Left auricle plugging device

Abstract

The invention relates to the technical field of left auricle plugging, and discloses a left auricle plugging device which comprises a delivery sheath and a composite sheath, and one end of the composite sheath penetrates through the delivery sheath and extends to the outside of the delivery sheath; an inflation pipeline, a gel injection pipeline and a blood pump-back pipeline are respectively arranged in the composite sheath. According to the left auricle plugging device, the delivery sheath, the composite sheath, the inflation pipeline, the gel injection pipeline, the blood pumpback pipeline and the plugging air bag are arranged, the plugging air bag temporarily seals a left auricle opening, the blood pumpback pipeline pumps out blood in a left auricle, plugging gel is circularly injected into a left auricle cavity through the gel injection pipeline, and the left auricle cavity is sealed. According to the left auricle plugging device, blood in a left auricle is replaced with plugging gel, then the plugging gel is jellied to completely and stably plug the left auricle, left auricle plugging is achieved, the left auricle plugging device can be suitable for left auricles of different forms, sizes and angles, and the risks of left auricle damage and pericardium filling caused by possible repeated recovery and release in the surgical operation process of a traditional plugging device are avoided.

Description

Technical Field

[0001] The present invention relates to the technical field of left atrial appendage occlusion, and particularly to a left atrial appendage occlusion device. Background Art

[0002] Atrial fibrillation is the most common persistent arrhythmia in clinical practice, which can cause the detachment of local thrombus in the left atrial appendage, and then lead to stroke and peripheral arterial embolism. The left atrial appendage occlusion technology aims to prevent stroke and peripheral arterial embolism by closing the left atrial appendage cavity. Since the left atrial appendage is an organ that has not been completely degenerated in humans, the morphology, size, angle, etc. of each person's left atrial appendage vary greatly, so it is called "a thousand people, a thousand ears". Due to the extreme individual differences, systematic analysis of the left atrial appendage morphology, selection of occlusion device specifications, release position and depth of the occluder, and verification after release are particularly important. It has high requirements for the experience of surgeons, operation techniques, and clinical specialists of device manufacturers. It is classified as a grade IV operation in clinical practice, that is, the highest level, and can only be carried out in large clinical centers with very rich experience. Currently, the most popular left atrial appendage occlusion technology in the market is to use an "alloy framework type" occluder to occlude the left atrial appendage, and different models, sizes, shapes, etc. of occluders are placed in the left atrial appendage to achieve the occlusion purpose.

[0003] The implementation of the left atrial appendage occlusion technology mainly includes the following steps: First, transseptal puncture; Second, send the delivery sheath to the left atrium through the guide wire, remove the guide wire and the inner core, and perform left atrial appendage angiography; Third, according to the morphology, size, depth, etc. of the left atrial appendage shown by the angiography, evaluate whether the left atrial appendage occlusion can be performed; and select a suitable specification of the occluder in vitro; Fourth, send the occluder to the appropriate position of the left atrial appendage and initially release the occluder; Fifth, verify the position, anchoring, occlusion, and compression of the occluder. If all aspects are satisfactory, the occluder is finally released; if not, after retrieving the occluder, adjust it again and then release it, or abandon the occlusion. Because in some patients, due to the overly special morphology of the atrial appendage, being too large, too small, too shallow, or having a "tricky" opening angle, the operation fails, or due to the dissatisfaction with the initial device release, it is necessary to repeatedly "retrieve - adjust - release again", which significantly increases the risk of surgical complications such as atrial appendage injury and cardiac tamponade; or there are risks such as delayed occluder dislodgment after surgery and the need for surgical thoracotomy to remove it. Summary of the Invention

[0004] In view of the deficiencies of the prior art, the present invention provides a left atrial appendage occlusion device, which solves the problems mentioned in the above background.

[0005] The present invention provides the following technical solution: A left atrial appendage occlusion device, comprising: a delivery sheath and a composite sheath, one end of the composite sheath passes through the delivery sheath and extends to the outside of the delivery sheath; An inflation pipeline, a gel injection pipeline, and a blood aspiration pipeline are respectively arranged inside the composite sheath. One end of the composite sheath passing through the delivery sheath is connected with a plugging airbag, the plugging airbag is communicated with the inflation pipeline, and one ends of the gel injection pipeline and the blood aspiration pipeline both extend to the outside of the composite sheath.

[0006] Preferably, one end of the inflation pipeline away from the plugging airbag extends to the outside of the composite sheath and is provided with an inflation valve.

[0007] Preferably, one end of the gel injection pipeline away from the plugging airbag extends to the outside of the composite sheath and is provided with an injection valve.

[0008] Preferably, one end of the blood aspiration pipeline away from the plugging airbag extends to the outside of the composite sheath and is provided with a blood aspiration valve.

[0009] Preferably, one end of the blood aspiration pipeline extending to the outside of the composite sheath is provided with a pigtail catheter, and a plurality of through holes are formed in the surface of the pigtail catheter.

[0010] Preferably, one end of the delivery sheath is provided with a connecting portion, a flushing pipe is arranged on the surface of the connecting portion, and a flushing valve is arranged on the surface of the flushing pipe.

[0011] Preferably, a rotating cap is rotatably connected to the surface of the connecting portion, internal thread teeth are arranged on the surface of the rotating cap, external thread teeth are arranged on one end of the composite sheath, and the external thread teeth are meshed with the internal thread teeth.

[0012] Preferably, an annular limiting groove is formed in the surface of the connecting portion, an annular limiting portion is arranged on the inner wall of the rotating cap, and the surface of the annular limiting portion is connected with the inner wall of the annular limiting groove.

[0013] Compared with the prior art, the present invention has the following beneficial effects: 1. In the present invention, by arranging the delivery sheath, the composite sheath, the inflation pipeline, the gel injection pipeline, the blood aspiration pipeline and the plugging airbag, the plugging airbag temporarily closes the opening of the left atrial appendage, the blood aspiration pipeline pumps out the blood in the left atrial appendage, and the gel injection pipeline injects the plugging gel into the left atrial appendage cavity in a circulating manner, so as to replace the blood in the left atrial appendage with the plugging gel. Subsequently, the plugging gel is gelled and completely and stably fills the left atrial appendage, so as to realize the occlusion of the left atrial appendage, which can be applicable to left atrial appendages with different shapes, sizes and angles, and avoids the risks of left atrial appendage injury and pericardial tamponade caused by possible repeated retrieval and release during the surgical operation of traditional occlusion devices.

[0014] 2. In the present invention, by arranging the pigtail catheter and the through holes, it is convenient to quickly pump out the blood inside the left atrial appendage. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 is a schematic structural diagram of the present invention; Figure 2 Structural schematic diagram of the connection part and the rotating cap of the present invention; Figure 3 Structural schematic diagram of the annular limiting part of the present invention; Figure 4 Side sectional structural schematic diagram of the gas charging pipeline position of the present invention; Figure 5 Structural schematic diagram of the inflated state of the plugging airbag of the present invention.

[0016] In the figure: 1. Delivery sheath; 2. Composite sheath; 3. Gas charging pipeline; 4. Gel injection pipeline; 5. Blood withdrawal pipeline; 6. Plugging airbag; 7. Inflation valve; 8. Injection valve; 9. Blood withdrawal valve; 10. Pigtail catheter; 11. Through hole; 12. Connection part; 13. Flushing pipe; 14. Flushing valve; 15. Rotating cap; 16. Internal thread teeth; 17. External thread teeth; 18. Annular limiting groove; 19. Annular limiting part. Detailed implementation manners

[0017] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0018] Please refer to Figures 1-5 , a left atrial appendage occlusion device, comprising: a delivery sheath 1 and a composite sheath 2. One end of the composite sheath 2 passes through the delivery sheath 1 and extends to the outside of the delivery sheath 1. An air charging pipeline 3, a gel injection pipeline 4 and a blood withdrawal pipeline 5 are respectively arranged inside the composite sheath 2. One end of the composite sheath 2 passing through the delivery sheath 1 is connected with a plugging airbag 6. The plugging airbag 6 is communicated with the air charging pipeline 3. One ends of the gel injection pipeline 4 and the blood withdrawal pipeline 5 both extend to the outside of the composite sheath 2. The plugging airbag 6 temporarily closes the left atrial appendage opening. After the left atrial appendage is closed, injecting gel inward will increase the overall volume or pressure. Therefore, it is necessary to draw out the blood in the left atrial appendage, replace the blood in the left atrial appendage with gel. The blood withdrawal pipeline 5 draws out the blood in the left atrial appendage, and injects the occluding gel into the left atrial appendage cavity in a circulating manner through the gel injection pipeline 4 to replace the blood in the left atrial appendage with the occluding gel. Subsequently, the occluding gel is jellied and completely and stably packed in the left atrial appendage to achieve the occlusion of the left atrial appendage, which can be applicable to left atrial appendages with different shapes, sizes and angles, and avoids the risks of left atrial appendage injury and pericardial tamponade caused by possible repeated recovery and release during the surgical operation of traditional occlusion devices.

[0019] One end of the inflation pipeline 3 away from the occlusion balloon 6 extends to the outside of the composite sheath 2 and is provided with an inflation valve 7. One end of the gel injection pipeline 4 away from the occlusion balloon 6 extends to the outside of the composite sheath 2 and is provided with an injection valve 8. One end of the blood aspiration pipeline 5 away from the occlusion balloon 6 extends to the outside of the composite sheath 2 and is provided with a blood aspiration valve 9.

[0020] One end of the blood aspiration pipeline 5 extending to the outside of the composite sheath 2 is provided with a pigtail catheter 10, and a plurality of through holes 11 are formed on the surface of the pigtail catheter 10, facilitating the rapid extraction of blood inside the left atrial appendage.

[0021] One end of the delivery sheath 1 is provided with a connection part 12. A flushing tube 13 is arranged on the surface of the connection part 12, and a flushing valve 14 is arranged on the surface of the flushing tube 13.

[0022] A rotating cap 15 is rotatably connected to the surface of the connection part 12. Internal thread teeth 16 are arranged on the surface of the rotating cap 15. One end of the composite sheath 2 is provided with external thread teeth 17, and the external thread teeth 17 are engaged with the internal thread teeth 16.

[0023] An annular limiting groove 18 is formed on the surface of the connection part 12. An annular limiting part 19 is arranged on the inner wall of the rotating cap 15, and the surface of the annular limiting part 19 is connected to the inner wall of the annular limiting groove 18.

[0024] During the operation, first perform a transseptal puncture; send the delivery sheath 1 to the left atrium through a guide wire, remove the guide wire and the inner core, and perform left atrial appendage angiography; send the composite sheath 2 into the left atrial appendage opening through the delivery sheath 1; inflate the occlusion balloon 6 through the inflation pipeline 3 to occlude the left atrial appendage opening with the occlusion balloon 6, and the gel injection pipeline 4 enters the deep part of the left atrial appendage; inject contrast agent through the gel pipeline to confirm sufficient occlusion; aspirate the blood in the left atrial appendage through the blood aspiration pipeline 5, and inject gel at the same time. During the injection process, retract the pipeline until it is inside the composite sheath 2; wait for the gel to solidify; deflate the occlusion balloon and retract it into the delivery sheath 1, then remove the delivery sheath 1, and the operation is completed. The occlusion balloon 6 temporarily occludes the left atrial appendage opening. After the left atrial appendage is occluded, injecting gel inward will increase the overall volume or pressure. Therefore, it is necessary to aspirate the blood in the left atrial appendage, replace the blood in the left atrial appendage with gel. The blood aspiration pipeline 5 aspirates the blood in the left atrial appendage, and injects the occlusion gel into the left atrial appendage cavity in a circulating manner through the gel injection pipeline 4 to replace the blood in the left atrial appendage with the occlusion gel. Subsequently, the occlusion gel is completely frozen and solidified to stably fill the left atrial appendage, realizing left atrial appendage occlusion. It can be applied to left atrial appendages with different shapes, sizes, and angles, avoiding the risks of left atrial appendage injury and pericardial tamponade caused by possible repeated retrieval and release during the operation of traditional occlusion devices.

[0025] Although embodiments of the present invention have been shown and described, it will be understood by those of ordinary skill in the art that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principles and spirit of the present invention, and the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A left atrial appendage occlusion device, characterized in that, Comprising: A delivery sheath (1) and a composite sheath (2), one end of the composite sheath (2) passes through the delivery sheath (1) and extends to the outside of the delivery sheath (1); An inflation pipeline (3), a gel injection pipeline (4) and a blood aspiration pipeline (5) are respectively arranged inside the composite sheath (2), a sealing balloon (6) is connected to the end of the composite sheath (2) passing through the delivery sheath (1), the sealing balloon (6) is communicated with the inflation pipeline (3), and one ends of the gel injection pipeline (4) and the blood aspiration pipeline (5) both extend to the outside of the composite sheath (2).

2. The left atrial appendage occlusion device according to claim 1, characterized in that One end of the inflation pipeline (3) far from the sealing balloon (6) extends to the outside of the composite sheath (2) and is provided with an inflation valve (7).

3. The left atrial appendage occlusion device according to claim 1, characterized in that, One end of the gel injection pipeline (4) far from the sealing balloon (6) extends to the outside of the composite sheath (2) and is provided with an injection valve (8).

4. The left atrial appendage occlusion device according to claim 1, characterized in that, One end of the blood aspiration pipeline (5) far from the sealing balloon (6) extends to the outside of the composite sheath (2) and is provided with a blood aspiration valve (9).

5. The left atrial appendage occlusion device according to claim 1, characterized in that, One end of the blood aspiration pipeline (5) extending to the outside of the composite sheath (2) is provided with a pigtail tube (10), and a plurality of through holes (11) are formed on the surface of the pigtail tube (10).

6. The left atrial appendage occlusion device according to claim 1, wherein One end of the delivery sheath (1) is provided with a connection part (12), a flushing tube (13) is arranged on the surface of the connection part (12), and a flushing valve (14) is arranged on the surface of the flushing tube (13).

7. The left atrial appendage occlusion device according to claim 6, characterized in that, A rotating cap (15) is rotatably connected to the surface of the connection part (12), internal thread teeth (16) are arranged on the surface of the rotating cap (15), external thread teeth (17) are arranged at one end of the composite sheath (2), and the external thread teeth (17) are meshed with the internal thread teeth (16).

8. The left atrial appendage occlusion device according to claim 7, wherein An annular limiting groove (18) is formed on the surface of the connection part (12), an annular limiting part (19) is arranged on the inner wall of the rotating cap (15), and the surface of the annular limiting part (19) is connected to the inner wall of the annular limiting groove (18).

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