Patent Description:
Disclosed herein are connection systems and methods thereof that address at least the foregoing wherein the first connector portion pierces a contamination barrier to couple with the second connector portion. <CIT> relates to a plug-type connection for connecting at least one sterile electrical, optical and/or fluid-carrying line to at least one non-sterile apparatus with one line-side and one equipment-side plug unit respectively. The equipment-side plug unit is surrounded by at least one sterile foil which is clamped tightly between respective corresponding sealing and clamping edges of the line-side and the equipment-side plug units which surround the line to be plugged in. The line-side and/or equipment-side plug unit has a cutting device to cut the foil in the area of the lines to be contacted.

Disclosed herein are connection systems and methods thereof that address at least the foregoing need.

The invention relates to a connection system for establishing both an optical connection and an electrical connection through a drape as defined in claim <NUM> and to a method for establishing both an optical connection and an electrical connection through a drape as defined in claim <NUM>. Embodiments of the invention are recited in the dependent claims. Disclosed herein is a connection system for establishing both an optical connection and an electrical connection through a drape. The connection system includes, in some embodiments, a plug and a receptacle, wherein the plug is configured to insert into the receptacle with the drape therebetween. The plug includes a plug housing, an optical terminal extending from the plug housing, and an electrical terminal extending from the plug housing. The electrical terminal is configured as a piercing element for piercing the drape. The receptacle includes a receptacle housing, an optical receiver within the receptacle housing, and an electrical receiver within the receptacle housing. The optical receiver is configured to form the optical connection with the optical terminal when the plug is inserted into the receptacle with the drape therebetween. The electrical receiver is configured to form the electrical connection with the electrical terminal when the plug is inserted into the receptacle with the drape therebetween.

In some embodiments, the piercing element includes a longitudinal cutout between the plug housing and a tip of the piercing element. The optical terminal extends from the plug housing into the longitudinal cutout of the piercing element.

In some embodiments, the piercing element is configured to deflect away from a longitudinal axis of the plug to expose the optical terminal.

In some embodiments, the electrical receiver includes a channel configured to deflect the piercing element away from the longitudinal axis of the plug upon inserting the plug into the receptacle. Deflecting the piercing element away from the longitudinal axis of the plug exposes the optical terminal for insertion into the optical receiver and formation of the optical connection.

In some embodiments, the channel of the electrical receiver is configured to keep the piercing element deflected away from the longitudinal axis of the plug. The channel of the electrical receiver is also configured form the electrical connection with an electrical contact within the electrical receiver upon fully inserting the plug into the receptacle.

In some embodiments, the piercing element is configured to deflect toward a longitudinal side of the plug.

In some embodiments, the electrical receiver includes a channel configured to deflect the piercing element toward the longitudinal side of the plug upon inserting the plug into the receptacle. Deflect the piercing element toward the longitudinal side of the plug exposes the optical terminal for insertion into the optical receiver and formation of the optical connection.

In some embodiments, the channel of the electrical receiver is configured to keep the piercing element deflected toward the longitudinal side of the plug. The channel of the electrical receiver is also configured to form the electrical connection with an electrical contact within the electrical receiver upon fully inserting the plug into the receptacle.

In some embodiments, the optical terminal includes an optical fiber extending from the plug housing into a ferrule, and the optical receiver includes an optical fiber disposed in a ferrule at a closed end of the optical receiver.

In some embodiments, the ferrules connect in a straight sleeve-type butt-joint connection.

In some embodiments, the ferrules connect in a tapered sleeve-type butt-joint connection.

In some embodiments, the plug is configured to simultaneously make both the optical and electrical connections with the receptacle from a sterile field established by the drape without compromising sterility of the sterile field.

Also disclosed herein is a connection system for establishing both an optical connection and an electrical connection through a drape. The connection system includes, in some embodiments, a plug and a receptacle, wherein the plug is configured to insert into the receptacle with the drape therebetween. The plug includes a plug housing, an optical terminal extending from the plug housing, and an electrical terminal extending from the plug housing. The optical terminal includes an optical fiber extending from the plug housing into a ferrule. The electrical terminal is configured as a piercing element for piercing the drape. The piercing element includes a longitudinal cutout between the plug housing and a tip of the piercing element, and the optical terminal extends from the plug housing into the longitudinal cutout of the piercing element. The receptacle includes a receptacle housing, an optical receiver within the receptacle housing, and an electrical receiver within the receptacle housing. The optical receiver is configured to form the optical connection with the optical terminal when the plug is inserted into the receptacle with the drape therebetween. The optical receiver including an optical fiber disposed in a ferrule at a closed end of the optical receiver. The electrical receiver is configured to form the electrical connection with the electrical terminal when the plug is inserted into the receptacle with the drape therebetween.

In some embodiments, the electrical receiver includes a channel configured to deflect the piercing element away from a longitudinal axis of the plug or toward a longitudinal side of the plug upon inserting the plug into the receptacle. Deflecting the piercing element away from the longitudinal axis of the plug or toward the longitudinal side of the plug exposes the optical terminal for insertion into the optical receiver and formation of the optical connection.

In some embodiments, the channel of the electrical receiver is configured to keep the piercing element deflected away from the longitudinal axis or toward the longitudinal side of the plug. The channel of the electrical receiver is also configured form the electrical connection with an electrical contact within the electrical receiver upon fully inserting the plug into the receptacle.

Also disclosed herein is a method for establishing both an optical connection and an electrical connection through a drape including, in some embodiments, establishing a sterile field with the drape; piercing the drape from a sterile side thereof with an electrical terminal configured as a piercing element that extends from a plug, wherein the piercing element includes a longitudinal cutout between a housing of the plug and a tip of the piercing element in which cutout an optical terminal that extends from the plug is disposed; inserting the plug into a receptacle on a non-sterile side of the drape, wherein the receptacle includes an optical receiver and an electrical receiver within a receptacle housing configured to form the optical connection with the optical terminal and the electrical connection with the piercing element, respectively; and establishing both the optical and electrical connections through the drape without compromising sterility of the sterile field.

In some embodiments, piercing the drape with the piercing element simultaneously advances the optical terminal through the drape in accordance with disposition of the optical terminal in the cutout of the piercing element.

In some embodiments, inserting the plug into the receptacle includes inserting the piercing element into a channel of the electrical receiver. The channel is configured to deflect the piercing element away from a longitudinal axis of the plug or toward a longitudinal side of the plug. Deflecting the piercing element away from the longitudinal axis of the plug or toward the longitudinal side of the plug exposes the optical terminal.

In some embodiments, inserting the plug into the receptacle includes forming a butt-joint connection between a ferrule-covered portion of the optical terminal and a ferrule-covered portion of optical fiber at a closed end of the optical receiver.

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

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

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

A connection system for establishing both an optical connection and an electrical connection through a drape is disclosed herein. The connection system includes, in some embodiments, a plug and a receptacle, wherein the plug is configured to insert into the receptacle with the drape therebetween. The plug includes a plug housing, an optical terminal extending from the plug housing, and an electrical terminal extending from the plug housing. The electrical terminal is configured as a piercing element for piercing the drape. The receptacle includes a receptacle housing, an optical receiver within the receptacle housing, and an electrical receiver within the receptacle housing. The optical receiver is configured to form the optical connection with the optical terminal when the plug is inserted into the receptacle with the drape therebetween. The electrical receiver is configured to form the electrical connection with the electrical terminal when the plug is inserted into the receptacle with the drape therebetween.

These and other features of the connection system provided herein will become more apparent with reference to the accompanying drawings and the following description, which provide particular embodiments of the connection system in greater detail. For context, a medical device including a portion of a connection system is described first followed by connection systems and methods thereof.

<FIG> illustrates a CVC <NUM> including an integrated optical-fiber stylet in accordance with some embodiments.

As shown, the CVC <NUM> includes a catheter tube <NUM>, a bifurcated hub <NUM>, two extension legs <NUM>, and two Luer connectors <NUM> operably connected in the foregoing order. While not shown in <FIG>, the catheter tube <NUM> includes two catheter-tube lumens and the optical-fiber stylet disposed in a longitudinal bead of the catheter tube <NUM> such as between the two catheter-tube lumens, as extruded. (See, e.g., optical-fiber stylet <NUM> in <FIG>. ) In addition, in a same or different longitudinal bead of the catheter tube <NUM>, the CVC <NUM> can further include an electrocardiogram ("ECG") stylet. The bifurcated hub <NUM> has two hub lumens correspondingly fluidly connected to the two catheter-tube lumens. Each extension leg of the two extension legs <NUM> has an extension-leg lumen fluidly connected to a hub lumen of the two hub lumens. The CVC <NUM> further includes a stylet extension tube <NUM> extending from the bifurcated hub <NUM>. The stylet extension tube <NUM> can be a skived portion of the catheter tube <NUM> including the optical-fiber stylet or the skived portion of the catheter tube <NUM> disposed in another tube, either of which can terminate in a portion of a connection system such as a connection-system plug as shown in <FIG>.

While the CVC <NUM> is provided as a medical device including a portion of a connection system, it should be understood that any of a number of medical devices including catheters such as a PICC can include at least an optical-fiber stylet and a stylet extension tube that terminates in a portion of a connection system for interfacing the optical-fiber stylet with procedural equipment or instrumentation.

<FIG> illustrates a connection system <NUM> including a plug <NUM> and a receptacle <NUM> in accordance with some embodiments. <FIG> illustrate deflection of a piercing element <NUM> of the plug <NUM> in accordance with some embodiments.

As shown in <FIG>, the connection system <NUM>, which is configured for establishing either an optical connection through a drape <NUM> or both optical and electrical connections through the drape <NUM>, includes the plug <NUM> and the receptacle <NUM>. The plug <NUM> can be at, for example, a proximal-end portion of the stylet extension tube <NUM> of the CVC <NUM>; however, the plug <NUM> is not limited to the foregoing medical device as set forth above. From a sterile field established by the drape <NUM>, the plug <NUM> is configured to insert into the receptacle <NUM> with the drape <NUM> therebetween without compromising sterility of the sterile field.

The plug <NUM> includes a plug housing <NUM>, an optical terminal <NUM> extending from the plug housing <NUM>, and a piercing element <NUM> extending from the plug housing <NUM> for piercing the drape <NUM>. The plug housing <NUM> can be coupled to, for example, a proximal-end portion of the stylet extension tube <NUM> of the CVC <NUM>. The piercing element <NUM> can also be an electrical terminal when the ECG stylet is present, so the electrical terminal is also referenced herein by reference numeral <NUM>. The optical terminal <NUM> extends from the plug housing <NUM> into a longitudinal cutout <NUM> of the piercing element <NUM> between the plug housing <NUM> and a tip of the piercing element <NUM>. (See <FIG> for the longitudinal cutout <NUM>. ) The longitudinal cutout <NUM> protects the optical terminal <NUM> from inadvertent damage both before and while piercing the drape <NUM> with the piercing element <NUM> to establish the optical connection.

The piercing element <NUM> is configured to deflect away from a longitudinal axis of the plug <NUM> to expose the optical terminal <NUM> as shown in <FIG>. The piercing element <NUM> is additionally or alternatively configured to deflect toward one or both longitudinal sides of the plug <NUM> as shown in <FIG>.

The receptacle <NUM>, which is generic to other receptacles disclosed herein, includes a receptacle housing <NUM>. Depending upon a particular configuration of the receptacle <NUM> such as that exemplified by receptacles <NUM> and <NUM> respectively of <FIG> and <FIG> and <FIG>, the receptacle <NUM> also includes an optical receiver <NUM> or <NUM> within the receptacle housing <NUM> and an electrical receiver <NUM> or <NUM> within the receptacle housing <NUM>. (See <FIG> for the optical receiver <NUM> and electrical receiver <NUM>, and see <FIG> and <FIG> for optical receiver <NUM> and electrical receiver <NUM>. ) The optical receiver <NUM> or <NUM> is configured to form the optical connection with the optical terminal <NUM> when the plug <NUM> is inserted into the receptacle <NUM> or <NUM> with the drape <NUM> therebetween. The electrical receiver <NUM> or <NUM> is configured to form the electrical connection with the electrical terminal <NUM> when the plug <NUM> is inserted into the receptacle <NUM> or <NUM> with the drape <NUM> therebetween.

<FIG> illustrate insertion of the plug <NUM> through the drape <NUM> and into the receptacle <NUM> in accordance with some embodiments. <FIG> illustrates a cross-section of the plug <NUM> completely inserted into the receptacle <NUM> forming both optical electrical connections in accordance with some embodiments.

As shown, the receptacle <NUM> includes the optical receiver <NUM> and the electrical receiver <NUM> within the receptacle housing <NUM>. The electrical receiver <NUM> includes an electrical-receiver channel <NUM> configured to deflect the piercing element <NUM> away from the longitudinal axis of the plug <NUM> upon inserting the plug <NUM> into the receptacle <NUM>. Deflecting the piercing element <NUM> away from the longitudinal axis of the plug <NUM> exposes the optical terminal <NUM> for insertion into an optical-receiver channel <NUM> of the optical receiver <NUM> and formation of the optical connection. The electrical-receiver channel <NUM> is further configured to keep the piercing element <NUM> deflected away from the longitudinal axis of the plug <NUM> to maintain the optical connection. The electrical-receiver channel <NUM> is even further configured to form the electrical connection with an electrical contact <NUM> within the electrical receiver <NUM> such as at a bottom of the electrical receiver <NUM> upon fully inserting the plug <NUM> into the receptacle <NUM>. Likewise, the optical-receiver channel <NUM> is configured to form the optical connection with an end portion of an optical fiber <NUM> within the optical receiver <NUM> such as at a bottom of the optical receiver <NUM> upon fully inserting the plug <NUM> into the receptacle <NUM>. The electrical contact <NUM> is electrically connected (e.g., soldered) to a wire, and both the optical fiber <NUM> and the wire extend from the receptacle <NUM> in a same or different cable <NUM> as shown.

<FIG> and <FIG> illustrates insertion of the plug <NUM> through the drape <NUM> and into a receptacle <NUM> in accordance with some embodiments. Note, the plug <NUM> of <FIG> and <FIG> is that of <FIG> but rotated clockwise around the longitudinal axis of the stylet extension tube <NUM> about <NUM>°.

As shown, the receptacle <NUM> includes the optical receiver <NUM> and the electrical receiver <NUM> within the receptacle housing <NUM>. The electrical receiver <NUM> includes an electrical-receiver channel <NUM> configured to deflect the piercing element <NUM> toward the longitudinal side of the plug <NUM> upon inserting the plug <NUM> into the receptacle <NUM> and turning the plug <NUM> upon engagement with the receptacle <NUM>, for example, about a ¼ turn. Deflecting the piercing element <NUM> toward the longitudinal side of the plug <NUM> exposes the optical terminal <NUM> for insertion into an optical-receiver channel <NUM> of the optical receiver <NUM> and formation of the optical connection. The electrical-receiver channel <NUM> is further configured to keep the piercing element <NUM> deflected toward the longitudinal side of the plug <NUM> to maintain the optical connection. The electrical-receiver channel <NUM> is even further configured to form the electrical connection with an electrical contact within the electrical receiver <NUM> such as at a bottom of the electrical receiver <NUM> upon fully inserting the plug <NUM> into the receptacle <NUM>. (For an example electrical contact, see the electrical contact <NUM> of <FIG>. ) Likewise, the optical-receiver channel <NUM> is configured to form the optical connection with an end portion of an optical fiber within the optical receiver <NUM> such as at a bottom of the optical receiver <NUM> upon fully inserting the plug <NUM> into the receptacle <NUM>. (For an example optical connection, see the optical connection between the optical terminal <NUM> and the end portion of the optical fiber <NUM> in <FIG>.

<FIG> illustrates a straight sleeve-type butt-joint connection of an optical connection in accordance with some embodiments. <FIG> illustrates a tapered sleeve-type butt-joint connection of an optical connection in accordance with some embodiments.

As shown among <FIG>, <FIG>, <FIG>, the optical terminal <NUM>, which is a proximal-end portion of an optical fiber such as that of the optical-fiber stylet <NUM>, extends from the plug housing <NUM> into a ferrule 865a or 865b. The optical receiver <NUM> includes the optical fiber <NUM> disposed in a ferrule 875a or 875b at a closed end or bottom of the optical receiver <NUM>. Likewise, the optical receiver <NUM> can include the optical fiber <NUM> disposed in the ferrule 875a or 875b at a closed end or bottom of the optical receiver <NUM>. The ferrules 865a and 875a connect in a straight sleeve-type butt-joint connection for the optical connection. The ferrules 865b and 875b connect in a tapered sleeve-type butt-joint connection for the optical connection.

A method for establishing both an optical connection and an electrical connection through the drape <NUM> includes establishing a sterile field with the drape <NUM>; piercing the drape <NUM> from a sterile side thereof with the electrical terminal or piercing element <NUM> that extends from the plug <NUM>, wherein the piercing element <NUM> includes the longitudinal cutout <NUM> between the housing <NUM> of the plug <NUM> and a tip of the piercing element <NUM> in which cutout <NUM> the optical terminal <NUM> that extends from the plug <NUM> is disposed; inserting the plug <NUM> into the receptacle <NUM> or <NUM> on a non-sterile side of the drape <NUM>, wherein the receptacle <NUM> or <NUM> includes the optical receiver <NUM> or <NUM> and the electrical receiver <NUM> or <NUM> within the receptacle housing <NUM> configured to form the optical connection with the optical terminal <NUM> and the electrical connection with the piercing element <NUM>, respectively; and establishing both the optical and electrical connections through the drape <NUM> without compromising sterility of the sterile field.

Piercing the drape <NUM> with the piercing element <NUM> simultaneously advances the optical terminal <NUM> through the drape <NUM> in accordance with disposition of the optical terminal <NUM> in the longitudinal cutout <NUM> of the piercing element <NUM>.

Inserting the plug <NUM> into the receptacle <NUM> or <NUM> includes inserting the piercing element <NUM> into the electrical-receiver channel <NUM> or <NUM>. The electrical-receiver channel <NUM> or <NUM> is configured to deflect the piercing element <NUM> away from the longitudinal axis of the plug <NUM> or toward the longitudinal side of the plug <NUM>. Deflecting the piercing element <NUM> away from the longitudinal axis of the plug <NUM> or toward the longitudinal side of the plug <NUM> exposes the optical terminal <NUM>.

Inserting the plug <NUM> into the receptacle <NUM> or <NUM> includes forming a butt-joint connection between a ferrule-covered portion of the optical terminal <NUM> and a ferrule-covered portion of the optical fiber <NUM> at a closed end of the optical receiver <NUM> or <NUM>.

Claim 1:
A connection system (<NUM>) for establishing both an optical connection and an electrical connection through a drape (<NUM>), comprising:
a plug (<NUM>) including:
a plug housing (<NUM>); an optical terminal (<NUM>) extending from the plug housing (<NUM>); and
an electrical terminal extending from the plug housing (<NUM>) configured as a piercing element (<NUM>) for piercing the drape (<NUM>); and
a receptacle (<NUM>, <NUM>, <NUM>) including:
a receptacle housing (<NUM>); an optical receiver (<NUM>, <NUM>) within the receptacle housing (<NUM>) configured to form the optical connection with the optical terminal (<NUM>) when the plug (<NUM>) is inserted into the receptacle (<NUM>, <NUM>, <NUM>) with the drape therebetween; and
an electrical receiver (<NUM>, <NUM>) within the receptacle housing (<NUM>) configured to form the electrical connection with the electrical terminal (<NUM>) when the plug (<NUM>) is inserted into the receptacle (<NUM>, <NUM>, <NUM>) with the drape (<NUM>) therebetween.