Patent Description:
Procedural fields are typically established about patients with one or more procedural barriers before medical procedures. For example, sterile fields can be established over or around patients by covering the patients with sterile drapes. Oftentimes, the medical procedures require multi-use medical devices that cannot be sterilized, which mandate placement of such medical devices under the sterile drapes; however, sterile single-use medical devices often need to be functionally connected to the multi-use medical devices. Some existing solutions rely on breaching sterile drapes to make functional connections between sterile single-use medical devices and multi-use medical devices. But breaching such sterile drapes risks contaminating the sterile fields carefully established about the patients. That, and establishing some functional connections such as optical connections between the sterile single-use medical devices and the multi-use medical devices can be difficult, particularly through breaches in the sterile drapes. What is needed are procedural barriers with integrated medical device-connecting features that facilitate establishing safe, functional connections between sterile single-use medical devices and multi-use medical devices.

<CIT> discloses methods and materials related to portals that can be used to create a channel through a surgical drape without compromising the sterile operating field. For example, a portal can include an applicator frame and sheath that is capable of creating a channel into a sterile operating filed so that a device, whether sterile or not can be used at the time of surgery without compromising the sterility of the surgical field.

<CIT> discloses a sterile handle for controlling a robotic surgical system from a sterile field.

<CIT> discloses systems and methods for breaching a sterile field for intravascular placement of a catheter.

<CIT> discloses a supply line for a robotic arm instrument.

<CIT> discloses ophthalmic surgical systems, methods and devices.

Disclosed herein are procedural barriers with integrated medical device-connecting features and methods thereof that address the foregoing.

The invention is defined by independent claims <NUM> and <NUM>. No methods for treatment of the human or animal body by surgery or therapy are claimed. Disclosed herein is a procedural barrier for a medical procedure. The procedural barrier includes, a sheet of one or more nonwoven materials and an integrated connecting means in the sheet for connecting one or more single-use medical devices in a procedural field to another medical device on a patient-facing side of the sheet. The sheet has a length and a width sufficient to establish the procedural field for the medical procedure on a side of the sheet opposite the patient-facing side of the sheet. The integrated connection means includes an integrated conduit passing through the sheet. The integrated conduit passes through the sheet for establishing an alternative electrical connection, an optical connection, or both the alternative electrical connection and the optical connection across the procedural barrier between a same or different single-use medical device in the procedural field to the other medical device on the patient-facing side of the sheet without compromising the procedural field.

The procedural barrier includes an integrated electrical connector integrated into the sheet for establishing an electrical connection across the procedural barrier by way of the integrated electrical connector.

In some embodiments, the procedural barrier includes the integrated conduit passing through the sheet adjacent to the integrated electrical connector for establishing the optical connection across the procedural barrier by way of the integrated conduit and the electrical connection across the procedural barrier by way of the integrated electrical connector.

In some embodiments, the procedural barrier further includes a fenestration in the sheet adjacent to the integrated electrical connector. The fenestration is covered by a transparent fenestration cover of a polymeric material having sufficient optical transmissibility for establishing the optical connection across the procedural barrier by way of the fenestration cover without compromising the procedural field.

In some embodiments, the polymeric material is a polyethylene, a polypropylene, or a polyurethane.

In some embodiments, the procedural barrier includes the integrated conduit passing through the sheet for establishing both the alternative electrical connection and the optical connection across the procedural barrier by way of the integrated conduit.

In some embodiments, the sheet includes one or more plies of the one-or-more nonwoven materials. Each ply of the one-or-more plies is formed of a nonwoven material selected from a polypropylene and a wood pulp.

In some embodiments, the sheet includes a single ply of spunbond polypropylene.

In some embodiments, the sheet includes a single ply of spunlace wood pulp.

In some embodiments, the sheet includes one ply of meltblown polypropylene between two plies of spunbond polypropylene.

In some embodiments, the procedural barrier is a sterile procedural drape.

Also disclosed is a method of a procedural barrier for a medical procedure. The method includes, a procedural barrier-placing step and a device-connecting step. The barrier-placing step includes placing the procedural barrier over a patient. The barrier-placing step establishes a procedural field for the medical procedure on a side of the procedural barrier opposite a patient-facing side of the procedural barrier. The device-connecting step includes connecting one or more single-use medical devices in the procedural field to another medical device on the patient-facing side of the procedural barrier.

procedural barrier includes an integrated connecting means in a sheet of one or more nonwoven materials for the connecting of the one-or-more single-use medical devices to the other medical device including an integrated electrical connector and an integrated conduit passing through the sheet. The integrated conduit passes through the sheet for establishing an alternative electrical connection, an optical connection, or both the alternative electrical connection and the optical connection across the procedural barrier between a same or different single-use medical device in the procedural field to the other medical device on the patient-facing side of the sheet without compromising the procedural field.

In some embodiments, the device-connecting step includes establishing the electrical connection across the procedural barrier by way of the integrated electrical connector into the sheet.

In some embodiments, the device-connecting step includes establishing the optical connection across the procedural barrier by way of the integrated conduit passing through the sheet adjacent to the integrated electrical connector.

In some embodiments, the device-connecting step includes establishing the optical connection across the procedural barrier by way of a transparent fenestration cover covering a fenestration in the sheet adjacent to the integrated electrical connector. The fenestration cover is of a polymeric material having sufficient optical transmissibility for establishing the optical connection.

In some embodiments, the polymeric material is a polyethylene, polypropylene, or polyurethane.

In some embodiments, the device-connecting step includes establishing both the alternative electrical connection and the optical connection across the procedural barrier by way of the integrated conduit passing through the sheet.

In some embodiments, the sheet includes one or more plies of the one-or-more nonwoven materials, each ply of the one-or-more plies formed of a nonwoven material selected from a polypropylene and a wood pulp.

In some embodiments, the sheet includes a single ply of spunbond polypropylene, a single ply of spunlace wood pulp, or one ply of meltblown polypropylene between two plies of spunbond polypropylene.

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

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

As set forth above, medical procedures often require multi-use medical devices that cannot be sterilized, which mandate placement of such medical devices under sterile drapes where it is difficult to functionally connect them to sterile single-use medical devices in sterile fields over or around patients established by the sterile drapes. As shown in <FIG>, some existing solutions rely on breaching sterile drapes to make functional connections between sterile single-use medical devices and multi-use medical devices. Indeed, <FIG> illustrates a functional connection (e.g. a power-and-data connection) from a peripherally inserted central catheter ("PICC") <NUM> in a sterile field to a relay module <NUM> of a console <NUM> outside the sterile field by way of a breach in a sterile drape <NUM>. But breaching such sterile drapes risks contaminating the sterile fields carefully established about the patients. That, and establishing some functional connections such as optical connections between the sterile single-use medical devices and the multi-use medical devices can be difficult, particularly through breaches in the sterile drapes.

Disclosed herein are procedural barriers with integrated medical device-connecting features and methods thereof that facilitate establishing safe, functional connections between sterile single-use medical devices and other medical devices such as multi-use medical devices.

<FIG> illustrates a procedural barrier <NUM> including an integrated electrical <NUM> connector and a fenestration covered by a fenestration cover <NUM> in accordance with some embodiments. <FIG> illustrates a procedural barrier <NUM> including the integrated electrical connector <NUM> and integrated conduit <NUM> in accordance with the invention. <FIG> illustrates a procedural barrier <NUM> including the integrated conduit <NUM> in accordance with some embodiments. <FIG> illustrates a procedural barrier <NUM> including the fenestration cover <NUM> in accordance with some embodiments.

Each procedural barrier of the procedural barriers <NUM>, <NUM>, <NUM>, and <NUM> disclosed herein is for a medical procedure but is not limited thereto. As set forth below, each procedural barrier of the procedural barriers <NUM>, <NUM>, <NUM>, and <NUM> includes a sheet <NUM> of one or more nonwoven materials and an integrated connecting means in the sheet <NUM> for functionally connecting one or more single-use medical devices (e.g. the PICC <NUM> having an electrocardiogram ["ECG"] stylet, an optical-fiber stylet, or both) in a procedural field over or around a patient to another medical device such as a multi-use medical device (e.g., the console <NUM> by way of the relay module <NUM>) on a patient-facing side of the procedural barrier <NUM>, <NUM>, <NUM>, or <NUM> or the sheet <NUM> thereof (i.e., under the procedural barrier <NUM>, <NUM>, <NUM>, or <NUM> or sheet <NUM> thereof). In some embodiments, the procedural barrier <NUM>, <NUM>, <NUM>, or <NUM> is a sterile drape. In such embodiments, the procedural field is a sterile field.

The sheet <NUM> has a length and a width sufficient to establish the procedural field for the medical procedure on a side of the sheet <NUM> opposite the patient-facing side of the sheet <NUM>. Again, such a procedural field can be a sterile field when the procedural barrier <NUM>, <NUM>, <NUM>, or <NUM> is a sterile drape.

The sheet <NUM> includes a single ply of the one-or-more nonwoven materials or two or more plies of the one-or-more nonwoven materials. The nonwoven material of any ply of the sheet <NUM> can be a polypropylene or a wood pulp. In other words, the single ply or each ply of the two-or-more plies of the sheet <NUM> can independently be a polypropylene or a wood pulp. For example, the sheet <NUM> can be a single ply of spunbond polypropylene. Alternatively, the sheet <NUM> can be a single ply of spunlace wood pulp. In another example, the sheet <NUM> includes one ply of meltblown polypropylene between two plies of spunbond polypropylene.

The integrated connection means is selected from at least an integrated electrical connector <NUM> integrated into the sheet <NUM>, an integrated conduit <NUM> passing through the sheet <NUM>, and both the integrated electrical connector <NUM> and the integrated conduit <NUM>.

As shown in <FIG> and <FIG>, the integrated electrical connector <NUM> is integrated into the sheet <NUM> for establishing an electrical connection across the procedural barrier <NUM> or <NUM> between a single-use medical device (e.g., the PICC <NUM> with the ECG stylet) in the procedural field to the multi-use medical device (e.g., the console <NUM> by way of the relay module <NUM>) on the patient-facing side of the procedural barrier <NUM> or <NUM> or the sheet <NUM> thereof. Notably, the integrated electrical connector <NUM> enables functional connections such as the foregoing electrical connection without compromising the procedural field. To effectuate the electrical connection, the integrated electrical connector <NUM> can be a molded piece snapped together over a fenestration in the sheet <NUM>, wherein the molded piece has electrical contacts complementary to both the single-use medical device and the multi-use medical device.

As shown in <FIG> and <FIG>, the integrated conduit <NUM> passes through the sheet <NUM> for establishing an alternative electrical connection to that of the integrated electrical connector <NUM>, an optical connection, or both the alternative electrical connection and the optical connection (e.g., a multimodal connection) across the procedural barrier <NUM> or <NUM> between a single-use medical device in the procedural field to the multi-use medical device (e.g., the console <NUM> by way of the relay module <NUM>) on the patient-facing side of the procedural barrier <NUM> or <NUM> or the sheet <NUM> thereof. When both the integrated electrical connector <NUM> and the integrated conduit <NUM> are present in the same sheet <NUM> as shown in <FIG> for the procedural barrier <NUM>, the integrated conduit <NUM> passes through the sheet <NUM> adjacent to the integrated electrical connector <NUM> for establishing, for example, an electrical connection across the procedural barrier <NUM> by way of the integrated electrical connector <NUM> and an optical connection across the procedural barrier <NUM> by way of the integrated conduit <NUM>. Notably, the integrated conduit <NUM> enables functional connections such as the foregoing alternative electrical and optical connections without compromising the procedural field. To effectuate the functional connections, the integrated conduit <NUM> can be a molded or extruded piece inserted into a fenestration in the sheet <NUM>, wherein the molded or extruded piece has electrical contacts therein complementary to both the single-use medical device and the multi-use medical device, an intermediate optical fiber-containing ferrule therein complementary to both the single-use medical device and the multi-use medical device, or both. Being molded or extruded, the integrated conduit can have alignment feature configured to align the functional connections.

As shown in <FIG> and <FIG>, the procedural barrier <NUM> and <NUM> can include a fenestration in the sheet <NUM> covered by the transparent fenestration cover <NUM> for establishing an optical connection across the procedural barrier <NUM> or <NUM> between a single-use medical device in the procedural field to the multi-use medical device (e.g., the console <NUM> by way of the relay module <NUM>) on the patient-facing side of the procedural barrier <NUM> or <NUM> or the sheet <NUM> thereof. When both the integrated electrical connector <NUM> and the fenestration cover <NUM> are present in the same sheet <NUM> as shown in <FIG> for the procedural barrier <NUM>, the fenestration cover <NUM> covers a fenestration in the sheet <NUM> adjacent to the integrated electrical connector <NUM> for establishing, for example, an electrical connection across the procedural barrier <NUM> by way of the integrated electrical connector <NUM> and an optical connection across the procedural barrier <NUM> by way of the fenestration cover <NUM>. Notably, the fenestration cover <NUM> enables functional connections such as the foregoing optical connection without compromising the procedural field. To effectuate the optical connection, the fenestration cover <NUM> can be a transparent polymeric material adhered onto the sheet <NUM> or between the two-or-more plys of the sheet <NUM>, wherein the fenestration cover <NUM> has a thickness sufficient for maintaining an integrity of the fenestration cover <NUM> while establishing the optical connection between, for example, complementarily magnetized optical connectors of the single-use medical device and the multi-use medical device, as well as an optical transmissibility sufficient for transmitting optical signals across the fenestration cover <NUM>.

The fenestration cover <NUM> includes a single non-laminated transparent sheet of the polymeric material or two-or-more layers of same or different polymeric materials laminated together in a laminated transparent sheet. The polymeric material of the transparent sheet can be a porous, breathable polymeric film such as a polyethylene, a polypropylene, or a polyurethane; however, a porosity of the breathable polymeric film should not be such that optical signals through the fenestration cover <NUM> are appreciably scattered. For the laminated transparent sheet, each layer of the two-or-more layers can include a same or different polymeric material than an adjacent layer of the two-or-more layers of the laminated transparent sheet.

Methods include methods of using a procedural barrier such as the procedural barrier <NUM>, <NUM>, <NUM>, or <NUM> for a medical procedure. Such a method includes, a procedural barrier-placing step and a device-connecting step.

The barrier-placing step includes placing the procedural barrier <NUM>, <NUM>, <NUM>, or <NUM> over a patient. The barrier-placing step establishes a procedural field for the medical procedure on a side of the procedural barrier <NUM>, <NUM>, <NUM>, or <NUM> opposite a patient-facing side of the procedural barrier <NUM>, <NUM>, <NUM>, or <NUM>. As set forth above, the procedural barrier <NUM>, <NUM>, <NUM>, or <NUM> includes an integrated connecting means in the sheet <NUM> of the one-or-more nonwoven materials for the connecting of one or more single-use medical devices to another medical device such as a multi-use medical device, wherein the integrated connecting means is selected from the integrated electrical connector <NUM> integrated into the sheet <NUM>, the integrated conduit <NUM> passing through the sheet <NUM>, or both the integrated electrical connector <NUM> and the integrated conduit <NUM>.

The device-connecting step includes connecting the one-or-more single-use medical devices (e.g., the PICC <NUM>) in the procedural field to the multi-use medical device (e.g., the console <NUM> by way of the relay module <NUM>) on the patient-facing side of the procedural barrier <NUM>, <NUM>, <NUM>, or <NUM>. For example, the device-connecting step includes establishing an electrical connection across the procedural barrier <NUM> or <NUM> by way of the integrated electrical connector <NUM> integrated into the sheet <NUM> or the integrated conduit <NUM> passing through the sheet <NUM>. In another example, the device-connecting step includes establishing an optical connection across the procedural barrier <NUM> or <NUM> by way of the integrated conduit <NUM> passing through the sheet <NUM>, optionally together with the electrical connection by way of the integrated conduit <NUM>. In yet another example, the device-connecting step includes establishing the optical connection across the procedural barrier <NUM> or <NUM> by way of the transparent fenestration cover <NUM> covering the fenestration in the sheet <NUM>, optionally along with the electrical connection by way of the integrated electrical connector <NUM>.

Claim 1:
A procedural barrier (<NUM>) for a medical procedure, comprising:
a sheet (<NUM>) of one or more nonwoven materials, the sheet (<NUM>) having a length and a width sufficient to establish a procedural field for the medical procedure on a side of the sheet opposite a patient-facing side of the sheet; and
an integrated connecting means in the sheet (<NUM>) for connecting one or more single-use medical devices in the procedural field to another medical device on the patient-facing side of the sheet, the integrated connection means comprising:
an integrated electrical connector integrated into the sheet for establishing an electrical connection across the procedural barrier between the single-use medical device in the procedural field to the other medical device on the patient-facing side of the sheet without compromising the procedural field, and
an integrated conduit (<NUM>) passing through the sheet (<NUM>) for establishing an alternative electrical connection, an optical connection, or both the alternative electrical connection and the optical connection across the procedural barrier (<NUM>) between the same or a different single-use medical device in the procedural field to the other medical device on the patient-facing side of the sheet without compromising the procedural field.