Delivery device for occluder

Abstract

The application provides a delivery device for occluder, comprising: a delivery sheath, comprising a sheath tube body and a locking joint, the locking joint is fixedly arranged at the proximal end of the sheath tube body; an outer sleeve, which is sleeved on the peripheral side of the sheath tube body, the outer sleeve comprises an outer sleeve body and a joint assembly, the joint assembly is used for connecting the outer sleeve body and the delivery sheath, the joint assembly comprises a screw cap, the screw cap comprises a screw compression ring and a locking ring, the screw compression ring and the locking ring can be independently rotated along the axial direction of the screw cap and are fixedly connected in the axial direction of the screw cap, wherein the screw compression ring is used for rotating and compressing a hemostatic pad of the joint assembly, and the locking ring is used for being clamped in the locking joint after being docked with the locking joint. The screw compression ring and the locking ring of the screw cap can be independently rotated relative to each other, one side rotating does not interfere with the other side, ensures that the delivery sheath is not damaged due to torsion, and improves the service life of the delivery device for occluder and the reliability and safety of the occlusion operation.

Description

Technical Field

[0001] This application relates to the field of cardiac occluder delivery devices, and more particularly to an occluder delivery device. Background Technology

[0002] Left atrial appendage occlusion (LAAO) is a procedure that uses an occluder to block the left atrial appendage (LAA) to prevent thrombus formation during atrial fibrillation, thereby reducing the risk of long-term disability or death due to thromboembolism in AFA patients. The delivery of the occluder to the LA requires a delivery device. During delivery, the pusher carrying the occluder needs to be moved back and forth or rotated within the delivery sheath under the operator's control. The operator also needs to use a twisting motion to set and compress a hemostatic pad on the outer cannula to achieve hemostasis. The outer cannula is fitted over the delivery sheath. These operations on the pusher and outer cannula can easily cause the delivery sheath to rotate, potentially leading to torsional deformation and damage, affecting the lifespan of the occluder delivery device and the reliability and safety of the occlusion procedure.

[0003] Therefore, there is an urgent need for a new plug delivery device. Summary of the Invention

[0004] This application provides a plugging device delivery apparatus, comprising:

[0005] The delivery sheath includes a sheath body and a locking connector, with the locking connector fixedly disposed at the proximal end of the sheath body;

[0006] The outer tube is fitted around the outer periphery of the sheath body. The outer tube includes the outer tube body and the connector assembly. The connector assembly is used to connect the outer tube body and the delivery sheath. The connector assembly includes a screw cap, which includes a screw compression ring and a locking ring. The screw compression ring and the locking ring can rotate relatively independently along the axial direction of the screw cap and are fixedly connected in the axial direction of the screw cap. The screw compression ring is used to rotate and compress the hemostatic pad of the connector assembly, and the locking ring is used to lock the locking connector after being mated with the locking connector by rotation.

[0007] This application provides a device for delivering an occluder. The connector assembly of the outer tube is equipped with a screw-on cap. Because the screw-on compression ring and locking ring within the cap can rotate relatively independently, rotation of one does not interfere with the other. During the delivery of the occluder using this device, the sheath body is inserted into the outer tube body. After the locking connector aligns with the locking ring, rotation locks them together, ensuring relative fixation between the sheath and the outer tube. This prevents the sheath from moving or rotating when the pusher moves the occluder within the sheath. When hemostasis is required, rotating the screw-on compression ring compresses the hemostatic pad located in the connector assembly. This rotation does not cause circumferential disturbance to the locking ring, and the sheath does not rotate, ensuring the sheath is not damaged by torsion. This improves the service life of the occluder delivery device and the reliability and safety of the occlusion procedure.

[0008] In some optional embodiments of this application, the screw compression ring and the locking ring are rotatably engaged in annular engagement by a matching annular groove and annular buckle.

[0009] In some optional embodiments of this application, a locking head is formed on the inner circumferential side of the locking ring. The locking head is located at the end opposite to the screw-on compression ring and protrudes radially along the locking ring itself.

[0010] The locking connector includes a sleeve body. A locking groove extending circumferentially along the end of the sleeve body near the locking ring is provided. The shape and size of the locking head match the locking groove. A locking slot is formed between the middle section and the end section of the locking groove so that when the locking ring rotates relative to the locking connector, the locking head is engaged in the locking groove and moves along the locking groove. After passing through the locking slot, it is locked in the end section of the locking groove.

[0011] In some optional embodiments of this application, the screw compression ring has a pressure post, a first internal thread, and a barb formed inside.

[0012] The axial direction of the pressure column coincides with the axial direction of the screw cap. The pressure column is used to compress the hemostatic pad. The first internal thread is set opposite to the part of the outer periphery of the pressure column near the locking ring. The barb is formed at the port of the screw compression ring facing away from the locking ring.

[0013] In some optional embodiments of this application, the connector assembly further includes:

[0014] The connector seat is located on the side of the screw compression ring facing away from the locking ring. The outer periphery of the connector seat near the screw compression ring has a first external thread that matches the first internal thread. The outer periphery of the connector seat has a top cover buckle that protrudes radially and engages with a barb. The connector seat has a hemostatic pad receiving cavity and a delivery tube cavity that are connected. The hemostatic pad receiving cavity is closer to the screw compression ring than the delivery tube cavity. The hemostatic pad is located in the hemostatic pad receiving cavity.

[0015] The pipe compression nut is threaded to one end of the connector seat with the cap screwed in the opposite direction. One end of the outer tube body is inserted into the delivery pipe cavity, and the outer tube body is fixedly connected to the connector seat via the pipe compression nut.

[0016] In some optional embodiments of this application, the outer tube body includes:

[0017] The outer casing is a straight pipe section, with one end connected to the fitting assembly.

[0018] The outer sleeve bend section is located at one end of the outer sleeve straight section opposite to the joint assembly and is connected to the outer sleeve straight section. The outer sleeve bend section is provided with a first bend section and a second bend section in sequence from the proximal end of the outer sleeve body to the distal end of the outer sleeve body. The first central axis of the first bend section is out of plane with the second central axis of the second bend section.

[0019] The hose head is located at the end of the outer sleeve bend that is furthest from the outer sleeve straight section.

[0020] In some optional embodiments of this application, the outer sleeve includes a first inner layer, a first intermediate layer, and a first outer layer. The first intermediate layer sequentially forms a first developing area, a first flexible area, and a first support area from the distal end of the outer sleeve to the proximal end of the sleeve. The first developing area includes a first developing ring disposed around the outer periphery of the first inner layer. The first flexible area includes a first elastic coil wound around the outer side of the first inner layer. The first support area includes a first mesh braided structure sleeved on the outer side of the first inner layer.

[0021] The straight section of the outer sleeve corresponds to the first support zone, the bent section of the outer sleeve corresponds to the first flexibility zone, and the hose head corresponds to the first developing zone.

[0022] In some optional embodiments of this application, the length of the sheath body is greater than the length of the outer tube body, and after the delivery sheath and the outer tube are fixedly connected, the distal end of the sheath body extends beyond the distal end of the outer tube body.

[0023] In some optional embodiments of this application, the tube wall of the sheath includes a second inner layer, a second intermediate layer and a second outer layer. The second intermediate layer has a second developing area and a second supporting area sequentially formed from the distal end to the proximal end of the sheath. The second developing area includes a second developing ring disposed around the outer periphery of the second inner layer. The second supporting area includes a second mesh braided structure sleeved on the outer side of the second inner layer.

[0024] In some optional embodiments of this application, the second developing ring is formed with at least one break extending axially along the sheath itself in the circumferential direction.

[0025] In some optional embodiments of this application, a second flexible region is further provided between the second developing region and the second supporting region, the second flexible region including a first elastic coil wound around the second inner layer.

[0026] In some optional embodiments of this application, a retrieval portion is formed at the distal end of the sheath body, the retrieval portion being located on the side of the second imaging ring opposite to the second mesh structure on the axis of the sheath body itself, and the retrieval portion includes an opening for the entry and exit of the plug.

[0027] In some optional embodiments of this application, the recovery section includes a plurality of arc-shaped lobes spaced apart along the circumference of the sheath body. The top edges of the plurality of arc-shaped lobes enclose an opening perpendicular to the axial direction of the sheath body itself. A groove is formed between two adjacent arc-shaped lobes, and the groove extends from the opening along the axial direction of the sheath body itself to the second imaging ring.

[0028] In some optional embodiments of this application, the opening is inclined, the edge of the opening forms a curved surface inclined toward the second developing ring, and the recovery part is formed with an inclined spoon.

[0029] In some optional embodiments of this application, the occluder delivery device further includes a pusher, which comprises:

[0030] The operating handle is located at the proximal end of the delivery sheath;

[0031] Connector, used for fixed connection with the plugging device;

[0032] The push rod is located between the operating handle and the connector. One end of the push rod is connected to the operating handle, and the other end is connected to the connector. A marking area is provided on the part of the push rod near the operating handle. The marking area includes multiple markers. Each marker can move back and forth in the marking area along the axial direction of the push rod to mark the position of different parts of the plug.

[0033] In some optional embodiments of this application, the push rod is a steel cable rod.

[0034] The marking element is an elastic collar, or a metal collar with internal threads formed on its inner circumference.

[0035] In some optional embodiments of this application, the same marking features of each marker are different from each other to mark different parts of the occluder. The marking features are selected from at least one of the outer contour shape, surface marking number and color. Attached Figure Description

[0036] Figure 1 This is a front view structural diagram of an embodiment of the plug delivery device provided in this application;

[0037] Figure 2 This is a bottom view of the screw cap in one embodiment of the plug delivery device provided in this application.

[0038] Figure 3 yes Figure 2 Cross-sectional view along the BB direction;

[0039] Figure 4 yes Figure 1 Exploded view of joint assembly 22;

[0040] Figure 5 This is a bottom view of the connector seat in one embodiment of the plug delivery device provided in this application;

[0041] Figure 6 yes Figure 5 Cross-sectional view at point AA along the middle;

[0042] Figure 7 This is a front view of the outer tube in one embodiment of the plug delivery device provided in this application;

[0043] Figure 8 This is a front view of the delivery sheath in one embodiment of the plug delivery device provided in this application;

[0044] Figure 9 This is a front view of the locking joint of the delivery sheath in one embodiment of the plug delivery device provided in this application;

[0045] Figure 10 This is a three-dimensional structural diagram of the process of the locking ring of the screw cap and the locking joint rotating and clamping in one embodiment of the plug delivery device provided in this application;

[0046] Figure 11 This is a schematic diagram of the structure of the occluder placed in the left atrial appendage tissue via occlusion.

[0047] Figure 12 This is a perspective view of the outer tube body in one embodiment of the plug delivery device provided in this application;

[0048] Figure 13 This is a schematic diagram of the structure of the outer tube body after the first outer layer is hidden in one embodiment of the plug delivery device provided in this application;

[0049] Figure 14 This is a schematic diagram of the sheath body after the second outer layer is hidden in one embodiment of the plug delivery device provided in this application;

[0050] Figure 15 This is a schematic diagram of the structure of the second imaging ring on the sheath in one embodiment of the plug delivery device provided in this application;

[0051] Figure 16 This is a schematic diagram of the recovery section structure at the distal end of the delivery sheath in one embodiment of the plug delivery device provided in this application;

[0052] Figure 17 This is a schematic diagram of the structure of the recovery section at the distal end of the delivery sheath after it is attached to the left atrial appendage tissue in one embodiment of the occluder delivery device provided in this application;

[0053] Figure 18 This is a schematic diagram of the process of the blocker being recovered via the recovery section at the distal end of the delivery sheath in one embodiment of the blocker delivery device provided in this application;

[0054] Figure 19 This is a schematic diagram of the recovery section structure at the distal end of the delivery sheath in another embodiment of the plug delivery device provided in this application;

[0055] Figure 20 This is a schematic diagram of the process of the blocker being recovered by the recovery section at the distal end of the delivery sheath in another embodiment of the blocker delivery device provided in this application;

[0056] Figure 21 This is a front view of the plugging device in its original state;

[0057] Figure 22 This is a front view of the pusher in one embodiment of the plug delivery device provided in this application;

[0058] Figure 23 This is a front view of a plugging device in its deployed state;

[0059] Figure 24 This is a schematic diagram of the occluder being loaded into the delivery sheath outside the body.

[0060] Explanation of reference numerals in the attached figures:

[0061] Conveyor sheath-1; Sheath body-11; Retrieval section-111; Arc-shaped flap-1111; Groove-1112; Angled spoon-shaped blade-1113;

[0062] Locking connector-12; Sleeve body-121; Locking groove-122; Bayonet-1221; Middle section of groove-a; Tail section of groove-b; Hemostatic valve-13; End face of hemostatic valve-131; Second imaging ring-14; Fragment-141;

[0063] Outer tube - 2; Outer tube body - 21; Straight section of outer tube - 211; Bent section of outer tube - 212; First bend section - 2121; Second bend section - 2122; Short straight section - 213; Tube head - 214; First imaging ring - 215;

[0064] Connector assembly-22; Screw cap-221;

[0065] Tightening compression ring-222; Pressure column-2221; First internal thread-2222; Barb-2223; Pipe hole-2224; First annular groove-2225; First annular buckle-2226;

[0066] Locking ring-223; Second annular buckle-2231; Second annular slot-2232; Clip head-2233;

[0067] Hemostatic pad-224; Three-way valve-225; Connector seat-226; Extension tube section-2261; Extension tube clip-2262; Clip cap-227; First external thread-2263; Top cover clip-2264; Hemostatic pad receiving cavity-2265; Delivery tube cavity-2266; Tube compression nut-228;

[0068] Pusher-3; Operating handle-31; Connector-32; Push rod-33; Marking area-M; Marker-331;

[0069] Plug-4; Hook-41; Mesh Plug-42; External Threaded Anchor-43; Left Disc Anchor-44; Left Disc-45; Waist-46; Right Disc-47;

[0070] Left atrial appendage tissue -5;

[0071] First developing area - A1; First flexible area - A2; First support area - A3;

[0072] Second developing area - B1; Second supporting area - B3. Detailed Implementation

[0073] The following will be combined with the appendix Figure 1 To be continued Figure 24 The technical solution of this application is described in detail.

[0074] This application provides a sealing device 4 delivery device, comprising:

[0075] The delivery sheath 1 includes a sheath body 11 and a locking connector 12, with the locking connector 12 fixedly disposed at the proximal end of the sheath body 11;

[0076] The outer tube 2 is fitted around the outer periphery of the sheath body 11. The outer tube 2 includes the outer tube body 21 and the connector assembly 22. The connector assembly 22 is used to connect the outer tube body 21 and the delivery sheath 1. The connector assembly 22 includes a screw cap 221. The screw cap 221 includes a screw compression ring 222 and a locking ring 223. The screw compression ring 222 and the locking ring 223 can rotate relatively independently along the axial direction of the screw cap 221 and are fixedly connected in the axial direction of the screw cap 221. The screw compression ring 222 is used to rotate and compress the hemostatic pad 224 of the connector assembly 22. The locking ring 223 is used to be docked with the locking connector 12 and then locked to the locking connector 12 by rotation.

[0077] This application provides a conveying device for a plugging device 4. The connector assembly 22 of the outer tube 2 is provided with a screw cap 221. Since the screw compression ring 222 and the locking ring 223 in the screw cap 221 can rotate relatively independently, the rotation of one does not interfere with the other. During the conveying of the plugging device 4 using the conveying device, the sheath body 11 of the conveying sheath 1 is inserted into the outer tube body 21. After the locking connector 12 and the locking ring 223 are connected, they are locked together by rotation. The screw compression ring 222 and the locking ring 223 are fixedly connected in the axial direction of the screw cap 221, which ensures the relative fixation between the conveying sheath 1 and the outer tube 2. This prevents the conveying sheath 1 from moving or rotating when the pusher 3 drives the plugging device 4 to move in the conveying sheath 1. When hemostasis is required, rotating the compression ring 222 compresses the hemostatic pad 224 located in the connector assembly 22. This rotation does not cause circumferential disturbance to the locking ring 223, and the delivery sheath 1 will not rotate accordingly, ensuring that the delivery sheath 1 is not damaged by torsion. This improves the service life of the occluder 4 delivery device and the reliability and safety of the occlusion surgery.

[0078] In some optional embodiments of this application, the occluder 4 delivery device further includes a pusher 3, which is used to load the occluder 4 and deliver the occluder 4 through the inner cavity of the delivery sheath 1 to the left atrial appendage tissue 5.

[0079] It should be noted that, Figure 1 To clearly illustrate the situation where the pusher 3 enters the outer tube body 21, the sheath body 11 that has already extended into the outer tube body 21 is hidden.

[0080] It should be noted that, in this application, the proximal end of any structure refers to the end closer to the surgeon during the occlusion procedure, and the distal end of any structure refers to the end farther from the surgeon and closer to the patient during the occlusion procedure.

[0081] In some optional embodiments of this application, the screw-on compression ring 222 and the locking ring 223 are rotatably engaged in annularly via a matching annular groove and annular snap-fit. In these embodiments, the relatively independent rotation between the screw-on compression ring 222 and the locking ring 223 is achieved through the rotatable annular engagement between the annular groove and the annular snap-fit.

[0082] like Figure 2 and Figure 3As shown, the outer periphery of the screw-down compression ring 222, near the locking ring 223, has a first annular groove 2225 and a first annular buckle 2226 continuously formed along its own axial direction. The inner periphery of the locking ring 223, near the screw-down compression ring 222, has a second annular groove 2232 and a second annular buckle 2231 continuously formed along its own axial direction. The first annular groove 2225 and the second annular buckle 2231 are engaged in a corresponding annular engagement, and the first annular buckle 2226 and the second annular groove 2232 are also engaged in a corresponding annular engagement, thus fixing the screw-down compression ring 222 and the locking ring 223 along the axial direction of the screw-down cap 221 while allowing them to rotate relatively independently.

[0083] like Figure 3 As shown, the screw-on compression ring 222 has a pressure post 2221, a first internal thread 2222, and a barb 2223 inside. The axial direction of the pressure post 2221 coincides with the axial direction of the screw-on cap 221. The pressure post 2221 is used to compress the hemostatic pad 224. The first internal thread 2222 is positioned opposite to the portion of the outer periphery of the pressure post 2221 near the locking ring 223. The barb 2223 is formed at the port of the screw-on compression ring 222 facing away from the locking ring 223. The pressure post 2221 has a hollow structure, and a tube hole 2224 is formed axially on the pressure post 2221.

[0084] Please refer to the above as well. Figures 1 to 7 The connector assembly 22 also includes:

[0085] The connector 226 is located on the side of the screw compression ring 222 facing away from the locking ring 223. The outer periphery of the connector 226 near the screw compression ring 222 forms a first external thread 2263 that matches the first internal thread 2222. The outer periphery of the connector 226 forms a top cover buckle 2264 that protrudes radially. The top cover buckle 2264 engages with the barb 2223. The connector 226 has a hemostatic pad receiving cavity 2265 and a delivery tube cavity 2266 that are connected. The hemostatic pad receiving cavity 2265 is closer to the screw compression ring 222 than the delivery tube cavity 2266. The hemostatic pad 224 is located in the hemostatic pad receiving cavity 2265.

[0086] The pipe compression nut 228 is threaded to one end of the cap 221 and screwed onto the connector seat 226 in the opposite direction. One end of the outer tube body 21 is inserted into the delivery tube cavity 2266. The outer tube body 21 is fixedly connected to the connector seat 226 via the pipe compression nut 228.

[0087] In these embodiments, the upper cover snap 2264 of the connector seat 226 engages with the barb 2223 of the screw compression ring 222, thereby connecting the connector seat 226 and the screw compression ring 222. During hemostasis, the screw compression ring 222 is rotated relative to the connector seat 226, causing the screw compression ring 222 to rotate toward the pipe compression nut 228 through the engagement between the first internal thread 2222 and the first external thread 2263. During the rotation, the pressure column 2221 formed inside the screw compression ring 222 compresses the hemostatic pad 224 disposed in the hemostatic pad receiving cavity 2265.

[0088] In some embodiments, the connector 226 further includes an extension tube section 2261, which communicates with the delivery tube cavity 2266 and is located beside the delivery tube cavity 2266. An extension tube clip 2262 is formed on the outer periphery of the extension tube section 2261, and the extension tube clip 2262 is connected to the infusion tube. A cap 227 is provided at the connection point to prevent leakage. A three-way valve 225 is connected to the extension tube section 2261 via the infusion tube.

[0089] Please refer to some optional embodiments in this application as well. Figure 3 and Figures 8 to 10 A locking head 2233 is formed on the inner circumferential side of the locking ring 223. The locking head 2233 is located at one end opposite to the screw-on compression ring 222 and protrudes radially along the locking ring 223 itself.

[0090] The locking connector 12 includes a sleeve body 121. A locking groove 122 extending circumferentially along the end of the sleeve body 121 near the locking ring 223 is provided. The clamp head 2233 matches the shape and size of the locking groove 122. A slot 1221 is formed between the middle section a and the end section b of the locking groove 122 so that when the locking ring 223 rotates relative to the locking connector 12, the clamp head 2233 is inserted into the locking groove 122 and moves along the locking groove 122. After passing through the slot 1221, it is locked in the end section b of the locking groove 122. In these embodiments, the width at the notch 1221 is smaller than that at the middle section a and the end section b of the groove. When the locking ring 223 is rotated, the locking head 2233 first enters from the notch 1112 of the locking groove 122. After passing through the middle section a, the locking head 2233 opens the notch 1221 and overcomes the obstruction of the protrusion at the notch 1221. After the locking head 2233 enters the end section b of the groove, the notch 1221 returns to its shape, thereby preventing the locking head 2233 from sliding out of the end section b of the groove. This ensures the relative fixation between the conveying sheath and the outer tube 2 and prevents the conveying sheath 1 from twisting or deforming.

[0091] A hemostatic valve 13 is connected to the end of the locking connector 12 facing away from the sheath body 11. The hemostatic function of the hemostatic valve 13 is achieved by screwing and compressing the sealing ring in the hemostatic valve.

[0092] In some optional embodiments of this application, the length of the sheath body 11 is greater than the length of the outer tube body 21. After the delivery sheath is fixedly connected to the outer tube 2, the distal end of the sheath body 11 extends beyond the distal end of the outer tube body 21.

[0093] In these embodiments, like Figure 11 As shown The occluder 4 typically has a hook 41 on the side of its mesh occluder body 42, and an externally threaded anchor 43 at its bottom, which is threaded to connect with the threaded connector in the pusher 3. In the current delivery device of the occluder 4, the length of the sheath body 11 is shorter than the length of the outer tube body 21. After the occluder 4 is pushed out of the delivery sheath 1 by the pusher 3, it still needs to enter the inner lumen of the outer tube body 21 and move a certain distance before finally reaching the left atrial appendage tissue 5. During the movement of the occluder 4 within the inner lumen of the outer tube body 21, the hook 41 is prone to scraping and rubbing against the inner wall of the outer tube body 21, which can easily tear the outer tube body 21 and introduce lint scraped from the inner wall of the outer tube body 21 into the cardiovascular system, posing a significant surgical safety risk. Furthermore, for some occluders 4 made of biodegradable materials, their poor elasticity and deformation recovery ability mean that prolonged friction during delivery within the outer tube body 21 can cause the occluder 4 to be difficult to restore its original shape. Therefore, in these embodiments, the length of the sheath body 11 is greater than the length of the outer tube body 21. The occluder 4 can be delivered directly from the inside of the sheath body 11 to the left atrial appendage tissue 5 without passing through the inner lumen of the outer tube body 21. This avoids transport friction in the outer tube body 21, prevents the shape of the occluder 4 from changing due to friction, ensures the safe delivery of the occluder 4 and prevents its shape from deteriorating, and ensures the safety and reliability of the occlusion surgery.

[0094] like Figure 7 and Figure 12 As shown, in some optional embodiments of this application, the outer tube body 21 includes:

[0095] The outer casing straight pipe section 211 is connected at one end to the connector assembly 22.

[0096] The outer tube bend section 212 is located at one end of the outer tube straight section 211 facing away from the joint assembly 22 and is connected to the outer tube straight section 211. The outer tube bend section 212 has a first bend section 2121 and a second bend section 2122 arranged sequentially from the proximal end of the outer tube body 21 to the distal end of the outer tube body 21. The first central axis of the first bend section 2121 is out of plane with the second central axis of the second bend section 2122.

[0097] The hose head 214 is located at the end of the outer sleeve bend section 212 that is away from the outer sleeve straight section 211.

[0098] In these embodiments, a short straight section 213 is also provided between the outer sheath bend section 212 and the flexible tube head 214. The short straight section 213 ensures that the delivery sheath 1 extends into the atrial appendage to complete the release process. In these embodiments, a spatial angle is formed between the first bend section 2121 and the second bend section 2122 of the outer sheath bend section 212, and their central axes are not coplanar, making the shape of the outer sheath bend section 212 more compatible with the physiological structures near the left atrial appendage, facilitating the delivery of the occluder 4. The flexible tube head 214 can prevent the outer sheath 2 from puncturing the left atrial appendage tissue 5 when it reaches the left atrial appendage.

[0099] like Figure 13 As shown, in some optional embodiments of this application, the outer tube body 21 includes a first inner layer, a first intermediate layer, and a first outer layer. The first intermediate layer sequentially forms a first developing area A1, a first flexible area A2, and a first support area A3 from the distal end of the outer tube 2 to the proximal end of the tube. The first developing area A1 includes a first developing ring 215 disposed around the outer periphery of the first inner layer. The first flexible area A2 includes a first elastic coil wound around the first inner layer. The first support area A3 includes a first mesh braided structure sleeved on the outside of the first inner layer.

[0100] The straight section 211 of the outer tube corresponds to the first support zone A3, the bent section 212 of the outer tube corresponds to the first flexibility zone A2, and the hose head 214 corresponds to the first developing zone A1.

[0101] In these embodiments, the first support region A3 is provided to enhance the pushability of the proximal end of the outer tube 21, making it easier for the operator to push the outer tube 2 into place without damaging blood vessels. The first flexibility region A2 enhances the bendability and flexibility of the distal end of the outer tube 21, making it easier to conform to the tissue or vascular structures near the left atrial appendage and avoid damage to the human body. The first imaging ring 215 provided in the first imaging region A1 surrounds the outer periphery of the first inner layer and is located at the tube head 214, facilitating imaging positioning.

[0102] The first inner layer and the first outer layer can be made of PTFE (Polytetrafluoroethylene), nylon and other polymer materials.

[0103] like Figure 14 As shown, in some optional embodiments of this application, the tube wall of the sheath body 11 includes a second inner layer, a second intermediate layer and a second outer layer. The second intermediate layer is formed sequentially from the distal end of the transport sheath 1 to the proximal end of the transport sheath 1, with a second developing area B1 and a second supporting area B3. The second developing area B1 includes a second developing ring 14 disposed around the outer periphery of the second inner layer, and the second supporting area B3 includes a second mesh braided structure sleeved on the outer side of the second inner layer.

[0104] In some examples of these embodiments, when the delivery sheath 1 extends into the outer tube body 21 and the delivery sheath 1 and the outer tube 2 are locked together with the locking connector 12 by the locking ring 223, the positions of the first developing ring 215 and the second developing ring 14 coincide, indicating that the plugger 4 has reached the ready position.

[0105] like Figure 15 As shown, in some embodiments of this application, the second developing ring 14 has at least one break 141 extending axially along the sheath body 11 in the circumferential direction. In these embodiments, the second inner layer is generally made of plastic, while the second developing ring 14 is made of metal, with plastic having much greater toughness than metal. When the plugging device 4 is pulled into the sheath body 11 from the distal end outside the sheath body 11 by the pusher 3, or when the plugging device 4 is pushed out of the sheath body 11 by the pusher 3, it needs to pass through the second developing ring 14. The plugging device 4 and the second developing ring 14 are squeezed against each other, which is not conducive to the delivery of the plugging device 4 and easily leads to deformation and damage of both the second developing ring 14 and the plugging device 4. After setting the break 141, when the plugging device 4 passes through the second developing ring 14, the second developing ring 14 expands radially, reducing the squeezing force between the second developing ring 14 and the plugging device 4, while retaining the developing function of the second developing ring 14.

[0106] In some embodiments of this application, a second flexible region is further provided between the second imaging region B1 and the second support region B3. The second flexible region includes a first elastic coil wound around the outer side of the second inner layer. In these embodiments, the second flexible region corresponds to the position of the first flexible region A2, and the second support region B3 corresponds to the position of the first support region A3. This ensures the pushing and supporting properties of the proximal end of the occluder 4 delivery device, as well as the flexibility and bendability of the distal end of the occluder 4 delivery device, which is beneficial for the high-quality implementation of the occlusion procedure.

[0107] like Figure 16 As shown, in some embodiments of this application, a retrieval section 111 is formed at the distal end of the sheath body 11. The retrieval section 111 is located on the side of the second imaging ring 14 facing away from the second mesh structure on its own axis. The retrieval section 111 includes an opening for the plugger 4 to enter and exit.

[0108] In some embodiments of this application, the recovery section 111 includes a plurality of arc-shaped lobes 1111 spaced upward along the circumference of the sheath body 11. The top edges of the plurality of arc-shaped lobes 1111 enclose an opening perpendicular to the axial direction of the sheath body 11. A groove 1112 is formed between two adjacent arc-shaped lobes 1111. The groove 1112 extends from the opening along the axial direction of the sheath body 11 to the second imaging ring 14.

[0109] like Figure 17As shown, in these embodiments, the slot 1112 formed by the recovery section 111 can prevent the distal end of the delivery sheath 1 from completely adhering to the left atrial appendage tissue 5 when the distal end of the delivery sheath 1 is delivered to the left atrial appendage tissue 5 and it is necessary to perform angiography to determine the location of the lesion or to aspirate blood and remove air, which would lead to failure of angiography or blood aspiration.

[0110] like Figure 18 As shown in these embodiments, when the plugger 4 is retrieved into the delivery sheath 1, the retrieval section 111 is in an unfolded state, with multiple arc-shaped petals 1111 opening, increasing the opening area of ​​the retrieval section 111, reducing the resistance to retrieval of the plugger 4 at the opening at the far end of the delivery sheath 1, and at the same time, each arc-shaped petal 1111 of the retrieval section 111 has a wrapping effect on the plugger 4, the contact area between the retrieval section 111 and the plugger 4 is large, the squeezing force on the plugger 4 in all directions is small, and the smooth retrieval of the plugger 4 is ensured.

[0111] In these embodiments, the arc-shaped petals 1111 of the recovery section 111 are formed by a second outer layer and a second inner layer stacked together.

[0112] like Figure 19 As shown, in some embodiments of this application, the opening of the recovery section 111 is inclined, and the edge of the opening forms a curved surface inclined toward the second developing ring 14. The recovery section 111 is formed with an inclined spoon 1113.

[0113] like Figure 20 As shown, the deployed plug 4 is retrieved. When the plug 4 enters from the far end of the delivery sheath 1, due to the inclined opening of the retrieval section 111, the retrieval section 111 forms an inclined spoon 1113. The contact area between the inclined spoon 1113 and the plug 4 is increased, and the inclined spoon 1113 applies a trapezoidal step force to the plug 4, causing the plug 4 to deflect and tilt towards the inclined opening in the retrieval section 111 during the retrieval process. This reduces the resistance of the far end opening of the delivery sheath 1 to the retrieval of the plug 4, avoids deformation of the plug 4, and increases the retrieval efficiency.

[0114] The inventors further discovered that while biodegradable occluders 4 are increasingly widely used in clinical practice, the lack of visual contrast within the body makes it difficult to determine their actual delivery location during administration, significantly impacting the occlusion procedure. Furthermore, the occluders 4 come in various models, necessitating the design of a pusher 3 to assist in determining the actual delivery location of different occluders 4.

[0115] In some optional embodiments of this application, the occluder 4 delivery device further includes a pusher 3, which comprises:

[0116] Operating handle 31 is located at the proximal end of delivery sheath 1;

[0117] Connector 32 is used for fixed connection with plug 4;

[0118] Push rod 33 is disposed between operating handle 31 and connector 32. One end of push rod 33 is connected to operating handle 31, and the other end of push rod 33 is connected to connector 32. A marking area M is provided on the part of push rod 33 near operating handle 31. The marking area M includes multiple marking elements 331. Each marking element 331 can move back and forth in the marking area M along the axial direction of push rod 33 to mark the position of different parts of the plugger 4.

[0119] In these embodiments, during the delivery of the occluder 4 through the delivery sheath 1, the operator holds the operating handle 31, and the connector 32 is fixedly connected to the occluder 4. In some examples, the connector 32 is threadedly connected to the occluder 4.

[0120] like Figure 21 As shown, in some examples, the plug 4 in its original state includes multiple parts of different shapes, from left to right including the left disc anchor head 44, the left disc body 45, the waist 46, the right disc body 47, and the external threaded anchor head 43.

[0121] Before performing the occlusion procedure, it is necessary to load the occluder 4 into the delivery sheath 1 externally. In this step, please refer to... Figures 22 to 24 The push rod 33 of the pusher 3 extends into the sheath body 11 of the delivery sheath 1 via the hemostatic valve 13, causing the connector 32 to extend from the distal end of the delivery sheath 1 into the sheath body 11. The occluder 4, in its original state, is threadedly connected to the connector 32 of the delivery sheath 1. Then, by holding the operating handle 31, the push rod 33 is pulled from the distal end of the delivery sheath 1 towards the proximal end. As the occluder 4 enters the sheath body 11 from the distal end of the delivery sheath 1, the occluder 4 changes from its original state to... Figure 23 The unfolded state shown. Figure 23 L1 corresponds to the unfolded portion of the left disc (45), L2 corresponds to the unfolded portion of the waist (46), and L3 corresponds to the unfolded portion of the right disc (47). For example... Figure 24As shown, in a specific example, after the waist 46 (i.e., L2) is observed to be fully inserted into the delivery sheath 1 during external loading, the designated marker 331 corresponding to the waist 46 is moved to a position flush with the end face 131 of the hemostatic valve and kept stationary. This marker 331 represents the starting position of the waist 46 when the occluder 4 is subsequently released internally. The occluder 4 is fully loaded into the delivery sheath 1, and the delivery sheath 1 containing the occluder 4, together with the pusher 3, enters the outer cannula 2 already placed inside the patient's body. When the first imaging ring 215 and the second imaging ring 14 are completely aligned, it can be determined that the occluder 4 has reached the ready position. At this point, after the locking ring 223 in the screw cap 221 aligns with the locking connector 12, the locking ring 223 rotates relative to the locking connector 12. During rotation, the clip 2233 on the locking ring 223 engages with the locking groove 122 and moves along the locking groove 122. After passing through the slot 1221, it is secured to the end section b of the locking groove 122, completing the fixed connection between the delivery sheath 1 and the outer tube 2. The operating handle 31 and the push rod 33 are detachably connected, and the operator can adjust the distance between the operating handle 31 and the hemostatic valve 13 according to the operating requirements and habits.

[0122] The operator holds the operating handle 31 and releases the occluder 4 from the proximal end to the distal end of the pusher 3. During the release process, when the marker 331 marking the starting position of the waist 46 is flush with the end face 131 of the hemostatic valve again, it indicates that the left disc 45 of the occluder 4 has been completely released. Taking this as an example, the junctions of various parts of the occluder 4 can be marked with the marker 331. By setting a movable marker 331 on the pusher 33, the occluder 4 can be released and positioned efficiently and quickly without imaging, eliminating the need for the tedious operation of repeatedly judging the position of the occluder 4 by ultrasound. This marking method is also applicable to different models and specifications of occluders 4, meeting the requirement of universality for marking various occluders 4.

[0123] In some optional embodiments, the push rod 33 is a steel cable rod, and the marker 331 is an elastic collar, or the marker 331 is a metal collar with internal threads on its inner circumference. The elastic collar allows the marker 331 to deform and detach from the steel cable rod, adjusting its position in the marking area M. It also utilizes its elastic recovery property to lock the collar in place at the designated marking position. As a metal collar with internal threads on its inner circumference, when adjusting the position of the metal collar in the marking area M, the collar is loosened, allowing it to move axially back and forth relative to the steel cable rod. When fixing the collar in the marked position, it is tightened onto the steel cable rod.

[0124] In some optional embodiments, the same marking features of each marker 331 are different to correspond to different parts of the marking occluder 4. The marking features are selected from at least one of the outer contour shape, surface marking number, and color. In these embodiments, the identifiable marking features of each marker 331 are different and can correspond to the boundaries between different parts of the marking occluder 4. For example, there are four markers 331 in the marking area M. Each marker 331 has a ring-shaped structure. The outer contour shape of the first marker 331 is triangular with a circular hole in the middle; the outer contour shape of the second marker 331 is quadrilateral with a circular hole in the middle; the outer contour shape of the third marker 331 is pentagonal with a circular hole in the middle; and the outer contour shape of the fourth marker 331 is circular with a circular hole in the middle.

[0125] The above description is merely a specific embodiment of this application, but the scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in this application should be included within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the scope of the claims.

Claims

1. A plugging device delivery apparatus, characterized in that, include: A delivery sheath includes a sheath body and a locking connector, wherein the locking connector is fixedly disposed at the proximal end of the sheath body; An outer tube, fitted around the outer periphery of the sheath body, includes an outer tube body and a connector assembly. The connector assembly connects the outer tube body to the delivery sheath. The connector assembly includes a screw cap, which includes a screw compression ring and a locking ring. The screw compression ring and the locking ring can rotate independently relative to each other along the axial direction of the screw cap and are fixedly connected along the axial direction of the screw cap. The screw compression ring is used to rotate and compress the hemostatic pad of the connector assembly, and the locking ring is used to engage with the locking connector and then be locked into the locking connector by rotation.

2. The plugging device conveying device according to claim 1, characterized in that, The screw-on compression ring and the locking ring are rotatably engaged in annular connection via a matching annular groove and annular buckle.

3. The plugging device conveying device according to claim 1, characterized in that, A locking head is formed on the inner circumference of the locking ring. The locking head is located at the end opposite to the screw-on compression ring and protrudes radially along the locking ring itself. The locking connector includes a sleeve body. A locking groove extending circumferentially along the end of the sleeve body near the locking ring is provided. The locking head matches the shape and size of the locking groove, and a locking slot is formed between the middle section and the end section of the locking groove, so that when the locking ring rotates relative to the locking connector, the locking head engages with the locking groove and moves along the locking groove, and is locked in the end section of the locking groove after passing through the locking slot.

4. The plugging device conveying device according to claim 1, characterized in that, The screw-on compression ring has a pressure post, a first internal thread, and a barb inside. The axial direction of the pressure column coincides with the axial direction of the screw cap. The pressure column is used to compress the hemostatic pad. The first internal thread is disposed opposite to the portion of the outer periphery of the pressure column near the locking ring. The barb is formed at the port of the screw compression ring facing away from the locking ring.

5. The plugging device conveying device according to claim 4, characterized in that, The connector assembly also includes: A connector seat is disposed on the side of the screw-compression ring facing away from the locking ring. The outer periphery of the connector seat near the screw-compression ring has a first external thread that matches the first internal thread. The outer periphery of the connector seat has a top cover buckle that protrudes radially and engages with the barb. The connector seat has a hemostatic pad receiving cavity and a delivery tube cavity that are connected. The hemostatic pad receiving cavity is closer to the screw-compression ring than the delivery tube cavity. The hemostatic pad is disposed in the hemostatic pad receiving cavity. The pipe compression nut is threaded to one end of the connector seat opposite to the screw cap. One end of the outer tube body is inserted into the delivery tube cavity. The outer tube body is fixedly connected to the connector seat via the pipe compression nut.

6. The plugging device conveying device according to claim 1, characterized in that, The outer tube body includes: The outer sleeve straight section is connected at one end to the connector assembly. The outer tube bend section is located at the end of the outer tube straight section opposite to the joint assembly and is connected to the outer tube straight section. The outer tube bend section is provided with a first bend section and a second bend section sequentially from the proximal end of the outer tube body to the distal end of the outer tube body, wherein the first central axis of the first bend section and the second central axis of the second bend section are out of plane. The hose head is located at the end of the outer sleeve bend that is away from the outer sleeve straight section.

7. The plugging device conveying device according to claim 6, characterized in that, The outer tube body includes a first inner layer, a first intermediate layer, and a first outer layer. The first intermediate layer sequentially forms a first developing area, a first flexible area, and a first support area from the distal end to the proximal end of the outer tube. The first developing area includes a first developing ring disposed around the outer periphery of the first inner layer. The first flexible area includes a first elastic coil wound around the outside of the first inner layer. The first support area includes a first mesh braided structure sleeved on the outside of the first inner layer. The straight section of the outer tube corresponds to the first support area, the bent section of the outer tube corresponds to the first flexibility area, and the hose head corresponds to the first developing area.

8. The plugging device conveying device according to claim 1, characterized in that, The length of the sheath body is greater than the length of the outer tube body. After the delivery sheath is fixedly connected to the outer tube, the distal end of the sheath body extends beyond the distal end of the outer tube body.

9. The plugging device conveying device according to claim 1, characterized in that, The tube wall of the sheath includes a second inner layer, a second intermediate layer and a second outer layer. The second intermediate layer has a second developing area and a second supporting area sequentially formed from the distal end of the delivery sheath to the proximal end of the delivery sheath. The second developing area includes a second developing ring arranged around the outer periphery of the second inner layer. The second supporting area includes a second mesh woven structure sleeved on the outside of the second inner layer.

10. The plugging device conveying device according to claim 9, characterized in that, The second developing ring has at least one break extending axially along the sheath itself in the circumferential direction.

11. The plugging device conveying device according to claim 9, characterized in that, A second flexible area is also provided between the second developing area and the second supporting area, the second flexible area including a first elastic coil wound around the outside of the second inner layer.

12. The plugging device conveying device according to claim 9, characterized in that, The distal end of the sheath body has a retrieval section, which is located on the side of the second imaging ring opposite to the second mesh structure on the axis of the sheath body itself. The retrieval section includes an opening for the occluder to enter and exit.

13. The plugging device delivery device according to claim 12, characterized in that, The recovery section includes a plurality of arc-shaped lobes spaced apart along the circumference of the sheath body. The top edges of the plurality of arc-shaped lobes enclose an opening perpendicular to the axial direction of the sheath body itself. A groove is formed between two adjacent arc-shaped lobes, and the groove extends from the opening along the axial direction of the sheath body itself to the second imaging ring.

14. The plugging device delivery device according to claim 13, characterized in that, The opening is inclined, and the edge of the opening forms a curved surface that is inclined toward the second developing ring. The recovery part is formed with an inclined spoon.

15. The plugging device delivery device according to claim 1, characterized in that, The occluder delivery device further includes a pusher, the pusher comprising: An operating handle is located at the proximal end of the delivery sheath; Connector, used for fixed connection with the plugging device; A push rod is disposed between the operating handle and the connector. One end of the push rod is connected to the operating handle, and the other end of the push rod is connected to the connector. A marking area is provided on the part of the push rod near the operating handle. The marking area includes multiple marking elements. Each marking element can move back and forth in the marking area along the axial direction of the push rod to mark the position of different parts of the occluder.

16. The plugging device delivery device according to claim 15, characterized in that, The push rod is a steel cable rod. The marking element is an elastic collar, or the marking element is a metal collar with internal threads formed on its inner circumference.

17. The plugging device delivery device according to claim 16, characterized in that, Each of the marking elements has a different marking feature to mark different parts of the occluder. The marking feature is selected from at least one of the outer contour shape, surface marking number and color.

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