Degradable esophageal fistula plugging device

Abstract

The invention belongs to the technical field of medical equipment, and discloses a degradable esophageal fistula plugging device which comprises a plugging block and a sheathing canal, and further comprises a supporting mechanism arranged on the outer wall of the plugging block; the stabilizing mechanism is arranged on the outer wall of the plugging block; the wire penetrates through the inner wall of the plugging block; the bracket is arranged on the outer wall of the plugging block; wherein the supporting mechanism comprises a moving block, and a supporting rod is hinged to the outer wall of the moving block through a hinge rod; the stabilizing mechanism comprises a soft cushion, and the inner wall of the soft cushion is fixedly connected with an inflator; through cooperation of the supporting rod, the hinge rod and other structures, after the device enters an esophageal fistula, the wire can be pulled out, the movable block is driven to move, the hinge rod turns over to drive the supporting rod to turn over and keep a vertical state, the supporting rod can provide good flexible supporting force, the device can be attached to the esophageal wall when the esophagus wriggles, and the fixing effect is ensured.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of medical devices, and particularly relates to a degradable esophageal fistula occluder. BACKGROUND

[0002] An esophageal fistula is a pathological state in which an abnormal channel appears in the esophageal wall, causing the esophagus to communicate with adjacent organs or the outside world, which can be caused by congenital developmental abnormalities, trauma, infection, tumors and other factors. The degradable esophageal fistula occluder is a new type of medical device for treating esophageal fistula, which is usually made of degradable materials such as polylactic acid and has good biocompatibility. After being placed in the esophageal fistula site, it can temporarily close the fistula, providing a time window for esophageal tissue repair. As the tissue gradually heals, the occluder will slowly degrade in the body and be absorbed by the human body, avoiding the disadvantages of traditional metal occluders that need to be removed twice, and providing a safer and more convenient choice for the treatment of esophageal fistula.

[0003] The existing occluder memory support at both ends is usually made of materials with memory effect such as nickel-titanium alloy, which can be temporarily deformed for operation outside the body to facilitate placement in the target site through the delivery system. After reaching the esophageal fistula, it can restore the preset shape, thereby effectively occluding the fistula. However, the esophagus is in a state of peristalsis at this time, and the support cannot deform in the peristaltic state and completely adhere to the esophageal wall, which may affect the occlusion and fixation effect. Therefore, the degradable esophageal fistula occluder is proposed to solve the above problems. SUMMARY

[0004] To solve the problems in the background art, the application provides a degradable esophageal fistula occluder.

[0005] To achieve the above purpose, the application provides the following technical scheme: a degradable esophageal fistula occluder, comprising an occlusion block and a sheath tube, further comprising:

[0006] A support mechanism is arranged on the outer wall of the occlusion block.

[0007] A stabilizing mechanism is arranged on the outer wall of the occlusion block.

[0008] A wire is arranged through the inner wall of the occlusion block.

[0009] A support is arranged on the outer wall of the occlusion block.

[0010] The support mechanism comprises a moving block, and the outer wall of the moving block is hinged with a support rod through a hinge rod.

[0011] The stabilizing mechanism comprises a soft pad, and the inner wall of the soft pad is fixedly connected with an air cylinder.

[0012] Preferably, the sheath tube is arranged on the outer wall of the occlusion block, and the sheath tube does not contact the outer wall of the occlusion block.

[0013] Preferably, the outer wall of the moving block is fixedly connected with a fixed block, the outer wall of the fixed block is fixedly connected with a convex block A, the outer wall of the blocking block is fixedly connected with a connecting block, the inner wall of the connecting block is provided with a groove, the outer wall of the guide wire is fixedly connected with a convex block B, and the inner wall of the blocking block is fixedly connected with a valve.

[0014] Preferably, one end of the articulated rod is articulated with the outer wall of the support rod, and the other end of the articulated rod is articulated with the outer wall of the moving block.

[0015] Preferably, the support rod is articulated on the outer wall of the blocking block, and the convex block A is in contact with the inner wall of the groove.

[0016] Preferably, the outer wall of the fixed block is in contact with the inner wall of the connecting block, and the convex block B is in contact with the inner wall of the fixed block.

[0017] Preferably, the guide wire is in contact with the inner wall of the moving block.

[0018] Preferably, the inner wall of the air cylinder is slidingly connected with a round rod, and the round rod is fixedly connected to the outer wall of the moving block.

[0019] Preferably, the soft pad is fixedly connected to the outer wall of the blocking block, and the air cylinder is fixedly connected in the inner wall of the blocking block.

[0020] Preferably, the soft pad is in communication with the air cylinder, and the air cylinder penetrates the outer wall of the blocking block.

[0021] Compared with the prior art, the beneficial effects of the present application are as follows:

[0022] By cooperating the structures of the support rod and the articulated rod, the guide wire can be pulled out after the device enters the esophageal fistula, the moving block is driven to move, the articulated rod is turned over to drive the support rod to turn over and keep a vertical state, the support rod can provide better flexible support force, which not only can adhere to the esophageal wall during esophageal peristalsis, but also can ensure the fixing effect.

[0023] By cooperating the structures of the soft pad and the air cylinder, in the process of moving the moving block, the round rod slides into the air cylinder, extrudes the gas in the air cylinder and makes the gas enter the soft pad, the soft pad in the contracted state is unfolded, the soft pad can better adhere to the outer wall of the esophagus, the impact of the esophageal peristalsis on the stent is reduced, and better flexible support is provided. BRIEF DESCRIPTION OF DRAWINGS

[0024] Figure 1 It is a sectional structure schematic view of the main body and sleeve of the present application;

[0025] Figure 2 It is a sectional structure schematic view of the blocking block and the connecting block of the present application;

[0026] Figure 3 Figure is a schematic diagram of the support mechanism and the soft pad structure of the present application;

[0027] Figure 4 Figure is a schematic diagram of the support mechanism and the soft pad structure of the present application;

[0028] Figure 5 Figure is a schematic diagram of the cross-sectional structure of the moving block and the connecting block of the present application;

[0029] Figure 6 Figure is a schematic diagram of the cross-sectional structure of the moving block, the blocking block and the soft pad of the present application.

[0030] In the figure: 1, blocking block; 2, support mechanism; 21, support rod; 22, hinged rod; 23, moving block; 24, fixed block; 25, protrusion A; 26, connecting block; 27, recess; 28, protrusion B; 29, valve; 3, stabilizing mechanism; 31, round rod; 32, air cylinder; 33, soft pad; 4, guide wire; 5, sheath; 6, stent. DETAILED DESCRIPTION

[0031] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0032] As shown in Figures 1 to 6 The present application provides a degradable esophageal fistula blocking device, which comprises a blocking block 1 and a sheath 5, and further comprises:

[0033] a support mechanism 2, which is arranged on the outer wall of the blocking block 1;

[0034] a stabilizing mechanism 3, which is arranged on the outer wall of the blocking block 1;

[0035] a guide wire 4, which penetrates the inner wall of the blocking block 1;

[0036] a stent 6, which is arranged on the outer wall of the blocking block 1;

[0037] The support mechanism 2 comprises a moving block 23, and the outer wall of the moving block 23 is hinged with a support rod 21 through a hinged rod 22.

[0038] The stabilizing mechanism 3 comprises a soft pad 33, and the inner wall of the soft pad 33 is fixedly connected with an air cylinder 32.

[0039] The above scheme is adopted as follows: the sealing block 1 is the main body of the esophageal fistula occluder, and its diameter is slightly smaller than the diameter of the esophageal fistula. The outer diameter of the sheath 5 is the same as the diameter of the esophageal fistula, and the inner diameter of the sheath 5 is larger than the outer diameter of the sealing block 1, the soft pad 33 in the retracted state, the stent 6, and the moving block 23. The stent 6 is a prior art, and its main body is a mesh stent woven from nickel-titanium alloy wire. It has super elasticity and shape memory function, and its surface is covered with a polyester film or polytetrafluoroethylene film to seal the fistula defect. In the delivery state, the stent 6 is in the retracted state. After being delivered to the esophageal fistula, the sealing block 1 is located at the esophageal wall, and the support mechanism 2 and the soft pad 33 are located on both sides of the esophageal fistula. At this time, the stent 6 can be unfolded by prior art. After the stent 6 is unfolded, its diameter is slightly larger than the diameter of the fistula, so that the esophageal fistula can be sealed.

[0040] like Figure 1 As shown, the sheath 5 is disposed on the outer wall of the sealing block 1, and the sheath 5 does not contact the outer wall of the sealing block 1.

[0041] Using the above scheme: the operator can control the sheath 5 to extend into the patient's esophagus and penetrate the esophageal fistula to deliver the device. After delivery, the sheath 5 can be removed from the body, while the sealing block 1, support mechanism 2, stabilizing mechanism 3, and lead wire 4 remain in the body. During the delivery of the device, the lead wire 4 will be delivered synchronously, and in the initial state, the protrusion B28 on the lead wire 4 is always in contact with the slot on the inner wall of the moving block 23.

[0042] like Figures 3 to 5 As shown, a fixed block 24 is fixedly connected to the outer wall of the movable block 23, a protrusion A25 is fixedly connected to the outer wall of the fixed block 24, a connecting block 26 is fixedly connected to the outer wall of the sealing block 1, a groove 27 is provided on the inner wall of the connecting block 26, a protrusion B28 is fixedly connected to the outer wall of the wire 4, and a valve 29 is fixedly connected to the inner wall of the sealing block 1.

[0043] The above-mentioned scheme employs the following method: Except for the sheath 5, the wire 4, and the support 6, all other components of the device are made of polylactic acid-glycolic acid copolymer, a material formed by the copolymerization of polylactic acid and polyglycolic acid. This material possesses both a certain degree of hardness and flexibility, and can be gradually degraded in vivo through hydrolysis into lactic acid and glycolic acid, ultimately metabolized into CO2 and H2O, adapting to the repair cycle of the esophageal fistula. After the sheath 5 is removed, the support mechanism 2 is located on the inner wall of the esophagus, while the cushion 33 and the support 6 are located on the outer wall of the esophagus. Pulling the wire 4 can... When the support mechanism 2 unfolds, the support rod 21 is in a vertical position, fitting against the inner wall of the esophagus. The esophageal wall is located between the support rod 21 and the soft pad 33, which can provide a good fixation effect for the entire device. Furthermore, the flexibility of the polylactic acid-glycolic acid copolymer material allows the support rod 21 to bend with the esophageal wall during esophageal peristalsis after fitting against the inner wall of the esophagus, maintaining its fit against the esophageal wall. Moreover, the surface of the part of the support rod 21 that contacts the esophageal wall can be processed into a rough granular, mesh, or fluffy texture to increase the friction at the microscopic level and enhance the fixation effect.

[0044] like Figures 3 to 5 As shown, one end of the hinge rod 22 is hinged to the outer wall of the support rod 21, and the other end of the hinge rod 22 is hinged to the outer wall of the moving block 23; the support rod 21 is hinged to the outer wall of the sealing block 1, and the protrusion A25 contacts the inner wall of the groove 27; the outer wall of the fixing block 24 contacts the inner wall of the connecting block 26, and the protrusion B28 contacts the slot on the inner wall of the fixing block 24; the wire 4 contacts the inner wall of the moving block 23.

[0045] Using the above scheme: When the wire 4 is pulled outward, the protrusion B28 on the wire 4 contacts the slot on the inner wall of the moving block 23, and there is a certain friction between them, which can drive the moving block 23 to move synchronously, drive the hinge rod 22 to flip, and lift the horizontal support rod 21 to a vertical state; during the movement of the moving block 23, the fixed block 24 will gradually insert into the connecting block 26, and the protrusion A25 on its surface will be deformed by the pressure of the inner wall of the connecting block 26. When the fixed block 24 is fully inserted into the connecting block 26, the protrusion A25 will deform. 5 engages with groove 27, at which point the fixing block 24 can no longer move. In this state, if the wire 4 is pulled, the protrusion B28 will be deformed by the inner wall slot of the moving block 23, detach from the inner wall of the slot, and the wire 4 will be pulled out from the moving block 23. By engaging with groove 27, the position of the moving block 23 can be fixed, ensuring that the position of the support rod 21 is fixed. When the wire 4 is pulled out from the sealing block 1, the valve 29 will be forced open. When it is completely pulled out from the body, the valve 29 will automatically reset, achieving the effect of isolation and sealing.

[0046] like Figure 2 , Figure 6 As shown, a round rod 31 is slidably connected to the inner wall of the air cylinder 32, and the round rod 31 is fixedly connected to the outer wall of the moving block 23; the soft pad 33 is fixedly connected to the outer wall of the sealing block 1, and the air cylinder 32 is fixedly connected to the inner wall of the sealing block 1; the soft pad 33 is connected to the air cylinder 32, and the air cylinder 32 penetrates the outer wall of the sealing block 1.

[0047] Using the above scheme: When the moving block 23 moves with the wire 4, it will drive the round rod 31 to move into the inner wall of the air cylinder 32; in the initial state, the air cylinder 32 contains gas, while the soft pad 33 is in a contracted state. The soft pad 33 is also made of polylactic acid-glycolic acid copolymer material formed by the copolymerization of polylactic acid and polyglycolic acid, but its material is more flexible; during the movement of the moving block 23, the round rod 31 will squeeze the gas out of the air cylinder 32. Since the air cylinder 32 and the soft pad 33 are connected, the gas will enter the soft pad 33, causing it to unfold, as... Figure 6 As shown, the left side of the cushion 33 fits against the outer wall of the esophagus, so that it can remain in contact with the esophagus as the esophagus moves, thus ensuring the stability of the stent 6.

[0048] Working principle and usage process of this invention:

[0049] In the initial state, the stent 6 is in the collapsed state, the nickel-titanium alloy mesh structure is compressed in the sheath, the soft pad 33 is in the collapsed state, the support rod 21 is in the horizontal folded state, the air cylinder 32 is pre-charged with a certain amount of gas, and the protrusion B28 of the guide wire 4 is engaged with the slot in the inner wall of the moving block 23. In this state, the support mechanism 2 and the stabilizing mechanism 3 are not triggered.

[0050] The operator inserts the sheath 5 into the esophagus through the mouth by endoscopy or interventional approach, pushes it along the esophageal lumen to the fistula location, and ensures that the distal end of the sheath 5 reaches the esophageal wall after penetrating the fistula. The inner diameter of the sheath 5 is larger than the outer diameter of the blocking block 1, the collapsed support mechanism 2 and the stabilizing mechanism 3, ensuring smooth passage of each component. The blocking block 1 is positioned at the fistula through the sheath 5, the stent 6 and the soft pad 33 are located outside the esophageal wall, the support mechanism 2 is located inside the esophageal wall, then the sheath 5 is pulled out, the stent 6 is released by existing technology, and the super-elasticity and shape memory function of nickel-titanium alloy are used to make the stent expand and adhere to the outside of the fistula, and the diameter of the stent 6 is slightly larger than that of the fistula to form a block.

[0051] Then slowly pull the guide wire 4 outward, due to the friction between the protrusion B28 and the slot in the inner wall of the moving block 23, the moving block 23 is moved towards the fistula, the moving block 23 pushes the support rod 21 to flip from the horizontal state to the vertical state through the hinge rod 22, until the support rod 21 adheres to the inner wall of the esophagus; when the moving block 23 moves to the fixed block 24 completely inserted into the connecting block 26, the protrusion A25 is pressed and deformed to be inserted into the groove 27, fixing the position of the moving block 23, ensuring the vertical fixation of the support rod 21, and tightly adhering to the inner wall of the esophagus.

[0052] At the same time, the moving block 23 moves the round rod 31 to slide into the air cylinder 32, extruding the gas in the air cylinder 32 into the soft pad 33, the gas fills the soft pad 33 to expand and unfold, adhering to the outer wall of the esophagus to form a flexible support surface, offsetting the impact of esophageal peristalsis on the stent 6, and at the same time, the rough surface of the soft pad 33 and the support rod 21 can increase the micro-friction, improving the stability.

[0053] After the support mechanism and the stabilizing mechanism are fixed, continue to pull the guide wire 4, the protrusion B28 is extruded and deformed from the slot, and the guide wire 4 is completely pulled out of the body, the valve 29 is automatically reset after the guide wire 4 is pulled out, closing the channel to prevent body fluid leakage.

[0054] The esophageal wall is clamped between the support rod 21 and the soft pad 33, forming a bidirectional mechanical fixation; the stent 6 is expanded on the outside of the fistula and covers the fistula defect with a polyester film or a polytetrafluoroethylene film, achieving physical blockage.

[0055] The device is in the body, postoperative by hydrolysis gradually degraded into lactic acid and glycolic acid, eventually metabolized to CO2 and H2O, the material degradation rate and esophageal fistula repair cycle synchronization, after the fistula healing, support mechanism 2 and stable mechanism 3 gradually degrade absorption, no secondary removal, reduce the trauma of patients.

[0056] It should be noted that the relational terms herein, such as first and second, and the like, are used solely to distinguish one entity or action from another, without necessarily requiring or implying any such actual relationship or order between such entities or actions. Moreover, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but can also include other elements not expressly listed or inherent to such process, method, article, or apparatus.

[0057] While embodiments of the application have been shown and described, it is to be understood that the application is not limited to the details of the embodiments described, since numerous further modifications and changes can be apparent to one skilled in the art without departing from the spirit and scope of the application. The scope of the application is defined by the appended claims and their equivalents.

Claims

1. A degradable esophageal fistula occluder comprising an occlusion block (1) and a sheath tube (5), characterized in that: Also include: Support mechanism (2), the support mechanism (2) is arranged on the outer wall of the blocking block (1); Stabilizing mechanism (3), the stabilizing mechanism (3) is arranged on the outer wall of the blocking block (1); Wire (4), the wire (4) penetrates the inner wall of the blocking block (1); Support (6), the support (6) is arranged on the outer wall of the blocking block (1); Wherein, the support mechanism (2) includes a moving block (23), the outer wall of the moving block (23) is hinged with a support rod (21) through a hinge rod (22); The stabilizing mechanism (3) includes a soft pad (33), and the inner wall of the soft pad (33) is fixedly connected with a gas cylinder (32).

2. The degradable esophageal fistula occluder of claim 1, wherein: The sheath (5) is arranged on the outer wall of the blocking block (1), and the sheath (5) is not in contact with the outer wall of the blocking block (1).

3. The degradable esophageal fistula occlusion device of claim 1, wherein: The outer wall of the moving block (23) is fixedly connected with a fixed block (24), the outer wall of the fixed block (24) is fixedly connected with a convex block A (25), the outer wall of the blocking block (1) is fixedly connected with a connecting block (26), the inner wall of the connecting block (26) is provided with a groove (27), the outer wall of the wire (4) is fixedly connected with a convex block B (28), and the inner wall of the blocking block (1) is fixedly connected with a valve (29).

4. The degradable esophageal fistula occluder of claim 3, wherein: One end of the hinge rod (22) is hinged with the outer wall of the support rod (21), and the other end of the hinge rod (22) is hinged with the outer wall of the moving block (23).

5. The degradable esophageal fistula occlusion device of claim 3, wherein: The support rod (21) is hinged on the outer wall of the blocking block (1), the convex block A (25) is in contact with the inner wall of the groove (27).

6. The degradable esophageal fistula occluder of claim 3, wherein: The outer wall of the fixed block (24) is in contact with the inner wall of the connecting block (26), and the convex block B (28) is in contact with the inner wall of the fixed block (24).

7. The degradable esophageal fistula occlusion device of claim 3, wherein: The wire (4) is in contact with the inner wall of the moving block (23).

8. The degradable esophageal fistula occlusion device of claim 1, wherein: The inner wall of the gas cylinder (32) is slidably connected with a round rod (31), and the round rod (31) is fixedly connected to the outer wall of the moving block (23).

9. The degradable esophageal fistula occluder of claim 8, wherein: The soft pad (33) is fixedly connected to the outer wall of the blocking block (1), and the gas cylinder (32) is fixedly connected in the inner wall of the blocking block (1).

10. The degradable esophageal fistula occluder of claim 8, wherein: The soft pad (33) is in communication with the gas cylinder (32), and the gas cylinder (32) penetrates the outer wall of the blocking block (1). The soft pad (33) is in communication with the gas cylinder (32), and the gas cylinder (32) penetrates the outer wall of the blocking block (1).

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