Patent Description:
In a typical surgical procedure, a sterile drape is placed over a patient to establish a sterile field, within which the surgical procedure is performed. For example, in a typical catheter-placement procedure, a sterile drape is placed over a patient to establish a sterile field for placement of the catheter. However, there is often a need to breach the sterile barrier in order to make electrical connections between components of various systems without compromising the sterility of the sterile field. In addition, there is a need to keep clinicians safe when handling the components of the various systems, particularly those components having piercing elements or the like for breaching a sterile drape.

Disclosed herein are connection systems and methods thereof for establishing electrical connections through a barrier such as a drape that address at least the foregoing need. <CIT> discloses an integrated catheter placement system for accurately placing a catheter within a patient's vasculature is disclosed. In one embodiment, the integrated system comprises a system console, a tip location sensor for temporary placement on the patient's chest, and an ultrasound probe. The tip location sensor senses a magnetic field of a stylet disposed in a lumen of the catheter when the catheter is disposed in the vasculature. The ultrasound probe ultrasonically images a portion of the vasculature prior to introduction of the catheter. ECG signal-based catheter tip guidance is included in the integrated system to enable guidance of the catheter tip to a desired position with respect to a node of the patient's heart.

In a first aspect of the present invention, there is provided a connection system according to claim <NUM>.

Disclosed herein is a connection system for establishing one or more electrical connections through a barrier. The connection system includes, in some embodiments, a first connector and a second connector. The first connector includes a first-connector housing, a cable, and at least a first piercing element. The first-connector housing defines a cavity. The cable extends from a slideable end piece having a first electrical lead coupled to a distal-end portion of the first-connector housing. The first piercing element is connected to the first electrical lead. The first piercing element is configured to enter the cavity and pierce the barrier when the barrier is disposed in the cavity and the slideable end piece is advanced toward a proximal-end portion of the first-connector housing. The slideable end piece is advanced during a transition from a safety state to an operable state of the first connector. The second connector includes a second-connector housing and at least a first receptacle within the second-connector housing. The first receptacle is configured to form at least a first electrical connection of the one or more electrical connections with the first piercing element when the transition from the safety state to the operable state of the first connector is complete.

In some embodiments, the first connector includes a pin shield over at least the first piercing element in the safety state. The pin shield is configured to be pushed into the slideable end piece when the first connector is disposed over the second connector during the transition from the safety state to the operable state.

In some embodiments, the pin shield is coupled to a compression spring configured to resist compression when the pin shield is pushed into the slideable end piece. The compression spring is configured to push the pin shield back over at least the first piercing element as the first connector is removed from the second connector. The first connector is removed from the second connector during a transition from the operable state to the safety state.

In some embodiments, the first-connector housing includes a slot opposite an opening of the cavity. The slot extends at least as far toward the proximal-end portion of the first connector housing as the pin shield extends into the cavity in the safety state.

In some embodiments, the slot functions as a visual aid for visualizing the pin shield thereunder during at least the transition from the safety state to the operable state.

In some embodiments, minor sides of each housing of the first-connector housing and the second-connector housing are dissimilar. Each minor side of the minor sides of the first-connector housing have a matching minor side of the minor sides of the second-connector housing. This enforces a single orientation of the first connector when disposing the first connector over the second connector.

In some embodiments, the first piercing element is a jack plug having a needle-like tip electrical contact, a ring electrical contact, and a sleeve electrical contact. The tip electrical contact is connected to the first electrical lead, the ring electrical contact is connected to a second electrical lead of the cable, and the sleeve electrical contact is connected to a third electrical lead of the cable.

In some embodiments, the first receptacle is a jack having complementary electrical contacts to the tip electrical contact, the ring electrical contact, and the sleeve electrical contact of the jack plug.

In some embodiments, the first connector further includes a second piercing element and a third piercing element. The second piercing element and the third piercing element are respectively connected to a second electrical lead and a third electrical lead of the cable. Each piercing element of the first, second, and third piercing elements is configured to pierce the barrier in a different location than the other piercing elements.

In some embodiments, the second connector further includes a second receptacle element and a third receptacle within the second-connector housing. The second receptacle and the third receptacle are configured to form at least a second electrical connection and a third electrical connection of the one or more electrical connections respectively with the second piercing element and the third piercing element when the transition from the safety state to the operable state of the first connector is complete.

Also disclosed herein is a connection system for a plurality of electrical connections through a drape. The connection system includes, in some embodiments, a tether connector and a fin connector. The tether connector is coupled to a stylet configured to be removably disposed in a catheter. The tether connector includes a tether-connector housing, a cable, and a plurality of piercing elements. The tether-connector housing defines a cavity. The cable extends from a slideable end piece coupled to a distal-end portion of the tether-connector housing. The plurality of piercing elements are respectively connected to a plurality of electrical leads of the cable. The piercing elements are configured to enter the cavity and pierce the drape when the drape is disposed in the cavity and the slideable end piece is advanced toward a proximal-end portion of the first-connector housing. The slideable end piece is advanced during a transition from a safety state to an operable state of the tether connector. The fin connector is part of a tip-location sensor configured to sense a location of a tip of the catheter. The fin connector includes a fin-connector housing and a plurality of receptacles within the fin-connector housing. The receptacles are configured to form the electrical connections with the piercing elements when the transition from the safety state to the operable state of the first connector is complete.

In some embodiments, the piercing elements are limited to three piercing elements. Each piercing element of the piercing elements is configured to pierce a sterile side of the drape in a different location than the other piercing elements.

In some embodiments, the tether connector includes a pin shield over the piercing elements in the safety state. The pin shield is configured to be pushed into the slideable end piece when the tether connector is disposed over the fin connector during the transition from the safety state to the operable state.

In some embodiments, the pin shield is coupled to a compression spring configured to resist compression when the pin shield is pushed into the slideable end piece. The compression spring is configured to push the pin shield back over the piercing elements as the tether connector is removed from the fin connector. The tether connector is removed from the fin connector during a transition from the operable state to the safety state.

In some embodiments, the tether-connector housing includes a slot opposite an opening of the cavity. The slot extends at least as far toward the proximal-end portion of the tether connector housing as the pin shield extends into the cavity in the safety state.

In some embodiments, minor sides of each housing of the tether-connector housing and the fin-connector housing are dissimilar. Each minor side of the minor sides of the tether-connector housing have a matching minor side of the minor sides of the fin-connector housing. This enforces a single orientation of the tether connector when disposing the tether connector over the fin connector.

Also disclosed herein is a method not forming part of the claimed invention for establishing one or more electrical connections through a barrier with a connection system. The method includes a placing step of placing the barrier over a second connector of the connection system. The method also includes an aligning step of aligning a first connector of the connection system with the second connector. The first connector includes a first-connector housing defining a cavity and a slideable end piece coupled to a distal-end portion of the first-connector housing.

The method also includes a disposing step of disposing the first connector over the second connector with the barrier in the cavity between the first connector and the second connector. The method also includes a sliding step of sliding the slideable end piece toward a proximal-end portion of the first-connector housing. At least a first piercing element of the first connector pierces a sterile side of the barrier and enters at least a first receptacle within the second-connector housing during the sliding. The method also includes a forming step of forming the one or more electrical connections between the first piercing element of the first connector and the first receptacle of the second connector.

In some embodiments, the disposing step includes using an obliquely downward motion to push a pin shield disposed over at least the first piercing element into the slideable end piece with a portion of the second-connector housing.

In some embodiments, the method further includes a visualizing step of visualizing the pin shield being pushed into the slideable end piece through a slot of the first-connector housing opposite an opening of the cavity.

In some embodiments, each connector of the first-connector housing and the second-connector housing includes dissimilar minor sides. The aligning step includes matching each minor side of the minor sides of the first-connector housing with a matching minor side of the minor sides of the second-connector housing. This enforces a single orientation of the first connector to the second connector.

In some embodiments, piercing the sterile side of the barrier with the first piercing element includes simultaneously piercing the sterile side of the barrier in two other locations with a second piercing element and a third piercing adj acent the first piercing element.

In some embodiments, the method further includes a disposing step of disposing a stylet in a catheter, wherein the first connector is a tether connector coupled to the stylet. The method also includes a sensing step of sensing a location of a tip of the catheter in a patient, wherein the second connector is a fin connector of a tip-location sensor on a chest of the patient under the barrier.

These and other features of the concepts provided herein will become more apparent to those of skill in the art in view of the accompanying drawings and following description, which disclose particular embodiments of such concepts in greater detail.

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

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

Disclosed herein are connection systems and methods thereof for establishing electrical connections through a barrier such as a drape that address at least the foregoing need.

For example, a connection system includes, in some embodiments, a first connector (e.g., the tether connector <NUM> set forth below) and a second connector (e.g., the fin connector <NUM> set forth below). The first connector includes a first-connector housing, a cable, and at least a first piercing element. The first-connector housing defines a cavity. The cable extends from a slideable end piece having a first electrical lead coupled to a distal-end portion of the first-connector housing. The first piercing element is connected to the first electrical lead. The first piercing element is configured to enter the cavity and pierce a barrier such as a drape, sheath, adhesive sheet, or the like, when the barrier is disposed in the cavity and the slideable end piece is advanced toward a proximal-end portion of the first-connector housing. The slideable end piece is advanced during a transition from a safety state to an operable state of the first connector. The second connector includes a second-connector housing and at least a first receptacle within the second-connector housing. The first receptacle is configured to form at least a first electrical connection of one or more electrical connections with the first piercing element when the transition from the safety state to the operable state of the first connector is complete. An example method for establishing one or more electrical connections through the barrier with the foregoing connection system is set forth below.

An example catheter-placement system incorporating the connection system will be at least initially described to provide context for the connection system. It should be understood the connection system is not limited to the example catheter-placement system. Indeed, the connection system can be incorporated into any system of various systems having a need to breach a sterile barrier between components of the system in order to make electrical connections therebetween without compromising the sterility of the sterile field.

<FIG> and <FIG> illustrate a catheter-placement system <NUM> for placing a catheter <NUM> in a body of a patient <NUM> in accordance with some embodiments. The catheter-placement system <NUM> is configured for assisting a clinician in placing the catheter <NUM> in a vasculature of the patient <NUM>. As shown, the catheter-placement system <NUM> includes a console <NUM> including a display <NUM>, an ultrasound probe <NUM>, and a tip-location sensor <NUM> configured for placement on the patient's chest or some other portion of the patient's body.

<FIG> illustrates a stylet <NUM> including a tether connector <NUM> of the catheter-placement system <NUM> in accordance with some embodiments. The stylet <NUM> is employed with the catheter <NUM> during insertion of the catheter <NUM> into the vasculature of the patient <NUM>. The stylet <NUM> includes a core wire <NUM> configured to be removably disposed in a lumen of the catheter <NUM> during a catheter-placement procedure, thereby enabling a distal tip <NUM> of the catheter <NUM> to be tracked by the catheter-placement system <NUM> using one or more of modalities for guiding the catheter <NUM> to a desired location within the patient's vasculature after insertion of the catheter <NUM> into a percutaneous insertion site <NUM> of the patient <NUM>. The one or more modalities include, but are not limited to ultrasound-based imaging of subcutaneous tissue of the patient in preparation for insertion of the catheter <NUM>; magnet-based tracking for determining orientation, advancement direction, and general internal location of the distal tip <NUM> of the catheter <NUM>; or ECG-based confirmation for confirming the distal tip <NUM> of the catheter <NUM> is positioned at a desired location for which ECG lead connector <NUM> is provided. (See <FIG> for ECG lead connector <NUM>. ) The stylet <NUM> further includes a tether <NUM> proximally extending from a handle <NUM>, the tether <NUM> terminating at a proximal end thereof with the tether connector <NUM>. The tether connector <NUM> is configured to mechanically couple and electrically connect with a fin connector <NUM> of the tip-location sensor <NUM> as shown in at least <FIG> in accordance with some embodiments of a connection system <NUM>.

Additional details for the catheter-placement system <NUM> shown in at least <FIG> and <FIG> can be found in <CIT>.

<FIG> illustrates the tip-location sensor <NUM> including a fin connector <NUM> of the catheter-placement system <NUM> in accordance with some embodiments. <FIG> illustrates the tether connector <NUM> connected to the fin connector <NUM> of the tip-location sensor <NUM> in accordance with some embodiments. As shown, the fin connector <NUM> is disposed on the tiplocation sensor <NUM> of the catheter-placement system <NUM>. Again, the tether connector <NUM> is configured to mechanically couple and electrically connect with the fin connector <NUM>, which enables the catheter-placement system <NUM> to track the distal tip <NUM> of the catheter <NUM>. A barrier such as a drape, for example, a sterile drape is configured to provide a sterile field about the patient <NUM>. The barrier can be interposed between the tip-location sensor <NUM> (e.g., under the sterile drape in a non-sterile field) and the stylet <NUM> (e.g., over the sterile drape in the sterile field). As set forth in more detail below, the tether connector <NUM> includes at least the first piercing element <NUM> configured to pierce the barrier and insert into at least a first receptacle <NUM> of the fin connector <NUM> to electrically connect the tether connector <NUM> and the fin connector <NUM>.

While not shown in, the catheter-placement system <NUM>, or the connection system <NUM> thereof, can include one or more light-emitting diodes ("LEDs") configured to change from a first state to a second state to indicate success in forming one or more electrical connections between the tether connector <NUM> and the fin connector <NUM>. The one or more LEDs can include an LED on the tip-location sensor <NUM>, an LED on the tether connector <NUM>, or both of the foregoing LEDs. Upon success in forming the one or more electrical connections between the tether connector <NUM> and the fin connector <NUM>, each LED of the one or more LEDs can change from a first state of being off to a second state of being on, a first state of being one color (e.g., red) to a second state of being another color (e.g., green), a first state of blinking light to a second state of a solid light, or various combinations thereof. Each LED of the one or more LEDs is configured to change from the first state to the second state upon completion of a dedicated LED circuit for the change of state upon forming the one or more electrical connections. When present, the LED on the tip-location sensor <NUM> is configured to be bright enough to see through a barrier such as a drape, thus enabling a clinician to see a change from the first state to the second state upon forming one or more electrical connections between the tether connector <NUM> and the fin connector <NUM> even when the barrier is in place.

In view of the foregoing catheter-placement system <NUM>, the connection system <NUM> includes a first connector such as the tether connector <NUM> and a second connector such as the fin connector <NUM> configured for mechanically coupling and establishing one or more electrical connections through a barrier such as a sterile drape without compromising the sterile field set up by the barrier. Having described the connection system <NUM> in the context of the catheter-placement system <NUM>, additional details for the tether connector <NUM> and the fin connector <NUM> of the connection system <NUM> will now be described with the understanding the connection system <NUM> is not limited to the catheter-placement system <NUM>.

<FIG> illustrate different views of the tether connector in a safety state in accordance with some embodiments. <FIG> illustrate different views of the tether connector in an operable state in accordance with some embodiments.

Again, the connection system <NUM> includes a first connector such as the tether connector <NUM> and a second connector such as the fin connector <NUM>, which are configured for mechanically coupling and establishing one or more electrical connections through a barrier such as a drape, for example, sterile drape without compromising the sterile field set up by the barrier.

The tether connector <NUM> includes a tether-connector housing <NUM>, a slideable end piece <NUM>, a cable <NUM> (i.e., the tether <NUM> set forth above), and at least a first piercing element <NUM>.

The tether-connector housing <NUM> defines a cavity <NUM> configured to accept therein a top portion of the fin connector <NUM> and a barrier such as a drape therebetween. When present, an outwardly facing ridge <NUM> around an opening of the cavity <NUM> can be commensurate with the cavity <NUM> within the tether-connector housing <NUM> for visualization of the cavity <NUM> when the cavity is oriented away from a user of the tether connector <NUM>. The tether-connector housing <NUM> includes a slot <NUM> opposite an opening of the cavity <NUM>. The slot <NUM> extends at least as far toward a proximal-end portion of the tether-connector housing <NUM> as the pin shield <NUM> set forth below extends into the cavity <NUM> in the safety state the tether-connector housing <NUM>. The slot <NUM> functions as a visual aid for visualizing the pin shield <NUM> thereunder during at least the transition from the safety state to the operable state, a transition from the operable state to the safety state, or both. The tether-connector housing <NUM> can be molded from a medically acceptable polymer such as a thermoplastic.

The slideable end piece <NUM> is captively but slidingly disposed over a distal-end portion of the tether-connector housing <NUM>. The slideable end piece <NUM> is configured to be advanced toward a proximal-end portion of the tether-connector housing <NUM> during a transition from the safety state to the operable state of the tether connector <NUM>. During the transition, at least the first piercing element <NUM> is advanced into the cavity <NUM>. If present, the ridge <NUM> provides a stop for stopping advancement of the slideable end piece <NUM> toward the proximal-end portion of the tether-connector housing <NUM>. If the ridge <NUM> is not present, tabs in place of the ridge <NUM> or a distal end of the slideable end piece <NUM> itself provides a stop for stopping advancement of the slideable end piece <NUM> toward the proximal-end portion of the tether-connector housing <NUM>.

The cable <NUM> extends from the slideable end piece <NUM>. The cable has at least a first electrical lead (not shown) coupled to a distal-end portion of the slideable end piece <NUM>. The first electrical lead is electrically connected to the first piercing element <NUM>.

The tether connector <NUM> includes a pin shield <NUM> over at least the first piercing element <NUM> in the safety state as shown in <FIG>. As shown by <FIG>, the pin shield <NUM> is configured to be pushed into the slideable end piece <NUM> when the tether connector <NUM> is disposed over the fin connector <NUM> during the transition from the safety state to the operable state. (For clarity, the fin connector <NUM> is not shown in <FIG>. ) As shown in <FIG>, the pin shield <NUM> remains in place over at least the first piercing element <NUM> when the slideable end piece <NUM> is advanced toward the proximal-end portion of the tether-connector housing <NUM> if the tether connector <NUM> is not disposed over the fin connector <NUM>, thereby maintaining the tether connector <NUM> in the safety state.

The pin shield <NUM> is coupled to a compression spring (not shown) disposed within the slideable end piece <NUM>. The compression spring is configured to resist compression when the pin shield <NUM> is pushed into the slideable end piece <NUM>. The compression spring is configured to extend and push the pin shield <NUM> back over at least the first piercing element <NUM> as the tether connector <NUM> is removed from the fin connector <NUM>. The tether connector <NUM> is removed from the fin connector <NUM> during a transition from the operable state to the safety state.

The first piercing element <NUM> can be the only piercing element of the tether connector <NUM>. In such embodiments, the first piercing element <NUM> can be a tip-sleeve ("TS") jack plug having a needle-like tip electrical contact and a sleeve electrical contact configured to make at least two of the one or more electrical connections upon insertion of the first piercing element <NUM> into a complementary jack as the first receptacle <NUM> within the fin-connector housing <NUM> set forth below. Alternatively, the first piercing element <NUM> can be a tip-ring-sleeve ("TRnS") jack plug having a needle-like tip, n ring electrical contacts with n ≥ <NUM> (<IMG>), and a sleeve electrical contact configured to make at least three of the one or more electrical connections upon insertion of the first piercing element <NUM> into a complementary jack as the first receptacle <NUM> within the fin-connector housing <NUM>. Each additional ring electrical contact of the first piercing element <NUM> when configured as a TRnS jack plug can be configured to support an additional communication channel for data transfer between the first piercing element <NUM> and the first receptacle <NUM>. Whether the first piercing element <NUM> is a TS or TRnS jack plug, the first piercing element <NUM> is connected to a number of electrical leads of the cable <NUM> corresponding to the electrical contacts of the first piercing element <NUM>. In a TRS jack plug, for example, the tip electrical contact is connected to the first electrical lead of the cable <NUM>, the ring electrical contact is connected to a second electrical lead of the cable <NUM>, and the sleeve electrical contact is connected to a third electrical lead of the cable <NUM>.

Continuing with another embodiment in which the first piercing element <NUM> is the only piercing element of the tether connector <NUM>, the first piercing element <NUM> can be a blade-like end portion of a printed circuit board having one or more electrical contacts printed thereon to make the one or more electrical connections upon insertion of the first piercing element <NUM> into a complementary slot as the first receptacle <NUM> within the fin-connector housing <NUM>. Each additional electrical contact printed on the blade-like end portion of the printed circuit board of the first piercing element <NUM> can be configured to support an additional communication channel for data transfer between the first piercing element <NUM> and the first receptacle <NUM>. Like the TS jack plug and TRnS jack-plug embodiments of the first piercing element <NUM>, the first piercing element <NUM> is also connected to a number of electrical leads of the cable <NUM> corresponding to the electrical contacts of the first piercing element <NUM> when configured as a blade-like end portion of a printed circuit board. For example, a first electrical contact, a second electrical contact, and a third electrical contact printed on the blade-like end portion of the printed circuit board are respectively connected to a first electrical lead, a second electrical lead, and a third electrical lead of the cable <NUM>.

In each of the foregoing embodiments in which the first piercing element <NUM> is the only piercing element of the tether connector <NUM>, the first piercing element <NUM> is configured to enter the cavity <NUM> and pierce a barrier such as a drape when the barrier is disposed in the cavity <NUM> over the fin connector <NUM> and the slideable end piece <NUM> is advanced toward a proximal-end portion of the tether-connector housing <NUM>.

The first piercing element <NUM> can be one of a number of piercing elements such as the three piercing elements shown in <FIG>. In such embodiments, the first piercing element <NUM> can be accompanied by a second piercing element <NUM> and a third piercing element <NUM>, each piercing element of the first, second, and third piercing elements <NUM>, <NUM>, and <NUM> configured to enter the cavity <NUM> and pierce the barrier in a different location than the other piercing elements when a barrier such as a drape is disposed in the cavity <NUM> over the fin connector <NUM> and the slideable end piece <NUM> is advanced toward a proximal-end portion of the tether-connector housing <NUM>. Each piercing element of the first, second, and third piercing elements <NUM>, <NUM>, and <NUM> includes one or more electrical contacts. More than one electrical contact is possible for any piercing element of the foregoing piercing elements if configured as a TS jack plug or a TRnS jack plug as set forth above. The number of piercing elements are connected to a number of electrical leads of the cable <NUM> corresponding to the electrical contacts of the first, second, and third piercing elements <NUM>, <NUM>, and <NUM>. For example, if the first piercing element <NUM>, the second piercing element <NUM>, and the third piercing element <NUM> are not configured as TS or TRnS jack plugs, the first piercing element <NUM> is connected to the first electrical lead of the cable <NUM>, the second piercing element <NUM> is connected to a second electrical lead of the cable <NUM>, and the third piercing element <NUM> is connected to a third electrical lead of the cable <NUM>.

The fin connector <NUM> includes a fin-connector housing <NUM> and at least a first receptacle <NUM> within the fin-connector housing <NUM>. The fin-connector housing <NUM> can be molded from a medically acceptable polymer such as a thermoplastic.

The first receptacle <NUM> can be the only receptacle of the fin connector <NUM>. In such embodiments, the first receptacle <NUM> can be a jack having complementary electrical contacts to the tip electrical contact, any ring electrical contacts, and the sleeve electrical contact of the first piercing element <NUM> when configured as a jack plug. In other embodiments, the first receptacle <NUM> can be a slot having complementary electrical contacts to the first piercing element <NUM> when configured as a blade-like end portion of a printed circuit board. Thus, the first receptacle <NUM> is configured to form at least a first electrical connection of the one or more electrical connections with the first piercing element <NUM> when the tether connector <NUM> is disposed over the fin connector <NUM> and the transition from the safety state to the operable state of the tether connector <NUM> is complete.

The first receptacle <NUM> can be one of a number of receptacles such as the three receptacles shown in <FIG>. In such embodiments, the first receptacle <NUM> can be accompanied by a second receptacle <NUM> and a third receptacle <NUM>, each receptacle of the first, second, and third receptacles <NUM>, <NUM>, and <NUM> having at least one complementary electrical contact to a corresponding piercing element such as the first piercing element <NUM>, the second piercing element <NUM>, the third piercing element <NUM>. More than one electrical contact is possible for any receptacle of the foregoing receptacles if configured as a TS jack or a TRnS jack. Thus, the first receptacle <NUM> is configured to form at least a first electrical connection of the one or more electrical connections with the first piercing element <NUM>, the second receptacle <NUM> is configured to form at least a second electrical connection of the one or more electrical connections with the second piercing element <NUM>, and the third receptacle <NUM> is configured to form at least a third electrical connection of the one or more electrical connections with the third piercing element <NUM> when the tether connector <NUM> is disposed over the fin connector <NUM> and the transition from the safety state to the operable state of the tether connector <NUM> is complete.

Minor sides of each housing of the tether-connector housing <NUM> and the fin-connector housing <NUM> are dissimilar. As shown in <FIG> and <FIG> by the cavity <NUM> of the tether-connector housing <NUM>, for example, the proximal-end portion of the tether-connector housing <NUM> is rounded while the distal-end portion of the tether-connector housing <NUM> is flat. Each minor side of the minor sides of the tether-connector housing <NUM> has a matching minor side of the minor sides of the fin-connector housing <NUM>, which enforces a single orientation of the tether connector <NUM> when disposing the tether connector <NUM> over the fin connector <NUM>. In addition to enforcing a single orientation when disposing the tether connector <NUM> over the fin connector <NUM>, the flat side of the fin-connector housing <NUM> matching that of the tether-connector housing <NUM> is configured to enhance engagement and facilitate pushing the pin shield <NUM> into the slideable end piece <NUM> when the tether connector <NUM> is disposed over the fin connector <NUM> with an obliquely downward motion.

An example method for establishing one or more electrical connections through a barrier such as a drape with the connection system <NUM> includes a placing step of placing the barrier over the fin connector <NUM> of the connection system <NUM>.

The method also includes an aligning step of aligning the tether connector <NUM> of the connection system <NUM> with the fin connector <NUM>. The aligning step can include matching each minor side of the minor sides of the tether-connector housing <NUM> with a matching minor side of the minor sides of the fin-connector housing <NUM>. This enforces a single orientation of the tether connector <NUM> to the fin connector <NUM>.

The method also includes a disposing step of disposing the tether connector <NUM> over the fin connector <NUM> with the barrier in the cavity <NUM> between the tether connector <NUM> and the fin connector <NUM>. When the barrier is a drape, the drape self-tightens over the fin connector <NUM> during the disposing step. The disposing step includes using an obliquely downward motion to push the pin shield <NUM> disposed over at least the first piercing element <NUM> into the slideable end piece <NUM> with a portion of the fin-connector housing <NUM>. The portion of the fin-connector housing <NUM> can be a top portion of the flat minor side of the fin-connector <NUM> set forth above.

The method also includes a sliding step of sliding the slideable end piece <NUM> toward the proximal-end portion of the tether-connector housing <NUM> to complete the transition from the safety state to the operable state of the tether connector <NUM>. At least the first piercing element <NUM> of the tether connector <NUM> pierces a sterile side of the barrier and enters at least the first receptacle <NUM> within the fin-connector housing <NUM> during the sliding. Piercing the sterile side of the barrier with the first piercing element <NUM> can include simultaneously piercing the sterile side of the barrier in two other locations with the second piercing element <NUM> and the third piercing adjacent <NUM> in embodiments have the second and third piercing elements <NUM> and <NUM>.

The method can also include a visualizing step of visualizing the pin shield <NUM> being pushed into the slideable end piece <NUM> through the slot <NUM> of the tether-connector housing <NUM>.

The method also includes a forming step of forming the one or more electrical connections between the first piercing element of the tether connector <NUM> and the first receptacle of the fin connector <NUM> at a time of completing the transition from the safety state to the operable state of the tether connector <NUM>.

The method can also include a confirming step of confirming the one or more electrical connections are formed by a change from the first state of the LED on the tether connector <NUM> to the second state of the LED upon forming the one or more electrical connections.

The method can also include a disposing step of disposing the stylet <NUM> in the catheter <NUM>, wherein the tether connector <NUM> is coupled to the stylet <NUM>.

The method can also include a sensing step of sensing a location of the distal tip <NUM> of the catheter <NUM> in a patient, wherein the fin connector <NUM> is part of the tip-location sensor <NUM> on a chest of the patient under the barrier.

Claim 1:
A connection system (<NUM>) for establishing one or more electrical connections through a barrier, the system comprising:
a first connector (<NUM>) including:
a first-connector housing (<NUM>) defining a cavity (<NUM>);
a slideable end piece (<NUM>) captively but slidingly disposed over a distal-end portion of the first-connector housing; a cable (<NUM>) extending from said slidable end piece (<NUM>) having a first electrical lead coupled to a distal-end portion of the first-connector housing (<NUM>); and
at least a first piercing element (<NUM>) connected to the first electrical lead, the first piercing element (<NUM>) configured to enter the cavity (<NUM>) and pierce the barrier when the barrier is disposed in the cavity and the slideable end piece (<NUM>) is advanced toward a proximal-end portion of the first-connector housing during a transition from a safety state to an operable state of the first connector (<NUM>); and
a second connector (<NUM>) including:
a second-connector housing (<NUM>); and
at least a first receptacle (<NUM>) within the second-connector housing (<NUM>) configured to form at least a first electrical connection of the one or more electrical connections with the first piercing element (<NUM>) when the transition from the safety state to the operable state of the first connector is complete.