Connection system, connection establishment device and method thereof

Abstract

The present application relates to a connection system, a connection establishing device and a method thereof. For example, the connection establishing device can include a cap and an extension arm. The cap is configured to be positioned over a protruding portion of a first medical device, wherein a surgical barrier is positioned between the connection establishing device and the first medical device. The extension arm is configured to push a male connector of a second medical device through the surgical barrier and into a female connector of the first medical device having the extension arm, which establishes one or more functional connections through the surgical barrier between the second medical device and the first medical device. An exemplary method for the connection establishing device includes a cap placement step, a hinging step, and a functional connection establishment step for establishing the one or more functional connections.

Description

[0001] Priority

[0002] This application claims priority to U.S. Provisional Application No. 63 / 106,809, filed October 28, 2020, the entire contents of which are incorporated herein by reference. TECHNICAL FIELD

[0003] The present application relates to the field of medical devices, and more particularly to a connection system, a connection establishment device, and methods thereof. BACKGROUND

[0004] A surgical area having one or more surgical barriers is typically established around a patient prior to a medical procedure. For example, a sterile field can be established over or around a patient by covering the patient with sterile drapes. Often, a medical procedure requires a multi-use medical device that cannot be sterilized, which requires that such medical device be placed under the sterile drape; however, a sterile single-use medical device often needs to be functionally connected to the multi-use medical device. Some existing solutions rely on arbitrarily breaking the sterile drape to make a functional connection between the sterile single-use medical device and the multi-use medical device. But arbitrarily breaking such sterile drape risks contaminating the sterile field that is carefully established around the patient. That, and establishing some functional connections (e.g., optical connections) between the sterile single-use medical device and the multi-use medical device can be difficult, especially through an arbitrarily, self-formed aperture in the sterile drape. What is needed is a surgical barrier breach connector and a connection establishment device for establishing a secure, routine functional connection between a sterile single-use medical device and a multi-use medical device.

[0005] Disclosed herein are surgical barrier breach connectors and connection establishment devices, and systems and methods thereof, for establishing an entry in a surgical barrier. SUMMARY

[0006] Disclosed herein is a connection system, which in some embodiments includes a male connector and a female connector. The male connector includes a base, an external thread around the base, and opposing wings around a portion of the base. The base includes a longitudinal through-hole having a terminal opening configured to hold a ferrule including an optical fiber in the base. The wings oppose the terminal opening. The wings are configured for hand-turning the male connector along a longitudinal axis of the male connector. The female connector includes a receiver and an internal thread around the receiver. The receiver includes a longitudinal through-hole having an internal opening configured to hold another ferrule including another optical fiber therein. The internal thread around the receiver is complementary to the external thread of the male connector. The male connector and the female connector are configured to establish an optical connection between the optical fiber of the male connector and the another optical fiber of the female connector when the optical fiber and the another optical fiber are held in the male connector and the female connector, respectively.

[0007] In some embodiments, the external thread around the base of the male connector and the internal thread around the receiver of the female connector are electrically conductive. The male connector and the female connector are configured to establish an electrical connection between a wire of the male connector and another wire of the female connector when the wire and the another wire are held in the male connector and the female connector, respectively, and connected to the internal thread and the external thread.

[0008] In some embodiments, the external thread around the base of the male connector includes a cutting edge configured to cut through a surgical barrier when the male connector is placed against the surgical barrier and turned along the longitudinal axis of the male connector by hand.

[0009] In some embodiments, the base of the male connector and the receiver of the female connector are complementarily tapered.

[0010] Also disclosed herein is a connection system, which in some embodiments includes a male connector and a female connector. The male connector includes two or more prongs and a fiber holder. The two or more prongs extend to a common terminal end of the male connector. The fiber holder is along a longitudinal axis of the male connector between the two or more prongs and does not reach the common terminal end. The fiber holder is configured to hold a ferrule including an optical fiber therein. The female connector includes two or more prong receivers and a fiber receiver. The two or more prong receivers correspond in number to the two or more prongs and extend to a common terminal end of the female connector. The fiber receiver is along a longitudinal axis of the female connector between the two or more prong receivers and commensurate with the common terminal end of the female connector. The fiber receiver is configured to hold another ferrule including another optical fiber therein. The male connector and the female connector are configured to establish an optical connection between the optical fiber of the male connector and the another optical fiber of the female connector when the optical fiber and the another optical fiber are held in the male connector and the female connector, respectively.

[0011] In some embodiments, two or more pins of the male connector and two or more contacts respectively disposed within two or more pin receivers of the female connector are conductive. The male and female connectors are configured to establish an electrical connection between the lead of the male connector and the other lead of the female connector when the lead of the male connector is connected to two or more pins of the male connector and the other lead of the female connector is connected to two or more contacts of the female connector, respectively.

[0012] In some implementations, each of the two or more pins of the male connector includes a cutting edge configured to cut through the surgical barrier when the male connector is placed against the surgical barrier and pushed through the surgical barrier by hand.

[0013] This document also discloses a connection system including a male connector and a female connector. The male connector includes a sleeve, a cut edge surrounding a main opening of the sleeve, and a plug. The sleeve has a through-hole configured to allow a cable including an optical fiber to be slidably disposed within the sleeve. The cut edge is opposite to the through-hole. The cut edge is configured to cut through the surgical barrier when the sleeve is placed against a surgical barrier and rotated by hand along the longitudinal axis of the sleeve. The plug is configured to be disposed above the cable or ferrule surrounding the optical fiber. The plug is configured to prevent the cable from sliding through the through-hole. The female connector includes an optical fiber receiver. The optical fiber receiver includes a longitudinal through-hole having an internal opening configured to retain another ferrule including another optical fiber within the optical fiber receiver. The male and female connectors are configured to establish an optical connection between the optical fiber of the male connector and the other optical fiber of the female connector when the optical fiber of the male connector and the other optical fiber of the female connector are respectively retained within the male and female connectors.

[0014] In some implementations, the male connector's sleeve has internal threads surrounding the inside of the sleeve, and the female connector has complementary external threads surrounding the outside of the fiber optic receiver. The internal threads of the male connector and the external threads of the female connector are configured to screw the male and female connectors together.

[0015] This document also discloses a connection system including a male connector and a female connector. The male connector includes a head, a splittable shank extending from the head, and a helical cut edge surrounding the splittable shank. The head has a through-hole configured to allow a cable including an optical fiber to be slidably disposed within the head. The splittable shank is configured to split along its length to allow a ferrule containing the optical fiber of the cable to be pushed past the end of the male connector. The helical cut edge is configured to cut through the surgical barrier when the male connector is placed against a surgical barrier and rotated by hand along its longitudinal axis. The female connector includes an optical fiber receiver. The optical fiber receiver includes a longitudinal through-hole having an internal opening configured to retain another ferrule including another optical fiber within the optical fiber receiver. The male and female connectors are configured to establish an optical connection between the optical fiber of the male connector and the other optical fiber of the female connector when the optical fiber of the male connector and the other optical fiber of the female connector are respectively retained within the male and female connectors.

[0016] In some implementations, the splittable rod is configured to split within the fiber optic receiver to allow a ferrule containing the fiber optic cable to be pushed past the end of the male connector.

[0017] This document also discloses a connection establishment device, which in some embodiments includes a cap and an extension arm. The cap is configured to be located above a protruding portion of a first medical device, wherein a surgical barrier is located between the connection establishment device and the first medical device. The extension arm is connected to the cap via a hinge pin. The extension arm is configured to establish one or more functional connections between a second medical device on the clinician-facing side of the surgical barrier and a first medical device on the patient-facing side of the surgical barrier by hinged extension arm and passing through the surgical barrier, while pushing the male connector of the second medical device through the surgical barrier and into the female connector of the first medical device.

[0018] This document also discloses a connection establishment device, which in some embodiments includes a cap, a clamping ring (bail wire) coupled to the cap, and an extension arm coupled to the cap. The cap is configured to be positioned above a protrusion of a first medical device, wherein a surgical barrier is located between the connection establishment device and the first medical device. The clamping ring is coupled to the cap via an end of the clamping ring in a hole in the cap. The clamping ring is configured to secure the cap above the protrusion of the first medical device via a hinge mechanism. The extension arm is coupled to the cap via a hinge pin. The extension arm is configured to push a male connector of a second medical device through the surgical barrier and into a female connector of the first medical device via the hinged extension arm. Thus, the extension arm is configured to establish one or more functional connections through the surgical barrier between the second medical device on the clinician-facing side of the surgical barrier and the first medical device on the patient-facing side of the surgical barrier.

[0019] This document also discloses a method for connecting a system, including a connector placement step, a connector rotation step, and an optical connection establishment step. The connector placement step includes placing the bottom of the male connector base into the top of the female connector receiver, with a surgical barrier between the bottom of the male connector base and the top of the female connector receiver. The connector rotation step includes rotating the male connector by hand along its longitudinal axis around a portion of the base opposite the bottom of the base, while placing the male connector against a surgical drape. The connector rotation step also includes cutting through the surgical barrier with external threads around the base of the male connector, which has a cutting edge. The optical connection establishment step includes establishing an optical connection between an optical fiber disposed in an end opening in the bottom of the male connector and another optical fiber disposed in an inner opening of the female connector, the optical fiber and the other optical fiber being held in the male connector and female connector, respectively.

[0020] In some embodiments, the method further includes an electrical connection establishment step. This step involves establishing an electrical connection between a lead of the male connector and another lead of the female connector. The lead and the other lead are respectively connected to the external threads of the male connector and the complementary internal threads around the receiver of the female connector.

[0021] This document also discloses a method for connecting a system, which in some embodiments includes a connector placement step, a connector pushing step, and an optical connection establishment step. The connector placement step includes placing two or more pins of a male connector against a surgical barrier. The connector pushing step includes pushing two or more pins through the surgical barrier into two or more pin receivers of a female connector, the two or more pin receivers of the female connector corresponding in number to the two or more pins of the male connector. The connector pushing step further includes cutting through the surgical barrier with a cutting edge of each of the two or more pins of the male connector. The optical connection establishment step includes establishing an optical connection between an optical fiber arranged in an optical fiber retainer along the longitudinal axis of the male connector between the two or more pins and another optical fiber arranged in an optical fiber receiver along the longitudinal axis of the female connector between the two or more pin receivers.

[0022] In some embodiments, the method further includes an electrical connection establishment step. The electrical connection establishment step includes establishing an electrical connection between a wire coupled to two or more pins of the male connector and another wire coupled to two or more contacts respectively disposed within two or more pin receivers of the female connector.

[0023] This document also discloses a method for connecting a system, which in some embodiments includes a connector placement step, a connector rotation step, and a cable sliding step. The connector placement step includes, with a surgical barrier between the bottom of the male connector sleeve and the top of the female connector receiver, placing the bottom of the male connector sleeve above the top of the female connector receiver. The connector rotation step includes, while placing the male connector against the surgical drape, manually rotating the male connector along the longitudinal axis of the sleeve. The connector rotation step also includes cutting through the surgical barrier with a cutting edge around the main opening of the sleeve opposite the through-hole. The cable sliding step includes sliding a cable including an optical fiber through the through-hole opposite the bottom of the male connector sleeve into the female connector receiver. The cable sliding step also includes establishing an optical connection between the optical fiber and another optical fiber disposed in the female connector receiver.

[0024] In some implementations, the male connector sleeve has an internal thread surrounding the inside of the sleeve, and the female connector has a complementary external thread surrounding the outside of the fiber optic receiver, for screwing the male and female connectors together after cutting the surgical drape during the connector rotation step.

[0025] This document also discloses a method for connecting a system, which in some embodiments includes a connector placement step, a connector rotation step, a connector insertion step, and a cable sliding step. The connector placement step includes placing the helical cut edge of the splittable shank of the male connector over the longitudinal through-hole of the receiver of the female connector, provided a surgical barrier exists between the helical cut edge of the splittable shank of the male connector and the longitudinal through-hole of the receiver of the female connector. The connector rotation step includes manually rotating the male connector along its longitudinal axis while it is placed against a surgical drape. The connector rotation step also includes cutting through the surgical barrier with the cut edge of the splittable shank. The connector insertion step includes inserting the splittable shank into the longitudinal through-hole of the receiver of the female connector and splitting the splittable shank along its length. The cable sliding step includes sliding a cable including an optical fiber through a through-hole in the head of the male connector opposite the splittable shank into the receiver of the female connector. The cable sliding step also includes establishing an optical connection between the optical fiber and another optical fiber disposed in the receiver of the female connector.

[0026] This document also discloses a method for establishing a connection, in some embodiments of which the method includes a cap placement step, a hinge step, and a functional connection establishment step. The cap placement step includes placing a cap over a protrusion of a first medical device, wherein a surgical barrier is present between the connection establishment device and the first medical device. The hinge step includes hinged via a hinge pin to an extension arm of the cap to push a male connector of a second medical device through the surgical barrier and into a female connector of the first medical device. The functional connection establishment step includes establishing one or more functional connections through the surgical barrier between the second medical device on the clinician-facing side of the surgical barrier and the first medical device on the patient-facing side of the surgical barrier.

[0027] This document also discloses a method for establishing a connection, which in some embodiments includes a cap placement step, a fixing step, a hinge step, and a functional connection establishment step. The cap placement step includes placing a cap over a protrusion of a first medical device, wherein a surgical barrier exists between the connection establishment device and the first medical device. The fixing step includes fixing the cap over the protrusion of the first medical device via a hinge mechanism of a locking ring, the hinge mechanism being coupled to the cap through an end of a locking ring in a hole in the cap. The hinge step includes hinged via a hinge pin coupled to an extension arm of the cap to push a male connector of a second medical device through the surgical barrier and into a female connector of the first medical device. The functional connection establishment step includes establishing one or more functional connections between the second medical device on the clinician-facing side of the surgical barrier and the first medical device on the patient-facing side of the surgical barrier.

[0028] These and other features of the concept provided herein will become more apparent to those skilled in the art in view of the accompanying drawings and the following description, which describe in more detail specific embodiments of such a concept. Attached Figure Description

[0029] Figure 1 A single-use medical device and a multiple-use medical device are shown in connection with an optical shape sensing system according to some embodiments.

[0030] Figure 2 A first connection system according to some implementation schemes is shown.

[0031] Figure 3 A first view of a second connection system according to some implementation schemes is shown.

[0032] Figure 4 A second view of a second connection system according to some implementation schemes is shown.

[0033] Figure 5 A first view of a third connection system according to some implementation schemes is shown.

[0034] Figure 6 A second view of a third connection system according to some implementation schemes is shown.

[0035] Figure 7 A male connector of a third connection system according to some embodiments is shown.

[0036] Figure 8 The following are examples of implementation schemes when the subject is... Figure 5 The gap in the surgical barrier when the male connector is damaged.

[0037] Figure 9 A first view of a fourth connection system according to some implementation schemes is shown.

[0038] Figure 10 A second view of a fourth connection system according to some implementation schemes is shown.

[0039] Figure 11 A male connector of a fourth connection system according to some embodiments is shown.

[0040] Figure 12 A first connection establishment device according to some embodiments is shown.

[0041] Figure 13 A second connection establishment device according to some embodiments is shown.

[0042] Figure 14 A third connection establishment device according to some implementation schemes is shown.

[0043] Figure 15 A fourth connection establishment device according to some implementation schemes is shown. Detailed Implementation

[0044] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that allow them to be readily separable from the specific embodiments and optionally combined with or substituted for features of any of the many other embodiments disclosed herein.

[0045] Regarding the terminology used herein, it should also be understood that these terms are for the purpose of describing certain specific embodiments, and that these terms do not limit the scope of the concepts presented herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a set of features or steps, and do not provide for any order or numerical limitation. For example, the features or steps “first,” “second,” and “third” do not need to appear in that order, and a particular embodiment including such features or steps does not need to be limited to three features or steps. For convenience, labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” etc., are used, and these labels are not intended to imply, for example, any particular fixed position, orientation, or direction. Rather, such labels are used to reflect, for example, relative position, orientation, or direction. The singular forms “a,” “an,” and “the” include plural references unless the context clearly indicates otherwise.

[0046] Regarding terms like "proximal," "proximal portion," or "proximal section" of a catheter, these terms include the portion of the catheter intended to be close to the clinician when used with the patient. Similarly, "proximal length" of a catheter includes the length of the catheter intended to be close to the clinician when used with the patient. For example, "proximal end" of a catheter includes the end of the catheter intended to be close to the clinician when used with the patient. A proximal portion, proximal section, or proximal length of a catheter may include the proximal end of the catheter; however, a proximal portion, proximal section, or proximal length of a catheter does not necessarily need to include the proximal end of the catheter. That is, unless the context otherwise suggests, a proximal portion, proximal section, or proximal length of a catheter is not the distal portion or distal length of the catheter.

[0047] Regarding terms like "distal," "distal portion," or "distal part" of a catheter, these terms include the portion of the catheter intended to be close to or within the patient when used with the catheter. Similarly, "distal length" of a catheter includes the length of the catheter intended to be close to or within the patient when used with the catheter. For example, "distal end" of a catheter includes the tip of the catheter intended to be close to or within the patient when used with the catheter. A distal portion, distal part, or distal length of a catheter may include the distal end of the catheter; however, a distal portion, distal part, or distal length of a catheter does not necessarily need to include the distal end of the catheter. That is, unless the context otherwise suggests, a distal portion, distal part, or distal length of a catheter is not the distal portion or distal length of the catheter.

[0048] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0049] Figure 1 A single-use medical device and a multiple-use medical device are shown in connection with an optical shape sensing system according to some embodiments.

[0050] As mentioned above, medical procedures often require reusable medical devices that cannot be sterilized, necessitating their placement under sterile drapes; however, sterile single-use medical devices typically need to be functionally connected to reusable devices. In fact, as shown in the figure, Figure 1 The optical shape sensing system includes a single-use peripherally inserted central catheter (“PICC”) 10 with an optical fiber probe 12 disposed in an extension tube 14, which is functionally connected to a relay module 16 located above the patient P but outside the sterile area, beneath a sterile drape 18. The relay module 16 further includes an optical fiber 20 disposed in a connector cable 22, which is functionally connected to a console 24 or its optical interrogator, also outside the sterile area. Similarly, some existing solutions rely on arbitrarily breaking the sterile drape (e.g., sterile drape 18) to establish a functional connection between a sterile single-use medical device (e.g., PICC 10) and a reusable medical device (e.g., relay module 16, console 24, etc.). However, arbitrarily breaking such a sterile drape carries the risk of contaminating the carefully established sterile area around the patient. Establishing functional connections (e.g., optical connections) between sterile single-use and reusable medical devices can be difficult, especially through arbitrary, self-formed gaps in the sterile drape. What is needed is a surgical barrier disruption connector and a connection establishment device for establishing a safe, routine, and functional connection between sterile single-use medical devices and multiple-use medical devices.

[0051] This article discloses a surgical barrier disruption connector and connection establishment device, system, and method for establishing an entry point in a surgical barrier.

[0052] Figure 2 A first connection system 200 according to some implementation schemes is shown.

[0053] As shown in the figure, the connection system 200 includes a male connector 202 and a female connector 204.

[0054] The male connector includes a base 206, an external thread 208 surrounding the base 206, and opposing wings 210 surrounding a portion of the base 206. The base 206 includes a longitudinal through-hole having an end opening configured to hold a ferrule therein comprising an optical fiber, such as the optical fiber of the optical fiber probe 12 shown. The external thread 208 surrounding the base 206 of the male connector 202 includes a cutting edge configured to cut through a surgical barrier, such as a sterile drape 18, when the male connector 202 is held against a surgical barrier and rotated manually along its longitudinal axis, for example, when the receiver 212 of the female connector 204 is pressed in and the surgical barrier is located therebetween. The wings 210 are opposite the end opening. The wings 210 are configured for manually rotating the male connector 202 along its longitudinal axis.

[0055] The female connector 204 includes a receiver 212 and an internal thread 214 surrounding the receiver 212. The receiver 212 includes a longitudinal through-hole having an internal opening (e.g., leading to a relay 16) configured to hold another ferrule therein, which includes another optical fiber, such as optical fiber 20. The receiver 212 of the female connector 204 and the base 206 of the male connector 202 are complementaryly tapered. Additionally, the internal thread 214 around the receiver 212 is complementary to the external thread 208 of the male connector 202.

[0056] The male connector 202 and the female connector 204 are configured to establish an optical connection between the optical fiber and the other optical fiber when the optical fiber of the male connector 202 and the other optical fiber of the female connector 204 are respectively held in the male connector 202 and the female connector 204.

[0057] The external thread 208 surrounding the base 206 of the male connector 202 and the internal thread 214 surrounding the receiver 212 of the female connector 204 are conductive. The male connector 202 and the female connector 204 are configured to establish an electrical connection between the lead of the male connector 202 and the other lead of the female connector 204 when the lead of the male connector 202 and the other lead of the female connector 204 are respectively held in the male connector 202 and the female connector 204 and connected to the external thread 208 and the internal thread 214.

[0058] Figure 3 and Figure 4 Different views of a second connection system 300 according to some implementation schemes are shown.

[0059] As shown in the figure, the connection system 300 includes a male connector 302 and a female connector 304.

[0060] The male connector 302 includes two or more pins 306 and an optical fiber retainer 308. The two or more pins 306 extend to a common end of the male connector 302. Each of the two or more pins 306 of the male connector 302 includes a cut edge configured to cut through a surgical barrier, such as a sterile drape 18, when the male connector 302 is held against a surgical barrier and manually pushed through the surgical barrier, for example, when pressed into the receiver 310 of the female connector 304 with the surgical barrier between them. The optical fiber retainer 308 lies between the two or more pins 306 along the longitudinal axis of the male connector 302 and does not reach the common end. The optical fiber retainer 306 is configured to retain a ferrule containing an optical fiber, such as the optical fiber of the optical fiber probe 12 shown.

[0061] The female connector 302 includes two or more pin receivers 310 and an optical fiber receiver 312. The two or more pin receivers 310 correspond in number to two or more pins 306 and extend to the common end of the female connector 304. The optical fiber receiver 312 is positioned between the two or more pin receivers 310 along the longitudinal axis of the female connector 304 and corresponds to the common end of the female connector 304. The optical fiber receiver 312 is configured to hold an additional ferrule therein, which includes another optical fiber, such as optical fiber 20.

[0062] The male connector 302 and the female connector 304 are configured to establish an optical connection between the optical fiber and the other optical fiber when the optical fiber of the male connector 302 and the other optical fiber of the female connector 304 are respectively held in the male connector 302 and the female connector 304.

[0063] Two or more pins 306 of the male connector 302 and two or more contacts respectively disposed within two or more pin receivers 310 of the female connector 304 are conductive. The male connector 302 and the female connector 304 are configured to establish an electrical connection between the wire and the other wire when a wire of the male connector 302 and another wire of the female connector 304 are respectively connected to two or more pins 306 of the male connector 302 and two or more contacts of the female connector 304.

[0064] Figure 5 and Figure 6 Different views of a third connection system 500 according to some implementation schemes are shown. Figure 7 A male connector 502 of a third connection system 500 according to some embodiments is shown. Figure 8 The following are examples of implementation schemes when the subject is... Figure 7 The male connector is damaged when there is a gap in the surgical barrier (e.g., sterile barrier 18). It should be understood that, althoughFigure 5 and Figure 6 The male connector 502 looks similar to Figure 7 The male connector 502 may differ from the female connector 504 described below, but the male connector 502 may be any form complementary to the female connector 504.

[0065] As shown in the figure, the connection system 500 includes a male connector 502 and a female connector 504.

[0066] The male connector 502 includes a sleeve 506, a cut edge 508 surrounding a main opening of the sleeve 506, and a plug 510 (e.g., an "O" ring). The sleeve 506 has a through-hole 512 configured to allow a cable (e.g., extension tube 14) including an optical fiber (e.g., the optical fiber of the optical fiber probe 12) to be slidably disposed in the through-hole so that the cable slides into the sleeve 506 to cut through a surgical barrier (e.g., sterile drape 18) or out of the main opening at the end of the male connector 502, and through a hole cut in the surgical drape (see...). Figure 8 This is used to form at least an optical connection. A cutting edge 508 is opposite to a through-hole 512. The cutting edge 508 is configured to cut through the surgical barrier when the sleeve 506 is held against the surgical barrier and rotated by hand along the longitudinal axis of the sleeve 506. Notably, the through-hole 512 of the sleeve 506 is also configured to allow a cable to be rotatably disposed therein for rotating the sleeve 506 and cutting through the surgical barrier with the cutting edge 508 without twisting the cable. A plug 510 is configured to be disposed above the cable or a ferrule surrounding the optical fiber to prevent the cable from sliding through the through-hole when the cable is slid into the sleeve 506 to cut through the surgical barrier.

[0067] The female connector 504 includes an optical fiber receiver 514. The optical fiber receiver 514 includes a longitudinal through-hole having an internal opening configured to hold another ferrule, including another optical fiber such as optical fiber 20, therein.

[0068] The male connector 502 and the female connector 504 are configured to establish an optical connection between the optical fiber and the other optical fiber when the optical fiber of the male connector 502 and the other optical fiber of the female connector 504 are respectively held in the male connector 502 and the female connector 504.

[0069] Optionally, the male connector 502 and the female connector 504 may include complementary threads. Specifically, the sleeve 506 of the male connector 502 may have an internal thread 516 surrounding the interior of the sleeve 506, and the female connector 504 may have complementary external threads 518 surrounding the exterior of the fiber optic receiver 514. The internal thread 516 of the male connector 502 and the external thread 518 of the female connector 504 are configured to screw the male connector 502 and the female connector 504 together.

[0070] Figure 9 and Figure 10 Different views of a fourth connection system 900 according to some implementation schemes are shown. Figure 9 A male connector 902 of a fourth connection system 900 according to some embodiments is shown.

[0071] As shown in the figure, the connection system 900 includes a male connector 902 and a female connector 904.

[0072] The male connector 902 includes a head 906, a splittable shank 908 extending from the head 906, and a helical cut edge 910 surrounding the splittable shank 908. The head 906 has a through-hole 912 configured to allow a cable (e.g., extension tube 14) including an optical fiber (e.g., the optical fiber of optical fiber probe 12) to be slidably disposed therein for sliding the cable out of the splittable shank 908 to form at least one optical connection. The splittable shank 908 is configured to split along its length to allow a ferrule including the optical fiber of the cable to be pushed past the end of the male connector 902. The helical cut edge 910 is configured to cut through a surgical barrier (e.g., sterile drape 18) when the male connector 902 is held against a surgical barrier and rotated by hand along its longitudinal axis.

[0073] The female connector 904 includes an optical fiber receiver 914. The optical fiber receiver 914 includes a longitudinal through-hole with an internal opening configured to hold another ferrule containing another optical fiber (e.g., optical fiber 20). The optical fiber receiver 914 is configured to split the splittable rod 908 when inserted therein, which in turn allows the ferrule containing the cable optical fiber to be pushed past the end of the male connector 902 to establish at least an optical connection with the female connector 904. In practice, the male connector 902 and the female connector 904 are configured to establish an optical connection between the optical fiber and the other optical fiber when the optical fiber of the male connector 902 and the other optical fiber of the female connector 904 are held in the male connector 902 and the female connector 904, respectively.

[0074] Figure 12 , Figure 13 and Figure 14 A first connection establishment device 1200, a second connection establishment device 1300, and a third connection establishment device 1400 according to some embodiments are shown respectively.

[0075] As shown in the figure, the connection establishment device 1200, 1300, or 1400 includes a cap 1202, 1302, or 1402 and an extension arm 1204, 1304, or 1404. The cap 1202, 1302, or 1402 is configured to be located above a protrusion 26 of, for example, a reusable medical device (e.g., relay module 16), providing a surgical barrier (e.g., a sterile drape 18) between the connection establishment device 1200, 1302, or 1400 and the reusable medical device. The extension arm 1204, 1304, or 1404 is connected to the cap 1202, 1302, or 1402 via a hinge pin 1206, 1306, or 1406. Extension arms 1204 or 1304 are configured to push the male connector (e.g., male connector 202 or 302) of a single-use medical device (e.g., PICC 10) through the surgical barrier and into the female connector (e.g., female connector 204 or 304) of a reusable medical device, while extension arm 1404 is configured to push a punch 1407, which includes an alternative male connector, through the surgical barrier and into the alternative female connector. In any case, by hinged extension arms 1204, 1304, or 1404, one or more functional connections (e.g., optical connections, electrical connections, or optical and electrical connections) are established between the single-use medical device on the clinician-facing side of the surgical barrier and the reusable medical device on the patient-facing side of the surgical barrier.

[0076] Advantageously, the connection establishment device 1200, 1300 or 1400 utilizes mechanical advantages to reduce the force required to make the one or more functional connections through the surgical barrier.

[0077] Figure 15 A fourth connection establishment device 1500 according to some embodiments is shown.

[0078] As shown in the figure, the connection establishment device 1500 includes a cap 1502, a locking ring 1504 connected to the cap 1502, and an extension arm 1506 connected to the cap 1502. The cap 1502 is configured to be positioned above the protrusion 26 of, for example, the reusable medical device described above, providing the same surgical barrier between the connection establishment device 1500 and the reusable medical device. The locking ring 1504 is connected to the cap 1502 via its end located in a hole in the cap 1502. The locking ring 1504 is configured to secure the cap 1502 above the protrusion 26 of the medical device via a hinge mechanism. The extension arm 1506 is connected to the cap 1502 via a hinge pin 1508. The extension arm 1506 is configured to, via a hinged extension arm 1506, push the male connector (e.g., male connector 202 or 302) of a single-use medical device (e.g., PICC 10) through the surgical barrier and into the female connector (e.g., female connector 204 or 304) of a reusable medical device. The extension arm 1506 is thus configured to establish one or more functional connections (e.g., optical connections, electrical connections, or both) between the single-use medical device on the clinician-facing side of the surgical barrier and the reusable medical device on the patient-facing side of the surgical barrier.

[0079] Advantageously, the connection establishment device 1500 utilizes mechanical advantages to reduce the force required to make the one or more functional connections through the surgical barrier.

[0080] method

[0081] The methods include the use of the surgical barrier disruption connector and connection establishment device described above, as well as the system thereof.

[0082] Reference is made to a first connection system 200 according to some embodiments. Figure 2 The method for connecting system 200 includes a connector placement step, a connector rotation step, and an optical connection establishment step.

[0083] The connector placement step includes placing the bottom of the base 206 of the male connector 202 on top of the receiver 212 of the female connector 204, with a surgical barrier (e.g., sterile drape 18) between the bottom of the base of the male connector and the top of the receiver of the female connector.

[0084] The connector rotation step includes manually rotating the male connector 204 along its longitudinal axis around a portion of the base 206 opposite the bottom of the base 206 via the opposing wing 210, while positioning the male connector 202 against the surgical drape. The connector rotation step also includes cutting through the surgical barrier with the external thread 208 around the base 206 of the male connector 204, which has a cut edge.

[0085] The optical connection establishment step includes establishing an optical connection between an optical fiber (e.g., the optical fiber of the optical fiber probe 12) disposed in the end opening at the bottom of the male connector 202 and another optical fiber (e.g., optical fiber 20) disposed in the inner opening of the female connector 204, wherein the optical fiber and the other optical fiber are respectively held in the male connector 202 and the female connector 204.

[0086] The method may also include an electrical connection establishment step. This step involves establishing an electrical connection between a conductor of the male connector 202 and another conductor of the female connector 204. This conductor and the other conductor are respectively connected to the external thread 208 of the male connector 202 and the complementary internal thread 214 around the receiver 212 of the female connector 204.

[0087] Reference is made to show different views of a second connection system 300 according to some embodiments. Figure 3 and Figure 4 The method for connecting system 300 includes a connector placement step, a connector pushing step, and an optical connection establishment step.

[0088] The connector placement step includes placing two or more pins 306 of the male connector 302 against a surgical barrier (e.g., sterile drape 18).

[0089] The connector pushing step includes pushing two or more pins 306 through the surgical barrier into two or more pin receivers 310 of the female connector 304, the two or more pin receivers 310 of the female connector corresponding in number to the two or more pins 306 of the male connector 302. The connector pushing step also includes cutting through the surgical barrier with a cutting edge of each of the two or more pins 306 of the male connector 302.

[0090] The optical connection establishment step includes establishing an optical connection between an optical fiber (e.g., the optical fiber of the optical fiber probe 12) arranged in the optical fiber retainer 308 along the longitudinal axis of the male connector 302 between two or more pins 306 and another optical fiber (e.g., optical fiber 20) arranged in the optical fiber receiver 312 along the longitudinal axis of the female connector 304 between two or more pin receivers 310.

[0091] The method also includes an electrical connection establishment step. The electrical connection establishment step includes establishing an electrical connection between a wire connected to two or more pins 306 of the male connector 302 and another wire connected to two or more contacts respectively arranged in two or more pin receivers 310 of the female connector 304.

[0092] same, Figure 5 and Figure 6Different views of a third connection system 500 according to some embodiments are shown; Figure 7 A male connector 502 of a third connection system 500 according to some embodiments is shown; and Figure 8 The following are examples of implementation schemes when the subject is... Figure 7 The male connector 502 is damaged when there is a gap in the surgical barrier. The method of connecting the system 500 includes a connector placement step, a connector rotation step, and a cable sliding step.

[0093] The connector placement step includes placing the bottom of the sleeve 506 of the male connector 502 above the top of the fiber optic receiver 514 of the female connector 504, with a surgical barrier (e.g., sterile drape 18) between the bottom of the sleeve of the male connector and the top of the fiber optic receiver of the female connector.

[0094] The connector rotation step includes manually rotating the male connector 502 along the longitudinal axis of the sleeve 506 while placing the male connector 502 against the surgical drape. The connector rotation step also includes cutting through the surgical barrier with a cutting edge 508 around the main opening of the sleeve 506 opposite the through-hole. As described above, the sleeve 506 of the male connector 502 has an internal thread 516 surrounding the interior of the sleeve 506, and the female connector 504 has a complementary external thread 518 surrounding the exterior of the receiver 514. Therefore, the connector rotation step may also include screwing the male connector 502 and the female connector 504 together after cutting the surgical drape in the aforementioned sub-steps of the connector rotation step.

[0095] The cable sliding step includes sliding a cable (e.g., extension tube 14) including an optical fiber (e.g., the optical fiber of the optical fiber probe 12) through a through-hole 512 opposite to the bottom of the sleeve 506 of the male connector 502 into the receiver 514 of the female connector 504. The cable sliding step also includes establishing an optical connection between the optical fiber and another optical fiber (e.g., optical fiber 20) disposed in the receiver 514 of the female connector 504.

[0096] same, Figure 9 and Figure 10 Different views of the fourth connection system 900 according to some embodiments are shown; and Figure 9 A male connector 902 of a fourth connection system 900 according to some embodiments is shown. The method of the connection system 900 includes a connector placement step, a connector rotation step, a connector insertion step, and a cable sliding step.

[0097] The connector placement step includes, with a surgical barrier (e.g., sterile drape 18) between the helical cut edge 910 of the splittable shaft 908 of the male connector 902 and the longitudinal through-hole of the fiber optic receiver 914 of the female connector 904, placing the splittable shaft 908 of the male connector 902 over the longitudinal through-hole of the fiber optic receiver 914 of the female connector 904. The connector rotation step also includes, while placing the male connector 902 against the surgical drape, manually rotating the male connector 902 along its longitudinal axis. The connector rotation step further includes cutting through the surgical barrier with the cut edge 910 of the splittable shaft 908.

[0098] The connector insertion step includes inserting the splittable rod 908 into the longitudinal through hole of the receiver 914 of the female connector 904, and splitting the splittable rod 908 along its length.

[0099] The cable sliding step includes sliding a cable (e.g., extension tube 14) including an optical fiber (e.g., the optical fiber of optical fiber probe 12) through a through-hole in the head 906 of the male connector 902 opposite to the splittable rod 908 into the receiver 914 of the female connector 904. The cable sliding step also includes establishing an optical connection between the optical fiber and another optical fiber (e.g., optical fiber 10) disposed in the receiver 914 of the female connector 904.

[0100] References show a first connection establishment device 1200, a second connection establishment device 1300, and a third connection establishment device 1400 according to some embodiments. Figure 12 , Figure 13 and Figure 14 The method of connecting the establishing device 1200, 1300 or 1400 includes a cap placement step, a hinge step, and a functional connection establishment step.

[0101] The cap placement step includes placing a cap 1202, 1302 or 1402 over a protrusion 26 of, for example, a reusable medical device (e.g., relay module 16), with a surgical barrier (e.g., sterile drape 18) between the connection establishment device 1200, 1300 or 1400 and the reusable medical device.

[0102] The articulation step includes articulating an extension arm 1204, 1304, or 1404 of the cap 1202, 1302, or 1402 with articulation pins 1206, 1306, or 1406 to push the male connector (e.g., male connector 202 or 302) of a single-use medical device (e.g., PICC 10) through the surgical barrier and into the female connector (e.g., female connector 204 or 304) of a multiple-use medical device.

[0103] The functional connection establishment step involves establishing one or more functional connections (e.g., optical connections, electrical connections, or optical and electrical connections) between a single-use medical device on the clinician-facing side of the surgical barrier and a multiple-use medical device on the patient-facing side of the surgical barrier.

[0104] Reference is made to a fourth connection establishing device 1500 according to some embodiments. Figure 15 The method for establishing a connection device includes a cap placement step, a fixing step, a hinge step, and a functional connection establishment step.

[0105] The cap placement step includes placing the cap 1502 over the protrusion 26 of a reusable medical device (e.g., relay module 16), wherein a surgical barrier (e.g., sterile drape 18) is present between the connection establishment device 1500 and the reusable medical device.

[0106] The securing step includes securing the cap 1502 above the protrusion 26 of the medical device via a hinge mechanism of a locking ring 1504, which is connected to the cap 1502 through the end of the locking ring 1504 in a hole in the cap 1502.

[0107] The articulation step includes articulating an extension arm 1506 of the cap 1502 via an articulation pin 1508 to push the male connector (e.g., male connector 202 or 302) of a single-use medical device (e.g., PICC 10) through the surgical barrier and into the female connector (e.g., female connector 204 or 304) of a multiple-use medical device.

[0108] The functional connection establishment steps involve establishing one or more functional connections across the surgical barrier between a single-use medical device on the clinician-facing side of the surgical barrier and a multiple-use medical device on the patient-facing side of the surgical barrier.

[0109] While certain specific embodiments have been disclosed herein, and while these specific embodiments have been disclosed in considerable detail, they are not intended to limit the scope of the concepts provided herein. Other adaptations and / or modifications will be apparent to those skilled in the art, and these adaptations and / or modifications are also covered in a broader sense. Therefore, changes may be made to the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A connection system, characterized in that, include: Male connector, the male connector comprising: Two or more pins that extend to the common end of the male connector; A fiber optic retainer, which runs along the longitudinal axis of the male connector between two or more pins and does not reach the common end, the fiber optic retainer being configured to retain a ferrule comprising an optical fiber therein; and Female connector, the female connector comprising: Two or more pin receivers, corresponding in number to the two or more pins extending to the common end of the female connector; and An optical fiber receiver, which runs along the longitudinal axis of the female connector between the two or more pin receivers and is symmetrical to the common end, is configured to retain another ferrule including another optical fiber therein, and the male connector and the female connector are configured to establish an optical connection between the optical fiber and the other optical fiber when the optical fiber of the male connector and the other optical fiber of the female connector are respectively retained in the male connector and the female connector; Each of the two or more pins of the male connector includes a cutting edge configured to cut through the surgical barrier when the male connector is placed against the surgical barrier and pushed through the surgical barrier by hand.

2. The connection system according to claim 1, characterized in that, Two or more pins of the male connector and two or more contacts respectively disposed within two or more pin receivers of the female connector are conductive, and the male connector and the female connector are configured to establish an electrical connection between the wire and the other wire when a wire of the male connector and another wire of the female connector are respectively connected to two or more pins of the male connector and two or more contacts of the female connector.

3. A connection system, characterized in that, include: Male connector, the male connector comprising: A sleeve having a through hole configured to allow a cable including an optical fiber to be slidably arranged therein; A cutting edge, surrounding a main opening of the sleeve opposite the through-hole, is configured to cut through the surgical barrier when the sleeve is placed against the surgical barrier and rotated by hand along the longitudinal axis of the sleeve; and A via plug, configured to be disposed above the cable or ferrule surrounding the optical fiber, the via plug being configured to prevent the cable from sliding through the via; and Female connector, the female connector comprising: An optical fiber receiver includes a longitudinal through-hole with an internal opening configured to hold another ferrule including another optical fiber therein, the male connector and the female connector being configured to establish an optical connection between the optical fiber and the other optical fiber when the optical fiber of the male connector and the other optical fiber of the female connector are respectively held in the male connector and the female connector.

4. The connection system according to claim 3, characterized in that, The male connector has an internal thread around the inside of the sleeve, and the female connector has a complementary external thread around the outside of the fiber optic receiver, for screwing the male connector and the female connector together.

5. A connection system, characterized in that, include: Male connector, the male connector comprising: The head has a through hole configured to allow a cable, including an optical fiber, to be slidably arranged therein; A splittable rod extending from the head, configured to split along its length to allow a ferrule comprising the optical fiber of the cable to be pushed past the end of the male connector; and A spiral cutting edge, surrounding the splittable rod, is configured to cut through the surgical barrier when the male connector is positioned against the surgical barrier and rotated by hand along the longitudinal axis of the male connector; and Female connector, the female connector comprising: An optical fiber receiver includes a longitudinal through-hole with an internal opening configured to hold another ferrule including another optical fiber therein, the male connector and the female connector being configured to establish an optical connection between the optical fiber and the other optical fiber when the optical fiber of the male connector and the other optical fiber of the female connector are respectively held in the male connector and the female connector.

6. The connection system according to claim 5, characterized in that, The splittable rod is configured to split in the fiber optic receiver to allow a ferrule containing the fiber optic cable to be pushed past the end of the male connector.

7. A method for connecting a system, characterized in that, include: In the presence of a surgical barrier, place the bottom of the base of the male connector into the top of the receiver of the female connector; Using the opposing wings, the male connector is rotated by hand along the longitudinal axis of the male connector around the portion of the base opposite the bottom of the base while the male connector is placed against the surgical drape, thereby cutting through the surgical barrier using the external threads with cutting edges around the base of the male connector. and An optical connection is established between an optical fiber disposed in the end opening at the bottom of the male connector and another optical fiber disposed in the inner opening of the female connector, wherein the optical fiber and the other optical fiber are respectively held in the male connector and the female connector.

8. The method according to claim 7, characterized in that, It also includes establishing an electrical connection between a wire of the male connector and another wire of the female connector, the wire and the other wire being connected to the external thread of the male connector and the complementary internal thread surrounding the receiver of the female connector, respectively.

9. A method for connecting a system, characterized in that, include: Two or more pins of the male connector are placed against the surgical barrier; The two or more pins are pushed through the surgical barrier into two or more pin receivers of the female connector, the two or more pin receivers corresponding in number to the two or more pins of the male connector, thereby cutting through the surgical barrier using the cutting edge of each of the two or more pins of the male connector; and An optical connection is established between an optical fiber and another optical fiber, the optical fiber being arranged in an optical fiber retainer between two or more pins along the longitudinal axis of the male connector, and the other optical fiber being arranged in an optical fiber receiver between two or more pin receivers along the longitudinal axis of the female connector.

10. The method according to claim 9, characterized in that, It also includes establishing an electrical connection between a wire connected to two or more pins of the male connector and another wire connected to two or more contacts respectively arranged in the receivers of two or more pins of the female connector.

11. A method for connecting a system, characterized in that, include: In the presence of a surgical barrier, place the bottom of the male connector sleeve above the top of the female connector receiver; Rotate the male connector by hand along the longitudinal axis of the sleeve while placing the male connector against the surgical drape, thereby cutting through the surgical barrier using the cutting edge of the main opening opposite the through hole around the sleeve; and A cable including an optical fiber is slid through a through-hole opposite the bottom of the sleeve of the male connector into the receiver of the female connector, thereby establishing an optical connection between the optical fiber and another optical fiber arranged in the receiver of the female connector.

12. The method according to claim 11, characterized in that, The male connector has a sleeve with an internal thread around the inside of the sleeve, and the female connector has a complementary external thread around the outside of the fiber optic receiver, for screwing the male connector and the female connector together by rotating the male connector along the longitudinal axis of the sleeve.

13. A method for connecting a system, characterized in that, include: In the presence of a surgical barrier, place the helical cut edge of the splittable rod of the male connector above the longitudinal through-hole of the receiver of the female connector; The male connector is placed against the surgical drape while the male connector is rotated by hand along its longitudinal axis, thereby cutting through the surgical barrier using the cutting edge of the splittable rod. Insert the splittable rod into the longitudinal through hole of the receiver of the female connector, and split the splittable rod along its length; and A cable including an optical fiber is slid through a through-hole in the head of the male connector, which is opposite to the splittable rod, into the receiver of the female connector, thereby establishing an optical connection between the optical fiber and another optical fiber arranged in the receiver of the female connector.

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