US-12622738-B2 - Medical devices and related methods

US12622738B2US 12622738 B2US12622738 B2US 12622738B2US-12622738-B2

Abstract

A medical device includes an electrode shaft and a tip. The electrode shaft is configured to deliver energy to a target site and includes an electrode shaft lumen configured to deliver fluid to the target site. The tip is coupled to a distal tip of the electrode shaft. The tip includes an inner portion of conductive material and an exterior layer of insulative material. The tip includes a tip lumen fluidly connected to the electrode shaft lumen and configured to deliver fluid to the target site.

Inventors

Daniel J. Foster
Matthew P. Jones
Allyn N. Jensrud
John Kummailil

Assignees

BOSTON SCIENTIFIC SCIMED INC.

Dates

Publication Date: 20260512
Application Date: 20210604

Claims (19)

1 . A medical device, comprising: a shaft including a shaft lumen configured to direct a flow of fluid through the shaft; an electrode shaft configured to deliver energy to a target site and including: an electrode shaft lumen configured to deliver fluid from the shaft lumen to the target site; and a distal end including a widened portion that extends radially outward relative to a longitudinal axis of the electrode shaft; and a tip coupled to the distal end of the electrode shaft, the tip including: two half portions that each include at least one groove on a radially inner face, wherein each groove is configured to receive at least a portion of the widened portion of the distal end of the electrode shaft, wherein each groove extends radially outward relative to the longitudinal axis of the electrode shaft, and wherein each half portion includes at least an exterior layer of insulative material; and an electrode plate on a proximal end of the tip, wherein the electrode plate is a separate component from the electrode shaft and the tip, and wherein the electrode plate is coupled to the proximal end of the tip, wherein the insulative material of the tip encapsulates an entire distal end of conductive material of the distal end of the electrode shaft, wherein the tip includes a tip lumen fluidly connected to the electrode shaft lumen and configured to deliver fluid to the target site, wherein the tip lumen and the electrode shaft lumen are longitudinally aligned and fluidically connected, and wherein a distal end portion of the tip lumen includes a widened chamfer to disperse fluid delivered to a target site, and wherein the electrode shaft and the tip with the exterior layer of insulative material are longitudinally movable together relative a distal end of the shaft.
2 . The medical device of claim 1 , wherein the tip lumen is positioned entirely distal from the electrode shaft lumen.
3 . The medical device of claim 2 , wherein an entire exterior of the tip comprises the exterior layer, and wherein the exterior layer is formed by a sputtering procedure.
4 . The medical device of claim 3 , wherein the insulative material is ceramic.
5 . The medical device of claim 4 , wherein the exterior layer is approximately 300 microns thick.
6 . The medical device of claim 1 , wherein the tip includes a rounded distal end and a cylindrical side portion.
7 . The medical device of claim 1 , wherein the tip is cylindrical and includes rounded edges.
8 . The medical device of claim 1 , wherein the electrode shaft includes a plurality of insulated portions, and wherein the plurality of insulated portions are longitudinally spaced apart on a length of the electrode shaft.
9 . The medical device of claim 1 , wherein the electrode plate is conductive and is electrically connected to the electrode shaft such that the electrode plate is energized when the electrode shaft is energized.
10 . The medical device of claim 9 , wherein the electrode plate is circular and covers an entirety of the proximal end of the tip.
11 . The medical device of claim 9 , wherein the electrode plate is triangular or star shaped.
12 . The medical device of claim 1 , wherein the electrode shaft is formed of one piece of metallic material.
13 . A medical device, comprising: a handle including a fluid port and an energy receiving hub; a shaft including a shaft lumen configured to direct a flow of fluid through the shaft from the fluid port; a conductive element electrically connected to the energy receiving hub and passing through at least a portion of the handle and/or the shaft; and an electrode coupled to a distal end of the shaft, wherein the electrode includes an electrode shaft and a tip extending distally from and fixedly coupled to the electrode shaft, and wherein the tip includes an inner portion of conductive material and an exterior layer of an insulative material, wherein the insulative material encapsulates an entire distal end of the conductive material, wherein the electrode shaft is electrically connected to the conductive element and includes an electrode shaft lumen fluidly connected to the shaft lumen, and wherein the tip includes a tip lumen extending through the exterior layer of insulative material, and wherein the tip lumen is fluidly connected to the electrode shaft lumen and configured to deliver fluid from a distal end of the electrode; wherein the electrode shaft and the tip are extendable and retractable together relative to the shaft; wherein the insulative material includes (i) a first half portion including a first portion of the tip lumen, and (ii) a second half portion including a second portion of the tip lumen, and wherein the first half portion and the second half portion are separate components that are coupled together to encapsulate the entire distal end of the conductive material and to form the tip lumen; and wherein the distal end of the electrode shaft or the conductive material of the tip includes a widened end portion, wherein the widened end portion extends radially outward relative to a longitudinal axis of the electrode shaft, wherein the first half portion and the second half portion of the tip each includes a groove on a radially inner face, wherein each groove is configured to receive at least a portion of the widened end portion, and wherein each groove extends radially outward relative to the longitudinal axis of the electrode shaft.
14 . The medical device of claim 13 , wherein the handle further includes a main body and a movable body, wherein movement of the movable body relative to the main body moves the electrode, including the electrode shaft and the tip, relative to the distal end of the shaft.
15 . The medical device of claim 14 , wherein, with the movable body in a proximally retracted position, only the tip of the electrode is exposed distally beyond the shaft, wherein, with the movable body in a distally extended position, the tip of the electrode and at least a portion of the electrode shaft are exposed distally beyond the shaft, and wherein a distal end portion of the tip lumen includes a widened chamfer to disperse fluid delivered to a target site.
16 . A medical device, comprising: an electrode shaft including an electrode shaft lumen configured to receive fluid, wherein a distal end of the electrode shaft includes a widened end portion, wherein the widened end portion extends radially outward relative to a longitudinal axis of the electrode shaft; and a tip fixedly coupled to a distal tip of the electrode shaft and including insulative material, wherein the insulative material of the tip includes a first tip half portion and a second tip half portion, and wherein the first tip half portion is a separate component from the second tip half portion, and wherein the first tip half portion is welded to the second tip half portion with the electrode shaft positioned between the first tip half portion and the second tip half portion, wherein the insulative material insulates at least a distal portion of the medical device, including insulating at least an entirety of the distal tip of the electrode shaft, wherein the tip includes a tip lumen fluidly connected to the electrode shaft lumen to form a channel, wherein the tip lumen extends through insulative material formed by the first tip half portion and the second tip half portion, and wherein a distal end portion of the tip lumen includes a widened chamfer to disperse fluid delivered to a target site, wherein the channel extends through the electrode shaft and the tip along a longitudinal axis of the medical device, and wherein the insulative material of the tip includes a groove on a radially inner face in each of the first tip half portion and the second tip half portion, wherein each groove extends radially outward relative to the longitudinal axis of the electrode shaft, and wherein each groove is configured to receive a portion of the widened end portion when the first tip half portion of insulative material and the second tip half portion of insulative material are welded together.
17 . The medical device of claim 16 , wherein the tip formed by the first tip half portion and the second tip half portion includes a rounded distal portion and a cylindrical side portion.
18 . The medical device of claim 16 , wherein the insulative material is ceramic.
19 . The medical device of claim 13 , wherein each of the first tip half portion and the second tip half portion include a partially cylindrical side portion and a partially rounded distal portion.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This present disclosure claims priority to U.S. Provisional Patent Application No. 63/037,185, filed on Jun. 10, 2020, the disclosure of which is incorporated herewith by reference. TECHNICAL FIELD Aspects of this disclosure generally relate to medical devices and related methods. Embodiments of the disclosure relate to medical devices and related methods configured for the treatment of tissue by delivering electrical energy to or into tissue and/or injecting fluid into and/or under tissue with an electrode having an insulated distal tip. BACKGROUND Medical devices, such as endoscopes or other suitable insertion devices, are employed for a variety of types of diagnostic and surgical procedures, such as endoscopy, laparoscopy, arthroscopy, gynoscopy, thoracoscopy, cystoscopy, etc. Many of these procedures involve delivering energy to tissue of an organ or a gland to treat tumors, infections, and the like. Examples of such procedures include Endoscopic Mucosal Resection (EMR), Endoscopic Sub-mucosal Resection (ESR), Endoscopic Sub-mucosal Dissection (ESD), polypectomy, mucosectomy, etc. In particular, such procedures may be carried out by inserting an insertion device into a subject's body through a surgical incision, or via a natural anatomical orifice (e.g., mouth, vagina, or rectum), and performing the procedure or operation at a target site with an auxiliary device inserted through the insertion device. At times, during a medical procedure, a user may use an injection needle and an energy delivery device for purposes of raising, separating, flushing, cutting, dissecting, ablating, marking, coagulating, cauterizing, or otherwise treating and/or manipulating tissue. The injection and energy delivery may be performed separately. For example, in order to deliver energy to the tissue, the user may be required to remove the injection needle from the insertion device and deliver the energy delivery device through the insertion device to the tissue being targeted, and vice versa. During the procedure, the user may alternate using the injection needle and the energy delivery device, and exchanging devices may increase the duration and risks of the medical procedure. Additionally, one or more portions of the energy delivery device may inadvertently contact or harm tissue (or an inner channel of the insertion device) when energized. The devices and methods of this disclosure may rectify one or more of the deficiencies described above or address other aspects of the art. SUMMARY Examples of the disclosure relate to, among other things, medical devices configured for treating tissue by delivering electrical energy to the tissue, and configured for delivering fluid into and/or under the tissue. Each of the examples disclosed herein may include one or more of the features described in connection with any of the other disclosed examples. In one example, a medical device may include an electrode shaft and a tip. The electrode shaft may be configured to deliver energy to a target site and may include an electrode shaft lumen configured to deliver fluid to the target site. The tip may be coupled to a distal tip of the electrode shaft. The tip may include an inner portion of conductive material and an exterior layer of insulative material. The tip may include a tip lumen fluidly connected to the electrode shaft lumen and configured to deliver fluid to the target site. The medical device may include one or more of the following features. An entire exterior of the tip may include the exterior layer. The exterior layer may be formed by a sputtering procedure. The insulative material may be ceramic. The exterior layer may be approximately 300 microns thick. The tip may include a rounded distal end and a cylindrical side portion. The tip may be cylindrical. The tip may include rounded edges. The medical device may further include an electrode plate on a proximal end of the tip. The electrode plate may be conductive and may be electrically connected to the electrode shaft such that the electrode plate is energized when the electrode shaft is energized. The electrode plate may be circular and may cover an entirety of the proximal end of the tip. The electrode plate may be triangular or star-shaped. The electrode shaft may include a plurality of insulated portions, and the insulated portions may be longitudinally spaced apart on a length of the electrode shaft. The electrode shaft and the inner portion of the tip may be formed of a metallic material, and the electrode shaft and the tip may be welded together. The electrode shaft and the inner portion of the tip may be formed of one piece of metallic material. In another example, a medical device may include a handle, a shaft, a conductive element, and an electrode. The handle may include a fluid port and an energy receiving hub. The shaft may include a shaft lumen configured to direct a flow of fluid through the shaft from the fluid port. The