Interventional delivery system for implanting occlusion device

Abstract

The application discloses an interventional delivery system for implanting a closure device, comprising: a closure member having a compressed loading state, a proximal end of the closure member being provided with a restraining ring; an interventional catheter; a delivery tube slidingly arranged in the interventional catheter, the delivery tube being provided with a pull wire passing through the restraining ring; a control handle comprising a housing and a cutting member and a driving member movably arranged, the interventional catheter being connected to the driving member, the delivery tube being connected to the housing, the cutting member being used for cutting the pull wire to release the closure member; the driving member having a first position and a second position for exposing the closure member, in the first position, the driving member blocks the cutting member from cutting the pull wire, in the second position, the pull wire is exposed to the cutting member to allow cutting. The application mechanically ensures that the cutting member can cut the pull wire in a preset working condition by isolating the pull wire from the cutting member in the first position of the driving member and exposing the pull wire for cutting in the second position, automatically associates the release timing with the advancing action, simplifies the operation and effectively prevents mistakes.

Description

Technical Field

[0001] This application relates to the field of vascular interventional therapy, and in particular to interventional delivery systems for implanting occlusion devices. Background Technology

[0002] In the field of interventional medicine, the precise and safe delivery and release of implants within the body is a core prerequisite for the success of minimally invasive treatments. This is especially true for smart materials that combine functionality and biocompatibility, where the performance of the accompanying delivery and release device directly determines the clinical application outcome. Shape memory polymers (SMPs), as a typical type of stimulus-responsive smart polymer material, can be used as occluders for vascular closure or embolization. They exhibit broad application prospects in this field due to their unique advantages. They possess a two-phase structure consisting of a fixed phase that maintains a permanent shape and a reversible phase that imparts temporary deformation capabilities. Under external stimuli such as temperature and moisture, they can precisely recover from a temporary deformed state to a preset shape. Furthermore, by controlling the raw material ratio, cross-linking degree, and molecular chain structure, they can flexibly adapt to the requirements of different treatment scenarios regarding shape memory temperature, recovery rate, mechanical strength, and degradation cycle, providing novel material solutions for minimally invasive interventional treatments such as vascular repair and tissue regeneration.

[0003] For the intervention, delivery, and release of SMP, some existing mechanical release devices can be used. However, most mechanical release devices face problems of complex structure and high operation difficulty. For example, the locking and unlocking of some mechanical release devices rely on the coordinated action of multiple components, which requires precise control by the operator. Some solutions have designed multiple constraint structures to improve connection stability, which leads to the need to overcome greater resistance during release, and there is a risk of implant jamming or accidental dislodgement.

[0004] Therefore, it is necessary to provide an interventional delivery system that can mechanically ensure that release can only be performed under preset conditions, in order to improve the controllability and safety of the implantation process. Summary of the Invention

[0005] To address the aforementioned technical problems, this application discloses an interventional delivery system for implanting an occlusion device, having a distal end and a proximal end, the interventional delivery system comprising: The sealing element has a compressed loaded state and a fully expanded preset state, and the proximal end of the sealing element is provided with a constraint ring; An interventional catheter for receiving the occlusion device in its loaded state; A delivery tube is slidably inserted inside the interventional catheter, and a pull wire passing through the restraint ring is provided inside the delivery tube; A control handle includes a housing and a cutting element and a drive element movably disposed relative to the housing, the interventional catheter being connected to the drive element, the delivery tube being connected to the housing, and the cutting element being used to cut the pull wire to release the occlusion element; The drive has an initial first position and a second position that drives relative movement of the tubing to expose the sealing element. In the first position, the drive isolates the pull wire and the cutter to prevent the cutter from cutting the pull wire. In the second position, the pull wire is exposed to the cutter to allow cutting.

[0006] Several alternative methods are provided below, but they are not intended as additional limitations on the overall solution above. They are merely further additions or optimizations. Provided there are no technical or logical contradictions, each alternative method can be combined individually with respect to the overall solution above, or multiple alternative methods can be combined with each other.

[0007] Referring to one embodiment, the drive member moves unidirectionally relative to the housing in a first direction.

[0008] Referring to one embodiment, the cutting member moves relative to the housing in a second direction, the first direction and the second direction intersect, and the driving member provides a mating cavity extending along its own direction of movement, the cutting member being received within the mating cavity; The mating cavity is provided with a cutting hole, and in the second position, the pull wire is exposed to the cutting hole.

[0009] According to one embodiment, the cutting member includes a blade holder movably fitted to the housing and a cutting edge disposed on the blade holder. The blade holder is provided with an elastic arm. During the process of the cutting member passing through the cutting hole to cut the wire, the elastic arm is deformed by compression against the inner circumferential surface of the cutting hole.

[0010] In one embodiment, the end of the elastic arm is provided with a positioning claw. When the cutting component moves to a preset position, the positioning claw engages with the edge of the cutting hole to prevent the cutting component from retracting.

[0011] Referring to one embodiment, the two ends of the pull cable are connected to the control handle and the middle extends to the distal end.

[0012] Referring to one embodiment, the extension path of the pull wire includes a cutting path located on the central axis of the housing and a detour path that avoids the cutting path. The housing is provided with a cutting table opposite to the cutting element, and the cutting element and the cutting table are respectively located on both sides of the cutting path.

[0013] Referring to one embodiment, the control handle further includes a recycling assembly, the recycling assembly including a recycling cylinder rotatably disposed on the housing, the pull wire including a fixed end fixed to the housing and a recycling end fixed to the recycling cylinder, and the cut pull wire is recycled and wound around the outer circumferential surface of the recycling cylinder.

[0014] Referring to one embodiment, the recycling component further includes: The drive knob is exposed outside the housing and rotates to set the position; The transmission mechanism is linked between the drive knob and the recovery cylinder; A one-way mechanism is disposed between the housing and the drive knob.

[0015] Referring to one embodiment, the sealing element is made of shape memory polymer foam, and the constraint ring is configured as follows: The base is formed by localized hardening of the proximal end of the sealing member, and the constraint ring is connected to the base; or The sealing element is locally hardened to form a ring structure to provide the constraint ring.

[0016] An embodiment of this application also discloses an interventional delivery system for implanting an occlusion device, having a distal end and a proximal end, the interventional delivery system comprising: The sealing element has a compressed loaded state and a fully expanded preset state, and the proximal end of the sealing element is provided with a constraint ring; An interventional catheter for receiving the occlusion device in its loaded state; The delivery tube is slidably inserted into the interventional catheter, and a gap is provided between the occlusion element in the loaded state and the distal end of the delivery tube to form a hollow section; A control handle includes a housing and a cutting element and a drive element movably disposed relative to the housing, the interventional catheter being connected to the drive element, the delivery tube being connected to the housing, and the cutting element being used to cut the pull wire to release the occlusion element; A pull wire, the proximal end of which is connected to the control handle, and the distal end of which is releasably connected to the constraint ring via the delivery tube, the pull wire driving the sealing member to move to change the length of the hollow section.

[0017] In one embodiment, the ratio between the length L2 of the hollow segment and the length L1 of the occlusion element in the extension direction of the interventional catheter ranges from 0.1 to 0.5.

[0018] The technical solution disclosed in this application isolates the pull wire and the cutting component in the first position by using a driving component, and exposes the pull wire for cutting in the second position. From a mechanical structure perspective, this ensures that cutting can only be performed when the occlusion component is fully exposed inside the blood vessel (expanded). This effectively prevents the occlusion component from being difficult or impossible to separate from the interventional delivery system due to incomplete exposure (partial expansion of the occlusion component inside the interventional lumen). The release timing and the advancement action are automatically linked, simplifying the operation.

[0019] The specific beneficial technical effects will be further explained in the specific implementation methods in conjunction with the specific structures or steps. Attached Figure Description

[0020] Figure 1 This is a schematic diagram of an interventional delivery system for implanting an occlusion device in one embodiment of this application; Figure 2 for Figure 1 A top-view schematic diagram of the interventional delivery system for implanting occlusion devices; Figure 3 for Figure 2 A schematic diagram of the assembly of some components of the control handle from the AA-axis cross-sectional view; Figure 4 for Figure 1 A schematic diagram of the explosion state of the interventional delivery system for implanting occlusion devices; Figure 5 for Figure 4 Enlarged view of section B in the middle; Figure 6 A schematic diagram showing the assembly of components after omitting the housing from the control handle portion; Figure 7 for Figure 6 A schematic diagram of the control handle's interaction from another perspective; Figure 8 for Figure 7 Enlarged view of section C in the middle; Figure 9 for Figure 1 Enlarged schematic diagram of the distal part of the interventional delivery system for implanting occlusion devices (to avoid obstruction, the occlusion device in the figure still maintains the dimensions of the loaded state). Figure 10 This is an enlarged schematic diagram of the distal portion of the interventional delivery system in another embodiment (to avoid obstruction, the sealing component in the figure still maintains the dimensions of the loaded state). Figure 11 for Figure 2 Schematic diagram of the assembly of the distal components from the AA-axis cross-sectional view; Figure 12 for Figure 11 A schematic diagram of the components in the extended state of the interventional delivery system; Figure 13 This is a schematic diagram showing the usage status of an interventional delivery system for implanting an occlusion device in one embodiment; Figure 14 for Figure 13 A schematic diagram of the intervention delivery system for implanting occlusion devices releasing the occlusion component.

[0021] The annotations in the figure are explained as follows: 100. Sealing component; 110. Constraint ring; 120. Pull wire; 121. Cutting path; 122. Detour path; 123. Fixed end; 124. Retrieval end; 200. Interventional catheter; 300. Delivery tube; 400. Control handle; 410. Housing; 4101. Upper housing; 4102. Lower housing; 4103. First opening; 411. Positioning tooth; 412. Cutting table; 4121. First guide groove; 4122. Second guide groove; 4123. Fixing groove; 413. Guide platform; 4131. Passing groove; 4132. Retaining structure; 420. Drive component; 4201. Mating cavity; 4202. Cutting hole; 4203. Clearance cavity; 4 21. Positioning claw; 422. Drive unit; 430. Cutting component; 431. Tool holder; 4311. Flexible arm; 4312. Positioning chuck; 4313. Extension arm; 4314. Trigger unit; 4315. Cantilever; 4316. Protective end; 432. Blade; 440. Recovery assembly; 441. Recovery cylinder; 442. Drive knob; 443. Transmission mechanism; 444. One-way mechanism; 4441. Ratchet; 4442. Positioning pin; 901. Far end; 902. Proximal end; 903. First direction; 904. Second direction; 905. Hollow section. Detailed Implementation

[0022] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0023] It should be noted that when a component is said to be "connected" to another component, it can be directly connected to the other component or it can be connected to a component in between. When a component is said to be "set on" another component, it can be directly set on the other component or it may be set to a component in between.

[0024] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the application. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0025] Reference Appendix Figure 1 To be continued Figure 4 As shown, this application discloses an interventional delivery system for implanting an occlusion device, having a distal end 901 and a proximal end 902. The interventional delivery system includes two relatively movable tubing components to achieve delivery, restraint, ejection, and release of the occlusion device 100. In the following text, unless otherwise specified, ejection of the occlusion device 100 refers to the movement of the interventional catheter 200 within the occlusion device 100 from the inside to the outside, i.e., the control handle 400 controls the occlusion device 100 solely through the pull cable 120; release of the occlusion device 100 refers to the disconnection of the pull cable 120 from the occlusion device 100, i.e., the control handle 400 loses control of the occlusion device 100.

[0026] The tubing specifically comprises the relatively movable interventional catheter 200 and delivery tube 300. The occlusion element 100 is in a compressed, loaded state (see attached diagram). Figure 11 Appendix Figure 13 (as shown) and the preset state of full expansion (see attached) Figure 14 (As shown). In the loaded state, the occlusion element 100 is housed within the interventional catheter 200, and the delivery tube 300 slides through the interventional catheter 200. The relative positions of the interventional catheter 200 and the delivery tube 300 are changed via a control handle 400, thereby enabling the occlusion element 100 to be extended. The control handle 400 includes a housing 410 and a drive member 420 movably disposed relative to the housing 410. The interventional catheter 200 is connected to the drive member 420, and the delivery tube 300 is connected to the housing 410. Depending on the different mating types of the interventional catheter 200 and the delivery tube 300, the occlusion element 100, the interventional catheter 200, and the delivery tube 300 in the loaded state can have various mating forms. For example, see attached... Figure 9 As shown, the interventional catheter 200 is fitted around the delivery tube 300, and the two are similar in size. The delivery tube 300 pushes the proximal end 902 of the occlusion member 100 to drive the occlusion member 100 out of the interventional catheter 200.

[0027] In addition to the interventional catheter 200 and delivery tube 300, the control handle 400 participates in the constraint of the occlusion member 100 via a pull wire 120. The proximal end 902 of the occlusion member 100 is provided with a constraint ring 110. One end of the pull wire 120 is coupled to the control handle 400, and the other end passes through the delivery tube 300 to the distal end 901 and is coupled to the constraint ring 110. The pull wire 120 can establish a constraint path to limit the relative distance between the occlusion member 100 and the control handle 400, thereby limiting the relative distance between the occlusion member 100 and the distal ends 901 of the interventional catheter 200 and the delivery tube 300. In this embodiment, the occlusion member 100 is made of shape memory polymer foam, and the corresponding constraint ring 110 can be implemented in various ways. For example, the proximal end 902 of the occlusion member 100 can be locally hardened to form a base, and the constraint ring 110 can be connected to the base; another example is that the occlusion member 100 can be locally hardened to form a ring structure to provide the constraint ring 110, and so on. Regardless of how the constraint ring 110 is configured, it can be understood as part of the sealing element 100. Preferably, the attached... Figure 11 The sealing element 100 and the constraint ring 110 shown are implemented in the following manner: First, insert the annular component containing the developing ring into the SMP material of the sealing component for initial fixation. After initial fixation, only a small part of the arc structure of the developing ring is exposed at the proximal end of the sealing component. Cover the entire annular component (especially the internal space of the developing ring) with an adhesive (such as UV glue) until the annular component is completely covered to form a locally hardened area near the end of the sealing component; Precision drill bits, needles, and other tools are used to precisely drill holes in the locally hardened areas to obtain the constraint ring 110 mentioned above for the installation of the guy wire.

[0028] The release of the pull wire 120 is achieved by a cutting element 430 movably disposed in the housing 410. Specifically, the cutting element 430 is used to cut the pull wire 120 to release the sealing element 100.

[0029] In this embodiment, the movement processes of the driving component 420 and the cutting component 430 are interlocked. Specifically, the driving component 420 has an initial first position and a second position that drives the pipe to move relative to each other to expose the sealing component 100 (see attached diagram). Figure 3 As shown), in the first position, the drive member 420 isolates the pull wire 120 and the cutter 430 to prevent the cutter 430 from cutting the pull wire 120, and in the second position, the pull wire 120 is exposed to the cutter 430 to allow cutting.

[0030] For detailed settings of driver 420, please refer to the attached document. Figure 3 To be continued Figure 4In the illustrated embodiment, the drive member 420 moves unidirectionally relative to the housing 410 in a first direction 903. Further, the unidirectional movement of the drive member 420 causes the interventional catheter 200 to retract relative to the delivery tube 300, thereby allowing the occlusion member 100 to leave the interior of the interventional catheter 200. A unidirectional mechanism 444 is provided between the drive member 420 and the housing 410 to achieve unidirectional movement. The unidirectional mechanism 444 includes a positioning tooth 411 disposed on one of the drive member 420 and the housing 410, and a positioning claw 421 disposed on the other of the drive member 420 and the housing 410. In the figure, the positioning tooth 411 is disposed on the side wall of the inner cavity of the housing 410, and the positioning claw 421 is disposed on the circumferential surface of the drive member 420. The drive member 420 is cylindrical in shape, and its outer circumferential dimensions are close to the inner cavity dimensions of the housing 410; the two slide against each other to achieve motion guidance. Positioning teeth 411 and positioning claws 421 are arranged in pairs to form one-way mechanisms 444, and multiple sets of one-way mechanisms 444 are provided. Multiple sets of one-way mechanisms 444 are spaced apart in the circumferential direction of the control handle 400. For example, refer to the attached... Figure 4 In the illustrated embodiment, the housing 410 includes an upper housing 4101 and a lower housing 4102 that interlock. Both the upper housing 4101 and the lower housing 4102 have a plurality of positioning teeth 411 on their inner circumferential surfaces, and at least one set of positioning teeth 411 engages with the same positioning claw 421 after the upper housing 4101 and the lower housing 4102 are assembled. The driving member 420 also includes a driving portion 422 extending to the outside of the housing 410. The housing 410 has a first open hole 4103 for avoiding the driving portion 422. The driving portion 422 and the driving member 420 can be an integral structure, or, as shown in the figures, the driving member 420 can have a insertion hole for the driving portion 422 to be inserted into. The distal end 901 of the drive unit 420 is fixedly connected to the interventional catheter 200, and the proximal end 902 has a mating cavity 4201 and a clearance cavity 4203 extending along its own movement direction. The mating cavity 4201 is used to release motion interference between the drive unit 420 and the cutting element 430, and the clearance cavity 4203 is used to release motion interference between the drive unit 420 and the pull wire 120 and the blade holder 431. See attached diagram for details. Figure 4 Regarding the direction indication, the cutting element 430 moves relative to the housing 410 in a second direction 904. The first direction 903 and the second direction 904 intersect. The cutting element 430 is housed in a mating cavity 4201, which has a cutting hole 4202. In the second position, the pull wire 120 is exposed through the cutting hole 4202. The pull wire 120 is located in a relief cavity 4203. The mating cavity 4201 and the relief cavity 4203 are interconnected through the cutting hole 4202.

[0031] For specific settings regarding cutting part 430, please refer to the attached document. Figure 4 Appendix Figure 7 and appendix Figure 8In the illustrated embodiment, the cutting element 430 includes a blade holder 431 movably fitted to the housing 410 and a cutting edge 432 disposed on the blade holder 431. The blade holder 431 is provided with an elastic arm 4311. During the process of the cutting element 430 penetrating the cutting hole 4202 to cut the wire 120, the elastic arm 4311 is deformed by compression against the inner circumferential surface of the cutting hole 4202. The blade holder 431 also includes an extension arm 4313 extending away from the cutting edge 432. The extension arm 4313 protrudes outside the housing 410 and is provided with a trigger part 4314. The trigger part 4314 is used to withstand the force exerted by the operator to drive the blade holder 431, along with the cutting edge 432, toward the cutting hole 4202. Further reference is made to the appendix. Figure 8 In the embodiment shown, the end of the elastic arm 4311 is provided with a positioning claw 4312. When the cutting piece 430 moves to the preset position (see attached figure), Figure 8 (As shown in the diagram), the positioning claw 4312 engages with the edge of the cutting hole 4202 to prevent the cutting element 430 from retracting. In this embodiment, the blade holder 431 is generally plate-shaped and partially dematerialized to form two opposing cantilever arms 4315. Between the two cantilever arms 4315 is a cavity for accommodating the blade with the cutting edge 432. The two cantilever arms 4315 are provided with blade grooves for inserting the two side edges of the blade. The extension length of the cantilever arm 4315 is greater than the extension length of the blade to form a protective end 4316. The protective end 4316 protrudes outward relative to the cutting edge 432. When the driving member 420 moves between the first position and the second position, the protective end 4316 slides with the inner circumferential surface of the mating cavity 4201 to avoid wear of the cutting edge 432. When the cutting element 430 cuts the pull wire 120, the cutting edge 432 located between the protective ends 4316 of the two cantilever arms 4315 engages with the pull wire 120 to achieve cutting. Positioning claws 4312 are arranged in pairs within the accommodating cavity. Two of the pair of positioning claws 4312 are located on either side of the blade 432 to adaptively adjust the relative position between the blade 432 and the cutting hole 4202.

[0032] Cutting between the cutting element 430 and the tensioned wire 120 can be achieved through the interaction of the cutting edge 432 and the tensioned wire 120, or a cutting table 412 can be provided to improve cutting efficiency. (See attached document) Figure 4 and attached Figure 5In the illustrated embodiment, the housing 410 is provided with a cutting table 412 opposite to the cutting member 430. The cutting table 412 is provided with a first guide groove 4121 for the pull wire 120 to pass through, and a second guide groove 4122 intersecting with the first guide groove 4121. The blade 432 of the cutting member 430 enters the second guide groove 4122 through the cutting hole 4202 to cut the pull wire 120. The depth of the second guide groove 4122 is greater than or equal to the depth of the first guide groove 4121. The cutting table 412 is provided with a fixing groove 4123, and the pull wire 120 is fixedly connected to the fixing groove 4123. For example, the fixing groove 4123 is fitted with a plug-in block (not shown in the figure), and the pull wire 120 is clamped by the fixing groove 4123 and the plug-in block to be positioned on the cutting table 412; or, for example, the fixing groove 4123 is filled with an adhesive that acts on the pull wire 120. The setting of the fixing groove 4123 enables the taut wire 120 to be pulled at the cutting table 412, thereby improving cutting efficiency.

[0033] For specific settings regarding the 120-gauge cable, please refer to the attached document. Figure 7 In the illustrated embodiment, the two ends of the pull cable 120 are connected to the control handle 400 and the middle extends to the distal end 901. Further, one end of the pull cable 120 is fixedly connected to the fixing groove 4123 of the cutting table 412, and the other end is fixedly connected to the housing 410. Before cutting, the pull cable 120 forms a complete constraint path to connect the sealing member 100; after cutting, the constraint path of the pull cable 120 opens to release the sealing member 100. The path of the pull cable 120 can be segmented according to different functions. For example, in one embodiment, the extension path of the pull cable 120 includes a cutting path 121 located on the central axis of the housing 410 and a detour path 122 that avoids the cutting path 121. The cutting member 430 and the cutting table 412 are located on both sides of the cutting path 121, respectively. The housing 410 is provided with a guide platform 413 surrounding the cutting table 412, which provides the detour path 122. The guide table 413 is provided with a passage groove 4131 for the pull wire 120 to pass through, and a number of pressure plates or corresponding holding structures 4132 for holding the pull wire 120 in the passage groove 4131. The middle part of the guide table 413 is offset relative to the cutting table 412 to provide a detour path 122, and the two ends of the guide table 413 and the cutting table 412 as a whole are located on the central axis of the housing 410.

[0034] The cut suture 120 can be withdrawn from the body along with the interventional catheter 200 and delivery tube 300, or it can be retrieved independently. (See attached reference.) Figure 3In the illustrated embodiment, the control handle 400 further includes a retrieval assembly 440, which includes a retrieval cylinder 441 rotatably mounted on the housing 410. A pull cord 120 includes a fixed end 123 fixed to the housing 410 and a retrieval end 124 fixed to the retrieval cylinder 441. The cut pull cord 120 is wound around the outer circumference of the retrieval cylinder 441. The retrieval cylinder 441 can be directly operated for retrieval or indirectly operated. For example, in one embodiment, the retrieval assembly 440 further includes: a drive knob 442 exposed outside the housing 410 and rotatably mounted; and a transmission mechanism 443 linked between the drive knob 442 and the retrieval cylinder 441. The transmission mechanism 443 allows for flexible arrangement of the drive knob 442 and the retrieval cylinder 441. For example, in the attached... Figure 3In this configuration, the rotation axis of the recovery cylinder 441 is perpendicular to the axial direction of the housing 410. The transmission mechanism 443 allows the drive knob 442 to be positioned at the axial end of the housing 410, providing a good user experience and adaptability for both left and right hands. The transmission mechanism 443 can also be used to configure the transmission ratio; in the accompanying drawings, the transmission mechanism 443 represents a meshing gear mechanism. In other embodiments, the transmission mechanism 443 can be a gear mechanism with a changeable meshing relationship to adapt to different control needs at different operating stages. For example, when the blocking member 100 is pushed out or in the early stage of releasing the blocking member 100, when it is necessary to finely adjust the tension of the pull line 120, the transmission mechanism 443 uses a close transmission ratio to improve control accuracy; after the cutting member 430 has finished cutting the pull line 120, the transmission mechanism 443 uses a sparse transmission ratio to improve the recovery efficiency of the pull line 120. For example, the transmission mechanism 443 includes a first bevel gear linked to the recovery cylinder 441 and a second bevel gear linked to the drive knob 442, with the first and second bevel gears meshing with each other. The recovery cylinder 441 is assembled from two identical parts and then mounted on the linkage shaft of the first bevel gear to optimize the forming and assembly process of the recovery cylinder 441 and the transmission mechanism 443. To achieve the above effects, the specific details of the variable transmission ratio transmission mechanism 443 can also be implemented using existing technology, which will not be elaborated here. In this embodiment, the recovery assembly 440 also includes a one-way mechanism 444 disposed between the housing 410 and the drive knob 442. The one-way mechanism 444 is used to prevent the recovery cylinder 441 from releasing the recovered pull wire 120, thereby causing a decrease in the control accuracy of the sealing component 100 and possible control failure. The one-way mechanism 444 consists of several ratchet teeth arranged radially relative to the housing 410. The ratchet teeth cooperate with the pawls on the inner circumferential surface of the drive knob 442 to achieve one-way release. Multiple ratchet teeth are provided on the ratchet disc 4441. The ratchet disc 4441 is provided with positioning pins 4442 that are inserted and positioned with the housing 410. The drive knob 442 and the transmission mechanism 443 cooperate with each other through the transmission shaft. The housing 410 is provided with an end face shaft hole to avoid the transmission shaft. Multiple positioning pins 4442 are provided and arranged around the end face shaft hole. The drive knob 442 is close to the end of the housing 410 to cover the ratchet disc 4441 and the end face shaft hole.

[0035] In summary, the specific embodiments in this application possess at least the following technical advantages: Prevent accidental cutting and improve release safety: By configuring the drive member 420 to have a first position and a second position, and in the first position physically isolating the pull wire 120 from the cutting member 430, preventing the cutting member 430 from contacting the pull wire 120; only after the drive member 420 moves to the second position (i.e., the occlusion member 100 has been fully exposed and positioned from the interventional catheter 200) is the pull wire 120 exposed to the cutting member 430 to allow cutting. This mechanical interlocking structure fundamentally avoids the risk of premature release or ectopic embolization caused by the operator accidentally triggering the cutting member 430 before the occlusion member 100 is in place, significantly improving the safety and fault tolerance of the implantation process.

[0036] Release timing is automatically linked to propulsion action, simplifying operation: The drive unit 420 moves unidirectionally relative to the housing 410 in the first direction 903, and the interventional catheter 200 is connected to the drive unit 420 and the delivery tube 300 is connected to the housing 410. The operator can simultaneously complete the exposure process of the occlusion unit 100 by advancing the drive unit 420. The cutting unit 430 is ready to cut only after the drive unit is in place. This design links the two steps of "advance positioning" and "allowing release" through a mechanical structure, eliminating the need for the operator to make additional judgments or remember the cutting timing, thus reducing the learning curve and the difficulty of intraoperative operation.

[0037] The cutting process is highly controllable, reliable, and prevents backtracking. The elastic arm 4311 of the cutting element 430 deforms against the inner circumferential surface of the cutting hole 4202 as it penetrates the hole, providing clear tactile feedback and cutting damping, allowing the operator to accurately perceive the cutting process. The positioning jaw 4312 engages with the edge of the cutting hole 4202 when the cutting element 430 moves to the preset position, preventing the cutting element 430 from retracting and ensuring that the pull wire 120 is completely cut. This avoids the phenomenon of incomplete cutting or "lingering" of the pull wire 120 due to the springback of the cutting element 430, improving the crispness and reliability of the release.

[0038] Optimize the routing path of the 120mm cable to reduce the risk of interference: The extension path of the draw wire 120 includes a cutting path 121 located on the central axis of the housing 410 and a detour path 122 that avoids the cutting path 121. The cutting element 430 and the cutting table 412 are located on both sides of the cutting path 121, respectively. This design allows the draw wire 120 to remain slack or deviate from the cutting path 121 when not cutting, avoiding unnecessary friction or interference between the draw wire 120 and the internal structure of the housing 410; at the same time, during cutting, the draw wire 120 is precisely guided between the cutting element 430 and the cutting table 412, ensuring the accuracy of the cutting position.

[0039] It has a retrieval function, improving the ability to make adjustments during surgery: The control handle 400 incorporates a retrieval assembly 440 (retrieval cylinder 441, drive knob 442, transmission mechanism 443, and one-way mechanism 444), allowing the cut pull wire 120 to be retrieved and wound around the outer circumference of the retrieval cylinder 441. Compared to traditional systems where adjustments are not possible after a single cut, this application allows the operator to pull back, recompress, or adjust the posture of the occluder 100 using the retrieval pull wire 120 before cutting and releasing or when the position is deemed unsatisfactory. This significantly increases the possibility of intraoperative repositioning or retrieval and replacement, and reduces medical risks caused by poor release positioning.

[0040] The pull cord 120 is fixed at both ends to the handle for easy operation and retrieval. The two ends of the pull cord 120 are fixed to the housing 410 and the retrieval cylinder 441, respectively, and the middle extends to the distal end 901, passing through the constraint ring 110. This closed-loop wiring layout allows the tension and slack of the pull cord 120 to be controlled by the handle end, eliminating the need for additional fixing points of the pull cord 120 outside the patient's body. The overall structure is compact, easy to operate, and also facilitates the uniform winding of the retrieval component 440.

[0041] One-way mechanism 444 ensures that the state is maintained after recovery: The recovery assembly 440 has a one-way mechanism 444 between the housing 410 and the drive knob 442, which allows the tension of the pull cable 120 to be maintained after the operator rotates the recovery pull cable 120 without automatically retracting. This makes it easy to maintain a temporary compressed or constrained state after adjusting the position of the sealing member 100, without having to continuously manually maintain the torque, thus reducing fatigue during long-term operation.

[0042] Optimize the connection between the sealing component 100 and the constraint ring 110 to improve structural consistency: By locally hardening the proximal end 902 of the sealing element 100 to form a base or directly forming a ring structure to provide a constraint ring 110, the weak connection between the additional metal or polymer constraint element and the foam matrix is ​​avoided, making the traction force of the pull wire 120 on the sealing element 100 more evenly distributed, reducing the risk of pull-out, and at the same time facilitating the overall loading of the sealing element 100 under compression.

[0043] Based on the above description, the occlusion device 100 and the delivery tube 300 are in a clearance fit, and this clearance can be adjusted by adjusting the length of the pull wire 120. Therefore, one embodiment of this application also discloses an interventional delivery system for implanting an occlusion device, having a distal end 901 and a proximal end 902, the interventional delivery system comprising: The sealing element 100 has a compressed loading state and a fully expanded preset state, and the proximal end 902 of the sealing element 100 is provided with a constraint ring 110. Interventional catheter 200, for accommodating the occlusion element 100 in its loaded state; The delivery tube 300 is slidably inserted into the interventional catheter 200, and a gap is provided between the occlusion member 100 in the loaded state and the distal end 901 of the delivery tube 300 to form a hollow section 905. The control handle 400 includes a housing 410 and a cutting member 430 and a drive member 420 movably disposed relative to the housing 410. The interventional catheter 200 is connected to the drive member 420, and the delivery tube 300 is connected to the housing 410. The cutting member 430 is used to cut the pull wire 120 to release the occlusion member 100. Pull cable 120, the proximal end 902 of pull cable 120 is connected to control handle 400, and the distal end 901 of pull cable 120 is releasably connected to restraint ring 110 via delivery tube 300. Pull cable 120 drives sealing member 100 to move to change the length of hollow section 905.

[0044] The main feature of the above embodiment is that a gap is formed between the occlusion member 100 in the loaded state and the distal end 901 of the delivery tube 300 to form a hollow section 905, and the pull wire 120 drives the occlusion member 100 to move to change the length of the hollow section 905. This structure allows the distal end of the interventional catheter 200 to adjust its adaptability (e.g., bending performance) through the hollow section 905 during the push process, thereby improving the controllability of the interventional process. For example, the length of the hollow section 905 can be reduced to increase distal rigidity and improve mechanical performance; correspondingly, the length of the hollow section 905 can be increased to reduce distal rigidity and improve adaptability. The specific settings of other components in this embodiment can also refer to the settings in the above embodiments, and will not be repeated here.

[0045] For details regarding the configuration of the 905 hollow section, please refer to the appendix. Figure 10 To be continued Figure 12 As shown, the ratio between the length L2 of the hollow section 905 and the length L1 of the sealing component 100 ranges from 0.1 to 0.5. Further, the ratio of length L2 to length L1 is 0.2 to 0.45. By optimizing the proportion of the hollow section 905, both pushing stability and release smoothness are considered. (Combined with the attached...) Figure 13 and attached Figure 14 It can be seen that the hollow section 905 can ensure that the occlusion element 100 has sufficient axial movement space within the interventional catheter 200 to reduce pushing resistance, and can also avoid the instability of the pushing direction or excessive swing of the occlusion element 100 during release caused by the hollow section 905 being too long, thus achieving a good balance between pushing stability and release controllability.

[0046] The technical features of the embodiments described above can be combined arbitrarily. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as the combination of these technical features does not contradict each other, it should be considered to be within the scope of this specification. When technical features of different embodiments are embodied in the same drawing, it can be regarded as the drawing also disclosing examples of combinations of the various embodiments involved.

[0047] The embodiments described above are merely examples of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these modifications and improvements all fall within the protection scope of this application.

Claims

1. An interventional delivery system for implanting an occlusion device, having a distal end and a proximal end, characterized in that, The intervention delivery system includes: The sealing element has a compressed loaded state and a fully expanded preset state, and the proximal end of the sealing element is provided with a constraint ring; An interventional catheter for receiving the occlusion device in its loaded state; A delivery tube is slidably inserted inside the interventional catheter, and a pull wire passing through the restraint ring is provided inside the delivery tube; A control handle includes a housing and a cutting member and a driving member movably disposed relative to the housing. The driving member moves unidirectionally relative to the housing in a first direction. An interventional catheter is connected to the driving member, and a delivery tube is connected to the housing. The cutting member is used to cut the pull wire to release the occlusion member. The cutting member moves relative to the housing in a second direction, where the first and second directions intersect. The driving member provides a mating cavity extending along its own direction of movement. The cutting member is housed within the mating cavity, which has a cutting hole. The cutting member includes a blade holder movably fitted to the housing and a cutting edge disposed on the blade holder. The blade holder has an elastic arm. During the process of the cutting member penetrating the cutting hole to cut the pull wire, the elastic arm is deformed by compression against the inner circumferential surface of the cutting hole. The drive has an initial first position and a second position that drives the tube to move relative to each other to fully expose the plug. In the first position, the drive isolates the pull wire and the cutter to prevent the cutter from cutting the pull wire. In the second position, the pull wire is exposed to the cutting hole and the cutter to allow cutting.

2. The interventional delivery system for implanting an occlusion device according to claim 1, characterized in that, The end of the elastic arm is provided with a positioning claw. When the cutting component moves to a preset position, the positioning claw engages with the edge of the cutting hole to prevent the cutting component from retracting.

3. The interventional delivery system for implanting an occlusion device according to claim 1, characterized in that, The two ends of the pull cable are connected to the control handle and the middle extends to the far end.

4. The interventional delivery system for implanting an occlusion device according to claim 3, characterized in that, The extension path of the pull wire includes a cutting path located on the central axis of the housing and a detour path that avoids the cutting path. The housing is provided with a cutting table opposite to the cutting element, and the cutting element and the cutting table are respectively located on both sides of the cutting path.

5. The interventional delivery system for implanting an occlusion device according to claim 1, characterized in that, The control handle also includes a recycling assembly, which includes a recycling cylinder rotatably mounted on the housing. The pull wire includes a fixed end fixed to the housing and a recycling end fixed to the recycling cylinder. The cut pull wire is wound and recycled around the outer circumference of the recycling cylinder.

6. The interventional delivery system for implanting an occlusion device according to claim 5, characterized in that, The recycling component also includes: The drive knob is exposed outside the housing and rotates to set the position; The transmission mechanism is linked between the drive knob and the recovery cylinder; A one-way mechanism is disposed between the housing and the drive knob.

7. The interventional delivery system for implanting an occlusion device according to claim 1, characterized in that, The sealing component is made of shape memory polymer foam, and the constraint ring is configured as follows: The sealing member is partially hardened at its proximal end to form a base, and the constraint ring is connected to the base; or The sealing element is locally hardened to form a ring structure to provide the constraint ring.

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