CN218305042U

CN218305042U - Interatrial septum stoma device

Info

Publication number: CN218305042U
Application number: CN202123227445.8U
Authority: CN
Inventors: 王钰; 邱硕实; 刘玉博; 范军; 焦政军; 王森; 宋睿; 周国磊
Original assignee: Shanghai Shenqi Medical Technology Co Ltd
Current assignee: Shanghai Shenqi Medical Technology Co Ltd
Priority date: 2021-12-21
Filing date: 2021-12-21
Publication date: 2023-01-17
Anticipated expiration: 2031-12-21

Abstract

The utility model belongs to the technical field of medical instrument, a interatrial septum stoma device is disclosed, including the elasticity mesh grid, the elasticity mesh grid includes first extension and the second extension that sets gradually along near-end to distal end direction, and first extension is the tubulose, and the second extension includes mounting and extensible member, and first extension is connected to the mounting, and the mounting has annular wire side. In the interatrial septum stoma device of the utility model, the tubular first extension part can pass through the puncture hole on the interatrial septum, and the annular net surface can be attached to the puncture hole; the second extension part can cover the tissue to be cut around the stoma from the far end side of the atrial septum, fix and position the atrial septum, is convenient for providing auxiliary control in the cutting process of the tissue around the stoma and prevents the cut tissue from falling off; after the tissue is cut off, the elastic woven mesh can assist in clamping the cut tissue from the far end side of the atrial septum and bring the tissue out of the body, so that embolism or myocardial tissue damage caused by tissue falling off is avoided.

Description

Interatrial septum stoma device

Technical Field

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

Background

Heart failure (abbreviated as heart failure) is a complex clinical syndrome of impaired ventricular filling or ejection capacity due to structural or functional abnormalities of the heart, with its major clinical manifestations of dyspnea and fatigue (limited exercise tolerance), and fluid retention (pulmonary congestion and peripheral edema). Heart failure is a severe and terminal stage of various heart diseases, has a high incidence rate, and is one of the most serious cardiovascular diseases today. There are left heart, right heart and whole heart failure according to the occurrence of heart failure. Interatrial sepstomy is the creation of an ostium at the interatrial septum of a patient's heart to create a shunt between the left and right atria for the treatment of pulmonary hypertension (right atrial left atrial shunt) or left heart failure (left atrial right atrial shunt) and has proven clinically effective. The existing traditional interatrial septum stoma method generally adopts cutting equipment with a gripping device, when the cutting equipment performs stoma on interatrial septum tissues, the gripping device firstly positions and grips partial tissues required to be cut, then the cutting device cuts the partial tissues gripped by the gripping device through a mechanical or high-frequency electric knife, and the cut tissues are taken out of the body by the gripping device, so that stoma is formed. Loosening of the grasping device, for example, during surgery or during post-operative retrieval, can result in the severed tissue becoming dislodged and forming emboli. In addition, loosening of the grasping device during cutting is also highly likely to result in damage to other myocardial tissue.

SUMMERY OF THE UTILITY MODEL

An object of the utility model is to provide an interatrial septum stoma device can avoid the interatrial septum tissue of cutting to drop among the operation process or when retrieving after the art, prevents to form embolism or cardiac muscle tissue impaired.

To achieve the purpose, the utility model adopts the following technical proposal:

the utility model provides a interatrial septum ostomy device, includes elasticity woven mesh, elasticity woven mesh includes first extension and the second extension that sets gradually along near-end to distal end direction, first extension is the tubulose, the second extension includes mounting and extensible member, the mounting is connected first extension, just the mounting has annular wire side.

As a preferred structure of the present invention, the interatrial septum stoma device further comprises a conveying sheath and a push-pull rod, the push-pull rod is inserted into the conveying sheath, the proximal end of the first extension is connected to the distal end of the conveying sheath, the push-pull rod passes the first extension and is connected to the distal end of the second extension.

As a preferable structure of the present invention, the push-pull rod is capable of moving in an axial direction with respect to the delivery sheath tube so as to extend and retract the second extension portion in a radial direction and/or an axial direction.

As a preferred structure of the present invention, the outer diameter of the annular net surface is greater than the outer diameter of the first extension portion.

As a preferred structure of the utility model, the interatrial septum stoma device further comprises an annular cutting knife, and the difference between the inner diameter of the cutting knife and the outer diameter of the annular net surface is 0mm-1mm.

As a preferred structure of the present invention, the push-pull rod is detachably connected to the distal end of the extensible member.

As a preferred structure of the utility model, the interatrial septum stoma device still includes first joint subassembly, first joint subassembly include first outer ring and suit in first inner ring in first outer ring, the one end joint of first inner ring the push-and-pull rod, the distal end joint of extensible member in between first outer ring and the first inner ring.

As a preferred structure of the utility model, the interatrial septum stoma device still includes second joint subassembly, the second joint subassembly include the second outer loop and suit in the endocyclic second inner ring of second outer, the one end joint of second inner ring carry the sheath pipe, the near-end joint of first extension in between second outer loop and the second inner ring.

As a preferable structure of the present invention, an included angle between the annular mesh surface and the axial direction of the push-pull rod is 80 ° to 100 °.

As the utility model discloses a preferred structure, the extensible member is including flexible changeover portion, the both ends of flexible changeover portion are big footpath end and path end respectively, big footpath end is connected annular wire side.

The utility model has the advantages that: the tubular first extension part can pass through the puncture hole on the atrial septum, and the annular net surface can be attached to the puncture hole; because of it is the torus net, the mounting can be laminated on the interatrial interval better, pinpoints the position of elasticity mesh grid, and does not damage the puncture. The second extension part can cover the tissues to be cut around the stoma from the far end side of the atrial septum, fix and position the atrial septum, and is convenient for providing auxiliary control in the cutting process of the tissues around the stoma, so that the cutting action is quicker and more accurate, and the cut tissues are prevented from falling off; after the tissue is cut off, the elastic woven mesh can assist in clamping the cut tissue from the far end side of the atrial septum and bring the tissue out of the body, so that embolism or myocardial tissue damage caused by tissue falling off is avoided.

Drawings

FIG. 1 is a schematic view of a compartmental ostomy device according to an embodiment of the present invention;

fig. 2 is a schematic structural view of an elastic mesh grid according to an embodiment of the present invention.

In the figure:

1. elastic woven mesh; 11. a first extension portion; 12. a second extension portion; 121. a fixing member; 1221. a transition section; 122. a telescoping member; 2. a delivery sheath; 3. a push-pull rod; 4. a cutting knife;

100. the atrial septum.

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 to be construed as limiting 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 "on," "above" and "over" the second feature may include the first feature being directly above and obliquely above the second feature, or simply 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.

It should be noted that the "proximal end" and the "distal end" in the present embodiment are relative to the operator, and when the operator holds the atrial septum ostomy device, the end closer to the operator is the proximal end, and the end farther from the operator is the distal end.

As shown in fig. 1-2, the present invention provides a interatrial septum ostomy device for performing an ostomy operation on an interatrial septum 100, which has been used to form a puncture hole in the interatrial septum 100 using a puncturing device before the ostomy operation. The atrial septal ostomy device comprises an elastic mesh grid 1, wherein the elastic mesh grid 1 comprises a first extension part 11 and a second extension part 12 which are sequentially arranged from the near end to the far end, the first extension part 11 is tubular, the second extension part 12 comprises a fixing part 121 and an expansion part 122, the fixing part 121 is connected with the first extension part 11, and the fixing part 121 is provided with an annular mesh surface. In the atrial septum ostomy device of the embodiment of the utility model, the tubular first extension part 11 can pass through the puncture hole on the atrial septum 100, and the annular net surface can be attached to the puncture hole; because it has the annular net face, mounting 121 can laminate on atrial septum 100 better, pinpoints the position of elasticity mesh grid 1, and does not damage the puncture hole. The second extension part 12 can cover the tissue to be excised around the stoma from the distal end side of the atrial septum 100, and fix and position the atrial septum 100, so as to provide auxiliary control in the cutting process of the tissue around the stoma, so that the excision action is faster and more accurate, and the excised tissue is prevented from falling off; after the tissue is cut off, the elastic mesh grid 1 can assist in clamping the cut tissue from the distal side of the atrial septum 100 and bring the tissue out of the body, so as to avoid embolism or myocardial tissue damage caused by tissue falling off.

Preferably, the elastic woven mesh 1 is formed by weaving a plurality of alloy wires, the material of the alloy wires includes nickel alloy, and may also be other alloy materials with memory capacity, the weaving method is prior art in the field, and the embodiment is not limited herein. Furthermore, the wire diameter range of the alloy wires is 0.05mm-0.15mm, the pore density of the elastic woven mesh 1 is 30-80 per inch of crossing number, and the mesh shape of the elastic woven mesh 1 can be circular or polygonal, so that the elastic woven mesh can maintain good elastic deformability and has enough fixed supporting strength. Specifically, the cross-sectional shape of the telescopic element 122 may be a regular or irregular polygon such as a triangle, a rectangle, a diamond, a star, etc., or a shape having an arc-shaped edge such as a circle, an ellipse, etc., which is within the protection scope of the present invention, and the present embodiment is not limited herein.

Furthermore, the interatrial septum stoma device further comprises a conveying sheath tube 2 and a push-pull rod 3, wherein the conveying sheath tube 2 is hollow, the push-pull rod 3 penetrates through the conveying sheath tube 2, the near end of the first extension portion 11 is connected to the far end of the conveying sheath tube 2, and the push-pull rod 3 penetrates through the first extension portion 11 and is connected to the far end of the second extension portion 12. It will be appreciated that the first extension 11 has an opening at one end for connection to the delivery sheath 2, and the push-pull rod 3 is passed from inside the delivery sheath 2 through the opening of the first extension 11 into the elastic braided mesh 1 and connected to the distal end of the second extension 12. The push-pull rod 3 is supported in the elastic knitted net 1, and can guide the elastic knitted net 1 to pass through the puncture hole of the atrial septum 100.

Further, the push-pull rod 3 is axially movable relative to the delivery sheath 2 to telescope the second extension 12 in a radial and/or axial direction. It will be understood that the elastic stretching of the elastic knitted mesh 1 includes radial stretching and axial stretching: when the push-pull rod 3 slides towards the left atrium and drives the elastic woven mesh 1 to penetrate through the puncture hole of the atrial septum 100, the elastic woven mesh 1 generates radial compression and axial expansion and can easily penetrate through the puncture hole with smaller aperture; when the push-pull rod 3 slides reversely, the elastic woven mesh 1 generates axial compression and radial expansion, the compressed elastic woven mesh 1 can be attached to the annular netted fixing part 121, the elastic woven mesh 1 after axial compression has a larger radial area, the annular mesh surface of the fixing part 121 can be used as a reference surface, the atrial septum 100 can be accurately abutted and fixed, and the clamping of tissues around the stoma is more effective. The elastic telescopic action of the elastic mesh grid 1 is controlled by the push-pull rod 3, the structure is simple, the looseness or fixation failure cannot occur, and the safety and the efficiency are higher; through the sliding position of push-pull rod 3, can control the elastic deformation degree of elasticity woven mesh 1, and then control elasticity woven mesh 1 to the pressure of interatrial septum 100, the degree of adaptation to the cutting action is higher.

Further, the outer diameter of the annular net surface is larger than the outer diameter of the first extension part 11, so that the annular net surface has a larger contact area, on one hand, more areas of the atrial septum 100 can be attached, the clamping of the tissue is more stable, on the other hand, the elastic woven net 1 can be prevented from being separated from the left atrium when the push-pull rod 3 slides reversely, and the atrial septum 100 or the device is prevented from being damaged.

Furthermore, the interatrial septum stoma device also comprises an annular cutting knife 4, and the outer diameter of the annular net surface is equal to or slightly smaller than the inner diameter of the cutting knife 4. Preferably, the difference between the inner diameter of the cutting blade 4 and the outer diameter of the annular mesh surface may be 0mm to 1mm. Preferably, the cutting knife 4 is slidably connected outside the delivery sheath 2, the delivery sheath 2 is aligned with the puncture hole, and the cutting knife 4 slides on the delivery sheath 2 and can slide along the axial direction of the delivery sheath 2, so as to abut against the interatrial septum 100 from the right atrium side and be located on both sides of the interatrial septum 100 with the second extension 12. In this embodiment, elasticity mesh grid 1 sets up with the axle center with cutting knife 4, and when the annular wire side external diameter of mounting 121 slightly was lighter than the internal diameter of cutting knife 4, elasticity mesh grid 1 can effectively be fixed the tissue of cutting, and simultaneously after the tissue cutting got off, elasticity mesh grid 1 can be drawn into the inner chamber of cutting knife 4 with the tissue that the cutting got off, avoids the tissue to drop. The structure of the cutting blade 4 and the principle of cutting the atrial septum 100 are the prior art in the field, and the detailed description of the embodiment is omitted here.

Further, the push-pull rod 3 is detachably connected to the distal end of the telescopic member 122. The push-pull rod 3 is positioned in the elastic woven mesh 1, and can provide axial guide in the elastic deformation process of the elastic woven mesh 1, so that the phenomenon that the push-pull rod is inclined in the axial compression process or is broken in the radial compression process is avoided; push-pull rod 3 is connected in the distal end of extensible member 122, can control whole elasticity woven mesh 1 and stretch out and draw back, easily guides the puncture hole that drives whole elasticity woven mesh 1 and pass interatrial 100, and has better fixed and recovery ability to the interatrial tissue of cutting in the operation process or after the operation.

Further, the interatrial ostomy device further comprises a first clamping assembly (not shown in the figure), the first clamping assembly comprises a first outer ring and a first inner ring sleeved in the first outer ring, one end of the first inner ring is clamped with the push-pull rod 3, and the distal end of the telescopic member 122 is clamped between the first outer ring and the first inner ring. It will be appreciated that the first outer ring and the first inner ring have a gap therebetween for receiving and securing the distal end of the telescopic member 122, and preferably, the first outer ring and the first inner ring are welded together and the first inner ring is welded to the push-pull rod 3, thereby increasing the reliability of the connection between the push-pull rod 3 and the telescopic member 122.

Further, the interatrial septum ostomy device further comprises a second clamping assembly (not shown in the figure), the second clamping assembly comprises a second outer ring and a second inner ring sleeved in the second outer ring, one end of the second inner ring is clamped with the conveying sheath tube 2, and the proximal end of the first extension part 11 is clamped between the second outer ring and the second inner ring. That is, the second joint subassembly has the same structure with first joint subassembly, and simple structure easily realizes carrying the dismouting between sheath pipe 2 and the elasticity mesh grid 1, and fixed reliable.

Furthermore, the angle between the annular net surface and the axial direction of the push-pull rod 3 is preferably 80-100 degrees. Within this angle range, the second extending portion 12 can easily pass through the puncture hole of the interatrial septum, and is not easy to fall off from the puncture hole and slide into the right atrium side. Specifically, for example, the angle between the annular mesh surface and the axial direction of the push-pull rod 3 may be 80 °, 85 °, 87 °, 90 °, 91 °, 95 °, 100 °, and the like. In other embodiments, the angle between the annular mesh surface and the axial direction of the push-pull rod 3 may be other angles, which is not limited in this embodiment.

Further, extensible member 122 includes flexible changeover portion 1221, and the both ends of flexible changeover portion 1221 are big footpath end and path end respectively, and annular wire side is connected to the big footpath end. The telescopic part 122 is divided into two parts by the transition section 1221, the small-diameter end with smaller diameter is positioned at the far end of the telescopic part 122, the push-pull rod 3 is easily connected through the first clamping assembly, and the elastic woven mesh 1 can be better guided to pass through the puncture hole of the atrial septum 100; the large diameter end with the larger diameter can cover the atrial septum 100 more greatly when expanding radially, and the fixing and clamping effect is better. The cross-sectional shape of the telescopic transition section 1221 between the large-diameter end and the small-diameter end may be a circle, an ellipse, a polygon, or other shapes, and the embodiment is not limited herein.

It is obvious that the above embodiments of the present invention are only examples for clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention. Numerous obvious variations, rearrangements and substitutions will now occur to those skilled in the art without departing from the scope of the invention. This need not be, nor should it be exhaustive of all embodiments. Any modification, equivalent replacement, and improvement made within the spirit and principle of the present invention should be included in the protection scope of the claims of the present invention.

Claims

1. The atrial septal ostomy device is characterized by comprising an elastic woven mesh (1), wherein the elastic woven mesh (1) comprises a first extension part (11) and a second extension part (12) which are sequentially arranged from the near end to the far end, the first extension part (11) is tubular, the second extension part (12) comprises a fixing part (121) and a telescopic part (122), the fixing part (121) is connected with the first extension part (11), and the fixing part (121) is provided with an annular mesh surface.

2. Interatrial septum ostomy device according to claim 1, further comprising a delivery sheath (2) and a push-pull rod (3), the push-pull rod (3) being arranged through the delivery sheath (2), the proximal end of the first extension (11) being connected to the distal end of the delivery sheath (2), the push-pull rod (3) passing through the first extension (11) and being connected to the distal end of the second extension (12).

3. Atrial septal ostomy device according to claim 2, wherein the push-pull rod (3) is axially movable relative to the delivery sheath (2) for telescoping the second extension (12) in radial and/or axial direction.

4. Atrial septal ostomy device according to claim 1, wherein the outer diameter of the annular web is larger than the outer diameter of the first extension (11).

5. Interatrial septum ostomy device according to claim 1, further comprising an annular cutting knife (4), the difference between the inner diameter of the cutting knife (4) and the outer diameter of the annular web surface being 0mm-1mm.

6. Interatrial septum ostomy device according to claim 2, wherein the push-pull rod (3) is detachably connected to the distal end of the telescopic member (122).

7. The interatrial septum ostomy device according to claim 6, further comprising a first clamping assembly, wherein the first clamping assembly comprises a first outer ring and a first inner ring sleeved in the first outer ring, one end of the first inner ring is clamped with the push-pull rod (3), and the distal end of the telescopic member (122) is clamped between the first outer ring and the first inner ring.

8. Atrial septal ostomy device according to claim 2, further comprising a second clamping assembly, wherein the second clamping assembly comprises a second outer ring and a second inner ring sleeved in the second outer ring, one end of the second inner ring is clamped with the delivery sheath (2), and the proximal end of the first extension part (11) is clamped between the second outer ring and the second inner ring.

9. The interatrial septum ostomy device according to claim 2, wherein the annular mesh surface is angled 80-100 ° from the axial direction of the push-pull rod (3).

10. The atrial septal ostomy device of any one of claims 1-9, wherein the telescoping piece (122) comprises a telescoping transition section (1221), the telescoping transition section (1221) having a large diameter end and a small diameter end at its ends, respectively, the large diameter end being connected to the annular mesh surface.