An atrial septostomy cutter device

Abstract

The application discloses a device for cutting atrial septum, which comprises a guide assembly and a cutting knife assembly; the guide assembly comprises a sleeve and an inner guide, the inner guide is movably arranged in the sleeve, and the cutting knife assembly is arranged at the front end of the inner guide; the inner guide comprises a guide pipe and a guide rod, the guide rod is movably arranged in the guide pipe, the front end of the guide rod extends out of the front end of the guide pipe, and the cutting knife assembly is arranged at the front end of the guide pipe and the guide rod; the cutting knife assembly comprises a plurality of cutting pieces which are distributed on the peripheral surface of the front end of the guide pipe and the guide rod; when the guide rod moves forward in the guide pipe, the plurality of cutting pieces are folded inward relative to the guide rod; and when the guide rod moves backward, the plurality of cutting pieces are unfolded outward. The front end of the guide assembly is operated to enter the atrium and pass through the atrial septum, then the inner guide is moved forward to drive the cutting knife assembly to push out to the front end of the sleeve, then the guide rod is moved backward relative to the guide pipe to drive the plurality of cutting pieces to unfold at the front end of the sleeve, then the whole guide assembly is operated to retreat from the atrial septum, and the plurality of unfolded cutting pieces complete the operation of forming an artificial opening in the process of retreating.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an atrial septum cutting knife device. BACKGROUND

[0002] Heart failure is mainly manifested in clinical as dyspnea and fatigue, and fluid retention (pulmonary congestion and peripheral edema). Heart failure is a serious and end-stage of various heart diseases, has a high incidence, and is one of the most important cardiovascular diseases today. According to the site of heart failure, it can be divided into left heart, right heart and whole heart failure.

[0003] In treatment, atrial septostomy is to make an opening in the atrial septum of a patient, thereby forming a shunt between the left and right atriums, which can be used for treating pulmonary hypertension (right-to-left shunt) or left heart failure (left-to-right shunt), and has been proven effective in clinical practice.

[0004] The traditional atrial septostomy method provides an opening support, which is characterized in that after percutaneous atrial septal puncture, an implant is percutaneously delivered to implant a shunt device at the atrial septal puncture site to keep the shunt opening unobstructed. However, this technology has the following defects: the implant for atrial shunt leaves a device at the opening, which can easily cause thrombosis or device shedding, forming an embolism. In addition, endothelial cell adhesion can cause the device opening to be blocked, and the channel is closed and loses the shunt effect.

[0005] To solve the problem of the traditional atrial septostomy method, the existing Chinese application number CN201921659130.0 atrial septostomy device drives the first cutting member and the second cutting member to move relative to the outer sheath tube by the inner sheath tube, so that when the first cutting member and the second cutting member are pushed out of the outer sheath tube, the first cutting member or the second cutting member can complete the opening operation. However, the first cutting member and the second cutting member of this scheme are made of elastic material, and when they are pushed out of the outer sheath tube, they are expanded by their own elasticity, and thus the opening diameter of this scheme is fixed and cannot be adjusted. However, in actual surgical procedures, the opening diameter needs to be selected according to different conditions of patients, and the existing patent's opening device cannot be realized in the surgical procedure. SUMMARY

[0006] The purpose of the present application is to provide an atrial septum cutting knife device, which aims to solve the problem that the opening diameter of the cutting member of the existing atrial septostomy device cannot be adjusted.

[0007] To solve the above technical problems, the purpose of the present application is achieved by the following technical scheme: an atrial septum cutting knife device is provided, which comprises a guide assembly and a cutting knife assembly;

[0008] The guiding assembly comprises a sleeve and an inner guide, the inner guide is movably arranged in the sleeve, and the cutting knife assembly is arranged at the front end of the inner guide;

[0009] The inner guide comprises a guide pipe and a guide rod, the guide rod is movably arranged in the guide pipe, and the front end of the guide rod extends out of the front end of the guide pipe, and the cutting knife assembly is arranged at the front end of the guide pipe and the guide rod;

[0010] The cutting knife assembly comprises a plurality of cutting pieces, the plurality of cutting pieces are circumferentially distributed on the outer circumferential surface of the front end of the guide pipe and the guide rod, when the guide rod moves backward in the guide pipe, the plurality of cutting pieces are driven to expand outward relative to the guide rod, and when the guide rod moves forward in the guide pipe, the plurality of cutting pieces are driven to retract inward relative to the guide rod.

[0011] Further, the cutting piece comprises a cutting knife and a connecting rod, one end of the cutting knife is hinged to the outer circumferential surface of the front end of the guide pipe, one end of the connecting rod is hinged to the knife wall of the cutting knife, and the other end of the connecting rod is hinged to the outer circumferential surface of the front end of the guide rod.

[0012] Further, the cutting knife is provided with a blade part on the side away from the connecting rod.

[0013] Further, the cutting knife has a strip-shaped sheet structure.

[0014] Further, the cutting piece is provided with at least two cutting pieces which are oppositely distributed on the outer circumferential surface of the front end of the guide rod.

[0015] Further, the cutting piece is provided with six cutting pieces.

[0016] Further, the outer circumferential surface of the front end of the guide pipe is provided with a first connecting part, a plurality of hinge positions are formed on the outer circumferential surface of the first connecting part, and one end of the cutting knife is hinged in the hinge position.

[0017] Further, the outer circumferential surface of the front end of the guide rod is provided with a second connecting part, a plurality of hinge positions are formed on the outer circumferential surface of the second connecting part, and the other end of the connecting rod is hinged in the hinge position.

[0018] Further, a limiting structure is arranged between the guide pipe and the guide rod, the guide rod moves forward and backward in the guide pipe through the limiting structure, when the guide rod moves backward to the maximum limit in the guide pipe, the cutting piece is completely expanded, and when the guide rod moves forward to the maximum limit in the guide pipe, the cutting piece is completely retracted.

[0019] Further, the limiting structure comprises a limiting opening and a limiting protrusion, the limiting opening is formed on the pipe wall of the guide pipe in the axial direction, and the limiting protrusion is arranged on the rod wall of the guide rod in the limiting opening.

[0020] The embodiment of the present application provides a room septum cutting knife device, which comprises a guide assembly and a cutting knife assembly; the guide assembly comprises a sleeve and an inner guide, the inner guide is movably arranged in the sleeve, and the cutting knife assembly is arranged at the front end of the inner guide; the inner guide comprises a guide pipe and a guide rod, the guide rod is movably arranged in the guide pipe, and the front end of the guide rod extends out of the front end of the guide pipe, and the cutting knife assembly is arranged on the front end of the guide pipe and the guide rod; the cutting knife assembly comprises a plurality of cutting pieces distributed on the peripheral surface of the front end of the guide pipe and the guide rod, and the guide rod drives the plurality of cutting pieces to fold inward relative to the guide rod when moving forward in the guide pipe, and the guide rod drives the plurality of cutting pieces to unfold outward when moving backward. The front end of the guide assembly is operated to enter the atrium and pass through the room septum, then the inner guide moves forward to drive the cutting knife assembly to push out to the front end of the sleeve, then the guide rod moves backward relative to the guide pipe to drive the plurality of cutting pieces to unfold at the front end of the sleeve, and then the whole guide assembly is operated to retreat from the room septum, and the plurality of cutting pieces unfolded during the retreat process complete the stoma operation. BRIEF DESCRIPTION OF DRAWINGS

[0021] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the drawings needed to be used in the embodiment description. Obviously, the drawings in the following description are some embodiments of the present application, and other drawings can also be obtained by those skilled in the art without creative labor.

[0022] Figure 1 The structure schematic diagram of the cutting knife assembly storage state provided by the embodiment of the present application is shown in the figure.

[0023] Figure 2 The structure schematic diagram of one unfolded state of the cutting knife assembly provided by the embodiment of the present application is shown in the figure.

[0024] Figure 3 The structure schematic diagram of another unfolded state of the cutting knife assembly provided by the embodiment of the present application is shown in the figure.

[0025] Figure 4 The cross-sectional structure schematic diagram of the cutting knife assembly is shown in the figure. Figure 3 The structure schematic diagram of the front end view of the cutting knife assembly is shown in the figure.

[0026] Figure 5 The structure schematic diagram of the front end view of the cutting knife assembly is shown in the figure. Figure 1 The structure schematic diagram of the front end view of the cutting knife assembly is shown in the figure.

[0027] Figure 6 The structure schematic diagram of the front end view of the cutting knife assembly is shown in the figure. Figure 2 The structure schematic diagram of the front end view of the cutting knife assembly is shown in the figure.

[0028] Figure 7 The structure schematic diagram of the front end view of the cutting knife assembly is shown in the figure. Figure 3 The structure schematic diagram of the front end view of the cutting knife assembly is shown in the figure.

[0029] Identification explanation in the figure:

[0030] 1, guide assembly; 11, sleeve; 12, guide pipe; 121, first connecting part; 122, limiting hole; 13, guide rod; 131, second connecting part; 132, limiting protrusion;

[0031] 2, cutting knife assembly; 21, cutting member; 211, cutting knife; 212, connecting rod. DETAILED DESCRIPTION

[0032] The technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are some of the embodiments of the present application, rather than all the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work fall within the protection scope of the present application.

[0033] It should be understood that the terms "comprising" and "including" as used in the specification and the appended claims indicate the presence of the recited features, integers, steps, operations, elements, and / or components but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0034] It should also be understood that the terms used in the present application specification are only for the purpose of describing specific embodiments and are not intended to limit the present application. As used in the present application specification and the appended claims, the singular forms "a", "an" and "the" are intended to include the plural forms unless the context clearly indicates otherwise.

[0035] It should be further understood that the term "and / or" as used in the present application specification and the appended claims means any combination of one or more of the associated listed items and all possible combinations, and includes these combinations.

[0036] In combination Figures 1-4 , the embodiments of the present application provide a room septum cutting knife device, which comprises a guide assembly 1 and a cutting knife assembly 2;

[0037] The guide assembly 1 comprises a sleeve 11 and an inner guide part, the inner guide part is movably arranged in the sleeve 11, and the cutting knife assembly 2 is arranged at the front end of the inner guide part;

[0038] The inner guide part comprises a guide pipe 12 and a guide rod 13, the guide rod 13 is movably arranged in the guide pipe 12, and the front end of the guide rod 13 extends out of the front end of the guide pipe 12, and the cutting knife assembly 2 is arranged at the front end of the guide pipe 12 and the guide rod 13;

[0039] The cutting knife assembly 2 comprises a plurality of cutting pieces 21 which are circumferentially distributed on the outer circumferential surface of the front end of the guide pipe 12 and the guide rod 13, and are unfolded outward relative to the guide rod 13 when the guide rod 13 moves backward in the guide pipe 12, and are folded inward relative to the guide rod 13 when the guide rod 13 moves forward in the guide pipe 12.

[0040] The sleeve 11 of the embodiment can enter the atrium of the patient and pass through the interatrial septum through other auxiliary devices such as an outer sheath. After the sleeve 11 passes through the interatrial septum at the front end, the inner guide is operated to move forward and drive the cutting knife assembly 2 to the front end of the sleeve 11. At this time, the cutting knife assembly 2 is still in the storage state. By operating the guide rod 13 to move backward relative to the guide pipe 12, the guide rod 13 moves backward while driving the plurality of cutting pieces 21 to unfold outward relative to the guide rod 13 at the front end of the sleeve 11. It should be noted that by controlling the stroke of the backward movement of the guide rod 13, the angle of the outward unfolding of the plurality of cutting pieces 21 can be controlled. In this way, the diameter of the stoma formed by the outermost end of the plurality of cutting pieces 21 is controllable. The medical staff can control the backward movement stroke of the guide rod 13 to adjust the required stoma diameter, which has the advantage of improving the use effect.

[0041] After adjusting the required stoma diameter by controlling the backward movement stroke of the guide rod 13, the entire guide assembly 1 is operated to retreat and exit the interatrial septum. During the retreat process, the plurality of cutting pieces 21 unfolded complete the stoma action. Then, the guide rod 13 is operated to move forward relative to the guide pipe 12 and drive the plurality of cutting pieces 21 to fold inward. Then, the inner guide is operated to retreat and drive the cutting knife assembly 2 to retreat to the inside of the front end of the sleeve 11. Finally, the cutting knife device is operated to exit the atrium of the patient, and the operation is completed.

[0042] It should be noted that the way of operating the sleeve 11 and the inner guide to move forward and backward in the embodiment can be completed by the medical staff through the operation part (such as the handle structure).

[0043] For the convenience of understanding, the following Figure 1 and Figure 5 At this time, the cutting knife assembly 2 is stored in the inside of the front end of the sleeve 11, and the diameter of the cutting knife assembly 2 after being stored is D1, which is smaller than the caliber of the sleeve 11.

[0044] For the convenience of understanding, the following Figure 2 and Figure 6 At this time, the cutting knife assembly 2 is pushed out to the front end of the sleeve 11, and the guide rod 13 moves backward relative to the guide pipe 12 by a certain stroke and drives the plurality of cutting pieces 21 to unfold outward by a certain angle. At this time, the diameter of the stoma is D2, which is adjustable. It only needs to be adjusted by controlling the backward movement stroke of the guide rod 13, which is simple and convenient to operate.

[0045] For the convenience of understanding, the following Figure 3 and Figure 7The guide rod 13 drives the plurality of cutting members 21 to continue to expand outward, and the stoma diameter at this time is D3, which is substantially the maximum stoma diameter.

[0046] The cutting member 21 of the present application is described below in detail:

[0047] In an embodiment, the cutting member 21 comprises a cutting knife 211 and a connecting rod 212, one end of the cutting knife 211 is hinged to the outer periphery of the front end of the guide tube 12, one end of the connecting rod 212 is hinged to the knife wall of the cutting knife 211, and the other end of the connecting rod 212 is hinged to the outer periphery of the front end of the guide rod 13.

[0048] In this embodiment, one end of the cutting knife 211 is hinged to the outer periphery of the front end of the guide tube 12, and the cutting knife 211 can be retracted and expanded relative to the guide rod 13 by controlling the hinged rotation of one end of the cutting knife 211. Based on this, one end of the connecting rod 212 is hinged to the knife wall of the cutting knife 211, and the other end of the connecting rod 212 is hinged to the outer periphery of the front end of the guide rod 13. In this way, when the guide rod 13 moves forward relative to the guide tube 12, the guide rod 13 drives the other end of the connecting rod 212 to move forward, causing the one end of the connecting rod 212 to pull the cutting knife 211 forward, causing the cutting knife to rotate towards the guide rod 13 and fold. Conversely, by moving the guide rod 13 backward relative to the guide tube 12, the guide rod 13 drives the other end of the connecting rod 212 to move backward, causing the one end of the connecting rod 212 to rotate the cutting knife 211 in a direction away from the guide rod 13 and expand.

[0049] In an embodiment, the cutting knife 211 is in the shape of a strip-shaped sheet, and the side of the cutting knife 211 away from the connecting rod 212 is provided with a blade portion, and the other side is provided with a blunt portion. In this embodiment, based on the above-mentioned stoma action when exiting the atrial septum, the blade portion of the cutting knife 211 is arranged on the side away from the connecting rod 212, so that the blade portion can perform stoma when exiting the atrial septum, and the entire cutting knife 211 device has also exited the atrial septum after stoma, which can avoid secondary interference to the incision of the atrial septum.

[0050] In an embodiment, the cutting member 21 is provided with at least two cutting members 21, and the two cutting members 21 are distributed relative to each other on the outer periphery of the front end of the guide rod 13, forming a linear stoma. The cutting member 21 can also be provided with three cutting members 21, and the three cutting members 21 are evenly distributed in the circumferential direction on the outer periphery of the front end of the guide rod 13, forming a regular triangular stoma. It should be noted that the number of cutting members 21 is not specifically limited here and can be set according to actual needs.

[0051] In some preferred embodiments, the cutting member 21 is provided with six cutting members 21, and the six cutting members 21 are evenly distributed in the circumferential direction on the outer periphery of the front end of the guide rod 13, forming a regular snowflake-like stoma.

[0052] In an embodiment, the front end of the guide pipe 12 is provided with a first connecting part 121, and a plurality of hinge positions are formed on the outer periphery of the first connecting part 121, and one end of the cutting knife 211 is hinged in the hinge position.

[0053] In the embodiment, the first connecting part 121 is a circular ring-shaped protruding structure, and a corresponding number of hinge positions can be formed on the outer periphery of the first connecting part 121 according to the number of cutting members 21. The hinge position can be a hinge port or a hinge protrusion, and one end of the cutting knife 211 is hinged in the hinge position to realize stable movement.

[0054] In an embodiment, the front end of the guide pipe 12 is provided with a first connecting part 121, and a plurality of hinge positions are formed on the outer periphery of the first connecting part 121, and one end of the cutting knife 211 is hinged in the hinge position.

[0055] In the embodiment, the first connecting part 121 is a circular ring-shaped protruding structure, and a corresponding number of hinge positions can be formed on the outer periphery of the first connecting part 121 according to the number of cutting members 21. The hinge position can be a hinge port or a hinge protrusion, and one end of the cutting knife 211 is hinged in the hinge position to realize stable movement.

[0056] It should be noted that the hinge positions on the first connecting part 121 and the hinge positions on the second connecting part 131 correspond one by one in the axial direction and are equal in number.

[0057] In an embodiment, a limiting structure is arranged between the guide pipe 12 and the guide rod 13, the guide rod 13 moves forward and backward in the guide pipe 12 through the limiting structure, and the cutting member 21 is completely unfolded when the guide rod 13 moves backward to the maximum limit in the guide pipe 12, and the cutting member 21 is completely stored when the guide rod 13 moves forward to the maximum limit in the guide pipe 12.

[0058] Specifically, the limiting structure includes a limiting port 122 and a limiting protrusion 132, and the limiting port 122 is formed on the pipe wall of the guide pipe 12 in the axial direction, and the limiting protrusion 132 is arranged on the rod wall of the guide rod 13 and located in the limiting port 122.

[0059] In the embodiment, the forward and backward movement strokes of the guide rod 13 relative to the guide pipe 12 are limited by the cooperation of the limiting port 122 and the limiting protrusion 132, which can ensure the stable storage and unfolding of the cutting member 21, and the hand feeling feedback when moving forward and backward to the maximum limit can prompt that the storage or the maximum unfolding angle has been completed.

[0060] The above merely illustrates the specific embodiments of the present application, but the protection scope of the present application is not limited thereto, and any skilled person in the art can easily think of various equivalent modifications or replacements within the technical range disclosed by the present application, and these modifications or replacements shall be covered within the protection scope of the present application. Therefore, the protection scope of the present application shall be subject to the protection scope of the claims.

Claims

1. An atrial septostomy blade device, characterized by: The guiding assembly and the cutting knife assembly are provided. The guiding assembly comprises a sleeve and an inner guide, the inner guide is movably arranged in the sleeve, and the cutting knife assembly is arranged at the front end of the inner guide. The inner guide comprises a guide pipe and a guide rod, the guide rod is movably arranged in the guide pipe, and the front end of the guide rod extends out of the front end of the guide pipe, and the cutting knife assembly is arranged at the front end of the guide pipe and the guide rod. The cutting knife assembly comprises a plurality of cutting knives, the plurality of cutting knives are circumferentially arranged on the outer circumferential surface of the front end of the guide pipe and the guide rod, and when the guide rod moves backward in the guide pipe, the plurality of cutting knives are unfolded outward relative to the guide rod, and when the guide rod moves forward in the guide pipe, the plurality of cutting knives are folded inward relative to the guide rod. The cutting knife comprises a cutting knife and a connecting rod, one end of the cutting knife is hingedly connected to the outer circumferential surface of the front end of the guide pipe, one end of the connecting rod is hingedly connected to the knife wall of the cutting knife, and the other end of the connecting rod is hingedly connected to the outer circumferential surface of the front end of the guide rod; the side of the cutting knife away from the connecting rod is provided with a blade part; and the cutting knife has a strip-shaped piece structure.

2. The atrial septostomy device of claim 1, wherein: The cutting knife is provided with at least two cutting knives which are oppositely arranged on the outer circumferential surface of the front end of the guide rod.

3. The device of claim 1, wherein: The cutting knife is provided with six cutting knives.

4. The atrial septostomy device of claim 1, wherein: The outer circumferential surface of the front end of the guide pipe is provided with a first connecting part, a plurality of hinged positions are arranged on the outer circumferential surface of the first connecting part, and one end of the cutting knife is hingedly connected to the hinged positions.

5. The atrial septostomy device of claim 1, wherein: The outer circumferential surface of the front end of the guide rod is provided with a second connecting part, a plurality of hinged positions are arranged on the outer circumferential surface of the second connecting part, and the other end of the connecting rod is hingedly connected to the hinged positions.

6. The atrial septostomy device of claim 1, wherein: A limiting structure is arranged between the guide pipe and the guide rod, the guide rod moves forward and backward in the guide pipe through the limiting structure, the guide rod moves backward to the maximum limit in the guide pipe, and the cutting knife is completely unfolded, and the guide rod moves forward to the maximum limit in the guide pipe, and the cutting knife is completely folded.

7. The device of claim 6, wherein: The limiting structure comprises a limiting hole and a limiting protrusion, the limiting hole is axially arranged on the pipe wall of the guide pipe, and the limiting protrusion is arranged on the rod wall of the guide rod and located in the limiting hole.

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