Sealing system
By designing an adjustable-length occlusion system, the problem of insufficient adaptability of existing patent foramen ovale occluders has been solved, achieving better occlusion effect and safety, and making it suitable for minimally invasive treatment of various cardiac defects.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- HANGZHOU NUOMAO MEDTECH CO LTD
- Filing Date
- 2022-04-29
- Publication Date
- 2026-06-12
Smart Images

Figure CN116407197B_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of medical device technology, and in particular to a sealing system. Background Technology
[0002] The foramen ovale usually closes within the first year of life. If the foramen ovale remains open in children older than 3 years, it is called patent foramen ovale (PFO). (20%–25% of adults have incompletely closed foramen ovale.) PFO refers to a condition where the primary and secondary septa in the foramen ovale do not fuse completely, leaving a permanent slit-like defect that leads to atrial shunt.
[0003] With advancements in technology, especially in cardiac catheterization, transcatheter occlusion devices have become an important method for minimally invasive treatment of congenital heart diseases such as patent foramen ovale (PFO), atrial septal defect (ASD), ventricular septal defect (VSD), and patent ductus arteriosus (PDA). Transcatheter occlusion devices are commonly used medical devices in transcatheter interventional treatments. Because PFO and ASD differ anatomically, necessary improvements are needed to the PFO occlusion device, building upon the ASD occlusion device. Existing PFO occlusion devices consist of a double-disc occlusion surface and a cylindrical slender waist perpendicular to the double-disc occlusion surface. The cylindrical slender waist compresses and deforms the primary and secondary septa, and the double-disc occlusion surface clamps and fixes the deformed defect to block blood flow.
[0004] However, existing patent foramen ovale (PFO) occluders are only suitable for treating PFOs with a short overlap between the primary and secondary septa. For PFOs with a longer overlap, the fixed distance between the two occluding surfaces of traditional occluders makes it impossible to adjust the distance of the waist according to the structure of the foramen ovale, thus making it difficult for the occluder to conform to the anatomical structure of the foramen ovale. Consequently, it is difficult to achieve the desired occlusion effect. After treatment, a large residual shunt is likely to form between the primary and secondary septa. When blood flows through the foramen ovale, it will cause changes in blood flow velocity, which can induce thrombosis. Therefore, patients need to prolong the anticoagulation treatment time. If the thrombus forms and enters the blood circulation, it can also cause serious adverse events such as embolism. Summary of the Invention
[0005] The purpose of this invention is to provide a sealing system that can adjust the waist distance to solve the problems in the prior art.
[0006] To solve the above-mentioned technical problems, the present invention adopts the following technical solution:
[0007] A containment system, comprising:
[0008] An occlusion device for sealing defects in a vascular system; the occlusion device includes two occlusion discs and a tightening line for inserting into the defect, the tightening line connecting the two occlusion discs, and the length of the tightening line between the two occlusion discs is adjustable;
[0009] A conveying device for conveying the sealing device; the conveying device includes a housing and an adjusting mechanism; the housing has a receiving space.
[0010] The adjustment mechanism includes a slider located within the receiving space. The slider is used to connect with the tightening line. The slider can move within the receiving space to drive the tightening line to move axially, thereby adjusting the length of the tightening line between the two sealing discs.
[0011] As can be seen from the above technical solution, the present invention has at least the following advantages and positive effects:
[0012] The occlusion system of this invention includes an occlusion device and a delivery device, which delivers the occlusion device into the human body. The occlusion device includes two occlusion discs and a tightening line. The delivery device includes a housing and an adjustment mechanism, which includes a sliding member. The tightening line of the occlusion device is connected to the sliding member and can move axially with the sliding member, thereby adjusting the length of the tightening line between the two occlusion discs to control the distance between them. This allows the occlusion system to adjust the lumbar distance according to the defect, thus adapting to the patient's anatomy and improving the fit between the two occlusion discs and the surrounding tissues, thereby stably occluding the defect. Attached Figure Description
[0013] Figure 1 This is a schematic diagram of the sealing system in this invention.
[0014] Figure 2 This is a front view of the sealing system in this invention.
[0015] Figure 3 This is a schematic diagram of the sealing device in this invention.
[0016] Figure 4 This is a schematic diagram of the tightening line in this invention.
[0017] Figure 5 This is a partial structural schematic diagram of the conveying device in this invention.
[0018] Figure 6 yes Figure 5 First-direction view of the conveyor device.
[0019] Figure 7 yes Figure 5 Second-direction view of the conveyor device.
[0020] Figure 8 yes Figure 5 Exploded view of the conveyor system.
[0021] Figure 9 This is an exploded view of the outer casing of the present invention.
[0022] Figure 10 This is a schematic diagram of the nozzle structure in this invention.
[0023] Figure 11 This is a structural schematic diagram of the fastener in this invention.
[0024] Figure 12 This is a partial structural diagram of the fixing member and push rod disposed inside the outer shell in this invention.
[0025] Figure 13 This is a schematic diagram of the push rod in this invention, wherein the head end is separated from the rod body.
[0026] Figure 14 This is a schematic diagram of the push rod in this invention, wherein the head end is connected to the rod body.
[0027] Figure 15A This is an exploded view of the adjustment mechanism in this invention.
[0028] Figure 15B yes Figure 15A A three-dimensional structural diagram of the sliding component in the adjustment mechanism at one angle.
[0029] Figure 15C yes Figure 15A A three-dimensional structural diagram of the sliding component in the adjustment mechanism from another angle.
[0030] Figure 15D yes Figure 15A A three-dimensional structural diagram of the positioning frame at one angle in the adjustment mechanism.
[0031] Figure 16 This is a partial schematic diagram of the adjustment mechanism in this invention.
[0032] Figure 17 This is an exploded view of the knot-releasing mechanism in this invention.
[0033] Figure 18 This is a partial assembly schematic diagram of the knot-releasing mechanism in this invention.
[0034] Figure 19 This is a partial structural diagram of the traction tube and the distal end of the push rod in the sealing system of this invention.
[0035] Figure 20 This is an exploded view of the locking mechanism in this invention.
[0036] Figure 21This is a partial structural diagram of the locking mechanism located inside the outer shell in this invention.
[0037] Figure 22 This is a partial structural diagram of the indicator block located inside the outer casing in this invention.
[0038] Figure 23 This is a schematic diagram of the slider in this invention.
[0039] Figure 24 This is a schematic diagram of the slide rail structure in this invention.
[0040] Figure 25 This is a schematic diagram of the structure of the indicator block in this invention.
[0041] Figure 26 This is a side view of the positioning cylinder in this invention.
[0042] Figure 27A This is a three-dimensional structural diagram of the tangent mechanism in this invention at one angle.
[0043] Figure 27B yes Figure 27A A three-dimensional structural diagram of the tangent mechanism from another angle.
[0044] Figure 28 This is an exploded view of the tangent mechanism in this invention.
[0045] Figure 29A yes Figure 28 A three-dimensional structural diagram of the central frame at one angle.
[0046] Figure 29B yes Figure 28 A three-dimensional structural diagram of the central frame from another angle.
[0047] Figure 29C yes Figure 28 A three-dimensional structural diagram of the central frame from another angle.
[0048] Figure 29D yes Figure 28 A three-dimensional structural diagram of the mid-base frame.
[0049] Figure 30 This is a cross-sectional view of the protective component in the present invention in the closed state.
[0050] Figure 31 This is a cross-sectional view of the protective component in the open state in this invention.
[0051] The annotations in the attached figures are explained as follows:
[0052] 1. Sealing device; 111. First sealing disc; 112. Second sealing disc; 116. Connector; 12. Tightening line; 121. Knot; 122. Connecting section; 123. Locking section; 124. Adjusting section; 13. Fixing line;
[0053] 2. Conveying device; 21. Outer shell; 211. Lower shell; 212. Upper cover; 213. Nozzle; 2131. Slot; 214. Locking strip; 215. Blocking component; 216. Stop component; 217. Limiting component; 2171. Step structure; 218. Abutting component;
[0054] 221. Fixing component; 2211. Limiting groove; 222. Push rod; 2221. Rod body; 2222. Head end; 2223. Head; 2224. Extension;
[0055] 23. Adjustment mechanism; 2311. Semi-slide rail component; 2312. First rack; 232. Sliding component; 2321. Connecting part; 2322. Transition part; 2323. Bending part; 2324. Pressing part; 2325. Second rack; 2326. Connecting hole; 233. Elastic component; 234. Positioning frame; 235. Adjustment button;
[0056] 2411. Semi-access component; 2412. Third rack; 242. Moving component; 2425. Fourth rack; 243. Telescopic component; 244. Positioning frame; 245. Knot release button; 246. Pulling tube; 2461. Protrusion;
[0057] 251. Rotating cylinder; 2511. Limiting ring; 2512. First thread; 2513. Second thread; 252. Slide rail; 2521. Limiting part; 2522. Opening; 2531. Proximal retaining ring; 2532. Distal retaining ring; 2533. Extension; 2534. Notch; 254. Slider; 2541. Engaging part; 2542. Connecting part; 2543. Positioning block; 2546. Sliding surface; 255. Indicator block; 2551. Fourth thread; 2552. Slot; 2556. Slide groove; 256. Positioning cylinder; 2561. Insert block; 2566. Guide rail; 257. Knob;
[0058] 26. Wire cutting mechanism; 261. Base frame; 2611. Base plate; 2612. Receiving plate; 2613. Support plate; 2614. Track; 2615. Insert post; 2616. Fixing block; 262. Base frame; 2621. Base plate; 2622. Support leg; 2623. Connecting plate; 2624. Winding part; 263. Wire cutting assembly; 2631. Wire cutting button; 2632. Wire cutting component; 2633. Positioning post; 2634. Return component; 264. Protection assembly; 2641. Protection button; 2642. Protection plate; 2643. Positioning hole; 2644. Through groove; 2646. Avoidance groove; 2647. Bending structure; 268. Channel; 269. Through cavity. Detailed Implementation
[0059] Typical embodiments embodying the features and advantages of the present invention will be described in detail in the following description. It should be understood that the present invention can have various variations in different embodiments without departing from the scope of the present invention, and the descriptions and illustrations herein are for illustrative purposes only and not intended to limit the present invention.
[0060] This invention provides a closure system for treating defects in the vascular system. These defects include, but are not limited to, foramen ovale, ductus arteriosus, atrial septal defect, and ventricular septal defect. This application uses the foramen ovale as an example to illustrate the advantages of the closure system in treating patent foramen ovale. It is understood that the defect can also be any of the other defects mentioned above.
[0061] In describing the orientation, this invention uses the operator of the blocking system as a reference, with the end closer to the operator being the proximal end and the opposite end being the distal end.
[0062] See Figure 1 and Figure 2 The occlusion system includes an occlusion device 1 for occluding defects in the vascular system and a delivery device 2 for delivering the occlusion device 1.
[0063] See Figure 3 The sealing device 1 includes two sealing discs and a tightening line 12. The distance between the two sealing discs can be adjusted by the tightening line 12, so that the two sealing discs can fit better with the tissue around the defect.
[0064] Specifically, the two sealing discs are used to cover the different openings of the foramen ovale, namely the two openings of the foramen ovale located in the left and right atria.
[0065] The two occlusion discs are a first occlusion disc 111 and a second occlusion disc 112. In this embodiment, during use, the first occlusion disc 111 is delivered to the left atrium and unfolds there, while the second occlusion disc 112 is delivered to the right atrium and unfolds there. That is, the first occlusion disc 111 is located at the distal end of the second occlusion disc 112, and the second occlusion disc 112 is located at the proximal end of the first occlusion disc 111.
[0066] In this embodiment, both the first sealing disc 111 and the second sealing disc 112 include a support frame and a membrane disposed on the support frame. The membrane disposed on both sealing discs facilitates immediate sealing of the orifice oval.
[0067] A connector 116 is provided at the geometric center of the support frame. The support frame can be an open-loop or closed-loop metal structure made by weaving or cutting metal materials. The support frame can be made of metal materials or biodegradable materials, such as non-degradable nickel-titanium alloys, biodegradable magnesium alloys, iron alloys, zinc alloys, or biodegradable polymer materials. A coating material covers the proximal or distal side of the support frame and can be made of non-degradable or biodegradable materials, such as polylactic acid, polycaprolactone, or polylactic acid-caprolactone copolymer. In an alternative embodiment, at least one of the first sealing disc 111 and the second sealing disc 112 may not be covered with a coating.
[0068] The tightening line 12 is used to pass through the oval aperture and connect the two sealing discs. The length of the tightening line 12 between the two sealing discs can be adjusted through the free end of the tightening line 12.
[0069] The tightening suture 12 can be a non-absorbable biocompatible suture, such as metal thread, cotton thread, polyester, polypropylene, etc. The tightening suture 12 can also be an absorbable biocompatible suture, such as catgut, polyglycolic acid, multifilament non-biodegradable suture, etc. The tightening suture 12 can also be a forced-wrap fiber suture, etc.
[0070] See Figure 4 The tightening line 12 is formed by winding and knotting one or more lines. For clarity, at the intersection of the lines in the figure, the line on the front side is represented by a continuous solid line, and the line on the back side is represented by a broken line at the intersection. The tightening line 12 includes a knot 121, a connecting section 122 connected to the knot 121, and a locking section 123 and an adjusting section 124 connected to the knot 121. The knot 121 is located near the second sealing plate 112; the connecting section 122 is connected to the distal end of the knot 121, connecting between the first sealing plate 111 and the second sealing plate 112; the locking section 123 and the adjusting section 124 are connected to the proximal end of the knot 121.
[0071] Specifically, the connecting segment 122 is connected between the first sealing disc 111 and the second sealing disc 112. Preferably, the connecting segment 122 is connected to the geometric center of the first sealing disc 111, and / or the connecting segment 122 is connected to the geometric center of the second sealing disc 112.
[0072] The locking section 123 includes a free end, and the adjusting section 124 includes a free end. The locking section 123, the adjusting section 124, and the knot 121 are all located on the side of the second sealing plate 112 away from the first sealing plate 111, that is, on the side of the second sealing plate 112 facing the conveying device 2. One end of the adjusting section 124 is connected to one end of the connecting section 122 through the knot 121. When the knot is not locked, the length of the connecting section 122 can be adjusted by the adjusting section 124. The free ends of the locking section 123 and the adjustment section 124 are connected to the conveying device 2. By controlling the conveying device 2 to pull the other end (free end) of the adjustment section 124, the length of the connecting section 122 between the first sealing disc 111 and the second sealing disc 112 is adjusted, thereby adjusting the distance between the two sealing discs. After the distance between the two sealing discs is adjusted, the free end of the locking section 123 is pulled by the conveying device 2 to lock the knot 121. As a result, the knot 121 tightens the end of the adjustment section 124 near the knot 121, and the conveying device 2 cannot adjust the length of the connecting section 122 by pulling the end of the adjustment section 124, thereby fixing the distance between the first sealing disc 111 and the second sealing disc 112.
[0073] Locking section 123 and adjusting section 124 are respectively connected to one end of connecting section 122, and knot 121 is located between connecting section 122 and locking section 123. Connecting section 122 is an adjusting loop formed by tightening line 12 in an inverted U shape. Both ends of connecting section 122 pass through the second sealing plate 112 and connecting knot 121. The part of adjusting loop away from knot 121 is slidably inserted into the first sealing plate 111.
[0074] On the first sealing disc 111 and the second sealing disc 112, the adjusting section 124 passes through the geometric center of the first sealing disc 111 and the second sealing disc 112, that is, the connecting piece 116 connecting the first sealing disc 111 and passing through the connecting piece 116 (which is tubular) of the second sealing disc 112. This facilitates the application of tension to the geometric center of the sealing disc when the tightening line 12 is pulled, resulting in uniform force distribution on the sealing disc and convenient operation. Figure 3As shown, one end of the connecting segment 122 that connects to the locking segment 123 does not pass through the connector 116 located at the geometric center of the second sealing disc 112, but rather passes through the surface of the second sealing disc 112, such as through the membrane on the second sealing disc 112 and the mesh formed between the support frame on the second sealing disc 112. This facilitates the formation of the knot 121 on the proximal side of the second sealing disc 112, preventing the knot 121 from sliding between the proximal and distal ends, which would be detrimental to control. It is understood that in some embodiments, one end of the connecting segment 122 that connects to the knot 121 passes through the connector located at the geometric center of the second sealing disc, and a physical gap is formed between the locking segment 123 and the adjusting segment 124 in the connector.
[0075] The connecting segment 122 between the first occlusion disc 111 and the second occlusion disc 112 is flexible and its length is adjustable. The connecting segment 122 passes through the foramen ovale. Pulling the adjusting segment 124 proximally shortens the connecting segment 122, that is, the distance between the first occlusion disc 111 and the second occlusion disc 112 gradually decreases. The primary diaphragm and the secondary diaphragm move closer to each other and are clamped by the first occlusion disc 111 and the second occlusion disc 112. The first occlusion disc 111 covers the primary diaphragm and the secondary diaphragm around the foramen ovale, and the second occlusion disc 112 covers the primary diaphragm and the secondary diaphragm around the foramen ovale. That is, the two openings of the foramen ovale in the left and right atria are covered and clamped by the first occlusion disc 111 and the second occlusion disc 112, respectively.
[0076] Since both the adjusting section 124 and the locking section 123 are movable lines connected to the sealing disc, operating the adjusting section 124 and the locking section 123 individually will cause the sealing disc to move, resulting in poor operability. Therefore, the sealing device 1 also includes a fixing line 13 for connecting the conveying device 2. The conveying device 2 fixes one of the two sealing discs to the far end of the conveying device 2 via the fixing line 13.
[0077] Specifically, a fixing line 13 is connected to the second sealing disc 112. The fixing line 13 is used to fix the second sealing disc 112 to the far end of the conveying device 2. Under the tension and fixation of the fixing line 13, the proximal side of the second sealing disc 112 abuts against the far end of the conveying device 2, thereby preventing the two sealing discs from shaking simultaneously when the adjusting section 124 and the locking section 123 are pulled. This allows for adjustment of the length of the connecting section 122 and locking of the adjusting section 124 by the knot 121. (See reference...) Figure 1 In this embodiment, one end of the fixing line 13 is connected to the second sealing plate 112, specifically to the connector of the second sealing plate 112, and the other end of the fixing line 13 is fixed to the conveying device 2.
[0078] In this embodiment, after the occlusion device 1 is implanted into the human body, the two occlusion discs respectively cover the area around the openings on opposite sides of the foramen ovale. That is, the tissue surrounding the foramen ovale is covered by the two occlusion discs. By adjusting the length of the connecting segment 122 between the two occlusion discs, the distance between the two occlusion discs is controlled, thereby adapting to the patient's anatomical structure and improving the fit between the two occlusion discs and the tissue surrounding the foramen ovale, thus stably occluding the foramen ovale. After implantation of the occlusion device 1, the deformation of the two diaphragms at the foramen ovale is minimized, without affecting the endothelialization of the two diaphragms towards the occlusion discs, reducing the generation of residual shunts. This avoids the trouble of needing to customize the occlusion device 1 due to the unique foramen ovale structure of individual patients, effectively expanding the applicability of the PFO occlusion device 1 and enabling more patients to benefit from minimally invasive surgery.
[0079] In embodiments where the defect has more than two openings, the sealing device 1 is also used to seal multiple openings in the defect from both sides.
[0080] The conveying device 2 is used to convey the sealing device 1 to the defect and adjust the distance between the two sealing discs of the sealing device 1.
[0081] See Figures 5-8 The conveying device 2 includes a housing 21, a pushing mechanism, an adjusting mechanism 23, a locking mechanism, a releasing mechanism, and a tangent mechanism 26. The housing 21 is hollow and has a receiving space. The pushing mechanism is connected between the sealing device 1 and the housing 21 and is used to convey the sealing device 1 to the defect. The adjusting mechanism 23, the locking mechanism, the releasing mechanism, and the tangent mechanism 26 are at least partially disposed in the receiving space. The operator operates the adjusting mechanism 23, the releasing mechanism, the locking mechanism, and the tangent mechanism 26 on the surface of the housing 21, thereby adjusting the distance between the two sealing discs by adjusting the length of the connecting section 122 between the two sealing discs of the sealing device 1 through the adjusting mechanism 23; releasing the knot 121 by pushing out the pre-fitted knot through the releasing mechanism; locking the knot 121 by moving the locking section 123 of the sealing device 1 to the proximal end through the locking mechanism; and cutting the fixing line 13, the locking section 123, and the adjusting section 124 through the tangent mechanism 26. The aforementioned mechanisms work together to deliver and release the occlusion device 1, enabling it to better adapt to the patient's anatomical structure, improve the fit between the two occlusion discs and the tissues surrounding the defect, thereby stably sealing the defect and improving the treatment effect.
[0082] Further, see Figure 9 The outer casing 21 is hollow inside and has an accommodating space. Specifically, the outer casing 21 includes a lower casing 211, an upper cover 212, and a nozzle 213. The lower casing 211, the upper cover 212, and the nozzle 213 are all connected in a detachable manner, such as by snap-fit or screw-fit.
[0083] The lower shell 211 and the upper cover 212 are connected to form a cylindrical body with a roughly circular cross-section. Both ends of the cylindrical body have openings, and the interior of the cylindrical body is hollow to form a receiving space.
[0084] A nozzle 213 is located at the distal end of the lower shell 211 and the upper cover 212. The nozzle 213 is cylindrical with openings at both ends, and its diameter gradually increases from the distal end to the proximal end. A groove 2131 is provided on the outer periphery of the nozzle 213 for engaging with the distal end of the lower shell 211 and the distal end of the upper cover 212.
[0085] See Figure 10 The slot 2131 extends in an arc shape in the circumferential direction, and the central angle is less than 360 degrees. After the far ends of the lower shell 211 and the upper cover 212 are respectively engaged in the slot 2131, it can not only restrict the circumferential rotation of the nozzle 213 relative to the lower shell 211 and the upper cover 212, but also restrict the axial movement of the nozzle 213 relative to the lower shell 211 and the upper cover 212.
[0086] The top cover 212 has multiple openings for mounting operation buttons. When the operator operates the operation buttons, the operation buttons are usually facing upwards. Therefore, when describing the orientation, the horizontal extension of the axis of the outer casing 21 is used as a reference, with the side facing the ground being downwards and the opposite being upwards.
[0087] Multiple snap-fit elements are spaced apart along the axial direction on the inner wall of the outer casing 21. Each snap-fit element is annular, or more specifically, partially annular, and is formed by extending radially from the inner wall of the outer casing 21 toward the axis of the outer casing 21.
[0088] A pushing mechanism is located at the distal end of the housing 21 and is used to push the occlusion device 1 to the lesion. Specifically, the pushing mechanism includes a fixing member 221, a push rod 222, a loader, and a delivery sheath. The fixing member 221 is connected to the distal end of the housing 21 and is used to fix the push rod 222 to the distal end of the housing 21. The push rod 222 is located at the distal end of the housing 21, specifically extending from the distal opening of the nozzle 213 of the housing 21 and extending axially distally, for the passage of the tightening wire 12 of the occlusion device 1. The loader and the delivery sheath are located around the push rod 222 and are used to deliver the occlusion device 1.
[0089] Please see Figures 11 to 14 The fastener 221 is snapped onto the far end of the housing 21. The fastener 221 is cylindrical and hollow inside, for the push rod 222 to pass through. In some embodiments, the fastener 221 is fixed in the receiving space inside the housing. In alternative embodiments, the connection method between the fastener 221 and the housing 21 is not limited, such as screw connection, snap connection, interference fit, etc.
[0090] A limiting groove 2211 is provided on the outer periphery of the fastener 221, and the limiting groove 2211 extends along the axial direction of the fastener 221.
[0091] The retainer 221 is circumferentially limited by the housing 21. When the retainer 221 is disposed within the receiving space of the housing 21, the retainer 221 is located near the proximal end of the nozzle 213, and the hollow interior of the retainer 221 communicates with the interior of the nozzle 213. (See reference...) Figure 12 A retaining strip 214 is provided radially inside the outer casing 21, and the retaining strip 214 extends axially. The retaining strip 214 is engaged in the limiting groove 2211 to restrict the fixing member 221 from rotating circumferentially around the outer casing 21.
[0092] The fixing member 221 is axially limited by the outer shell 21. The outer periphery of the fixing member 221 and the inner shell 21 are provided with interlocking structures, so that the fixing member 221 is interlocked with the outer shell 21, thereby restricting the axial movement of the fixing member 221 along the outer shell 21.
[0093] The push rod 222 is disposed at the distal end of the fixing member 221 and extends along the axial direction of the housing 21. Specifically, the proximal end of the push rod 222 is inserted into the nozzle 213 and the fixing member 221. In some embodiments, the push rod 222 and the fixing member 221 are fixed by adhesive bonding.
[0094] See Figure 13 The push rod 222 has an axially extending cavity inside, through which the adjusting section 124 and the locking section 123 both extend proximally. Preferably, the fixing line 13 also extends proximally through the cavity. In some embodiments, the push rod 222 has one cavity through which the adjusting section 124, locking section 123, and fixing line 13 all extend proximally. In some embodiments, there are two cavities, with two of the adjusting section 124, locking section 123, and fixing line 13 sharing one cavity, and the other line occupying a separate cavity.
[0095] In this embodiment, the push rod 222 forms three independent cavities along the axial direction: a first cavity, a second cavity, and a third cavity. Each of the adjusting section 124, the locking section 123, and the fixing line 13 occupies a separate cavity. Specifically, the adjusting section 124 passes through the first cavity, the locking section 123 passes through the second cavity, and the fixing line 13 passes through the third cavity. By placing the adjusting section 124, the locking section 123, and the fixing line 13 in independent cavities, it is ensured that the movement of the three sections does not interfere with each other.
[0096] Furthermore, such as Figures 13 to 14 As shown, the push rod 222 includes a cylindrical rod body 2221 and a head end 2222 disposed at the distal end of the rod body 2221. Both the rod body 2221 and the head end 2222 are used to deliver the device into the human body and are withdrawn after the occlusion device 1 is implanted.
[0097] Corresponding to the three cavities mentioned above, the rod body 2221 has three independent through holes, each extending along the axial direction of the rod body 2221. The three through holes are designated as a first through hole 2221a, a second through hole 2221b, and a third through hole 2221c. The diameters of both the second through hole 2221b and the third through hole 2221c are smaller than the diameter of the knot 121, preventing the knot 121 from entering either hole and ensuring that the knot 121 is located at the distal end of the rod body 2221. Specifically, in this embodiment, the diameter of the first through hole 2221a is larger than the diameter of the second through hole 2221b, and the diameter of the second through hole 2221b is equal to the diameter of the third through hole 2221c. It is understood that the diameters of the second through hole 2221b and the third through hole 2221c may not be equal.
[0098] The head end 2222 includes a head 2223 and an extension 2224 located near the proximal end of the head 2223. The head end 2222 is engaged with the rod body 2221. Specifically, the outer diameter of the extension 2224 is adapted to the inner diameter of the first through hole 2221a, so that the extension 2224 is engaged with the distal end of the rod body 2221. Both the head 2223 and the extension 2224 are cylindrical, and the outer diameter of the head 2223 is larger than the outer diameter of the extension 2224.
[0099] The head end 2222 has three independent through holes, each extending axially along the head end 2222. The three through holes are a first through hole 2222a, a second through hole 2222b, and a third through hole 2222c. The first through hole 2222a penetrates the head end 2223 and the extension 2224. The diameter of the first through hole 2222a is smaller than the diameter of the first through hole 2221a. Specifically, in this embodiment, the diameter of the first through hole 2222a is larger than the diameter of the second through hole 2222b, and the diameter of the second through hole 2222b is equal to the diameter of the third through hole 2222c. It is understood that the diameters of the second through hole 2222b and the third through hole 2222c may not be equal.
[0100] The first through hole 2221a and the first through hole 2222a are connected, the second through hole 2221b and the second through hole 2222b are connected, and the third through hole 2221c and the third through hole 2222c are connected. Specifically, the first cavity of the push rod 222 is composed of the connected first through hole 2221a and the first through hole 2222a, the second cavity is composed of the connected second through hole 2221b and the second through hole 2222b, and the third cavity is composed of the connected third through hole 2221c and the third through hole 2222c.
[0101] The loader is located at the distal end of push rod 222, and the delivery sheath is located at the distal end of the loader. The structure of the loader and the delivery sheath adopts the structure in related technologies, which will not be described in detail here.
[0102] The delivery sheath of the pushing mechanism delivers the occlusion device 1 to the lesion, and the push rod 222 provides a cavity through which the adjustment section 124, locking section 123 and fixing wire 13 of the occlusion device pass.
[0103] See Figure 15A , Figure 15B , Figure 15C , Figure 15D and Figure 16 The adjusting mechanism 23 is used to connect the adjusting section 124 to adjust the length of the connecting section 122 located between the two sealing discs, thereby adjusting the distance between the two sealing discs. The adjusting mechanism 23 includes a slider 232 located within the receiving space. The slider 232 is connected to the tightening line 12. The slider 232 can move within the receiving space to drive the tightening line 12 to move axially, thereby adjusting the length of the tightening line 12 between the two sealing discs. In some embodiments, one end of the slider 232 is exposed on the surface of the housing 21, and the operator can adjust the length of the connecting section 122 by controlling the slider 232 to move axially towards the distal or proximal end.
[0104] In this embodiment, the adjustment mechanism 23 includes a slide rail, a sliding member 232, an elastic member 233, a positioning frame 234, and an adjustment button 235. In some embodiments, the sliding member 232 is exposed on the surface of the housing 21, thus eliminating the need for the adjustment button 235. The slide rail and the sliding member 232 slide together. The adjustment button 235 moves the sliding member 232, which is connected to the tightening line 12, thereby moving the tightening line 12 and adjusting the length of the adjustment section 124 between the two sealing discs.
[0105] The slide rail is disposed within the receiving space of the housing 21. Specifically, the slide rail engages with the snap-fit member inside the housing 21, thereby fixing the slide rail within the receiving space.
[0106] The slide rail has a through hole extending from its top to its bottom, and the through hole extends axially along the housing 21. This through hole constitutes the slide rail of the slide rail. In this embodiment, the slide rail extends through the top and bottom of the slide rail. In an alternative embodiment, the slide rail extends through any two surfaces of the slide rail, such as the top surface and a side wall of the slide rail. The slider 232 extends along the slide rail from the top of the slide rail for operator control, and the slider 232 extends along the slide rail from the side wall of the slide rail to connect to the adjustment section 124.
[0107] In this embodiment, the slide is box-shaped with internal space.
[0108] In this embodiment, the slide rail component includes two slide rail halves 2311, which are detachably connected, for example, by snap-fit or screw-fit. The length of each slide rail half 2311 extends axially, and a slide rail is formed between the two slide rail halves 2311. In some embodiments, the two slide rail halves 2311 are arranged in a mirror-symmetrical manner, such that the slide rail extends along the length direction of the half slide rail half 2311, and the slide rail is located at the middle of the width direction of the slide rail component.
[0109] Each semi-slide component 2311 is provided with a first rack 2312, that is, the slide component has two first racks 2312. Each first rack 2312 extends axially.
[0110] In this embodiment, the first rack 2312 is located inside the semi-slide member 2311, with the serrated surface facing the bottom of the semi-slide member 2311.
[0111] The sliding member 232 slides in conjunction with the slide rail and can move axially. Specifically, the sliding member 232 slides in conjunction with the slide rail, and the bottom of the sliding member 232 extends from the bottom of the slide rail and connects to the tightening line 12, thereby driving the tightening line 12 to move axially and adjusting the length of the tightening line 12 between the two sealing discs. Specifically, the sliding member 232 includes a connecting part 2321, a transition part 2322, and a pressing part 2324. In this example, the sliding member 232 is integrally formed.
[0112] The connecting portion 2321 stands upright within the slide rail. The bottom of the connecting portion 2321 extends out of the slide rail to connect to the tightening line 12; that is, the bottom of the connecting portion 2321 extends downward beyond the slide rail, and a connecting hole 2326 extending axially along the outer casing 21 is provided on the downwardly extending portion, i.e., the connecting hole 2326 is located below the slide rail. This connecting hole 2326 is used for the adjustment section 124 of the tightening line 12 to pass through, be wound around, or be fixed. It is understood that the connecting hole 2326 can also be a columnar, hook-shaped, or other structure for connecting the adjustment section 124.
[0113] The transition portion 2322 is disposed at the top of the connecting portion 2321, that is, the connecting portion 2321 is connected to the bottom of the transition portion 2322.
[0114] In this embodiment, the extension direction of the transition portion 2322 is different from that of the connecting portion 2321. Specifically, in this embodiment, the transition portion 2322 is perpendicular to the connecting portion 2321, that is, the transition portion 2322 extends in a horizontal direction. In this embodiment, the dimensions of the transition portion 2322 are larger than those of the connecting portion 2321 both along the axial direction and along the width direction perpendicular to the axial direction. Figure 15B and Figure 15CAs shown, in the width direction, one side of the transition portion 2322 is flush with the connecting portion 2321, and the other side protrudes from the connecting portion 2321; in the axial direction, both ends of the transition portion 2322 protrude from the connecting portion 2321, wherein each end is connected between the one side and the other side.
[0115] The top surface of the transition portion 2322 is provided with a second rack 2325, which meshes with the first rack 2312, and the bottom surface of the transition portion 2322 is used to abut against the elastic member 233.
[0116] The pressing part 2324 is connected to the top of the transition part 2322 and is used to extend the slide piece for pressing.
[0117] In this embodiment, the pressing part 2324 is located above the connecting part 2321 and both extend vertically.
[0118] The elastic element 233 is disposed between the sliding element 232 and the positioning frame 234, and can extend and retract radially along the outer shell 21, causing the second rack 2325 to move radially closer to or further away from the first rack 2312, thereby engaging or disengaging the second rack 2325 with the first rack 2312. Specifically, the elastic element 233 has elasticity, and its two ends abut against the bottom of the transition portion 2322 and the positioning frame 234, respectively. In this embodiment, the elastic element 233 includes two springs.
[0119] When the elastic element 233 is in its natural state, the first rack 2312 and the second rack 2325 are engaged, and the sliding element 232 cannot move relative to the slide rail. When the elastic element 233 is in a compressed state in the radial direction of the housing 21, the first rack 2312 and the second rack 2325 are disengaged, and the sliding element 232 can move axially relative to the slide rail.
[0120] like Figure 15A and Figure 15DAs shown, the positioning frame 234 is disposed within the slide rail and at the bottom of the sliding member 232, for following the sliding member 232 in axial movement and positioning the elastic member 233. Specifically, the positioning frame 234 has an open top and an internal positioning space. The positioning frame 234 includes a base plate 2341, two side plates 2342, and two end plates 2343. The side plates 2342 are arranged opposite to each other, and the end plates 2343 are arranged opposite to each other. The side plates 2342 and the end plates 2343 are sequentially connected to form the side walls around the perimeter of the positioning frame 234. The base plate 2341 and the side walls enclose the positioning space. The two end plates 2343 are respectively connected to the proximal and distal ends of the base plate 2341, and the two side plates 2342 are connected between the two end plates 2343, that is, each side plate 2342 is connected between the two end plates 2343. In this embodiment, the base plate 2341 extends horizontally, and the radial height of the end plate 2343 is greater than the radial height of the side plate 2342, i.e., the radial height of the side plate 2342 is less than that of the end plate 2343. The transition portion 2322 extends from the top of the side plate 2342 out of the positioning space along one side of the connecting portion 2321, and the connecting portion 2321 is disposed outside the positioning frame 234. The axial length of the side plate 2342 is greater than or equal to the axial length of the transition portion 2322.
[0121] like Figure 16 As shown, in this embodiment, after the positioning frame 234 is installed, the elastic member 233 is located within the positioning space, and both ends of the elastic member 233 abut against the bottom of the base plate 2341 and the bottom of the transition portion 2322 of the positioning frame 234, respectively. The connecting portion 2321 is connected to one side of the transition portion 2322 and is located outside the positioning space, while part of the transition portion 2322 is located within the positioning space. The two end plates 2343 are respectively disposed on the near and far sides of the transition portion 2322. The two end plates 2343 have a higher radial height, and the near and far ends of the transition portion 2333 abut against the inner surface of one end plate 2343 of the positioning frame 234, respectively. Thus, when the sliding member 232 moves axially within the slide, it drives the positioning frame 234 to move together through the transition portion 2322.
[0122] like Figure 15A As shown, the adjustment button 235 is connected to the pressing part 2324 of the slider 232, which drives the pressing part 2324 and the slider 232 to move up and down in the radial direction and compress the elastic member 233 in the radial direction, while also driving the slider 232 to slide along the slide rail.
[0123] Specifically, the slide rail extends through the top of the housing 21, and the adjustment button 235 protrudes outward from the housing 21 along the slide rail. The sliding member 232 moves up and down by pressing with external force, and moves axially by driving with external force.
[0124] The adjustment principle of the adjustment mechanism 23 is as follows:
[0125] In its natural state, when the adjustment button 235 is not pressed by external force, the second rack 2325 of the slider 232 engages with the first rack 2312 of the slide rail, preventing the slider 232 from moving along the slide rail. The position of the adjustment button 235 is locked, thus preventing the slider 232 from moving axially due to misoperation. When the adjustment button 235 is pressed, the elastic element 233 is compressed radially, and the slider 232 moves inward toward the inside of the outer casing 21 within the slide rail. The second rack 2325 disengages from the first rack 2312, and the adjustment button 235 can drive the slider 232 to move axially. At this time, by using external force to drive the adjustment button 235 to move axially, the slider 232 is driven to move axially, thereby moving the tightening line 12 passing through the bottom of the slider 232, thereby adjusting the length of the connecting section 122 located between the two sealing discs, thus realizing the adjustment function.
[0126] Specifically, when the line knot is not locked, the adjusting section 124 moves with the sliding member 232 to adjust the length of the connecting section 122. When the sliding member 232 moves towards the proximal end, the length of the connecting section 122 decreases, and the two sealing discs of the sealing device 1 slowly move closer together, achieving the purpose of adjusting the distance between the two sealing discs. If it is found to be too tight, that is, the two sealing discs are too close together, push the adjusting button 235 towards the distal end, and at the same time pull the outer casing 21 towards the proximal end to widen the distance between the two sealing discs again, and then readjust.
[0127] like Figure 15B , Figure 15C as well as Figure 16 As shown, the slider 232 includes a bent portion 2323, which is stepped and connects the pressing portion 2324 and the transition portion 2322. Specifically, one end of the bent portion 2323 is connected to the middle region of the transition portion 2322.
[0128] Specifically, the bending portion 2323 includes a first bending portion 23231 connected to the pressing portion 2324, and a second bending portion 23232 connected to the transition portion 2322. The first bending portion 23231 and the second bending portion 23232 are interconnected and extend in different directions. Further, both the first bending portion 23231 and the second bending portion 23232 are flat, extending perpendicularly to each other. The first bending portion 23231 extends horizontally, and the second bending portion 23232 extends vertically. One side of the first bending portion 23231 is connected to the pressing portion 2324, and the other side is connected to the second bending portion 23232. The top of the second bending portion 23232 is connected to the first bending portion 23231, and the bottom of the second bending portion 23232 is connected to the central region of the top surface of the transition portion 2322. The bending section 23232 extends axially, and the top surface of the transition section 2322, which is connected to the bending section 23232, divides the transition section 2322 into two parts on both sides along the circumferential direction.
[0129] On the top surface of the transition portion 2322, second racks 2325 are provided on both sides of the bent portion 2323 (bent portion 23232), respectively engaging with the first racks 2312 of the two half slide rail components 2311. In some embodiments, on the top surface of the transition portion 2322, a second rack 2325 is provided on one side of the bent portion 2323 (bent portion 23232), and the other side surface is flat, with corresponding first racks 2312 engaged with the second racks 2325 on the half slide rail component 2311. When the pressing portion 2324 is not pressed radially inward, the bent portion 2323 can abut against the inner wall of the slide rail component under the abutment action of the elastic member 233, specifically against the bottom surface of the top wall, thereby stopping the sliding member 232 and preventing the sliding member from tilting and disengaging from the slide rail component. In addition, as Figure 16 As shown, the top surface of the bend 2323 can abut against the bottom surface of the top wall of the slide rail component, thereby the bend 2323 blocks the slide rail from the inside of the outer shell. That is, when looking into the slide rail from the outer shell 21, the top surface of the bend 2323 (specifically the bend 23231) can be seen, but the transition part 2322, the slide rail formed by the slide rail component, and other components inside the outer shell cannot be seen.
[0130] In some embodiments, the positioning frame 244 is omitted from the adjustment mechanism 23. That is, the adjustment mechanism 23 includes two semi-slide rails 2311, a sliding member 232, and an elastic member 233. The elastic member 233 elastically abuts against the transition portion 2322 of the sliding member 232 and the semi-slide rails 2311. Preferably, the relative position of the elastic member 233 and the transition portion 2322 is fixed. For example, the top end of the elastic member 233 is fixed to the transition portion 2322, and the bottom end of the elastic member 233 contacts the top surface of the bottom wall of the semi-slide rail 2311 and can slide on the bottom wall of the semi-slide rail 2311. In some embodiments, the elastic member 233 is a spring that passes through the periphery of the positioning post protruding from the bottom surface of the transition portion 2322. It is understood that in modified embodiments, the connection method between the elastic member 233 and the transition portion 2322 is not limited.
[0131] The knot-releasing mechanism is used to push out the knot 121 pre-fitted onto the knot-releasing mechanism, thereby detaching the knot 121 from the knot-releasing mechanism. In this embodiment, the knot-releasing mechanism is located at the distal end of the adjusting mechanism 23. (See also...) Figures 17 to 19 , Figure 17 and Figure 18The diagram shows a portion of the knot-releasing mechanism, which specifically includes a passage component, a movable component 242, a telescopic component 243, a positioning frame 244, a pulling tube 246, and a knot-releasing button 245. The knot 121 of the sealing device 1 is pre-fitted onto the distal end of the pulling tube 246. The movable component 242 slides in conjunction with the passage component, and the pulling tube 246 is connected to the movable component 242. The knot-releasing button 245 moves the movable component 242 and the pulling tube 246 towards the proximal end, thereby causing the knot 121 to detach from the pulling tube 246, thus achieving the knot-releasing function.
[0132] The passage component is disposed within the receiving space of the housing 21. Specifically, the passage component engages with the snap-fit component inside the housing 21, thereby fixing the passage component within the receiving space of the housing 21.
[0133] The structure of the passage component is the same as that of the slide component. That is, the structure of the two halves of the passage component 2411 and their interconnection can be referred to the structure of the half slide component 2311, which will not be described in detail here. Among them, the rack provided on the half passage component is the third rack 2412. The passage component has a passage, which is equivalent to the slide of the slide component, and the passage extends along the axial direction of the outer shell 21.
[0134] Both the passage component and the slide component of the adjustment mechanism 23 are disposed circumferentially on the outer shell 21, and both the passage and the slide extend axially. The difference between the passage component and the slide component of the adjustment mechanism 23 is that the passage component and the slide component are positioned differently on the outer shell 21. In this embodiment, the circumferential and axial positions of the passage component and the slide component on the outer shell 21 are different, so that the through direction of the passage component and the through direction of the slide component have an angle. Specifically, when the user holds the outer shell 21 with his right hand and the slide component is disposed at the top of the outer shell 21, the through direction of the slide is from the top to the bottom of the outer shell 21. The passage component is disposed on the left side wall of the outer shell 21. Viewed from the near side to the far side, the passage component is equivalent to the slide component after being rotated 90 degrees counterclockwise. The left side wall of the passage component is equivalent to the top wall of the slide component, so that the user can operate the release button 245 with his left hand. The through direction of the passage is from the left side wall to the right side wall of the outer shell. In fact, the through direction of both the slide and the passage is radial. In the modified embodiments, the positions of the passage component and the slide component differ in the circumferential direction or in the axial direction. It is understood that the various specific embodiments of the slide component described above can all be applied to the passage component, and will not be elaborated upon here.
[0135] In other embodiments, the relative positions of the passage component and the slide component along the circumference of the housing 21 can also be other relationships, such as the included angle between the passage component and the slide component in the circumference of the housing 21 being 60 degrees, 180 degrees or other arbitrary angles.
[0136] The movable member 242 slides along the passage and can move axially. Specifically, the movable member 242 includes a connecting part, a transition part, a bending part, and a pressing part. The specific structure of the movable member 242 is the same as that of the sliding member 232 of the adjusting mechanism 23, and can be referred to the description of the sliding member 232, which will not be repeated here. Among them, the rack provided on the transition part of the movable member 242 is a fourth rack 2425.
[0137] The traction tube 246 is fixedly connected to the movable component 242, allowing the traction tube 246 to move axially with the movable component 242. In this embodiment, the traction tube 246 is connected to the movable component 242 by adhesive bonding.
[0138] Specifically, the portion of the connecting part extending beyond the passage member has a connecting hole (similar to the connecting hole 2326 of the sliding member 232). The connecting hole extends axially, or in other words, its extension direction is consistent with the passage. The pulling tube 246 is fixedly connected to the position of the connecting hole. Further, the proximal end of the pulling tube 246 passes through the connecting hole of the moving member 242, and the pulling tube 246 is reinforced at the position of the connecting hole by adhesive bonding. In some embodiments, the pulling tube 246 is fixed to the connecting part by means of snap-fit or other methods. Optionally, the pulling tube 246 and the connecting part are reinforced by means of adhesive bonding, welding, or other methods.
[0139] The pulling tube 246 passes through the cavity of the push rod 222, with both ends extending out of the push rod 222. Specifically, the pulling tube 246 passes through the first cavity of the push rod 222, and the adjusting section 124 passes through the first cavity. The second and third cavities are used to pass through the locking section 123 and the fixing line 13, respectively. Each cavity is used to pass through a section of line. The first cavity is used to pass through the pulling tube 246 and the adjusting section 124. The inner diameter of the pulling tube 246 is larger than that of the line adjusting section 124. As mentioned above, the size of the first cavity is relatively larger than that of the second and third cavities, which facilitates the insertion of the pulling tube 246.
[0140] The diameter of the first perforation 2221a is larger than the diameter of the traction tube 246, which facilitates the reduction of friction between the traction tube 246 and the inner wall of the first cavity in the push rod 222 during the instrument assembly process, thereby improving assembly efficiency.
[0141] An adjusting section 124 is inserted inside the pulling tube 246, and the adjusting section 124 extends beyond the push rod 222 and the distal end of the pulling tube 246. Inserting the adjusting section 124 inside the pulling tube 246 facilitates the centering of the sealing device 1. Furthermore, the knot 121 is sleeved around the distal end of the pulling tube 246, and the adjusting section 124 is inserted inside the pulling tube 246. This prevents the knot 121 from locking the adjusting section 124 before it is released from the pulling tube 246, thereby ensuring that the adjusting mechanism adjusts the connecting section 122 smoothly and effectively.
[0142] Specifically, the traction tube 246 includes a distal tube section 246a and a proximal tube section located at the proximal end of the distal tube section 246a along the axial direction, wherein the distal tube section 246a extends beyond the distal end of the push rod 222, and the proximal tube section passes through the first cavity inside the push rod 222.
[0143] The distal tube segment 246a is used to extend into the human body. Preferably, the distal tube segment 246a is made of nickel-titanium tubing, which facilitates the formation of a thin-walled tubular structure with a small radial dimension, allowing for easy insertion of the adjustment section 124. The proximal tube segment can be made of high-density polyethylene (HDPE), polyetheretherketone (PEEK), polyimide (PI), or nylon (PA), etc.
[0144] In this embodiment, the outer diameter of the distal pipe section 246a matches the inner diameter of the proximal pipe section, so that the distal pipe section 246a is inserted into the proximal pipe section.
[0145] The distal segment 246a of the pulling tube 246 has a protrusion 2461 and a positioning tube 2462. The protrusion 2461 is located at the distal end of the distal segment 246a, and the positioning tube 2462 is connected to the proximal end of the distal segment 246a. The protrusion 2461 protrudes outward along the circumference of the pulling tube 246, and in its natural state, the radial dimension of the protrusion 2461 is larger than that of the positioning tube 2462. Specifically... Figure 18 As shown, the protrusion 2461 is a basket-shaped structure obtained by laser cutting the distal portion of the distal section 246a. The protrusion 2461 includes multiple support rods arranged circumferentially. The proximal ends of these support rods are joined together, and the distal ends are joined together. The portion between the proximal and distal ends of the support rods protrudes radially outward, with a large radial dimension. The positioning tube 2462 is a straight tube.
[0146] The knot 121 of the sealing device 1 is pre-fitted onto the distal end of the pulling tube 246, specifically between the proximal side of the protrusion 2461 and the distal end face of the push rod 222, that is, fitted around the periphery of the positioning tube 2462. See details. Figure 19 That is, the proximal side of the knot 121 faces the distal end of the push rod 222, and the distal side of the knot 121 faces the protrusion 2461. In other words, the knot 121 is sleeved on the periphery of the positioning tube 2462 between the distal end of the push rod 222 and the proximal end of the protrusion 2461. The radial dimension of the positioning tube 2462 is smaller than that of the protrusion 2461 and the distal end of the push rod 222. The positioning tube 2462, the protrusion 2461, and the distal end of the push rod 222 are connected to form a pit. During the movement of the push rod 222 and the protrusion 2461 to the distal end or to the proximal end, the positioning tube 2462 can drive the knot 121 to move synchronously.
[0147] In some embodiments, the protrusion 2461 of the pulling tube 246 is omitted, that is, the part of the pulling tube 2461 that extends beyond the far end of the push rod 222 is a tube of equal diameter.
[0148] The telescopic member 243 and the elastic member 233 have similar structures and functions, and various specific technical solutions of the elastic member 233 can be applied to the telescopic member 243. The telescopic member 243 is disposed between the passage member and the moving member 242, and can extend and retract radially along the outer shell 21, so that the fourth rack 2425 moves radially closer to or further away from the third rack 2412, thereby engaging or disengaging the fourth rack 2425 with the third rack 2412.
[0149] Specifically, the telescopic member 243 is elastic, and its two ends abut against the bottom of the transition portion 2322 and the inner wall of the passage member, respectively. In this embodiment, the telescopic member 243 includes two springs.
[0150] When the telescopic member 243 is in its natural state, the fourth rack 2425 engages with the third rack 2412, and the moving member 242 cannot move. When the telescopic member 243 moves into the outer casing 21 and is in a compressed state, the third rack 2412 and the fourth rack 2425 disengage, and the moving member 242 can move axially.
[0151] Positioning frame 244 is similar in structure and function to positioning frame 234, and various specific technical solutions for positioning component 234 can be applied to positioning frame 244. Positioning frame 244 is disposed within the passage component and located at the bottom of moving component 242, and is used to position telescopic component 243.
[0152] In this embodiment, after the positioning frame 244 is installed, the telescopic member 243 is located within the positioning space, and both ends of the telescopic member 243 abut against the bottom of the positioning frame 244 and the transition portion, respectively. The connecting portion is located outside the positioning space, and part of the transition portion is located within the positioning space. When the moving member 242 moves axially, it drives the positioning frame 244 to move together through the transition portion.
[0153] The release button 245 is connected to the pressing part of the movable member 242, causing the movable member 242 to move radially and slide axially. Specifically, the outer shell 21 has an opening corresponding to the passage member. The release button 245 protrudes outward from the outer shell 21. The movable member 242 moves radially by pressing with external force and moves axially by being driven by external force. Since the passage member and the slide member are offset by 90 degrees in the circumferential direction of the outer shell 21, the release button 245 and the adjustment button 235 are spaced apart in the circumferential direction of the outer shell 21, and the movement directions of the release button 245 and the adjustment button when moving into the outer shell 21 are perpendicular to each other.
[0154] The knot-releasing principle of the knot-releasing mechanism is as follows:
[0155] S111: In the natural state, the release button 245 is not pressed by external force. The fourth rack 2425 of the moving member 242 meshes with the third rack 2412 of the passage member, preventing the moving member 242 from moving and locking the position of the release button 245. This avoids axial movement of the moving member 242 due to misoperation. The knot 121 is not locked, and the pulling tube 246 passes through at least one slack loop formed by the unlocked knot 121.
[0156] S112: Pressing the release button 245 compresses the telescopic member 243, moves the moving member 242 into the housing 21, disengages the fourth rack 2425 from the third rack 2412, and the release button 245 can drive the moving member 242 to move axially.
[0157] S113: Keep pressing the release button 245 and pull the release button 245 towards the proximal end, which will move the pulling tube 246 towards the proximal end. The protrusion 2461 will also move towards the proximal end. As the distal end of the pulling tube 246 is gradually received into the first cavity of the push rod 222, under the pushing action of the distal end face of the push rod 222, the knot 121 gets closer and closer to the distal end of the pulling tube 246.
[0158] The distal end face of the push rod 222 is used to abut the knot 121 against its distal side. Preferably, in the first cavity, the inner diameter of the first through hole 2222a is smaller than the first through hole 2221a, so that the inner diameter of the first through hole 2222a formed at the head end 2222 matches the outer diameter of the positioning tube 2462 near the protrusion 2461 in the pulling tube 246. The gap formed between the positioning tube 2462 and the first through hole 2222a is insufficient for the knot 121 or the adjusting section 124 to enter, thereby using the abutment of the distal end face of the push rod 222 to move the knot 121 distally relative to the pulling tube 246.
[0159] It should be noted that the outer diameter of the positioning tube 2462 is smaller than the outer diameter of the protrusion 2461. The positioning tube 2462 can be at least a part of the proximal section of the pulling tube 246, or it can be the part of the distal section 246a of the pulling tube 246 located near the protrusion 2461.
[0160] S114: Continue to press the release button 245 and pull the release button 245 proximally. As the release button 245 moves the pulling tube 246 proximally relative to the push rod 222, the protrusion 2461 is received into the first cavity. After the knot 121 crosses the protrusion 2461 from the proximal side to the distal side, the pulling tube 246 continues to move proximally until the distal end of the push rod 222 pushes the knot 121 out of the distal end of the pulling tube 246. The distal end of the pulling tube 246 is separated from the knot 121, thereby causing the knot 121 to come out of the distal end of the pulling tube 246.
[0161] During the process of releasing the knot 121 by the knot release mechanism, the pulling tube 246 moves proximally along the first cavity. The inner diameter of the first through hole 2222a is similar to the outer diameter of the positioning tube 2462. Under the constricting effect of the first through hole 2222a, the radial dimension of the protrusion 2461 gradually decreases and is housed in the head end 2222. As the protrusion 2461 gradually retracts into the head end 2222, friction is generated between it and the inner wall of the first through hole 2222a. Preferably, the head end 2222 of the push rod 222 is made of a biocompatible metal material, such as stainless steel or nickel-titanium alloy, so that the axial friction of the protrusion 2461 will not damage the surface of the inner wall of the first through hole, such as scraping off the surface material of the inner wall of the first through hole 2222a, thus ensuring the integrity of the inner wall of the first cavity and ensuring the safety of the head end 2222 during use. In some embodiments, the head end 2222 is made of metal. If the rod body 2221 is made of polymer material, it is convenient to connect the head end 2222 and the rod body 2221 by heat fusion.
[0162] The locking mechanism is connected to the locking section 123 and is used to move the locking section 123 to lock the knot 121. In this embodiment, the locking mechanism is located near the adjustment mechanism 23. Specifically, the locking mechanism is located near the housing 21. In an alternative embodiment, the relative positional relationship between the locking mechanism and the adjustment mechanism 23 is not limited.
[0163] See Figure 20 The locking mechanism includes a rotating cylinder 251, a slide rail 252, and a slider 254. The rotating cylinder 251 is cylindrical with an internal cavity, located within the receiving space, and can rotate circumferentially along the outer casing 21. The slide rail 252 is located inside the rotating cylinder 251 and extends axially along the rotating cylinder 251. The slider 254 is slidably engaged with the slide rail 252 and is used to connect with the locking section 123. The rotating cylinder 251 is connected to the slider 254, and when the rotating cylinder 251 rotates circumferentially, it drives the slider 254 to slide along the slide rail 252, thereby driving the locking section 123 to move axially towards its proximal end. The slider 254 and the slide rail 252 are installed inside the rotating cylinder 251. The slider 254 moves along the slide rail 252 under the influence of the rotating cylinder 251, pulling the locking section 123 towards its proximal end, thereby locking the knot 121 and achieving the locking purpose. In some preferred embodiments, the rotating cylinder 251 is threadedly engaged with the slider 254.
[0164] Combination Figure 20 and Figure 21 The rotating cylinder 251 is disposed within the receiving space of the housing 21 and is capable of rotating circumferentially along the housing 21. Specifically, the rotating cylinder 251 is located near the slide member.
[0165] The rotating cylinder 251 is cylindrical, with an internal cavity extending axially through its distal and proximal ends, meaning that openings are formed at both ends. The slider 254 and the slide rail 252 are both disposed within the internal cavity of the rotating cylinder 251. In some embodiments, the proximal end of the rotating cylinder 251 is closed, meaning the cavity does not penetrate the proximal end face of the rotating cylinder 251.
[0166] The outer circumference of the rotating cylinder 251 is provided with a plurality of limiting rings 2511. Specifically, in this embodiment, there are two limiting rings 2511, one located at the distal end and the other located at the middle in the axial direction. In other embodiments, the number of limiting rings 2511 may be three or other numbers, and their positions may be set according to actual conditions. In this embodiment, the limiting rings 2511 are annular. In alternative embodiments, the surface of the rotating cylinder 251 is provided with other limiting mechanisms for axial upper limit, such as a non-annular structure protruding from the surface of the rotating cylinder 251, or a groove structure recessed into the surface of the rotating cylinder 251.
[0167] See Figure 22 The outer casing 21 has at least one set of blocking members spaced apart along its axial direction. Each set of blocking members includes two blocking members 215 arranged in pairs and spaced apart along the axial direction. In this embodiment, there are two sets of blocking members 215, which are corresponding to the two limiting rings 2511 on the outer periphery of the rotating cylinder 251.
[0168] When the rotating cylinder 251 is installed inside the housing 21, the limiting ring 2511 is located between the two corresponding blocking members 215 in the axial direction, thereby restricting the axial movement of the rotating cylinder 251. Accordingly, in an alternative embodiment, the housing 21 is provided with other blocking structures for axially limiting the rotating cylinder 251, that is, limiting the range of motion of the rotating cylinder 251 in the axial direction.
[0169] The inner wall of the rotating cylinder 251 is provided with an internal thread for threaded engagement with the slider 254.
[0170] The slide rail 252 is located inside the rotating cylinder 251 and extends along the axial direction of the rotating cylinder 251.
[0171] The slide rail 252 has a limiting portion 2521. Specifically, the limiting portion 2521 is hollow and partially cylindrical, extending axially, and has an axially extending opening 2522 formed at its top. The two ends of the limiting portion 2521 surrounding the opening circumferentially are used to abut against the slider (specifically, its sliding surface 2546). The inner wall of the limiting portion 2521, opposite to the opening 2522, is used to support the slider 254 and provide a track for the slider 254 to slide axially.
[0172] The limiting part 2521 has a receiving space extending along its own axis, which is a partially cylindrical space enclosed by the limiting part for carrying the slider 254.
[0173] Slider 254 slides in conjunction with slide rail 252. (See reference...) Figure 23 The slider 254 includes an engaging portion 2541 and a connecting portion 2542 disposed at the distal end of the engaging portion 2541. The connecting portion 2542 is used to connect the locking section 123. The engaging portion 2541 is disposed on the top of the slider 254 and has an external thread on its outer periphery. This external thread engages with the internal thread inside the rotating cylinder 251, thereby enabling the slider 254 to slide along the slide rail 252 when the rotating cylinder 251 rotates.
[0174] The slider 254 has a sliding surface 2546 circumferentially disposed thereon, specifically on the circumferential side of the engaging portion 2541. The limiting portion 2521 abuts against the sliding surface 2546 circumferentially, thereby limiting the circumferential rotation of the slider 254 relative to the slide rail 252. Specifically, in this embodiment, the top side of the cross-sectional profile of the engaging portion 2541 is arc-shaped, and an external thread is disposed on the top of the engaging portion 2541. The sliding surface is connected to the arc-shaped surface. The sliding surface is the two end faces of the engaging portion 2541 in the circumferential direction, extending axially and radially, for abutting against the limiting portion 2521. The limiting portion 2521 is used to support the engaging portion 2541 at the position of the sliding surface 2546.
[0175] The sliding surface 2546 abuts against the two ends of the limiting part 2521 in the circumferential direction, so that the sliding surface 2546 can move axially along the limiting part 2521 of the slide rail 252, and restricts the slider 254 from rotating circumferentially relative to the slide rail 252.
[0176] The connecting part 2542 is used to connect with the tightening line 12. Specifically, the connecting part 2542 is provided with a connecting hole for the locking section 123 to pass through, or for direct winding and fixing.
[0177] In this embodiment, the cross-section of the connecting portion 2542 is also arc-shaped. The connecting portion 2542 and the engaging portion 2541 are disposed opposite to each other, specifically, the concave surfaces of the connecting portion 2542 and the engaging portion 2541 are disposed opposite to each other.
[0178] The connecting part 2542 is located at the bottom of the engaging part 2541, so that when the sliding surface of the engaging part 2541 abuts against the two ends of the limiting part 2521 in the circumferential direction, the connecting part 2542 can be located in the receiving space and can move in the receiving space as the engaging part 2541 moves.
[0179] In this embodiment, the slider 254 further includes a positioning block 2543, which is disposed on the side of the engagement portion 2541 opposite to the external thread in the circumferential direction. That is, in this embodiment, the external thread is disposed on the outer periphery of the engagement portion 2541, and the positioning block 2543 is disposed on the bottom of the engagement portion 2541. Thus, when the slider 254 slides into contact with the slide rail 252, that is, when the sliding surface 2546 of the engagement portion 2541 abuts against the two ends of the limiting portion 2521 in the circumferential direction, the positioning block 2543 moves within the receiving space of the limiting portion 2521. In other words, the positioning block 2543 is located within the receiving space and can move within the receiving space as the engagement portion 2541 moves.
[0180] The positioning block 2543 is located at the proximal end of the engagement part 2541. Meanwhile, the connecting portion 2542 is disposed at the distal end of the engaging portion 2541. At least one of the positioning block 2543 and the connecting portion 2542 is used to contact the inner wall of the limiting portion 2521. Specifically, at least one of the positioning block 2543 and the connecting portion 2542 has its circumferential surface away from the axis used to contact the inner wall of the limiting portion 2521 that is directly opposite to the opening 2522. That is, at least one of the positioning block 2543 and the connecting portion 2542 is used to support the engaging portion 2541. In this embodiment, both the positioning block 2543 and the connecting portion 2542 have their circumferential surfaces away from the axis used to contact the inner wall of the limiting portion 2521 that is directly opposite to the opening 2522. That is, both the positioning block 2543 and the connecting portion 2542 are used to support the engaging portion 2541, so that both axial ends of the bottom of the engaging portion 2541 are constrained by force, thereby maintaining the balance of both axial ends of the engaging portion 2541 and ensuring that the sliding surface can abut against the limiting portion.
[0181] The positioning block 2543 is semi-circular. In some embodiments, the positioning block 2543 can be omitted, meaning the slider 254 includes a connecting portion 2542 at the distal end and an engaging portion 2541 at the proximal end. Preferably, the engaging portion 2541 has a much smaller mass than the connecting portion 2542 to ensure the stability of the slider 254 sliding in the slide rail 252. In some embodiments, the bottom of the engaging portion 2541 has a structure extending to be flush with the bottom of the connecting portion 2542, meaning the positioning block 2543 extends from the proximal end of the slider 254 to the connecting portion 2542. In some embodiments, the connecting portion 2542 extends proximally to the bottom of the engaging portion 2541.
[0182] The locking principle of the locking mechanism is as follows:
[0183] An external force rotates the rotating cylinder 251, causing the external thread of the slider 254 to engage with the internal thread of the rotating cylinder 251, thereby driving the slider 254 to move axially within the slide rail 252. The movement of the slider 254 causes the locking section 123, which passes through the connecting hole, to move towards the proximal end, thereby locking the knot 121 and achieving the purpose of locking.
[0184] Furthermore, the distal end of the slide rail 252 extends out of the rotating cylinder 251. The slide rail 252 has retaining rings protruding from both ends of the limiting portion 2521 for axially stopping the slider 254. The two retaining rings are a proximal retaining ring 2531 and a distal retaining ring 2532. The proximal end face of the distal retaining ring 2532 is used to axially stop the distal slider 254, and the distal end face of the proximal retaining ring 2531 is used to axially stop the proximal slider 254, i.e., the slider 254 is contained within the receiving space of the limiting portion 2521 between the proximal retaining ring 2531 and the distal retaining ring 2532.
[0185] A proximal retaining ring 2531 protrudes from the proximal end of the limiting portion 2521, and a distal retaining ring 2532 protrudes from the distal end of the limiting portion 2521. The extending directions of the two retaining rings are different from those of the limiting portion 2521. Specifically, in conjunction with Figure 20 and Figure 24 The proximal retaining ring 2531 and the distal retaining ring 2532 extend in directions perpendicular to the extending direction of the limiting portion 2521, meaning that both the proximal retaining ring 2531 and the distal retaining ring 2532 protrude radially from the end of the limiting portion 2521. In other embodiments, the extending directions of the proximal retaining ring 2531 and the distal retaining ring 2532 are not limited to being perpendicular to the extending direction of the limiting portion 2521; the extending directions of the proximal retaining ring 2531 and the distal retaining ring 2532 may also be inclined at an angle to the extending direction of the limiting portion 2521, for example, an acute angle or an obtuse angle.
[0186] like Figure 20 and Figure 24 As shown, the distal retaining ring 2532 is annularly protruding from the distal end of the slide rail 252. The outer diameter of the distal retaining ring 2532 is larger than the outer diameter of the proximal retaining ring 2531, and also larger than the radial dimension of the proximal opening of the rotating cylinder 251. Therefore, after the slide rail 252 is installed inside the rotating cylinder 251, the distal retaining ring 2532 cannot be accommodated inside the rotating cylinder 251. The distal retaining ring 2532 is located outside the rotating cylinder 251, and the limiting part 2521 is accommodated inside the rotating cylinder 251. The proximal end face of the distal retaining ring 2532 is used to abut against the distal end face of the rotating cylinder 251, thereby restricting the slide rail 252 from moving axially towards the proximal end relative to the rotating cylinder 251, and preventing the slide rail 252 from moving towards the proximal end and coming out of the proximal opening of the rotating cylinder 251.
[0187] Correspondingly, the outer shell 21 provides axial restraint for the distal retaining ring 2532. After the locking mechanism is assembled with the outer shell 21, an axial restraint structure is provided at least at the distal end of the distal retaining ring 2532. For example, an annular, strip-shaped, or irregular structure is protruding on the inner surface of the outer shell 21, thereby preventing the distal retaining ring 2532 from moving to the distal end and thus dislodging from the rotating cylinder 251. Specifically, in this embodiment, a stop member 216 is protruding on the surface of the outer shell 21. The stop member 216 and the blocking member 215 located at the distal end are spaced apart along the axial direction of the outer shell 21. The distal end face of the distal retaining ring 2532 abuts against the proximal end face of the stop member 216.
[0188] Since the outer casing 21 limits the rotating cylinder 251 in the axial direction, after assembly, the axial position of the rotating cylinder 251 relative to the outer casing 21 is limited. Since the rotating cylinder 251 and the outer casing 21 simultaneously limit the distal retaining ring 253 in the axial direction, the axial position of the distal retaining ring 253 is limited. Consequently, the axial movement range of the slide rail 252 relative to the outer casing 21 and the rotating cylinder 21 is limited. Preferably, the axial position of the rotating cylinder 251 relative to the outer casing 21 is fixed, and the axial position of the slide rail 252 relative to the outer casing 21 and the rotating cylinder 21 is also fixed.
[0189] The distal retaining ring 2532 has an opening so that the locking section 123 of the tightening wire 12 or the connecting portion 2542 of the slider 254 can pass through the opening of the distal retaining ring 2532, so that the locking section 123 of the tightening wire 12 and the slider 254 can be connected to each other through the opening of the distal retaining ring 2532. Preferably, the distal retaining ring 2532 has the opening at its geometric center. Specifically, in some embodiments, when the slider 254 is located at the farthest end of the receiving space in the slide rail 252, the connecting portion 2542 can extend from the far end of the slide rail 252. As the slider 254 moves axially towards the proximal end, the connecting portion 2542 gradually retracts into the internal cavity of the rotating cylinder 251 until the proximal end of the engaging portion 2541 abuts against the proximal retaining ring 2531.
[0190] In this embodiment, the proximal retaining ring 2531 is disposed at the proximal end of the slide rail 252 and is used to prevent the slider 254 from disengaging from the top of the limiting portion 2521. In some embodiments, the proximal retaining ring 2531 can protrude from the top of the limiting portion 2521 and abut against the slider 254, and the specific structure of the proximal retaining ring 2531 is not limited.
[0191] See Figure 24The slide rail 252 also has an extension 2533 at the distal end of the distal retaining ring 253. The extension 2533 has a notch 2534 that extends out of the rotating cylinder 251. Specifically, the extension 2533 protrudes from the distal end face of the distal retaining ring 2532 and extends distally, forming a partial ring (arc shape) in the circumferential direction. It is C-shaped in the cross section perpendicular to the axis, and the extension 2533 has a notch 2534 formed in the circumferential direction. The housing 21 includes a limiting member 217 disposed on the inner side. The notch 2534 abuts against the limiting member 217 disposed on the inner side of the housing 21 to restrict the slide rail 252 from rotating circumferentially along the housing 21.
[0192] The limiting member 217 extends radially and abuts against the sidewall at the notch 2534. See details... Figure 22 Along the circumference of the outer shell 21, the middle part of the limiting member 217 protrudes radially from both sides of the outer shell 21, and two stepped structures 2171 are formed on both sides of the middle part. The middle part of the limiting member 217 is used to extend into the C-shaped space enclosed by the extension 2533 from the position of the notch 2534. The two stepped structures 2171 abut against the side walls of the notch 2534 to prevent the slide rail 252 from rotating circumferentially.
[0193] In this embodiment, the slide rail 252 can be formed by cutting off a portion of a cylindrical body with a circular cross-section, leaving a portion of the cylindrical body in a circular shape at the proximal end to form a proximal retaining ring 2531. A portion of the cylindrical body in a circular shape is also left at the other end, and a distal retaining ring 2532 is fitted around its outer periphery. The portion at the distal end of the distal retaining ring 2532 is the extension 2533, which has a notch 2534. The opening between the proximal retaining ring 2531 and the distal retaining ring 2532 forms an opening 2522.
[0194] Combining 20 and Figure 21 As shown, the locking mechanism further includes a knob 257. The operator rotates the rotating cylinder 251 by rotating the knob 257, thereby causing the slider 254 to slide along the slide rail 252. In this embodiment, the knob 257 and the rotating cylinder 251 are connected by a thread. In a modified embodiment, the knob 257 and the rotating cylinder 251 are fixed by adhesive bonding, snap-fitting, or integral molding. For details, please refer again. Figure 20 The rotating cylinder 251 has a first thread 2512 at its near end for threaded engagement with the knob 257. The first thread is an external thread.
[0195] The knob 257 is a cylindrical shape with one end open, connected to the near end of the outer casing 21, and fitted around the near end of the rotating cylinder 251. In this embodiment, the inner wall of the knob 257 is provided with a third thread (not shown in the figure). The third thread is an internal thread, which is adapted to the first thread 2512 so that the knob 257 is screwed to the rotating cylinder 251.
[0196] The knob 257 is located at the near end of the housing 21 and exposed on the surface of the conveying device 2 for easy operation by the operator.
[0197] When the knob 257 is connected to the rotating cylinder 251, the proximal end of the rotating cylinder 251 extends out of the proximal end of the housing 21, exposing the first thread 2512 on the rotating cylinder 251 outside the housing 21. The third thread inside the knob 257 is adapted to the first thread 2512, thereby realizing the screw connection between the knob 257 and the rotating cylinder 251.
[0198] In some embodiments, the knob 257 rotates circumferentially in a first direction to achieve screwing with the rotating cylinder 251 until the first thread 2512 and the third thread are tightened together. Subsequently, if the knob 257 continues to rotate in the first direction, the knob 257 can drive the rotating cylinder 251 to rotate in the first direction, and the slider 254 moves axially towards the proximal end until the locking section 123 is tightened and the knot 121 locks the adjusting section 124. When the knob rotates circumferentially in a second direction, the knob 257 disengages from the rotating cylinder 251. For example, the first direction is clockwise and the second direction is counterclockwise; in some embodiments, the first direction is counterclockwise and the second direction is clockwise.
[0199] Please refer to it again. Figure 20 The locking mechanism also includes a positioning cylinder 256 and an indicator block 255, wherein the positioning cylinder 256 is used to position the indicator block 255.
[0200] Correspondingly, the outer casing 21 is provided with a light-transmitting indicator window. The position of the indicator block 255 within the indicator window determines whether the locking is complete. In this embodiment, the locking is indicated when the indicator block 255 moves into the indicator window. In some embodiments, the indicator block 255 is provided with an indicator pattern; the locking is indicated when the indicator pattern is fully moved and displayed within the indicator window. In some embodiments, the indicator window or the outer casing 21 is provided with markings or other signs at specific positions corresponding to the indicator window. The locking is indicated when the indicator pattern on the indicator block and the markings on the indicator window satisfy a specific relationship.
[0201] The outer circumference of the rotating cylinder 251 is provided with a second thread 2513, which is located at the distal end of the first thread 2512. Further, the first thread 2512 is located at the proximal end of the rotating cylinder 251, and the second thread 2513 is located between the two limiting rings 2511.
[0202] The indicator block 255 is used to be assembled on the outer periphery of the rotating cylinder 251, that is, it is sandwiched between the rotating cylinder 251 and the lower shell 212. The indicator block 255 is engaged with the rotating cylinder 251, and the rotation of the rotating cylinder 251 can drive the indicator block 255 to move axially.
[0203] Specifically, in combination Figure 22 and Figure 25 The indicator block 255 has a fourth thread 2551 on its surface facing the rotating cylinder 251. The fourth thread 2551 engages with the second thread 2513 on the outer periphery of the rotating cylinder 251, thereby driving the indicator block 255 to move along the axial direction of the rotating cylinder 251 when the rotating cylinder 251 rotates.
[0204] In this embodiment, the indicator block 255 has an indicator pattern on its surface facing away from the rotating cylinder 251, i.e., on the surface facing the operator, for the operator to identify. The locking is completed when the indicator pattern is fully displayed in the indicator window.
[0205] The indicator block 255 has a slot 2552 with an opening facing the proximal end. The slot 2552 can be a through groove that extends axially and forms openings at both ends of the indicator block 255.
[0206] The positioning cylinder 256 is fitted onto the near end of the outer casing 21 and located at the far end of the knob 257, meaning the positioning cylinder 256 is sandwiched between the outer casing 21 and the knob 257. Figure 20 , Figure 21 and Figure 26 The positioning cylinder 256 includes a cylinder body 2562 and an insert block 2561 and a positioning element 2563 disposed at the far end of the cylinder body 2562.
[0207] The cylinder 2562 is fitted onto the proximal end of the outer casing 21, partially exposed on the surface of the conveying device 2, and connected to the distal end of the knob 257.
[0208] The positioning element 2563 and the insertion block 2561 are spaced apart along the circumference of the cylinder. In this embodiment, the positioning element 2563 is arc-shaped, and the concave surface of the positioning element 2563 faces the insertion block 2561.
[0209] Continue reading Figure 21 The near end of the outer shell 21 is provided with an abutment 218, which abuts against the positioning member 2563 along the circumference of the cylinder, thereby restricting the positioning cylinder 256 from rotating along the circumference of the outer shell 21. In this embodiment, the abutment 218 is also arc-shaped, and the concave surface of the abutment 218 is arranged opposite to the concave surface of the positioning member 2563.
[0210] The insert 2561 protrudes axially toward the distal side of the cylinder 2562 and is used to be inserted into the slot 2552 within the housing 21. When the indicator block 255 is moved to the position where it is inserted into the slot 2552, the insert 2561 can guide the indicator block 255 to continue moving axially toward its proximal end, such that at least the cylinder 2562 defines the proximal limit position of the indicator block 255. Furthermore, the insertion of the insert 2561 into the slot 2552, i.e., the indicator block 255 is fitted around the outer periphery of the insert 2561, provides circumferential and radial positioning for the indicator block 255, thereby preventing the indicator block 255 from shifting on the surface of the rotating cylinder 251 and disengaging from the third thread of the rotating cylinder 251.
[0211] Furthermore, such as Figure 26 As shown, a guide rail 2566 protrudes from the insert block 2561 and extends between the proximal and distal ends of the insert block 2561. The extension direction of the guide rail 2566 is consistent with the sliding direction of the slider 255. More specifically, the extension direction of the guide rail 2566 and the sliding direction of the slider 255 both extend axially. Correspondingly, the indicator block 255 is provided with a groove 2556 that slides with the guide rail. The guide rail 2566 is accommodated in the groove 2556 and can slide in the groove 2556, thereby further ensuring the stability of the slider 255 sliding axially.
[0212] As the rotating cylinder 251 rotates, it drives the indicator block 255 to move axially. When the indicator pattern on the indicator block 255 can be fully observed in the indicator window, the locking is completed.
[0213] The tangent mechanism 26 is axially disposed on the far side of the adjusting mechanism 23 and the locking mechanism, and on the near side of the releasing mechanism, for cutting off the locking section 123, the adjusting section 124 and the fixing line 13.
[0214] See Figure 27A , Figure 27B and Figure 28The thread-cutting mechanism 26 includes a support member, a thread-cutting assembly 263, and a protective assembly 264. The support member has a channel 268 through which a thread (in this embodiment, a locking section 123, an adjusting section 124, and a fixing line 13; in other embodiments, the thread can be at least one other thread, such as a suture thread, metal thread, etc.) passes, and a passage cavity 269 through which part of the thread-cutting assembly 263 passes, with the passage cavity 269 communicating with the channel 268. The thread-cutting assembly 263 can move within the passage cavity 269 to cut the thread located within the channel 268, such as the locking section 123, adjusting section 124, and fixing line 13 in a tightening thread. The protective assembly 264 can move between an open position and a closed position, thereby enabling the thread-cutting assembly 263 to reach the channel 268 to cut the aforementioned thread, or preventing it from reaching the channel 268 to provide protection and avoid accidental cutting of the thread. When the protection component 264 is in the closed position, the protection component 264 stops the tangent component 263 from moving along the through cavity 269 toward the channel 268, preventing the tangent component 263 from reaching the channel 268; when the protection component 264 is in the open position, the tangent component 263 can move along the through cavity 269 into the channel 268 and cut the wire located in the channel 268.
[0215] A support member is disposed within the receiving space of the housing 21. A channel 268 extends between the proximal and distal ends of the housing 21, and a through cavity 269 communicates with the channel 268. Specifically, in this embodiment, the extending direction of the channel 268 is parallel to the axial direction of the housing 21, and the through cavity 269 extends perpendicular to the axial direction of the housing 21. In other embodiments, the extending direction of the channel 268 may also have an angle with the axial direction of the housing 21, such as 70 degrees, 80 degrees, or other angles, and the extending direction of the through cavity 269 may also have an angle with the axial direction of the housing 21, such as 70 degrees, 80 degrees, or other angles. The angle between the extending direction of the through cavity 269 and the extending direction of the channel 268, exemplarily, can be 70 degrees, 80 degrees, or other angles.
[0216] like Figure 29A , Figure 29B as well as Figure 29C As shown, specifically, the support includes a base frame 261. The base frame 261 includes a base plate 2611 and a receiving plate 2612 disposed on the top of the base plate 2611, that is, the bottom of the receiving plate 2612 is connected to the top of the base plate 2611, and the receiving plate 2612 is used to support and accommodate part of the tangent assembly 263.
[0217] In this embodiment, the extending direction of the substrate 2611 is parallel to the axial direction of the outer shell 21. The substrate 2611 has an opening that extends through its thickness direction, that is, the axis of the opening is perpendicular to the axis of the outer shell 21.
[0218] The extending direction of the receiving plate 2612 is parallel to the axial direction of the housing 21. There is a gap between the receiving plate 2612 and the substrate 2611.
[0219] The receiving plate 2612 is provided with a through hole 26121 that extends through its thickness direction (radial). The tangent assembly 263 can pass through the through hole 26121 and be received in the through cavity 269. The through cavity 269 includes the space enclosed by the through hole 26121 and the opening on the substrate 2611.
[0220] The receiving plate 2612 is provided with a receiving groove, the opening of which is away from the substrate 2611, that is, the opening of the receiving groove is at the top of the receiving plate 2612. The through hole 26121 penetrates the bottom wall of the receiving groove.
[0221] Channel 268 and through cavity 269 can be disposed on base frame 261, for example, channel 268 can be formed at the bottom of base frame 261, and channel 268 can also be disposed on base frame 261 and other structures. In this embodiment, the support member also includes base frame 262, and channel 268 is formed by both base frame 261 and base frame 262. Base frame 262 is disposed at the bottom of base frame 261, and base frame 262 and receiving plate 2612 are arranged on opposite sides of base plate 2611.
[0222] Specifically, the base frame 261 also includes a post 2615 and a fixing block 2616 disposed at the bottom of the base plate 2611.
[0223] See Figure 29A , Figure 29B as well as Figure 29C As shown, two insertion posts 2615 are spaced apart at the bottom of the far end of the substrate 2611. Specifically, the two insertion posts 2615 are spaced apart along the circumference of the housing 21.
[0224] A fixing block 2616 is disposed between two inserts 2615. The fixing block 2616 is block-shaped and parallel to the extension direction of the inserts 2615. If not necessary, the bottom of the fixing block 2616 is flush with the bottom of the inserts 2615.
[0225] The fixing block 2616 has a through cavity 269 extending through its top and bottom surfaces, so that the tangent assembly 263 can pass through from top to bottom to reach the channel 268. In this embodiment, the through cavity 269 extends along an axial direction perpendicular to the outer shell 21, and the through cavity 269 includes an opening on the substrate 2611 and a through hole 26121 on the receiving plate 2612.
[0226] The bottom of the fixing block 2616 is provided with a notch 26161. The notch 26161 is provided on the side of the fixing block 2616 away from the substrate 2611, and the notch 26161 communicates with the through cavity 269.
[0227] like Figure 28 As shown, the base frame 262 includes a base plate 2621, support legs 2622 disposed at the bottom of the base plate 2621, and a connecting plate 2623.
[0228] The extension direction of the base plate 2621 is parallel to the axial direction of the outer casing 21. The base plate 2621 is disposed at the bottom of the base plate 2611.
[0229] The base plate 2621 has an opening at its far end, which is a clearance groove 26211 facing the far end.
[0230] Two legs 2622 are located at the far end of the base plate 2621. The two legs 2622 are spaced apart around the perimeter of the outer casing 21. Specifically, the two legs 2622 are arranged on both sides of the clearance groove 26211. Each leg 2622 is provided with a socket 26221 for inserting a post 2615.
[0231] The connecting plate 2623 is connected to the bottom of the two legs 2622.
[0232] When the base frame 261 is connected to the bottom frame 262, the insertion posts 2615 are respectively inserted into the insertion holes 26221 of the support legs 2622, and the bottom plate 2621 and the base plate 2611 can abut against each other. The connecting plate 2623, the two support legs 2622, and the base plate 2611 enclose a first space, through which the channel 268 passes and the through cavity 269 passes. Specifically, the fixing block 2616 is disposed in the aforementioned first space.
[0233] After the base frame 261 and the bottom frame 262 are inserted, the fixing block 2616 is accommodated in the clearance groove 26211 of the bottom frame 262, and the connecting plate 2623 is located below the notch 26161 to seal the bottom of the notch 26161. The notch between the connecting plate 2623 and the fixing block 2616 forms a channel 268 for the fixing line 13, the locking section 123 and the adjusting section 124 to pass through.
[0234] like Figure 28As shown, the tangent assembly 263 includes a tangent button 2631, a tangent element 2632, and a positioning post 2633. In this embodiment, the tangent element 2632 is connected to the tangent button 2631. In an alternative embodiment, the tangent element 2632 is connected to at least one of the tangent button 2631 and the positioning post 2633. The tangent element 2632 can be a blade. In this embodiment, the bottom of the tangent element 2632 has a sharp edge with a cutting function, which is housed in the through cavity 269 at one end away from the channel 268, and can move along the through cavity 269. The tangent button 2631 is connected to the top of the tangent element 2632, and the tangent button 2631 can drive the tangent element 2632 to move, thereby enabling the tangent element 2632 to move into the channel 268. In the modified embodiment, when no external force is applied to the tangent button 2631, the tangent member 2632 is located inside the through cavity 269 and outside the channel 268. After an external force is applied to the tangent button 2631, the tangent member 2632 can move along the through cavity 269 and can move into the channel 268.
[0235] The tangent button 2631 has a portion protruding from the housing 21 and a portion located inside the housing 21, and can move into the housing 21 under the action of external force. Specifically, the tangent button 2631 is partially located in the receiving groove, and the tangent button 2631 can move along the groove wall within the receiving groove, thereby ensuring the direction of movement of the tangent button 2631.
[0236] Please combine Figure 29A The cutting element 2632 is disposed at the bottom of the cutting button 2631, and passes through the through hole 26121 on the receiving plate 2612 and the opening on the substrate 2611 to pass through the cavity 269. The cutting element 2632 can move with the movement of the cutting button 2631, and can move into the channel 268 to cut off the locking section 123, the adjusting section 124 and the fixing line 13 located in the channel 268.
[0237] The positioning post 2633 is connected to the tangent button 2631, meaning that the positioning post 2633 moves together with the tangent button 2631 and the tangent component 2632. Specifically, the positioning post 2633 is fixed to the bottom of the tangent button 2631. Further, the positioning post 2633 and the tangent component 2632 are spaced apart at the bottom of the tangent button 2631.
[0238] In this embodiment, there are two positioning posts 2633, arranged on both sides of the tangent member 2632. The extending direction of the positioning posts 2633 is parallel to that of the tangent member 2632.
[0239] A through hole 26122 is formed on the receiving plate 2612, and the extending direction of the through hole 26122 corresponds to the positioning post 2633. Specifically, the through hole 26122 is provided on the bottom wall of the receiving groove and communicates with the receiving groove. During the movement of the tangent member 2632 along the through cavity 269 to the channel 268, the positioning post 2633 can pass through the through hole 26122, that is, the through hole 26122 is used to allow the positioning post 2633 to pass through during the movement of the tangent member 2632 along the through cavity 269 to the channel 268.
[0240] In this embodiment, there are two positioning posts 2633, and correspondingly, there are also two through holes 26122.
[0241] like Figure 28 As shown, the tangent assembly 263 further includes a return member 2634. The return member 2634 is disposed within the receiving groove, preferably sleeved around the outer periphery of the positioning post 2633, allowing the return member 2634 to extend and retract along the extending direction of the positioning post 2633. Both ends of the return member 2634 abut against the bottom of the tangent button 2631 and the bottom wall of the receiving groove, respectively.
[0242] The return element 2634 is elastic, providing the power required for the tangent button 2631 to reset, and providing the power for the positioning post 2633 and the tangent element 2632 to move away from the channel 268, thereby resetting the tangent button 2631, positioning post 2633, and tangent element 2632. In this embodiment, the return element 2634 is a spring. There are two return elements 2634, corresponding one-to-one with the two positioning posts 2633. In other embodiments, the return element 2634 is not limited to being sleeved on the outer periphery of the positioning post 2633.
[0243] The tangent principle of tangent assembly 263 is as follows:
[0244] Pressing the cutting button 2631 moves it into the housing 21, causing the cutting component 2632 to enter the channel 268 along the through cavity 269, thereby cutting off the fixed wire 13, locking section 123, and adjusting section 124 located in the channel 268. After cutting is complete, releasing the cutting button 2631 causes the return component 2634 to provide the power to reset the cutting button 2631, causing the cutting button 2631, positioning post, and cutting component 2632 to move away from the channel 268, thus achieving a reset.
[0245] like Figure 28As shown, the protective component 264 is disposed on the top of the support member and is movable between an open position and a closed position. Specifically, when the protective component 264 is in the closed position, it stops the tangent component 263 from moving along the through cavity 269 towards the channel 268, preventing the tangent component 263 from reaching the channel 268. When the protective component 264 is in the open position, the tangent component 263 can move along the through cavity 269 into the channel 268 and cut the wire located within 268.
[0246] In this specific embodiment, the open and closed positions are spaced apart circumferentially along the housing 21. In other embodiments, the open and closed positions may also be spaced apart axially along the housing 21, or spaced apart in other directions.
[0247] Specifically, the protection component 264 includes a protection plate 2642. The protection plate 2642 is movable circumferentially along the housing 21.
[0248] The protective plate 2642 is located between the receiving plate 2612 and the base plate 2611. The protective plate 2642 has a positioning hole 2643 and a through groove 2644. The positioning hole 2643 is for the positioning post 2633 to pass through, and the through groove 2644 is for the tangent 2632 to pass through.
[0249] In this embodiment, there are two positioning holes 2643, which are spaced apart and correspond to two positioning posts 2633. The through groove 2644 corresponds to the shape and position of the tangent member 2632.
[0250] When the protection component 264 is in the closed position, the protection plate 2642 stops the wire-cutting button 2631 and the wire-cutting piece 2632 from moving downwards, preventing the bottom of the wire-cutting piece 2632 from reaching the channel 268, thus preventing the cutting of the fixing wire 13, the locking section 123, and the adjusting section 124, thereby achieving the protection function. When the protection component 264 is in the open position, the wire-cutting piece 2632 can move into the channel 268 to cut the fixing wire 13, the locking section 123, and the adjusting section 124.
[0251] Specifically, the receiving plate 2612 and the base plate 2611 are connected by two pillars. The two pillars are spaced apart circumferentially along the outer casing 21. The protective plate 2642 is also provided with an avoidance groove 2646 with its opening facing away from the positioning hole 2643. This avoidance groove 2646 corresponds to the pillar 2617 located at the near end. Viewed from the near end to the far end, the pillar 2617 located at the near end is located on the right side of the protective plate 2642, and the opening of the avoidance groove 2646 is located on the right side of the protective plate 2642, extending to the left from its opening. When the protective plate 2642 moves circumferentially, there is a gap between its far end and the pillar located at the far end, and the two do not interfere with each other. The pillar located at the near end can move in the avoidance groove 2646 of the protective plate 2642, so that the pillar does not interfere with the movement of the protective plate 2642. In this embodiment, the avoidance groove 2646 and the through groove 2644 are arranged parallel and spaced apart.
[0252] The protection component 264 includes a protection button 2641.
[0253] The protection button 2641 is located near the end of the protection plate 2642. The protection button 2641 protrudes from the surface of the housing 21, and the protection button 2641 can move to drive the protection plate 2642 to move, thereby giving the protection assembly 2641 an open position and a closed position.
[0254] A protective button 2641 is disposed on the top of the base frame 261. Correspondingly, the base frame 261 also includes a support plate 2613 protruding from the top of the base plate 2611. The protective button 2641 is disposed on the support plate 2613 to support the protective button 2641. The support plate 2613 and the receiving plate 2612 are located on the same side of the base plate 2611, specifically the top side, and the support plate 2613 is disposed near the end of the receiving plate 2612. A track 2614 is provided on the support plate 2613. Specifically, the support plate 2613 has two track plates spaced apart along the axial direction, and the track plates extend circumferentially along the outer casing 21. The two track plates form the track 2614.
[0255] The protective button 2641 slides in conjunction with the track 2614, thereby ensuring the movement direction of the protective plate 2642. Specifically, the bottom of the protective button 2641 is provided with a sliding space, which has an opening facing the bottom, allowing the protective button 2641 to be fitted onto the outer periphery of the track 2614, enabling the protective button 2641 to move along the track 2614. In this embodiment, the protective button 2641 includes a top wall and four side walls extending downward from the top wall.
[0256] Specifically, the protection plate 2642 and the protection button 2641 are connected by a bending structure 2647, creating a height difference between the protection button 2641 and the protection plate 2642. Figure 28Viewed from the indicated direction, the protective button 2641 is higher than the protective plate 2642, causing the protective button 2641 to protrude from the outer casing 21. The bent structure 2647 is provided at the connection between the substrate 2611 and the support plate 2613 (in some embodiments, it may be fitted), that is, when the protective assembly 264 is mounted on the support, the protective button 2641 is located on top of the support plate 2613, and the protective plate 2642 is located between the substrate 2611 and the receiving plate 2612.
[0257] The protection principle of protection component 264 is as follows:
[0258] See Figure 30 When the protection button 2641 slides along the track 2614 to the closed position, the positioning post 2633 and the positioning hole 2643 are misaligned, and the positioning post 2633 abuts against the protection plate 2642. The protection plate 2642 stops the downward movement of the positioning post 2633, the wire cutting button 2631 and the wire cutting component 2632, so that the bottom of the wire cutting component 2632 cannot reach the channel 268, and thus cannot cut the wire, such as the fixing wire 13, the locking section 123 and the adjusting section 124, to achieve the protection function.
[0259] See Figure 31 When the protection button 2641 slides along the track 2614 to the open position, the positioning post 2633 on the tangent assembly 263 can pass through the through hole on the receiving plate 2612 and the positioning hole 2643 on the protection plate 2642, so that the tangent 2632 can move along the through cavity 269 into the channel 268 to cut the fixing line 13, the locking section 123 and the adjusting section 124.
[0260] like Figure 28 and Figure 29C As shown, preferably, the base frame 262 further includes two winding portions 2624. Specifically, the two winding portions 2624 are disposed near the end of the base plate 2621. The two winding portions 2624 are spaced apart circumferentially along the outer casing 21, that is, the two winding portions 2624 and the two legs 2622 are respectively disposed at the four corners of the base plate 2621. In an alternative embodiment, the two winding portions 2624 and the two legs 2622 are not limited to being respectively disposed at the four corners of the base plate 2621.
[0261] Furthermore, each winding section 2624 includes a column and a stop block disposed on the column and protruding from the column. The column is used for winding the wire, and the stop block is used to prevent the wire wound on the column from falling off. In this embodiment, the stop block protrudes from the outer periphery of the column along the axial direction of the outer casing 21. And each column has two stop blocks at its bottom.
[0262] Specifically, the free end of the locking section 123 passing through the channel 268 passes through the connecting part 2542 of the locking mechanism and extends to the distal end, and is fixed to the winding part 2624, for example, by winding and knotting; the free end of the adjusting section 124 passing through the channel 268 extends proximally through the connecting part 2321 of the adjusting mechanism 23 and extends to the distal end, and is fixed to the winding part 2624, for example, by winding and knotting; the free end of the fixing line 13 passing through the channel 268 can be directly fixed to the winding part 2624, thereby fixing the free ends of the fixing line 13, the locking section 123, and the adjusting section 124.
[0263] The conveying device 2 and the sealing device 1 need to be used in conjunction with guide wires and expanders, etc. The specific steps are as follows:
[0264] S1. Insert the guidewire into the left superior pulmonary vein, retain the guidewire, and insert the dilator into the middle of the left atrium to establish a passage to the foramen ovale.
[0265] S2. The delivery sheath of the delivery device 2 is delivered to the left atrium through the channel reaching the foramen ovale, and the first occlusion disc 111 located at the distal end of the delivery device 2 is released in the left atrium until the first occlusion disc 111 is deployed in the left atrium.
[0266] S3. Retract the distal end of the delivery device 2 into the right atrium and release the second occlusion disc 112 until it unfolds within the right atrium. At this point, the knot 121 is fitted onto the distal end of the traction tube 246 and is in a relaxed state.
[0267] S4. The adjusting section 124 is pulled proximally by the adjusting mechanism 23 of the conveying device 2, thereby reducing the length of the connecting section 122 and shortening the distance between the first occlusion plate 111 and the second occlusion plate 112. This causes the first occlusion plate 111 and the second occlusion plate 112 to move relative to the atrial septum until the inner side of the first occlusion plate 111 is attached to one side of the atrial septum around the foramen ovale and the inner side of the second occlusion plate 112 is attached to the other side of the atrial septum around the foramen ovale.
[0268] Specifically, pressing the adjustment button 235 causes the slider 232 to move into the housing 21 within the slide rail, disengaging the first rack 2312 from the second rack 2325. Then, the adjustment button 235 is moved towards the proximal end, causing the slider 232 to move axially towards the proximal end, thereby pulling the free end of the adjustment section 124 towards the proximal end.
[0269] S5. When the atrial septum around the foramen ovale is firmly clamped by the first occlusion disc 111 and the second occlusion disc 112, the knot 121 is dislodged from the distal end of the traction tube 246 by moving proximally through the knot release mechanism.
[0270] Specifically, pressing the knot release button 245 causes the moving part 242 to move into the housing 21, disengaging the third rack 2412 from the fourth rack 2425. Then, the knot release button 245 is moved proximally, thereby moving the pulling tube 246. As the pulling tube 246 moves proximally, the knot 121 detaches from the distal end of the pulling tube 246, thus releasing the knot.
[0271] S6. The locking section 123 is pulled towards the near end by the locking mechanism of the conveying device 2, so that the knot 121 is gradually tightened and the adjusting section 124 is locked, so that the length of the connecting section 122 between the first sealing plate 111 and the second sealing plate 112 is fixed.
[0272] Specifically, looking from the near end to the far end, turning the knob 257 clockwise causes the rotating cylinder 251 to rotate, thereby causing the locking section 123 to move towards the near end, thus locking the knot 121 and achieving the purpose of locking.
[0273] The locking of the adjustment section 124 by the suture knot 121 is achieved, so that the distance between the first occlusion plate 111 and the second occlusion plate 112 is relatively fixed. This fixes the distance between the first occlusion plate 111 and the second occlusion plate 112, which is beneficial to maintain the relative position and close contact between the two occlusion plates and the tissues around the foramen ovale during and after the operation. This reduces the difficulty of retracting the delivery device 2 and is conducive to the growth of the two diaphragms towards the occlusion device 1 after the operation to complete endothelialization and form a permanent atrial septum.
[0274] S7. The tangent mechanism 26 cuts off the fixed line 13, the locking section 123 and the adjusting section 124, and withdraws the conveying device 2 to complete the sealing of the oval hole.
[0275] Specifically, the protection button 2641 is turned to the open state, and the wire cutting button 2631 is pressed down to move the wire cutting button 2631 into the housing 21, which in turn moves the wire cutting component 2632. The wire cutting component 2632 cuts the fixed wire 13, the locking section 123 and the adjusting section 124 to complete the wire cutting function.
[0276] It is understandable that after step S7, the procedure may include cutting the fixing line 13, locking section 123, and adjusting section 124 near the proximal end of the second occlusion disc inside the patient's body.
[0277] The occlusion system in this embodiment includes an occlusion device 1 and a delivery device 2. The occlusion device 1 includes two occlusion discs and a tightening line. The delivery device 2 includes a housing 21, a pushing mechanism, an adjusting mechanism 23, a locking mechanism, a releasing mechanism, and a tangent mechanism 26. The pushing mechanism delivers the occlusion device 1 to the lesion. The adjusting mechanism 23 adjusts the length of the tightening line between the two occlusion discs, thus adjusting the distance between them. The releasing mechanism releases the pre-fitted knot 121, achieving the releasing function. The locking mechanism moves the locking section 123 of the occlusion device proximally, locking the knot and achieving the locking purpose. The tangent mechanism 26 cuts the fixing line and the tightening line, withdrawing the delivery device 2 and completing the release of the occlusion device 1. The coordination of these mechanisms enables the delivery and release of the occlusion device 1, allowing it to better adapt to the patient's anatomy, improving the fit between the two occlusion discs and the surrounding tissue, thereby stably occluding the defect and improving the treatment effect.
[0278] It should be noted that the specific technical solutions in the above embodiments are applicable to each other without contradiction, and will not be elaborated upon here. Although the present invention has been described with reference to several typical embodiments, it should be understood that the terminology used is descriptive and exemplary, not restrictive. Since the present invention can be embodied in many forms without departing from the spirit or essence of the invention, it should be understood that the above embodiments are not limited to any of the foregoing details, but should be interpreted broadly within the spirit and scope defined by the appended claims. Therefore, all variations and modifications falling within the scope of the claims or their equivalents should be covered by the appended claims.
Claims
1. A sealing system, characterized in that, include: An occlusion device for sealing defects in a vascular system; the occlusion device includes two occlusion discs and a tightening line for inserting into the defect, the tightening line connecting the two occlusion discs, and the length of the tightening line between the two occlusion discs is adjustable; A conveying device for conveying the sealing device; the conveying device includes a housing and an adjusting mechanism; the housing has a receiving space. The adjustment mechanism includes a slider located within the receiving space. The slider is used to connect with the tightening line. The slider can move within the receiving space to drive the tightening line to move axially, thereby adjusting the length of the tightening line between the two sealing discs. The two sealing discs are a first sealing disc and a second sealing disc, with the first sealing disc located at the distal end of the second sealing disc. The tightening line includes: The wire knot located near the second sealing plate; The connecting segment at the distal end of the knot is connected between the first sealing plate and the second sealing plate; and A locking section and an adjusting section are connected near the end of the knot. One end of the adjusting section is connected to one end of the connecting section through the knot. The other end of the adjusting section is connected to the sliding member. When the knot is not locked, the adjusting section can move with the sliding member to adjust the length of the connecting section. The conveying device includes a pushing mechanism and a knot-releasing mechanism. The pushing mechanism includes a push rod disposed at the distal end of the housing and extending axially; the push rod has an axially extending cavity inside. The knot-releasing mechanism includes a pulling tube located within the cavity of the push rod and extending beyond the distal end of the push rod. A knot is pre-fitted onto the distal end of the pulling tube, and an adjusting section passes through the pulling tube. When the pulling tube moves proximally relative to the push rod, the knot disengages from the pulling tube.
2. The sealing system according to claim 1, characterized in that, The adjustment mechanism includes: A slide rail component is disposed within the receiving space; the slide rail component has a slide rail extending along the axial direction, and a first toothed rack is provided inside the slide rail component; The sliding member slides in conjunction with the slide rail and is able to move axially; the sliding member is provided with a second rack that meshes with the first rack. An elastic element is disposed between the sliding element and the slide rail element, and is capable of radial extension and retraction along the outer shell, so that the second rack moves radially closer to or further away from the first rack, thereby engaging or disengaging the second rack with the first rack; When the sliding member moves axially, it drives the tightening line to move, thereby adjusting the length of the tightening line between the two sealing discs.
3. The sealing system according to claim 2, characterized in that, The slide rail extends through the slide rail component; the bottom of the slide rail extends out from the slide rail component along the slide rail and connects to the tightening line.
4. The sealing system according to claim 3, characterized in that, The slider includes: The transition section has the second toothed rack on its top surface and its bottom surface for abutting against the elastic element; A connecting part is attached to the bottom of the transition part, and the bottom of the connecting part is used to extend the slide member to connect the tightening line; The pressing part is connected to the top of the transition part and is used to extend the slide member along the slide for pressing; When the pressing part moves radially and axially along the outer shell, it drives the connecting part and the transition part to move.
5. The sealing system according to claim 4, characterized in that, The pressing part and the transition part are connected by a bending part, and the top surface of the bending part can abut against the bottom surface of the top wall of the slide piece.
6. The sealing system according to claim 4, characterized in that, The conveying device includes a winding portion disposed in the receiving space, the winding portion being disposed in the distal region of the slider; The free end of the tightening wire is connected to the winding portion, and at least one other section of the tightening wire, excluding the free end, is connected to the connecting portion.
7. The sealing system according to claim 6, characterized in that, The connecting portion has a connecting hole through which the tightening wire passes.
8. The sealing system according to claim 4, characterized in that, The adjustment mechanism is equipped with a positioning frame; the top of the positioning frame is open, and the interior has a positioning space. The positioning frame is located inside the slide rail and at the bottom of the slide rail. The elastic member is located in the positioning space, and both ends of the elastic member abut against the positioning frame and the slide rail, respectively.
9. The sealing system according to claim 8, characterized in that, The positioning frame includes a base plate and a side wall connected to the base plate. The base plate and the side wall form the positioning space. The side wall includes two end plates connected to the proximal end and the distal end of the base plate, respectively. Part of the transition portion is located within the positioning space. The two end plates are respectively disposed on the proximal side and the distal side of the transition portion and are used to abut against the proximal end and the distal end of the transition portion.
10. The sealing system according to claim 8, characterized in that, The sidewall of the positioning frame includes two side plates connected between two end plates. The radial height of the side plates is less than that of the end plates. The transition portion extends from the top of the side plate into the positioning space, and the connection portion is located outside the positioning frame.
11. The sealing system according to any one of claims 1 to 10, characterized in that, The conveying device further includes a locking mechanism; the locking mechanism is connected to the locking section and can drive the locking section to move towards the proximal end, thereby locking the knot to fix the length of the connecting section.
12. The sealing system according to claim 11, characterized in that, The locking mechanism includes: A rotating cylinder is located within the receiving space and is capable of rotating circumferentially along the outer shell; the inner wall of the rotating cylinder is provided with internal threads; A slide rail is located inside the rotating cylinder and extends along the axial direction of the rotating cylinder; The slider slides in conjunction with the slide rail; the slider is connected to the locking section; the outer periphery of the slider is provided with an external thread that meshes with the internal thread; When the rotating cylinder rotates circumferentially, the external thread engages with the internal thread, causing the slider to slide along the slide rail, which in turn causes the locking section to move axially toward the proximal end.
13. The sealing system according to claim 12, characterized in that, The outer casing includes a limiting member disposed on the inner side; The limiting member extends radially and abuts against the slide rail to restrict the slide rail from rotating circumferentially along the housing; The slider has a sliding surface in the circumferential direction, and the slide rail has a limiting part. The limiting part abuts against the sliding surface in the circumferential direction, thereby restricting the slider's rotation relative to the slide rail in the circumferential direction.
14. The sealing system according to claim 13, characterized in that, The slide rail has an extension protruding from its far end, and the extension has a notch in the circumferential direction, which extends out of the rotating cylinder. The limiting member abuts against the sidewall at the notch in the circumferential direction, thereby restricting the slide rail from rotating circumferentially along the outer shell.
15. The sealing system according to claim 13, characterized in that, The limiting part is a partially cylindrical shape extending along the axial direction, with an opening formed at the top of the limiting part, and the two ends of the limiting part surrounding the opening in the circumferential direction are used to abut against the sliding surface.
16. The sealing system according to claim 12, characterized in that, The slider includes an engaging portion and a connecting portion disposed at the distal end of the engaging portion; The outer periphery of the engagement part is provided with an external thread for engaging with the internal thread, and the connecting part is used to connect with the locking section; The slide rail is provided with a distal retaining ring at its distal end. The proximal end face of the distal retaining ring is used to stop the slider on the distal side in the axial direction. The distal retaining ring has an opening. The locking section and the connecting part can be connected to each other through the opening of the distal retaining ring.
17. The sealing system according to claim 12, characterized in that, The locking mechanism further includes: The indicator block is located within the accommodating space; The outer casing is equipped with a light-transmitting indicator window; The outer periphery of the rotating cylinder is connected to the indicator block by a threaded engagement, so that when the rotating cylinder rotates, the rotating cylinder drives the indicator block to move axially, thereby enabling the determination of whether the locking is completed based on the position of the indicator block in the indicator window.
18. The sealing system according to claim 17, characterized in that, The indicator block has a slot with an opening facing the near end; The locking mechanism further includes a positioning cylinder sleeved on the proximal end of the housing; the positioning cylinder has a plug protruding to the distal end, the plug being inserted into the slot within the housing.
19. The sealing system according to claim 11, characterized in that, Both the adjustment section and the locking section extend proximally through the cavity.
20. The sealing system according to claim 19, characterized in that, The number of cavities is multiple, and the multiple cavities are independent of each other. The adjustment section and the locking section are respectively installed in the independent cavities.
21. The sealing system according to claim 19, characterized in that, The sealing device further includes a fixing line; the two ends of the fixing line are respectively connected to the conveying device and the second sealing disc, so as to fix the second sealing disc to the far end of the conveying device; The fixing line passes through the cavity.
22. The sealing system according to claim 19, characterized in that, The knot-releasing mechanism includes: A passage component is disposed within the receiving space; the passage component has a passage extending along the axial direction, and a third rack is provided within the passage component; The movable component is slidably engaged with the passage and is capable of moving axially; the movable component is provided with a fourth rack that meshes with the third rack; A telescopic member is disposed between the moving member and the passage member, and is capable of radial extension and retraction along the outer shell, thereby causing the fourth rack to move radially closer to or further away from the third rack, thus engaging or disengaging the fourth rack from the third rack. The traction tube is fixedly connected to the moving part. As the pulling tube moves proximally relative to the push rod along with the moving member, the knot disengages from the pulling tube.
23. The sealing system according to claim 20, characterized in that, The push rod includes a rod body and a head end disposed at the distal end of the rod body. The push rod forms a plurality of cavities, including a first cavity. The head end is provided with a first through hole extending axially therefrom. The rod body includes a first through hole extending axially therefrom. The first cavity includes a first through hole and a first through hole that communicate with each other. The pulling tube is inserted into the first cavity. The distal end of the pulling tube extends out from the distal end of the push rod through the first cavity. The radial dimension of the first through hole is smaller than that of the first through hole. During the process of the pulling tube moving proximally relative to the push rod, the distal end face of the push rod pushes the knot out from the distal end of the pulling tube, thereby detaching the knot from the pulling tube.
24. The sealing system according to claim 20, characterized in that, The push rod includes a rod body and a head end disposed at the distal end of the rod body. The push rod forms a plurality of cavities including a first cavity. The head end is provided with a first through hole extending along its axial direction. The rod body includes a first through hole extending along its axial direction. The first cavity includes a first through hole and a first through hole communicating with each other. The traction tube passes through the first cavity. The head end and the distal portion of the traction tube are both made of metal material.
25. The sealing system according to claim 22, characterized in that, The distal end of the traction tube includes a circumferentially outward protrusion, and the knot is used to be fitted between the proximal side of the protrusion and the distal end of the push rod.