CN214157398U - Puncture-able atrial septal occluder - Google Patents
Puncture-able atrial septal occluder Download PDFInfo
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- CN214157398U CN214157398U CN202022964603.7U CN202022964603U CN214157398U CN 214157398 U CN214157398 U CN 214157398U CN 202022964603 U CN202022964603 U CN 202022964603U CN 214157398 U CN214157398 U CN 214157398U
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- 210000003157 atrial septum Anatomy 0.000 claims description 14
- 239000000463 material Substances 0.000 claims description 11
- 230000000903 blocking effect Effects 0.000 claims description 9
- 238000009941 weaving Methods 0.000 claims description 9
- 235000012046 side dish Nutrition 0.000 claims description 7
- 239000000956 alloy Substances 0.000 claims description 5
- 230000008602 contraction Effects 0.000 claims description 5
- 229910001285 shape-memory alloy Inorganic materials 0.000 claims description 5
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- 229910000831 Steel Inorganic materials 0.000 claims description 3
- 229910052751 metal Inorganic materials 0.000 claims description 3
- 239000002184 metal Substances 0.000 claims description 3
- 239000002861 polymer material Substances 0.000 claims description 3
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- 230000017531 blood circulation Effects 0.000 abstract description 7
- 230000002285 radioactive effect Effects 0.000 abstract 1
- 210000004971 interatrial septum Anatomy 0.000 description 12
- 239000010410 layer Substances 0.000 description 11
- 210000005246 left atrium Anatomy 0.000 description 10
- 238000009940 knitting Methods 0.000 description 9
- 239000012528 membrane Substances 0.000 description 8
- 208000013914 atrial heart septal defect Diseases 0.000 description 4
- 230000009286 beneficial effect Effects 0.000 description 4
- 238000005728 strengthening Methods 0.000 description 4
- 208000035478 Interatrial communication Diseases 0.000 description 3
- 206010003664 atrial septal defect Diseases 0.000 description 3
- 230000007547 defect Effects 0.000 description 3
- 201000010099 disease Diseases 0.000 description 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 3
- 229910001000 nickel titanium Inorganic materials 0.000 description 3
- 206010003658 Atrial Fibrillation Diseases 0.000 description 2
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- 210000005248 left atrial appendage Anatomy 0.000 description 1
- 230000006386 memory function Effects 0.000 description 1
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Abstract
The utility model relates to the technical field of medical equipment, in particular to a pierceable atrial septal occluder, the main body of which is made by heat setting after being integrally woven by wires with memorability, comprising a bracket formed by connecting a left disc, a right disc and a waist, a central large through hole penetrating the bracket and a gap formed in the center of the left disc and the right disc after penetrating, a flow-resisting film is arranged in the central through hole, a plurality of connecting wires are arranged at the gap in the center of the right disc, one ends of the connecting wires are assembled and connected with a conveying part, and the other ends are connected with the right disc in a radioactive manner, the utility model keeps the structure and the working principle of the traditional occluder, ensures the safety and the effectiveness of the traditional occluder, a totally-closed sheet-shaped flow-resisting film is arranged in the central large through hole, and the sheath tube can be easily punctured and expanded by using the thin and brittle characteristic of the flow-resisting film and the size of the large through hole when the blood flow passes through the occluder, and reserving a channel for subsequent interatrial puncture intervention.
Description
Technical Field
The utility model relates to the technical field of medical equipment, in particular to a pierceable atrial septal occluder.
Background
Atrial septal defects are a common congenital heart disease, and the mainstream treatment method is percutaneous (femoral vein) atrial septal occlusion by using an occluder. In this procedure, an occluder is one of the most important medical devices.
The current occluders are all of nickel-titanium alloy woven double-disc one-waist I-shaped structures, and the safety and the effectiveness of the occluders are widely proved clinically. Most of patients for atrial septal defect plugging are young patients, the probability of diseases such as atrial fibrillation and mitral regurgitation in the later stage is high, and the complicated diseases can be treated by adopting operations of radio frequency ablation, left atrial appendage plugging, mitral valve clamping and the like which enter the left atrium through the femoral vein and then puncture the atrial septal wall to perform minimally invasive intervention.
However, because the existing occluder has larger volume and dense grids, the whole interatrial space is almost occupied after being implanted into a human body, and the design of double-disk four-layer, dense grids and small meshes (phi 2mm) makes it impossible to puncture the interatrial space to send a sheath tube (phi 3-9mm) into the left atrium, so that a patient loses the interatrial space, and the opportunity of minimally invasive intervention treatment on diseases such as atrial fibrillation and mitral regurgitation is lost.
For example, the occluder a disclosed in patent CN2524710Y (see fig. 1) is a double-disk one-waist structure, which is not provided with a central through hole, so that the puncture sheath cannot pass through the occluder a at all when puncture is needed later.
The patent CN101234042A discloses an occluder b (see fig. 2), which is also of a double-disk-waist structure, and the occluder b is also not provided with a central through hole, and a memory alloy wire is additionally arranged in the waist, so that the occluder b cannot be penetrated through at all when the atrial septum needs to be punctured in the later period.
On the basis of the above patent technology, the applicant designs an occluder c (see fig. 3) disclosed in patent CN206228378U, which is an occluder with a hole in the center, and reserves a small through hole for incompletely sealing the defect of the atrial septum, so as to prevent the condition of the patient from being relieved by the small through hole even after pulmonary hypertension occurs in the later period, the occluder does not completely seal the defective atrial septum, the blood flow can still pass through the through hole, and the occlusion effect is reduced, the size of the central through hole is too small (phi 5-8mm, the diameter of the waist is much larger than the diameter of the through hole), so that the delivery sheath (phi 3-9mm) is difficult to pass through the defect, and the through hole has a certain length, and the delivery sheath is bent, so that the delivery sheath is difficult to pass through the through hole, and even the condition that the occluder is driven by a wall hanging occurs, which.
Therefore, it is necessary to design a safe and simple atrial septal occlusion device which can puncture and keep the atrial septal occlusion safe and effective.
Disclosure of Invention
The utility model discloses broken through prior art's a difficult problem, designed one kind and can support the puncture of machinery in the middle of and send into sheath pipe and safe effectual interatrial septum occluder, under the safe effectual prerequisite of guaranteeing interatrial septum occluder, intervene the operation for follow-up interatrial septum puncture and remain the passageway, give the patient and stride the chance that the interatrial septum wicresoft intervened the operation.
In order to achieve the purpose, the utility model discloses a pierceable atrial septal occluder, which comprises a support made of memory wire materials through integrated weaving and heat setting, wherein the support is formed by connecting a left disc, a right disc and a waist; the plugging device further comprises a central through hole penetrating through the support, and a notch formed in the center of the left disc and the right disc after the central through hole penetrates through the central through hole, and is characterized in that: the diameter of the central through hole is close to the inner diameter of the waist to the maximum extent, so that the puncture sheath can safely and easily penetrate through the occluder to enter the left atrium, a flow blocking film is arranged in the central through hole to block the central through hole from the inside, and the blood flow is guaranteed to be blocked, so that the safety and the effectiveness of the atrial septal occlusion are guaranteed; the breach department in right side dish central authorities is equipped with a plurality of connecting wires, and is a plurality of the one end of connecting wire assembles and connects in conveying part, and is a plurality of the other end of connecting wire is radioactivity and is connected with the right side dish, has realized being connected of plugging device and conveying system for the plugging device can draw in or withdraw in the conveying sheath pipe.
Further, the occluding device has a shape memory and two shapes of contraction and expansion, wherein the contraction shape is a strip-shaped conveying shape that the occluding device is compressed into a sheath, and the expansion shape is an I-shaped working shape that the occluding device is freely stretched to form double discs and one waist. The occluder can automatically restore from a delivery form to a working form due to the fact that the occluder has a form memory characteristic.
Furthermore, the flow blocking membrane is sheet-shaped, is made of high polymer materials or degradable materials, has the same sheet-shaped form as the cross section of the central through hole, is arranged in the central through hole to achieve the purpose of blocking blood flow, is easy to puncture and expand due to the fact that the flow blocking membrane is thin and brittle, is convenient to puncture, and when puncture is needed, the sheath tube can easily penetrate through the central through hole and then puncture the flow blocking membrane to enter the left atrium to carry out interventional therapy.
Furthermore, the left disc, the right disc and the waist are of an integrated grid-like structure and are manufactured by adopting wires which are integrally woven and then subjected to heat setting, the wires are made of memory alloy materials, preferably nickel-titanium alloy materials, and the memory alloy materials have a memory function, so that the manufactured occluder support has shape memory and can automatically return to a working shape from a conveying shape, and the grid-like weaving of the waist is beneficial to strengthening the supporting force and recovering the memory shape.
Furthermore, the left disc and the right disc are both of double-layer grid-like structures, the double-layer structures are favorable for strengthening the supporting force of the disc-shaped structures, and the grid weaving is favorable for recovering the structural memory form.
Preferably, the edges of the central gaps of the left disc and the right disc are all knitted in an encrypted manner, and the knitting density of the reinforced knitted area is 2-5 times that of other common areas, so that the capacity of the occluder for recovering the memory shape is enhanced.
Furthermore, the connecting wire is arranged on the outer layer of the right disc at the connecting position of the right disc, and the connecting mode is integrated knitting shaping or split physical connection.
The integrated weaving and shaping connection ensures that the connection between the connecting wire and the right disc is smooth and flat, the wire falling-off condition cannot be generated, but the quantity and the connection position of the connecting wire cannot be changed due to the integrated connection.
The split type physical connection is woven the design relatively with the integral type and is connected, has made an independent structure with the connecting wire, is connected with the right side dish again, and the connection mode can select welding, sew up, weave access or other connection modes, in order to guarantee the fastness and the planarization of connecting, most adoption in concrete implementation weaves the mode of access. The number and the connecting positions of the connecting wires can be adaptively changed by adopting split physical connection, the increase of the connecting wires or the decrease of the connecting wires are extremely easy, and the adaptability of the occluder is improved.
Further, when the connecting wire adopts split type physical connection, the connecting wire is independent structure, is made by metal or polymer silk material or degradable polymeric material for the connecting wire has memory shape nature, and because the independent structural design of connecting wire makes quantity, the connecting wire of connecting wire and the hookup location of right side dish can conveniently carry out the adaptability adjustment fast moreover.
Furthermore, the connecting wires are rotationally and symmetrically distributed about the conveying part, and a gap for the puncture sheath tube to pass through is arranged between the adjacent connecting wires, so that the sheath tube can smoothly pass through the interatrial septum plugging device to enter the left atrium to complete puncture.
Further, the quantity of connecting silk is 12 at most, is 3 at least, and the connecting silk is too much to make the gap between the adjacent connecting silk reduce, leads to the puncture sheath pipe can't pass central through-hole entering left atrium from the right dish, and the connecting silk undersize then can cause the influence to the transport of interatrial septum occluder and the anchoring of right atrium of right dish, consequently through a large amount of experiments, preferred connecting silk setting is the optimum in 3-12.
Further, the conveying component is a wire clamping steel sleeve or a condensation ball, one end of the conveying component is connected with the connecting wire, the other end of the conveying component is a free end, and the free end is provided with a connecting port and is connected with the conveying system.
Compared with the prior art, the utility model, having kept the structure and the theory of operation of traditional plugging device, guaranteeing that the safety of plugging device is effective, set up totally closed slice in central through-hole and hinder the flow membrane, when blocking the blood flow and passing through the plugging device, utilize the thin and fragile characteristic that hinders the flow membrane for its easy is by puncture, expansion, thereby can be easily with the sheath pipe from the puncture of plugging device central through-hole department and send into, intervene the operation for follow-up implementation interatrial septum and have remain the passageway.
Drawings
Figure 1 shows a septal occluder a used in the prior art.
Figure 2 shows a septal occluder b used in the prior art.
Figure 3 shows a septal occluder c used in the prior art.
Figure 4 is a top view of a pierceable septal occluder in an embodiment (the flow-blocking membrane not shown).
Figure 5 is a cross-sectional view of one embodiment of a pierceable septal occluder in an expanded configuration (left and right discs being asymmetrical).
Figure 6 is a comparison of a design with a central encryption braid (left) versus a design without a central encryption braid in a pierceable septal occlusion device in accordance with one embodiment.
Figure 7 is a cross-sectional view of one embodiment of a pierceable septal occluder in an expanded configuration (left and right disc symmetry).
Figure 8 is a cross-sectional view of a pierceable septal occluder in one embodiment in a collapsed configuration (left and right discs being asymmetrical).
Wherein, 1 is the left side dish, 2 is the right side dish, 3 is the waist, 4 is central through-hole, 5 is the choked flow membrane, 6 is the connecting wire, 7 is the conveying part.
Detailed Description
The present invention will be further described with reference to the accompanying drawings, which are not intended as limitations of the present invention.
It should be noted that the following detailed description is exemplary and is intended to provide further explanation of the invention. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
It is noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of example embodiments in accordance with the invention.
In the present invention, the terms such as "upper", "lower", "front", "rear", "vertical", "horizontal", "side", "bottom", "top", etc. indicate the position or positional relationship based on the position or positional relationship shown in the drawings, and only the relation words determined for the convenience of describing the structural relationship of each component or element of the present invention, which is not specific to any component or element of the present invention, and is not to be construed as limiting the present invention.
In the present invention, terms such as "fixedly connected", "connected", and the like are to be understood in a broad sense, and may be fixedly connected, or may be integrally connected or detachably connected; may be directly connected or indirectly connected through an intermediate. The meaning of the above terms in the present invention can be determined according to specific situations by persons skilled in the art, and should not be construed as limiting the present invention.
In a specific embodiment, terms such as "left" and "right" correspond to the left atrial direction and the right atrial direction of the heart in which the occluder is implanted, and the left disc and the right disc may be symmetric discs or asymmetric discs, see fig. 5 and 7, which can be selected according to the atrial septal defect.
Referring to fig. 4 to 7, in a specific embodiment, a pierceable atrial septal occluder is designed, which includes a left disc 1, a right disc 2, a waist 3, and a central through hole 4, the left disc 1 is connected to the right disc 2 by the waist 3, the central through hole 4 sequentially penetrates through the left disc 1, the waist 3, and the right disc 2, a gap is formed in the center of the left disc 1 and the right disc 2, the diameter of the central through hole is close to the inner diameter of the waist to the maximum extent, so as to ensure that a puncture sheath can safely and easily pass through the occluder to enter the left atrium, 1 to 4 layers of flow-blocking films 5 are sewn in the central through hole 4, the central through hole 4 is completely blocked from the inside, so as to block blood circulation, the flow-blocking films 5 can be made of any one of polyester film, polyurethane film, polytetrafluoroethylene film, and other polymer materials, or made of degradable materials, and the sheet shape of the flow-blocking films is the same as the cross section shape of the central through hole 4, referring to fig. 5, the cross section of the central through hole 4 is circular in the present embodiment, so that a circular shape is also adopted for the flow blocking film.
Referring to fig. 4 and 5, a connecting wire 6 is arranged at the notch in the center of the right disc 2, one end of the connecting wire 6 is converged above the notch in the center of the right disc 2 and is connected to a conveying part 7, and the other end of the connecting wire 6 is radially connected with the right disc 2.
Preferably, the connecting position of the connecting wire 6 and the right disc 2 is the outer layer of the right disc, and the connecting mode is integrated knitting shaping or split physical connection.
When the integrated knitting and shaping are adopted, the connecting wire is made of the same material as the main body plugging device.
When the split physical connection is adopted, the connecting wire is of an independent structure and can be made of metal or high-molecular wire materials or degradable polymeric materials. And then the outer layer of the right disc is connected by welding, knitting, cross-linking or sewing, wherein the outer layer refers to the outer surface layer in the double-layer structure of the right disc.
Preferably, the number of connecting wires 6 is 12 at most, and is 3 at least, and the setting mode is for 7 rotational symmetry distribution about the delivery unit, and is adjacent be equipped with the clearance that can supply the puncture sheath pipe to pass between the connecting wire, guarantee that the sheath pipe can pass the interatrial septum plugging device smoothly and get into the left atrium and accomplish the puncture, connecting wire and delivery unit have realized being connected of plugging device main part and conveying system for the plugging device can draw in or withdraw in the delivery sheath pipe.
In quantity, the gaps between the adjacent connecting wires are reduced due to the fact that the connecting wires are too many, the puncture sheath cannot penetrate into the central through hole from the right disc to enter the left atrium, the conveying of the interatrial septum occluder and the anchoring of the right atrium by the right disc are affected due to the fact that the connecting wires are too small, and therefore through a large number of experiments, the optimal selection of the connecting wires is that the optimal connecting wires are arranged at 3-12.
Preferably, the left disc 1, the right disc 2 and the waist 3 are of an integrated mesh-like structure and are made by integrally weaving wires and then performing heat setting, and the wires are made of memory alloy materials, preferably nickel-titanium alloy, so that the occluder has shape memory and can be converted between a contraction shape and an expansion shape, as shown in fig. 5, 7 and 8, wherein the contraction shape is a strip-shaped delivery shape in which the occluder is compressed into a sheath tube, and the expansion shape is an I-shaped working shape in which the occluder is freely stretched and then has double discs and a waist. The occlusion device has the shape memory characteristic, so the occlusion device can automatically recover to the working shape from the conveying shape, and the grid-like weaving of the waist part is beneficial to strengthening the supporting force and recovering the memory shape.
Preferably, the left disc 1 and the right disc 2 are both of double-layer grid-like structures, the double-layer structures are beneficial to strengthening the supporting force of the disc-shaped structures, and the grid weaving is beneficial to recovering the structural memory form.
Preferably, the edges of the central gap of the left disc 1 and the right disc 2 can be selected to be made of encrypted knitting, referring to fig. 6, the knitting density of the reinforced knitting area is 2-5 times of the knitting density of other common areas, so as to enhance the capacity of the occluder to restore the memory shape.
Preferably, the conveying component 7 is a wire-clamping steel sleeve or a coagulated ball, one end of the conveying component 7 is connected with the connecting wire, the other end of the conveying component 7 is a free end, and the free end is provided with a connecting port and is connected with a conveying system, so that the plugging device is integrally pulled in or pushed out of the conveying sheath tube.
In a specific embodiment, the utility model relates to an occluder's waist is short waist, and length is only 2-8mm, and central through-hole is circular to the membrane that hinders of selection also is circular slice film, guarantees to block the circulation of blood.
And still a special place lie in, the utility model discloses a central through-hole compares than prior art's mesh (2mm), and the diameter size increases far away, is close at the at utmost the internal diameter size of waist, and the diameter size setting of central through-hole is between 8 ~ 46mm in the specific embodiment to guarantee that puncture sheath pipe can be safe light pass the plugging device gets into the left atrium.
The utility model discloses a model of occluder is more, for example according to different through-hole diameters division specification, and in use can select the model that is suitable for according to the atrial septal defect condition. Simultaneously the utility model discloses a big through-hole still makes the puncture passageway of reservation obviously descend in the degree of difficulty when puncturing, has strengthened the success rate that follow-up interatrial puncture intervenes the operation.
In particular embodiment, the utility model discloses keep the structure and the theory of operation of a traditional two dishes waist, guaranteed the security and the validity of occluder, simultaneously, set up on the big through-hole that occluder central authorities increase and the through-hole, when blocking the blood flow and passing through the occluder, because the thin fragile of the film that hinders flows, easily puncture and expansion for it is very easy to send into the sheath pipe from occluder central authorities puncture. Make the utility model discloses when reaching safe effectual treatment interatrial septum defect, remain the passageway for the follow-up intervention operation of implementing through the interatrial septum puncture, remain the chance of carrying out the intervention operation of interatrial septum wicresoft for the patient.
The above description is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, a plurality of improvements and additions can be made without departing from the method of the present invention, and these improvements and additions should also be regarded as the protection scope of the present invention.
Claims (12)
1. A pierceable atrial septal occluder comprises a support which is made of memory wires by integrally weaving and then performing heat setting, wherein the support is formed by connecting a left disc (1), a right disc (2) and a waist part (3); the plugging device further comprises a central through hole (4) penetrating through the support, and a notch formed in the center of the left disc (1) and the right disc (2), and is characterized in that: the diameter of the central through hole (4) is close to the inner diameter of the waist part (3) to the maximum extent, and a flow blocking film (5) is arranged in the central through hole (4) to block the central through hole (4) from the inside; the breach department in right side dish (2) central authorities is equipped with a plurality of connecting wire (6), and is a plurality of the one end of connecting wire (6) is assembled and is connected in conveyor components (7), and is a plurality of the other end of connecting wire (6) is radioactivity and is connected with right dish (2).
2. A pierceable atrial septum occluder according to claim 1, wherein: the occlusion device has shape memory, and has two shapes of contraction and expansion.
3. A pierceable atrial septum occluder according to claim 1, wherein: the flow-resistant film (5) is sheet-shaped and made of high polymer materials or degradable materials, and the shape of the sheet-shaped film is the same as that of the cross section of the central through hole (4).
4. A pierceable atrial septum occluder according to claim 1, wherein: the left disc (1), the right disc (2) and the waist (3) are of an integrated grid-like structure, and wires are made of memory alloy materials.
5. A pierceable atrial septum occluder according to claim 4, wherein: the left disc (1) and the right disc (2) are both of double-layer grid-like structures.
6. A pierceable atrial septum occluder according to claim 5, wherein: the edges of the central gaps of the left disc (1) and the right disc (2) are all woven in an encrypted manner.
7. A pierceable atrial septum occluder according to claim 1, wherein: the connecting wire (6) is arranged on the outer layer of the right disc (2) at the connecting position of the right disc (2), and the connecting mode is integrated weaving shaping or split physical connection.
8. A pierceable atrial septum occluder according to claim 7, wherein: when the connecting wire (6) adopts split type physical connection, the connecting wire is made of metal or high polymer wire materials or degradable polymeric materials.
9. A pierceable atrial septum occluder according to claim 7, wherein: the specific connection method of the split physical connection comprises the following steps: welding or braiding, or stitching.
10. A pierceable atrial septum occluder according to claim 1 or 8, wherein: the connecting wires (6) are rotationally and symmetrically distributed relative to the conveying part (7), and a gap through which a puncture sheath tube can pass is formed between every two adjacent connecting wires.
11. A pierceable atrial septum occluder according to claim 10, wherein: the number of the connecting wires (6) is at most 12, and at least 3.
12. A pierceable atrial septum occluder according to claim 1, wherein: the conveying component (7) is a wire-clamping steel sleeve or a coagulated ball, one end of the conveying component (7) is connected with a connecting wire, the other end of the conveying component (7) is a free end, and the free end is provided with a connecting port and is connected with a conveying system.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202022964603.7U CN214157398U (en) | 2020-12-11 | 2020-12-11 | Puncture-able atrial septal occluder |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202022964603.7U CN214157398U (en) | 2020-12-11 | 2020-12-11 | Puncture-able atrial septal occluder |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114767179A (en) * | 2022-04-09 | 2022-07-22 | 四川大学华西医院 | Atrial septal defect plugging device |
| CN114767180A (en) * | 2022-04-11 | 2022-07-22 | 四川大学华西医院 | Atrial septal defect plugging device |
| CN116269547A (en) * | 2023-05-23 | 2023-06-23 | 杭州德诺电生理医疗科技有限公司 | Plugging device and plugging system |
-
2020
- 2020-12-11 CN CN202022964603.7U patent/CN214157398U/en active Active
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114767179A (en) * | 2022-04-09 | 2022-07-22 | 四川大学华西医院 | Atrial septal defect plugging device |
| CN114767180A (en) * | 2022-04-11 | 2022-07-22 | 四川大学华西医院 | Atrial septal defect plugging device |
| CN116269547A (en) * | 2023-05-23 | 2023-06-23 | 杭州德诺电生理医疗科技有限公司 | Plugging device and plugging system |
| CN116269547B (en) * | 2023-05-23 | 2023-08-15 | 杭州德诺电生理医疗科技有限公司 | Plugging device and plugging system |
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