US-12623074-B2 - Electroporation device with detachable needle array with lock-out system

US12623074B2US 12623074 B2US12623074 B2US 12623074B2US-12623074-B2

Abstract

An electroporation device with a needle array removably attached thereto, the needle array having a body, a shroud movable with respect to the body between a rest position and one or more actuated positions, and an auto-lock assembly. Where the auto-lock assembly is adjustable between a locked configuration, where the shroud is not movable with respect to the body, and an unlocked configuration, where the shroud is movable with respect to the body, and where biasing the shroud from the rest position to the one or more actuated positions and back to the rest position adjusts the auto-lock from the unlocked configuration to the locked configuration.

Inventors

Beat Stadelmann
Stephen Kemmerrer
Alejandro Campillo-Agusti
Eduardo Ho
Nathan Lovell
Steven Masterson

Assignees

INOVIO PHARMACEUTICALS, INC.

Dates

Publication Date: 20260512
Application Date: 20230825

Claims (19)

1 . A single-use needle array for an electroporation device, the single-use needle array comprising: a body member; a shroud movable with respect to the body member along an axial direction oriented along a central axis of the needle array between a rest position and one or more actuated positions; and an auto-lock, comprising: a contact surface and a locking surface that are each fixed with respect to the body member, and a resilient body that is spaced from the central axis along a radial direction that is perpendicular to the central axis, the resilient body having a first end fixedly coupled to the shroud and a second end opposite the first end, wherein the auto-lock is configured such that: the second end of the resilient body engages the contact surface when the shroud is in the rest position, and axial movement of the shroud from the rest position to the one or more actuated positions causes the resilient body to flex in a lateral direction perpendicular to the axial and radial directions so that the second end engages the locking surface.
2 . The single-use needle array of claim 1 , wherein the locking surface has a first portion and a second portion offset from the first portion, the second end of the resilient body engages the second portion of the locking surface when the shroud is in the one or more actuated positions.
3 . The single-use needle array of claim 2 , wherein the resilient body is configured such that axial movement of the shroud from the one or more actuated positions back to the rest position causes the second end of the resilient body to additionally flex in the lateral direction into engagement with the first portion of the locking surface, wherein the shroud is blocked from returning to the one or more actuated positions once the second end of the resilient body engages the first portion of the locking surface.
4 . The single-use needle array of claim 3 , wherein the axial movement of the shroud from the one or more actuated positions back to the rest position causes the second end of the resilient body to slide along the second portion of the locking surface before engaging the first portion of the locking surface, and the second end of the resilient body is slidable along the second portion of the locking surface without inhibiting movement of the shroud with respect to the body member in the axial direction.
5 . The single-use needle array of claim 3 , wherein: the locking surface has an intermediate portion extending between the first and second portions, and the locking surface is configured such that, when the second end of the resilient body contacts the first portion of the locking surface, the intermediate portion faces the second end of the resilient body so as to block the shroud from returning to the one or more actuated positions.
6 . The single-use needle array of claim 1 , wherein the resilient body defines a locking tip at the second end, wherein the locking tip extends radially inward toward the central axis from a remainder of the resilient body, the locking tip engages the contact surface when the shroud is in the rest position, and the locking tip engages the locking surface when the shroud is in the one or more actuated positions.
7 . The single-use needle array of claim 6 , wherein a rear edge of the contact surface defines an activation point, such that once the locking tip passes the activation point during movement of the shroud from the rest position to the one or more actuated positions, the locking tip flexes into engagement with the locking surface.
8 . A single-use needle device, comprising: a body member having a contact surface and a locking surface; a shroud movable with respect to the body member along an axial direction oriented along an axis between a rest position and one or more actuated positions; and a resilient body spaced from the axis along a radial direction perpendicular to the axis, the resilient body having a first end fixedly coupled to the shroud and a second end opposite the first end, wherein the resilient body defines a locking tip at the second end, the locking tip extending radially inward toward the axis from a portion of the resilient body intermediate the first and second ends of the resilient body, wherein the resilient body is configured such that: the locking tip engages the contact surface when the shroud is in the rest position, and axial movement of the shroud from the rest position to the one or more actuated positions causes the resilient body to flex in a lateral direction perpendicular to the axial and radial directions so that the locking tip engages the locking surface.
9 . The single-use needle device of claim 8 , wherein the locking surface has a first portion and a second portion offset from the first portion, the locking tip of the resilient body engages the second portion of the locking surface when the shroud is in the one or more actuated positions.
10 . The single-use needle device of claim 9 , wherein the resilient body is configured such that axial movement of the shroud from the one or more actuated positions back to the rest position causes the second end of the resilient body to additionally flex in the lateral direction thereby bring the locking tip into engagement with the first portion of the locking surface, wherein the shroud is blocked from returning to the one or more actuated positions once the locking tip of the resilient body engages the first portion of the locking surface.
11 . The single-use needle device of claim 9 , wherein the axial movement of the shroud from the one or more actuated positions back to the rest position causes the locking tip of the resilient body to slide along the second portion of the locking surface before engaging the first portion of the locking surface, and the locking tip of the resilient body is slidable along the second portion of the locking surface without inhibiting movement of the shroud with respect to the body member in the axial direction.
12 . The single-use needle device of claim 9 , wherein: the locking surface has an intermediate portion extending between the first and second portions, and the locking surface is configured such that, when the locking tip of the resilient body contacts the first portion of the locking surface, the intermediate portion faces the second end of the resilient body so as to block the shroud from returning to the one or more actuated positions.
13 . The single-use needle device of claim 12 , wherein the first, intermediate, and second portions of the locking surface form a Z-shape.
14 . The single-use needle device of claim 8 , wherein a rear edge of the contact surface defines an activation point, such that once the locking tip passes the activation point during movement of the shroud from the rest position to the one or more actuated positions, the resilient body flexes the locking tip into engagement with the locking surface.
15 . The single-use needle device of claim 8 , further comprising a needle assembly coupled to the body member, wherein the needle assembly is unexposed when the shroud is in the rest position, and at least a portion of the needle assembly is exposed when the shroud is in the one or more actuated positions.
16 . The single-use needle device of claim 15 , wherein the needle assembly includes one or more electrodes that (1) are positioned within the shroud when the shroud is in the rest position, and (2) extend outside the shroud when the shroud is in the one or more actuated positions.
17 . The single-use needle device of claim 16 , wherein the shroud defines a contact plate at a distal end of the shroud, and the contact plate is configured to press against a patient, thereby causing the shroud to move from the rest position toward the one or more actuated positions.
18 . The single-use needle device of claim 17 , wherein the contact plate defines one or more apertures, such that movement of the shroud from the rest position toward the one or more actuated positions causes a tip of each of the one or more electrodes to pass through a corresponding one of the one or more apertures.
19 . The single-use needle device of claim 17 , wherein the needle assembly includes an injection needle, and the contact plate defines an injection aperture, such that movement of the shroud from the rest position toward the one or more actuated positions causes a tip of the injection needle to pass through the injection aperture.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a divisional of U.S. patent application Ser. No. 17/366,477, filed Jul. 2, 2021, which is a continuation of application Ser. No. 16/067,481, which is a National Stage Application that claims priority to International Patent Application No. PCT/US2016/069438, filed Dec. 30, 2016, which claims priority to U.S. Provisional Patent Application No. 62/272,758, filed Dec. 30, 2015. The above referenced applications are each hereby incorporated by reference in their entireties. BACKGROUND OF THE INVENTION The present invention relates to a detachable needle array for use on an electroporation device, and more specifically a detachable needle array having two, independent needle lock-out mechanisms. SUMMARY Modern medical treatments, such as electroporation treatments, injections, and the like, generally require the use of some form of needle, electrode, or other form of sharps. During use, these items may come into contact with or are inserted into a patient, causing the items to become contaminated with the patient's tissue and bodily fluids. Even after the items have been removed from the patient and are no longer in use, they still pose numerous safety risks to the clinicians and the patients. Some safety risks may include cross-contamination, needle sticks, and the like. Furthermore, the electroporation process requires the use of different sharps at different times. For examples, a hypodermic needle may be initially required to inject agent into the target tissue but then may no longer be needed when the electroporation signal is administered. Because of these elements of the electroporation process, it may be necessary to lock-out various sets and subsets of elements (i.e., sharps) independently of one another. Such capabilities not only provide more control and flexibility during the electroporation process, they also provide a safer device assuring that any elements that are no longer needed are safely locked-out and unable to come into contact with the target tissue. In one aspect, an electroporation device including a handset, where the handset includes a housing defining a mounting point, and a signal generator positioned within the housing. The electroporation device also includes a needle array removably couplable to the mounting point and in electrical communication with the signal generator when the needle array is coupled to the mounting point, the needle array including a body, a shroud movable with respect to the body between a rest position and one or more actuated positions, an auto-lock adjustable between a locked configuration, where the shroud is not movable with respect to the body, and an unlocked configuration, where the shroud is movable with respect to the body, and where biasing the shroud from the rest position to the one or more actuated positions and back to the rest position adjusts the auto-lock from the unlocked configuration to the locked configuration. In another aspect, an electroporation device includes a handset including a housing defining a mounting point, a power source, and a signal generator in electrical communication with the power source. The electroporation device also includes a needle array releasably couplable to the mounting point of the housing, the needle array including a body, one or more electrodes coupled to the body, a shroud movable with respect to the body between a rest position and one or more actuated positions, and where at least a portion of the one or more electrodes are positioned outside the shroud when the shroud is in each of the one or more actuated positions, a receiver moveable with respect to the body between an injection position and a retracted position, the receiver having a hypodermic needle extending therefrom, and a locking pin coupled to one of the body and the receiver and moveable with respect thereto between a locked position, where the receiver is fixed with respect to the body, and an unlocked position, where the receiver is movable with respect to the body, and where the locking pin is biased toward the locking position such that when receiver is positioned in a predetermined location with respect to the body, the locking pin moves into the locked position In still another aspect, an electroporation system for performing electroporation treatment, the system including a base station, and a handset that is removably couplable to the base station. Where the handset includes a housing having a mount formed thereon, a power source positioned within the housing, and an injection assembly having a release member thereon. The electroporation system also including a needle array releasably couplable to the mount of the housing, the needle array including a body, one or more electrodes coupled to the body, a shroud movable with respect to the body between a rest position and one or more actuated positions, and where at least a portion of the one or more electrodes are exposed w