A hemostatic plugging device

Abstract

The present invention relates to a plugging and hemostasis device, which includes a delivery tube, a first push rod, a positioning element and a second push rod. The delivery tube is in a long strip shape, and a first delivery channel and a second delivery channel are provided inside the delivery tube, and the first delivery channel and the second delivery channel are not communicated with each other; the first push rod is inserted into the first delivery channel, and a positioning element is connected to the distal end of the first push rod for pushing the positioning element out of and pulling it back to the distal end of the first delivery channel; the second push rod is inserted into the second delivery channel, and an implant is further provided in the second delivery channel. The implant 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 to push the implant out of the distal end of the second delivery channel. The implant can be implanted into the puncture point with high precision, improving the plugging function of the puncture point.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly relates to a plugging and hemostasis device. Background Art

[0002] In recent years, the interventional techniques for the heart, large blood vessels and peripheral blood vessels have developed rapidly. To a certain extent, this has promoted the development of vascular closure devices for puncture site hemostasis. Commonly used vascular closure devices can be roughly divided into coagulation-promoting types, suture types and staple / clamp types. The staple / clamp type closure device relies on metal staples / clamps to function and cannot support repeated punctures. The suture type closure device occupies a large share of the vascular puncture site closure market and can be used for the closure of large-caliber puncture sites. However, the complex operation and non-degradable suture are its existing disadvantages.

[0003] There are various coagulation-promoting type vascular closure devices. According to the invasion site, there are roughly two forms: bilateral clamping inside and outside the blood vessel wall and external plugging of the blood vessel wall. The bilateral clamping vascular closure device can provide a better plugging effect, but the implant inside the blood vessel undoubtedly occupies part of the blood vessel lumen space and has a higher risk of forming thrombus. The external plugging vascular closure device of the blood vessel wall reduces the risk of occupying the blood vessel lumen. However, the stability of the implant placement, that is, the stable release of the implant at the external puncture site of the blood vessel wall without entering the blood vessel and being able to closely adhere to the blood vessel wall, is a long-term challenge. In addition, most of the coagulation-promoting type vascular closure devices can only plug puncture sites with a smaller diameter, which also restricts the application of such devices. Summary of the Invention

[0004] In view of this, the present invention provides a plugging and hemostasis device, which can accurately implant a degradable implant into the puncture site and improve the plugging function of the puncture site.

[0005] The technical solution adopted by the present invention is as follows:

[0006] A plugging and hemostasis device for plugging a vascular puncture opening, comprising a delivery tube, a first push rod, a positioning element and a second push rod. The delivery tube is in a long strip shape, and a first delivery channel and a second delivery channel are arranged inside 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 penetrates through the distal end of the delivery tube, the proximal end of the first delivery channel penetrates through the proximal end of the delivery tube, the distal end of the second delivery channel penetrates through the distal end of the delivery tube, and the proximal end of the second delivery channel penetrates through the proximal end of the delivery tube; the first delivery channel and the second delivery channel are not communicated with each other;

[0007] The first push rod is disposed in the first delivery channel, and the distal end of the first push rod is connected with the positioning element for pushing the positioning element out of and pulling it back into the distal end of the first delivery channel;

[0008] The positioning element has a storage state and an unfolded state. In the natural state, the positioning element is in the unfolded state. Under the action of an external force, the positioning element can be deformed under the action of the external force, and the positioning element can be compressed into the first conveying channel. In the first conveying channel, the positioning element is in the storage state; in the unfolded state, the radial dimension of the positioning element becomes larger and is greater than the size of the puncture opening;

[0009] The second push rod passes through the second conveying channel, and an implant is further provided in the second conveying channel. The implant 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 conveying channel to push the implant out from the distal end of the second conveying channel.

[0010] Preferably, the delivery tube includes a coaxial inner tube and an outer tube. The inner tube is located inside the outer tube, and the first conveying channel is formed inside the inner tube; a plurality of connecting strips are further provided inside the outer tube, and the outer wall of the inner tube is connected to the outer tube through the connecting strips. In the circumferential direction of the delivery tube, the plurality of connecting strips are arranged at equal angles;

[0011] An annular conveying channel is formed between the inner tube and the outer tube, and the plurality of connecting strips divide the conveying channel into a plurality of fan-shaped second conveying channels; the second push rod and the implant are respectively disposed through each of the second conveying channels.

[0012] Preferably, the lumen of the delivery tube constitutes the first conveying channel. The ratio of the diameter of the first conveying channel to the outer diameter of the delivery tube is (2-4):10. At least three second conveying channels are formed on the tube wall of the delivery tube. The cross section of the second conveying channel is circular, and the ratio of the diameter of the second conveying channel to the diameter of the first conveying channel is (5-15):10.

[0013] Preferably, at the distal end of the second conveying channel, the second conveying channel is bent, and from near to far, the distal end of the second conveying channel is bent radially outward.

[0014] Preferably, when the circumferential dimension of the delivery tube is 5-9F, the deflection angle of the distal end of the second conveying channel is 5°-15°;

[0015] When the circumferential dimension of the delivery tube is 10-18F, the deflection angle of the distal end of the second conveying channel is 15°-30°;

[0016] When the circumferential dimension of the delivery tube is 20-24F, the deflection angle of the distal end of the second conveying channel is 30°-40°.

[0017] Preferably, the positioning element is woven from nitinol wire. In the deployed state, the positioning element is in a disc shape, and the radial dimension of the positioning element is 2-4 mm larger than the outer diameter of the delivery tube.

[0018] Preferably, the positioning element is a balloon. The first push rod is a hollow tube. The balloon includes a connecting portion and a balloon body portion that 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.

[0019] An infusion channel is formed in the first push rod. In the retracted state of the positioning element, the balloon body portion is received in the distal end portion of the infusion channel.

[0020] Liquid is introduced into the balloon through the infusion channel to push the balloon body portion out of the infusion channel. The balloon body portion is filled with liquid, causing the balloon to switch to the deployed state.

[0021] Preferably, the first push rod includes a first section and a second section that are connected to each other. The first section is located on the distal side of the second section. The inner diameter of the first section is larger than the inner diameter of the second section. In the retracted state of the positioning element, the balloon body portion is received in the first section, and the length of the first section is 3-7 mm.

[0022] Preferably, the implant is made of biodegradable polyurethane, gelatin, chitosan, and / or polylactic acid. It 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 adsorb blood and switch to the expanded state. The volume ratio of the expanded implant to the compressed implant is (30-60):1.

[0023] Preferably, it further includes a handle. An adjustment mechanism is provided at the handle. 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 and the second gear are coaxially arranged. The second gear meshes with the intermediate gear, and the intermediate gear also meshes with the second rack. The first rack is controllably engaged with or disengaged from the first gear through a clutch. The first rack is connected to the first push rod to drive the first push rod to act, and the second rack is connected to the delivery tube to drive the delivery tube to act.

[0024] Preferably, the tooth ratio of the first gear to the second gear is 4:(1-3).

[0025] Advantages of the present invention:

[0026] When it is necessary to seal the puncture point, insert the delivery tube along the sinus tract and insert the distal end of the delivery tube into the puncture point. Push the first push rod distally, and the first push rod will push 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, and the positioning element switches to the deployed state. In the deployed state, the size of the positioning element is larger than the puncture point, so the positioning element will not break away from the puncture point; move the sealing and hemostasis device proximally so that the distal end of the delivery tube exits the puncture point, and the positioning element adheres tightly to the inner wall of the blood vessel; retract the first push rod, and under the action of the adjustment mechanism, the delivery tube exits proximally, and at the same time keep the position of the second push rod unchanged. Therefore, the second push rod will push forward relative to the second delivery channel, thereby pushing the implant out of the second delivery channel. Since the positioning element is located inside the puncture point, the implant can be exactly pushed to the outside of the puncture point, thus achieving precise sealing of the outside of the puncture point. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Through the following description of the embodiments of the present invention with reference to the drawings, the above and other objects, features and advantages of the present invention will become clearer. In the drawings:

[0028] Figure 1 is a schematic structural diagram of the sealing and hemostasis device;

[0029] Figure 2 is a schematic structural diagram of the first embodiment of the delivery tube;

[0030] Figure 3 is a schematic structural diagram of the second embodiment of the delivery tube;

[0031] Figure 4 is a cross-sectional view of the delivery tube;

[0032] Figure 5 is a schematic structural diagram of the delivery tube;

[0033] Figure 6 is a schematic diagram of the implant when released and the blood vessel wall;

[0034] Figure 7 is a schematic diagram of the deployed state of the positioning element woven from nitinol wire Figure 1 ;

[0035] Figure 8 is a schematic diagram of the deployed state of the positioning element woven from nitinol wire Figure 2 ;

[0036] Figure 9 is a schematic diagram of the storage state of the positioning element woven from nitinol wire;

[0037] Figure 10 is a schematic diagram of the deployed state of the positioning element of the balloon;

[0038] Figure 11 Schematic diagram of the storage state of the positioning element of the balloon;

[0039] Figure 12 Schematic diagram of the structure of the adjusting mechanism Figure 1 ;

[0040] Figure 13 Schematic diagram of the structure of the adjusting mechanism Figure 2 。

[0041] In the figure: 1. Delivery tube; 2. First push rod; 3. Positioning element; 4. Implant;

[0042] 11. First delivery channel; 12. Second delivery channel; 13. Inner tube; 14. Outer tube; 15. Connecting strip;

[0043] 21. First section; 22. Second section; 31. Connecting part; 32. Bladder part;

[0044] 51. First gear; 52. Second gear; 53. Intermediate gear; 54. First rack; 55. Second rack;

[0045] 121. Distal end part. Detailed implementation manners

[0046] The present invention will be 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 obscuring the essence of the present invention, well-known methods, processes, procedures, and components are not described in detail.

[0047] In addition, those of ordinary skill in the art should understand that the drawings provided herein are for illustrative purposes only, and the drawings are not necessarily drawn to scale.

[0048] Unless the context clearly requires otherwise, the words "including", "comprising", and the like in the entire specification and claims should be construed in an inclusive sense rather than an exclusive or exhaustive sense; that is, the meaning of "including but not limited to".

[0049] 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 construed as indicating or implying relative importance. In addition, in the description of the present invention, unless otherwise specified, the meaning of "a plurality of" is two or more.

[0050] In the present invention, in a surgical situation, the end far from the operator is "distal", and the side close to the operator is "proximal".

[0051] See Figures 1 - 13, the present invention provides a plugging and hemostasis device for plugging a vascular puncture opening, including a delivery tube 1, a first push rod 2, a positioning element 3 and a second push rod. The delivery tube 1 is in a long strip shape. A first delivery channel 11 and a second delivery channel 12 are provided in the delivery tube 1. Both the first delivery channel 11 and the second delivery channel 12 extend along the length direction of the delivery tube 1. The distal end of the first delivery channel 11 penetrates through the distal end of the delivery tube 1, and the proximal end of the first delivery channel 11 penetrates through the proximal end of the delivery tube 1. The distal end of the second delivery channel 12 penetrates through the distal end of the delivery tube 1, and the proximal end of the second delivery channel 12 penetrates 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;

[0052] The first push rod 2 is disposed in the first delivery channel 11. The distal end of the first push rod 2 is connected with the positioning element 3 for pushing the positioning element 3 out of and pulling it back into the distal end of the first delivery channel 11;

[0053] The positioning element 3 has a storage state and an expanded state. In the natural state, the positioning element 3 is in the expanded state. Under the action of an external force, the positioning element 3 can be deformed under the action of the external force. 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 expanded state, the radial dimension of the positioning element 3 becomes larger and is greater than the dimension of the puncture opening. It is in a disc shape (it can also be other shapes, such as triangular, oval or rectangular, etc.);

[0054] The second push rod is disposed in the second delivery channel 12. An implant 4 is further 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 of the distal end of the second delivery channel 12.

[0055] 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. Therefore, 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.

[0056] Taking an interventional operation as an example, after the interventional operation is completed, it is necessary to plug the puncture point on the blood vessel. At this time, the present invention can be used to plug the puncture point; the operation process is as follows:

[0057] Initially, the positioning element 3 is in a stored state and is 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. Push the first push rod 2 towards the distal side, and the first push rod 2 will push the positioning element 3 out of the first delivery channel 11. Therefore, the positioning element 3 will enter the blood vessel and expand within the blood vessel. The positioning element 3 switches to the expanded state. Then, keep the first push rod 2 stationary and pull the delivery tube 1 towards 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 exits from the puncture point; then, continue to pull the delivery tube 1 towards the proximal side while ensuring that the position of the second push rod remains unchanged, so that the implant 4 will not move towards the proximal side. Therefore, 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 outside the puncture point until the entire implant 4 is pushed out of the second delivery channel 12, and the implant 4 will exactly block the puncture point, thus achieving the purpose of blocking the puncture point.

[0058] In addition, the distal end of the first push rod 2 is connected to the positioning element 3. Pull the first push rod 2 towards the proximal side, and the first push rod 2 will drive the positioning element 3 to penetrate out of the puncture point. Since the positioning element 3 can be compressed, the positioning element 3 can re-enter the first delivery channel 11 through the puncture point. Then, withdraw the entire delivery tube 1 from the sinus tract, and 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.

[0059] 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.

[0060] The delivery tube 1 includes an inner tube 13 and an outer tube 14 arranged coaxially. The inner tube 13 is located inside the outer tube 14, and the first delivery channel 11 is formed inside the inner tube 13; there are also a plurality of connecting strips 15 provided inside the outer tube 14 (for example Figure 2 in the illustrated embodiment, the number of connecting strips 15 is 2). The outer wall of the inner tube 13 is connected to the outer tube 14 through the connecting strips 15. In the circumferential direction of the delivery tube 1, the plurality of connecting strips 15 are arranged at equal angles;

[0061] An annular delivery channel is formed between the inner tube 13 and the outer tube 14. 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 provided with the second push rod and the implant 4.

[0062] The arrangement of the inner tube 13 and the outer tube 14 reduces the manufacturing difficulty of the delivery tube 1. The arrangement of the connecting strip 15 enables the inner tube 13 and the outer tube 14 to form an integral body 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.

[0063] In addition, in this embodiment, there are two second delivery channels 12, and each second delivery channel 12 is provided with a second push rod to push a corresponding implant 4 respectively (that is, the number of implants 4 is two).

[0064] In addition, the second delivery channel 12 is located on the periphery of the first delivery channel 11, and the first delivery channel 11 exactly corresponds to the puncture point. Therefore, the implant sent out from the second delivery channel can block the puncture point from the periphery of the puncture point inward to ensure the blocking effect.

[0065] 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. At least three second delivery channels 12 are formed on the tube wall of the delivery tube 1 (as Figure 3 shown in the embodiment, the number of the second delivery channels 12 is 6). The cross-section of the second delivery channel 12 is circular, and the ratio of the diameter of the second delivery channel 12 to the diameter of the first delivery channel 11 is (5 - 15):10.

[0066] The diameter of the first delivery channel 11 is less than half of the outer diameter of the delivery tube 1, so that the tube wall of the delivery tube 1 has a certain thickness, which facilitates the formation of the second delivery channel 12 on the tube wall, and at the same time ensures 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 enabling the distal end of the delivery tube 1 to enter the blood vessel from the puncture point.

[0067] The diameter of the second delivery channel 12 can be smaller than the diameter of the first delivery channel 11 or larger than the diameter of the first delivery channel 11. For example, the diameter of the second delivery channel 12 is 0.5 - 0.8 times the diameter of the first delivery channel 11, so that the second delivery channel 12 can be formed on the tube wall and ensure that the second delivery channel 12 does not communicate with the first delivery channel 11, while taking into account the structural strength of the delivery tube 1.

[0068] Of course, in practical applications, the first delivery channel is mainly for the positioning element 3 to pass through. The positioning element 3 is woven from nitinol wire and has a 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 implants with a larger volume and improve the blocking effect on the puncture point.

[0069] At the distal end of the second delivery channel 12, the second delivery channel 12 is bent, and from near to far, the distal end of the second delivery channel 12 is bent radially outward.

[0070] Of course, the distal end of the second delivery channel 12 may not be bent, which is applicable to the case where the circumferential dimension of the delivery tube is small, such as the circumferential dimension being 5F - 9F.

[0071] When pushing the implant 4 towards the distal side of the second delivery channel 12, the first push rod 2 can be synchronously pulled towards the proximal side. The distal end (distal portion 121) of the second delivery channel 12 is bent radially outward, which will cause the implant 4 to protrude radially outward, thereby reducing the interference between the implant 4 and the pulled-out positioning element 3 and preventing the implant 4 from being wound around the positioning element 3.

[0072] It should be noted that during the interventional surgery process, the size of the puncture point will become larger. Therefore, when the implant 4 is implanted at the puncture point in an outward-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 cause most of the implant 4 to contact the blood vessel wall, enhancing the support effect on the implant 4.

[0073] It is worth noting that during the process of the implant 4 being pushed out from the distal end of the second delivery channel 12, it takes a certain amount of time. During this process, the first push rod 2 is pulled towards the proximal side, causing the positioning element 3 to be gradually pulled out of the blood vessel. During this process, a part of the positioning element 3 will be located inside the blood vessel, thus providing support to the blood vessel wall on the inner side. The implant 4 expands on the outer side. Therefore, the positioning element 3 and the implant 4 interact with each other across the blood vessel wall, enhancing the sealing effect of the implant 4 on the puncture point.

[0074] 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 of the distal end and the axial direction of the delivery tube 1) is 5° - 15°;

[0075] 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°;

[0076] 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°.

[0077] The circumferential dimension of the delivery tube 1 is consistent with the dimension of the puncture point. For example, if the puncture point is 10F (with a diameter of approximately 3 mm), the dimension of the delivery tube 1 is also selected as 10F. When the dimension of the puncture point is larger, a larger implant 4 (volume) is required to seal the puncture point, and thus the possibility of interference between the positioning element 3 and the implant 4 is greater. In the present invention, the larger the circumferential dimension of the overall delivery tube 1, the larger the deflection angle, causing the implant 4 to deflect more outwardly, thereby avoiding interference between the implant 4 and the positioning element 3.

[0078] See Figures 7 - 9 , the positioning element 3 is woven from nitinol wire and, in the deployed state, is in a disc shape (it can also be other shapes, such as triangular, elliptical, or rectangular, etc.). 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 does not detach from the puncture point in the deployed state.

[0079] See Figure 10 and Figure 11 , for the positioning element 3, in another alternative embodiment, the positioning element is a balloon. At this time, the first push rod is a hollow tube. The balloon includes a connecting portion 31 and a balloon body portion 32 that are connected to each other. The connecting portion 31 is sleeved outside the distal end of the first push rod and is heat-sealed to the first push rod;

[0080] An infusion channel is formed inside the first push rod. In the retracted state of the positioning element, the balloon body portion 32 is retracted inside the distal end portion of the infusion channel;

[0081] Liquid is introduced into the balloon through the infusion channel to push the balloon body portion 32 out of the infusion channel. The liquid fills the balloon body portion 32, causing the balloon to switch to the deployed state.

[0082] Initially, the balloon portion 32 is received within the distal end portion 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 on 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. The first push rod 2 is pushed distally, and the distal end of the first push rod 2 extends out of the distal end of the first delivery channel 11. From the proximal side of the infusion channel, normal saline is pumped into the infusion channel. The normal saline enters the balloon portion 32 through the first delivery channel 11 and pushes the balloon portion 32 out of the infusion channel, such that the balloon portion 32 exists independently within the blood vessel. The balloon portion 32 is filled with normal saline and expands. After the balloon portion 32 expands to a predetermined size (determined according to the actual situation), pumping of the normal saline is stopped. At this time, the balloon switches to the deployed state. Then, the first push rod 2 is kept stationary, and the delivery tube 1 is pulled proximally (the position of the second push rod relative to the delivery tube 1 remains unchanged), such that the distal end of the delivery tube 1 exits from the puncture point. Then, the delivery tube 1 is continuously pulled proximally while ensuring that the position of the second push rod remains unchanged, so that the implant 4 does not move proximally. 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 outside the puncture point until the entire implant 4 is pushed out of the second delivery channel 12, and the implant 4 will exactly block the puncture point, thereby achieving the purpose of blocking the puncture point.

[0083] When removing the present invention, first, normal saline is aspirated through the infusion channel, such that the normal saline within the balloon is pumped out, causing the balloon (the balloon portion 32 contracts). Then, the first push rod 2 is pulled proximally, and the first push rod 2 will drive the deflated balloon portion 32 to penetrate through the puncture point and cause the balloon portion 32 to be pulled into 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, achieving the purpose of precisely blocking the puncture point without leaving other structures within the body, thereby improving the surgical effect.

[0084] The balloon is shaped from medical materials such as polyurethane, polyester, and polyethylene. The connecting portion 31 is sleeved outside the distal end of the first push rod and is heat-sealed, enabling effective connection and sealing between the two, such that the normal saline passing through the infusion channel can enter the balloon portion 32. After the balloon portion 32 is filled with normal saline, it assumes a spherical shape, and the radial dimension can increase as the normal saline is filled, thereby enabling the positioning function.

[0085] 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 on the distal side of the second section. The inner diameter of the first section 21 is greater than that of the second section. In the received state of the positioning element, the bladder portion 32 is received within the first section 21, and the length of the first section 21 is 3 - 7 mm.

[0086] 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 bladder portion 32 is received within the infusion channel. Therefore, the inner diameter of the infusion channel in the first section 21 is larger, facilitating the receipt of the bladder portion 32 into the first section 21. The inner diameter of the infusion channel in the second section is smaller. On the one hand, it can meet the purpose of delivering physiological saline, and on the other hand, it can reduce the influence of the infusion channel on the rigidity of the first push rod, enabling the first push rod to effectively support the balloon.

[0087] In addition, since the size of the bladder portion 32 is small, the length of the first section 21 is controlled to be 3 - 7 mm, making the length of the first section 21 much smaller than that of the second section, further ensuring the rigidity of the first push rod.

[0088] The implant 4 is made of biodegradable polyurethane, gelatin, chitosan, and / or polylactic acid. It has a compressed state and an expanded state. When the implant 4 is located within the second delivery channel 12, the implant 4 is in the compressed state; after the implant 4 is pushed out from the second delivery channel 12, the implant 4 can adsorb blood and switch to the expanded state. The volume ratio of the expanded implant 4 to the compressed implant 4 is (30 - 60):1.

[0089] It further includes a handle. An adjustment mechanism is provided at the handle. 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 meshes with the intermediate gear 53. The intermediate gear 53 also meshes with the second rack 55. The first rack 54 is controllably engaged or disengaged 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 act. The second rack 55 is connected to the delivery tube 1 to drive the delivery tube 1 to act.

[0090] Preferably, the tooth ratio of the first gear 51 to the second gear 52 is 4:(1 - 3).

[0091] After the distal end of the delivery tube 1 is inserted into the blood vessel from the puncture point, at this time, the first gear 51 disengages from the first rack 54, the delivery tube 1 is pulled toward the proximal side, and the position of the first rack 54 is kept unchanged, so that the first rack 54 abuts against the first push rod 2, so that the positioning element 3 extends out from the distal end of the first delivery channel 11; then the first rack 54 meshes with the first gear 51, 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, 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, so as to achieve the purpose of releasing the implant 4 and recovering the positioning element 3 at the same time.

[0092] The tooth ratio of the first gear 51 to the second gear 52 reaches 4:(1-3), so that the moving speed of the first rack 54 toward the proximal side is faster than that of the second rack 55 toward the proximal side, so that the positioning element 3 can enter the first delivery channel 11.

[0093] It should be understood that the above embodiments are exemplary rather than restrictive. Without departing from the basic principle of the present invention, various obvious or equivalent modifications or substitutions made by those skilled in the art to the above details will be included within 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, and an implant is also arranged 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. 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; 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.

2. The hemostatic blocking device according to claim 1, 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°.

3. The hemostatic blocking device according to any one of claims 1 to 2, 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.

4. The hemostatic blocking device according to any one of claims 1 to 2, 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.

5. The hemostatic blocking device according to claim 4, 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.

6. The hemostatic blocking device according to any one of claims 1 to 2, 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.

7. The hemostatic blocking device according to any one of claims 1 to 2, 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.

8. The hemostatic occlusion device according to claim 7, characterized in that: The gear ratio between the first gear and the second gear is 4:(1-3).

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