Vascular puncture part self-absorption closing device and system

Abstract

The invention relates to a blood vessel puncture part self-absorption closing device and system.The blood vessel puncture part self-absorption closing device comprises a closing assembly and a pushing assembly, and the closing assembly and the pushing assembly are conveyed through a conveying sheath tube; the closing mechanism can be implanted into a blood vessel and closes a puncture part inside the blood vessel, and the anchoring mechanism is used for anchoring the closing assembly on the blood vessel outside the blood vessel; the closing assembly extends out of the far-end tube opening of the conveying sheath tube through the pushing assembly and is elastically released in the blood vessel. The closing mechanism comprises a closing wire mesh ring used for being implanted into a blood vessel, the anchoring mechanism comprises an anchoring nail which is located at the near end of the closing assembly and is used for anchoring outside the blood vessel, and the closing wire mesh ring and the anchoring nail are both connected to a closing short tube which can be arranged at a blood vessel puncture part; the closing assembly is connected with a traction line, and the near end of the closing assembly extends out of the body through the conveying sheath tube and is reserved for a certain length. The self-absorption expansion of the closing assembly can be realized through the mutual matching with the existing sheathing canal and the guide wire.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to a self-absorption closure device and system for a vascular puncture site. Background Art

[0002] When using conventional interventional methods to treat cardiovascular diseases, a channel is first established through a sheath and a guidewire. Under the guidance of the guidewire, a coronary stent or balloon catheter is inserted into the blood vessel and corresponding treatment is performed.

[0003] During the treatment process, especially in minimally invasive interventional surgery, it is necessary to puncture the blood vessel to create an incision for the sheath and guide wire to pass through.

[0004] However, after the surgery is complete, the puncture site on the blood vessel needs to be closed to restore normal blood flow within the vessel. Existing closure structures for vascular puncture sites often use a tether, combined with a pulling operation, to secure a biodegradable closure component to the puncture site on the inner side of the vessel wall.

[0005] The existing tether structure and the operation of closing by pulling force make it difficult to control the fitting position of the closure component in the blood vessel, and the manual pulling force is extremely difficult to control the strength. For the vascular puncture site, it is very likely to cause damage from other factors and cannot achieve the ideal closure effect at the vascular puncture site. Summary of the Invention

[0006] The purpose of this application is to provide a self-absorption closure device and system for a vascular puncture site, which, through cooperation with an existing sheath and guide wire, can achieve self-absorption and expansion of the closure component, as well as self-absorption and biodegradation during the closure process. At the same time, the closure component can be anchored at the vascular puncture site through an anchoring structure arranged on the outside of the blood vessel, thereby achieving effective separation of the closure component from the delivery component after release, closure and anchoring.

[0007] To achieve the above objectives, in a first aspect, the present invention provides a self-absorbable closure device for a vascular puncture site, comprising: a closure component and a push component that are separately arranged, wherein the closure component and the push component are delivered through a delivery sheath; The closure assembly includes a closure mechanism and an anchoring mechanism. The closure mechanism can be implanted in a blood vessel and close the puncture site inside the blood vessel. The anchoring mechanism is used to anchor the closure assembly to the blood vessel outside the blood vessel. The pushing component can be in contact with the closing component to control the closing component to extend from the delivery sheath; In the delivery state, the closing component and the pushing component are accommodated in the delivery sheath, and the closing component is elastically compressed at the distal end of the delivery sheath; After being delivered to the designated position, the closing component is extended from the distal end of the delivery sheath through the pushing component and elastically released inside the blood vessel; The closure component is provided with a blood return hole that can communicate with the blood vessel, and whether the blood returns to the delivery sheath through the blood return hole is used to judge whether the closure component elastically compressed at the distal end of the delivery sheath is delivered into place and into the blood vessel; The closure mechanism includes a closed wire mesh ring located at the distal end of the closure component and used for implantation in a blood vessel, and the anchoring mechanism includes an anchoring pin located at the proximal end of the closure component and anchored outside the blood vessel, and the closed wire mesh ring and the anchoring pin are both connected to a closed short tube that can be placed at the blood vessel puncture site; The closing component is connected with a pulling wire, the distal end of the pulling wire is connected to the closing short tube, and the proximal end is extended out of the body from the delivery sheath tube with a certain length left.

[0008] In an optional embodiment, the delivery sheath is delivered under the guidance of a guide wire, the pushing assembly includes a pushing tube, the guide wire passes through the closed short tube and the pushing tube and extends from the proximal end of the pushing tube, and a closed diaphragm for the guide wire to pass through is provided inside the closed short tube, and the closing pressure of the closed diaphragm is greater than the blood pressure in the blood vessel.

[0009] In an optional embodiment, the blood return hole is arranged on the closed short tube and is opened on the side wall of the closed short tube between the closed wire mesh ring and the anchoring pin. The closed short tube includes an open distal tube opening, and the blood return hole and the distal tube opening are both connected to the lumen of the closed short tube.

[0010] In an optional embodiment, the closed short tube includes a flush port at the proximal end, and the closed diaphragm is connected to the tube wall at the distal end of the flush port; The push tube includes a hollow lumen, and a closed plug is provided at the distal end of the push tube to form a flush end capable of abutting against the flush port, and a guide wire insertion hole is provided on the closed plug; The guide wire passes through the sealing membrane and the sealing plug.

[0011] In an optional embodiment, the closed wire mesh ring includes an annular wire mesh ring connected to the distal end of the closed short tube and in a ring-shaped state in a released state, and in an elastically compressed state during transportation, the annular wire mesh ring is sleeved on the outside of the closed short tube in a straight cylindrical shape; The proximal end and distal end of the annular wire mesh ring are respectively provided with a proximal connecting ring and a distal connecting ring, the distal connecting ring is connected to the distal end of the closed short tube, and the proximal connecting ring is movably sleeved on the closed short tube; The annular wire mesh ring includes a closed wire mesh and a closed film lining attached to the inner side of the closed wire mesh.

[0012] In an optional embodiment, a pull wire connection hole is provided on the tube wall of the closed short tube between the closed diaphragm and the flush port, and the distal end of the pull wire is connected to the pull wire connection hole.

[0013] In an optional embodiment, the anchoring nail includes a plurality of anchoring steel wires that are evenly spaced circumferentially, the root of each anchoring steel wire is connected to the outer wall of the closed short tube and is distributed parabolically on the outside of the closed short tube, and the connection root of the anchoring steel wire is arranged at the position between the blood return hole and the closed diaphragm.

[0014] In an optional embodiment, the anchoring steel wires are uniformly fanned outwards toward the radially outer side of the closed short tube, or the anchoring steel wires are fanned outwards in a cross-direction across the closed short tube; In an elastically compressed state during delivery, the anchoring wire bends and extends toward the proximal end of the closed short tube.

[0015] In an optional embodiment, the closed short tube, the annular wire mesh ring, the closed membrane, the anchoring wire and the pull wire are all made of bioabsorbable materials.

[0016] In a second aspect, the present invention provides a self-absorbable closure system for a vascular puncture site, comprising a delivery sheath and a self-absorbable closure device for a vascular puncture site according to any one of the aforementioned embodiments. During use, the self-absorbable closure system for a vascular puncture site comprises the following steps: Under the condition that a guidewire is left in the blood vessel, the tail end of the guidewire outside the body is passed through the delivery sheath, the closure component and the push component in sequence, so that the distal end of the push component is pressed against the closure component, and the self-absorbable closure device at the puncture site of the blood vessel is pushed into the delivery sheath from the proximal end of the delivery sheath until the closure component in the compressed state reaches the distal end of the delivery sheath; Under the guidance of the guidewire, the delivery sheath loaded with the self-absorbable closure device at the vascular puncture site is implanted into the body. The blood return hole on the closure component and the presence of blood return in the delivery sheath are combined to determine whether the distal end of the delivery sheath has entered the blood vessel. After determining that the distal end of the delivery sheath has entered the blood vessel, the delivery sheath is further advanced for a certain length as a whole, and then the pushing assembly is fixed and withdrawn from the delivery sheath to release the closing assembly in the blood vessel. Then, under the condition that the anchoring mechanism is elastically compressed inside the delivery sheath, the pushing assembly and the delivery sheath are synchronously withdrawn as a whole until there is no blood returning to the delivery sheath. Then, the pushing assembly is fixed and withdrawn from the delivery sheath to release the anchoring mechanism and fix the closing assembly at the puncture site. The guide wire, push assembly and delivery sheath are removed from the body to complete the closure of the blood vessel puncture site.

[0017] The self-absorbable closure device for the blood vessel puncture site of the present invention can achieve precise control of the closure component during the implantation process and reliable anchoring at the puncture site after implantation.

[0018] Through the mutual cooperation between the self-absorbable closing device at the vascular puncture site and the delivery sheath, the closing device as a whole can be delivered in a compressed and contained state. At the same time, after it is determined that the implant is in place, the closing mechanism can be extended and released through the pushing component, and the closing mechanism can be retracted and adjusted when the anchoring mechanism is not released. Combined with the subsequent release of the anchoring mechanism outside the blood vessel, the closing mechanism can be tightly attached to the puncture site inside the blood vessel, and the overall position of the closing component can be fine-tuned during the release of the anchoring mechanism to ensure a tight closing effect at the vascular puncture site.

[0019] Combined with the compressed accommodation of the anchoring mechanism in the delivery sheath in the unreleased state, on the basis of the early release of the closing component in the blood vessel, the position of the closing component in the blood vessel can be withdrawn and fine-tuned through the synchronous overall withdrawal of the delivery sheath and the pushing component. Then, after the withdrawal fine-tuning, while ensuring that the closing short tube does not return blood to the delivery sheath, the pushing component is fixed and withdrawn into the delivery sheath to release the anchoring mechanism outside the blood vessel and anchor the closing component at the puncture site of the blood vessel.

[0020] The separate setting of the pushing component and the closing component, as well as the abutting contact between the pushing component and the closing component, can reduce the connection between the pushing component and the closing component, and can realize the extension and release of the closing component relative to the delivery sheath under the action of the pushing component. At the same time, it can facilitate the subsequent separation of the pushing component and the closing component, greatly reducing the difficulty of the separation operation, so that the pushing component can be removed synchronously with the delivery sheath after fully exerting the effect of controlling the implantation.

[0021] The self-absorbable closing device for the blood vessel puncture site of the present invention can accurately determine whether the closing mechanism for closing the wound has entered the blood vessel, and can control the release position of the anchoring mechanism outside the blood vessel through the pushing component.

[0022] Compared with existing conventional vascular closure forms, the self-absorbable closure device at the vascular puncture site in the present invention can accurately control the fitting position of the closure mechanism within the blood vessel, and at the same time, combined with the anchoring mechanism, realize the adaptive adjustment and anchoring of the entire closure component at the vascular puncture site, avoiding the risk factors easily caused by manually pulling the tether for fixation.

[0023] Through the pulling wire connected to the closing component, the pulling wire can be sutured to the skin wound site, and the pulling and fixing relationship of the closing component is maintained, which secondary guarantees the fixing effect of the closing component at the blood vessel puncture site.

[0024] The pull wire in this application does not directly pull the closing mechanism. The fixation of the closing mechanism at the blood vessel puncture site is mainly carried out by the anchoring mechanism. On the basis of the anchoring of the anchoring mechanism, the pull wire can constitute a secondary fixation of the closing mechanism, and can cooperate with the anchoring mechanism to control the elastic deformation of the closing mechanism, and then be used to adjust the degree of closure of the closing mechanism at the blood vessel puncture site.

[0025] Other features and advantages of the present application will be described in detail in the subsequent detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following is a brief introduction to the drawings required for use in the embodiments. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other relevant drawings can be obtained based on these drawings without creative work.

[0027] Figure 1 This is a schematic diagram of the structure of the self-absorbable closure device for the vascular puncture site in the present application in the delivery state; Figure 2 This is a schematic diagram of the structure of the closing component after release in this application; Figure 3 This is a schematic diagram of the structure of the annular wire mesh coil after being released in the blood vessel; Figure 4 Schematic diagram of the structure after the anchoring pin is released outside the blood vessel; Figure 5 This is a schematic diagram of the structure after the push tube and the closing short tube are separated.

[0028] icon: 1-closing assembly; 11-closing mechanism; 111-closing wire mesh ring; 111a-proximal connecting ring; 111b-distal connecting ring; 12-anchoring mechanism; 121-anchoring nail; 122-anchoring wire; 13-closed short tube; 131-blood return hole; 132-sealed diaphragm; 133-distal tube port; 2-push assembly; 21-push tube; 22-push handle; 3-delivery sheath; 4-Puncture wound; 5-Pull line; 6-Guide wire. DETAILED DESCRIPTION

[0029] To make the objectives, technical solutions, and advantages of the embodiments of the present application more clear, the technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the accompanying drawings of the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, not all of the embodiments. Generally, the components of the embodiments of the present application described and shown in the drawings herein can be arranged and designed in various different configurations.

[0030] In the description of this application, it should be noted that the terms "inner" and "outer" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, or the orientations or positional relationships in which the product of this application is typically placed when in use. These terms are intended solely to facilitate the description of this application and simplify the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on this application. Furthermore, the terms "first" and "second" and the like are used solely for distinction and should not be construed as indicating or implying relative importance.

[0031] It should also be noted that, in the description of this application, unless otherwise expressly specified or limited, the terms "disposed" and "connected" should be understood in a broad sense. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to direct connections, indirect connections through an intermediate medium, or internal connections between two components. Those skilled in the art will understand the specific meanings of the above terms in this application based on the specific circumstances.

[0032] The self-absorbable closure device for the vascular puncture site in this application mainly reduces the difficulty of operating the closure device during the closure process of the vascular puncture site by simplifying the structural composition of the existing closure device, while reducing the intervention of unnecessary structures. By controlling the implantation of the closure mechanism and the control and adjustment of the elastic deformation, it achieves tight closure, adaptive adjustment and anchoring inside the blood vessel.

[0033] See also Figure 1 , and combined with Figure 2-Figure 5 The self-absorption closing device for the blood vessel puncture site of the present invention has a main structure including a closing component 1 and a pushing component 2.

[0034] Specifically, the self-absorption closing device for the blood vessel puncture site includes a separately arranged closing component 1 and a pushing component 2. When the pushing component 2 is in contact with the closing component 1, the pushing component 2 can achieve a relative indirect push of the closing component 1 by withdrawing the delivery sheath 3, so that the closing mechanism 11 at the distal end of the closing component 1 is implanted into the blood vessel to close the puncture wound 4. At the same time, after the closing component 1 is implanted in place as a whole, the pushing component 2 can be directly separated from the closing component 1, thereby reducing the operation of other auxiliary structures and simplifying the composition and operation of the closing device to the greatest extent.

[0035] By transporting the closing component 1 and the pushing component 2 in the delivery sheath 3, the delivery sheath 3 can be used as a delivery carrier, and the closing component 1 elastically compressed in the delivery sheath 3 and the pushing component 2 in contact with the closing component 1 can be transported to the blood vessel part in the body under the guidance of the guide wire 6.

[0036] The closing component 1 specifically includes a closing mechanism 11 and an anchoring mechanism 12. At least a portion of the closing component 1, specifically the closing mechanism 11 located at the distal end, can be implanted inside a blood vessel and internally close the puncture wound 4 of the blood vessel, thereby ensuring the closing effect of the blood vessel puncture site 4 and avoiding the defect of fixing the closing component 1 such as a closing piece at the puncture wound 4 by a tether.

[0037] The anchoring mechanism 12 can anchor the entire closure component 1 at the puncture wound 4 outside the blood vessel, maintaining the fixation of the closure component 1 at the puncture wound 4, while producing a certain degree of fine-tuning effect during the retention and release process.

[0038] During the implantation process of the closure assembly 1, when the closure mechanism 11 at the distal end of the delivery sheath 3 enters the blood vessel, the distal closure mechanism 11 is first released inside the blood vessel. Then, with the anchoring mechanism 12 compressed and contained in the delivery sheath 3, the delivery sheath 3 and the push assembly 2 are synchronously withdrawn, so that the delivery sheath 3 and the closure assembly 1 are withdrawn and adjusted. After ensuring that the anchoring mechanism 12 is located outside the blood vessel, combined with the push assembly 2 pressing against the closure assembly 1, the anchoring mechanism 12 is released by controlling the withdrawal of the delivery sheath 3 relative to the push assembly 2, so that the anchoring mechanism 12 is anchored in contact with the outer wall of the blood vessel. While releasing and producing an anchoring effect, the closure mechanism 11 tends to move outward, forming an adaptive adjustment that presses against the puncture wound 4. When implanted in place, the outer wall of the closure short tube 13 is in close contact with the puncture wound 4, forming a tight closure of the puncture wound 4.

[0039] The pushing assembly 2 can be in contact with the closing assembly 1 and is used to control the closing assembly 1 to extend out of the delivery sheath 3 during the process of fixing the pushing assembly 2 and retracting the delivery sheath 3 .

[0040] In the delivery state, by accommodating the closing component 1 and the pushing component 2 in the delivery sheath 3, the position of the closing component 1 and the pushing component 2 can be kept fixed during the delivery process. Combined with the abutting contact relationship maintained between the two, after the delivery is in place, that is, after the closing mechanism 11 located at the distal end of the delivery sheath 3 enters the blood vessel, the delivery sheath 3 can be retracted to push the pushing component 2 relative to the closing component 1.

[0041] By elastically compressing the closure component 1 at the distal end of the delivery sheath 3, the release of the closure component 1 in the blood vessel is facilitated, while the release travel of the closure mechanism 11 in the blood vessel is reduced, thereby ensuring the reliability of the closure of the puncture wound 4.

[0042] After being delivered into place, combined with the withdrawal of the delivery sheath 3 and the abutment relationship between the pushing component 2 and the closing component 1, the closing mechanism 11 is extended from the distal tube mouth 133 of the delivery sheath 3 in the blood vessel and elastically released, which enables the closing mechanism 11 delivered into the blood vessel to be extended and released relative to the distal tube mouth 133 of the delivery sheath 3. After being released, while the anchoring mechanism 12 is still compressed in the delivery sheath 3, the pushing component 2 and the delivery sheath 3 are withdrawn as a whole, so that the closing component 1 can be synchronously withdrawn following the delivery sheath 3, thereby realizing the adhesion of the closing mechanism 11 at the distal end of the closing component 1 to the puncture wound 4 in the blood vessel, and the following outward movement of the anchoring mechanism 12, to ensure the release and anchoring of the anchoring mechanism 12 outside the blood vessel.

[0043] The blood return hole 131 that can communicate with the blood vessel is set on the closing component 1, and combined with the compression accommodation of the closing component 1 at the distal end of the delivery sheath 3 when it is not released, it is possible to judge whether the closing component 1 elastically compressed at the distal end of the delivery sheath 3 is delivered into the blood vessel by observing whether the blood return hole 131 returns blood to the delivery sheath 3, thereby ensuring precise control of the delivery positioning.

[0044] The closing mechanism 11 includes a closing wire mesh ring 111 located at the distal end of the closing component 1 and used for implantation in the blood vessel. The closing wire mesh ring 111 can fit the puncture wound 4 in the blood vessel after elastic release. At the same time, the anchoring mechanism 12 includes an anchoring pin 121 located at the proximal end of the closing component 1 and anchored outside the blood vessel, which can play the above-mentioned anchoring role and at the same time keep the closing mechanism 11 in close contact with the puncture wound 4 in the blood vessel to a certain extent.

[0045] During the delivery process, the closing wire mesh ring 111 and the anchoring pin 121 are elastically compressed inside the delivery sheath 3, and can elastically expand after breaking free from the constraints of the delivery sheath 3, thereby completing the closure of the blood vessel puncture wound 4 and the overall anchoring of the closing component 1 at the puncture wound 4.

[0046] On the basis of connection, the closed wire mesh ring 111 and the anchoring nail 121 are both connected to the closed short tube 13. Preferably, the closed wire mesh ring 111 is close to the distal end of the closed short tube 13, and the anchoring nail 121 is close to the proximal end of the closed short tube 13. The closed short tube 13 constitutes the connection structural basis between the closed wire mesh ring 111 and the anchoring nail 121. At the same time, the closed short tube 13 can be placed on the blood vessel puncture wound 4. Combined with the anchoring of the anchoring nail 121 outside the blood vessel, the closed short tube 13 can also form a certain anchoring structural foundation at the puncture wound 4.

[0047] The closing component 1 in the present application is connected to a pulling wire 5. By connecting the distal end of the pulling wire 5 to the closing short tube 13, the closing component 1 can be effectively fixed by the anchoring mechanism 12, and the elastic deformation degree of the closing mechanism 11 in the blood vessel can be controlled by the pulling force thus generated, thereby adjusting the closing force of the closing mechanism 11 at the puncture site.

[0048] The pulling wire 5 does not directly pull out the closing mechanism 11. The fixation of the closing mechanism 11 at the blood vessel puncture site is mainly carried out by the anchoring mechanism 12. On the basis of the anchoring of the anchoring mechanism 12, the pulling wire 5 can constitute a secondary fixation of the closing mechanism 11, and can cooperate with the anchoring mechanism 12 to control the elastic deformation of the closing mechanism 11. Since the closing wire mesh ring 111 included in the closing mechanism 11 has high elasticity, when the tensioning force of the pulling wire 5 between the skin and the blood vessel is large, the elastic deformation degree of the closing wire mesh ring 111 is larger. When the tensioning force of the pulling wire 5 between the skin and the blood vessel is small, the elastic deformation degree of the closing wire mesh ring 111 is smaller, which is then used to adjust the closing degree of the closing mechanism 11 at the blood vessel puncture site.

[0049] Based on the fact that the closing component 1 as a whole is transported in the delivery sheath 3 under elastic compression, further, the delivery sheath 3 is guided and transported under the guidance of the guide wire 6, the guide wire 6 is required to pass through the closing component 1 and the pushing component 2 located inside the delivery sheath 3 to transport the closing component 1, the pushing component 2 and the delivery sheath 3 as a whole.

[0050] From the perspective of specific structure, the pushing component 2 includes a pushing tube 21, and the guide wire 6 passes through the closing short tube 13 and the pushing tube 21 on the closing component 1 and extends from the proximal end of the pushing tube 21. Preferably, the pushing tube 21 includes a pushing handle 22 located at the proximal end, and the pushing handle 22 protrudes from the proximal end of the delivery sheath 3, so that the relative extension movement of the pushing tube 21 and the closing component 1 relative to the delivery sheath 3 can be controlled by the pushing handle 22.

[0051] Since the self-absorbable closing device for the vascular puncture site in the present application is suitable for different types of blood vessels, especially for closing the aortic puncture wound 4, in order to prevent the backflow of blood flow in the blood vessel during the operation, a closing diaphragm 132 for the guide wire 6 to pass through is provided in the lumen of the closing short tube 13. The closing diaphragm 132 mainly plays the effect of sealing the closing short tube. Furthermore, when the distal end of the closing component drives the closing mechanism into the aorta, in order to prevent the blood pressure of the aorta from squeezing the blood flow out of the closing short tube and flowing back, the closing diaphragm 132 should have sufficient pressure-bearing capacity. Specifically, the closing pressure of the closing diaphragm 132 is greater than the blood pressure in the blood vessel, which can effectively prevent the blood flow from being squeezed and flowing back outward.

[0052] The closed diaphragm 132 can be a flexible diaphragm structure with a certain strength. The edge of the diaphragm is connected to the inner wall of the closed short tube. At the same time, a microhole for the guide wire 6 to pass through can be opened on the closed diaphragm 132. After the guide wire 6 passes through the closed diaphragm 132, the microhole can tightly clamp the guide wire 6, thereby taking into account the passing of the guide wire 6 and the overall pressure bearing of the closed diaphragm 132.

[0053] In order to determine whether the closed wire mesh ring 111 at the distal end of the closing component 1 has reached the inside of the blood vessel, the blood return hole 131 is set on the closed short tube 13, specifically on the side wall of the closed short tube 13 between the closed wire mesh ring 111 and the anchoring pin 121. Preferably, the blood return hole 131 is set on the distal side close to the connection root of the anchoring pin 121, so that the blood return hole 131 can be maintained outside the blood vessel when the closing component 1 is anchored as a whole, avoiding the risk of blood reflux through the blood return hole 131.

[0054] Furthermore, the closed short tube 13 includes an open distal tube opening 133 , and the blood return hole 131 and the distal tube opening 133 are both communicated with the lumen of the closed short tube 13 .

[0055] During the implantation process of the closing component 1, after the closing mechanism 11 of the closing component 1 enters the blood vessel, the blood flow in the blood vessel enters through the distal tube mouth 133 of the closing short tube 13, and flows out from the blood return hole 131 on the closing short tube 13 into the delivery sheath 3. The blood flow returned by the delivery sheath 3 is used to determine whether the implantation is in place. When the blood flow returns, in order to ensure that the closing wire mesh ring 111 can completely enter the blood vessel, the closing component 1, the pushing component 2 and the delivery sheath 3 are assembled and transported forward for a distance, and then the closing wire mesh ring 111 is released.

[0056] After release, the closure mesh ring 111 maintains the elastic compression of the anchoring mechanism 12 of the closure component 1 within the delivery sheath 3. The closure component 1, pusher component 2, and delivery sheath 3 are then retracted. The blood return hole 131 confirms that there is no blood flow back, indicating that the root of the anchoring pin 121 is located outside the blood vessel. The anchoring mechanism is then released. The blood return hole 131 effectively determines the implantation position of the closure component 1, allowing for targeted release of different mechanisms and ensuring implant accuracy.

[0057] In order to ensure that the push tube 21 is in contact with the closed short tube 13, the closed short tube 13 includes a flush port at the proximal end, and the closed diaphragm 132 is connected to the tube wall at the distal end of the flush port. That is, the closed diaphragm 132 is connected to the inner side of the closed short tube 13 to prevent the push tube 21 from damaging the closed diaphragm 132 when it is in contact with the closed short tube 13.

[0058] The push tube 21 includes a hollow lumen, and a closed plugging plate is provided at the distal end of the push tube 21 to form a flush end that can be in contact with the flush port of the proximal end of the closed short tube 13. A guide wire 6 insertion hole is provided on the closed plugging plate to facilitate the passage of the guide wire 6. The guide wire 6 passes through the closed diaphragm 132 and the closed plugging plate, and is led out through the hollow lumen of the push tube 21.

[0059] In order to prevent the closing diaphragm 132 from falling off, the edge of the closing diaphragm 132 is connected to the inner wall of the straight tube section of the closing short tube 13 and is arranged close to the flush port. That is to say, by setting the closing diaphragm 132 at a position away from the open distal tube mouth 133 of the closing short tube 13, it is prevented from falling into the blood vessel under the flushing of blood flow, thereby avoiding risks.

[0060] The closed wire mesh ring 111 in the present invention includes an annular wire mesh ring connected to the distal end of the closed short tube 13 and in a ring-shaped state in the released state. In the elastic compression state during the transportation process, the closed wire mesh ring 111 is arranged in a straight cylindrical shape on the outside of the closed short tube 13. This compression state can facilitate the rapid release of the annular wire mesh ring and the degree of deformation response of the annular wire mesh ring when it is pushed outward and released relative to the distal end tube mouth 133 of the transportation sheath 3.

[0061] The proximal end and distal end of the annular wire mesh ring are respectively provided with a proximal connecting ring 111a and a distal connecting ring 111b. The distal connecting ring 111b is connected to the distal tube mouth 133 of the closed short tube 13 and does not block the distal tube mouth 133 of the closed short tube 13. The proximal connecting ring 111a is movably sleeved on the closed short tube 13 and can slide along the axial direction of the closed short tube 13 and on the outside of the closed short tube 13 during the release process, and then expand in the radial direction after the conveying sheath 3 releases the restraint of the closed wire mesh ring 111.

[0062] At the same time, the annular wire mesh ring has a high memory elastic deformation ability, can maintain the elastic compression relationship during the delivery process, and is released in the blood vessel after extending out of the distal tube opening 133 of the delivery sheath 3, forming an effective closing structure for the blood vessel puncture site 4.

[0063] From the perspective of ensuring the closing effect, the closed wire mesh ring 111 after release includes a ring structure located at the proximal end, and the closed surface of the ring structure is an arc structure. In the vertical section, the closed wire mesh ring 111 includes an arc-shaped curved surface located on the proximal side and the distal side, thereby forming an overall structure similar to a swimming ring, ensuring the closing effect of the arc-shaped closed curved surface at the proximal end on the puncture wound 4.

[0064] Based on the elastic deformation and closure of the four parts of the blood vessel puncture site of the annular wire mesh ring, the annular wire mesh ring includes a closed wire mesh and a closed membrane lining attached to the inner side of the closed wire mesh. The closed wire mesh is mainly used to compress and release the elastic deformation, while the closed membrane is mainly used to provide a good closing effect.

[0065] To ensure that the pull wire 5 pulls the closure assembly 1, a pull wire 5 connection hole is provided on the wall of the closure short tube 13 between the closure diaphragm 132 and the flush port. The distal end of the pull wire 5 is connected to the pull wire 5 connection hole, maintaining the connection and pulling relationship between the pull wire 5 and the closure assembly 1. In this connection structure, under the premise that the anchor assembly fixes the closure assembly 1 as a whole at the puncture site, by controlling the pulling tension of the pull wire 5, the degree of deformation of the closure wire coil 111 within the blood vessel can be adjusted under the effect of blood vessel obstruction, thereby adjusting the magnitude of the closing force at the puncture site.

[0066] The anchoring nail 121 includes multiple anchoring wires 122 evenly spaced circumferentially. The multiple anchoring wires 122 are positioned proximal to the proximal end of the closure tube 13. Specifically, the root of each anchoring wire 122 is connected to the outer wall of the closure tube 13 and is distributed parabolically on the outside of the closure tube 13. Similarly, the anchoring wires 122 also have excellent elastic memory deformation properties, and can expand and deform circumferentially outward after release. In the form of a multi-claw distribution, the ends of the anchoring wires 122 are anchored and abutted against the outer wall of the blood vessel outside the puncture wound 4, thereby forming a stable anchoring for the closure assembly 1.

[0067] The anchoring steel wires 122 are evenly spread outwardly toward the radially outer side of the closed short tube 13 , and can generate a certain anchoring performance in the form of even spreading outwardly.

[0068] Further preferably, the anchoring wire 122 crosses and spreads outward over the closed short tube 13, that is, the anchoring wire 122 is parabolically bent toward the other side of the root connection position relative to the closed short tube 13, which can enhance the anchoring force on the outer wall of the blood vessel in the form of cross-outward dispersion.

[0069] In the elastic compression state during the delivery process, the anchoring wire 122 bends and extends toward the proximal end of the closed short tube 13, so that after the delivery sheath 3 is withdrawn, the anchoring wire 122 can be freed from the restraint of the closed short tube 13 and effectively perform external anchoring.

[0070] Based on the closed wire mesh ring 111 being in a straight cylindrical shape in a compressed state and its expansion deformation in the radial direction, in order to prevent it from excessive expansion in the radial direction, the anchoring wire 122 can be anchored outside the vascular puncture wound 4 while exerting a certain restraining effect on the formation of the closed wire mesh ring 111, preventing the closed wire mesh ring 111 from excessive expansion and reducing the thickness, thereby maintaining a stable closed state.

[0071] The closed short tube 13, annular wire mesh ring, closed membrane, anchoring steel wire 122 and pulling wire 5 in the present invention are all made of bioabsorbable materials. Preferably, the closed short tube 13, annular wire mesh ring and anchoring steel wire 122 are preferably made of magnesium-aluminum alloy or absorbable materials such as polylactic acid and polycaprolactone, while the closed membrane and closed membrane sheet 132 are preferably made of bioabsorbable polymer film materials to enhance the overall biocompatibility of the closed component 1 in the body.

[0072] The self-absorbable closure device at the blood vessel puncture site of the present invention can effectively control the closure component 1 during the implantation process, while ensuring the accuracy of the placement of the closure component 1 inside and outside the blood vessel.

[0073] The present invention also provides a self-absorption closure system for a vascular puncture site, comprising a delivery sheath 3 and the self-absorption closure device for a vascular puncture site as described above. The application of the self-absorption closure system for a vascular puncture site ensures the closure effect of the vascular puncture site 4.

[0074] Specifically, the use of the self-absorbable closure system for vascular puncture sites is mainly divided into two different stages: in vitro assembly and in vivo implantation, including the following steps: During the in vitro assembly process, under the premise that a guide wire 6 is placed in the blood vessel, the tail end of the guide wire 6 located outside the body is passed through the delivery sheath 3, the closing component 1 and the pushing component 2 in sequence, and then the closing component 1, the pushing component 2 and the delivery sheath 3 are assembled.

[0075] The distal end of the pushing component 2 is pressed against the proximal end of the closing component 1, and the self-absorbable closing device of the blood vessel puncture site composed of the closing component 1 and the pushing component 2 is delivered into the delivery sheath 3 from the proximal tube opening of the delivery sheath 3. On the one hand, it is convenient for subsequent delivery. On the other hand, in the process of being delivered into the delivery sheath 3 through the proximal tube opening, the annular wire mesh ring and the anchoring nail 121 on the closing component 1 are compressed in the state described above until the closing component 1 in the compressed state reaches the distal end of the delivery sheath 3, completing the overall assembly process.

[0076] During the implantation process, the guide wire 6 guides the delivery sheath 3 loaded with the self-absorbable closure device for the vascular puncture site to be implanted in the body in an inclined state until the delivery sheath 3 reaches the site adjacent to the blood vessel, and the implantation speed is slowed down.

[0077] Based on the blood return hole 131 on the closure component 1 and whether there is blood reflux in the delivery sheath 3, it is specifically determined whether the distal end of the delivery sheath 3 has entered the blood vessel; After determining that the distal end of the delivery sheath 3 has entered the blood vessel, the delivery sheath 3 is further advanced as a whole for a certain length, so that the annular wire mesh ring compressed and lying at the distal end of the delivery sheath 3 can completely enter the blood vessel, and then the annular wire mesh ring can be released.

[0078] After advancing a certain distance, the pushing component 2 is fixed and the delivery sheath 3 is relatively withdrawn, so that the closing component 1 is passively extended from the distal opening of the delivery sheath 3, and then the closing mechanism 11 of the closing component 1 is freed from the restraint of the delivery sheath 3 and is released inside the blood vessel.

[0079] Then the pushing component 2 and the delivery sheath 3 are retracted synchronously as a whole, with the purpose of adjusting the position of the anchoring pin. After retraction until it is determined that there is no blood returning to the delivery sheath 3 through the blood return hole 131, the pushing component 2 is fixed to retract the delivery sheath 3 to release the anchoring pin 121. After the restraint of the delivery sheath 3 is released, the anchoring pin 121 is released radially outward from the closing short tube 13. At the same time, during the release process, the anchoring pin 121 is anchored on the outer wall of the blood vessel outside the puncture wound 4, so that the closing component 1 as a whole tends to move outward relative to the puncture wound 4. In the form of external pull-out fine-tuning, the proximal side fitting surface of the annular wire mesh ring is pressed and fitted to the puncture wound 4 on the inner side of the blood vessel, thereby ensuring the closing effect of the puncture wound 4.

[0080] It should be pointed out that when the annular wire mesh ring or the anchoring pin 121 is in a compressed state, the closing short tube 13 can be kept fixed in the delivery sheath 3 to a certain extent, limiting the movement of the closing component 1 in the delivery sheath 3. When the compression restraint of the anchoring pin 121 is completely released, the pushing tube 21 can be directly separated from the closing short tube 13 in the anchored state, and finally the guide wire 6, the pushing tube 21 and the delivery sheath 3 are removed from the body to complete the closure of the blood vessel puncture wound 4.

[0081] By suturing the absorbable traction thread 5 to the skin wound in a tensioned state, the traction and tension of the closing component 1 are maintained, and the closing mechanism 11 is controlled to maintain an effective and reliable deformation state, ensuring that the annular wire mesh ring is tightly closed to the blood vessel puncture wound 4.

[0082] Through the use of the self-absorption closure system for the blood vessel puncture site in this application, the operation process and steps are simplified compared to the existing blood vessel closure angle, and the closure effect and anchoring effect of the blood vessel puncture site 4 are guaranteed.

[0083] It should be noted that, unless there is any conflict, the features in the embodiments of this application can be combined with each other.

[0084] The above description is merely a preferred embodiment of the present application and is not intended to limit the present application. Various modifications and variations are possible for those skilled in the art. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present application shall be included within the scope of protection of the present application.

Claims

1. A self-absorbable closure device for a vascular puncture site, characterized in that: include: A closure component and a push component are separately provided, and the closure component and the push component are delivered through a delivery sheath; The closure assembly includes a closure mechanism and an anchoring mechanism. The closure mechanism can be implanted in a blood vessel and close the puncture site inside the blood vessel. The anchoring mechanism is used to anchor the closure assembly to the blood vessel outside the blood vessel. The pushing component can be in contact with the closing component to control the closing component to extend from the delivery sheath; In the delivery state, the closing component and the pushing component are accommodated in the delivery sheath, and the closing component is elastically compressed at the distal end of the delivery sheath; After being delivered to the designated position, the closing component is extended from the distal end of the delivery sheath through the pushing component and elastically released inside the blood vessel; The closure component is provided with a blood return hole that can communicate with the blood vessel, and whether the blood returns to the delivery sheath through the blood return hole is used to judge whether the closure component elastically compressed at the distal end of the delivery sheath is delivered into place and into the blood vessel; The closure mechanism includes a closed wire mesh ring located at the distal end of the closure component and used for implantation in a blood vessel, and the anchoring mechanism includes an anchoring pin located at the proximal end of the closure component and anchored outside the blood vessel, and the closed wire mesh ring and the anchoring pin are both connected to a closed short tube that can be placed at the blood vessel puncture site; The closing component is connected with a pulling wire, the distal end of the pulling wire is connected to the closing short tube, and the proximal end is extended out of the body from the delivery sheath tube with a certain length left.

2. The self-absorption closure device for a vascular puncture site according to claim 1, characterized in that: The delivery sheath is delivered under the guidance of a guide wire. The pushing assembly includes a pushing tube. The guide wire passes through the closed short tube and the pushing tube and extends from the proximal end of the pushing tube. A closed diaphragm for the guide wire to pass through is provided inside the closed short tube. The closing pressure of the closed diaphragm is greater than the blood pressure in the blood vessel.

3. The self-absorption closure device for a vascular puncture site according to claim 1, characterized in that: The blood return hole is arranged on the closed short tube and is opened on the side wall of the closed short tube between the closed wire mesh ring and the anchoring nail. The closed short tube includes an open distal tube opening. The blood return hole and the distal tube opening are both connected to the tube cavity of the closed short tube.

4. The self-absorption closure device for a vascular puncture site according to claim 2, characterized in that: The closed short tube includes a flush port at a proximal end, and the closed diaphragm is connected to the tube wall at a distal end of the flush port; The push tube includes a hollow lumen, and a closed plug is provided at the distal end of the push tube to form a flush end capable of abutting against the flush port, and a guide wire insertion hole is provided on the closed plug; The guide wire passes through the sealing membrane and the sealing plug.

5. The self-absorption closure device for a vascular puncture site according to claim 4, characterized in that: The closed wire mesh ring includes an annular wire mesh ring connected to the distal end of the closed short tube and in a ring-shaped state in a released state. In an elastically compressed state during transportation, the annular wire mesh ring is sleeved on the outside of the closed short tube in a straight cylindrical shape. The proximal end and distal end of the annular wire mesh ring are respectively provided with a proximal connecting ring and a distal connecting ring, the distal connecting ring is connected to the distal end of the closed short tube, and the proximal connecting ring is movably sleeved on the closed short tube; The annular wire mesh ring includes a closed wire mesh and a closed film lining attached to the inner side of the closed wire mesh.

6. The self-absorption closure device for a vascular puncture site according to claim 5, characterized in that: A pull wire connection hole is provided on the tube wall of the closed short tube between the closed diaphragm and the flush port, and the distal end of the pull wire is connected to the pull wire connection hole.

7. The self-absorbable closure device for a vascular puncture site according to claim 5, characterized in that: The anchoring nail includes a plurality of anchoring steel wires that are evenly spaced circumferentially. The root of each anchoring steel wire is connected to the outer wall of the closed short tube and is distributed parabolically on the outside of the closed short tube. The connection root of the anchoring steel wire is arranged between the blood return hole and the closed diaphragm.

8. The self-absorbable closure device for a vascular puncture site according to claim 7, characterized in that: The anchoring steel wires are evenly spread outwards toward the radial outside of the closed short tube, or the anchoring steel wires cross the closed short tube and spread outwards; In an elastically compressed state during delivery, the anchoring wire bends and extends toward the proximal end of the closed short tube.

9. The self-absorbable closure device for a vascular puncture site according to claim 7, characterized in that: The closed short tube, the annular wire mesh ring, the closed membrane, the anchoring wire and the pulling wire are all made of bioabsorbable materials.

10. A self-absorbable closure system for a vascular puncture site, characterized in that: The invention comprises a delivery sheath and a self-absorbable closure device for a vascular puncture site according to any one of claims 1 to 9. The self-absorbable closure system for a vascular puncture site comprises the following steps during use: Under the condition that a guidewire is left in the blood vessel, the tail end of the guidewire outside the body is passed through the delivery sheath, the closure component and the push component in sequence, so that the distal end of the push component is pressed against the closure component, and the self-absorbable closure device at the puncture site of the blood vessel is pushed into the delivery sheath from the proximal end of the delivery sheath until the closure component in the compressed state reaches the distal end of the delivery sheath; Under the guidance of the guidewire, the delivery sheath loaded with the self-absorbable closure device at the vascular puncture site is implanted into the body. The blood return hole on the closure component and the presence of blood return in the delivery sheath are combined to determine whether the distal end of the delivery sheath has entered the blood vessel. After determining that the distal end of the delivery sheath has entered the blood vessel, the delivery sheath is further advanced for a certain length as a whole, and then the pushing assembly is fixed and withdrawn from the delivery sheath to release the closing assembly in the blood vessel. Then, under the condition that the anchoring mechanism is elastically compressed inside the delivery sheath, the pushing assembly and the delivery sheath are synchronously withdrawn as a whole until there is no blood returning to the delivery sheath. Then, the pushing assembly is fixed and withdrawn from the delivery sheath to release the anchoring mechanism and fix the closing assembly at the puncture site. The guide wire, push assembly and delivery sheath are removed from the body to complete the closure of the blood vessel puncture site.

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