Atrial septostomy

Abstract

The present invention relates to the field of medical devices, and discloses an atrial septostomy. The atrial septostomy includes a control part, a cutting head, and an outer sheath; one end of the cutting head is connected to one end of the control part, and the control part drives the cutting head to move axially along the outer sheath; the cutting head includes a plurality of cutting pieces, one end of each of which is connected to the control part, and the cutting pieces are made of elastic metal material, and at least one side of the cutting pieces is provided with a blade. The atrial septostomy provided by the present invention, by setting the cutting head to be made of elastic metal material and connecting the cutting head to the control part, can complete the adjustment of the opening and closing size of the cutting head through the elastic force of the cutting head itself and the restriction of the cutting head by the outer sheath, so that medical staff can conveniently use the atrial septostomy to complete the stoma, which is easy to operate, simple in structure, safe and reliable.

Description

Technical Field

[0001] The invention relates to the field of medical devices, in particular to an atrial septal stoma device. Background Art

[0002] Heart failure (HF) is a complex clinical syndrome caused by any abnormality in cardiac structure or function that leads to impaired ventricular filling or ejection capacity. Its main clinical manifestations are dyspnea and fatigue (limited activity tolerance), as well as fluid retention (pulmonary congestion and peripheral edema). HF is a serious and terminal stage of various heart diseases with a high incidence rate. It is one of the most serious cardiovascular diseases today. According to the location of heart failure, it can be divided into left heart failure, right heart failure and total heart failure.

[0003] Atrial septostomy is a procedure that creates a septum in the patient's atrial septum, thereby forming a shunt between the left and right atria. It is used to treat pulmonary hypertension (right-to-left shunt) or left heart failure (left-to-right shunt), and has proven effectiveness in clinical practice.

[0004] The traditional method of atrial septal stoma is to perform atrial septal puncture and then perform balloon dilatation to create a septal stoma. After the stoma is created, the myocardial tissue tends to rebound, and the stoma will shrink or even completely close after a period of time. In order to solve the problem of stoma shrinkage or even closure, the prior art provides a stoma stent and discloses an implant for atrial shunt, 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 open.

[0005] Another stoma method includes a cutting device and a grasping device. When the instrument is making a stoma on the tissue, the grasping device first locates and grasps the part of the tissue that needs to be cut; then the cutting device cuts the part of the tissue grasped by the grasping device through a mechanical or high-frequency electric knife, and the cut part of the tissue is taken out of the body by the grasping device, thereby forming a stoma.

[0006] Both of the above technologies have defects. The first way is to use an atrial shunt implant, leaving the device at the stoma, which can easily lead to thrombosis or device fall-off, forming an embolism. In addition, due to intimal hyperplasia, the device opening may be blocked, the channel may be closed and the shunt function may be lost. The second way is to cut the intracardiac tissue mechanically or with a high-frequency electric knife during surgery, which has a higher risk. For example, if the grasping device becomes loose during surgery or is retrieved after surgery, the cut tissue may fall off and form an embolism. In addition, if the grasping device becomes loose during the cutting process, it is very easy to cause damage to other myocardial tissues. Summary of the invention

[0007] 1. Technical issues to be resolved

[0008] The purpose of the present invention is to provide an atrial septum stoma to solve the problems of complex structure and difficult operation of stomas in the prior art.

[0009] (II) Technical solution

[0010] In order to solve the above technical problems, the present invention provides an atrial septal stoma device. The atrial septal stoma device comprises a control member, a cutting head and an outer sheath; one end of the cutting head is connected to one end of the control member, and the control member drives the cutting head to move along the axial direction of the outer sheath; the cutting head comprises a plurality of cutting members, one end of each of the plurality of cutting members is connected to the control member, the cutting members are made of elastic metal material, and at least one side of the cutting member is provided with a blade.

[0011] Furthermore, the other ends of the plurality of cutting members are independent of or connected to each other, or the other ends of the plurality of cutting members are connected via a supporting member.

[0012] Furthermore, a plurality of the cutting members are arranged at intervals along the radial direction of the control member.

[0013] Furthermore, the number of the cutting members is at least 3, and the three cutting members are arranged at equal intervals along the radial direction of the control member.

[0014] Furthermore, a protection end is provided between the other end of the cutting member and the supporting member.

[0015] Furthermore, a sleeve is connected between the cutting member and the control member, and one end of a plurality of cutting members is connected to the sleeve.

[0016] Furthermore, the cutting member has an axial length ranging from 0.25 cm to 1 cm.

[0017] Furthermore, the atrial septal stoma device also includes a locking assembly, which includes a locking end cap and a locking piece, the locking end cap is connected to the outer sheath, the control piece passes through the locking end cap, and the locking piece is connected to the control piece and is used to limit its relative position with the locking end cap.

[0018] Furthermore, a developing ring is also provided on the outer sheath tube.

[0019] Furthermore, the control element is provided with a scale mark.

[0020] (III) Beneficial effects

[0021] The atrial septal stoma device provided by the present invention, by configuring the cutting piece to be made of elastic metal material and connecting the cutting piece to a control piece, can adjust the opening and closing size of the cutting head through the elastic force of the cutting piece itself and the restriction of the cutting piece by the outer sheath, so that medical staff can conveniently use the atrial septal stoma device to complete the stoma, which is easy to operate, simple in structure, safe and reliable. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 A schematic structural diagram of a first cutting head of an atrial septum stoma provided in an embodiment of the present invention;

[0023] Figure 2 for Figure 1 A schematic structural diagram of the cutting head in the use state;

[0024] Figure 3 A schematic structural diagram of a second cutting head of an atrial septum stoma provided in an embodiment of the present invention;

[0025] Figure 4 for Figure 3 A schematic structural diagram of the cutting head in the use state;

[0026] Figure 5 A schematic structural diagram of a third cutting head of the interatrial septum stoma provided in an embodiment of the present invention.

[0027] Description of Figure Numbers:

[0028] 1. Control part; 2. Outer sheath; 3. Cutting part; 4. Support part; 5. Protective end; 6. Sleeve. DETAILED DESCRIPTION

[0029] The specific implementation of the present invention is further described in detail below in conjunction with the accompanying drawings and examples. The following examples are used to illustrate the present invention, but are not intended to limit the scope of the present invention.

[0030] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0031] Combined with reference Figures 1 to 5The atrial septostomy device includes a control member 1, a cutting head and an outer sheath 2; one end of the cutting head is connected to one end of the control member, and the control member drives the cutting head to move axially along the outer sheath 2; the cutting head includes a plurality of cutting members 3, one end of each of the plurality of cutting members 3 is connected to the control member 1, the cutting member 3 is made of an elastic metal material, and at least one side of the cutting member 3 is provided with a blade.

[0032] The atrial septal stoma device provided by the present invention can adjust the opening and closing size of the cutting head by setting the cutting piece in the cutting head to be made of elastic metal material and connecting the cutting head to the control piece, and the elastic force of the cutting piece 3 itself and the restriction of the cutting piece 3 by the outer sheath 2 can complete the adjustment of the opening and closing size of the cutting head. When the cutting piece 3 is pushed out of the outer sheath 2, it is equivalent to forming a stoma structure. In addition, since at least one side of the cutting piece 3 is provided with a blade, medical staff can conveniently use the atrial septal stoma device to complete the stoma, which is easy to operate, simple in structure, safe and reliable.

[0033] Specifically, the cutting head in this embodiment can be made of a metal sheet, wherein the thickness of the metal sheet should not be too thick to avoid a reduction in the elastic deformation of the metal sheet due to the excessive thickness, such as stainless steel, nickel-titanium alloy and other materials.

[0034] The control member 1 is used to drive the cutting head to move along the axial direction of the outer sheath tube 2. The control member 1 can be set to the structure of the main control wire, for example, it can be made of a metal wire with a higher hardness, and its interior can be set to a solid structure or a hollow through hole. The cutting member 3 is connected to one end of the control member 1. The purpose of this setting is that the cutting member 3 can rotate with the control member 1 as the connection point under the action of its own elastic deformation. The rotation described here can be a rotation in a free direction or a rotation in a fixed direction. That is, the cutting member 3 can rotate along the radial direction of the control member 1, or along the tangential direction of the control member 1 or in a spiral shape.

[0035] Of course, the connection described herein can be specifically a detachable fixed connection or a rigid connection. When the cutting head and the control member 1 are detachably fixedly connected, for example, the cutting member 3 and the control member 1 can be arranged in a bolted connection. Since the cutting member 3 is in a compressed state inside the outer sheath 2, when the cutting member 3 is pushed out of the outer sheath 2, the cutting member 3 can be opened under the action of its own elastic force to form the structure of the stoma. When the cutting member 3 and the control member 1 are rigidly connected, for example, the cutting member 3 and the control member 1 can be arranged in a welding manner, and the cutting member 3 can also be opened under the action of its own elastic force to form the structure of the stoma.

[0036] In addition, the one end of the cutting member 3 mentioned above specifically refers to the end of the cutting member 3 away from the patient when the atrial septostomy device is in use. The one end of the control member 1 specifically refers to the end of the control member 1 close to the patient when the atrial septostomy device is in use.

[0037] The outer sheath tube 2 is used to accommodate the control component 1 and the cutting head, wherein the outer sheath tube 2 can be made of a plastic tube with high hardness and good toughness, such as PE, HDPE, Pebax and other materials.

[0038] Furthermore, a developing ring is also provided on the outer sheath tube 2. The developing ring can ensure that the medical staff can determine the lesion site of the patient by referring to the position of the outer sheath tube 2 under X-ray fluoroscopy during the operation.

[0039] Furthermore, in the present embodiment, in order to ensure that the relative position of the control member 1 and the outer sheath tube 2 can be limited, and thereby the opening and closing size of the cutting head can be limited to a fixed size, in a preferred embodiment, the atrial septal stoma device also includes a locking assembly, the locking assembly includes a locking end cap and a locking member, the locking end cap is connected to the outer sheath tube 2, the control member 1 passes through the locking end cap, the locking member is connected to the control member 1 and is used to limit its relative position with the locking end cap.

[0040] Specifically, a locking end cap is provided at a position of one end of the outer sheath tube 2 away from the cutting head, and the control member 1 passes through the locking end cap. Therefore, a through hole needs to be opened on the locking end cap, and preferably, the through hole is a threaded hole. Then, a section of external thread section matching the threaded hole is provided on the control member 1. In other words, the medical staff can adjust the angle, size, etc. of the cutting head extending or retracting from the outer sheath tube 2 by rotating the control member, thereby being able to adjust the opening and closing angle and size of the cutting head.

[0041] In addition, in order to further lock the relative position of the control member 1 and the outer sheath tube 2, a locking member is also provided on the extended end of the locking end cap on the control member 1. For example, the locking member can be a locking nut, etc. In order to prevent loosening, two locking nuts can be provided.

[0042] Of course, in some alternative embodiments, the purpose of limiting the relative positions of the two may be achieved by other means, which are not further limited here.

[0043] Furthermore, the control element is also provided with a scale mark, which can ensure that the medical staff can accurately judge the length of the cutting head pushed out or the angle of the cutting head, thereby ensuring the accuracy of the stoma operation.

[0044] In the embodiment of the present invention, the cutting head includes a plurality of cutting members 3, and one end of each of the plurality of cutting members 3 is connected to the control member 1. As mentioned above, the cutting head can be made of metal sheets, that is, each of the plurality of cutting members 3 can be made of elastic metal material.

[0045] One end of each of the plurality of cutting members 3 is connected to the control member 1, so that the plurality of cutting members 3 can be rotated or swung around the connection point. For example, the number of the cutting members 3 can be three, and the three cutting members 3 are evenly connected to the connection point with the connection point as the center. For another example, the number of the cutting members 3 can be four, and the four cutting members 3 are evenly connected to the connection point with the connection point as the center, so that a cross-shaped stoma can be formed.

[0046] In other words, the plurality of cutting members 3 are arranged at intervals along the radial direction of the control member 1, and preferably, the intervals between two adjacent cutting members 3 are equal. Of course, the intervals between two adjacent cutting members 3 can also be set to be unequal according to actual needs.

[0047] Furthermore, in order to ensure that multiple cutting members 3 can complete the stoma operation, a blade is provided on the side of each cutting member 3. The blade can be provided on the inner side of the cutting member 3 (i.e., the side of the cutting member 3 facing the control member 1), and the blade can also be provided on the inner side and outer side of the stoma (i.e., the side of the cutting member 3 facing away from the control member 1). Preferably, the blade is provided only on the inner side of the cutting member 3, and the blade is not provided on the outer side of the cutting member 3 to prevent the cutting member 3 from scratching the inner wall of the inner sheath. For example, a chamfered structure can be provided on the outer side of each cutting member 3.

[0048] In addition, the cross-sections of the cutting elements 3 may be the same or different, but are preferably the same.

[0049] The lengths of the cutting pieces 3 may be equal or unequal, preferably equal. For example, the length of the cutting pieces 3 may be 0.5 cm, so that when the number of the cutting pieces 3 is 4, a stoma with a maximum diameter of 1 cm can be formed.

[0050] Furthermore, in order to meet the stoma function of different sizes, the cutting member 3 in this embodiment has a range of 0.25 cm to 1 cm along its axial length. In other words, when the cutting member is completely pushed out of the outer sheath 2, the cutting member 3 is in a fully open state. At this time, the range of the distance between the top of the cutting member 3 and the control member 1 satisfies the above range. In this way, by controlling the length of the control member 1 extending out of the outer sheath 2, a stoma diameter of 0.5 cm to 2 cm can be achieved, thereby greatly improving the scope of application of the atrial septal stoma.

[0051] The cutting head in this embodiment has three implementation modes, and the cutting heads in the three implementation modes are described below:

[0052] Implementation method 1:

[0053] like Figure 1 and Figure 2 As shown, in this embodiment, one end of each cutting member 3 is connected to the control member 1, and the other end is free. Among them, one end of each cutting member 3 is connected to the control member 1 through a sleeve 6.

[0054] When the cutting head is pushed out of the outer sheath 2, one end of the multiple cutting pieces 3 is connected to the control piece 1, and the other ends of the multiple cutting pieces 3 are freely expanded, thereby ensuring that the multiple cutting pieces 3 can be expanded outward under the action of their own elastic force, and medical staff can use the atrial septum stoma device to complete the stoma operation.

[0055] The stoma method corresponding to this embodiment is:

[0056] First, after successfully puncturing the oval fossa with an interatrial puncture needle, the outer sheath 2 and the control piece 1 are retained;

[0057] Then, the control member 1 containing the cutting head is introduced into the atrial septal puncture site along the outer sheath tube 2 through the control member 1; the control member 1 and the outer sheath tube 2 are passed through the oval fossa as a whole and pushed forward by about 2 to 3 cm, and then the outer sheath tube 2 is withdrawn to release the cutting head;

[0058] Finally, control piece 1 is withdrawn to complete the atrial septostomy.

[0059] Implementation method 2:

[0060] like Figure 3 and Figure 4 As shown, in this embodiment, one end of each cutting member 3 is connected to the control member 1 through the sleeve 6, and the other end is connected to each other, that is, the cutting members 3 in this embodiment form a closed annular structure with each other.

[0061] When the cutting head is pushed out of the outer sheath 2, one end of the plurality of cutting pieces 3 is connected to the control piece 1, and the other ends of the plurality of cutting pieces 3 are also connected together, thus forming the aforementioned closed annular structure. The cutting piece 3 will be propped outward under the action of its own elastic force, thereby ensuring that the medical staff can complete the stoma operation using the atrial septal stoma device.

[0062] The stoma method corresponding to this embodiment is:

[0063] First, after successfully puncturing the oval fossa with an interatrial puncture needle, retain the outer sheath 2 control piece 1;

[0064] Then, the control member 1 containing the cutting head is introduced into the atrial septal puncture site along the outer sheath tube 2 through the control member 1;

[0065] Then, by operating the control member 1, the cutting member 3 in the cutting head is opened, and the cutting head, the control member 1 and the outer sheath tube 2 are pushed forward along the control member 1 through the oval fossa for about 2 to 3 cm, and then the outer sheath tube 2 is withdrawn to release the cutting head end;

[0066] Finally, control piece 1 is withdrawn to complete the atrial septostomy.

[0067] Implementation method three:

[0068] like Figure 5 As shown, in this embodiment, one end of each cutting member 3 is connected to the control member 1 through a sleeve 6, and the other end is connected through a support member 4. The difference between this embodiment and the first embodiment is that the other end of each cutting member 3 is in a non-free state. When the cutting head is pushed out, the multiple cutting members 3 will prop up themselves under the action of their own elastic force, so that medical staff can use the atrial septostomy device to complete the stoma operation.

[0069] The support member 4 can be a linear structural member or a sheet structural member, and its material can be made of the same material as the cutting member 3 .

[0070] Further, a protection end 5 is provided between the other end of the cutting element 3 and the support element 4. That is, a protection end 5 is provided at the other end of each cutting element 3, and the support element 4 is connected to the protection ends 5 on two adjacent cutting elements 3.

[0071] Furthermore, the protection end 5 is made of a material with developing properties, thereby ensuring the developing effect.

[0072] The stoma method corresponding to this embodiment is:

[0073] First, after successfully puncturing the oval fossa with an interatrial puncture needle, the outer sheath 2 and the control piece 1 are retained;

[0074] Then, the control member 1 containing the cutting head is introduced into the atrial septal puncture site along the outer sheath tube 2 through the control member 1; the control member 1 and the outer sheath tube 2 are passed through the oval fossa as a whole and pushed forward by about 2 to 3 cm, and then the outer sheath tube 2 is withdrawn to release the cutting head;

[0075] Finally, control piece 1 is withdrawn to complete the atrial septostomy.

[0076] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. An atrial septal stoma, characterized in that: It comprises a control part (1), a cutting head and an outer sheath tube (2); One end of the cutting head is connected to one end of the control member (1), and the control member (1) drives the cutting head to move along the axial direction of the outer sheath tube (2); The cutting head comprises a plurality of cutting members (3), one end of each of the plurality of cutting members (3) is connected to the control member (1), at least one side of each of the cutting members (3) is provided with a blade, and the blade is provided on the side of the cutting member (3) facing the control member (1); the other ends of the plurality of cutting members (3) are independent of each other or connected to each other, or the other ends of the plurality of cutting members (3) are connected via a support member (4); the plurality of cutting members (3) are arranged at intervals along the radial direction of the control member (1); The control member (1) is withdrawn to drive the cutting member (3) to move toward one side of the control member (1), and the atrial septal stoma is performed with the blades of each cutting member (3).

2. The atrial septal stoma device according to claim 1, characterized in that: The number of the cutting members (3) is at least three, and the three cutting members (3) are arranged at equal intervals along the radial direction of the control member (1).

3. The atrial septal stoma device according to claim 1, characterized in that: A protection end (5) is also provided between the other end of the cutting member (3) and the supporting member (4).

4. The atrial septostomy device according to any one of claims 1 to 3, characterized in that: A sleeve (6) is also connected between the cutting element (3) and the control element (1), and one end of a plurality of the cutting elements (3) is connected to the sleeve (6).

5. The atrial septal stoma device according to claim 4, characterized in that: The cutting element (3) has an axial length ranging from 0.25 cm to 1 cm.

6. The atrial septal stoma device according to claim 4, characterized in that: The atrial septal stoma device also includes a locking assembly, which includes a locking end cap and a locking member, wherein the locking end cap is connected to the outer sheath (2), the control member (1) passes through the locking end cap, and the locking member is connected to the control member (1) and is used to limit the relative position between the control member (1) and the locking end cap.

7. The atrial septal stoma device according to claim 4, characterized in that: The outer sheath tube (2) is also provided with a developing ring.

8. The atrial septal stoma device according to claim 4, characterized in that: The control element (1) is provided with a scale mark.

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