Needle electrode placement, stabilization, and safety

Abstract

A device can be used to place in a patient, and secure in place on the patient, at least one subdermal needle electrode. The device is designed to prevent accidental sticks of the sharp distal end of the needle electrode into a person that is placing and / or securing the device on a patient or that is removing the device from the patient.

Description

[0001]AƩorney Docket No.: ALERA‐004 / 01WO 39427 / 13 NEEDLE ELECTRODE PLACEMENT, STABILIZATION, AND SAFETY Cross-Reference to Related Applications This application claims priority to, and the benefit of, U.S. Provisional Application No.63 / 546,581, filed on October 31, 2023, the content of which is incorporated by reference herein in its entirety. Technical Field The invention generally relates to subdermal needle electrodes for use in patient monitoring. Background Information A neurophysiologist can assist a surgeon in a vascular, cardiac, orthopedic, urological, neurosurgical, or other type of medical procedure by real-time monitoring the patient’s neural functioning during the procedure. The neurophysiologist’s ability to monitor the patient’s neural functioning while the surgeon performs the procedure on the patient is made possible by multiple needle electrodes that were placed into the patient, such as into the skin on the patient’s head, and that provide relevant signals to monitoring equipment used by the neurophysiologist. Subdermal needle electrodes can be used in connection with intraoperative neuromonitoring (IONM) and / or continuous electroencephalogram (cEEG) testing, for example. Such a needle electrode has a sharp point on its distal end for insertion into the patient’s skin. While traditional needle electrodes (once inserted into the patient’s skin) typically are held in place on the patient by pieces of tape and can pose an accidental-needle- stick risk to surgery team members involved in the procedure performed on the patient, a newer type of subdermal needle electrode is available from Rhythmlink International, LLC of Columbia, South Carolina (which has a website at rhythmlink.com and a product called “Guardian Needle” which is a registered U.S. trademark, registration no.6,669,350) that generally does not require tape to be applied to the patient’s body to hold the needle electrode in place. The Guardian Needle electrode is AƩorney Docket No.: ALERA‐004 / 01WO 39427 / 13 designed to reduce needle sticks, according to Rhythmlink International, LLC’s website. Rhythmlink International, LLC’s Guardian Needle electrode is described and shown in a six-page article put out by MUSC Medical University of South Carolina titled “Guardian Needle, MUSC Health clinicians’ safer neuromonitoring needle design, debuts in OR” (dated January 11, 2021). The Guardian Needle electrode also is described in an undated five-page “white paper” that is titled “Subdermal Needle Designed to Reduce or Eliminate Accidental Needle Injuries during Intraoperative Neuromonitoring (IONM) and Continuous EEG (cEEG)” and that is available on the Guardian Needle product page of Rhythmlink International, LLC’s website under the heading “Instructions For Use”. The Guardian Needle also appears on pages 20, 22, 39, and 43 in Rhythmlink International, LLC’s 52-page product catalog for 2023. Also, U.S. Patent Nos.10,932,683 and 11,690,549 could be relevant or related to Rhythmlink International, LLC’s Guardian Needle electrode. Summary of the Invention The invention relates to a device for placing at least one needle electrode into a patient and securing or stabilizing the placed needle electrode(s) on the patient. The device also is configured to eliminate the possibility, or at least significantly reduce the possibility, of a person being stuck with a sharp distal tip of the needle electrode(s), both before and during placement of the device on the patient as well as during and after removal of the device from the patient. A device according to the invention can be a device for use in patient monitoring, and the device can include first and second tabs. An adhesive can be fixed to a portion of a bottom surface of the second tab and / or the first tab. The device also can include a member for receiving at least a portion of a distal section of a lead wire, where the lead wire has the needle electrode extending from its distal end. The device also can include a connector that is disposed between the first and second tabs and that is configured to allow the first and second tabs to be moved toward and / or away from each other. The first tab of the device can be U-shaped, and the device (without the AƩorney Docket No.: ALERA‐004 / 01WO 39427 / 13 adhesive or the lead wire) can be a single-piece unit that is formed by an injection molding process. A user of the inventive device (such as a member of a surgical team performing a medical procedure on a patient in an operating room) can remove it from its sterile packaging and then insert the lead wire into the receiving member to put the sharp distal tip of the needle electrode in its place within the device, or the lead wire could come in the sterile packaging with the device and already be placed properly into the receiving member of the device. The user then would remove release liners from the adhesive on the bottom surface(s) of the tab(s) to ready the device for use with the patient and to reveal the sharp distal tip of the needle electrode which will be resting upon the adhesive that is on the bottom surface of at least one of the two tabs. The user then uses his or her index finger and thumb of one hand to move the two tabs toward the lead wire and thereby expose the sharp distal tip of the needle electrode. The sharp distal tip then can be inserted subdermal into the skin of the patient at a desired location on the patient (such as on the forehead or scalp of the patient) while the user is holding the two bent-back tabs. With the needle electrode inserted into the patient’s skin, the user would fold the two tabs down to sit flat against the exterior surface of the patient’s skin, and the adhesive on the bottom surface(s) of the tab(s) will hold the device in place on the patient’s skin and thus also hold the inserted sharp distal tip of the needle in place in the patient’s skin. When it is time to remove the inserted needle from the patient’s skin, the user will peel off the tabs from the patient’s skin by pulling the tabs up. The adhesive is designed to hold to the exterior surface of the patient’s skin but to release when pulled off. The adhesive is similar to, or the same as, the adhesive used on surgical or medical tape that can be used on a patient’s exterior skin surfaces for wound dressings. The tabs can be held up above the patient’s skin and pinched together against the lead wire by the user’s index finger and thumb, just as the user held the tabs together during the needle electrode insertion action. With the tabs pulled away from the patient’s skin and held against the lead wire by the hand of the user, the user easily can pull the needle electrode out of the patient’s skin. The user would then fold the two tabs together to enclose the sharp distal tip between the two tabs. If each of AƩorney Docket No.: ALERA‐004 / 01WO 39427 / 13 the two tabs has an adhesive on its bottom surface, then the sharp distal tip of the needle electrode will be sandwiched between the two tabs and encapsulated in the adhesive. These and other aspects and details of devices according to the invention will become clearer by referring to the following parts of this document, and various methods of making and using such devices will become clearer as well. The entirety of this document illustrates devices and methods that embody the invention, but the invention is not limited only to the specific devices and methods disclosed herein. Various ideas and combinations that can be derived from the contents of this document (including both the text and the accompanying drawings) are to be considered as disclosed and included herein. Brief Description of the Drawings Figures 1-5D show a first embodiment of a device that provides needle electrode placement, stabilization, and safety, in accordance with the invention. Figure 1 is a top perspective view with the device in its ready-for-use state, after it is removed from sterile packaging and before it is used on a patient. Figure 2 is a bottom perspective view with the device in the same state as shown in Figure 1, except in Figure 2 the device’s release liners are shown exploded and removed to reveal the device’s adhesive pads. Figure 3A shows the device with its wings or tab members (on which the adhesive pads are disposed) folded partly back to reveal at least the sharp distal tip of the needle electrode. Figure 3B shows the device with the release liners partially removed from the adhesive pads and with the device’s wings or tabs folded fully back. Figure 4 shows the device with its wings or tabs down such that the adhesive pads are contacting the exterior body (skin surface) of the patient, and at least the sharp distal tip (not shown) of the needle electrode is now inserted into the skin of the patient. Figure 5A shows the device after use and withdrawn from the patient, with the needle electrode pulled up and out of the patient’s skin and the wings or tabs pulled up and off of the patient’s skin and folded back partially. Figure 5B also shows the device after use and removal from the patient, but now with the wings or tabs folded back all the way. Figure 5C shows how the wings or tabs of the device then can be moved forward AƩorney Docket No.: ALERA‐004 / 01WO 39427 / 13 toward the needle, and Figure 5D shows the sharp distal end of the withdrawn-from- the-patient needle electrode completely enclosed or encapsulated by the wings or tabs being moved together such that the respective adhesive pads touch and sandwich the distal portion of the needle between those two adhesive pads. Figures 6-8D show a second embodiment of a device that provides needle electrode placement, stabilization, and safety, in accordance with the invention. Figure 6 is similar to Figure 1, in that Figure 6 also is a top perspective view. Figure 6 shows the second embodiment of the device in its ready-for-use state, after the device is removed from its sterile packaging and before it is used on a patient. Like Figure 2, Figure 7 is a bottom perspective view. Figure 7 shows the second embodiment of the device in the same state as shown in Figure 6, except in Figure 7 the device’s release liners are shown exploded and removed to reveal the device’s adhesive pads. Figure 8A shows the device of Figure 6 but with its wings or tab members (on which the adhesive pads are disposed) folded partly back to reveal at least the sharp distal tip of the needle electrode. Figure 8B is similar to Figure 8A, but Figure 8B shows the device’s release liners being removed to reveal the adhesive pads of the two wings or tabs. Figure 8C shows the device with its wings or tabs down such that the adhesive pads are contacting the exterior of the skin of the patient, and at least the sharp distal tip (not shown) of the needle electrode is now inserted into the skin of the patient. Figure 8D shows the second embodiment of the device after it has been withdrawn from the patient and with the wings or tabs pushed together to completely enclose or encapsulate at least the sharp distal tip of the needle electrode between the two now- touching adhesive pads. Figures 9-12 show a third embodiment of a device that provides needle electrode placement, stabilization, and safety, in accordance with the invention. Figure 9 is a top perspective view of the third embodiment of the device. Figure 9 shows the third embodiment of the device in its ready-for-use state, after the device has been removed from its sterile packaging and before it is used on a patient. Figure 10 is a bottom perspective view of the device of Figure 9, with the device in the same state as shown in Figure 9. It is noted that this third embodiment of the device is shown in Figures 9-12 with just one adhesive pad (disposed on one of the device’s two wings or AƩorney Docket No.: ALERA‐004 / 01WO 39427 / 13 tabs) and is not shown with a release liner on that adhesive pad, but a release liner typically will be provided so the sticky adhesive pad is preserved and available for sticking onto the exterior surface of the skin of a patient only after the release liner is removed. Also, this third embodiment of the device could have an adhesive pad (and a corresponding release liner) disposed on the other wing or tab of the device. Figure 11 is a side view of the third embodiment of the device with one of the device’s wings or tabs moved to place the wings or tabs in a 90-degree, or approximately 90-degree, angle to each other, and thus with the sharp distal end of the needle electrode exposed (and ready to be inserted into the skin of a patient). Figure 12 is a perspective view of the device of Figure 11. While not shown in any of the figures with respect to this third embodiment of the device, it is noted that the sharp distal tip of the needle electrode can be inserted into the skin of the patient, and the wings or tabs of the device can be placed down flat, or substantially flat, against the exterior surface of the skin of the patient. Also, the placed device thereafter can be removed from the patient by a person pulling the wings or tabs up and off of the patient’s skin and the needle electrode out of the patient’s skin, and finally the wings or tabs of the removed device can be folded down to sandwich the sharp distal end of the needle electrode between the two wings or tabs of the device. Each of these drawings is referenced again and explained in more detail below. Detailed Description The invention relates to a device that can be used to place a needle electrode in the skin of a patient, stabilize the needle electrode once it is placed in the patient’s skin, and keep users of the device safe from any needle sticks by not exposing any user to the sharp distal tip of the needle electrode before and during placement of the needle electrode in the patient and also during and after removal of the needle electrode from the patient. Turning to the drawings to help illustrate certain embodiments according to the invention, it is noted that Figures 1-5D show a first embodiment of a device 100 that provides needle electrode placement, stabilization, and safety features, in accordance with the invention. In Figure 1, the device 100 has a member 102 for receiving at least AƩorney Docket No.: ALERA‐004 / 01WO 39427 / 13 a portion of a distal section of a lead wire. The lead wire has the needle electrode extending from its distal end, and the needle electrode has a sharp distal tip, as can be seen in Figures 1 and 2. The receiving member 102 can have one or more circular or semi-circular protrusions 108 that form the tunnel or path that receives the portion of the distal section of the lead wire. Other shapes for the protrusion(s) 108 are possible, but, given that lead wires used for patient monitoring typically are cylindrical, the shape shown in Figures 1, 4, and 5D typically is the shape that will be used for the protrusion(s) 108. The lead wire with the needle electrode extending from its distal end can be pre-installed in the device 100 and sealed in sterile packaging with the device 100, or a user at the location where the device 100 will be used can insert or install the lead wire with the needle electrode into the device 100 after the device 100 is removed from its sterile packaging. As shown in Figures 1 and 2, the device 100 has a first tab (or wing) 104 and a second tab (or wing) 106. Figure 2 shows that a portion of the bottom surface of each of the first and second tabs 104, 106 has an adhesive pad 124, 126, and a release liner 120, 122 for each of the adhesive pads 124, 126 typically will be placed over the adhesive pads 124, 126 before the device 100 is put into its sterile packaging for shipment to a hospital or other location where users of the device 100 work. Turning back to Figure 1, the two tabs 104, 106 are connected to each other by a spine 110 and two living hinges 112, 114 that are disposed on either side of the spine 110. The spine 110 has an aperture 116 that is aligned with the tunnel formed by the protrusion(s) 108 and that allows the needle electrode to pass therethrough. The first tab 104 can be U-shaped, as shown in Figure 1. As also shown in Figure 1, there can be space or a clearance 118 between the receiving member 102 and the first tab 104. As shown in Figure 4, the first tab 104 can have a groove 128 that is formed in the first tab 104, that is aligned with the tunnel formed by the protrusion(s) 108, and that is configured to accommodate the lead wire. Figure 3A shows the device 100 with its two tabs 104, 106 folded partly back to reveal at least the sharp distal tip of the needle electrode, and Figure 3B shows the device 100 with the release liners 120, 122 partially removed from the adhesive pads 124, 126 and with the tabs 104, 106 folded fully back. Figure 4 shows the device 100 AƩorney Docket No.: ALERA‐004 / 01WO 39427 / 13 with its tabs 104, 106 down such that the adhesive pads 124, 126 are contacting the exterior skin surface of the patient. In Figure 4, the sharp distal tip (not shown) of the needle electrode is inserted into the skin of the patient. Figure 5A shows the device 100 after use and withdrawn from the patient, with the needle electrode pulled up and out of the patient’s skin and the tabs 104, 106 pulled up and off of the patient’s skin and folded back partially. Figure 5B also shows the device 100 after use and removal from the patient, but now with the tabs 104, 106 folded back all the way. Figure 5C shows how the tabs 104, 106 of the device 100 then can be moved forward toward the sharp distal tip of the needle electrode, and Figure 5D shows the sharp distal end of the withdrawn-from-the-patient needle electrode completely enclosed or encapsulated by the tabs 104, 106 having been moved together such that the respective adhesive pads 124, 126 touch and sandwich the distal portion of the needle between those two adhesive pads 124, 126. Figures 6-8D show a second embodiment of a device 200 that provides needle electrode placement, stabilization, and safety, in accordance with the invention. Like Figure 1 with respect to the device 100, Figure 6 shows the device 200 in its ready-for- use state, after the device is removed from its sterile packaging and before it is used on a patient. Figure 7 shows the device 200 in the same state as shown in Figure 6, except in Figure 7 the release liners 220, 222 of the device 200 are shown exploded and removed to reveal the adhesive pads 224, 226 of the device 200. In Figures 6 and 7, the device 200 is shown as having a second tab 206 and a first tab that consists of a pair of tabs 204a, 204b as well as a receiving member 202. The components and features of the device 200 are similar to the components and features of the device 100. The device 200 has one or more protrusions 208, a spine 210, first and second living hinges 212, 214, and an aperture 216 in the spine 210. The device 200 also has a space or clearance 218 that is similar to the clearance 118 of the device 100. Use of the device 200, as shown in Figures 8A-8D, is similar to how the device 100 is used, as shown in Figures 3A-5D. Figure 8A shows the device 200 of Figure 6 but with its tab 204a, 204b and 206 folded partly back to reveal the sharp distal tip of the needle electrode. Figure 8B is similar to Figure 8A, but Figure 8B shows the release liners 220, 222 of the device 200 removed to reveal the adhesive pads 224, AƩorney Docket No.: ALERA‐004 / 01WO 39427 / 13 226 of the two tabs 204a, 204b and 206. Figure 8C shows the device 200 with its tabs 204a, 204b and 206 down such that the adhesive pads 224, 226 are contacting the exterior of the skin of the patient, and the sharp distal tip (not shown) of the needle electrode is now inserted into the skin of the patient. Figure 8D shows the device 200 after it has been withdrawn from the patient and with the tabs 204a, 204b and 206 pushed together to completely enclose or encapsulate the sharp distal tip of the needle electrode between the two now-touching adhesive pads 224, 226. A third embodiment of a device 300 that provides needle electrode placement, stabilization, and safety, in accordance with the invention, is shown in Figures 9-12. Figure 9 shows the device 300 in its ready-for-use state, after the device 300 has been removed from its sterile packaging and before it is used on a patient. Figure 10 is a bottom perspective view of the device 300 of Figure 9, with the device in the same state as shown in Figure 9. It is noted that the device 300 is shown in Figures 9-12 with just one adhesive pad 322 (disposed on just one of the tabs 304 of the two tabs 302, 304 that the device 300 has) and is not shown with a release liner on that adhesive pad 322, but a release liner typically will be provided so the sticky adhesive pad 322 is preserved and available for sticking onto the exterior surface of the skin of a patient only after the release liner is removed. Also, this device 300 could have an adhesive pad (and a corresponding release liner) disposed on the other tab 302 of the device 300, but it is not shown that way in Figures 9-12. For the device 300, the tab 302 and the receiving member 302 are one in the same. The protrusion(s) 308 are formed on the tab / receiving member 302. Unlike the device 100 and the device 200, the device 300 has a single living hinge 306 and no spine. There is an aperture 310 in the living hinge 306 that allows the needle electrode to pass therethrough. Unlike the device 100 and the device 200, the device 300 has a connection assembly 312 for releasably connecting the tabs 302, 304 and maintaining the tabs 302, 304 in a 90- degree, or approximately 90-degree, orientation to each other. The connection assembly 312 could be configured to achieve a different angle between the tabs 302, 304 other than 90 degrees, such as 30, 45, or 60 degrees, for example. The connection assembly 312 of the device 300 includes, as part of the tab 302, a ridge member 314 and two protrusions 316 formed opposite each other on the ridge AƩorney Docket No.: ALERA‐004 / 01WO 39427 / 13 member 314. The connection assembly 312 includes, as part of the tab 304, a pair of knuckle members 318 and an aperture 320 define in each knuckle member 318. The apertures 320 are configured to receive and hold the corresponding protrusions 316 on the ridge member 314. Figure 11 is a side view of the device 300 with one of the tabs 302, 304 moved to place the tabs 302, 304 in a 90-degree, or approximately 90-degree, angle to each other, and thus with the sharp distal end of the needle electrode exposed (and ready to be inserted into the skin of a patient). Figure 12 is a perspective view of the device 300 of Figure 11. While not shown in any of the figures with respect to this third embodiment of the device 300, it is noted that the sharp distal tip of the needle electrode can be inserted into the skin of the patient, and the tabs 302, 304 of the device 300 can be placed down flat, or substantially flat, against the exterior surface of the skin of the patient. Also, the placed device 300 thereafter can be removed from the patient by a person pulling one or both of the tabs 302, 304 up and off of the patient’s skin and thus the needle electrode out of the patient’s skin. And, finally, the tabs 302, 304 of the removed device 300 can be folded down to sandwich the sharp distal end of the needle electrode between the two tabs 302, 304 of the device 300. Not including the adhesive pads, release liners, lead wires, and needle electrodes, each of the devices 100, 200, and 300 can be made as a single-piece unit from a plastic material by using an injection molding process. A medical grade plastic typically would be used in such a process of making that unit. As one example, polyethylene is a common medical grade plastic polymer that can be used in an injection molding process to create a medical device. Each of the adhesive pads can have a bottom surface with an adhesive material on it that is designed to releasably adhere to the skin of a patient (such as a human or other mammal), and typically a different adhesive material will be on the opposite side of the adhesive pads to make the adhesive pads fixedly attach more securely or permanently to the bottom surface of the tabs of the devices. The adhesive pads could be ultrasound welded to the bottom surfaces of the tabs, for example, as opposed to being fixedly adhered with some type of adhesive, in order to make the adhesive pads more permanently attached to the bottom surfaces of the tabs. The point being that the pads should not AƩorney Docket No.: ALERA‐004 / 01WO 39427 / 13 release from the tabs when the adhesive pads are stuck to and removed from the patient’s exterior skin surface. The adhesive pads should hold to the patient’s skin when placed there, and the adhesive pads should pull away from the patient’s skin when pulled by the hand force applied by the user of the device, but the adhesive pads should remain securely fixed to the bottom surfaces of the tabs during normal handling and operation of the devices. The release liners are made of a material that will release easily (with the typical force a person can apply when peeling off the liner by hand) from the adhesive side of the pads that is designed to releasably attach to the exterior skin surface of a patient. Each of the embodiments shown and described herein with reference to Figures 1-5D, 6-8D, and 9-12 have certain features and aspects, and it is noted that one or more features and aspects of one embodiment can be applied to one or more of the other disclosed embodiments even if not expressly stated as such herein. Also, still other embodiments of devices and methods according to the invention are to be considered included herein even if not expressly stated or shown given that the invention is not limited only to the specific details or embodiments disclosed herein.

Claims

AƩorney Docket No.: ALERA‐004 / 01WO 39427 / 13 Claims 1. A device for use in patient monitoring, the device comprising: a first tab; a second tab including an adhesive on at least a portion of a bottom surface of the second tab; a member for receiving at least a portion of a distal section of a lead wire, the lead wire having a needle electrode extending from a distal end of the lead wire, and the needle electrode having a sharp tip at a distal end of the needle electrode; and a connector disposed between the first and second tabs and configured to allow the first and second tabs to be moved.

2. The device of claim 1 wherein the first tab is U-shaped.

3. The device of claim 1 wherein the first tab includes the adhesive on at least a portion of a bottom surface of the first tab.

4. The device of claim 1 wherein the device, without the adhesive or the lead wire, is formed as a single-piece unit by an injection molding process.

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