510  within the pocket  1514  of the location sensor  50 . 
       FIGS. 6 and 7  show details of the ECG stylet  130 , including the pin contact  170  included in a channel  172  of the tether connector  132 , as described further above. As shown in  FIGS. 8A and 8B , the tether connector  132  is slid over the fin  1520  in a snug friction fit such that the pin contact  170  is received within the ECG stylet wire receptacle  1542 . The ECG stylet wire receptacle  1542  is operably connected within the interface body  1512  with the ECG stylet wire contact  1560 A. Thus, this connection establishes an electrically conductive pathway from the ECG stylet  130  to the location sensor  50  via the operable connections of the pin contact  170  with the ECG stylet wire receptacle  1542 , and the ECG stylet wire contact  1560 A ( FIG. 4C ) of the interface  1510  with the ECG stylet wire pin  1580 A ( FIG. 5 ) of the location sensor. This, in turn, enables ECG signals detected by the ECG stylet  130  to be conveyed to the location sensor  50  and, in one embodiment, the console  20  for processing by the system  10 . 
     Correspondingly,  FIG. 8B  shows the connector ends of the leads of the ECG external electrodes  158  received within the ECG lead connector receptacles  1530  of the interface  1510  such that they each operably connect with a corresponding one of the electrical contacts  1530 A therewithin. Thus, conductive pathways are established from the ECG external electrodes  158  to the location sensor via the operable connections of the connector ends of the ECG external electrode leads with ECG lead connector receptacles  1530 , and the ECG lead contacts  1560 B ( FIG. 4C ) of the interface  1510  with the ECG lead pins  1580 B ( FIG. 5 ) of the location sensor. 
     Also, conductive pathways are established from the location sensor  50  to the console  20  ( FIGS. 1, 2 ) via the operable connection of the console cable  140 , namely, the operable connection of its male connector  1550  of the interface  1510  ( FIG. 4C ) with the receptacle  1570  of the location sensor ( FIG. 5 ). Note that while shown as a USB-type cable, the console cable can include other styles, types, form factors, etc. 
     In the above-described configurations, therefore, the location sensor and attached components are ready for use by the catheter placement system  10 , in one embodiment. Indeed,  FIG. 12  shows the manner of use of the location sensor  50  when connected with the various components described above during a catheter insertion procedure using the catheter placement system  10 . Note that the tether connecter  132  is configured to pierce a sterile drape  1600  (which is placed over the patient during catheter insertion procedures) such that regions above the drape are considered a sterile environment, while the location sensor  50 , the fin  1520 , and the console cable  140  are not considered sterile. The manner in which the tether connector  132  is able to pierce the drape  1600  and operably connect with the location sensor  50  enables such a connection without compromising the sterility of the sterile field. 
     Note that the various connecting components described with the above electrically conductive connections can vary in size, type, number, etc., from what is discussed herein. Note further that in the present embodiment attachment of the interface  1510  with the location sensor  50  is maintained via the friction fit of the various electrical connections between the interface and the location sensor, as just discussed above. In another embodiment, additional features can be included on one or both of the interface body  1512  and the location sensor  50  to provide a friction fit or other type of securement to maintain attachment between the interface and the location sensor. 
       FIGS. 9-11  depict the interface  1510  according to another embodiment, wherein the ECG stylet wire contact  1560 A and the two ECG lead contacts  1560 B discretely extend from interface body  1512  instead of being included in a male plug ( FIG. 10 ). Correspondingly, the ECG stylet wire pin  1580 A and the two ECG lead pins  1580 B of the location sensor  50  are discretely positioned instead of grouped within a receptacle in the location sensor pocket  1514  ( FIG. 9 ). Also, note that the shape and configuration of the track  1516  of the location sensor  50  ( FIG. 9 ) differs from that of the previous embodiment. These and other modifications are therefore contemplated. 
       FIG. 13  shows an interface connector configuration according to another embodiment, wherein a connector block  1660  includes not only the ECG stylet wire contact  1560 A and the ECG lead contacts  1560 B, but also two electromagnetic contacts  1660 A for providing power to an electromagnet element disposed in the ECG stylet  130  to be used when the system  10  is in TLS mode, described above. The particular arrangement and configuration of the various connectors can vary from what is shown here. 
     It is noted that the interface  1510  in one embodiment is reusable for multiple catheter insertion procedures, but is easily removable and replaceable should the need arise, such as in cases where damage to the wires or cables of the catheter insertion system  10  have been damaged due to use, accident, or repeated cleaning cycles. This, in turn enables replacement without the need to replace the entire location sensor, which can involve considerably more cost. Further, it is appreciated that the ECG stylet  130  and the external ECG electrodes and their leads are disposable and are disposed of after a single catheter insertion is complete. The console cable in one embodiment is permanently attached with the interface  1510  and thus is reusable. Also, though described here as employed with a location sensor, the interface in other embodiments can be employed to operably connect with other types of medical devices where interconnections as are enabled by the interface as described herein are needed. Further, note that various types of electrical connectors can be used to operably connect the various components described herein, including circuit board-edge connectors, peg and cuff-type connectors, type-C and other types of USB connectors, spring-loaded pins for pressing against conductive pads, etc. These and other connectors are therefore contemplated. 
     Embodiments of the invention may be embodied in other specific forms without departing from the spirit of the present disclosure. The described embodiments are to be considered in all respects only as illustrative, not restrictive. The scope of the embodiments is, therefore, indicated by the appended claims rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.