An entry establishing apparatus for establishing an entry in a surgical barrier and a method thereof

Abstract

Disclosed herein are an entry establishment device for establishing an entry in a surgical barrier and methods thereof. For example, the entry establishment device includes an entry and a destruction mechanism. The entry includes an entry barrier located in a protruding end portion thereof. The entry is configured to enable one or more functional connections, e.g., optical connections or electrical connections, across the surgical barrier between a single-use medical device on a clinician-facing side of the surgical barrier and another medical device on a patient-facing side of the surgical barrier. The destruction mechanism is configured to destroy the surgical barrier and place the entry over a gap in the surgical barrier. Methods of the entry establishment device include methods of using the entry establishment device.

Description

[0001] priority

[0002] This application claims priority to U.S. Provisional Application No. 63 / 091,185, filed October 13, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This application relates to the field of medical devices, and more specifically to an access creation device and method for creating an access in a surgical barrier. Background Technology

[0004] A surgical field is typically established for a patient before a medical procedure using one or more surgical barriers. For example, a sterile area can be established above or around the patient by covering them with a sterile drape. Often, medical procedures require reusable medical devices that cannot be sterilized, necessitating the placement of such devices under a sterile drape; however, drape-only medical devices often need to be functionally connected to reusable devices. Some existing solutions rely on disrupting the sterile drape to establish a functional connection between the drape-only and reusable devices. However, arbitrarily disrupting such a drape carries the risk of contaminating the carefully established sterile area for the patient. Furthermore, establishing functional connections (e.g., optical connections) between drape-only and reusable devices can be difficult, especially through arbitrary, self-made gaps in the drape. What is needed is a surgical barrier with a medical device portal that facilitates a safe, routine, and functional connection between a drape-only medical device and another medical device (e.g., a reusable device).

[0005] This article discloses an entry creation device and method for creating an entry in a surgical barrier. Summary of the Invention

[0006] This document discloses an entry point establishment device, which in some embodiments includes an entry point and a breaching mechanism. The entry point includes an entry barrier located in its protruding end portion. The entry point is configured to enable 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 another medical device on the patient-facing side of the surgical barrier. The breaching mechanism is configured to breach the surgical barrier and place the entry point over a notch in the surgical barrier.

[0007] In some implementations, the entry barrier is a transparent sheet of polymeric material. The sheet has sufficient optical transmittance to establish an optical connection across the sheet for one or more functional connections between a single-use medical device and another medical device.

[0008] In some implementations, the sheet has sufficient tear resistance to establish electrical connections across the sheet for one or more functional connections between a single-use medical device and another medical device without causing any holes or tears to form in the sheet of polymeric material to enable the electrical connections.

[0009] In some implementations, the entry barrier is a split diaphragm used to establish an optical connection, electrical connection, or both optical and electrical connection across the entry barrier for establishing one or more functional connections between a single-use medical device and another medical device.

[0010] In some embodiments, the breaching mechanism includes an internally threaded extension of the inlet configured to screw into an externally threaded protrusion of another medical device. The extension of the inlet is configured to breach the surgical barrier using an internal cutting edge when screwed into the protrusion of another medical device in the presence of a surgical barrier between the extension and the protrusion of the reusable medical device.

[0011] In some embodiments, the breaching mechanism includes an extension of the inlet having one or more internal magnetic elements configured to engage with one or more external magnetic elements of a protrusion of another medical device. The extension of the inlet is configured to breach the surgical barrier using an internal cutting edge when engaged with the protrusion of another medical device in the presence of a surgical barrier between the extension and the protrusion of a reusable medical device.

[0012] In some embodiments, the breaching mechanism includes an externally threaded extension of the inlet configured to screw into an internally threaded protrusion of another medical device. The extension of the inlet is configured to breach the surgical barrier using an external cutting edge when screwed into the protrusion of another medical device in the presence of a surgical barrier between the extension and the protrusion of the reusable medical device.

[0013] In some implementations, the disruption mechanism includes a cap connected to a rigid band via a hinged pin, the cap being configured to sit on a protrusion of another medical device, with the surgical barrier interposed therebetween. The cap is configured to disrupt the surgical barrier using a cutting edge when it is closure over the band.

[0014] In some implementations, the inlet extends from the cap along the centerline of the cap, such that when the surgical barrier is breached by the cap, the inlet barrier aligns with a gap in the surgical barrier.

[0015] In some embodiments, the breaching mechanism includes a cap configured to sit on a protrusion of another medical device, with a surgical barrier situated therebetween. An extension arm connected to the cap by a hinge pin is configured to breach the surgical barrier with the punch of the extension arm when the extension arm is hinged and a punch is pushed through the surgical barrier.

[0016] In some implementations, the inlet extends from the extension arm along the centerline of the punch but opposite to the punch, such that when the surgical barrier is broken by the punch, the inlet barrier aligns with a notch in the surgical barrier.

[0017] In some implementations, the breaching mechanism includes a rigid band configured to sit on a protrusion of another medical device, with a surgical barrier interposed therebetween. A cap connected to the band by a hinge pin is configured to breach the surgical barrier by pushing a punch through it when the cap is hinged.

[0018] In some implementations, the inlet extends from the cap along the centerline of the punch but opposite to the punch, such that when the surgical barrier is broken by the punch, the inlet barrier aligns with a notch in the surgical barrier.

[0019] In some implementations, the entry device is sterile, and the surgical barrier is a sterile drape.

[0020] This document also discloses a method for establishing an entry point. The method includes a surgical barrier disruption step and an entry point setup step. The surgical barrier disruption step includes disrupting the surgical barrier using a disruption mechanism of the entry point setup device, the surgical barrier being located between a single-use medical device on the clinician-facing side of the surgical barrier and another medical device on the patient-facing side of the surgical barrier. The entry point setup step includes placing an entry point over a notch in the surgical barrier. The entry point setup step establishes one or more functional connections between the single-use medical device and the other medical device through the entry point of the entry point setup device.

[0021] In some embodiments, the method further includes a functional connection establishment step. The functional connection establishment step includes establishing an optical connection for one or more functional connections across a transparent polymeric material sheet that acts as an entry barrier, the sheet having sufficient optical transmittance for the optical connection.

[0022] In some implementations, the functional connection establishment step includes establishing an electrical connection across the sheet for one or more functional connections. When establishing the electrical connection, the sheet has sufficient tear resistance for the functional connection establishment step without causing any holes or tears to be formed in the sheet to achieve the electrical connection.

[0023] In some implementations, the method further includes a functional connection establishment step. This step includes establishing optical, electrical, or both optical and electrical connections across a split diaphragm that serves as an entry barrier for one or more functional connections.

[0024] In some embodiments, the method further includes a device mating step. The device mating step includes screwing an internally threaded extension of the inlet to an externally threaded protrusion of another medical device. The surgical barrier disruption step further includes, during the device mating step, disrupting the surgical barrier between the extension of the inlet and the protrusion of the other medical device using an internal cutting edge of the extension of the inlet.

[0025] In some embodiments, the method further includes a device mating step. The device mating step includes magnetically connecting an extension of the inlet having one or more internal magnetic elements to a protrusion of another medical device having one or more external magnetic elements. The surgical barrier disruption step further includes, during the device mating step, disrupting the surgical barrier between the extension of the inlet and the protrusion of the other medical device using an internal cutting edge of the extension of the inlet.

[0026] In some embodiments, the method further includes a device mating step. The device mating step includes screwing an externally threaded extension of the inlet to an internally threaded protrusion of another medical device. The surgical barrier disruption step further includes, during the device mating step, disrupting the surgical barrier between the extension of the inlet and the protrusion of the other medical device using an external cutting edge of the extension of the inlet.

[0027] In some embodiments, the surgical barrier disruption step further includes sealing a cap, which is articulated to a rigid band via a hinge pin, over a protrusion of another medical device. Additionally, the surgical barrier disruption step includes, while sealing the cap over the protrusion of the other medical device, disrupting the surgical barrier between the cap and the protrusion of the other medical device with the cutting edge of the cap.

[0028] In some embodiments, the surgical barrier breaking step further includes hinged an extension arm, which is connected to the cap by a hinge pin, to a protrusion of another medical device. Additionally, the surgical barrier breaking step includes breaking the surgical barrier between the cap and the protrusion of the other medical device by pushing a punch of the extension arm through the surgical barrier while the extension arm is hinged.

[0029] In some embodiments, the surgical barrier disruption step further includes hinged a cap, which is connected to a rigid band via a hinge pin, onto a protrusion of another medical device. Additionally, the surgical barrier disruption step includes disrupting the surgical barrier by pushing a punch from the cap through the surgical barrier between the cap and the protrusion of the other medical device while the cap is hinged.

[0030] In some implementations, the entry device is sterile, and the surgical barrier is a sterile drape.

[0031] This document also discloses a surgical barrier, in some embodiments of which the surgical barrier includes an inlet integrated into the surgical barrier. The inlet includes an inlet barrier located in its protruding end portion, the inlet being configured to enable 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 another medical device on the patient-facing side of the surgical barrier.

[0032] These and other features of the concepts provided herein will become more apparent to those skilled in the art in light of the accompanying drawings and the following description, which describe specific embodiments of these concepts in more detail. Attached Figure Description

[0033] Figure 1 The optical shape sensing system according to some embodiments is shown to be functionally connected to single-use and multiple-use medical devices.

[0034] Figure 2 An entrance barrier with a sheet of transparent polymeric material is shown according to some embodiments.

[0035] Figure 3 An entrance with a splittable diaphragm is shown according to some embodiments.

[0036] Figure 4 A first entry establishment device with a first destruction mechanism is shown according to some embodiments.

[0037] Figure 5 A second entry device with a second destruction mechanism is shown according to some embodiments.

[0038] Figure 6 A third entry device with a third destruction mechanism is shown according to some embodiments.

[0039] Figure 7 A fourth entry point establishment device with a fourth destruction mechanism is shown according to some embodiments.

[0040] Figure 8A fifth entry device with a fifth breaching mechanism is shown according to some implementation schemes.

[0041] Figure 9 A sixth entry device with a sixth destruction mechanism is shown according to some embodiments.

[0042] Figure 10 A seventh entry point establishment device with a seventh destruction mechanism is shown according to some embodiments.

[0043] Figure 11 An eighth entry device with an eighth destruction mechanism is shown according to some implementation schemes.

[0044] Figure 12 A ninth entry point establishment device with a ninth destruction mechanism is shown according to some implementation schemes. Detailed Implementation

[0045] 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 can be easily separated from the specific embodiments, and may optionally be combined with or substituted for features of any of the many other embodiments disclosed herein.

[0046] Regarding the terminology used herein, it should also be understood that these terms are for describing specific embodiments and 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 within a set of features or steps and do not provide for a sequence or numerical limitation. For example, the features or steps “first,” “second,” and “third” need not appear in that order, and a specific embodiment including such features or steps is not limited to these three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” and “back” are used for convenience and do not imply any particular fixed position, orientation, or direction. Rather, such labels are used to reflect, for example, relative position, orientation, or direction. Unless the context clearly specifies otherwise, the singular forms “a,” “an,” and “the” include the plural forms, unless the context clearly specifies otherwise.

[0047] Regarding "proximal," for example, the "proximal portion" or "proximal portion" of a catheter disclosed herein includes the portion of the catheter intended to be close to the clinician when the catheter is used in a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter intended to be close to the clinician when the catheter is used in a patient. For example, the "proximal end" of a catheter includes one end of the catheter intended to be close to the clinician when the catheter is used in a patient. The proximal portion, proximal portion, or proximal length of a catheter may include the proximal end of the catheter; however, the proximal portion, proximal portion, or proximal length of a catheter does not need to include the proximal end of the catheter. That is, unless the context otherwise requires, the proximal portion, proximal portion, or proximal length of a catheter is not the distal portion or distal length of the catheter.

[0048] Regarding "distal," for example, the "distal portion" or "distal part" of a catheter disclosed herein includes the portion of the catheter intended to be close to or within the patient when the catheter is used in the patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter intended to be close to or within the patient when the catheter is used in the patient. For example, the "distal end" of a catheter includes one end of the catheter intended to be close to or within the patient when the catheter is used in the patient. The distal portion, distal part, or distal length of a catheter may include the distal end of the catheter; however, the distal portion, distal part, or distal length of a catheter does not need to include the distal end of the catheter. That is, unless the context otherwise requires, the distal portion, distal part, or distal length of a catheter is not the distal portion or distal length of the catheter.

[0049] 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.

[0050] Figure 1 The optical shape sensing system according to some embodiments is shown to be functionally connected to single-use and multiple-use medical devices.

[0051] As mentioned above, medical procedures often require reusable medical devices that cannot be sterilized, necessitating the placement of such devices under sterile drapes; however, drape-only medical devices often need to be functionally connected to reusable devices. In practice, as shown, an optical shape sensing system includes a single-use peripherally inserted central catheter (“PICC”) 10 with an optical fiber needle 12 disposed in an extension tube 14, functionally connected to a relay module 16 located above the patient P but outside the sterile area under a sterile drape 18. The relay module 16 further includes an optical fiber 20 disposed in a plug cable 22, functionally connected to a console 24 or its optical interrogator, also located outside the sterile area. Similarly, some existing solutions rely on disrupting the sterile drape (e.g., sterile drape 18) to establish a functional connection between the drape-only medical device (e.g., PICC 10) and the reusable medical device (e.g., relay module 16, console 24, etc.). However, arbitrarily disrupting such sterile drapes carries the risk of contaminating the carefully established sterile area for the patient. Furthermore, establishing functional connections (e.g., optical connections) between sterile drape-only medical devices and reusable medical devices can be difficult, especially through arbitrary, self-made gaps in the sterile drape. What is needed is a surgical barrier with access points for medical devices that facilitates the establishment of safe, routine, and functional connections between sterile drape-only medical devices and another medical device (e.g., reusable medical devices).

[0052] This article discloses an entry creation device and method for creating an entry in a surgical barrier.

[0053] Entrance establishment equipment

[0054] Each of the entry creation devices disclosed herein includes an entry point and a breaching mechanism. A description of the entry point follows immediately below. Subsequently, a description of the breaching mechanism is given in the context of one or more entry creation devices.

[0055] Figure 2 and Figure 3 Alternative entry points 200 and 300 for establishing the entry device according to some implementation schemes are shown.

[0056] As shown in the figure, inlet 200 or 300 is a conduit 202 (e.g., a hollow upright column) that includes an inlet barrier 204 or 304 located in the protruding end portion of inlet 200 or 300 or its conduit 202 that protrudes from the inlet establishment device. Inlet 200 or 300 is configured to enable one or more functional connections (e.g., optical connections, electrical connections, etc.) between a single-use medical device (e.g., PICC 10) on the clinician-facing side of the surgical barrier (e.g., sterile barrier 18) and another medical device (e.g., a multiple-use medical device (e.g., repeater 16, console 24, etc.) on the patient-facing side of the surgical barrier.

[0057] Figure 2 An entrance 200 of an entrance barrier 204 of a sheet of transparent polymeric material is shown according to some embodiments.

[0058] The entry barrier 204 is a sheet of transparent polymeric material, such as a single non-laminated sheet of polymeric material or two or more layers of polymeric material laminated together as a laminated sheet. The sheet may have sufficient optical transmittance to establish optical connections across the sheet for one or more functional connections between single-use and reusable medical devices. The sheet may have sufficient tear resistance to establish electrical connections across the sheet for one or more functional connections between single-use and reusable medical devices without allowing any pores or tears formed in the sheet of polymeric material to achieve the electrical connections to propagate. The polymeric material of the sheet may be polyethylene, polypropylene, or polyurethane. For laminated sheets, each of the two or more layers may comprise the same or different polymeric material as the adjacent layers of the two or more layers of the laminated sheet.

[0059] Figure 3 An inlet 300 with a splittable diaphragm is shown according to some embodiments.

[0060] The inlet barrier 304 is a split diaphragm having a slit 306 passing through it, configured to establish an optical, electrical, or both optical and electrical connection across the diaphragm for one or more functional connections between single-use and multiple-use medical devices. When the conduit 202 of the inlet 300 is formed of a flexible material (e.g., a thermoplastic, such as polyethylene), the protruding portion of the inlet 300 or the opposing sides of its conduit 202 can be squeezed together to open the diaphragm for one or more functional connections. Notably, the protruding portion of the inlet 300 or the opposing sides of its conduit 202 should be those at the ends of the slit 306 of the split diaphragm. The polymeric material of the split diaphragm can be rubber, such as silicone rubber.

[0061] Figures 4-12An entrance establishment device 400-1200 with different destruction mechanisms according to some implementation schemes is shown.

[0062] Each disrupting mechanism of the entry establishment devices 400-1200 described below is configured to disrupt the surgical barrier (e.g., sterile barrier 18) and position the entry 200 or 300 over a gap in the surgical barrier. It is noteworthy that in one operation of the disrupting mechanism, the disrupting mechanism is often configured to disrupt the surgical barrier and position the entry 200 or 300 over a gap in the surgical barrier; in some embodiments, this operation may consist of a single movement. As described above, the entry 200 or 300 is configured to enable one or more functional connections (e.g., optical connections, electrical connections, etc.) across the surgical barrier between a single-use medical device (e.g., PICC 10) on the clinician-facing side of the surgical barrier and a multiple-use medical device (e.g., repeater 16, console 24, etc.) on the patient-facing side of the surgical barrier.

[0063] Figure 4 A first entry establishment device 400 with a first destruction mechanism is shown according to some embodiments.

[0064] As shown in the figure, the first disruption mechanism includes an extension 408 with internal threads 410 at inlet 200 or 300, configured to be screwed together with a protrusion 26 with external threads 28 of a reusable medical device (e.g., repeater 16). The extension 408 at inlet 200 or 300 is configured to disrupt the surgical barrier using an internal cutting edge (e.g., a sharpened portion of the internal threads 410) when screwed together with the protrusion 26 of the reusable medical device in the presence of a surgical barrier between it and the reusable medical device.

[0065] Figure 5 A second entry establishment device 500 with a second destruction mechanism is shown according to some embodiments.

[0066] As shown, the disruption mechanism includes an extension 408 of inlet 200 or 300 having one or more internal magnetic elements 512 configured to engage with one or more external magnetic elements 30 of a protrusion 26 of a reusable medical device (e.g., repeater 16). The extension 408 of inlet 200 or 300 is configured to disrupt the surgical barrier using an internal cutting edge (not shown) when engaged with the protrusion 26 of the reusable medical device in the presence of a surgical barrier between itself and the reusable medical device.

[0067] Figure 6 A third entry point establishment device 600 with a third breaching mechanism according to some embodiments is shown, and Figure 7A fourth entry point establishment device 700 with a fourth destruction mechanism is shown according to some embodiments.

[0068] like Figure 6 As shown, the disruption mechanism includes an extension 608 with external threads 610 at inlet 200 or 300, configured to screw into a protrusion 26 with internal threads 32 of a reusable medical device (e.g., repeater 16). The extension 608 at inlet 200 or 300 is configured to disrupt the surgical barrier with an external cutting edge (e.g., a sharp tip of the extension 608, a sharp portion of the external threads 610, etc.) when screwed into the protrusion 26 of the reusable medical device in the presence of a surgical barrier between it and the reusable medical device.

[0069] However, as Figure 7 As shown, the breaching mechanism does not need to include the external thread 610 on the extension 608 of the inlet 200 or 300. In fact, the extension 608 of the inlet 200 or 300 can be configured to breach the surgical barrier with its sharp tip when inserted into the protrusion 26 of the reusable medical device in the presence of a surgical barrier between it and the reusable medical device.

[0070] Figure 8 A fifth entry point establishment device 800 with a fifth breaching mechanism is shown according to some embodiments.

[0071] As shown, the breaching mechanism includes a cap 814 connected to a rigid band 818 via a hinge pin 816. The cap is configured to rest over a protrusion 26 of a reusable medical device (e.g., repeater 16) having a surgical barrier therebetween. The cap 814 is configured to breach the surgical barrier with a cutting edge (e.g., the edge of the cap 814) when it is placed over the band 818. An inlet 200 or 300 extends from the cap 814 along its centerline such that when the surgical barrier is breached by the cap 814, the inlet barrier 204 or 304 aligns with a notch in the surgical barrier.

[0072] Figure 9 A sixth entry point establishment device 900 with a sixth destruction mechanism is shown according to some embodiments. Figure 10 A seventh entry point establishment device 1000 with a seventh destruction mechanism is shown according to some embodiments. Figure 11 An eighth entry establishment device 1100 with an eighth destruction mechanism is shown according to some embodiments.

[0073] As shown, the disruption mechanism includes a cap 914, 1014, or 1114, configured to sit on a protrusion 26 of a reusable medical device (e.g., repeater 16) with a surgical barrier in between. An extension arm 920, 1020, or 1120, having a lever arm configured to complement the construction of the cap 914, 1014, or 1114, is connected to the cap 914, 1014, or 1114 via a hinge pin 922. The extension arm 920, 1020, or 1120 is configured to disrupt the surgical barrier by pushing a punch 924 through the surgical barrier when the extension arm 920 is hinged. Inlet 200 or 300 extends from extension arm 920, 1020 or 1120 along the centerline of punch 924, but opposite to the punch, such that when the surgical barrier is broken by punch 924, inlet barrier 204 or 304 aligns with a notch in the surgical barrier.

[0074] Figure 12 A ninth entry establishment device 1200 with a ninth destruction mechanism is shown according to some embodiments.

[0075] As shown, the breaching mechanism includes a rigid band 1218 configured to rest on a protrusion 26 of a reusable medical device (e.g., repeater 16) with a surgical barrier therebetween. A cap 1214, connected to the band 1218 by a hinge pin 922, is configured to breach the surgical barrier by pushing a punch 924 through the surgical barrier when the cap 1214 is hinged. An inlet 200 or 300 extends from the cap 1214 along the centerline of the punch 924, but opposite the punch, such that when the surgical barrier is breached by the punch 924, the inlet barrier 204 or 304 aligns with a notch in the surgical barrier.

[0076] Surgical barrier

[0077] Although not shown, a surgical barrier (e.g., sterile barrier 18) may include an inlet 200 or 300 integrated into the surgical barrier. As described above, the inlet 200 or 300 includes an inlet barrier 204 or 304 in its protruding end portion, which is configured to enable one or more functional connections across the surgical barrier 204 or 304 between a single-use medical device on the clinician-facing side of the surgical barrier and another medical device on the patient-facing side of the surgical barrier (e.g., a multiple-use medical device on the patient-facing side of the surgical barrier (e.g., repeater 16, console 24, etc.)).

[0078] method

[0079] The methods for using the entry point creation device 400-1200 include methods for using the entry point creation device 400-1200. Each method in the methods for using the entry point creation device 400-1200 includes at least a surgical barrier disruption step and an entry point setup step.

[0080] The surgical barrier disruption step includes disrupting the surgical barrier (e.g., sterile barrier 18) between a single-use medical device (e.g., PICC 10) on the clinician-facing side of the surgical barrier and another medical device (e.g., a multiple-use medical device (e.g., repeater 16, console 24, etc.) on the patient-facing side of the surgical barrier using the disruption mechanism of entry establishment devices 400, 500, 600, 700, 800, 900, 1000, 1100, or 1200). Depending on the entry establishment device 400, 500, 600, 700, 800, 900, 1000, 1100, or 1200, the surgical barrier disruption step includes one or more additional features or sub-steps as described below for each of the aforementioned entry establishment devices.

[0081] The inlet setup step includes placing inlet 200 or 300 above a gap in the surgical barrier. The inlet setup step establishes one or more functional connections between single-use and multi-use medical devices through inlets 200 or 300 of devices 400, 500, 600, 700, 800, 900, 1000, 1100, or 1200.

[0082] Figure 4 A portion of a method for establishing device 400 using a first entry point is further illustrated according to some implementation schemes.

[0083] As shown in the figure, the method further includes a device mating step. The device mating step includes screwing an extension 408 of inlet 200 or 300 with internal threads 410 to a protrusion 26 of a reusable medical device (e.g., repeater 16) with external threads 28. According to the device mating step, the surgical barrier disruption step further includes, during the device mating step, disrupting the surgical barrier (e.g., sterile barrier 18) between the extension 408 of inlet 200 or 300 and the protrusion 26 of the reusable medical device using the internal cutting edge of the extension 408.

[0084] Figure 5 A portion of a method for establishing device 500 using a second entry point is further illustrated according to some implementation schemes.

[0085] As shown in the figure, the method further includes a device mating step. The device mating step includes magnetically connecting an extension 408 of inlet 200 or 300 having one or more internal magnetic elements 512 to a protrusion 26 of a reusable medical device (e.g., repeater 16) having one or more external magnetic elements 30. According to the device mating step, the surgical barrier disruption step further includes, during the execution of the device mating step, disrupting the surgical barrier (e.g., sterile barrier 18) between the extension 408 of inlet 200 or 300 and the protrusion 26 of the reusable medical device using an internal cutting edge.

[0086] Figure 6 A portion of a method for establishing device 600 using a third entry point, according to some implementation schemes, is further illustrated.

[0087] As shown in the figure, the method further includes a device mating step. The device mating step includes screwing an extension 608 of inlet 200 or 300 with external threads 610 to a protrusion 26 of a reusable medical device (e.g., repeater 16) with internal threads 32. According to the device mating step, the surgical barrier disruption step further includes, during the device mating step, disrupting the surgical barrier (e.g., sterile barrier 18) between the extension 608 of inlet 200 or 300 and the protrusion 26 of the reusable medical device using the outer cutting edge of the extension 608 of inlet 200 or 300.

[0088] Figure 8 A portion of a method for establishing device 800 using a fifth entry point is further illustrated according to some implementation schemes.

[0089] As shown in the figure, the surgical barrier disruption step further includes sealing a cap 814, which is connected to a rigid band 818 via a hinge pin 816, over a protrusion 26 of a reusable medical device (e.g., repeater 16). Furthermore, the surgical barrier disruption step includes, while sealing the protrusion 26 of the reusable medical device with the cap 814, disrupting the surgical barrier (e.g., sterile barrier 18) between the cap 814 and the protrusion 26 of the reusable medical device with the cutting edge of the cap 814.

[0090] Figure 9 A portion of a method for establishing device 900 using a sixth entry point is further illustrated according to some implementation schemes. Figure 10 A portion of the method for establishing the device 1000 using a seventh inlet with a seventh destruction mechanism is further illustrated. Figure 11 A portion of a method for establishing device 1100 using an eighth entry point is further illustrated according to some implementation schemes.

[0091] As shown in the figure, the surgical barrier disruption step further includes hinged an extension arm 920, 1020, or 1120, connected to a cap 914, 1014, or 1114 via a hinge pin 922, onto a protrusion 26 of a reusable medical device (e.g., repeater 16). Furthermore, the surgical barrier disruption step includes disrupting the surgical barrier (e.g., sterile barrier 18) between the cap 914, 1014, or 1114 and the protrusion 26 of the reusable medical device by pushing a punch 924 of the extension arm 920, 1020, or 1120 through the surgical barrier while the extension arm 920, 1020, or 1120 is hinged.

[0092] Figure 12 A portion of a method for establishing device 1200 using a ninth entry point is further illustrated according to some implementation schemes.

[0093] As shown in the figure, the surgical barrier disruption step further includes hinged cap 1214, which is connected to rigid band 1218 via hinge pin 922, to protrusion 26 of reusable medical device (e.g., repeater 16). Furthermore, the surgical barrier disruption step includes disrupting the surgical barrier (e.g., sterile barrier 18) between cap 1214 and protrusion 26 of reusable medical device by pushing punch 924 of cap 1214 through the surgical barrier while cap 1214 is hinged.

[0094] again, Figure 2 An entrance 200 is shown as an entrance barrier 204 with a transparent polymeric material sheet according to some embodiments.

[0095] The method may also include a functional connection establishment step for the inlet 200. The functional connection establishment step may include establishing an optical connection for one or more functional connections across a transparent polymeric material sheet that serves as an inlet barrier (e.g., inlet barrier 204), the sheet having sufficient optical transmittance for the optical connection.

[0096] The functional connection establishment step may additionally or alternatively include establishing an electrical connection across the sheet for one or more functional connections. When establishing the electrical connection, the sheet has sufficient tear resistance for the functional connection establishment step without causing any holes or tears to be formed in the sheet to achieve the electrical connection.

[0097] again, Figure 3 An inlet 300 with a splittable diaphragm is shown according to some embodiments.

[0098] The method may also include a functional connection establishment step for the inlet 300. The functional connection establishment step may include establishing an optical connection, an electrical connection, or both an optical connection and an electrical connection across a split diaphragm that serves as an inlet barrier (e.g., inlet barrier 304) for one or more functional connections.

[0099] While specific embodiments have been disclosed herein, and have been described in detail, these specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be apparent to those skilled in the art, and are included in a broader sense. Therefore, deviations from the specific embodiments disclosed herein are possible without departing from the scope of the concepts provided herein.

Claims

1. An entrance establishment device, characterized in that, include: An inlet, comprising an inlet barrier in a protruding end portion of the inlet, the inlet being configured to enable one or more functional connections between a single-use medical device on the clinician-facing side of the surgical barrier and another medical device on the patient-facing side of the surgical barrier, spanning the surgical barrier. and A breaching mechanism configured to break the surgical barrier and place the entry point over a gap in the surgical barrier. The inlet barrier is a transparent sheet of polymer material with sufficient optical transmittance to establish an optical connection across the sheet for the one or more functional connections between the single-use medical device and the other medical device. The sheet has sufficient tear resistance to establish an electrical connection across the sheet for the one or more functional connections between the single-use medical device and the other medical device, without causing any holes or tears to form in the sheet to enable the electrical connection.

2. The entrance establishment device according to claim 1, characterized in that, The disruption mechanism includes an internally threaded extension of the inlet, the extension being configured to screw together with an externally threaded protrusion of the other medical device, the extension of the inlet being configured to disrupt the surgical barrier using an internal cutting edge when screwed together with the protrusion of the other medical device and the surgical barrier is between them.

3. The entrance establishment device according to claim 1, characterized in that, The disruption mechanism includes an extension of the inlet having one or more internal magnetic elements configured to engage with one or more external magnetic elements of a protrusion of the other medical device, the extension of the inlet being configured to disrupt the surgical barrier using an internal cutting edge when engaged with the protrusion of the other medical device and the surgical barrier is between them.

4. The entrance establishment device according to claim 1, characterized in that, The disruption mechanism includes an externally threaded extension of the inlet, the extension being configured to screw together with an internally threaded protrusion of the other medical device, the extension being configured to disrupt the surgical barrier using an external cutting edge when screwed together with the protrusion of the other medical device and the surgical barrier is between them.

5. The entrance establishment device according to claim 1, characterized in that, The disruption mechanism includes a cap connected to a rigid band via a hinge pin, the cap being configured to be disposed over a protrusion of the other medical device and the surgical barrier being located between the cap and the protrusion of the other medical device, the cap being configured to disrupt the surgical barrier with a cutting edge when it is closed over the band.

6. The entrance establishment device according to claim 5, characterized in that, The inlet extends from the cap along the center line of the cap, such that when the surgical barrier is damaged by the cap, the inlet barrier aligns with a gap in the surgical barrier.

7. The entrance establishment device according to claim 1, characterized in that, The breaching mechanism includes: a cap configured to be disposed on a protrusion of the other medical device and the surgical barrier being located between the cap and the protrusion of the other medical device; and an extension arm connected to the cap by a hinge pin, the extension arm being configured to breach the surgical barrier by means of the punch when the punch of the extension arm is pushed through the surgical barrier by hinged extension arm.

8. The entrance establishment device according to claim 7, characterized in that, The inlet extends from the extension arm along the centerline of the punch but opposite to it, such that when the surgical barrier is broken by the punch, the inlet barrier aligns with a notch in the surgical barrier.

9. The entrance establishment device according to claim 1, characterized in that, The breaching mechanism includes: a rigid band configured to be disposed on a protrusion of the other medical device and the surgical barrier being located between the rigid band and the protrusion of the other medical device; and a cap connected to the band by a hinge pin, the cap being configured to breach the surgical barrier by means of the punch when the punch of the cap is pushed through the surgical barrier by hinged cap.

10. The entrance establishment device according to claim 9, characterized in that, The inlet extends from the cap along the centerline of the punch but opposite to it, such that when the surgical barrier is broken by the punch, the inlet barrier aligns with a notch in the surgical barrier.

11. The entrance establishment device according to claim 1, characterized in that, The inlet establishment device is sterile, and the surgical barrier is a sterile drape.

12. A method for establishing an entrance using any one of claims 1 to 11, characterized in that, include: The surgical barrier is destroyed by the destruction mechanism of the entry device between the single-use medical device on the clinician-facing side of the surgical barrier and the other medical device on the patient-facing side of the surgical barrier; and The inlet is placed over a gap in the surgical barrier, thereby establishing one or more functional connections between the single-use medical device and the other medical device through the inlet.

13. The method according to claim 12, characterized in that, It also includes establishing an optical connection for the one or more functional connections across a transparent polymeric material sheet that serves as the entry barrier, the sheet having sufficient optical transmittance for the optical connection.

14. The method according to claim 13, characterized in that, It also includes establishing an electrical connection across the sheet for the one or more functional connections, the sheet having sufficient tear resistance to establish the electrical connection without causing any holes or tears to form in the sheet to enable the electrical connection.

15. The method according to claim 12, characterized in that, It also includes establishing optical connections, electrical connections, or both optical and electrical connections across the split diaphragm that serves as the entry barrier for the connection of one or more functions.

16. The method according to claim 12, characterized in that, Also includes: The internally threaded extension of the inlet is screwed together with the externally threaded protrusion of the other medical device; and While screwing the extension of the inlet together with the protrusion of the other medical device, the surgical barrier between the extension of the inlet and the protrusion of the other medical device is destroyed using the inner cutting edge of the extension of the inlet.

17. The method according to claim 12, characterized in that, Also includes: The extension of the inlet having one or more internal magnetic elements is magnetically connected to the protruding portion of the other medical device having one or more external magnetic elements; and While magnetically connecting the extension of the inlet to the protrusion of the other medical device, the surgical barrier between the extension of the inlet and the protrusion of the other medical device is destroyed using the inner cutting edge of the extension of the inlet.

18. The method according to claim 12, characterized in that, Also includes: The externally threaded extension of the inlet is screwed together with the internally threaded protrusion of the other medical device; and While screwing the extension of the inlet together with the protrusion of the other medical device, the surgical barrier between the extension of the inlet and the protrusion of the other medical device is broken using the outer cutting edge of the extension of the inlet.

19. The method according to claim 12, characterized in that, Also includes: A cap, connected to a rigid band via a hinge pin, is placed over the protruding portion of the other medical device. and While the cap is placed over the protrusion of the other medical device, the surgical barrier between the cap and the protrusion of the other medical device is disrupted by the cutting edge of the cap.

20. The method according to claim 12, characterized in that, Also includes: The extension arm, which is connected to the cap via a hinge pin, is hinged to the protruding part of another medical device. and While the extension arm is hinged, the surgical barrier is disrupted by pushing the punch of the extension arm through the surgical barrier between the cap and the protrusion of the other medical device.

21. The method according to claim 12, characterized in that, Also includes: The cap, which is connected to the rigid band by a hinge pin, is hinged to the protruding part of the other medical device. and While the cap is hinged, the surgical barrier is disrupted by pushing the punch of the cap through the surgical barrier between the cap and the protrusion of the other medical device.

22. The method according to claim 12, characterized in that, The inlet establishment device is sterile, and the surgical barrier is a sterile drape.

23. A surgical barrier, characterized in that, include: An inlet integrated into the surgical barrier, the inlet including an inlet barrier in a protruding end portion of the inlet, the inlet configured to enable one or more functional connections between a single-use medical device on the clinician-facing side of the surgical barrier and another medical device on the patient-facing side of the surgical barrier. The inlet barrier is a transparent sheet of polymer material with sufficient optical transmittance to establish an optical connection across the sheet for the one or more functional connections between the single-use medical device and the other medical device. The sheet has sufficient tear resistance to establish an electrical connection across the sheet for the one or more functional connections between the single-use medical device and the other medical device, without causing any holes or tears to form in the sheet to enable the electrical connection.

Images