A closure hemostatic device

Abstract

The application discloses a plugging and hemostasis device, which comprises a shell, a pull tube, one end of the pull tube being movably connected with the shell, the other end of the pull tube extending to the distal end of the shell, a catheter, the catheter penetrating through the pull tube and being capable of moving relative to the axial direction of the pull tube, and a sealant, the sealant being located between the pull tube and the catheter and being arranged close to the distal end of the pull tube. After the first locking mechanism is unlocked, the pushing mechanism pushes the push tube to move to the distal end, pushes the sealant exposed to the tissue to be tight, is attached to the tissue wall of the blood vessel puncture hole, extrudes the sealant to make the sealant fully attach to the outer wall of the blood vessel and is compacted, and the blood vessel is effectively plugged and hemostasis.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a occlusion and hemostasis device. Background Technology

[0002] Some diagnostic and surgical procedures require access to a patient's vascular system, such as imaging surgery, angioplasty, stent delivery, coil delivery, or other methods that require entry into the vascular system. Percutaneous access to the patient's vascular system creates a puncture site through the patient's tissue (vascular wall). This puncture site is closed after the procedure using various mechanical or biological solutions, such as applying external pressure (by hand or instruments to compress the puncture site), tightening, suturing, delivering a metal implant, using sealants, or plugs, or a combination of these methods. However, many of these closure procedures are time-consuming, expensive, and cause prolonged discomfort for the patient. Prolonged closure procedures waste significant time for both doctors and patients, and carry a greater risk of bleeding and hematoma.

[0003] Chinese Patent Application No. 201580061128.1 discloses a closure system for closing an arterial incision site. The closure system includes: a handle portion; a sheath adapter including an attachment structure for releasable attachment to a procedural sheath; an external catheter extending distally from the handle portion, the external catheter including a proximal segment and a distal segment; an internal catheter extending through the external catheter, the external catheter being axially movable relative to the internal catheter; a sealant positioned in the distal segment of the external catheter; and a support tube proximal to the sealant and radially between the external catheter and the internal catheter. In use, this technical solution suffers from difficulty in accurately controlling the sealant release position, leading to inaccurate positioning, poor hemostasis, and increased operational difficulty. Therefore, this application is filed. Summary of the Invention

[0004] To address at least one of the technical problems existing in the background art, the present invention proposes a occlusion and hemostasis device.

[0005] The present invention provides a closure and hemostasis device, comprising:

[0006] case;

[0007] A pull tube, one end of which is movably connected to the housing, and the other end of which extends to the distal end of the housing;

[0008] A conduit that passes through the pull tube and is axially movable relative to the pull tube;

[0009] A sealant is located between the pull tube and the conduit, and is disposed near the distal end of the pull tube;

[0010] A first expandable member is disposed at the distal end of the tube;

[0011] A push tube is arranged between the pull tube and the guide tube, and is located on the side of the sealant away from the first expandable member;

[0012] The release part includes a pushing mechanism and a retraction mechanism. The retraction mechanism is used to drive the pull tube to release the sealant, and the pushing mechanism is used to push the sealant tight.

[0013] A retraction mechanism for moving the conduit and the first expandable member toward the proximal end of the housing;

[0014] A first locking mechanism is connected to the conduit. The first locking mechanism has a locked state and an unlocked state. When the first locking mechanism is in the locked state, it prevents the release part from moving. When the conduit pulls the first locking mechanism to switch to the unlocked state, the pushing mechanism is configured to move the push tube toward the direction close to the sealant. The retraction mechanism is configured to move the pull tube toward the proximal end of the housing.

[0015] A first indicating mechanism is used to indicate the position status of the first locking mechanism and the position status of the first expandable member.

[0016] The first locking mechanism includes:

[0017] A movable component, configured to move relative to the housing, the movable component being configured to drive the release part to move;

[0018] A locking element, connected to the conduit, is used to lock or unlock the movable element. The locking element can be separated from the movable element by the action of the conduit to allow the first locking mechanism to be in an unlocked state.

[0019] One of the locking member and the movable member is provided with a first insertion section, and the other is provided with a first insertion slot that cooperates with the first insertion section.

[0020] The movable component is provided with a first gear tooth in the circumferential direction;

[0021] The retraction mechanism includes a pull frame, a first rotating shaft, a first gear, and a second gear. The pull frame is slidably disposed within the housing and connected to the pull tube. The pull frame has a second gear tooth along its length, which meshes with the first gear tooth. The first rotating shaft is rotatably connected to the housing. The first gear is mounted on the first rotating shaft and meshes with the second gear tooth. The second gear is mounted on the first rotating shaft.

[0022] The pushing mechanism includes a pushing member, which is movably connected to the housing and connected to the pushing tube. The pushing member is provided with a third gear tooth that meshes with the second gear along its moving direction.

[0023] The first actuating element is used to drive the movable element to rotate.

[0024] The first actuating element includes a first elastic element, which is configured to drive the movable element to rotate. One end of the first elastic element is connected to the movable element, and the other end is connected to the housing.

[0025] Alternatively, the housing may be provided with a movable groove; the first actuating element is a pressing element, which is connected to the movable element through the movable groove.

[0026] The pushing component includes a pushing block and a pushing plate. The pushing block is slidably connected to the housing. One end of the pushing block is connected to the pushing tube, and the other end is engaged with the pushing plate. The pushing plate is slidably connected to the housing.

[0027] One of the push block and the push plate is provided with a second insertion slot, and the other is provided with a second insertion segment for insertion into the second insertion slot; the second insertion slot has a working surface that mates with the second insertion segment, and when the movable part is in the locked state, there is a gap between the end face of the second insertion segment and the working surface;

[0028] The third gear tooth is located on the push plate.

[0029] The first indicating mechanism includes a first mark and a first indicating element. The locking element is provided with the first mark, and the housing is provided with a first observation window. The first observation window is provided with the first indicating element for cooperating with the first mark for indication.

[0030] And / or, the occlusion and hemostasis device further includes a second indicating mechanism, the second indicating mechanism including a second mark and a second indicating element, the pusher being provided with the second mark, the housing being provided with a second observation window, and the second observation window being provided with a second indicating element for cooperating with the second mark for indication.

[0031] The sealing and hemostasis device also includes:

[0032] The second locking mechanism has a locked state and an unlocked state. When the second locking mechanism is in the locked state, it prevents the retraction mechanism from operating. When the release part moves and triggers the second locking mechanism to be in the unlocked state, the retraction mechanism can operate to move the conduit toward the proximal end of the housing.

[0033] The retraction mechanism includes a second actuating element for activating the retraction structure to retract the conduit and the first expandable element.

[0034] The pushing mechanism includes a pushing member with a push plate, the push plate being used to drive the push tube to push the sealant tightly;

[0035] The second locking mechanism is a third insertion section disposed on the push plate; the retraction mechanism is provided with a third insertion groove or limiting step that cooperates with the third insertion section; or,

[0036] The second locking mechanism is a third insertion slot provided on the push plate; the retraction mechanism is provided with a third insertion section or limiting step that cooperates with the third insertion slot.

[0037] The housing has a first mounting port, wherein the second actuating element is a second button, which is installed inside the housing through the first mounting port and has a limiting groove; the retraction mechanism further includes a connector, a second elastic element, and a third elastic element. The connector is slidably connected to the housing and is located within the limiting groove. The connector is connected to the conduit; one end of the second elastic element is connected to the connector, and the other end is connected to the housing. When the limiting groove moves away from the first mounting port and separates from the connector, the second elastic element drives the connector to move towards the proximal end of the housing; the third elastic element is configured to provide a force to the second button toward the first mounting port.

[0038] or,

[0039] The second actuating element is a second button, which is installed inside the housing through the first mounting port; the retraction mechanism also includes a bending part, which is configured to bend the conduit under the action of the second button, thereby driving the first expandable element to move towards the proximal end of the housing.

[0040] The near end of the housing is provided with a first through hole;

[0041] The sealing and hemostasis device also includes:

[0042] A first support tube is located inside the housing and is connected to the conduit and the first through hole.

[0043] A flow guide tube, the first end of which is located outside the housing, and the second end of which is connected to and communicates with the first support tube. The flow guide tube is used to introduce or withdraw fluid into the first support tube to cause the first expandable component to expand or contract.

[0044] A third indicating mechanism is used to protrude from the first through hole when the first expandable member is in an expanded state.

[0045] The beneficial effects of this invention are:

[0046] After the first locking mechanism unlocks, the pushing mechanism moves the push tube distally, pressing the sealant exposed in the tissue firmly against the vascular puncture site and tissue wall. The sealant is then compressed to ensure it adheres firmly to the outer wall of the blood vessel, effectively sealing and stopping bleeding. The operation is simple and easy to control. Furthermore, with the assistance of the first indicating mechanism, the release position is easier to control and more accurate. Attached Figure Description

[0047] Figure 1 This is a schematic diagram of Embodiment 1 disclosed in this invention;

[0048] Figure 2 This is a schematic diagram of the housing, etc., of Embodiment 1 disclosed in this invention;

[0049] Figure 3 This is a cross-sectional view of the first expandable component, etc., disclosed in this invention;

[0050] Figure 4 This is a schematic diagram of a locking component, etc., disclosed in this invention;

[0051] Figure 5 This is a schematic diagram of the movable parts, etc., of Embodiment 1 disclosed in this invention;

[0052] Figure 6 This is a schematic diagram of the second button in Embodiment 1 of the present invention;

[0053] Figure 7 This is a schematic diagram of the second button, push plate, etc., according to Embodiment 1 of the present invention;

[0054] Figure 8 This is a schematic diagram of the second button, second elastic element, etc., according to Embodiment 1 of the present invention;

[0055] Figure 9 This is a cross-sectional view of the second button, the first support tube, etc., of Embodiment 1 disclosed in this invention;

[0056] Figure 10 This is a schematic diagram of the locking member, the movable member, the second elastic member, etc., of Embodiment 1 disclosed in this invention;

[0057] Figure 11 This is a schematic diagram of the first expandable member, locking member, movable member, second elastic member, etc., of Embodiment 1 disclosed in this invention;

[0058] Figure 12 This is a front view of the push tube portion area disclosed in this invention;

[0059] Figure 13 This is a schematic diagram of the movable component of Embodiment 1 of the present invention;

[0060] Figure 14 This is a schematic diagram of the first expandable component of Embodiment 1 of the present invention located inside a blood vessel;

[0061] Figure 15 The present invention discloses Figure 14 Enlarged view of a portion of the area;

[0062] Figure 16 This is a schematic diagram of the first expandable member of Embodiment 1 of the present invention abutting against the blood vessel wall;

[0063] Figure 17 The present invention discloses Figure 16 Enlarged view of the central area;

[0064] Figure 18 This is a schematic diagram of the sealant located inside the puncture hole as disclosed in this invention;

[0065] Figure 19 This is a schematic diagram of the first identifier, first indicator, second identifier, and second indicator of Embodiment 1 disclosed in this invention;

[0066] Figure 20 This is a schematic diagram of the pressing element, etc., according to Embodiment 2 of the present invention;

[0067] Figure 21 This is a cross-sectional view of Embodiment 2 disclosed in this invention;

[0068] Figure 22 This is a schematic diagram of Embodiment 2 disclosed in this invention. Detailed Implementation

[0069] It should be noted that, unless otherwise specified, the embodiments and features described in this application can be combined with each other. The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0070] In the description of this invention, it should be understood that the terms "upper," "lower," "front," "rear," "left," and "right," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the indicated position or element must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations of the invention. The terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance. Furthermore, unless otherwise expressly specified and limited, the term "connection" should be interpreted broadly. For example, "connection" can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or a transmission connection; it can be a direct connection or an indirect connection through an intermediate medium; it can also refer to the internal communication of two elements or the interaction between two elements.

[0071] Reference Figure 1-19 The present invention proposes a occlusion and hemostasis device, comprising a housing 1, a pull tube 2, a conduit 3, a sealant 4, a first expandable member 5, a push tube 6, a release part, a retraction mechanism, a first locking mechanism, and a first indicating mechanism.

[0072] One end of the pull tube 2 is movably connected to the housing 1, and the other end extends to the distal end of the housing 1; the conduit 3 passes through the pull tube 2 and is able to move axially relative to the pull tube 2; the conduit 3 is able to move relative to the pull tube 2.

[0073] The sealant 4 is located between the pull tube 2 and the conduit 3, and is positioned near the distal end of the pull tube 2; the first inflatable element 5 is positioned at the distal end of the pull tube 2. In this embodiment, the first inflatable element 5 is a balloon.

[0074] The push tube 6 is arranged between the pull tube 2 and the guide tube 3, and is located on the side of the sealant 4 away from the first expandable member 5.

[0075] The release section includes a pushing mechanism and a retraction mechanism. The retraction mechanism is connected to the pull tube 2 and is used to release the sealant 4. The pushing mechanism is used to push the sealant 4 tight.

[0076] The retraction mechanism is connected to the conduit 3 and is used to move the first expandable member 5 toward the proximal end of the housing 1.

[0077] The first locking mechanism is connected to the conduit 3. The first locking mechanism has a locked state and an unlocked state. When the first locking mechanism is in the locked state, the first locking mechanism prevents the release part from moving. When the conduit 3 pulls the first locking mechanism to switch to the unlocked state, the pushing mechanism is configured to drive the push tube 6 to move toward the direction of the sealant 4. The retraction mechanism is configured to drive the pull tube 2 to move toward the proximal end of the housing 1.

[0078] The first indicating mechanism is used to indicate the position status of the first locking mechanism. The position status of the first locking mechanism and the position status of the first expandable member can be determined through the first indicating mechanism.

[0079] Initially, the first locking mechanism is in the locked state. The first expandable element 5 is located inside the blood vessel, and the pull tube 2 is located inside the puncture hole K, combined with... Figure 14 , 15 .

[0080] The first expandable component is configured to contact the vessel wall, thus unlocking the first locking mechanism. During the outward pulling of the first expandable component 5, once it contacts the vessel wall, the catheter 3 activates the first locking mechanism to unlock, and the retraction mechanism moves the pull tube 2, exposing the sealant 4. The pushing mechanism then pushes the push tube 6 to compress the sealant 4, compacting it.

[0081] Combination Figure 16 , 17 18. After the first expandable part 5 shrinks, the catheter 3 and the first expandable part 5 are retracted using the retraction mechanism, so that the sealant 4 adheres to the vascular puncture hole K and the tissue wall, effectively sealing and stopping the bleeding.

[0082] In this embodiment, the first locking mechanism includes a movable member 7 and a locking member 8. The movable member 7 is configured to move relative to the housing 1 and is configured to drive the release part to move; the locking member 8 is connected to the conduit 3 and is used to lock or unlock the movable member 7. The locking member 8 can be separated from the movable member 7 under the action of the conduit 3 so that the first locking mechanism is in an unlocked state.

[0083] In this embodiment, the locking member 8 is provided with a first insertion section 9, and the movable member 7 is provided with a first insertion groove 10 that cooperates with the first insertion section 9. Of course, in another embodiment, the locking member 8 can be provided with a first insertion groove 10, and the movable member 7 can be provided with a first insertion section 9.

[0084] When the first insertion section 9 is located in the first insertion groove 10, the movable part 7 is locked. When the conduit 3 moves the locking part 8 to the distal end, the first insertion section 9 and the first insertion groove 10 separate, the movable part 7 is in the unlocked state, the movable part 7 drives the release part to move, and the push tube 6 compacts the sealant 4 to retract the pull tube 2.

[0085] To prevent the first insertion segment 9 from accidentally separating from the first insertion groove 10, this embodiment also includes a spring C, one end of which is connected to the housing 1 and the other end abuts against the locking member 8, applying a force towards the proximal end to the locking member 8. This prevents the first insertion segment 9 from accidentally separating from the first insertion groove 10.

[0086] Specifically, the movable part 7 has a first gear tooth 11 in the circumferential direction, and the housing 1 has an arc-shaped groove that cooperates with the movable part 7, allowing the movable part 7 to move along the arc-shaped groove.

[0087] The retraction mechanism includes: a pull frame 12, a first rotating shaft 13, a first gear 14, and a second gear 15.

[0088] The pull bracket 12 is slidably disposed inside the housing 1. The pull bracket 12 is connected to the pull tube 2. The pull bracket 12 is provided with a second gear 121 along its length direction. The second gear 121 meshes with the first gear 11.

[0089] The first rotating shaft 13 is rotatably connected to the housing 1; the first gear 14 is mounted on the first rotating shaft 13 and meshes with the second gear 121; the second gear 15 is mounted on the first rotating shaft 13.

[0090] Connecting and linking via gear transmission allows for more precise control of the movement distance and reduces errors.

[0091] The pushing mechanism includes a pushing member, which is movably connected to the housing 1 and connected to the push tube 6. The pushing member is provided with a third gear tooth 193 that meshes with the second gear 15 along its moving direction; and a first starting member, which is used to drive the movable member 7 to rotate.

[0092] Combination Figure 10 , 11 When the movable part 7 is in the unlocked state, the first actuating element drives the movable part 7 to rotate, and the first gear 11 drives the second gear 121 and the pull bracket 12 to move towards the proximal end. The pull bracket 12 pulls the pull tube 2 towards the proximal end, completely exposing the sealant 4.

[0093] The second gear 121 drives the first gear 14 and the first rotating shaft 13 to rotate, which in turn drives the second gear 15 to rotate. The second gear 15 then drives the third gear 193, the pusher, and the push tube 6 to move to the far end, pushing the sealant 4 and compacting it.

[0094] In this embodiment, the first actuating element includes a first elastic element 16, which is configured to drive the movable element 7 to rotate. One end of the first elastic element 16 is connected to the movable element 7, and the other end is connected to the housing 1. The first elastic element 16 can be a spring. In this embodiment, the first actuating element is configured to be automatically triggered. When the first locking mechanism is unlocked, the first elastic element 16 drives the movable element 7 to rotate.

[0095] When the movable part 7 is in the locked state, the first elastic element 16 is in the stretched state. After the movable part 7 is in the unlocked state, the first elastic element 16 pulls the movable part 7 to move, thereby automatically driving the pull bracket 12 and the pull tube 2 to move towards the proximal end, exposing the sealant 4 and realizing the automatic release of the sealant. It also automatically drives the first gear 14 and the second gear 15 to rotate, driving the pusher and the push tube 6 to compact the sealant 4.

[0096] The second gear teeth 121 can be continuously distributed or divided into two parts, which mesh with the first gear teeth 11 and the first gear 14 respectively.

[0097] In this embodiment, the pushing component includes a pushing block 18 and a pushing plate 19. The pushing block 18 is slidably connected to the housing 1. One end of the pushing block 18 is connected to the pushing tube 6, and the other end is connected to the pushing plate 19. The pushing plate 19 is slidably connected to the housing 1.

[0098] In this embodiment, the push block 18 is provided with a second insertion slot 181, and the push plate 19 is provided with a second insertion segment 191 for insertion into the second insertion slot 181. Of course, in another embodiment, the second insertion segment 191 can also be provided on the push block 18, and the second insertion slot 181 can be provided on the push plate 19.

[0099] The second insertion slot 181 has a working surface that mates with the second insertion section 191. When the movable part 7 is in the locked state, there is a gap between the end face of the second insertion section 191 and the working surface; wherein, the third gear tooth 193 is located on the push plate 19.

[0100] When the second gear 15 drives the third gear 193 and the push plate 19 to move to the far end, there is a gap between the end face of the second insertion section 191 and the working surface, resulting in a free stroke. The second insertion section 191 moves one distance before contacting the working surface, pushing the push block 18 and the push tube 6 to move to the far end. It does not drive the push tube 6 to move immediately, so there is a certain lag. After the pull tube 2 basically exposes the sealant 4, the sealant 4 is pushed. This can prevent the sealant 4 from being compressed and stuck in the push tube 6.

[0101] In this embodiment, the first gear 14 and the second gear 15 are set in a certain ratio so that the distance the pull bracket 12 moves towards the proximal end is greater than the distance the pusher moves towards the distal end, that is, the speed at which the pull tube 2 releases the sealant is greater than the speed at which the push tube 6 pushes the sealant. This setting can avoid pushing the sealant to an unsuitable position or getting it stuck at the distal end of the pull tube 2.

[0102] In this embodiment, the first indicating mechanism includes a first identifier 20 and a first indicating element 21. The locking element 8 is provided with the first identifier 20, and the housing 1 is provided with a first observation window 102. The first observation window 102 is provided with a first indicating element 21 for cooperating with the first identifier 20 for indication. The first identifier 20 can be observed through the first observation window 102. After the first identifier 20 and the first indicating element 21 are aligned, the moving element 7 is fully unlocked.

[0103] The first indicating mechanism is configured to indicate at least two position states of the first locking mechanism. For example, the first indicating mechanism can be configured to indicate two states of the first locking mechanism: "locked state" and "unlocked state," or it can be configured to indicate three states: "locked state," "unlocked state," and "overload state." In the overload state, the pull tube 2 is some distance from the outer wall of the blood vessel X, which can easily lead to incorrect placement of the sealant. Simultaneously, the first indicating mechanism can indicate the position state of the first expandable member 5 throughout the entire use of the occlusion and hemostasis device. It is configured to indicate at least two position states of the first locking mechanism, such as indicating that the first expandable member 5 is in either "not in contact with the blood vessel wall" or "in contact with the blood vessel wall," or it can be configured to indicate that the first expandable member 5 is in a state of not contacting the blood vessel wall, contacting the blood vessel wall, or overloaded contact with the blood vessel wall.

[0104] Here, catheter 3 is connected to locking member 8, and first actuating member is connected to movable member 7. Therefore, the first actuating member will not affect the first marking 20 on catheter 3 and locking member 8. After locking member 8 and movable member 7 are unlocked, the movement of movable member 7 drives the retraction mechanism and pushing mechanism to release and tighten the sealant through the transmission of first gear 11, second gear 121, first gear 14, second gear 15, and third gear 193. During the sealant release process, the operator can operate and can use the indication of the first indicating mechanism to ensure that the first expandable member 5 is always in contact with the blood vessel wall. That is, the operation of the release part does not limit the movable member 7 and catheter 3. Therefore, the operation of the release part and the indication observation at the first observation window do not affect each other. Thus, the operator can still observe through the first observation window while operating the release mechanism to ensure that the first expandable member 5 is always in contact with the inner wall of blood vessel X during the release of sealant 4, preventing the first expandable member 5 from displacing during the release of sealant 4 and causing sealant to enter the blood vessel. The first indicating mechanism in this embodiment can provide indication throughout the entire operation process.

[0105] The occlusion and hemostasis device also includes a second indicating mechanism, which includes a second indicator 22 and a second indicator 23. The pusher is provided with the second indicator 22, and the housing 1 is provided with a second observation window. The second observation window is provided with a second indicator 23 for cooperating with the second indicator 22 for indication. The second indicator 22 can be observed through the second observation window. After the second indicator 22 and the second indicator 23 are aligned, it can be determined that the pusher and the push tube 6 have moved into place.

[0106] Furthermore, this embodiment also includes a second locking mechanism.

[0107] The second locking mechanism has a locked state and an unlocked state. When the second locking mechanism is in the locked state, it prevents the retraction mechanism from operating. When the release part moves and triggers the second locking mechanism to be in the unlocked state, the retraction mechanism can operate to move the conduit 3 toward the proximal end of the housing 1.

[0108] The second locking mechanism is a third insertion section 192 provided on the push plate 19; the retraction mechanism is provided with a third insertion groove 241 that cooperates with the third insertion section 192.

[0109] To prevent the retraction mechanism from malfunctioning, the third insertion section 192 is initially positioned within the third insertion slot 241, preventing the retraction mechanism from operating.

[0110] After the release part causes the third insertion section 192 to separate from the third insertion groove 241, the second locking mechanism is in the unlocked state, and the retraction mechanism can be used to retract the conduit 3 and the first expandable member 5.

[0111] Of course, in another embodiment, the second locking mechanism can be a third insertion slot 241 provided on the push plate 19; the retraction mechanism is provided with a third insertion section 192 that cooperates with the third insertion slot 241. In addition, in another embodiment, the third insertion slot that cooperates with the third insertion section can also be replaced with a limiting step (not shown) that cooperates with the third insertion section.

[0112] The second indicator mechanism can also be used to determine whether the position of the second locking mechanism is in an unlocked or locked state.

[0113] The retraction mechanism includes a second actuating element, which is used to activate the retraction mechanism to retract the conduit 3 and the first expandable member 5. The second actuating element is configured as an automatically triggered actuating element or an externally operated actuating element. When the second actuating element is configured as an automatically triggered actuating element, it is configured to provide power when the second locking mechanism is unlocked, causing the retraction mechanism to move the first expandable member towards the proximal end of the housing. Alternatively, the second actuating element is configured as an externally operated actuating element, which is configured to be activated under external operation when the second locking mechanism is unlocked. After the externally operated actuating element is activated, it causes the retraction mechanism to move the first expandable member towards the proximal end of the housing.

[0114] In this embodiment, the housing 1 is provided with a first mounting port 104, wherein the second actuating element is a second button 24, and the retraction mechanism also includes a connecting element 25 and a second elastic element 26.

[0115] The second button 24 is installed inside the housing 1 through the first mounting port 104. The second button 24 is provided with a limiting groove 242. The connector 25 is slidably connected to the housing 1. The connector 25 is located in the limiting groove 242 and is connected to the conduit 3. The limiting groove 242 may have an opening on one side for the connector 25 to pass through, and may be stepped.

[0116] One end of the second elastic member 26 is connected to the connector 25, and the other end is connected to the housing 1. When the limiting groove 242 moves away from the first mounting port 104 and separates from the connector 25, the second elastic member 26 drives the connector 25 to move towards the near end of the housing 1.

[0117] In this embodiment, the connector 25 includes a connecting block 251 and a first baffle 252 located on the side of the connecting block 251 near the second elastic member 26. The first baffle 252 is connected to the second elastic member 26. The connecting block 251 is connected to the conduit 3, and the first baffle 252 can move relative to the housing 1.

[0118] Combination Figure 6 When the conduit 3 moves distally relative to the shell 1, it drives the connecting block 251 to move distally.

[0119] When it is necessary to retract the first expandable component 5, press the second button 24. The connector 25 separates from the limiting groove 242. Under the action of the elastic force of the second elastic component 26, the first baffle 252 is pulled to move towards the proximal end. The first baffle 252 drives the connector 25 and the guide tube 3 to move towards the proximal end, thereby retracting the first expandable component 5.

[0120] To facilitate the distal movement of the conduit 3 relative to the housing 1 without affecting the retraction mechanism, the conduit 3 located within the housing 1 can be appropriately relaxed, without needing to be taut. The conduit 3 has a certain margin of movement relative to the housing 1.

[0121] The connector 25 also includes a top plate connected to the first baffle 252. The housing 1 has a sliding groove, the top plate is slidably connected to the sliding groove and partially located in the sliding groove, and the sliding groove restricts the movement direction of the top plate.

[0122] The connector 25 also includes a second baffle connected to the top plate. The second baffle is located on the connector 251 away from the first baffle 252, which facilitates the stable movement of the top plate. In addition, the second baffle can limit the displacement of the connector 251, preventing the guide tube 3 from moving excessively to the distal end and causing damage to the retraction mechanism.

[0123] To prevent accidental pressing of the second button 24, the device also includes a third elastic element 27, which is configured to provide a force on the second button 24 toward the first mounting opening 104. By utilizing the third elastic element 27 to provide an upward elastic force to the second button 24, the first inflatable member 5 is only retracted when pressed by an external operation, thus preventing accidental pressing of the second button 24 and the accidental retraction of the first inflatable member 5.

[0124] In this embodiment, the third insertion slot 241 is located on the second button 24. When the third insertion segment 192 is located in the third insertion slot 241, it can prevent the second button 24 from descending, thereby further preventing the second button 24 from being accidentally pressed and preventing the first expandable member 5 from being accidentally retracted.

[0125] In this embodiment, the near end of the housing 1 is provided with a first through hole 105.

[0126] The occlusion and hemostasis device also includes: a first support tube 28, a guide tube 29, and a third indicating mechanism 30.

[0127] The first support tube 28 is located inside the housing 1 and is connected to the conduit 3 and the first through hole 105. The first end of the guide tube 29 is located outside the housing 1, and the second end of the guide tube 29 is connected to and communicates with the first support tube 28. The guide tube 29 is used to introduce or withdraw fluid into the first support tube 28 to expand or contract the first expandable member 5. The third indicating mechanism 30 is used to protrude from the first through hole 105 when the first expandable member 5 is in the expanded state.

[0128] The third indicating mechanism 30 can be a movable column, which is movably connected to the first support tube 28.

[0129] In use, the first expandable element 5 is inserted into the blood vessel X through the blood vessel sheath.

[0130] The syringe is connected to the drainage tube 29. When a liquid such as saline is injected, the syringe A is pushed to inject the saline or other liquid into the drainage tube 29, the catheter 3, and the first expandable member 5. The saline enters the first expandable member 5 and the first expandable member 5 expands outward.

[0131] After the liquid enters the guide tube 29 and the first support tube 28, it enters the conduit 3 and the first expandable member 5. The liquid also pushes the movable column to move proximally, with one end of the movable column extending out of the housing 1 through the first through hole 105, which can be observed by the operator. When the movable column extends out of the housing 1, it indicates that the first expandable member 5 has expanded to its full extent. When the movable column retracts into the housing 1, it indicates that the first expandable member 5 has contracted.

[0132] After injection, the entire device retracts proximally, and the first expandable member 5 adheres tightly to the inner wall of blood vessel X, with the inner wall of the blood vessel exerting resistance on the first expandable member 5.

[0133] The conduit 3 moves the locking member 8, and when the first mark 20 is aligned with the first indicator 21, it indicates that the locking member 8 has been completely unlocked from the moving member 7.

[0134] The first elastic element 16 drives the movable element 7 to rotate, which in turn drives the pull frame 12 to move towards the proximal end, and then drives the first gear 14 and the second gear 15 to rotate, which in turn drives the push plate 19 to push the push tube 6 to move towards the distal end.

[0135] When the puller 12 moves proximally, it drives the pull tube 2 to move proximally, completely exposing the sealant 4 to the tissue.

[0136] After a short period of inactivity, the push plate 19 drives the push block 18 to move the push tube 6 distally, compressing the sealant 4 to ensure it fully adheres to and compacts against the outer wall of the blood vessel. The push tube 6 pushes the sealant 4 exposed in the tissue tightly, adhering it to the puncture hole K of the blood vessel X and the tissue wall, effectively sealing and stopping bleeding.

[0137] When the second indicator 22 aligns with the second indicator 23, it indicates that the push tube 6 has been pushed into place. This facilitates the operator in proceeding to the next step and reduces operation time.

[0138] After pressing for 1-2 minutes, close the locking mechanism on syringe A. The locking mechanism can be a Luer lock or the like.

[0139] Pull the syringe to the end and lock it. Open the Luer lock, and the syringe will generate negative pressure. The first expandable part 5 will contract, and the movable column will also contract.

[0140] After observing the retraction of the movable column, press the second button 24 to separate the connector 25 from the limiting groove 242. Use the second elastic element 26 to move the connector 25 and the conduit 3 proximally, retracting the first expandable element 5 back into the pull tube 2. Then pull the housing 1 to remove it from the puncture hole K.

[0141] When the sealant 4 is slowly pulled to the outer wall of blood vessel X, the first locking mechanism unlocks, releasing the sealant 4 outside the blood vessel wall. This allows for accurate release of the sealant 4 at a controllable position, effectively preventing inaccurate positioning and poor hemostasis when the device is pulled backward. It also reduces the number of steps required from the operator and increases operational stability.

[0142] This embodiment also includes a connector and a drainage tube located at the distal end of the housing 1. The connector is located inside the housing 1 and mounted on the pull frame 12. The pull tube 2 is coupled to the connector P1, and a blood return hole 201 is provided near the distal end of the pull tube 2. One end of the drainage tube P2 is connected to the connector P1, and the other end extends out of the housing 1. A guide groove 601 is provided on the outer wall of the push tube 6, and the guide groove 601 is connected to the blood return hole 201 and the connector P1. In use, the distal end of the device is inserted into the blood vessel X through the vascular sheath. After the vascular sheath is withdrawn, the blood return hole is exposed to the blood, allowing blood to flow out from the blood return hole 201 through the guide groove 601 from the connector P1 and the drainage tube P2. The operator can observe the pulsating blood return. Figure 14 , 15 As shown. The presence of pulsating blood return can be used to visually observe whether the drainage tube 2 has entered the blood vessel. If pulsating blood return is observed at the drainage tube P2, it indicates that the next step can be performed.

[0143] The beneficial effects of the sealing and hemostasis device of the present invention are as follows:

[0144] 1. The sealing and hemostasis device seals the puncture hole by releasing and compacting the sealant. It has a short application time for hemostasis, which can quickly and effectively stop bleeding and provides a good patient experience.

[0145] 2. The occlusion and hemostasis device is equipped with a first locking mechanism, a second locking mechanism, a first indicating mechanism, a second indicating mechanism, and a third indicating mechanism to ensure the accurate and stable completion of the operation steps in sequence. The first and second locking mechanisms prevent subsequent steps from being performed at inappropriate times, reduce the difficulty of operation, make it easier to learn, avoid misoperation problems, and reduce surgical risks; the indicating function allows the surgeon to observe the status of the device so that the operator can take the next step immediately, effectively shortening the overall operation time.

[0146] 3. The sealing and hemostasis device, through gear transmission, positioning of the first expandable component, and indication by the first indicating mechanism, ensures the sealant is stably placed and compacted on the outer side of the blood vessel wall. This precise positioning, stable operation, and safety ensure reliability, preventing surgical failure or reducing related complications. The first indicating mechanism provides guidance throughout the sealant release process, ensuring the surgeon can maintain the first expandable component in the correct position against the blood vessel wall throughout the release, guaranteeing accurate and stable sealant release and improving operational safety and reliability.

[0147] 4. The occlusion and hemostasis device includes a first indicator mechanism, a second indicator mechanism, and multiple indicator functions such as blood return feedback, which makes it easier for the surgeon to identify the status of the device according to the indicators, thereby improving the safety of the surgical procedure and reducing surgical risks.

[0148] 5. The sealing and hemostasis device achieves asynchronous release and compaction functions by adjusting the idle stroke between the push block and the push plate, and the ratio between the first gear and the second gear. This prevents the sealant from being squeezed and stuck in the push tube, which could lead to surgical failure.

[0149] 6. The sealing and hemostasis device is equipped with an automatic sealant release function, which further avoids positioning problems that may occur when pressing the button when dragging the device to the proximal end, reduces the number of operation steps required by the operator, and further increases the stability of operation.

[0150] 7. The retraction mechanism of the sealing and hemostasis device can achieve a longer retraction distance.

[0151] Example 2, combined with Figure 20 , 21 22. The difference between this embodiment and Embodiment 1 is:

[0152] The housing 1 is provided with a movable groove 101; the first actuating element is a pressing element 17, which is connected to the movable element 7 through the movable groove 101.

[0153] After the first insertion section 9 separates from the first insertion groove 10, the pressing member 17 can be pressed down to drive the movable member 7 to rotate.

[0154] In this embodiment, the first actuating element is configured for external triggering. When the first locking mechanism is unlocked, the external pressing element 17 drives the movable element 7 to rotate. When the first actuating element is externally triggered, a second indicating mechanism can be selected as needed. When the second indicating mechanism is not selected, the operation of the first actuating element itself can also indicate whether the release agent has been released and whether the pushing element has been fully advanced. For example, pressing the pressing element 17 to the bottom will push the pushing element and release the release agent.

[0155] Example 3, the difference between this example and Example 1 is:

[0156] The first actuating element is a torsion spring, one end of which is connected to the movable part 7 and the other end of which is connected to the housing 1. After the movable part 7 is unlocked, it drives the movable part 7 to rotate, which in turn drives the pull frame 12 to move towards the proximal end.

[0157] Example 4 differs from Example 1 in that the retraction mechanism includes: a second button 24 and a bending portion.

[0158] The second button 24 is installed inside the housing 1 through the first mounting port; the bending part is configured to bend the guide tube 3 under the action of the second button 24, thereby driving the first expandable member 5 to move towards the near end of the housing 1.

[0159] By pressing down on the second button 24, the conduit 3 is bent using the bending part, thereby retracting the first expandable component 5.

[0160] The bending section can be directly connected to the second button, or it can be connected to the second button through other linkage mechanisms. Driven by the second button, the guide tube is bent, and the first expandable part is retracted.

[0161] Example 5, the difference between this example and Example 1 is:

[0162] The conduit 3 includes a first conduit and a second conduit. The first conduit is located near the far end of the housing relative to the second conduit. The first conduit is sleeved on the outside or inside of the second sleeve. The first conduit can move relative to the second conduit and has a certain displacement distance to avoid the first conduit moving to the far end and affecting the retraction mechanism.

[0163] The limiting member is connected to the first conduit, and there is a gap between the limiting member and the second button 24 or the second baffle to realize the displacement distance between the first conduit and the second conduit.

[0164] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. A device for sealing and stopping bleeding, characterized in that, include: case; A pull tube, one end of which is movably connected to the housing, and the other end of which extends to the distal end of the housing; A conduit that passes through the pull tube and is axially movable relative to the pull tube; A sealant is located between the pull tube and the conduit, and is disposed near the distal end of the pull tube; A first expandable member is disposed at the distal end of the tube; A push tube is arranged between the pull tube and the guide tube, and is located on the side of the sealant away from the first expandable member; The release part includes a pushing mechanism and a retraction mechanism. The retraction mechanism is used to drive the pull tube to release the sealant, and the pushing mechanism is used to drive the push tube to tighten the sealant. A retraction mechanism is used to move the conduit and the first expandable member toward the proximal end of the housing; A first locking mechanism is connected to the conduit. The first locking mechanism has a locked state and an unlocked state. When the first locking mechanism is in the locked state, it prevents the release part from moving. When the conduit pulls the first locking mechanism to switch to the unlocked state, the pushing mechanism is configured to move the push tube toward the direction close to the sealant. The retraction mechanism is configured to move the pull tube toward the proximal end of the housing. A first indicating mechanism is used to indicate the position status of the first locking mechanism and the position status of the first expandable member; The first locking mechanism includes: A movable component, configured to move relative to the housing, the movable component being configured to drive the release part to move; A locking element, which is connected to the conduit, is used to lock or unlock the movable element. The locking element can be separated from the movable element under the action of the conduit so that the first locking mechanism is in an unlocked state. The movable component is provided with a first gear tooth in the circumferential direction; The retraction mechanism includes a pull frame, a first rotating shaft, a first gear, and a second gear. The pull frame is slidably disposed within the housing and connected to the pull tube. The pull frame has a second gear tooth along its length, which meshes with the first gear tooth. The first rotating shaft is rotatably connected to the housing. The first gear is mounted on the first rotating shaft and meshes with the second gear tooth. The second gear is mounted on the first rotating shaft. The pushing mechanism includes a pushing member, which is movably connected to the housing and connected to the pushing tube. The pushing member is provided with a third gear tooth that meshes with the second gear along its moving direction. The first actuating element is used to drive the movable element to rotate.

2. The occlusion and hemostasis device according to claim 1, characterized in that, The first actuating element includes a first elastic element, which is configured to drive the movable element to rotate. One end of the first elastic element is connected to the movable element, and the other end is connected to the housing. Alternatively, the housing may be provided with a movable groove; the first actuating element is a pressing element, which is connected to the movable element through the movable groove.

3. The occlusion and hemostasis device according to claim 1, characterized in that, The pushing component includes a pushing block and a pushing plate. The pushing block is slidably connected to the housing. One end of the pushing block is connected to the pushing tube, and the other end is engaged with the pushing plate. The pushing plate is slidably connected to the housing. One of the push block and the push plate is provided with a second insertion slot, and the other is provided with a second insertion segment for insertion into the second insertion slot; the second insertion slot has a working surface that mates with the second insertion segment, and when the movable part is in the locked state, there is a gap between the end face of the second insertion segment and the working surface; The third gear tooth is located on the push plate.

4. The occlusion and hemostasis device according to claim 1, characterized in that, The first indicating mechanism includes a first mark and a first indicating element. The locking element is provided with the first mark, and the housing is provided with a first observation window. The first observation window is provided with the first indicating element for cooperating with the first mark for indication. And / or, the occlusion and hemostasis device further includes a second indicating mechanism, the second indicating mechanism including a second mark and a second indicating element, the pusher being provided with the second mark, the housing being provided with a second observation window, and the second observation window being provided with a second indicating element for cooperating with the second mark for indication.

5. The occlusion and hemostasis device according to claim 1, characterized in that, The occlusion and hemostasis device further includes: a second locking mechanism, which has a locked state and an unlocked state. When the second locking mechanism is in the locked state, it prevents the retraction mechanism from operating. When the release part moves and triggers the second locking mechanism to be in the unlocked state, the retraction mechanism can operate to move the catheter toward the proximal end of the housing. The retraction mechanism includes a second actuating element for activating the retraction structure to retract the conduit and the first expandable element.

6. The occlusion and hemostasis device according to claim 5, characterized in that, The pushing mechanism includes a pushing member with a push plate, the push plate being used to drive the push tube to push the sealant tightly; The second locking mechanism is a third insertion section disposed on the push plate; the retraction mechanism is provided with a third insertion groove or limiting step that cooperates with the third insertion section; or, The second locking mechanism is a third insertion slot provided on the push plate; the retraction mechanism is provided with a third insertion section or limiting step that cooperates with the third insertion slot.

7. The occlusion and hemostasis device according to claim 5, characterized in that, The housing is provided with a first mounting port. The second actuating element is a second button, which is installed inside the housing through the first mounting port and has a limiting groove. The retraction mechanism further includes a connector, a second elastic element, and a third elastic element. The connector is slidably connected to the housing and is located within the limiting groove. The connector is connected to the conduit. One end of the second elastic element is connected to the connector, and the other end is connected to the housing. When the limiting groove moves away from the first mounting port and separates from the connector, the second elastic element drives the connector to move towards the proximal end of the housing. The third elastic element is configured to provide a force to the second button toward the first mounting port. Alternatively, the second actuating element is a second button, which is installed inside the housing through the first mounting port; the retraction mechanism further includes a bending portion, which is configured to bend the conduit under the action of the second button, thereby driving the first expandable element to move towards the proximal end of the housing.

8. The occlusion and hemostasis device according to claim 5, characterized in that, The near end of the housing is provided with a first through hole; The sealing and hemostasis device also includes: A first support tube is located inside the housing and is connected to the conduit and the first through hole. A flow guide tube, the first end of which is located outside the housing, and the second end of which is connected to and communicates with the first support tube. The flow guide tube is used to introduce or withdraw fluid into the first support tube to cause the first expandable component to expand or contract. A third indicating mechanism is used to protrude from the first through hole when the first expandable member is in an expanded state.

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