Plugging hemostasis device

Abstract

The invention relates to a blocking hemostasis device which comprises a conveying pipe, a first push rod, a positioning element and a second push rod, the conveying pipe is in a long strip shape, a first conveying channel and a second conveying channel are formed in the conveying pipe, and the first conveying channel and the second conveying channel are not communicated with each other; the first push rod is arranged in the first conveying channel in a penetrating mode, and the far end of the first push rod is connected with a positioning element used for pushing out and pulling back the positioning element from the far end of the first conveying channel. The second push rod is arranged in the second conveying channel in a penetrating mode, an implant is further arranged in the second conveying channel, the implant is located on the far end side of the second push rod and abuts against the second push rod, and the second push rod can slide relative to the second conveying channel so that the implant can be pushed out from the far end of the second conveying channel. An implant can be implanted into a puncture point with high precision, and the plugging function on the puncture point is improved.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to a blocking and hemostasis device. Background Art

[0002] In recent years, cardiac, large vessel and peripheral vascular intervention technologies have developed rapidly. This has, to a certain extent, promoted the development of vascular closure devices for hemostasis at puncture sites. Commonly used vascular closure devices can be roughly divided into procoagulant, suture and nail / clip types. Nail / clip closure devices rely on metal nails / clips to function and cannot support re-puncture. Suture closure devices occupy a large share of the vascular puncture site closure market and can be used to close large-caliber puncture sites. However, the complicated operation and non-degradable sutures are its real disadvantages.

[0003] There are many kinds of procoagulant vascular closure devices. According to the site of invasion, there are roughly two forms, bilateral clamping of the vessel wall inside and outside and blocking of the vessel wall outside. Bilaterally clamped vascular closure devices can provide better blocking effects, but the implants in the blood vessels undoubtedly occupy part of the vascular cavity space and have a higher risk of thrombosis. Vascular closure devices that block the vessel wall outside reduce the risk of space occupation in the vascular cavity. However, the stability of implant placement, that is, the stable release of the implant at the puncture point outside the vessel wall without entering the blood vessel and being able to adhere closely to the vessel wall, is a long-term challenge. In addition, most procoagulant vascular closure devices can only block puncture points of smaller calibers, which also restricts the application of such devices. Summary of the invention

[0004] In view of this, the present invention provides a blocking and hemostatic device, which can implant a degradable implant into the puncture point with high precision, thereby improving the blocking function of the puncture point.

[0005] The technical solution adopted by the present invention is: A blocking hemostasis device for blocking a puncture hole in a blood vessel comprises a delivery tube, a first push rod, a positioning element and a second push rod. The delivery tube is in an elongated strip shape. A first delivery channel and a second delivery channel are arranged in the delivery tube. Both the first delivery channel and the second delivery channel extend along the length direction of the delivery tube. The distal end of the first delivery channel passes through the distal end of the delivery tube, the proximal end of the first delivery channel passes through the proximal end of the delivery tube, the distal end of the second delivery channel passes through the distal end of the delivery tube, and the proximal end of the second delivery channel passes through the proximal end of the delivery tube. The first delivery channel and the second delivery channel are not connected to each other. The first push rod is disposed in the first delivery channel, and the distal end of the first push rod is connected to the positioning element, so as to push the positioning element out and pull it back from the distal end of the first delivery channel; The positioning element has a stowed state and an expanded state. In a natural state, the positioning element is in an expanded state. Under the action of an external force, the positioning element can be deformed under the action of an external force, and the positioning element can be compressed into the first delivery channel. In the first delivery channel, the positioning element is in a stowed state; in the expanded state, the radial dimension of the positioning element becomes larger and is larger than the dimension of the puncture port; The second push rod is inserted into the second delivery channel. An implant is also provided in the second delivery channel. The implant is located at the distal end of the second push rod and abuts against the second push rod. The second push rod can slide relative to the second delivery channel to push the implant out from the distal end of the second delivery channel.

[0006] Preferably, the delivery tube comprises an inner tube and an outer tube which are coaxially arranged, the inner tube is located inside the outer tube, and the first delivery channel is formed inside the inner tube; a plurality of connecting strips are further arranged inside the outer tube, and the outer wall of the inner tube is connected to the outer tube through the connecting strips, and a plurality of the connecting strips are arranged at equal angles in the circumference of the delivery tube; An annular delivery channel is formed between the inner tube and the outer tube, and the plurality of connecting strips divide the delivery channel into a plurality of second delivery channels in a fan shape; each of the second delivery channels is penetrated by the second push rod and the implant.

[0007] Preferably, the lumen of the delivery tube constitutes the first delivery channel, the ratio of the diameter of the first delivery channel to the outer diameter of the delivery tube is (2-4):10, at least three second delivery channels are formed on the tube wall of the delivery tube, the cross-section of the second delivery channel is circular, and the ratio of the diameter of the second delivery channel to the diameter of the first delivery channel is (5-15):10.

[0008] Preferably, at the distal end of the second delivery channel, the second delivery channel is bent, and from proximal to distal, the distal end of the second delivery channel is bent radially outward.

[0009] Preferably, when the circumferential dimension of the delivery tube is 5-9F, the deflection angle of the distal end of the second delivery channel is 5°-15°; When the circumferential dimension of the delivery tube is 10-18F, the deflection angle of the distal end of the second delivery channel is 15°-30°; When the circumferential dimension of the delivery tube is 20-24F, the deflection angle of the distal end of the second delivery channel is 30°-40°.

[0010] Preferably, the positioning element is woven from nickel-titanium alloy wires. In the expanded state, the positioning element is disc-shaped, and the radial dimension of the positioning element is 2-4 mm larger than the outer diameter of the delivery tube.

[0011] Preferably, the positioning element is a balloon, the first push rod is a hollow tube, the balloon comprises a connecting portion and a capsule body portion which are connected to each other, the connecting portion is sleeved on the outside of the distal end of the first push rod and is heat-sealed to the first push rod; An infusion channel is formed in the first push rod, and when the positioning element is in the stored state, the capsule portion is stored in the distal end portion of the infusion channel; Liquid is introduced into the balloon through the infusion channel to push the balloon body out of the infusion channel, and the balloon body is filled with liquid, so that the balloon is switched to the expanded state.

[0012] Preferably, the first push rod includes a first section and a second section connected to each other, the first section is located at the distal side of the second section, the inner diameter of the first section is larger than the inner diameter of the second section, and when the positioning element is in the stored state, the capsule portion is stored in the first section, and the length of the first section is 3-7 mm.

[0013] Preferably, the implant is made of degradable polyurethane, gelatin, chitosan and / or polylactic acid, and has a compressed state and an expanded state. When the implant is located in the second delivery channel, the implant is in the compressed state; after the implant is pushed out of the second delivery channel, the implant can absorb blood and switch to the expanded state, and the ratio of the volume of the implant in the expanded state to the volume of the implant in the compressed state is (30-60):1.

[0014] Preferably, it also includes a handle, and an adjustment mechanism is provided on the handle, and the adjustment mechanism includes a first rack, a second rack, a gear set and an intermediate gear, and the gear set includes a first gear and a second gear, the first gear is coaxially arranged with the second gear, the second gear is meshed with the intermediate gear, and the intermediate gear is also meshed with the second rack, the first rack is controlled to engage or disengage with the first gear through a clutch, the first rack is connected to the first push rod to drive the first push rod to move, and the second rack is connected to the conveying pipe to drive the conveying pipe to move.

[0015] Preferably, the gear ratio between the first gear and the second gear is 4:(1-3).

[0016] Beneficial effects of the present invention: When the puncture point needs to be blocked, the delivery tube is inserted along the sinus tract, and the distal end of the delivery tube is inserted into the puncture point, and the first push rod is pushed distally, and the first push rod pushes the positioning element out of the first delivery channel. At this time, the positioning element enters the blood vessel, and the positioning element is no longer restricted by the first delivery channel. The positioning element switches to an expanded state. In the expanded state, the size of the positioning element is larger than the puncture point, so the positioning element will not detach from the puncture point; the blocking hemostasis device is moved proximally, so that the distal end of the delivery tube withdraws from the puncture point, and the positioning element is close to the inner wall of the blood vessel; the first push rod is retracted, and under the action of the adjustment mechanism, the delivery tube withdraws toward the proximal side, and at the same time, the position of the second push rod remains unchanged, so that the second push rod will be pushed forward relative to the second delivery channel, thereby pushing the implant out of the second delivery channel. Since the positioning element is located on the inner side of the puncture point, the implant can be pushed just to the outside of the puncture point, thereby achieving precise blocking of the outside of the puncture point. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The above and other objects, features and advantages of the present invention will become more apparent through the following description of the embodiments of the present invention with reference to the accompanying drawings, in which: Figure 1 is a schematic diagram of the structure of the occluding hemostasis device; Figure 2 is a schematic structural diagram of a first embodiment of a delivery pipe; Figure 3 is a schematic structural diagram of a second embodiment of a delivery pipe; Figure 4 is a cross-sectional view of the delivery pipe; Figure 5 It is a schematic diagram of the structure of the conveying pipe; Figure 6 is a schematic diagram of the implant in contact with the vessel wall when released; Figure 7 This is a schematic diagram of the deployment state of the positioning element woven from nickel-titanium alloy wire. Figure 1 ; Figure 8 This is a diagram of the expanded positioning element made of nickel-titanium alloy wire. Figure 2 ; Fig. 9 It is a schematic diagram of the positioning element woven from nickel-titanium alloy wire in the stowed state; Fig.10 is a schematic diagram of the deployment state of the positioning element of the balloon; Fig.11 is a schematic diagram of the storage state of the positioning element of the balloon; Fig.12 This is a schematic diagram of the structure of the adjustment mechanism. Figure 1 ; Fig.13 This is a schematic diagram of the structure of the adjustment mechanism. Figure 2 .

[0018] In the figure: 1, delivery tube; 2, first push rod; 3, positioning element; 4, implant; 11. first conveying channel; 12. second conveying channel; 13. inner tube; 14. outer tube; 15. connecting strip; 21, first section; 22, second section; 31, connecting portion; 32, capsule portion; 51, first gear; 52, second gear; 53, intermediate gear; 54, first rack; 55, second rack; 121. Distal end. DETAILED DESCRIPTION

[0019] The present invention is described below based on embodiments, but the present invention is not limited to these embodiments. In the following detailed description of the present invention, some specific details are described in detail. In order to avoid confusing the essence of the present invention, known methods, processes, procedures, and components are not described in detail.

[0020] In addition, persons of ordinary skill in the art will appreciate that the drawings provided herein are for illustration purposes and are not necessarily drawn to scale.

[0021] Unless the context clearly requires otherwise, throughout the specification and claims, the words "include", "comprising" and similar words should be interpreted in an inclusive sense rather than an exclusive or exhaustive sense; that is, in the sense of "including but not limited to".

[0022] In the description of the present invention, it should be understood that the terms "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or implying relative importance. In addition, in the description of the present invention, unless otherwise specified, "plurality" means two or more.

[0023] In the present invention, in a surgical situation, the end away from the operator is "distal", and the side close to the operator is "proximal".

[0024] See also Figure 1-Figure 13The present invention provides a blocking and hemostatic device for blocking a puncture port of a blood vessel, comprising a delivery tube 1, a first push rod 2, a positioning element 3, and a second push rod. The delivery tube 1 is in an elongated shape, and a first delivery channel 11 and a second delivery channel 12 are arranged in the delivery tube 1. The first delivery channel 11 and the second delivery channel 12 both extend along the length direction of the delivery tube 1. The distal end of the first delivery channel 11 passes through the distal end of the delivery tube 1, the proximal end of the first delivery channel 11 passes through the proximal end of the delivery tube 1, the distal end of the second delivery channel 12 passes through the distal end of the delivery tube 1, and the proximal end of the second delivery channel 12 passes through the proximal end of the delivery tube 1; the first delivery channel 11 and the second delivery channel 12 are not connected to each other; The first push rod 2 is inserted into the first conveying channel 11, and the distal end of the first push rod 2 is connected to the positioning element 3, which is used to push the positioning element 3 out and pull it back from the distal end of the first conveying channel 11; The positioning element 3 has a storage state and an expansion state. In the natural state, the positioning element 3 is in the expansion state. Under the action of external force, the positioning element 3 can be deformed under the action of external force, and the positioning element 3 can be compressed into the first delivery channel 11. In the first delivery channel 11, the positioning element 3 is in the storage state; in the expansion state, the radial dimension of the positioning element 3 becomes larger and is larger than the dimension of the puncture port. It is disc-shaped (it can also be other shapes, such as triangle, ellipse or rectangle, etc.); The second push rod is inserted into the second delivery channel 12, and an implant 4 is also provided in the second delivery channel 12. The implant 4 is located on the distal side of the second push rod and abuts against the second push rod. The second push rod can slide relative to the second delivery channel 12 to push the implant 4 out from the distal end of the second delivery channel 12.

[0025] A first delivery channel 11 and a second delivery channel 12 are formed in the delivery tube. A first push rod 2 is provided in the first delivery channel 11, and a second push rod is provided in the second delivery channel 12. The first push rod 2 can slide relative to the first delivery channel 11, and the second push rod can slide relative to the second delivery channel 12, so that the positioning element 3 can be pushed out of the first delivery channel 11, and the implant 4 can be pushed out of the second delivery channel 12.

[0026] Taking interventional surgery as an example, after the interventional surgery is completed, the puncture point on the blood vessel needs to be blocked. At this time, the present invention can be used to block the puncture point. The operation process is: Initially, the positioning element 3 is in the stored state and stored at the distal end of the first delivery channel 11, and the implant 4 is stored at the distal end of the second delivery channel 12; the delivery tube 1 is inserted along the sinus tract, and the distal end of the delivery tube 1 is inserted into the blood vessel from the puncture point, and the first push rod 2 is pushed toward the distal end, and the first push rod 2 will push the positioning element 3 out of the first delivery channel 11, so that the positioning element 3 will enter the blood vessel and expand in the blood vessel, and the positioning element 3 will switch to the expanded state, and then the first push rod 2 is kept stationary, and the delivery tube 1 (the second push rod 2) is pulled toward the proximal end. Then, the delivery tube 1 is continuously pulled toward the proximal end while ensuring that the position of the second push rod remains unchanged, so that the implant 4 does not move toward the proximal end. As a result, the implant 4 is exposed from the distal end of the second delivery channel 12. Since the distal end of the second delivery channel 12 is close to the puncture point, the implant 4 expands on the outside of the puncture point until the entire implant 4 is pushed out of the second delivery channel 12. The implant 4 just blocks the puncture point, thereby achieving the purpose of blocking the puncture point.

[0027] In addition, the distal end of the first push rod 2 is connected to the positioning element 3. When the first push rod 2 is pulled toward the proximal side, the first push rod 2 will drive the positioning element 3 to pass through the puncture point. Since the positioning element 3 can be compressed, the positioning element 3 can re-pass through the puncture point and enter the first delivery channel 11. Then, the entire delivery tube 1 is withdrawn from the sinus tract, and the implant 4 can be left at the puncture point, thereby achieving the purpose of accurately blocking the puncture point without leaving other structures in the body, thereby improving the surgical effect.

[0028] In the present invention, the puncture point is positioned by the positioning element 3, so that the implant 4 can accurately block the puncture point.

[0029] The delivery pipe 1 comprises an inner pipe 13 and an outer pipe 14 which are coaxially arranged. The inner pipe 13 is located inside the outer pipe 14. The inner pipe 13 forms the first delivery channel 11. The outer pipe 14 is also provided with a plurality of connecting strips 15 (e.g. Figure 2 In the embodiment shown, the number of the connecting strips 15 is 2), the outer wall of the inner tube 13 is connected to the outer tube 14 via the connecting strips 15, and a plurality of the connecting strips 15 are arranged at equal angles in the circumferential direction of the delivery tube 1; An annular delivery channel is formed between the inner tube 13 and the outer tube 14 , and the plurality of connecting strips 15 divide the delivery channel into a plurality of fan-shaped second delivery channels 12 ; each of the second delivery channels 12 is penetrated by the second push rod and the implant 4 .

[0030] The arrangement of the inner tube 13 and the outer tube 14 reduces the difficulty of manufacturing the delivery tube 1. The arrangement of the connecting strip 15 enables the inner tube 13 and the outer tube 14 to form a whole, and enables the inner tube 13 and the outer tube 14 to be coaxial, so that the first delivery channel 11 and the second delivery channel 12 can extend almost in a straight state, facilitating the sliding of the first push rod 2 and the second push rod.

[0031] In addition, in the present embodiment, there are two second delivery channels 12 , and a second push rod is disposed in each second delivery channel 12 to push a corresponding implant 4 (that is, the number of the implants 4 is two).

[0032] In addition, the second delivery channel 12 is located outside the first delivery channel 11, and the first delivery channel 11 corresponds to the puncture point. Therefore, the implant delivered from the second delivery channel can block the puncture point from the outside to the inside, ensuring the blocking effect.

[0033] The lumen of the delivery tube 1 constitutes the first delivery channel 11, the ratio of the diameter of the first delivery channel 11 to the outer diameter of the delivery tube 1 is (2-4):10, and at least three second delivery channels 12 (such as Figure 3 In the illustrated embodiment, the number of the second conveying channels 12 is 6), the cross-section of the second conveying channels 12 is circular, and the ratio of the diameter of the second conveying channels 12 to the diameter of the first conveying channels 11 is (5-15):10.

[0034] The diameter of the first delivery channel 11 is less than half of the outer diameter of the delivery tube 1, so that the wall of the delivery tube 1 has a certain thickness, thereby facilitating the formation of the second delivery channel 12 on the wall, while ensuring that the delivery tube 1 has a certain structural strength, ensuring that the delivery tube 1 can be smoothly inserted along the sinus tract, and allowing the distal end of the delivery tube 1 to enter the blood vessel from the puncture point.

[0035] The diameter of the second conveying channel 12 can be smaller than the diameter of the first conveying channel 11, or larger than the diameter of the first conveying channel 11. For example, the diameter of the second conveying channel 12 is 0.5-0.8 times the diameter of the first conveying channel 11, so that the second conveying channel 12 can be formed on the pipe wall and ensure that the second conveying channel 12 will not be connected to the first conveying channel 11, while taking into account the structural strength of the conveying pipe 1.

[0036] Of course, in actual applications, the first delivery channel is mainly for the positioning element 3 to pass through. The positioning element 3 is woven from nickel-titanium alloy wire and has a relatively large compression ratio. Therefore, the diameter of the first delivery channel 11 can be smaller than the diameter of the second delivery channel 12, so that the second delivery channel can accommodate a larger implant and improve the blocking effect on the puncture point.

[0037] At the distal end of the second delivery channel 12 , the second delivery channel 12 is bent, and from proximal to distal, the distal end of the second delivery channel 12 is bent radially outward.

[0038] Of course, the distal end of the second delivery channel 12 may not be bent, which is suitable for situations where the circumferential dimension of the delivery tube is smaller, such as a circumferential dimension of 5F-9F.

[0039] When the implant 4 is pushed out toward the distal side of the second delivery channel 12, the first push rod 2 can be pulled toward the proximal side simultaneously, and the distal end (distal end portion 121) of the second delivery channel 12 is bent radially outward, causing the implant 4 to extend radially outward, thereby reducing interference between the implant 4 and the pulled-out positioning element 3, and preventing the implant 4 from being entangled with the positioning element 3.

[0040] It should be noted that during the interventional surgery, the size of the puncture point will become larger. Therefore, when the implant 4 is implanted at the puncture point in an outwardly offset manner, the implant 4 will cover a larger area, thereby ensuring that the enlarged puncture point can be blocked. Moreover, the implant 4 with a larger coverage area will make most of the implant 4 contact the blood vessel wall, thereby enhancing the support effect of the implant 4.

[0041] It is worth noting that it takes a while for the implant 4 to be pushed out from the distal end of the second delivery channel 12. During this process, the first push rod 2 is pulled toward the proximal side, so that the positioning element 3 is gradually pulled out of the blood vessel. During this process, a part of the positioning element 3 is located in the blood vessel, thereby supporting the blood vessel wall on the inside, and the implant 4 expands on the outside. Therefore, the positioning element 3 and the implant 4 interact with each other across the blood vessel wall, thereby improving the blocking effect of the implant 4 on the puncture point.

[0042] When the circumferential dimension of the delivery tube 1 is 5-9F, the deflection angle of the distal end of the second delivery channel 12 (the angle between the tangent direction of the distal end and the axial direction of the delivery tube 1) is 5°-15°; When the circumferential dimension of the delivery tube 1 is 10-18F, the deflection angle of the distal end of the second delivery channel 12 is 25°-30°; When the circumferential dimension of the delivery tube 1 is 20-24F, the deflection angle of the distal end of the second delivery channel 12 is 30°-40°.

[0043] The circumferential size of the delivery tube 1 is consistent with the size of the puncture point. For example, if the puncture point is 10F (about 3mm in diameter), the size of the delivery tube 1 is also selected to be 10F. When the size of the puncture point is larger, a larger implant 4 (volume) is required to block the puncture point. Therefore, the possibility of mutual interference between the positioning element 3 and the implant 4 is greater. In the present invention, the larger the circumferential size of the overall delivery tube 1, the larger the deflection angle, so that the implant 4 is more deflected to the outside, thereby avoiding mutual interference between the implant 4 and the positioning element 3.

[0044] See also Figure 7-Figure 9 The positioning element 3 is woven from nickel-titanium alloy wires and is disc-shaped (or other shapes, such as triangle, ellipse or rectangle) in the unfolded state. The radial dimension of the positioning element 3 is 2-4 mm larger than the outer diameter of the delivery tube 1. Ensure that the positioning element 3 will not detach from the puncture point in the unfolded state.

[0045] See also Fig.10 and Fig.11 As for the positioning element 3, in another optional embodiment, the positioning element is a balloon. In this case, the first push rod is a hollow tube. The balloon includes a connecting portion 31 and a capsule portion 32 connected to each other. The connecting portion 31 is sleeved on the outer side of the distal end of the first push rod and is heat-sealed to the first push rod. An infusion channel is formed in the first push rod, and when the positioning element is in the stored state, the capsule portion 32 is stored in the distal end portion of the infusion channel; Liquid is introduced into the balloon through the infusion channel to push the balloon body 32 out of the infusion channel. The balloon body 32 is filled with liquid, so that the balloon switches to the expanded state.

[0046] Initially, the sac 32 is accommodated in the distal end of the infusion channel, the first push rod is inserted into the first delivery channel 11, and the distal end of the first push rod 2 is located at the proximal side of the distal end of the first delivery channel 11, or is flush with the distal end of the first delivery channel 11; the delivery tube 1 is inserted along the sinus tract, and the distal end of the delivery tube 1 is inserted into the blood vessel from the puncture point, and the first push rod 2 is pushed toward the distal side, and the distal end of the first push rod 2 extends out of the distal end of the first delivery channel 11; physiological saline is pumped into the infusion channel from the proximal side of the infusion channel, and the physiological saline enters the sac 32 through the first delivery channel 11, and pushes the sac 32 out of the infusion channel, so that the sac 32 exists independently in the blood vessel, and the sac 32 is filled with physiological saline, and the sac 32 expands. After the portion 32 expands to a predetermined size (determined according to actual conditions), the pumping of saline is stopped, and the balloon is switched to the expanded state; then the first push rod 2 is kept stationary, and the delivery tube 1 is pulled toward the proximal side (the position of the second push rod relative to the delivery tube 1 remains unchanged), so that the distal end of the delivery tube 1 withdraws from the puncture point; then, the delivery tube 1 is continued to be pulled toward the proximal side, while ensuring that the position of the second push rod remains unchanged, so that the implant 4 does not move toward the proximal side, and thus the implant 4 will be exposed from the distal end of the second delivery channel 12. Since the distal end of the second delivery channel 12 is close to the puncture point, the implant 4 will expand on the outside of the puncture point until the entire implant 4 is pushed out of the second delivery channel 12, and the implant 4 will just block the puncture point, thereby achieving the purpose of blocking the puncture point.

[0047] When withdrawing from the present invention, physiological saline is first sucked through the infusion channel so that the physiological saline in the balloon is drawn out, causing the balloon (the balloon body 32 to shrink), and then the first push rod 2 is pulled toward the proximal side, the first push rod 2 will drive the deflated balloon body 32 to pass through the puncture point, and the balloon body 32 is pulled into the first delivery channel 11, and then the entire delivery tube 1 is withdrawn from the sinus tract, so that the implant 4 can be left at the puncture point, achieving the purpose of accurately blocking the puncture point without leaving other structures in the body, thereby improving the surgical effect.

[0048] The balloon is formed of medical materials such as polyurethane, polyester, and polyethylene. The connecting portion 31 is sleeved on the outer side of the distal end of the first push rod and is heat-sealed so that the two can be effectively connected and sealed, so that the saline through the infusion channel can enter the balloon body 32. After the balloon body 32 is filled with saline, it is spherical, and the radial dimension can increase as the saline is filled, so that the positioning function can be achieved.

[0049] Preferably, the first push rod includes a first section 21 and a second section which are connected to each other, the first section 21 is located at the distal side of the second section, the inner diameter of the first section 21 is larger than the inner diameter of the second section, and when the positioning element is in the stored state, the capsule portion 32 is stored in the first section 21, and the length of the first section 21 is 3-7 mm.

[0050] The first push rod is a hollow tube. Compared with a solid push rod, the infusion channel will reduce the rigidity of the first push rod. Initially, the capsule body 32 is received in the infusion channel. Therefore, the inner diameter of the infusion channel in the first section 21 is larger, so that it is convenient to receive the capsule body 32 in the first section 21, and the inner diameter of the infusion channel in the second section is smaller. On the one hand, it can meet the purpose of conveying physiological saline, and on the other hand, it can reduce the influence of the infusion channel on the rigidity of the first push rod, so that the first push rod can effectively support the balloon.

[0051] In addition, since the size of the capsule portion 32 is relatively small, the length of the first section 21 is controlled within 3-7 mm, so that the length of the first section 21 is much smaller than the length of the second section, further ensuring the rigidity of the first push rod.

[0052] The implant 4 is made of degradable polyurethane, gelatin, chitosan and / or polylactic acid, and has a compressed state and an expanded state. When the implant 4 is located in the second delivery channel 12, the implant 4 is in a compressed state; after the implant 4 is pushed out of the second delivery channel 12, the implant 4 can absorb blood and switch to an expanded state, and the ratio of the volume of the implant 4 in the expanded state to the volume of the implant 4 in the compressed state is (30-60):1.

[0053] It also includes a handle, on which an adjustment mechanism is provided, the adjustment mechanism includes a first rack 54, a second rack 55, a gear set and an intermediate gear 53, the gear set includes a first gear 51 and a second gear 52, the first gear 51 and the second gear 52 are coaxially arranged, the second gear 52 is meshed with the intermediate gear 53, the intermediate gear 53 is also meshed with the second rack 55, the first rack 54 is controlled to engage or disengage with the first gear 51 through a clutch, the first rack 54 is connected to the first push rod 2 to drive the first push rod 2 to move, and the second rack 55 is connected to the conveying pipe 1 to drive the conveying pipe 1 to move.

[0054] Preferably, the gear ratio between the first gear 51 and the second gear 52 is 4:(1-3).

[0055] After the distal end of the delivery tube 1 is inserted into the blood vessel from the puncture point, the first gear 51 is disengaged from the first rack 54, and the delivery tube 1 is pulled toward the proximal side, while the position of the first rack 54 is kept unchanged, so that the first rack 54 supports the first push rod 2, so that the positioning element 3 extends from the distal end of the first delivery channel 11; then the first rack 54 is meshed with the first gear 51, and by rotating the first gear 51, the first gear 51 and the second gear 52 rotate synchronously, the first gear 51 drives the first rack 54 to move toward the proximal side, and at the same time, the second gear 52 drives the second rack 55 to move toward the proximal side through the intermediate gear 53, the first rack 54 drives the first push rod 2 to move toward the proximal side, and the second rack 55 drives the delivery tube 1 to move toward the proximal side, thereby achieving the purpose of releasing the implant 4 and recovering the positioning element 3 at the same time.

[0056] The gear ratio of the first gear 51 to the second gear 52 reaches 4:(1-3), so that the first rack 54 moves toward the proximal side faster than the second rack 55 , so that the positioning element 3 can enter the first conveying channel 11 . It should be understood that the above-mentioned embodiments are merely illustrative and not restrictive. Without departing from the basic principles of the present invention, various obvious or equivalent modifications or substitutions that can be made by those skilled in the art to the above-mentioned details will all be included in the scope of the claims of the present invention.

Claims

1. A hemostatic device, characterized in that: Used for blocking a puncture port of a blood vessel, comprising a delivery tube, a first push rod, a positioning element and a second push rod, wherein the delivery tube is in an elongated strip shape, and a first delivery channel and a second delivery channel are arranged inside the delivery tube, wherein both the first delivery channel and the second delivery channel extend along the length direction of the delivery tube, wherein the distal end of the first delivery channel penetrates the distal end of the delivery tube, the proximal end of the first delivery channel penetrates the proximal end of the delivery tube, the distal end of the second delivery channel penetrates the distal end of the delivery tube, and the proximal end of the second delivery channel penetrates the proximal end of the delivery tube; the first delivery channel and the second delivery channel are not connected to each other; The first push rod is disposed in the first delivery channel, and the distal end of the first push rod is connected to the positioning element, so as to push the positioning element out and pull it back from the distal end of the first delivery channel; The positioning element has a stowed state and an expanded state. In a natural state, the positioning element is in an expanded state. Under the action of an external force, the positioning element is deformed and can be compressed into the first delivery channel. In the first delivery channel, the positioning element is in a stowed state. In the expanded state, the radial dimension of the positioning element becomes larger and is larger than the dimension of the puncture port. The second push rod is inserted into the second delivery channel. An implant is also provided in the second delivery channel. The implant is located at the distal end of the second push rod and abuts against the second push rod. The second push rod can slide relative to the second delivery channel to push the implant out from the distal end of the second delivery channel.

2. The hemostatic blocking device according to claim 1, characterized in that: The delivery pipe comprises an inner pipe and an outer pipe which are coaxially arranged, wherein the inner pipe is located inside the outer pipe, and the first delivery channel is formed inside the inner pipe; a plurality of connecting strips are also arranged inside the outer pipe, and the outer wall of the inner pipe is connected to the outer pipe through the connecting strips, and a plurality of the connecting strips are arranged at equal angles in the circumference of the delivery pipe; An annular delivery channel is formed between the inner tube and the outer tube, and the plurality of connecting strips divide the delivery channel into a plurality of second delivery channels in a fan shape; each of the second delivery channels is penetrated by the second push rod and the implant.

3. The hemostatic occlusion device according to claim 1, characterized in that: The lumen of the delivery tube constitutes the first delivery channel, and the ratio of the diameter of the first delivery channel to the outer diameter of the delivery tube is (2-4):

10. At least three second delivery channels are formed on the tube wall of the delivery tube. The cross-section of the second delivery channel is circular, and the ratio of the diameter of the second delivery channel to the diameter of the first delivery channel is (5-15):

10.

4. The hemostatic blocking device according to claim 3, characterized in that: At the distal end of the second delivery channel, the second delivery channel is bent, and from proximal to distal, the distal end of the second delivery channel is bent radially outward.

5. The hemostatic blocking device according to claim 4, characterized in that: When the circumferential dimension of the delivery tube is 5-9F, the deflection angle of the distal end of the second delivery channel is 5°-15°; When the circumferential dimension of the delivery tube is 10-18F, the deflection angle of the distal end of the second delivery channel is 15°-30°; When the circumferential dimension of the delivery tube is 20-24F, the deflection angle of the distal end of the second delivery channel is 30°-40°.

6. The hemostatic blocking device according to any one of claims 1 to 5, characterized in that: The positioning element is woven from nickel-titanium alloy wires. In the unfolded state, the positioning element is disc-shaped, and the radial dimension of the positioning element is 2-4 mm larger than the outer diameter of the delivery tube.

7. The hemostatic blocking device according to any one of claims 1 to 5, characterized in that: The positioning element is a balloon, the first push rod is a hollow tube, the balloon comprises a connecting portion and a capsule body portion which are connected to each other, the connecting portion is sleeved on the outer side of the distal end of the first push rod and is heat-sealed to the first push rod; An infusion channel is formed in the first push rod, and when the positioning element is in the stored state, the capsule portion is stored in the distal end portion of the infusion channel; Liquid is introduced into the balloon through the infusion channel to push the balloon body out of the infusion channel, and the balloon body is filled with liquid, so that the balloon is switched to the expanded state.

8. The hemostatic occlusion device according to claim 7, characterized in that: The first push rod includes a first section and a second section connected to each other, the first section is located at the distal side of the second section, the inner diameter of the first section is larger than the inner diameter of the second section, and when the positioning element is in the stored state, the capsule part is stored in the first section, and the length of the first section is 3-7mm.

9. The hemostatic blocking device according to any one of claims 1 to 5, characterized in that: The implant is made of degradable polyurethane, gelatin, chitosan and / or polylactic acid, and has a compressed state and an expanded state. When the implant is located in the second delivery channel, the implant is in the compressed state; after the implant is pushed out of the second delivery channel, the implant can absorb blood and switch to the expanded state, and the ratio of the volume of the implant in the expanded state to the volume of the implant in the compressed state is (30-60):

1.

10. The hemostatic blocking device according to any one of claims 1 to 5, characterized in that: It also includes a handle, on which an adjustment mechanism is provided, the adjustment mechanism includes a first rack, a second rack, a gear set and an intermediate gear, the gear set includes a first gear and a second gear, the first gear is coaxially arranged with the second gear, the second gear is meshed with the intermediate gear, the intermediate gear is also meshed with the second rack, the first rack is controlled to engage or disengage with the first gear through a clutch, the first rack is connected to the first push rod to drive the first push rod to move, and the second rack is connected to the delivery pipe to drive the delivery pipe to move.

11. The hemostatic blocking device according to claim 10, characterized in that: The gear ratio between the first gear and the second gear is 4:(1-3).

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