US-20260123985-A1 - MULTIPLE ELECTRODE HEART VALVE SLITTING DEVICE

US20260123985A1US 20260123985 A1US20260123985 A1US 20260123985A1US-20260123985-A1

Abstract

An apparatus includes a flexible elongate member positionable within a patient body, and including a first tine having a first crossing electrode and a first cutting electrode, a second tine having a second crossing electrode and a second cutting electrode; and a polymer jacket positioned around the first tine and the second tine. The polymer jacket is configured to prevent longitudinal and rotational motion of the first tine and second tines relative to one another. The first tine and second tines are configured to transition between a straight configuration and a hook-shaped configuration. The first crossing electrode and second crossing electrode are configured to cut anatomy of the patient body while the first tine and second tine are in the straight configuration. The first cutting electrode and second cutting electrode are configured to cut the anatomy while the first tine and second tine are tine are in the hook-shaped configuration.

Inventors

Mikhail Borisovich Tikh
James Allen Jensen

Assignees

KONINKLIJKE PHILIPS N.V.

Dates

Publication Date: 20260507
Application Date: 20251001

Claims (17)

1 . An apparatus, comprising: a flexible elongate member configured to be positioned within a patient body and comprising: a first tine comprising a first crossing electrode and a first cutting electrode; a second tine comprising a second crossing electrode and a second cutting electrode; and a polymer jacket positioned around the first tine and the second tine, wherein the polymer jacket is configured to prevent longitudinal motion and rotational motion of the first tine and the second tine relative to one another, wherein the first tine and the second tine are configured to transition between a straight configuration and a hook-shaped configuration, wherein the first crossing electrode and the second crossing electrode are configured to cut anatomy of the patient body while the first tine and the second tine are in the straight configuration, wherein the first cutting electrode and the second cutting electrode are configured to cut the anatomy while the first tine and the second tine are tine are in the hook-shaped configuration.
2 . The apparatus of claim 1 , wherein the first tine and the second tine each comprise a proximal portion and a distal portion, wherein the polymer jacket is positioned around the proximal portion of the first tine and the second tine.
3 . The apparatus of claim 2 , wherein the first crossing electrode and the first cutting electrode are positioned at the distal portion of the first tine, wherein the second crossing electrode and the second cutting electrode are positioned at the distal portion of the second tine, wherein the polymer jacket is not positioned around the distal portion of the first tine and the second tine such that the distal portion of the first tine and the second tine are uncovered to allow transition between the straight configuration and the hook-shaped configuration.
4 . The apparatus of claim 1 , wherein the flexible elongate member comprises a third tine comprising a third crossing electrode and a third cutting electrode.
5 . The apparatus of claim 4 , wherein the first tine, the second tine, and the third tine are arranged in a triangular configuration.
6 . The apparatus of claim 5 , wherein the jacket is configured to fixedly maintain the first tine, the second tine, and the third tine in the triangular configuration.
7 . The apparatus of claim 4 , wherein the polymer jacket is bonded with a polymer of the first tine, a polymer of the second tine, and a polymer of the third tine.
8 . The apparatus of claim 1 , wherein the first tine and the second tine are more radially spaced from one another in the hooked configuration than in the straight configuration.
9 . The apparatus of claim 8 , wherein the second tine is configured to have radial motion in a first direction relative to the first tine when the first tine and the second tine transition from the straight configuration to the hooked configuration.
10 . The apparatus of claim 9 , wherein the flexible elongate member comprises a third tine configured to transition between the straight configuration and the hook-shaped configuration, wherein the third tine is configured to have radial motion in an opposite, second direction relative to the first tine when the first tine, the second tine, and the third tine transition from the straight configuration to the hook-shape configuration.
11 . The apparatus of claim 10 , wherein the first tine comprises a central tine, wherein the second tine is positioned on a first side of the central tine, and the third tine is positioned on an opposite second side of the central tine.
12 . The apparatus of claim 1 , wherein the first tine and the second tine comprise a different structure from one another.
13 . The apparatus of claim 12 , wherein the second tine and not the first tine comprises a first plurality of slits configured to provide radial motion relative to the first tine, wherein the plurality of slits are positioned proximal of the second crossing electrode and the second cutting electrode.
14 . The apparatus of claim 13 , wherein the first tine and the second tine comprise a second plurality of slits configured to provide deflection, in a same direction, for: the first crossing electrode and the first cutting electrode; and the second crossing electrode and the second cutting electrode.
15 . The apparatus of claim 1 , wherein the anatomy comprises a heart valve leaflet, wherein, to cut the heart valve leaflet, the first crossing electrode and the second crossing electrode are configured to simultaneously puncture the heart valve leaflet, wherein, to cut the heart valve leaflet, the first cutting electrode and the second cutting electrode are configured to simultaneously slit the heart valve leaflet.
16 . The apparatus of claim 15 , wherein the first crossing electrode and the second crossing electrode are configured to simultaneously puncture the heart valve leaflet during an individual first movement of the intracardiac device, and wherein the first cutting electrode and the second cutting electrode are configured to simultaneously slit the heart valve leaflet during an individual second movement of the intracardiac device.
17 . The apparatus of claim 16 , wherein the individual first movement of the intracardiac device comprises a forward longitudinal movement of the intracardiac device while in a straight configuration, wherein the individual second movement of the intracardiac device comprises a backward longitudinal movement of the intracardiac device while in a hook-shaped configuration.

Description

TECHNICAL FIELD The subject matter described herein relates to cardiac valve replacement and, in particular, to the reducing or eliminating blood flow obstruction to the human heart before/during cardiac valve replacement procedures (e.g., to prepare the site for valve replacement). For example, a catheter-deployed, multi-tined intravascular leaflet slitting device may be utilized to produce multiple simultaneous slits in a heart valve (e.g., aortic valve) leaflet, to prevent obstruction of coronary arteries. BACKGROUND One common type of valve disease is aortic valve stenosis, in which the valve between the aorta and the heart’s left ventricle is narrowed and doesn't fully open. This reduces blood flow from the heart to the aorta and thus to the rest of the body. With the advent of minimally invasive procedures, valve replacement may currently be the most common therapy for aortic valve stenosis. More particularly, transvenous/transcatheter aortic valve replacement (TAVR) is becoming a more common valve replacement procedure, as technology and doctor skillsets improve. This minimally invasive approach to valve replacement is an alternative to open heart surgical aortic valve replacement (SAVR). In a TAVR procedure, the damaged valve, whether the valve is a natural aortic valve or a previous SAVR or TAVR valve, is left in place. These valves may have anatomical abnormalities, calcification, or infection. TAVR has been approved for low-risk patients, who in general are of younger age and live longer. Recent studies have shown that the life of a TAVR valve will only be on average 8 years, so there will be an increase in replacement TAVR procedures. Old TAVR leaflets may be fibrosed, calcified, or thickened during the life of the TAVR valve, creating a barrier to the replacement TAVR valve. The old leaflets may also pose a more serious risk of coronary obstruction than native valves. Thus, certain structural heart procedures such as trans-catheter valve replacement can cause the leaflets of the native valve, or those of a previously implanted valve, to be forced outward radially from the valve, thereby closing off either vessels that originate in the vicinity of the valve, or the blood path downstream from the valve (outflow tract). Accordingly, many structural heart procedures, including TAVR and other valve replacement procedures, benefit from slitting of the leaflets of native and/or implanted valves. However, with current methods, there is no practical way to produce multiple slits in a heart valve leaflet, even where it is advantageous to do so. Thus, a need exists for improved intracoronary methods to address the foregoing and other concerns. The information included in this Introduction section of the specification, including any references cited herein and any description or discussion thereof, is included for context and/or technical reference purposes only and is not to be regarded as subject matter by which the scope of the disclosure is to be bound or otherwise limited in any manner. SUMMARY Disclosed herein is a multi-tined leaflet puncture and slitting device, with associated systems and methods. The device includes multiple first electrodes capable of puncturing the tissue of the leaflet and multiple second, hook-shaped electrodes capable of extending the puncture to slit the leaflet. The electrodes are energized with electrical energy. This leaflet puncture and slitting device enables a clinician to simultaneously produce multiple punctures the leaflet in precise locations and then simultaneously produce multiple slits in a controlled manner, in a direction away from the wall of the heart or aorta, thus preventing unintended damage to nearby anatomical structures. The leaflet puncture and slitting device has particular but not exclusive utility for modifying heart valve leaflets during intracardiac valve replacements. A system of one or more computers can be configured to perform particular operations or actions by virtue of having software, firmware, hardware, or a combination of them installed on the system that in operation causes or cause the system to perform the actions. One or more computer programs can be configured to perform particular operations or actions by virtue of including instructions that, when executed by data processing apparatus, cause the apparatus to perform the actions. One general aspect includes an apparatus that includes a puncture and slitting device, which may include: a flexible elongate member configured to be positioned within a body lumen of a patient, and a cutting assembly positioned at a distal portion of the flexible elongate member. The cutting assembly may include: a first conductor, a crossing electrode configured to be energized by the first conductor, a second conductor electrically isolated from the first conductor, and a cutting electrode configured to be energized by the second conductor. Other examples of this aspect include corresponding computer