JP-7855741-B2 - Long medical needles

JP7855741B2JP 7855741 B2JP7855741 B2JP 7855741B2JP-7855741-B2

Inventors

アブマリー、ルンド
ミラー、ブロック
バルコベック、クリスチャン
エルデミル、ベルナ

Assignees

ボストンサイエンティフィックメディカルデバイスリミテッド

Dates

Publication Date: 20260508
Application Date: 20250108
Priority Date: 20200730

Claims (15)

In a device used for measuring a patient's biological characteristics, A long medical needle configured to be operated toward the said biological characteristics of the patient and positioned in close proximity to the said biological characteristics of the patient, comprising a long non-conductive body having an outer surface extending between a non-conductive distal portion and a non-conductive proximal portion, A conductive wire, which is aligned in close proximity along the outer surface of the elongated body and has an outer layer of electrical insulation, extending between the distal and proximal portions, and configured at the proximal portion to be electrically connectable to an energy source device, An apparatus comprising: an exposed conductive portion attached to the distal portion, comprising a metal outer layer forming a pattern of non-insulating portions, electrically connected to the conductive wire at the distal portion of the elongated medical needle via the metal outer layer , and configured to receive energy from the conductive wire in response to the conductive wire receiving energy from the energy source device, and to release the energy toward the biological feature after the elongated medical needle has been manipulated toward the biological feature and positioned in close proximity to the biological feature, and after the conductive wire has received the energy from the energy source device .
The elongated body defines an elongated needle lumen extending between the distal and proximal portions, The inside of the elongated needle lumen is electrically insulated by the elongated body . The apparatus according to claim 1, wherein the elongated needle lumen is configured to at least partially slidably receive an elongated guidewire assembly and to guide the movement of the elongated guidewire assembly between the proximal and distal portions .
The apparatus according to claim 2, wherein the elongated needle lumen provides an inclined surface that leads to a distal portal formed through the outer surface of the side wall of the elongated needle lumen.
The apparatus according to claim 1 , wherein the conductive portion is also configured to puncture the biological feature in response to the selective release of energy from the conductive portion toward the biological feature during use.
The apparatus according to claim 1 , wherein the outer diameter of the conductive wire is smaller than the outer diameter of the elongated body.
The apparatus according to claim 1 , wherein the distal portion includes a non-conductive cap.
The apparatus according to claim 1 , wherein the conductive portion forms a linear contour positioned above the distal portion.
The apparatus according to claim 1 , wherein the conductive portion forms a group of parallel lines extending across the outer tip of the distal portion.
The apparatus according to claim 1 , wherein the conductive portion forms a line extending across the outer tip of the distal portion.
The apparatus according to claim 1 , wherein the conductive portion forms an X-shaped configuration extending across the outer tip of the distal portion.
The elongated body defines the elongated needle lumen, and the elongated needle lumen extends between the distal portion and the proximal portion. The apparatus according to claim 1 , wherein the inside of the elongated needle lumen is electrically insulated by the elongated body.
The apparatus according to claim 11 , wherein the elongated needle lumen provides an inclined surface that leads to a distal portal formed through the outer surface of the side wall of the elongated needle lumen.
In order to receive the conductive wire at least partially, a channel is formed in the elongated body and the distal portion. The apparatus according to claim 1, wherein the conductive wire includes an internal conductor portion surrounded by an insulating portion, the insulating portion being received within the channel.
The distal portion has a metal outer layer formed on the outer surface of the distal portion. The apparatus according to claim 1 , wherein the electrical insulating material is formed on the metal outer layer.
The apparatus according to claim 1, wherein the elongated medical needle has a first circuit and a second circuit for emitting high-frequency energy (RF), the first circuit being configured to deliver RF energy in a first conductive portion, and the second circuit being differentially selected to deliver RF energy in a second conductive portion .

Description

This document relates to (but is not limited to) the technical field of long medical needles (and methods thereof). Known medical devices are configured to facilitate medical procedures and help healthcare providers diagnose and/or treat the medical conditions of patients with illnesses. It will be understood that there is a need to mitigate (at least partially) one problem associated with existing (known) medical needles. After much research and experimentation with existing (known) medical needles, a (at least partially) understanding of the problem and its solution have been (at least partially) identified and can be stated (at least partially) as follows: Epicardial access can be performed using a sharp mechanical needle. This needle is used to perforate the pericardial layer (of the heart) to gain access to the pericardial cavity/epicapericardium. This procedure can carry a high risk to the patient due to the proximity of the underlying epicardial layer and the myocardial layer beneath the thin pericardial layer. Performing this operation is analogous to perforating a piece of plastic wrap covering a steak without damaging the steak itself. Transseptal access to the left atrium may be performed by puncturing through the fossa ovale from the right atrium (of the heart). The puncture device, used with an accessory device, is positioned ideally to enter and traverse the right atrium via the femoral vein, inferior vena cava, and superior vena cava. Puncturing the tissue of the atrial septum using a mechanical needle carries the risk of cardiac tamponade and, otherwise, is unpredictable in terms of the required input. Radiofrequency energy source devices are configured to provide energy (such as radiofrequency energy) to known radiofrequency medical needles for tissue puncture, and do not require mechanical force input compared to mechanical needles. Considering this, known radiofrequency medical needles do not need to be mechanically sharp, reducing the risk of inadvertently puncturing the myocardial layer in epicardial access situations and reducing the risk of cardiac tamponade in transseptal access situations. Known radiofrequency medical needles may contain a hollow internal lumen to facilitate the injection and flow of contrast agent, in addition to guidewire insertion. However, in relation to radiofrequency medical needles, the internal lumen must be electrically insulated. If a metal guidewire is inserted into the needle lumen and the inner lumen is not electrically insulated, it could inadvertently deliver an electric shock (and/or burn) to the operator. Generally, the body of known radiofrequency medical needles is made from a core metal component such as stainless steel. It can transmit high-frequency energy to the distal electrode for tissue puncture. By insulating known radiofrequency medical needles from the inside, the inner diameter of the needle is reduced, which can decrease the flow of contrast agent and potentially eliminate compatibility with the guidewire. Known medical needles, unfortunately, have a long, electrically conductive body (the entire length of the known medical needle), and therefore, known medical needles may require a sufficient amount of electrical insulation (for the safety of the patient and the user or operator). Providing sufficient electrical insulation is a challenge; on the one hand, electrical insulation is necessary for safety, but on the other hand, utilizing a sufficient amount of electrical insulation increases the overall outer diameter of the known medical needle (therefore potentially limiting the applications of the known medical needle). To mitigate at least one problem related to existing technologies, an apparatus is provided (according to its primary embodiment). The apparatus is intended for use in conjunction with a patient's biometric features. The apparatus includes, but is not limited to, an elongated medical needle. The elongated medical needle is configured to be manipulated toward a patient's biometric feature and to be positioned in close proximity to the patient's biometric features. The elongated medical needle includes an electrically insulated elongated body having an outer surface extending between an electrically insulated distal portion and an electrically insulated proximal portion. An insulated conductive wire is aligned in close proximity along the outer surface between the electrically insulated distal portion and the electrically insulated proximal portion. An exposed conductive portion is attached to the electrically insulated distal portion. The exposed conductive portion is electrically connected to the insulated conductive wire. To mitigate at least one problem related to existing technologies, an apparatus is provided (according to its primary embodiment). The apparatus is intended for use in conjunction with a patient's biometric features. The apparatus includes, but is not limited to, an elongated medical needle. The elong