Patent Application
20210249812
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.
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, 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 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 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 adjacent 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.
Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.
Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.
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.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.
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.
For example, a connection system includes, in some embodiments, a first connector (e.g., the tether connector 132 set forth below) and a second connector (e.g., the fin connector 152 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.
Additional details for the catheter-placement system 10 shown in at least FIGS. 1 and 2 can be found in U.S. Pat. No. 9,649,048, which is incorporated by reference in its entirety into this application.
While not shown in, the catheter-placement system 10, or the connection system 100 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 132 and the fin connector 152. The one or more LEDs can include an LED on the tip-location sensor 50, an LED on the tether connector 132, or both of the foregoing LEDs. Upon success in forming the one or more electrical connections between the tether connector 132 and the fin connector 152, 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 50 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 132 and the fin connector 152 even when the barrier is in place.
In view of the foregoing catheter-placement system 10, the connection system 100 includes a first connector such as the tether connector 132 and a second connector such as the fin connector 152 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 100 in the context of the catheter-placement system 10, additional details for the tether connector 132 and the fin connector 152 of the connection system 100 will now be described with the understanding the connection system 100 is not limited to the catheter-placement system 10.
Again, the connection system 100 includes a first connector such as the tether connector 132 and a second connector such as the fin connector 152, 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 132 includes a tether-connector housing 140, a slideable end piece 142, a cable 134 (i.e., the tether 134 set forth above), and at least a first piercing element 144.
The tether-connector housing 140 defines a cavity 146 configured to accept therein a top portion of the fin connector 152 and a barrier such as a drape therebetween. When present, an outwardly facing ridge 148 around an opening of the cavity 146 can be commensurate with the cavity 146 within the tether-connector housing 140 for visualization of the cavity 146 when the cavity is oriented away from a user of the tether connector 132. The tether-connector housing 140 includes a slot 150 opposite an opening of the cavity 146. The slot 150 extends at least as far toward a proximal-end portion of the tether-connector housing 140 as the pin shield 154 set forth below extends into the cavity 146 in the safety state the tether-connector housing 140. The slot 150 functions as a visual aid for visualizing the pin shield 154 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 140 can be molded from a medically acceptable polymer such as a thermoplastic.
The slideable end piece 142 is captively but slidingly disposed over a distal-end portion of the tether-connector housing 140. The slideable end piece 142 is configured to be advanced toward a proximal-end portion of the tether-connector housing 140 during a transition from the safety state to the operable state of the tether connector 132. During the transition, at least the first piercing element 144 is advanced into the cavity 146. If present, the ridge 148 provides a stop for stopping advancement of the slideable end piece 142 toward the proximal-end portion of the tether-connector housing 140. If the ridge 148 is not present, tabs in place of the ridge 148 or a distal end of the slideable end piece 142 itself provides a stop for stopping advancement of the slideable end piece 142 toward the proximal-end portion of the tether-connector housing 140.
The cable 134 extends from the slideable end piece 142. The cable has at least a first electrical lead (not shown) coupled to a distal-end portion of the slideable end piece 142. The first electrical lead is electrically connected to the first piercing element 144.
The tether connector 132 includes a pin shield 154 over at least the first piercing element 144 in the safety state as shown in
The pin shield 154 is coupled to a compression spring (not shown) disposed within the slideable end piece 142. The compression spring is configured to resist compression when the pin shield 154 is pushed into the slideable end piece 142. The compression spring is configured to extend and push the pin shield 154 back over at least the first piercing element 144 as the tether connector 132 is removed from the fin connector 152. The tether connector 132 is removed from the fin connector 152 during a transition from the operable state to the safety state.
The first piercing element 144 can be the only piercing element of the tether connector 132. In such embodiments, the first piercing element 144 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 144 into a complementary jack as the first receptacle 158 within the fin-connector housing 156 set forth below. Alternatively, the first piercing element 144 can be a tip-ring-sleeve (“TRnS”) jack plug having a needle-like tip, n ring electrical contacts with n≥1 (N), 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 144 into a complementary jack as the first receptacle 158 within the fin-connector housing 156. Each additional ring electrical contact of the first piercing element 144 when configured as a TRnS jack plug can be configured to support an additional communication channel for data transfer between the first piercing element 144 and the first receptacle 158. Whether the first piercing element 144 is a TS or TRnS jack plug, the first piercing element 144 is connected to a number of electrical leads of the cable 134 corresponding to the electrical contacts of the first piercing element 144. In a TRS jack plug, for example, the tip electrical contact is connected to the first electrical lead of the cable 134, the ring electrical contact is connected to a second electrical lead of the cable 134, and the sleeve electrical contact is connected to a third electrical lead of the cable 134.
Continuing with another embodiment in which the first piercing element 144 is the only piercing element of the tether connector 132, the first piercing element 144 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 144 into a complementary slot as the first receptacle 158 within the fin-connector housing 156. Each additional electrical contact printed on the blade-like end portion of the printed circuit board of the first piercing element 144 can be configured to support an additional communication channel for data transfer between the first piercing element 144 and the first receptacle 158. Like the TS jack plug and TRnS jack-plug embodiments of the first piercing element 144, the first piercing element 144 is also connected to a number of electrical leads of the cable 134 corresponding to the electrical contacts of the first piercing element 144 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 134.
In each of the foregoing embodiments in which the first piercing element 144 is the only piercing element of the tether connector 132, the first piercing element 144 is configured to enter the cavity 146 and pierce a barrier such as a drape when the barrier is disposed in the cavity 146 over the fin connector 152 and the slideable end piece 142 is advanced toward a proximal-end portion of the tether-connector housing 140.
The first piercing element 144 can be one of a number of piercing elements such as the three piercing elements shown in
The fin connector 152 includes a fin-connector housing 156 and at least a first receptacle 158 within the fin-connector housing 156. The fin-connector housing 156 can be molded from a medically acceptable polymer such as a thermoplastic.
The first receptacle 158 can be the only receptacle of the fin connector 152. In such embodiments, the first receptacle 158 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 144 when configured as a jack plug. In other embodiments, the first receptacle 158 can be a slot having complementary electrical contacts to the first piercing element 144 when configured as a blade-like end portion of a printed circuit board. Thus, the first receptacle 158 is configured to form at least a first electrical connection of the one or more electrical connections with the first piercing element 144 when the tether connector 132 is disposed over the fin connector 152 and the transition from the safety state to the operable state of the tether connector 132 is complete.
The first receptacle 158 can be one of a number of receptacles such as the three receptacles shown in
Minor sides of each housing of the tether-connector housing 140 and the fin-connector housing 156 are dissimilar. As shown in
An example method for establishing one or more electrical connections through a barrier such as a drape with the connection system 100 includes a placing step of placing the barrier over the fin connector 152 of the connection system 100.
The method also includes an aligning step of aligning the tether connector 132 of the connection system 100 with the fin connector 152. The aligning step can include matching each minor side of the minor sides of the tether-connector housing 140 with a matching minor side of the minor sides of the fin-connector housing 156. This enforces a single orientation of the tether connector 132 to the fin connector 152.
The method also includes a disposing step of disposing the tether connector 132 over the fin connector 152 with the barrier in the cavity 146 between the tether connector 132 and the fin connector 152. When the barrier is a drape, the drape self-tightens over the fin connector 152 during the disposing step. The disposing step includes using an obliquely downward motion to push the pin shield 154 disposed over at least the first piercing element 144 into the slideable end piece 142 with a portion of the fin-connector housing 156. The portion of the fin-connector housing 156 can be a top portion of the flat minor side of the fin-connector 156 set forth above.
The method also includes a sliding step of sliding the slideable end piece 142 toward the proximal-end portion of the tether-connector housing 140 to complete the transition from the safety state to the operable state of the tether connector 132. At least the first piercing element 144 of the tether connector 132 pierces a sterile side of the barrier and enters at least the first receptacle 158 within the fin-connector housing 156 during the sliding. Piercing the sterile side of the barrier with the first piercing element 144 can include simultaneously piercing the sterile side of the barrier in two other locations with the second piercing element 143 and the third piercing adjacent 145 in embodiments have the second and third piercing elements 143 and 145.
The method can also include a visualizing step of visualizing the pin shield 154 being pushed into the slideable end piece 142 through the slot 150 of the tether-connector housing 140.
The method also includes a forming step of forming the one or more electrical connections between the first piercing element of the tether connector 132 and the first receptacle of the fin connector 152 at a time of completing the transition from the safety state to the operable state of the tether connector 132.
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 132 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 130 in the catheter 72, wherein the tether connector 132 is coupled to the stylet 130.
The method can also include a sensing step of sensing a location of the distal tip 76 of the catheter 72 in a patient, wherein the fin connector 152 is part of the tip-location sensor 50 on a chest of the patient under the barrier.
While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.
This application is a continuation of U.S. patent application Ser. No. 16/598,952, filed Oct. 10, 2019, now U.S. Pat. No. 10,992,079, which claims the benefit of priority to U.S. Provisional Application No. 62/746,450, filed Oct. 16, 2018, each of which is incorporated by reference in its entirety into this application.
| Number | Date | Country | |
|---|---|---|---|
| 62746450 | Oct 2018 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16598952 | Oct 2019 | US |
| Child | 17240894 | US |
