CN114041872A - Valve leaflet segmenting device - Google Patents

本发明涉及一种瓣叶分割装置，包括：推送管；第一固定件和第二固定件，其近端均固定于推送管的远端；第一固定件和第二固定件的远端在自然状态下远离推送管的延伸方向；切割导管，可滑动地设置于推送管内；切割导管的远端具有切割部，切割部包括切割电极；切割部的远端在自然状态下远离切割导管的延伸方向；内管，可滑动地设置于切割导管内；限位端头，设置于内管的远端；限位端头具有能够容纳第二固定件远端的限位孔。本发明设置切割电极并通过推送管递送到主动脉瓣，能够对瓣叶进行准确快速的切割。设置第一固定件和第二固定件，且第二固定件的远端能够容纳在限位孔内，在需要固定瓣叶时第二固定件再从限位孔内分离，保证对瓣叶准确定位。

The invention relates to a valve leaflet dividing device, comprising: a pushing tube; a first fixing piece and a second fixing piece, the proximal ends of which are both fixed to the distal end of the pushing tube; the distal ends of the first fixing piece and the second fixing piece are In a natural state, it is far away from the extension direction of the pushing tube; the cutting catheter is slidably arranged in the pushing tube; the distal end of the cutting catheter has a cutting part, and the cutting part includes a cutting electrode; the distal end of the cutting part is away from the extension of the cutting catheter in a natural state The inner tube is slidably arranged in the cutting catheter; the limiting tip is arranged at the distal end of the inner tube; the limiting tip has a limiting hole capable of accommodating the distal end of the second fixing piece. The invention sets the cutting electrode and delivers it to the aortic valve through a push tube, so that the valve leaflet can be cut accurately and quickly. A first fixing member and a second fixing member are provided, and the distal end of the second fixing member can be accommodated in the limiting hole, and the second fixing member is separated from the limiting hole when the valve leaflet needs to be fixed, so as to ensure accurate positioning of the valve leaflet. position.

Valve leaflet segmenting device

Technical Field

The invention relates to the field of medical instruments, in particular to a valve leaflet segmentation device and a valve leaflet segmentation system.

Background

Aortic stenosis is a common cardiac structural disorder in the elderly, with increasing incidence with age. Aortic valve replacement by open surgical procedure is an effective treatment for aortic stenosis, but patients of about 1/3 cannot receive open surgical procedure due to advanced age, weakness or other factors. Transcatheter Aortic Valve Replacement (TAVR) is a minimally invasive Valve Replacement, which is a procedure in which a prosthetic heart Valve is delivered to the Aortic Valve site by an interventional catheter technique, thereby completing implantation of the prosthetic Valve and restoring the Valve function. TAVR has become the current treatment of replacement for patients with surgical high risk symptomatic severe aortic stenosis and the first choice for patients with surgical contraindications.

In our country, a considerable proportion of patients with aortic stenosis have had their native aortic valves heavily calcified and bilobally malformed lesions. In bilobal aortic valve lesions, the leaflets of the patient's aortic valve partially merge such that the aortic valve is composed of two leaflets rather than the normal three leaflets and the open orifice area is reduced. Before TAVR surgery is performed, a physician may need to separate two fused leaflets, expanding the effective open area of the orifice, so that the prosthetic valve can smoothly achieve valve crossing and be placed in a proper position of the native aortic valve, thereby ensuring optimal deployment of the prosthetic valve.

Delivery of cutting devices through a catheter for cutting fused leaflets has been reported in the art, but either the cutting devices employ complex positioning and cutting structures or are unable to specifically cut a single leaflet, resulting in less than optimal leaflet segmentation.

Disclosure of Invention

The invention discloses a valve leaflet segmenting device, which is used for solving the problems that in the prior art, a complex positioning and cutting structure is adopted, single-side valve leaflets are inconvenient to cut in a targeted mode, and the valve leaflet segmenting effect is not ideal.

In order to solve the problems, the invention adopts the following technical scheme:

provided is a leaflet parting device, comprising:

pushing the pipe;

the proximal ends of the first fixing piece and the second fixing piece are fixed at the distal end of the pushing tube; the far ends of the first fixing piece and the second fixing piece are far away from the extending direction of the pushing pipe in a natural state;

a cutting catheter slidably disposed within the push tube; the distal end of the cutting catheter has a cutting portion comprising a cutting electrode; the distal end of the cutting part is far away from the extending direction of the cutting catheter in a natural state;

an inner tube slidably disposed within the cutting catheter;

the limiting end is arranged at the far end of the inner tube; the limiting end head is provided with a limiting hole capable of accommodating the far end of the second fixing piece.

In the above aspect, the first fixing member and the second fixing member are arranged at the distal end of the push tube in a substantially overlapping arrangement along the axial direction of the push tube, wherein the second fixing member is located at the opposite distal end.

In the above scheme, the first fixing piece is provided with a first through groove, and/or the second fixing piece is provided with a second through groove.

In the above aspect, the first fixing member and the second fixing member are made of an elastic material.

In the above scheme, the second fixing piece can approach the inner tube under the action of external force; when the far end of the second fixing piece is inserted into the limiting hole, the second fixing piece is limited to bounce.

In the above scheme, when the inner tube slides towards the distal end relative to the pushing tube, the distal end of the second fixing piece can be pulled out of the limiting hole and bounced.

In the above scheme, the distal end of the cutting catheter is provided with a strip-shaped groove, and the cutting part is arranged in the strip-shaped groove and fixed at the proximal end of the strip-shaped groove; the cutting part is in a linear or curved strip shape or a cylindrical shape, and the cutting electrode is in a strip shape and is arranged on one side of the cutting part.

In the scheme, the far end of the limiting tip has a smaller diameter than the near end; the limiting hole is close to the inner tube.

In the above solution, the distal end of the pushing tube and the distal end of the cutting catheter can only slide axially, but cannot rotate axially relative to each other;

at least part of the cutting part can penetrate through the first through groove and/or the second through groove under the driving of the cutting catheter, and the natural valve leaflet clamped between the first fixing piece and the second fixing piece is cut.

In the above scheme, the cutting device further comprises an electrode lead which is arranged in the pushing pipe and connected with the cutting electrode.

In the above aspect, the pusher tube has a compressible stent graft at a location proximal to the distal end.

In the above scheme, the covered stent is an umbrella-shaped structure sleeved on the pushing tube.

In the above scheme, the covered stent is a funnel structure arranged on the pushing tube, and the funnel structure is arranged near one side of the proximal end of the first fixing piece.

In the above aspect, the open end edge of the stent graft is connected to the first fixing element.

In the scheme, the device also comprises an outer tube which is sleeved outside the pushing tube; the first fixing member and the stent graft are compressible and receivable in the outer tube, and are sequentially releasable when the outer tube is withdrawn proximally.

In the above aspect, the outer tube has at least one bend adjusting section.

In the above scheme, the outer tube has a first bend-adjusting section and a second bend-adjusting section.

In the above scheme, the first fixing piece and/or the second fixing piece are/is provided with saw-tooth-shaped protrusions as an anti-slip structure of the valve leaflet.

In the above scheme, the cutting tool further comprises a handle, wherein the handle comprises a cutting control switch; the cutting control switch is electrically connected with the cutting electrode.

In the above scheme, the electric cutting machine further comprises an electric cutting main machine, and the electric cutting main machine is electrically connected with the cutting control switch.

In the above solution, the handle has at least one bend control operation device, and the bend control operation device is used for controlling the bending of the bend adjusting section.

The technical scheme adopted by the invention can achieve the following beneficial effects:

set up cutting electrode and deliver to aortic valve through the propelling movement pipe, can carry out accurate quick cutting to the leaflet, realized carrying out the pertinence cutting to unilateral leaflet. Set up first mounting and second mounting, utilize first mounting to treat as the setting element and cut the valve leaflet and fix a position, and the distal end of second mounting can hold in spacing downthehole, and the second mounting separates from spacing downthehole again when needs fix the valve leaflet, guarantees to valve leaflet pinpoint, and location structure is simple, makes the cutting electrode can accurate cutting valve leaflet.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the description of the embodiments will be briefly introduced below to form a part of the present invention, and the exemplary embodiments and the description thereof illustrate the present invention and do not constitute a limitation of the present invention. In the drawings:

fig. 7 is a structural schematic view of a stent graft of a leaflet parting device arranged on a push tube according to another preferred embodiment of the disclosure in example 2;

fig. 8 is a schematic structural view of a leaflet parting device according to another preferred embodiment of the disclosure in example 2;

fig. 11 is a schematic structural view of a leaflet parting device disclosed in embodiment 3 of the present invention;

FIG. 12 is a schematic view of a stent graft deployed according to the disclosure of example 3;

fig. 13 is a schematic view of the structure of the distal end of the second securing member exiting the position-limiting hole of the leaflet parting device of embodiment 3 of the invention;

fig. 14 is a schematic view of a leaflet parting device disclosed in embodiment 4 of the invention guiding a guidewire to be placed inside a leaflet before use;

fig. 15 is a schematic view of a leaflet parting device spanning an aortic valve as disclosed in embodiment 4 of the invention.

Description of reference numerals:

pushing the pipe-10; cutting the catheter-20; an inner tube-30; an electrode lead-40; an outer tube-50; a handle-60; an electric cutting main machine-70; leaflet-80; guide wire-90; a first fixing member-11; a second fixing member-12; a covered stent-13; a cutting electrode-21; a strip-shaped groove-22; a limiting end-31; a limiting hole-32; a first bend-adjusting section-51; a second bend-adjusting section-52; a cutting control switch-61; a first through slot-111; a second through groove-121.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the technical solutions of the present invention will be clearly and completely described below with reference to the specific embodiments of the present invention and the accompanying drawings. In the description of the present invention, it is noted that the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.

In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

It is to be understood that the described embodiments are merely exemplary of the invention, and not restrictive of the full scope of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

Example 1

Example 2

Example 3

Example 4

This example 3 provides a method of using a leaflet parting device, as follows:

The specific operation method of the valve leaflet segmenting device after entering the human body is as follows:

The cutting electrode is arranged and delivered to the aortic valve through the pushing pipe, so that the valve leaflet can be accurately and quickly cut, and the targeted cutting of the unilateral valve leaflet is realized. Set up first mounting and second mounting, utilize first mounting to treat as the setting element and cut the valve leaflet and fix a position, and the distal end of second mounting can hold in spacing downthehole, and the second mounting separates from spacing downthehole again when needs fix the valve leaflet, guarantees to valve leaflet pinpoint, and location structure is simple, makes the cutting electrode can accurate cutting valve leaflet.

While the present invention has been described with reference to the embodiments shown in the drawings, the present invention is not limited to the embodiments, which are illustrative and not restrictive, and it will be apparent to those skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope of the invention as defined in the appended claims.