A vascular occlusion device

Abstract

The present invention provides a vascular occlusion device, which includes a handle, a sheath, a puncture guide wire, a positioning guide wire and a push rod. The positioning guide wire and the push rod are arranged side by side and inserted into the inner cavity of the sheath. A plug corresponding to the push rod is provided at the distal end of the sheath. The occluder can be used without an arterial sheath (long sheath). The puncture guide wire is conveyed into the blood return port at the distal end of the sheath and led out through the guide wire exchange port. The normal use of the puncture guide wire is realized by adding an independent puncture guide wire channel. After the puncture guide wire is withdrawn, it is judged whether the blood return port at the distal end is inserted into the blood vessel according to the blood outflow condition of the guide wire exchange port. During the use process, there is no need to replace the long sheath and the short sheath, which improves the treatment efficiency and reduces the physical injury of the patient.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a blood vessel occluding device. Background Art

[0002] Complications at the puncture site of the vascular access are a major cause of complications after the entire catheter intervention procedure. Currently, manual compression (MC) is a common method to achieve hemostasis at the arterial puncture site. However, due to the need to interrupt anticoagulation, prolonged bed rest, patient discomfort, and especially the need for long-term compression for puncture sites larger than 8F, manual compression can no longer fully meet the needs of doctors and patients.

[0003] Vascular occlusion devices are currently commonly used medical devices for hemostasis at puncture sites. They can improve patient comfort, reduce medical staff resources, shorten hemostasis time, and the time required to get out of bed and be discharged from the hospital, and reduce complications after interventional surgery. The use of vascular occlusion devices requires that occluding materials be placed at the site of vascular puncture to block the vascular puncture. The accuracy of the release position of the occluding material will seriously affect the effect of hemostasis. Currently, the use of occluders for treatment requires the use of short sheaths no longer than 11 cm, and during the operation, a guide wire needs to be inserted through the blood return port of the long sheath delivery sheath. Once the long sheath is used, the occluder cannot be used. At this time, the long sheath must be withdrawn and replaced with a short sheath before the occluder can be used normally.

[0004] Therefore, it is necessary to provide an improved technical solution to address the above-mentioned deficiencies in the prior art. Summary of the invention

[0005] The purpose of the present invention is to overcome the above-mentioned deficiencies in the prior art, and the present invention provides a blood vessel occluding device.

[0006] In order to achieve the above object, the present invention provides the following technical solutions:

[0007] A blood vessel occluding device comprises a handle, a sheath tube, a puncture guide wire, a positioning guide wire and a push rod, wherein the positioning guide wire and the push rod are inserted into the inner cavity of the sheath tube in parallel, and a sealing plug corresponding to the push rod is arranged at the distal end of the sheath tube;

[0008] The sheath is provided with a blood return port at the proximal end corresponding to the sealing plug, and the handle is provided with a guide wire exchange port corresponding to the sheath. The proximal end of the puncture guide wire extends into the sheath and then extends out from the guide wire exchange port. After the puncture guide wire is withdrawn, the position of the blood return port is determined by the bleeding situation at the guide wire exchange port.

[0009] Preferably, the proximal end of the positioning guide wire extends into the handle, and an exchange connector corresponding to the sheath is provided in the handle, and a guide tube extends out from the side of the exchange connector to form the guide wire exchange port;

[0010] The proximal end of the exchange connector is provided with two pushing holes corresponding to the pushing rod and the positioning guide wire respectively.

[0011] Preferably, the sheath tube is provided with push channels independently corresponding to the puncture guide wire, the positioning guide wire and the push rod, and the side of the sealing plug is provided with a strip-shaped give-way groove.

[0012] Preferably, a driving assembly is provided in the handle, and the driving assembly includes a double rack, a gear set, a transmission member and a stop table, the double rack is slidably assembled inside the handle, a gear set is provided at the proximal end of the double rack, the sliding rack is correspondingly engaged with one of the gears of the gear set and is slidably assembled in the double rack, the transmission member is correspondingly engaged with the other gear of the gear set and is slidably assembled in the double rack or inside the handle, the end of the transmission member abuts against the driving rod, and the distal end of the driving rod extends out of the handle;

[0013] The distal end of the positioning guide wire is made of elastic material and is heat-formed into an annular hook at the distal end. An directional seat corresponding to the positioning guide wire is provided on the double-linked rack. The positioning guide wire is assembled on the directional seat through a stop table so that the annular hook can be formed along a set direction after being extended.

[0014] Preferably, the gear set comprises a large gear and a small gear of different diameters, wherein the sliding rack meshes with the large gear, and the side of the transmission member is provided with a driving tooth corresponding to the small gear and extending along the pushing direction.

[0015] Preferably, the inner wall of the handle is provided with two clamping platforms spaced apart in the pushing direction, and the side of the driving rod is provided with wedge-shaped clamping teeth corresponding to the clamping platforms and with the smaller end pointing to the proximal end;

[0016] The distal end of the driving rod is provided with a collar corresponding to the sheath after extending out of the handle, and a positioning column is provided on the other side of the collar relative to the driving rod, and the positioning column is slidably inserted into the distal end of the handle.

[0017] Preferably, a notch corresponding to a button is provided in the middle of the handle, one end of the button extends into the handle from the notch and is hinged through a hinge shaft, a half gear is hinged on the side of the button corresponding to the double rack, and a driving tooth corresponding to the half gear meshing is provided on the double rack.

[0018] Preferably, the orientation seat includes two positioning plates distributed at intervals, the anti-rotation platform is fixed between the two positioning plates, the positioning plate located on the distal side is provided with a positioning groove corresponding to the setting direction of the annular hook, and the anti-rotation platform is provided with an insertion plate corresponding to the positioning groove.

[0019] Preferably, the rotation prevention platform is in a columnar or frustum-shaped structure, with a perforation corresponding to the positioning guide wire in the middle thereof, and the insertion plate extends along the generatrix of the rotation prevention platform;

[0020] The positioning plate located on the distal side is slidably assembled on the sliding rack, the distal end of the rotation prevention platform penetrates through the positioning plate located on the distal side, and a stop flange corresponding to the positioning plate on the proximal side is provided at the proximal end of the rotation prevention platform.

[0021] Preferably, there are two positioning grooves, and the two positioning grooves are distributed at 90°.

[0022] Advantageous effects: The occluder can be used without an arterial sheath (long sheath). The puncture guide wire is sent into the blood return port at the distal end of the sheath tube and led out from the guide wire exchange port. The normal use of the puncture guide wire is realized by adding an independent puncture guide wire channel. After the puncture guide wire is withdrawn, it is judged whether the distal blood return port is inserted into the blood vessel according to the blood outflow situation of the guide wire exchange port. During the use process, there is no need to replace the long sheath and the short sheath, which improves the treatment efficiency and reduces the physical damage to the patient. Description of the Drawings

[0023] The specification drawings forming a part of the present application are used to provide a further understanding of the present invention. The schematic embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation to the present invention. Among them:

[0024] Figure 1 It is the front view of the occluder in the specific embodiment provided by the present invention;

[0025] Figure 2 It is the rear view of the occluder in the specific embodiment provided by the present invention;

[0026] Figure 3 It is the internal structure assembly drawing of the occluder in the specific embodiment provided by the present invention;

[0027] Figure 4 It is the internal structure schematic diagram of the occluder plug in the ejected state in the specific embodiment provided by the present invention;

[0028] Figure 5 It is the assembly schematic diagram of the drive assembly in the specific embodiment provided by the present invention;

[0029] Figure 6 It is the structure schematic diagram of the double-link rack in the specific embodiment provided by the present invention;

[0030] Figure 7 It is the structure schematic diagram of the sliding rack in the specific embodiment provided by the present invention;

[0031] Figure 8 It is the structure schematic diagram of the sheath tube in the specific embodiment provided by the present invention;

[0032] Figure 9 Structural schematic diagram of the button in the specific embodiment provided by the present invention;

[0033] Figure 10 Structural schematic diagram of the transmission member in the specific embodiment provided by the present invention;

[0034] Figure 11 Structural schematic diagram of the gear set in the specific embodiment provided by the present invention;

[0035] Figure 12 Cross-sectional schematic diagram of the exchange connector in the specific embodiment provided by the present invention;

[0036] Figure 13 Structural schematic diagram of the stop turntable in the specific embodiment provided by the present invention;

[0037] Figure 14 Structural schematic diagram of the drive rod in the specific embodiment provided by the present invention;

[0038] Figure 15 Reference diagram of the insertion state of the puncture guide wire in the specific embodiment provided by the present invention;

[0039] Figure 16 Reference diagram of the pushing state of the drive rod in the specific embodiment provided by the present invention;

[0040] Figure 17 Reference diagram of the pushing-out state of the plug in the specific embodiment provided by the present invention.

[0041] In the figure: 1. Handle; 2. Sheath; 3. Exchange connector; 4. Drive rod; 5. Button; 6. Second reset hole; 7. Double-rack; 8. Gear set; 9. Sliding rack; 10. Transmission member; 11. Observation window; 12. Half gear; 13. Display member; 14. Spring; 15. Stop turntable; 16. Positioning plate; 17. First reset hole; 18. Positioning guide wire; 19. Pushing rod; 20. Positioning groove; 21. Skin; 22. Puncture guide wire; 23. Blood return port; 24. Blood vessel;

[0042] 401. Sleeve ring; 402. Wedge-shaped clamping tooth; 801. Large gear; 802. Small gear; 101. Limit hook; 151. Insertion plate; 152. Stop flange; 181. Ring hook. Specific embodiments

[0043] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention belong to the scope of protection of the present invention.

[0044] In the description of the present invention, the orientation or positional relationship indicated by the terms "longitudinal", "transverse", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", etc. is based on the orientation or positional relationship shown in the drawings. It is only for the convenience of describing the present invention and does not require the present invention to be constructed and operated in a specific orientation. Therefore, it should not be construed as a limitation to the present invention. The terms "connected" and "coupled" used in the present invention should be understood in a broad sense. For example, it can be a fixed connection or a detachable connection; it can be directly connected or indirectly connected through an intermediate component. For those of ordinary skill in the art, the specific meanings of the above terms can be understood according to specific circumstances.

[0045] The present invention will be described in detail below with reference to the drawings and in conjunction with embodiments. It should be noted that, without conflict, the embodiments in the present invention and the features in the embodiments can be combined with each other.

[0046] It should be noted that for the use of a vascular occlusion device, an occlusion material needs to be placed at the site of vascular puncture to occlude the vascular puncture opening. In the following embodiments, the end away from the operator is defined as the distal end, and the end close to the operator is defined as the proximal end.

[0047] As Figure 1 shown, the vascular occluder includes a handle 1, a sheath 2, a positioning guide wire 18, and a push rod 19. The handle 1 is made of injection molding material, and the outer surface is designed with a streamlined shape suitable for grasping. The handle 1 includes two shells that are snap-fitted with each other. The two shells are connected in a detachable manner to form the handle 1. They are in interference fit through an installation hole and a post. A driving assembly is assembled inside the handle 1. The driving assembly is used to drive the positioning guide wire 18 and the push rod 19 to move. The sheath 2 is slidably assembled at the distal end of the handle 1. The sheath 2 is a hollow structure for the positioning guide wire 18 and the push rod 19 to penetrate and slide independently. An installation notch is provided in the middle of the handle 1, and a button 5 is provided in the notch. The button 5 correspondingly drives the internal driving assembly to move along the pushing direction. A driving rod 4 corresponding to the driving assembly is also provided inside the handle 1. The driving rod 4 is slidably assembled inside the handle 1 and slides along the pushing direction. The distal end of the driving rod 4 extends out of the handle 1, so as to drive the internal driving assembly to operate, and drive the positioning guide wire 18 to be pushed forward out of the sheath 2 under the drive of the driving assembly. Scale lines are provided on the outside of the sheath 2.

[0048] In an optional embodiment, a sealing plug is provided at the distal end of the sheath 2, a blood return port 23 is provided at a position corresponding to the proximal end of the sealing plug of the sheath 2, a guide wire exchange port corresponding to the connecting sheath 2 is provided at the handle 1, an exchange connector 3 corresponding to the connecting sheath 2 is provided in the handle 1, a connecting tube extends from the side of the exchange connector 3 to form a guide wire exchange port, so that the puncture guide wire 22 can be inserted from the blood return port 23 and pass through the guide wire exchange port of the exchange connector 3, after the puncture guide wire 22 is pulled out, bleeding is carried out through the guide wire exchange port, and the specific position of the distal end of the organ is judged according to the amount of bleeding, a strip hole corresponding to the connecting tube is provided on the side of the handle 1, so that the connecting tube can be extended and make way for the pushing and withdrawal of the connecting tube, and the extended part of the connecting tube can be connected to other pipelines after the puncture guide wire 22 is withdrawn.

[0049] like Figure 2 As shown, the current vascular occluder stores the finger guide wire ring in the product's delivery tube. Once the product is assembled, the finger guide wire ring is located in the delivery tube and cannot be detected, which affects the release position of the finger guide wire ring. At the same time, once the finger guide wire ring is released, the process is irreversible and the product is scrapped and invalid. The vascular occluder provided in this embodiment has a reset function. Specifically, a first reset hole 17 corresponding to the drive rod 4 and a second reset hole 6 corresponding to the transmission member 10 are provided on the side of the handle 1. The reset column can be a rubber or metal rod. After passing through the first reset hole 17, the reset column can deform the drive rod 4 to release the lock of the wedge-shaped engaging teeth 402 and the clamping column. In addition, the second reset hole 6 is a strip, and the transmission member 10 is reset by toggling, so that the vascular occluder can be restored and can be used again. The reset hole diameter is about 1-1.5mm.

[0050] like Figure 3 As shown, the driving assembly includes a double rack 7, a gear set 8, a transmission member 10 and a stop table 15, wherein the double rack 7 is mainly used to install the gear set 8, the sliding rack 9 and the gear set 8, and a sliding groove corresponding to the sliding rack 9 is provided inside the double rack 7, and the transmission member 10 and the sliding rack 9 are linked by the linkage of the gear set 8, wherein the sliding rack 9 is connected to the proximal end of the positioning guide wire 18 through a directional seat, so that in the process of the driving rod 4 pushing the transmission member 10, the sliding rack 9 is driven to slide through the gear set 8, thereby pushing the positioning guide wire 18 forward, and winding it into a hook shape after the distal end of the positioning guide wire 18 is extended.

[0051] The main size specifications of the current occluder are 5F / 6F / 7F. Once the vascular puncture opening is enlarged to 8F, the finger guide wire at the front end of the vascular occluder will find it difficult to hook the puncture opening of the blood vessel 24, which makes it difficult to judge the accuracy of the release position of the occluding material. In this embodiment, the direction of the hook body of the guide wire ring is set by the turntable 15, which increases the feedback range of the finger guide wire ring and can hook the 8F puncture opening.

[0052] The distal end of the positioning guide wire 18 is heat-formed into a hook shape, and the proximal end extends into the handle 1. A spring 14 is provided at the proximal end of the positioning guide wire 18. The spring 14 correspondingly abuts between the exchange connector 3 and the display member 13 and is fixed to both of them, so that the sliding rack 9 and the exchange connector 3 are buffer-connected, and the exchange connector 3 can be driven during the retraction process of the sliding rack 9.

[0053] As Figure 4 shown, the driving rod 4 drives the transmission member 10, so that the positioning guide wire 18 is pushed forward. After leaving the pushing channel, it automatically bends and winds at least one turn to form a hook-shaped structure. When the transmission member 10 moves proximally, the driving gear drives the pinion 802 to rotate and drives the large gear 801 to rotate synchronously, and then the sliding rack 9 is pushed distally, and then the proximal end of the positioning guide wire 18 is pushed, so that the distal end of the positioning guide wire 18 extends out of the sheath 2.

[0054] As Figure 5 shown, the double-link rack 7 of the driving assembly is in a groove shape, and a sliding groove corresponding to the sliding rack 9 and a driving tooth parallel to the sliding rack 9 are provided inside it. A button 5 is also provided at the notch of the handle 1. A half gear 12 that meshes with the driving tooth is correspondingly hinged in the middle of the button 5. The half gear 12 is coaxially distributed with the axis hinge of the button 5. In this way, when the button 5 is driven, the half gear 12 drives the driving tooth to move, specifically, to slide proximally, so as to drive the positioning guide wire 18 to retract, so that the hook-shaped structure at the distal end of the positioning guide wire 18 enters the pushing channel to form a strip shape.

[0055] In this embodiment, in order to reduce the space occupied by the button 5, the half gear 12 extends a connecting end, and the connecting end is hinged to the middle of the button 5 or the end far from the hinge point through a hinge shaft. In this way, during the pressing process, taking the hinge point between the connecting end of the half gear 12 and the button 5 as the center of the circle, a torque is generated on the driving tooth of the linkage rack; or an arc-shaped protrusion concentric with the half gear 12 is provided on at least one side of the half gear 12, and an arc-shaped groove corresponding to the arc-shaped protrusion is provided on the inner side of the handle 1, so as to limit the driving track of the half gear 12.

[0056] As Figure 6 shown, the proximal end of the linkage rack is correspondingly rotationally connected to the gear set 8. The sliding rack 9 is located inside the linkage rack under the engagement of the large gear 801. Correspondingly, a sliding groove corresponding to the linkage rack is provided inside the handle 1.

[0057] As Figure 7As shown, the proximal end of the sliding rack 9 is provided with driving teeth corresponding to the large gear 801, and an orientation seat is provided in the middle of the sliding rack 9, and the orientation seat is used to fix the anti-rotation table 15. Specifically, the orientation seat includes two positioning plates 16, wherein the positioning plate 16 on the proximal side is fixed to the sliding rack 9, and the positioning plate 16 on the distal side is slidably assembled. After the anti-rotation table 15 is installed, the positioning plate 16 on the distal side slides toward the proximal side along the pushing direction, so as to confine the anti-rotation table 15 between the two positioning plates 16, and then the positioning plate 16 on the distal side is fixed by glue or screws.

[0058] like Figure 8 As shown, the display component 13 is fixedly connected to the positioning guide wire 18, and a display component 13 located at the proximal end of the spring 14 and fixedly connected is provided on the positioning guide wire 18 between the directional seat and the exchange connector 3. The display component 13 is provided with multi-color markings spaced apart along the pushing direction, and an observation window 11 corresponding to the display component 13 is provided on the handle 1.

[0059] Furthermore, the inside of the sheath 2 is provided with push channels which independently correspond to the puncture guide wire 22, the positioning guide wire 18 and the push rod 19, wherein the push channel of the positioning guide wire 18 extends to the distal end of the sheath 2, and the side of the sealing plug is provided with a strip-shaped give-way groove corresponding to the push channel of the positioning guide wire 18.

[0060] In an optional embodiment, there is a certain distance between the push channel of the puncture guide wire 22 and the sealing plug, and the push channel of the push rod 19 extends between the push channel of the puncture guide wire 22 and the sealing plug. The distal end of the push rod 19 is provided with a push disk, and the cross section of the push disk is adapted to the cross section of the sealing plug. The push disk and the push rod 19 are integrally formed or glued or hot-melt fixed. The push disk is connected to the distal end of the push rod 19 by glue, and the proximal end of the push rod 19 is designed as a double right angle. The positioning guide wire 18 is a nickel-titanium wire, and the distal end is a circular ring after heat treatment. The nickel-titanium wire rod body is received in the corresponding push channel. A developing ring or a marking ring is also provided on the sheath tube 2, and the sealing plug and the sheath tube 2 are interference fit.

[0061] like Figure 9 As shown, a hinge shaft is provided at one end of the button 5 extending into the handle 1, a corresponding hinge station is provided inside the handle 1, a connecting end is extended from the half gear 12, and the connecting end is hinged to the middle part of the button 5 or the end away from the hinge point through the hinge shaft, an anti-slip groove is provided on the outside of the button 5, an arc-shaped protrusion concentric with the half gear 12 is provided on at least one side of the half gear 12, and an arc-shaped groove corresponding to the arc-shaped protrusion is provided on the inside of the handle 1.

[0062] The proximal end of the push rod 19 is fixed to the inner wall of the handle 1, or a positioning post corresponding to the push rod 19 is provided inside the handle 1. The proximal end of the push rod 19 is blocked on the positioning post in a bent form. Since the sheath tube 2 is slidably assembled with the handle 1, when the button 5 is pressed and the sliding rack 9 retracts, the display member 13 drives the exchange connector 3 through the spring 14, and the exchange connector 3 drives the sheath tube 2 to move proximally. Under the block of the positioning post, the push rod 19 displaces relative to the sheath tube 2, thereby pushing out the sealing plug.

[0063] As Figure 10 shown, the outer contour of the transmission member 10 is square. The transmission member 10 is made of an elastic material. The transmission member 10 is slidably assembled on the double rack 7, and a chute corresponding to the transmission member 10 is provided on the inner wall of the handle 1 to limit the running track of the transmission member 10 and ensure the reciprocating running stability of the transmission member 10. A strip hole or strip notch corresponding to the second reset hole 6 is provided on the transmission member 10, and a limit hook 101 or limit notch corresponding to the reset post is provided in the strip hole or strip notch. Two limit hooks 101 are provided. The limit hooks 101 provide a force point for the reset post so as to be toggled by the reset post.

[0064] The distal end of the transmission member 10 is provided with a flat surface corresponding to the drive rod 4. A boss protrudes from one side of the transmission member 10 close to the gear set 8, and a drive tooth corresponding to the meshing pinion 802 is provided on the boss. The sliding track of the transmission member 10 is limited by the linkage rack and the chute inside the arm.

[0065] As Figure 11 shown, the gear set 8 includes a large gear 801 and a small gear 802 with different diameters. The large gear 801 corresponds to meshing with the large gear 801 of the sliding rack 9, and the small gear 802 corresponds to meshing with the drive tooth of the transmission member 10. The large gear 801 and the small gear 802 have the same module, and the diameter difference is set according to the displacement ratio of the positioning guide wire 18 and the drive rod 4.

[0066] As Figure 12 shown, the distal end of the exchange connector 3 is fixedly corresponding to the sheath tube 2. Two push holes corresponding to the push rod 19 and the positioning guide wire 18 are provided at the proximal end of the exchange connector 3. A strip hole corresponding to the exchange connector 3 is provided on the side of the handle 1.

[0067] As Figure 13 shown, the anti-rotation table 15 is of a columnar or frustum-shaped structure. Correspondingly, preferably, the outer wall of the anti-rotation table 15 is a conical surface. A corresponding round hole is provided on the distal positioning plate 16, and a through hole corresponding to the positioning guide wire 18 is provided in the middle thereof. The insertion plate 151 extends along the generatrix of the anti-rotation table 15, and a through hole corresponding to the positioning guide wire 18 is provided on the proximal positioning plate 16.

[0068] As Figure 14As shown, the distal end of the driving rod 4 extends out of the handle 1 and is slidably assembled with the handle 1. After the distal end of the driving rod 4 extends out of the handle 1, a ring 401 corresponding to the sheath 2 is provided. The diameter of the ring 401 is larger than the sheath 2. A positioning column is provided on the other side of the ring 401 relative to the driving rod 4. The positioning column is slidably inserted into the distal end of the handle 1, and a corresponding through hole is provided at the distal end of the handle 1 to avoid uneven force on the driving rod 4 when it is pushed toward the proximal end.

[0069] In an optional embodiment, a blood vessel occluding device includes a handle 1, a sheath 2, a puncture guide wire 22, a positioning guide wire 18 and a pushing rod 19. The sheath 2 is arranged at the distal end of the handle 1. The positioning guide wire 18 and the pushing rod 19 are inserted into the inner cavity of the sheath 2 in parallel, and the two can be pumped independently. The positioning guide wire 18 is made of elastic material, and is heat-formed into a ring-shaped hook at its front end so that it can automatically form into a hook after extending the sheath 2. After withdrawing the sheath 2, it is formed into a strip shape by the limiting position of the sheath 2 to facilitate pumping. The distal end of the sheath 2 is provided with a sealing plug corresponding to the pushing rod 19. The sealing plug is arranged at the distal end of the sheath 2, and the two are interference fit. The front end of the pushing rod 19 contacts the sealing plug, and the sealing plug can be pushed out to block the blood vessel 24. A blood return port 23 is provided at the proximal end of the corresponding occluding plug, and a guide wire exchange port corresponding to the connecting sheath tube 2 is provided at the handle 1. The blood return port 23 and the guide wire exchange port are connected to each other, so that the proximal blood return port 23 of the puncture guide wire 22 can be inserted into the sheath tube 2 and then extended from the guide wire exchange port. After the puncture guide wire 22 is withdrawn, the position of the blood return port 23 can be judged by the bleeding situation of the guide wire exchange port. The occluder and the puncture guide wire 22 can be used normally without the arterial sheath (long sheath). After the puncture guide wire 22 is withdrawn, the position of the distal blood return port 23 is judged whether to insert the blood vessel 24 according to the blood outflow situation of the guide wire exchange port. During use, there is no need to replace the long sheath and the short sheath, which improves the treatment efficiency and reduces the patient's physical damage.

[0070] In an optional embodiment, the proximal end of the positioning guide wire 18 extends into the handle 1, and a drive assembly corresponding to the positioning guide wire 18 is provided in the handle 1, and an exchange connector 3 corresponding to the connecting sheath 2 is provided in the handle 1, and a connecting hole corresponding to the sheath 2 is provided at the distal end of the exchange connector 3, and the two can be glued and fixed by medical glue, and a connecting tube extends from the side of the exchange connector 3 to form a guide wire exchange port, which is inclined toward the proximal side of the handle 1 to facilitate the insertion of the puncture guide wire 22, and the connecting tube extends out of the handle 1, and a strip hole corresponding to the connecting tube is provided on the handle 1, and two pushing holes corresponding to the pushing rod 19 and the positioning guide wire 18 are provided at the proximal end of the exchange connector 3, and the two pushing holes are independent of each other to ensure that the positioning guide wire 18 and the pushing rod will not interfere with each other during the pushing process.

[0071] In this embodiment, a pushing channel corresponding to the puncture guide wire 22, the positioning guide wire 18, and the pushing rod 19 respectively and independently is provided inside the sheath tube 2. Multiple through holes corresponding to the puncture guide wire 22, the positioning guide wire 18, and the pushing rod 19 respectively can be provided inside the sheath tube 2 as the pushing channels, or multiple flexible tubes or elastic tubes corresponding to the puncture guide wire 22, the positioning guide wire 18, and the pushing rod 19 respectively can be provided inside the sheath tube 2 as the pushing channels, so as to perform independent pushing between the components.

[0072] Preferably, a flexible tube or an elastic tube is provided as the pushing channel. The pushing channel of the positioning guide wire 18 extends to the distal end of the sheath tube 2, and the pushing channel of the puncture guide wire 22 extends to the blood return port 23. There is a certain distance between the blood return port 23 and the sealing plug. The pushing channel corresponding to the pushing rod 19 extends between the blood return port 23 and the sealing plug and abuts against the sealing plug. A strip-shaped relief groove is provided on the side of the sealing plug, and the relief groove is an arc groove corresponding to the pushing channel of the positioning guide wire 18.

[0073] In an alternative embodiment, a driving assembly is provided inside the handle 1. The driving assembly links the positioning guide wire 18 and the pushing rod 19. The driving assembly includes a double-link rack 7, a gear set 8, a transmission member 10, and a rotation stop platform 15. The double-link rack 7 is slidably assembled inside the handle 1. A sliding station for accommodating the sliding rack 9 is provided inside the double-link rack 7, and a driving tooth parallel to the sliding rack 9 is provided in the middle. The driving tooth is used for meshing with the half gear 12, so that the double-link rack 7 can be retracted under the drive of the handle 1. An articulated plate is provided at the proximal end of the double-link rack 7 to rotatably connect the gear set 8. The sliding rack 9 correspondingly meshes with one of the gears of the gear set 8 and is slidably assembled inside the double-link rack 7. Under the limitation of the gear set 8, the sliding track of the sliding rack 9 is limited. The transmission member 10 correspondingly meshes with the other gear of the gear set 8 and is slidably assembled inside the double-link rack 7 or the handle 1. The end of the transmission member 10 abuts against the driving rod 4. The distal end of the driving rod 4 extends out of the handle 1. Thus, when the transmission member 10 is pushed proximally, the sliding rack 9 is transmitted through the gear set 8 to move distally and push the positioning guide wire 18 out of the sheath tube 2.

[0074] The distal end of the positioning guide wire 18 is made of an elastic material and is thermally formed into an annular hook 181 at the distal end. The annular hook 181 surrounds at least one circle. A positioning seat corresponding to the positioning guide wire 18 is provided on the double-link rack 7 to fix the proximal end of the positioning guide wire 18. The positioning guide wire 18 is assembled on the positioning seat through the rotation stop platform 15 so that the annular hook 181 is formed along a set direction after extending out.

[0075] In an alternative embodiment, the gear set 8 includes a large gear 801 and a small gear 802 with different diameters. The two are fixed by the same main shaft and rotate synchronously. Among them, the sliding rack 9 meshes with the large gear 801 correspondingly. On the side of the transmission member 10, there are drive teeth corresponding to the small gear 802 and extending along the pushing direction. The modulus and diameter are set according to the length of the sealing plug and the extending length of the positioning guide wire 18 to maintain the pushing accuracy.

[0076] In an alternative embodiment, there are two clamping platforms spaced apart in the pushing direction on the inner wall of the handle 1. The clamping platforms can prevent failure in the use state of the positioning guide wire 18. On the side of the driving rod 4, there are wedge-shaped clamping teeth 402 corresponding to the clamping platforms and pointing the smaller end towards the proximal end. The driving rod 4 is made of an elastic material. It passes through by deforming when passing through the clamping platforms and resets after passing through. It is positioned by the abutment of the wedge-shaped clamping teeth 402, so as to ensure the internal stability of the plugging device in the use state.

[0077] In an alternative embodiment, there is a notch corresponding to the button 5 in the middle of the handle 1. The shape of the notch is adapted to the shape of the button 5. A first reset hole 17 is provided at the edge of the notch. One end of the button 5 extends into the handle 1 through the notch and is hinged by a hinge shaft. The button 5 is an injection molded part, and the hinge shaft is integrally formed with the button 5. A half gear 12 is hinged on the side of the button 5 corresponding to the double-link rack 7. The distal end of the half gear 12 is provided with a connection end for hinging the button 5. The double-link rack 7 is provided with drive teeth corresponding to meshing with the half gear 12, so that the half gear 12 is linked by pressing the button 5, and the drive teeth of the linkage rack are driven through gear meshing.

[0078] In an alternative embodiment, the orientation seat includes two spaced-apart positioning plates 16. The anti-rotation platform 15 is fixed between the two positioning plates 16 for fixing the anti-rotation platform 15 and limiting the angle of the annular hook 181 through the anti-rotation platform 15. A positioning groove 20 for setting the direction corresponding to the annular hook 181 is provided on the positioning plate 16 on the distal side. An insertion plate 151 corresponding to the positioning groove 20 is provided on the anti-rotation platform 15. The setting directions of the positioning groove 20 and the annular hook 181 are the same.

[0079] Further, the rotation stop platform 15 is in a columnar or frustum shape, with a perforation corresponding to the positioning guide wire 18 provided in the middle thereof for fixing the positioning guide wire 18 with glue. The insertion plate 151 extends along the generatrix of the rotation stop platform 15. The rotation stop platform 15 can be made of plastic or rubber. For the convenience of installing the rotation stop platform 15, preferably, the rotation stop platform 15 is in a frustum shape. The positioning plate 16 on the distal side slides and fits on the sliding rack 9. An installation hole corresponding to the rotation stop platform 15 is provided on the positioning plate 16. First, insert the rotation stop platform 15 into the installation hole in the middle of the positioning plate 16 on the distal side, and align the positioning groove 20 with the insertion plate 151 to insert the distal end of the rotation stop platform 15 through the positioning plate 16 on the distal side. A stop flange 152 corresponding to the proximal side positioning plate 16 is provided at the proximal end of the rotation stop platform 15. The positioning plate 16 slides to make the stop flange 152 abut against the proximal side positioning plate 16. Then, fix the distal positioning plate 16 and the sliding rack 9 with glue or other fixing forms. A perforation corresponding to the positioning guide wire 18 is provided on the proximal positioning plate 16.

[0080] To enrich the angle selection of the annular hook 181, it is set that there are two positioning grooves 20, and the two positioning grooves 20 are distributed at 90°.

[0081] In the above embodiments, the usage method of the occluder is as follows:

[0082] Step 1: Insert the 0.38-inch puncture guide wire 22 into the product from the guiding blood return port 23, and the guide wire exchange port extends out, as Figure 15 shown.

[0083] Step 2: Withdraw the puncture guide wire 22. At this time, the blood flow flows into the guiding blood return port 23 and spurts out from the guide wire exchange port, indicating that both the guiding blood return port 23 and the distal end of the sheath 2 are in the blood vessel.

[0084] Step 3: Press the driving rod 4 so that its collar 401 fits with the handle 1. At this time, the ring at the distal end of the positioning guide wire 18 extends out of the sheath 2 and is released, as Figure 16 shown.

[0085] Step 4: Then, withdraw the occluder as a whole. The annular hook 181 at the front end of the positioning guide wire 18 hooks the wall of the blood vessel 24 (a special design to increase the hooking size). Note that the blood flow at the guide wire exchange port significantly decreases or disappears. At this time, slowly withdraw the product and observe the colored block display in the observation window 11. At this time, the sheath 2 is exactly outside the wall of the blood vessel 24.

[0086] Step 5: Figure 17 As shown, press the button 5. The button 5 drives the semi-gear 12 in linkage. The semi-gear 12 drives the linkage rack, and then drives the sheath 2 to withdraw through the gear set 8 in linkage. Since the proximal end of the internal push rod 19 is blocked, the occluding plug will be left outside the wall of the blood vessel 24.

[0087] Step Six: Withdraw the whole product, leaving the plug on the outer side of the blood vessel wall 24 to complete the occlusion of the puncture site.

[0088] After the product is used, the button 5 is pressed, driving the transmission member 10 and releasing the annular hook 181. The positioning guide wire 18 is restored as follows:

[0089] Press inward with the reset post to unlock the drive rod 4. Cooperate with lifting the button 5 upward to reposition the wedge-shaped engaging teeth 402 of the drive rod 4 with the catch. Use the recovery rod to move the transmission member 10 distally, and then slide the rack 9. Finally, the positioning guide wire 18 is driven to retract and is restored to the initial state.

[0090] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present invention are within the scope of protection of the pending claims of the present invention.

Claims

1. A vascular occlusion device, characterized in that, The invention comprises a handle, a sheath tube, a puncture guide wire, a positioning guide wire and a pushing rod, wherein the positioning guide wire and the pushing rod are inserted into the inner cavity of the sheath tube in parallel, and the distal end of the sheath tube is provided with a sealing plug corresponding to the pushing rod; the sheath tube is provided with a blood return port at the proximal end corresponding to the sealing plug, and the handle is provided with a guide wire exchange port corresponding to the sheath tube, the proximal end of the puncture guide wire is extended into the sheath tube from the blood return port and then extends out from the guide wire exchange port, and after the puncture guide wire is withdrawn, the position of the blood return port is judged by the bleeding situation of the guide wire exchange port, the proximal end of the positioning guide wire extends into the handle, and an exchange connector corresponding to the sheath tube is provided in the handle, and a connecting tube is extended from the side of the exchange connector to form the guide wire exchange port; the proximal end of the exchange connector is provided with two pushing holes corresponding to the pushing rod and the positioning guide wire respectively; A driving assembly is provided in the handle, and the driving assembly includes a double rack, a gear set, a transmission member and a stop plate. The double rack is slidably assembled inside the handle, and a gear set is provided at the proximal end of the double rack. The sliding rack corresponds to meshing with one of the gears of the gear set and is slidably assembled in the double rack. The transmission member corresponds to meshing with another gear of the gear set and is slidably assembled in the double rack or inside the handle. The end of the transmission member abuts against the driving rod, and the distal end of the driving rod extends out of the handle; the distal end of the positioning guide wire is made of elastic material and is heat-formed into an annular hook at the distal end. An directional seat corresponding to the positioning guide wire is provided on the double rack, and the positioning guide wire is assembled on the directional seat through the stop plate, so that the annular hook is formed along a set direction after being extended; The orientation seat includes two positioning plates distributed at intervals, the anti-rotation platform is fixed between the two positioning plates, the positioning plate located on the distal side is provided with a positioning groove corresponding to the setting direction of the annular hook, and the anti-rotation platform is provided with an insert plate corresponding to the positioning groove.

2. The vascular occlusion device according to claim 1, characterized in that, The sheath tube is provided with push channels which are respectively and independently corresponding to the puncture guide wire, the positioning guide wire and the push rod, and the side of the sealing plug is provided with a strip-shaped giving way groove.

3. The vascular occlusion device according to claim 1, wherein The gear set comprises a large gear and a small gear with different diameters, wherein the sliding rack meshes with the large gear correspondingly, and the side of the transmission member is provided with a driving tooth corresponding to the small gear and extending along the pushing direction.

4. The vascular occlusion device according to claim 1, wherein, The inner wall of the handle is provided with two card platforms spaced apart in the pushing direction, and the side of the driving rod is provided with wedge-shaped card-engaging teeth corresponding to the card platforms and with the smaller end pointing to the proximal end; after the distal end of the driving rod extends out of the handle, a ring corresponding to the sheath is provided, and a positioning column is provided on the other side of the ring relative to the driving rod, and the positioning column is slidably inserted into the distal end of the handle.

5. The vascular occlusion device according to claim 1, wherein A notch corresponding to the button is provided in the middle of the handle, one end of the button extends into the handle from the notch and is hinged through a hinge shaft, a half gear is hinged on the side of the button corresponding to the double rack, and the double rack is provided with a driving tooth corresponding to the half gear meshing with the half gear.

6. The vascular occlusion device according to claim 1, characterized in that, The anti-rotation table has a columnar or frustum-shaped structure, with a perforation corresponding to the positioning guide wire in the middle, and the insertion plate extends along the generatrix of the anti-rotation table; the positioning plate on the distal side is slidably assembled on the sliding rack, the distal end of the anti-rotation table penetrates through the positioning plate on the distal side, and a stop flange corresponding to the positioning plate on the proximal side is provided at the proximal end of the anti-rotation table.

7. The vascular occlusion device according to claim 6, characterized in that, There are two positioning grooves, and the two positioning grooves are distributed at 90°.

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