CN218305041U - Interatrial septum stoma device - Google Patents

Abstract

The utility model relates to the technical field of medical equipment, a interatrial septum stoma device is disclosed. Wherein the interatrial septum ostomy device comprises a first tube body, a second tube body and a cutting assembly. The distal end of the second tube body is connected with a cutting knife, the cutting knife is provided with a cavity communicated with the tube cavity of the second tube body, and the first tube body is slidably arranged in the second tube body and the cutting knife in a penetrating way; the auxiliary assembly comprises a push-pull rod and a cutting auxiliary piece, the push-pull rod penetrates through the first pipe body in a sliding mode, the near end of the cutting auxiliary piece is connected with the far end of the first pipe body, the far end of the cutting auxiliary piece is connected with the far end of the push-pull rod, and the push-pull rod can slide relative to the first pipe body so that the cutting auxiliary piece can be switched between an unfolding state and a stretching state; the cutting auxiliary piece can be contained in the cavity when being in a stretching state; when the cutting auxiliary part is in an unfolding state, the cutting auxiliary part is provided with a mesh surface facing the cutting knife, and the mesh surface is used for collecting the atrial septal tissue cut by the cutting knife and drawing the atrial septal tissue into the cavity.

Description

Interatrial septum stoma device

Technical Field

The utility model relates to the technical field of medical equipment, especially, relate to a interatrial septum ostomy device.

Background

Heart failure, which is the severe and terminal stage of various heart diseases, is highly prevalent and is one of the most serious cardiovascular diseases today. There are left heart, right heart and whole heart failure according to the location of heart failure. Pulmonary hypertension (right-to-left diversion) or left heart failure (left-to-right diversion) is typically treated clinically with an atriostomy, which is a stoma at the patient's interatrial septum, forming a shunt in the left and right heart rooms.

Conventional interatrial septal ostomy is usually performed by providing a pre-opening in the interatrial septum, leaving a guide wire in the pre-opening, moving the instrument along the guide wire to the pre-opening, and then using the instrument to make a stoma in the pre-opening of the interatrial septum. When the instrument is used for carrying out stoma on tissues, the grabbing device firstly positions and grabs partial tissues needing to be cut, then the cutting device cuts the partial tissues grabbed by the grabbing device, and the cut partial tissues are taken out of the body by the grabbing device, so that the stoma is formed. This has a high risk of loosening the grasping device during surgery or of causing the cut tissue to fall out and form an embolus during post-operative retrieval. In addition, if in the cutting process, the loosening of the gripping device is easy to cause other myocardial tissues to be damaged, and the device of the method has complex structure and inconvenient operation.

In view of the foregoing, there is a need for an interatrial septum ostomy device that solves the above-mentioned problems.

SUMMERY OF THE UTILITY MODEL

Based on the above, an object of the utility model is to provide an interatrial septum ostomy device, the interatrial septum tissue that can avoid the operation in-process or cut when retrieving after the operation drops, prevents to form embolism or cardiac muscle tissue impaired.

In order to achieve the purpose, the utility model adopts the following technical proposal:

an atrial septal ostomy device comprising:

a first pipe body;

the far end of the second pipe body is connected with a cutting knife, the cutting knife is provided with a cavity communicated with the pipe cavity of the second pipe body, and the first pipe body is slidably arranged in the second pipe body and the cutting knife in a penetrating mode;

the auxiliary assembly comprises a push-pull rod and a cutting auxiliary piece, the push-pull rod is slidably arranged in the first pipe body in a penetrating mode, the near end of the cutting auxiliary piece is connected with the far end of the first pipe body, the far end of the cutting auxiliary piece is connected with the far end of the push-pull rod, and the push-pull rod can slide relative to the first pipe body so that the cutting auxiliary piece can be switched between a spreading state and a stretching state;

the cutting auxiliary piece can be contained in the cavity when in the stretching state; when the cutting auxiliary part is in the unfolding state, the cutting auxiliary part is provided with a net surface facing the cutting knife, and the net surface is used for collecting the atrial septum tissues cut by the cutting knife and pulling the atrial septum tissues into the cavity.

As a preferred technical scheme of the interatrial septum ostomy device, a limiting table is arranged in the cavity, and the cutting auxiliary piece can be abutted against the limiting table.

As a preferred technical solution of the interatrial septum ostomy device, the cutting aid is an elastic mesh grid comprising a first extension and a second extension sequentially arranged in a proximal to distal direction;

the first extension part is connected with the far end of the first pipe body, and the push-pull rod penetrates through the first extension part and is connected with the second extension part;

the proximal end of the second extension has a mesh surface facing the cutting blade when the cutting aid is in the deployed state.

As a preferred technical solution of the interatrial septum ostomy device, the mesh-like surface is a pre-shaped structure.

As a preferable aspect of the interatrial septum ostomy device, the mesh surface has an outer diameter equal to or greater than an inner diameter of the lumen when the cutting aid is in the deployed state.

As a preferable technical solution of the atrial septal ostomy device, when the cutting assistance member is in the unfolded state, an included angle between the mesh surface and the push-pull rod is 80 to 90 degrees.

As a preferred technical scheme of interatrial septum ostomy device, still include the third body, the second body slides and wears to locate the third body.

As an preferred technical scheme of interatrial septum stoma device, interatrial septum stoma device still includes first drive assembly, first drive assembly includes first casing and first driving piece, the near-end of second body stretches into first casing, the near-end of second body is connected with first guide, first guide way has been seted up on the inner wall of first casing, first guide way is followed the axial extension of second body, first guide slide set up in the first guide way, first driving piece can drive the second body is along axial displacement.

As an optimum technical scheme of interatrial septum stoma device, first drive assembly still includes first screw rod, first driving piece set up in the first casing, just first screw hole has been seted up on the first driving piece, first screw rod threaded connection in first screw hole, the one end of first screw rod is connected the near-end of second body, the other end of first screw rod is worn out first driving piece, just first guide connects the lateral wall of first screw rod.

As an preferred technical scheme of interatrial septum stoma device, interatrial septum stoma device still includes second drive assembly, second drive assembly includes the second casing, the near-end edge of first casing the axial extension of first body has connecting portion, the coaxial first perforation of having seted up on the connecting portion, first perforation with the inner chamber intercommunication of first casing, connecting portion stretch into in the second casing, just the second casing can be followed connecting portion slide, the tip of first body passes first perforation and fixed connection in the inside of second casing.

As a preferred technical solution of the interatrial septum ostomy device, the interatrial septum ostomy device further comprises a third driving assembly, the third driving assembly comprises a second driving member, the second driving member is connected to one end of the second housing far away from the first housing, a second through hole is formed in one end of the second housing far away from the first housing, the proximal end of the push-pull rod passes through the second through hole and is connected to the second driving member, and the second driving member can drive the push-pull rod to move along the axial direction.

As a preferred technical solution of the interatrial septum ostomy device, the third driving assembly further includes a connecting rod and a second screw rod, the connecting rod is coaxially connected to the proximal end of the push-pull rod, at least a portion of the connecting rod is disposed in the second through hole, one end of the connecting rod, which is far away from the push-pull rod, penetrates through the second through hole and is coaxially connected with the second screw rod, a second threaded hole is formed in the second driving member, the second screw rod is in threaded connection with the second threaded hole, and the second driving member is rotatably connected to one end of the second housing, which is far away from the first housing.

The utility model has the advantages that:

when the cutting auxiliary assembly is used, the cutting auxiliary assembly in a stretching state is coated on the outer surface of the push-pull rod, and the cutting auxiliary assembly has a smaller outer diameter and can be accommodated in the cavity of the cutting knife, so that the cutting knife and the auxiliary assembly can move in a blood vessel simultaneously, and the conveying process is simplified; when the interatrial septum ostomy device integrally slides towards the left atrium and drives the cutting assembly to penetrate through the pre-opening hole of the interatrial septum, at the moment, the cutting auxiliary part is in a stretching state, namely, is radially compressed and axially expanded, and can easily penetrate through the pre-opening hole; after the cutting auxiliary member passed the trompil in advance, when the push-and-pull rod reverse slip, the cutting auxiliary member was the expansion state, produced axial compression and radial expansion promptly, and the cutting auxiliary member of compressed can butt room interval deviate from one side of cutting knife to fix the tissue that needs the excision from room interval's both sides with the cutting knife. Then the second pipe body and the cutting knife are driven to move towards the far end relative to the first pipe body, the cutting knife cuts the interatrial septum, and under the fixation of the cutting auxiliary piece, the cutting auxiliary piece can provide auxiliary control and fix and position the interatrial septum, so that the cutting action of the cutting knife is quicker and more accurate, and the cut tissue is prevented from falling off; after the tissue to be cut off is finished, the cut atrial septal tissue enters the cavity of the cutting knife under the fixation of the cutting auxiliary piece, so that the damage of embolism myocardial tissue caused by the falling of the tissue is avoided. The elastic telescopic action of the cutting auxiliary part is controlled by the push-pull rod, the structure is simple, looseness or fixation failure cannot occur, and the safety and the efficiency are higher; through the sliding position of the push-pull rod, the elastic deformation degree of the cutting auxiliary piece can be controlled, the abutting pressure of the cutting auxiliary piece on the interatrial space is further controlled, the degree of fitting on a cutting knife is higher, and the safety of an operation is improved.

Drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings required to be used in the description of the embodiments of the present invention will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the contents of the embodiments of the present invention and the drawings without creative efforts.

FIG. 1 is a schematic view of a cutting aid in an interatrial septum ostomy device according to an embodiment of the present invention in a stretched state;

FIG. 2 is a schematic view of a cutting aid in an atrial septal ostomy device according to an embodiment of the present invention in an expanded state;

fig. 3 is a first schematic structural diagram of a cutting knife provided by an embodiment of the present invention;

fig. 4 is a second schematic structural view of a cutting knife provided by the embodiment of the present invention;

fig. 5 is a third schematic structural diagram of a cutting knife provided by an embodiment of the present invention;

fig. 6 is a schematic structural diagram of a cutting auxiliary provided by an embodiment of the present invention;

FIG. 7 is a schematic view of a compartmental ostomy device according to an embodiment of the present invention;

figure 8 is a cross-sectional view of a septum ostomy device according to an embodiment of the invention from a first viewing angle;

figure 9 is a cross-sectional view from a second perspective of a septal ostomy device provided by an embodiment of the present invention;

fig. 10 is a schematic structural diagram of a first driving assembly provided in an embodiment of the present invention;

fig. 11 is a schematic structural diagram of a second driving assembly provided in an embodiment of the present invention;

fig. 12 is a schematic structural diagram of a third driving assembly according to an embodiment of the present invention.

The figures are labeled as follows:

100. the atrial septum;

1. a first pipe body; 11. a guidewire lumen; 12. a push-pull rod cavity; 2. a second tube body;

3. a third tube; 31. connecting the pipe body;

4. a cutting knife; 41. a cavity; 42. a limiting table; 43. an accommodating cavity; 44. a glue storage tank; 45. a blade;

5. an auxiliary component; 51. a push-pull rod; 52. cutting the auxiliary member; 521. a first extension portion; 522. a second extension portion; 5221. a fixing member; 5222. a telescoping member; 52221. a transition section;

6. a first drive assembly; 61. a first housing; 611. a first guide groove; 612. a connecting portion; 62. a first driving member; 63. a first screw; 631. a first guide member; 632. dispensing holes;

7. a second drive assembly; 71. a second housing; 711. a second guide groove; 712. a third guide groove; 72. a second guide member; 73. locking the screw;

8. a third drive assembly; 81. a second driving member; 82. a second screw; 83. a connecting rod; 84. a third guide member.

Detailed Description

The present invention will be described in further detail with reference to the accompanying drawings and examples. It is to be understood that the specific embodiments described herein are merely illustrative of the invention and are not limiting of the invention. It should be further noted that, for the convenience of description, only some of the structures related to the present invention are shown in the drawings, not all of the structures.

In the description of the present invention, unless expressly stated or limited otherwise, the terms "connected," "connected," and "fixed" are to be construed broadly, e.g., as meaning permanently connected, detachably connected, or integral to one another; can be mechanically or electrically connected; either directly or indirectly through intervening media, either internally or in any other relationship. The specific meaning of the above terms in the present invention can be understood in specific cases to those skilled in the art.

In the present disclosure, unless expressly stated or limited otherwise, the first feature "on" or "under" the second feature may comprise direct contact between the first and second features, or may comprise contact between the first and second features not directly. Also, the first feature being "on," "above" and "over" the second feature includes the first feature being directly on and obliquely above the second feature, or merely indicating that the first feature is at a higher level than the second feature. "beneath," "under" and "beneath" a first feature includes the first feature being directly beneath and obliquely beneath the second feature, or simply indicating that the first feature is at a lesser elevation than the second feature.

In the description of the present embodiment, the terms "upper", "lower", "left", "right", and the like are used in the orientation or positional relationship shown in the drawings only for convenience of description and simplicity of operation, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed in a specific orientation, and be operated, and thus should not be construed as limiting the present invention. Furthermore, the terms "first" and "second" are used only for descriptive purposes and are not intended to have a special meaning.

First, it should be noted that in the description of the present embodiment, "distal" refers to the end of the component away from the operator, i.e., the end close to the heart, when in use, and "proximal" refers to the end of the component close to the operator, i.e., the end away from the heart, when in use.

As shown in fig. 1 and 2, the present embodiment provides a interatrial septum ostomy device including a first tube 1, a second tube 2 and an auxiliary assembly 5.

Specifically, cutting knife 4 is connected to the 2 distal ends of second body, and cutting knife 4 is provided with the cavity 41 with the lumen intercommunication of second body 2, and first body 1 slides and wears to locate in second body 2 and cutting knife 4. The auxiliary assembly 5 comprises a push-pull rod 51 and a cutting auxiliary member 52, the push-pull rod 51 is slidably disposed through the first pipe body 1 and can extend out of the first pipe body 1, the proximal end of the cutting auxiliary member 52 is connected to the distal end of the first pipe body 1, the distal end of the cutting auxiliary member 52 is connected to the distal end of the push-pull rod 51, and the push-pull rod 51 can slide relative to the first pipe body 1.

The cutting aid 52 has an expanded state and a stretched state. When the cutting aid 52 is in a stretched state, the cutting aid 52 can cover the outer surface of the push-pull rod 51, and at this time, the cutting aid 52 has a smaller outer diameter, can be accommodated in the cavity 41 of the cutting blade 4, and can pass through the pre-opened hole on the atrial septum 100. The cutting aid 52, which in its extended state extends from the cavity 41 of the cutting blade 4, has a web-like surface facing the cutting blade 4, the outer diameter of which is equal to or greater than or slightly less than the inner diameter of the cavity 41, so that it can be used to collect and pull into the cavity 41 the interatrial tissue cut by the cutting blade 4.

The push-pull rod 51 is movable relative to the first tubular body 1 to switch the cutting aid 52 between the deployed state and the stretched state. When the push-pull rod 51 is moved in the distal-to-proximal direction with respect to the first tubular body 1, the cutting aid 52 is contracted in the axial direction while being expanded in the radial direction, so that the cutting aid 52 is switched from the stretched state to the expanded state. When the push-pull rod 51 is moved in the proximal-to-distal direction with respect to the first tubular body 1, the cutting aid 52 is stretched in the axial direction while being contracted in the radial direction, so that the cutting aid 52 is switched from the deployed state to the stretched state.

The cutting auxiliary member 52 of the present embodiment can be accommodated in the cavity 41 of the cutting blade 4 in a stretched state, so that the cutting blade 4 and the auxiliary member 5 can be delivered to the interatrial 100 at the same time, and the cutting blade 4 and the auxiliary member 5 do not need to be delivered to the interatrial 100 separately in sequence, thereby simplifying the operation steps and saving the operation time.

When performing a compartmental ostomy using the compartmental ostomy device of the present embodiment, the cutting blade 4 and the cutting aid 52 are delivered to the interatrial 100 simultaneously, and at this time, the cutting aid 52 is in a stretched state and is received in the cavity 41 of the cutting blade 4. The first tube 1 is driven to move the first tube 1 in a proximal to distal direction relative to the second tube 2 so that the cutting aid 52 extends from within the cavity 41 of the cutting blade 4 and through the pre-opening at the atrial septum 100. After the cutting aid 52 has passed through the pre-opening, the push-pull rod 51 is actuated to move the push-pull rod 51 in a distal-to-proximal direction relative to the first tubular body 1, causing the cutting aid 52 to switch from the stretched state to the expanded state. In the expanded state, the cutting aid 52 has a web-like surface facing the cutting blade 4 and can abut against the atrial septum 100 on the side facing away from the cutting blade 4, thereby securing the tissue to be resected with the cutting blade 4 from both sides of the atrial septum 100. Then drive second body 2, make second body 2 for first body 1 by near-end to distal end direction removal, second body 2 drives cutting knife 4 and removes towards interatrial septum 100 to the interatrial septum tissue is cut under the fixed of cutting auxiliary 52. The cutting aid 52 is capable of positioning and fixing the septal tissue to be cut, so that the cutting operation of the cutting knife 4 is faster and more accurate. After the tissue to be cut off is finished, the cut atrial septal tissue can enter the cavity 41 of the cutting knife 4 under the fixation of the cutting auxiliary member 52, so that the damage of the embolism myocardial tissue caused by the shedding of the atrial septal tissue is avoided.

The cutting aid 52 may be an elastic woven mesh and have a pre-shaped configuration. In particular, when the cutting aid 52 is in the extended condition, it has a web-like surface facing the cutting blade 4, which web-like surface is of a pre-shaped configuration. Through the movement of the push-pull rod 51 relative to the first pipe body 1, the elastic deformation degree of the cutting auxiliary piece 52 can be controlled, and further the abutting force of the cutting auxiliary piece 52 on the atrial septum 100 is controlled, so that the degree of fitting on the cutting knife 4 is higher, and the safety of the operation is improved.

It should be noted that the outer diameter of the mesh surface may be greater than, equal to, or slightly less than the inner diameter of the cavity 41 when the cutting aid 52 is in the deployed state. When the outer diameter of the mesh surface is equal to or slightly smaller than the inner diameter of the cavity 41, the mesh surface can pull the cut atrial septal tissue into the cavity 41 after the cutting blade 4 cuts the atrial septal tissue, and at least part of the mesh surface can also be pulled into the cavity 41. When the outer diameter of the mesh surface is larger than the inner diameter of the cavity 41, the push-pull rod 51 is pulled after the septal tissue is cut by the cutting blade 4, and the mesh surface pulls the cut septal tissue into the cavity 41 and against the distal end of the cutting blade 4. In other embodiments, when the outer diameter of the mesh surface is larger than the inner diameter of the cavity 41, the shape of the mesh surface can be controlled by the push-pull rod 51, and after the cutting blade 4 cuts the atrial septal tissue, the push-pull rod 51 is controlled to slightly move from the proximal end to the distal end, so that the outer diameter of the mesh surface is reduced to be equal to or smaller than the inner diameter of the cavity 41.

When the cutting knife 4 cuts off the atrial septal tissue, in order to prevent the second tube 2 and the cutting knife 4 from moving too far in the direction from the proximal end to the distal end, a limit table 42 may be provided in the cavity 41. After the second tube body 2 and the cutting knife 4 cut the atrial septal tissue, if continue to move from the near end to the far end, the cutting auxiliary member 52 will abut against the limiting table 42, and at this time, the second tube body 2 and the cutting knife 4 stop moving to complete the stoma.

The means of connection of the cutting blade 4 to the second tubular body 2 include, but are not limited to, the means shown in figures 3-5. As shown in fig. 3, the proximal end of the cutting blade 4 is provided with a receiving cavity 43 extending along the circumferential direction thereof, and the inner diameter of the cutting blade 4 at the position of the receiving cavity 43 is preferably the same as the outer diameter of the second tube 2. The distal end of the second tube 2 extends into the accommodating cavity 43, and the outer wall of the second tube 2 is attached to the wall of the accommodating cavity 43. The junction of cutting knife 4 and second body 2 passes through glue and bonds, perhaps establishes the pyrocondensation pipe at the junction cover of cutting knife 4 and second body 2, heats the pyrocondensation pipe in order to realize being connected between cutting knife 4 and the second body 2.

As shown in fig. 4, the cutting blade 4 extends into the distal end of the second tube 2 towards one end of the second tube 2 and is fixedly connected to the second tube 2. The outer diameter of the proximal end of the cutting blade 4 is preferably the same as the inner diameter of the distal end of the second tubular body 2. During cutting knife 4 stretched into second body 2 towards the one end of second body 2, and the inner wall of second body 2 and the outer wall laminating of cutting knife 4 and bond through glue, perhaps establish the pyrocondensation pipe at the junction cover of cutting knife 4 and second body 2, the heating pyrocondensation pipe is in order to realize being connected between cutting knife 4 and the second body 2.

As shown in fig. 5, the cutting blade 4 is opposite to and attached to the end surface of the second pipe 2 facing each other. The outer wall of the cutting knife 4 is provided with a glue storage groove 44 along the circumferential direction, and the glue storage groove 44 does not penetrate through the end face of the cutting knife 4. After the end face of the second pipe body 2 is attached to the cutting knife 4, glue is coated on the joint of the second pipe body 2 and the cutting knife 4 along the circumferential direction, the glue is extended into the glue storage groove 44, the connection area is increased, and the firm degree of bonding is ensured. And a heat shrink tube can be sleeved at the joint of the cutting knife 4 and the second pipe body 2 and heated to realize the connection between the cutting knife 4 and the second pipe body 2.

Preferably, in this embodiment, the distal end of the cutting blade 4 is provided with a cutting edge 45, and the shape of the cutting edge 45 is any shape such as a ring shape, a rectangle shape, or an oval shape, which is within the protection scope of the present invention, and this embodiment is not limited herein. Specifically, the blade 45 is formed by chamfering the side wall of the cutter 4, the chamfering may be in the form of an inner wall chamfer, an outer wall chamfer or both an inner wall and an outer wall chamfer forming the cutting edge 45. The material of cutting knife 4 can be stainless steel or titanium alloy etc. and on the one hand, structural strength satisfies the user demand, and on the other hand has the developability, during the operation, is convenient for know the position of cutting knife 4. The axial length of the cutting knife 4 can be 10-20mm, the inner diameter can be 4-10mm, the outer diameter can be 6-12mm, and the chamfer angle at the cutting edge 45 can be 15-30 degrees.

Further, as shown in fig. 6, the cutting aid 52 is an elastic woven mesh including a first extension 521 and a second extension 522 sequentially arranged in a proximal to distal direction; the first extension 521 is connected to the distal end of the first pipe body 1, and the push-pull rod 51 passes through the first extension 521 and is connected to the second extension 522; the proximal end of the second extension 522 has a web-like surface facing the cutting blade 4 when the cutting aid 52 is in the deployed state. The first extension 521 is preferably cylindrical, and the proximal end of the first extension 521 has an opening, through which the first extension 521 can pass through the pre-opened hole of the atrial septum 100, and is sleeved on the distal end of the first tube 1 or bonded to the distal end of the first tube 1. The push-pull rod 51 passes from within the first body 1 through an opening into the cutting aid 52. Preferably, the first extension 521 accurately defines the position of the cutting aid 52 without damaging the pre-drilled hole. One end of the second extension portion 522 is fixedly connected to the other end of the first extension portion 521 away from the first pipe body 1, the push-pull rod 51 passes through the first extension portion 521 and is connected to the bottom of the second extension portion 522, and the second extension portion 522 can be unfolded and/or stretched during the process of pulling the push-pull rod 51 relative to the cutting aid 52.

Preferably, the cutting aid 52 is positioned in the extended position with the mesh surface at an angle of 80-90 degrees to the push-pull rod 51, which improves the stability of the mesh surface to secure the atrial septum 100.

Preferably, the push-pull rod 51 is connected to the distal end of the second extension 522. The cutting aid 52 is formed into a bag-like woven mesh by the first and second extensions 521 and 522, and is capable of accommodating the push-pull rod 51 therethrough, having a superior elastic stretchability in both radial and axial directions, easily passing through the pre-perforated hole of the atrial septum 100, and effectively fixing the cut tissue. The push-pull rod 51 is located within the cutting aid 52 and provides axial guidance during elastic deformation of the cutting aid 52 to avoid tilting during axial compression or breaking during radial compression.

Preferably, the push-pull rod 51 is made of metal and is welded to the cutting auxiliary 52, so that the connection reliability is improved, and the risk of falling off of the cutting auxiliary 52 is reduced. Further, the push-pull rod 51 comprises a straight rod portion and an elastic portion, the straight rod portion and the elastic portion are axially arranged, the straight rod portion is located at the near end of the push-pull rod 51, the elastic portion is located at the far end of the push-pull rod 51, the straight rod portion is connected with the elastic portion in a welded mode, and the elastic portion is arranged, so that the push-pull rod 51 can be bent at the elastic portion, and accurate reaching of the position of the pre-hole is facilitated. Wherein, the elastic part can be a spring.

Preferably, the cross-sectional shape of the second extension portion 522 may be a regular or irregular polygon such as a triangle, a rectangle, a diamond, a star, etc., and may also be a shape having an arc-shaped side such as a circle, an ellipse, etc., which are within the protection scope of the present invention, and the present embodiment is not limited herein.

Further, the second extension part 522 includes a fixing part 5221 and an expansion part 5222, wherein one side of the fixing part 5221 is connected with the first extension part 521, and the other side is connected with the expansion part 5222. The fixing member 5221 can be a predetermined mesh surface, and the shape of the mesh surface is preferably circular, but in other embodiments of the present invention, the mesh surface can also be regular or irregular shapes such as oval, diamond, etc. Fixing piece 5221 can laminate the room interval 100 when being netted face form and deviate from one side of cutting knife 4 for it is more firm to the centre gripping of room interval 100 with cutting knife 4. When the push-pull rod 51 slides in the distal-to-proximal direction, the cutting assistance member 52 is compressed axially and expanded radially, and the fixing member 5221 is in a mesh-shaped form, so that the cutting assistance member 52 can accurately clamp the atrial septum 100 with the fixing member 5221 as a reference surface.

Further, telescoping member 5222 comprises a transition section 52221 and a distal section disposed in series in the proximal-to-distal direction. The transition section 52221 has a predetermined shape, when the cutting auxiliary element 52 is in the expanded state, the transition section 52221 is preferably in a frustum shape, the diameter of the transition section 52221 gradually decreases from the proximal end to the distal end, and the frustum-shaped transition section 52221 supports the fixing element 5221, so that the deformation resistance of the fixing element 5221 can be further increased, the fixing element 5221 is prevented from being folded towards the direction away from the cutting blade 4 in the cutting process, and the success rate of the operation is increased. The distal end of push-pull rod 51 is removably attached to the distal section of telescoping member 5222, which has a smaller diameter to better guide cutting aid 52 through the pre-fenestration of atrial septum 100. Transition section 52221 has great diameter under the expanded state, can have bigger area of contact to the interatrial septum tissue, and fixed effect is better.

Further, the cutting auxiliary member 52 may be formed by weaving a plurality of alloy wires, the material of the alloy wires may be nickel alloy, or may be other alloy materials with memory capability, and the weaving method may be any existing weaving technology in the art, and the embodiment is not limited herein. Further, the wire diameter of the alloy wire may be in the range of 0.05mm to 0.15mm, and the hole density of the cutting aid 52 may be in the range of 30 to 80 per inch of crossing, so that good elastic deformability can be maintained and sufficient fixing support strength can be obtained. It is within the scope of the present invention that the mesh shape of the cutting aid 52 may be circular or polygonal, etc.

Further, the first tube 1 comprises a plurality of fasteners, which are disposed at the distal end of the first tube 1 and can engage with the cutting aid 52. Preferably, the buckle joint is at the opening of first extension 521, through the buckle, can carry out quick assembly disassembly to first body 1 and cutting auxiliary 52, and the operating efficiency is higher.

Preferably, as shown in fig. 8, the first tube 1 may be a double lumen tube including a push-pull rod cavity 12 and a guide wire cavity 11 axially penetrating therethrough, the push-pull rod cavity 12 being used for penetrating the push-pull rod 51, and the guide wire cavity 11 being used for penetrating the guide wire. Preferably, the push-pull rod cavity 12 is arranged coaxially with the first body 1. In other embodiments, the first tube body 1 may be a single lumen tube, the push-pull rod 51 can be slidably disposed in the single lumen tube, the push-pull rod 51 is provided with a guidewire lumen 11, and the guide guidewire can be slidably disposed in the guidewire lumen 11. The cutting auxiliary 52 is provided with a guide wire through hole facing the guide wire cavity 11, and the guide wire can penetrate through the guide wire through hole and extend into the guide wire cavity 11, or the mesh on the cutting auxiliary 52 is arranged facing the guide wire cavity 11, which is not limited herein.

Further, as shown in fig. 7-9, the interatrial septum ostomy device of the present invention further comprises a third tube 3, and the second tube 2 is slidably inserted into the third tube 3. In the delivery process of the interatrial septum stoma device, the third pipe body 3 coats the first pipe body 1, the second pipe body 2, the cutting knife 4 and the auxiliary component 5, so that the cutting knife 4 is prevented from touching the blood vessel part, and the first pipe body 1, the second pipe body 2, the cutting knife 4 and the auxiliary component 5 are protected, thereby improving the operation safety.

It should be noted that the interatrial septum ostomy device further comprises a first driving assembly 6, a second driving assembly 7 and a third driving assembly 8, the first driving assembly 6 being capable of driving the second tube 2 to move axially, the second driving assembly 7 being capable of driving the first tube 1 to move axially, and the third driving assembly 8 being capable of driving the push-pull rod 51 to move axially to switch the cutting aid 52 between the deployed state and the stretched state.

Specifically, as shown in fig. 10, the first driving assembly 6 includes a first housing 61 and a first driving member 62, the proximal end of the second pipe 2 extends into the first housing 61, the proximal end of the second pipe 2 is connected with a first guiding member 631, a first guiding groove 611 is formed on the inner wall of the first housing 61, the first guiding groove 611 extends along the axial direction of the second pipe 2, the first guiding member 631 is slidably disposed in the first guiding groove 611, and the first driving member 62 can drive the second pipe 2 to move along the axial direction. Through setting up first guide way 611 and first guide 631, improved second body 2 along axial displacement's reliability, guaranteed the position department that reachs the trompil in advance that can be accurate, guaranteed the accuracy of stoma position, guaranteed the security of operation, reduced the operation risk, first guide 631 can be protected to first casing 61, has guaranteed the durability.

Further, the distal end of the first housing 61 is connected to the third tube 3, the proximal end of the third tube 3 is coaxially connected to the connection tube 31, and the connection tube 31 is connected to the first housing 61. The proximal end of the third tube 3 extends into the connecting tube 31, and the outer wall of the third tube 3 is bonded to the inner wall of the connecting tube 31. The end face of the connection pipe 31 far from the third pipe 3 is connected to the first housing 61, the first housing 61 is provided with a communication hole, so that the cavity of the first housing 61 is communicated with the connection pipe 31, and the second pipe 2 can penetrate through the communication hole from the first housing 61 to the third pipe 3.

Further, the first driving assembly 6 further includes a first screw 63, the first driving member 62 is disposed in the first housing 61, and the first driving member 62 is provided with a first threaded hole, the first screw 63 is threaded in the first threaded hole, one end of the first screw 63 is connected to the proximal end of the second tube 2, the other end of the first screw 63 penetrates through the first driving member 62, and the first guiding member 631 is connected to the side wall of the first screw 63. Above-mentioned structure sets up, realizes the rectilinear movement of second body 2 through rotating first driving piece 62, simple structure, and processing is convenient.

Specifically, the first screw 63 is coaxially connected to the proximal end of the second tube 2, and the first screw 63 has a through hole coaxially formed therein, and the through hole penetrates through both axial ends of the first screw 63, so that the first tube 1 is conveniently inserted. The near end of the second pipe body 2 extends into the through hole of the first screw 63, the side wall of one end, facing the second pipe body 2, of the first screw 63 is provided with a glue dispensing hole 632, the glue dispensing hole 632 penetrates through the through hole of the first screw 63, glue can be dripped onto the side wall of the second pipe body 2 through the glue dispensing hole 632, and the adhesion between the second pipe body 2 and the first screw 63 is achieved. In other embodiments, the connection between the second tube 2 and the first screw 63 can be realized by other means, which are not limited herein.

In this embodiment, seted up on the lateral wall of first casing 61 and adjusted the opening, first driving piece 62 can expose in first casing 61 through adjusting the opening, and operating personnel can stir first driving piece 62 through adjusting the opening and rotate, is convenient for adjust second body 2 along axial removal, has improved the practicality.

Further, a plurality of long grooves may be circumferentially disposed on an outer side wall of the first driving member 62, and the long grooves are axially disposed along the second pipe body 2, so as to increase friction force, facilitate manual rotation of the first driving member 62, and achieve movement of the second pipe body 2.

In this embodiment, one end of the first housing 61 away from the second tube 2 is provided with a connecting portion 612, the connecting portion 612 extends along the axial direction of the first tube 1, and the connecting portion 612 is provided for connecting the second driving assembly 7. Specifically, a first through hole is coaxially formed in the connecting portion 612, and the first through hole is communicated with the inner cavity of the first housing 61, so that the first pipe body 1 can conveniently pass through the first through hole to reach the second pipe body 2.

Preferably, as shown in fig. 11, the second driving assembly 7 includes a second housing 71, the connecting portion 612 extends into the second housing 71, and the second housing 71 can slide along the connecting portion 612, the end of the first pipe 1 passes through the first through hole and is fixedly connected inside the second housing 71, and through relative sliding between the second housing 71 and the first housing 61, the first pipe 1 moves along the axial direction, the structure is simple, and the production and the processing are convenient.

Further, the second driving assembly 7 further includes a second guiding element 72, a second guiding groove 711 is formed on an inner wall of the second housing 71, the second guiding element 72 is connected to one end of the connecting portion 612 far away from the second tube 2, and the second guiding element 72 is disposed in the second guiding groove 711 and can slide along the second guiding groove 711. Through setting up second guide 72 and second guide way 711, played the guide effect to first body 1, improved first body 1 along axial displacement's stability, guaranteed the position department that can be accurate reachs the trompil in advance, guaranteed the accuracy of stoma position, guaranteed the security of operation. Specifically, the connecting portion 612 has a cylindrical shape, the second guide 72 is disposed to protrude from a sidewall of the connecting portion 612, and a protruding portion of the second guide 72 is disposed in the second guide groove 711.

Still further, the second driving assembly 7 further includes a locking screw 73, a threaded through hole is formed in a side wall of the second housing 71, and the locking screw 73 is screwed in the threaded through hole and can abut against the connecting portion 612. When the first pipe body 1 reaches the preset position, the locking screw 73 is screwed down, so that the locking screw 73 is abutted to the connecting portion 612, the relative position between the second shell 71 and the connecting portion 612 is limited, the effect of limiting the position of the second shell 71 is achieved, the first pipe body 1 is prevented from moving, the positions of the cutting knife 4 and the push-pull rod 51 are prevented from being influenced, and the possibility of cutting position deviation is reduced.

Preferably, as shown in fig. 12, the third driving assembly 8 includes a second driving member 81, the second driving member 81 is connected to an end of the second housing 71 away from the first housing 61, an end of the second housing 71 away from the first housing 61 is provided with a second through hole, a proximal end of the push-pull rod 51 is connected to the second driving member 81 through the second through hole, and the second driving member 81 can drive the push-pull rod 51 to move along the axial direction. The second driving member 81 is connected to the second housing 71, and since the first pipe body 1 is fixedly connected to the second housing 71, when the first pipe body 1 and the push-pull rod 51 are driven to move toward the pre-hole-opening position, the push-pull rod 51 and the first pipe body 1 can be driven to move simultaneously only by pushing the second housing 71, so that the operation process is simplified, and the practicability is improved.

Further, the third driving assembly 8 further includes a connecting rod 83 and a third guiding member 84, the connecting rod 83 is coaxially connected to the proximal end of the push-pull rod 51, the connecting rod 83 is at least partially disposed in the second through hole, a third guiding groove 712 is disposed on a wall of the second through hole, the third guiding groove 712 extends along the axial direction of the push-pull rod 51, a side wall of the connecting rod 83 is connected to the third guiding member 84, the third guiding member 84 protrudes from the connecting rod 83, and the third guiding member 84 is disposed in the third guiding groove 712 and can slide along the third guiding groove 712. By providing the third guide groove 712 and the third guide member 84, the reliability of the axial movement of the push-pull rod 51 is improved, and the position where the pre-opening hole can be accurately reached is ensured, so that the cutting auxiliary member 52 can pass through the pre-opening hole and be switched to the unfolded state, and the smooth proceeding of the stoma opening process is ensured. It is understood that, in order to prevent the third guide member 84 from slipping off the third guide groove 712, the third guide groove 712 is not penetrated through both end faces of the second through hole.

Preferably, the third driving assembly 8 further includes a second screw 82, one end of the connecting rod 83, which is far away from the push-pull rod 51, penetrates through the second through hole and is coaxially connected to the second screw 82, a second threaded hole is formed in the second driving member 81, the second screw 82 is in threaded connection with the second threaded hole, and the second driving member 81 is rotatably connected to one end of the second housing 71, which is far away from the first housing 61. The structure is simple, and the production and the processing are convenient.

Preferably, the cutting knife 4 is circular, and the cutting knife 4 is made of metal, stainless steel and the like. One end of the cutting knife 4 is provided with an annular cutting edge, the other end of the cutting knife 4 is connected with the second tube body 2, and the first tube body 1 and the auxiliary component 5 are arranged in the cutting knife 4 in a penetrating way. The second tube body 2 is a structure formed by coating a stainless steel braid layer with a Pebax (polyether block polyamide) material.

In this embodiment, the first driving assembly 6 can drive the second pipe body 2 to move axially; the second housing 71 is slidably connected to the first driving assembly 6, and the first pipe 1 penetrates through the first driving assembly 6 and is fixedly connected to the inside of the second housing 71; the second driving member 81 is connected to the proximal end of the second casing 71 of the second driving assembly 7, the proximal end of the second casing 71 is provided with a second through hole, the proximal end of the push-pull rod 51 is connected to the second driving member 81 through the second through hole, and the second driving member 81 of the third driving assembly 8 can drive the push-pull rod 51 to move along the axial direction. The first driving assembly 6, the second driving assembly 7 and the third driving assembly 8 are connected with each other, so that the structure is simple and the size is reduced. And the push-pull rod 51 can move simultaneously with the first pipe body 1 through the second driving component 7, so that the auxiliary component 5 passes through the pre-opened hole to reach a specified position, and the push-pull rod 51 can be driven independently through the second driving component 81, so that the auxiliary component 5 is switched between a stretching state and a unfolding state.

For ease of understanding, the present embodiment provides the following steps for the operation of the interatrial septum ostomy device:

firstly, the third tube 3 covers the first tube 1, the second tube 2, the cutter 4 and the auxiliary assembly 5, the cutting auxiliary member 52 is in a stretching state, the guide wire penetrates into the guide wire cavity 11, and the third tube 3, the second tube 2, the first tube 1 and the auxiliary assembly 5 can reach the pre-perforation position along the guide wire. The second housing 71 of the second driving assembly 7 is pushed, so that the first tube 1 and the auxiliary assembly 5 are further moved toward the pre-drilling position, and the auxiliary assembly 5 passes through the pre-drilling position to reach the designated position. The third drive assembly 8 is then used to pull the push-pull rod 51 back, causing the cutting aid 52 to assume the deployed state, with the cutting aid 52 resting against one side of the pre-cut hole. The second tube 2 is driven to advance by the first driving assembly 6, the cutting blade 4 cuts the interatrial septum tissue, and the excised tissue enters the cavity 41 under the fixation of the cutting aid 52, completing the stoma. Finally, the first driving assembly 6 and the second driving assembly 7 adjust the first pipe body 1, the second pipe body 2, the cutting knife 4 and the auxiliary assembly 5 to retreat into the third pipe body 3, and the interatrial ostomy device is integrally withdrawn.

It should be noted that the foregoing is only a preferred embodiment of the present invention and the technical principles applied. It will be understood by those skilled in the art that the present invention is not limited to the particular embodiments described herein, but is capable of various obvious changes, rearrangements and substitutions as will now become apparent to those skilled in the art without departing from the scope of the invention. Therefore, although the present invention has been described in greater detail with reference to the above embodiments, the present invention is not limited to the above embodiments, and may include other equivalent embodiments without departing from the scope of the present invention.

Claims (10)

1. An interatrial septum ostomy device, comprising:

a first pipe body (1);

the far end of the second pipe body (2) is connected with a cutting knife (4), the cutting knife (4) is provided with a cavity (41) communicated with the pipe cavity of the second pipe body (2), and the first pipe body (1) is slidably arranged in the second pipe body (2) and the cutting knife (4) in a penetrating mode;

the auxiliary assembly (5) comprises a push-pull rod (51) and a cutting auxiliary piece (52), the push-pull rod (51) is slidably arranged in the first pipe body (1), the near end of the cutting auxiliary piece (52) is connected with the far end of the first pipe body (1), the far end of the cutting auxiliary piece (52) is connected with the far end of the push-pull rod (51), and the push-pull rod (51) can slide relative to the first pipe body (1) so that the cutting auxiliary piece (52) can be switched between a spreading state and a stretching state;

the cutting aid (52) being receivable within the cavity (41) when in the extended condition; the cutting aid (52) has a web-like surface facing the cutting blade (4) in the deployed state, said web-like surface being used to collect and pull the septal tissue cut by the cutting blade (4) into the cavity (41).

2. Atrial septum ostomy device according to claim 1, wherein a stop (42) is provided in the cavity (41), the cutting aid (52) being able to abut against the stop (42).

3. Atrial septum ostomy device according to claim 1, wherein the cutting aid (52) is an elastic mesh grid comprising a first extension (521) and a second extension (522) arranged in sequence in a proximal-to-distal direction;

the first extension part (521) is connected with the distal end of the first pipe body (1), and the push-pull rod (51) penetrates through the first extension part (521) and is connected with the second extension part (522);

the proximal end of the second extension (522) has a web-like surface facing the cutting blade (4) when the cutting aid (52) is in the deployed state.

4. The interatrial septum ostomy device of claim 1, wherein the mesh surface is a pre-shaped structure.

5. Atrial septal ostomy device according to claim 1, wherein the mesh surface has an outer diameter equal to or greater than the inner diameter of the cavity (41) when the cutting aid (52) is in the deployed state.

6. Atrial septal ostomy device according to claim 3, wherein the angle between the mesh surface and the push-pull rod (51) is 80-90 degrees when the cutting aid (52) is in the deployed state.

7. Atrial septal ostomy device according to claim 1, further comprising a third tube (3), the second tube (2) being slidingly arranged through the third tube (3).

8. The interatrial septum ostomy device of claim 1, further comprising a first driving assembly (6), wherein the first driving assembly (6) comprises a first housing (61) and a first driving member (62), the proximal end of the second tube (2) extends into the first housing (61), the proximal end of the second tube (2) is connected with a first guiding member (631), a first guiding groove (611) is formed on the inner wall of the first housing (61), the first guiding groove (611) extends along the axial direction of the second tube (2), the first guiding member (631) is slidably disposed in the first guiding groove (611), and the first driving member (62) can drive the second tube (2) to move along the axial direction.

9. Atrial septal ostomy device according to claim 8, further comprising a second driving assembly (7), wherein the second driving assembly (7) comprises a second housing (71), a connecting portion (612) extends from the proximal end of the first housing (61) along the axial direction of the first tube (1), a first through hole is coaxially formed on the connecting portion (612), the first through hole is communicated with the inner cavity of the first housing (61), the connecting portion (612) extends into the second housing (71), the second housing (71) can slide along the connecting portion (612), and the end of the first tube (1) passes through the first through hole and is fixedly connected to the inside of the second housing (71).

10. Atrial septal ostomy device according to claim 9, wherein the atrial septal ostomy device further comprises a third driving assembly (8), the third driving assembly (8) comprises a second driving member (81), the second driving member (81) is connected to an end of the second housing (71) away from the first housing (61), an end of the second housing (71) away from the first housing (61) is provided with a second through hole, a proximal end of the push-pull rod (51) is connected to the second driving member (81) through the second through hole, and the second driving member (81) can drive the push-pull rod (51) to move axially.

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