CN117694939A - Vascular closure device and vascular closure system - Google Patents

Abstract

The invention relates to a vascular sealing device and a vascular sealing system, wherein the vascular sealing device comprises a first disc surface, a second disc surface and a connecting piece for connecting the first disc surface and the second disc surface, the first disc surface is used for being released by being attached to the inner wall of a blood vessel, the second disc surface is used for being released by being covered by the outer wall of the blood vessel, the second disc surface comprises a framework and a covering film covered on the framework, and one side of the framework, which is far away from the center of the second disc surface, exceeds the covering film. According to the vascular sealing device provided by the invention, the side, far away from the center of the second disc surface, of the skeleton of the second disc surface exceeds the tectorial membrane, so that the possibility that tissues are extruded on the tectorial membrane unfolding path in the unfolding process of the second disc surface can be reduced, the extrusion influence of the tissues on the tectorial membrane unfolding process is reduced, the skeleton of the second disc surface is facilitated to drive the tectorial membrane to unfold so as to better fit the outer wall of a blood vessel, and the sealing effect of the tectorial membrane on a puncture hole is increased.

Description

Vascular closure device and vascular closure system

Technical Field

The invention relates to the technical field of interventional medical instruments, in particular to a vascular sealing instrument and a vascular sealing system.

Background

In percutaneous arterial puncture procedures, where the implant to be implanted is delivered to the target lesion site through a catheter and the treatment is performed, all percutaneous arterial puncture procedures have vascular access to the puncture site, and after the procedure is completed, the doctor needs to stop bleeding at the puncture site, and although the Seldinger technique has performed percutaneous vascular puncture for half a century, how to quickly, safely and effectively stop bleeding at the puncture site remains a clinical challenge.

The traditional closing mode has a manual compression hemostasis method, is time-consuming and labor-consuming, increases discomfort of patients such as pain, insomnia and difficult urination, and the hemostasis effect is influenced by the experience skills of compression practitioners and the matching degree of the patients. Complications such as bleeding (including hematomas) are also believed to be increased, although in most cases minor hematomas, pseudoaneurysms, the risk of infection with venous fistulae and arteriovenous thrombosis, especially in patients who require complete anticoagulation after surgery, and the expense of hospitalization of the patient is increased, even without increasing the risk of complications. In the existing puncture hemostasis technology, besides the traditional manual compression hemostasis method, the existing puncture hemostasis technology also comprises a vascular suture device which is sutured by utilizing a suture line and a two-piece vascular sealing instrument. Wherein, the vascular suture device closes the puncture with large caliber through operating the suture, but the operation is complex, and the learning curve of doctors is long.

The two-piece vascular sealing device has the advantages of simple operation, higher success rate and short sealing time, and the distal disc surface of the vascular sealing device is used for releasing in blood vessels and the proximal disc surface is used for covering the outer walls of the blood vessels for releasing. The far-end disk surface can only comprise two disk surfaces of the skeleton for anchoring the vascular closure device, and the skeleton and the tectorial membrane are arranged on the near-end disk surface for anchoring and choking; the distal disc surface may also include a skeleton and a covering film covering the skeleton, but since the distal disc surface is released in the blood vessel, in order to reduce the implant left in the blood vessel, the distal disc surface generally has a smaller expansion area than the proximal disc surface, so even if the proximal disc surface is provided with the covering film, there is a risk that the vascular closure device is not tightly sealed to the puncture hole, and based on this, even if the distal disc surface is provided with the covering film, the proximal disc surface is provided with the covering film, so as to increase the success rate of the vascular closure device. However, due to the fact that tissues are attached to the outer wall of the blood vessel, the spreading of the covering film on the proximal disc surface is easy to be extruded by the tissues towards the center direction of the second disc surface, so that the covering film on the proximal disc surface is not completely spread, and a better sealing effect on the puncture hole cannot be achieved.

Disclosure of Invention

The invention solves the technical problem of better unfolding the disk surface of the vascular sealing device positioned outside the vascular wall and reduces the extrusion influence of tissues.

The invention provides a vascular sealing device which comprises a first disc surface, a second disc surface and a connecting piece for connecting the first disc surface and the second disc surface, wherein the first disc surface is used for being attached to the inner wall of a blood vessel for release, the second disc surface is used for being covered by the outer wall of the blood vessel for release, the second disc surface comprises a framework and a covering film covered on the framework, and one side of the framework far away from the center of the second disc surface exceeds the covering film.

In one embodiment, the skeleton comprises trunks radially distributed along the second disk surface from the center of the second disk surface, branches are arranged between two adjacent trunks, and the branches extend from the trunks to the direction away from the center of the disk surface between the two trunks in a bending manner and exceed the coating film.

In one embodiment, the edge of the coating divides the second disk surface formed by the framework into a first area and a second area, the coating covers the first area, the trunk comprises an inner section and an outer section, the inner section is positioned in the first area, the outer section is positioned in the second area, and the branches bend and extend from the outer section towards a direction away from the center of the disk surface between the two trunks.

In one embodiment, the branch comprises a shielding part and a puncture part, the shielding part is positioned in the second area, the shielding part comprises a starting end connected with the trunk and a connecting end opposite to the starting end, and the puncture part extends from the connecting end towards a direction away from the center of the second disk surface.

In one embodiment, the branch further comprises a support portion at least partially located in the first region.

In one embodiment, the shielding part is arranged along the position between two adjacent trunks without interruption.

In one embodiment, two adjacent trunks are respectively provided with a starting end of a shielding part, and connecting ends of the two trunks extend and converge to the same puncture part, the two shielding parts form a folding angle alpha at the connecting point of the two trunks, and the folding angle alpha meets the following conditions: alpha is not equal to 180 degrees.

In one embodiment, the second disk surface and the connecting piece are slidably connected along the axial direction.

In one embodiment, the first disk surface, the connecting piece and the second disk surface are all made of degradable shape memory polymer materials.

The invention also provides a vascular closure system comprising the vascular closure device and a conveyor for conveying the vascular closure device.

According to the vascular sealing device provided by the invention, the skeleton of the second disc surface is arranged at one side far away from the center of the second disc surface and exceeds the tectorial membrane, so that the skeleton penetrates into tissues on the outer wall of a blood vessel in the unfolding process of the second disc surface, the part of the skeleton exceeding the tectorial membrane has a thrust to the tissues on the outer wall of the blood vessel, a buffer area is formed between the tectorial membrane and the tissues, the possibility that the tissues are extruded on an tectorial membrane unfolding path is reduced, the extrusion influence of the tissues on the tectorial membrane in the unfolding process is reduced, the skeleton of the second disc surface is facilitated to drive the tectorial membrane to be unfolded, the tectorial membrane can be better attached to the outer wall of the blood vessel, and the sealing effect of the tectorial membrane on a puncture hole is increased.

Drawings

The invention will be further described with reference to the accompanying drawings and examples, in which:

FIG. 1 is a perspective view of a vascular occlusion device according to embodiment 1 of the present invention;

FIG. 2 is a cross-sectional view of a vascular occlusion device according to example 1 of the present invention;

FIG. 3 is a schematic illustration of a vascular occlusion system provided by the present invention releasing a vascular occlusion device into a blood vessel;

FIG. 4 is a cross-sectional view along the direction of blood flow of the vascular occlusion device of example 1 of the present invention mated with the wall of a blood vessel;

FIG. 5 is a perspective view of a second disk surface of the vascular occlusion device of embodiment 1 of the present invention;

FIG. 6 is a top view of a second disk surface of the vascular occlusion device of embodiment 1 of the present invention;

FIG. 7 is a schematic view of a vascular occlusion system according to example 1 of the present invention;

FIG. 8 is a cross-sectional view taken along the direction A-A in FIG. 7;

FIG. 9a is an enlarged view at B in FIG. 8 (a state where the vascular occlusion device is retracted in the delivery device);

FIG. 9b is an enlarged view of FIG. 8C (a view of the handle when the vascular occlusion device is retracted in the delivery device);

FIG. 10a is a schematic view of the vascular occlusion device with the sheath released from the first disc in the vascular occlusion device;

FIG. 10b is a schematic view of the first pusher block in a state in which the sheath is released from the first disc in the vascular occlusion device;

FIG. 11a is a schematic view of the vascular occlusion device with the sheath released from the second disc surface;

FIG. 11b is a schematic view of the first pusher block in a second disc surface of the vascular occlusion device releasing the sheath;

FIG. 12 is a perspective view of a second disk face of the vascular occlusion device of example 2 provided by the present invention;

FIG. 13 is a top view of a second disk surface of the vascular occlusion device of example 2 provided by the present invention;

FIG. 14 is a top view of a second disk surface of a vascular occlusion device in accordance with another embodiment of the present invention;

FIG. 15 is a cross-sectional view (corresponding to the direction A-A in FIG. 7) of the vascular occlusion system of example 2 provided by the present invention;

FIG. 16 is an enlarged view of FIG. 15 at D (schematic view of the occluding device collapsed in a transporter);

FIG. 17 is a schematic view showing the state of the vessel sealing device when the sheath is released from the second disk surface in example 2 provided by the present invention;

FIG. 18 is a schematic view of embodiment 2 of the present invention in which pushing the sealant distally causes the slider to move distally of the chute;

FIG. 19 is a schematic view of the sealant of example 2 according to the present invention, wherein the sealant is expanded and softened to further push the second pushing block so that the sealant is attached to the second disk surface.

Detailed Description

In order that the invention may be readily understood, a more complete description of the invention will be rendered by reference to the appended drawings. The drawings illustrate preferred embodiments of the invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

It will be understood that when an element is referred to as being "fixed to" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "inner", "outer", "left", "right" and the like are used herein for illustrative purposes only and do not represent the only embodiment.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "and/or" as used herein includes any and all combinations of one or more of the associated listed items.

For convenience of description, the terms "distal" and "proximal" are defined herein, as are conventional terms in the art of interventional medical devices. Specifically, "distal" refers to the end of the procedure that is distal to the operator, and "proximal" refers to the end of the procedure that is proximal to the operator. Axial "generally refers to the longitudinal direction of the medical device as it is being delivered," circumferential "generally refers to the direction about the" axial "direction, and" radial "generally refers to the direction of the medical device perpendicular to its" axial "direction and passing through the central axis, and defines the" axial "and" radial "directions of any component of the medical device in accordance with this principle.

Example 1

Embodiment 1 provides a vascular occlusion device 10 for closing a puncture hole in an arterial interventional puncture operation, as shown in fig. 1-6, for example, the device is used for closing a femoral artery in a femoral arterial interventional puncture operation, so as to achieve the effect of quickly, safely and efficiently stopping bleeding at a puncture point, and can be used for closing puncture holes of other arteries, such as carotid arteries, etc. Referring to fig. 1-4, the vascular sealing device 10 includes a first disc surface 11, a connecting member 12 and a second disc surface 13, the connecting member is connected between the first disc surface and the second disc surface, the first disc surface 11 is an inner sheet which is attached to an inner wall of a blood vessel and is released, the second disc surface 13 is an outer sheet which is used for covering an outer wall of the blood vessel and is released, that is, the vascular sealing device 10 has a double-sheet type radially foldable structure, and the first disc surface 11 and the second disc surface 13 are both in a curved surface structure with a curved radian conforming to the shape of the blood vessel in a natural state, as shown in fig. 1-5.

The second disc surface 13 includes a skeleton 131 and a covering film 132 covering the skeleton 131, and since the blood vessel is tubular, the shape of the first disc surface 11 and the second disc surface 13 that are naturally unfolded is a shape that is attached to the blood vessel wall 82, as shown in fig. 1 and 4, the shape of the skeleton 131 is curved and extended from two opposite sides of a circular or oval plane toward the distal end to attach to the blood vessel wall 82, that is, the cross sections of the first disc surface 11 and the second disc surface 13 are arc structures that match with the blood vessel structure, and one end of the skeleton 131 away from the center of the second disc surface 13 exceeds the covering film 132, as shown in fig. 5-6.

As shown in fig. 1 in combination with fig. 3 to 4, the first disc surface 11 includes a distal end skeleton 111 and a distal end covering film 112 covering the distal end skeleton 111, and since the first disc surface 11 is to be embedded in a blood vessel, the distal end covering film 112 uses an absorbable material, the surface of the distal end covering film 112 is smooth, has a micro-porous structure, is not easy to form thrombus, and is beneficial to accelerating endothelialization of the blood vessel. In order to reduce the area of the inner vessel, the expansion area of the first disk surface 11 is smaller than the expansion area of the second disk surface 13, the expansion area of the distal skeleton 111 is smaller than the expansion area of the skeleton 131 of the second disk surface 13, and the expansion area of the distal coating 112 is smaller than the expansion area of the coating 132 of the second disk surface 13.

As shown in fig. 5 to 6, one end of the skeleton 131 of the second disk surface 13 far from the center of the second disk surface 13 exceeds the covering film 132, and the skeleton 131 of the second disk surface 13 includes trunks 1311 radially distributed from the center of the second disk surface 13 in a direction away from the center of the disk surface 13, and the radial distribution of the trunks 1311 may be uniform radial or nonuniform radial. The cover film 132 of the second disk face 13 is made of an absorbable material that is a blood coagulation material having water absorbability that facilitates rapid blood coagulation outside the blood vessel wall at the puncture.

In the present embodiment, the side of the skeleton 131 of the second disk surface 13 away from the center of the second disk surface 13 exceeds the cover film 132, and the boundary of the cover film 132 between the adjacent two trunks 1311 is within the sector-like region formed by the adjacent two trunks 1311, as shown in fig. 6. As shown in fig. 6 in combination with fig. 3-4, by setting that the side of the skeleton 131 of the second disk 13 far from the center of the second disk 13 exceeds the covering film 132, so that the skeleton 131 pierces the tissue 81 on the outer wall of the blood vessel in the process that the second disk 13 is unfolded in a natural state, the part of the skeleton 131 exceeding the covering film 132 has a thrust to the tissue 81 on the outer wall of the blood vessel, thereby forming a buffer zone between the tissue 81 and the covering film 132, reducing the possibility that the tissue 81 is extruded on the unfolding path of the covering film 132, reducing the extrusion influence of the tissue 81 on the unfolding process of the covering film 132, helping the skeleton 131 of the second disk 13 to drive the unfolding of the covering film 132, so that the covering film 132 can be unfolded as much as possible, the outer wall of the blood vessel can be better attached, and the sealing effect of the covering film 132 on the puncture hole is increased.

The connecting member 12 includes a connecting portion 121 and an extension portion 122, the connecting portion 121 connects the first disk surface 11 and the second disk surface 13, the extension portion 122 extends from a proximal end of the connecting portion 121 toward a direction away from the first disk surface 11, and the extension portion 122 is configured to connect to the transporter 70, as shown in fig. 1-2 in conjunction with fig. 8, so as to facilitate the transportation of the vascular occlusion device 10 to the puncture site for occlusion by the transporter 70. In the present embodiment, the distal end of the connection portion 121 is connected to the first disk surface 11, the proximal end of the connection portion 121 is connected to the second disk surface 13, and the same material as the coating film 132 of the second disk surface 13 may be coated on the surface of the connection portion 121, which is a coagulation material having water absorbability, and further contributes to rapid coagulation at the puncture hole. The extension 122 extends from the junction of the connection portion 121 and the second disk surface 13 in a proximal direction, and the extension 122 is provided with an internally threaded hole for threaded connection with an external thread at the distal end of the mandrel 73 of the conveyer 70, so that the vascular closure device 10 in a compressed state is connected to the conveyer 70, and simultaneously, the vascular closure device 10 is released from the mandrel 73 of the conveyer 70. In this embodiment, the vascular occlusion device 10 is a two-piece radially collapsible structure that is radially collapsed or bent to reduce its radial dimension so as to be receivable within the sheath 71 of the delivery device 70.

As shown in fig. 4 in combination with fig. 1-3, the distal skeleton 111 of the first disk surface 11 cooperates with the skeleton 131 of the second disk surface 13 inside and outside the vessel wall 82 such that the vascular occlusion device 10 is anchored integrally inside and outside the vessel wall 82. In other embodiments, to reduce the implant left in the blood vessel 83, the first disk 11 may also include only the distal end skeleton 111 for anchoring the vascular sealing device 10 to the inner wall 821 of the blood vessel, the distal end skeleton 111 of the first disk 11 and the skeleton 131 of the second disk 13 together anchor the vascular sealing device 10 integrally inside and outside the blood vessel wall 82, and at the same time, the covering film 132 of the second disk 13 is spread under the driving of the expansion of the skeleton 131 of the second disk 13, so as to be attached to the outer wall 822 of the blood vessel, thereby achieving further sealing and sealing of the vascular puncture.

In this embodiment, the distal skeleton 111 and the distal covering film 112 of the first disc surface 11, the connecting member 12, and the skeleton 131 and the covering film 132 of the second disc surface 13 are made of absorbable biological materials, and the vascular sealing device 10 prepared by using the absorbable biological materials can gradually degrade the vascular sealing device 10 after wound healing, so that the secondary interventional operation is not affected. Wherein, the absorbable biomaterial for preparing the skeleton can be one or a plurality of Polyglycolide (PGA), polylactic acid-glycolic acid copolymer (PLGA), polyethylene glycol (Polyethylene glycol, PEG), polycaprolactone (PCL), 1, 3-Propanediol (PDO), collagen, silk fibroin, sodium alginate, calcium alginate, chitosan and gelatin; the absorbable biomaterial from which the coating is made may be one or more of Polyglycolide (PGA), polylactic-co-glycolic acid (PLGA), polyethylene glycol (Polyethylene glycol, PEG), polycaprolactone (PCL), 1, 3-Propanediol (PDO), collagen, and silk fibroin.

In this embodiment, the distal end skeleton 111 of the first disc surface 11 and the connecting piece 12 may be integrally injection molded, where the thickness of the distal end skeleton 111 is 0.02-0.5mm, and a certain supporting strength is provided, so as to be anchored to the inner wall of a blood vessel; the frame 131 of the second disc 13 and the connecting piece 12 are integrally injection molded, then the covering films 132 are sewn on the frame 131, and the thickness of each frame 131 is larger than that of each covering film 132. In other embodiments, the second disc surface and the connecting piece can also adopt a structure capable of being connected in a sliding manner along the axial direction, so that the second disc surface 13 can move towards the distal end along the axial direction relative to the connecting piece 12 under the action of external force after being released, the distance between the unfolded first disc surface 11 and the unfolded second disc surface 13 is reduced, and the first disc surface 11 and the second disc surface 13 clamp the inside and outside of the blood vessel wall around the puncture hole together so as to adapt to the blood vessel walls with different thicknesses, and simultaneously, the inner and outer disc surfaces of the blood vessel sealing device 10 are more closely attached to the inner and outer walls of the blood vessel, and the sealing performance is better. In other embodiments, in order to gradually degrade the whole of the first disk surface 11 and the second disk surface 13 from outside to inside completely, the thickness of the distal skeleton 111 of the first disk surface 11 is gradually reduced from the center of the disk surface in a direction away from the center, so that the whole of the first disk surface gradually degrades completely from the edge of the disk surface to the center, and the edge portion is prevented from falling off to form thrombus.

This embodiment also provides a vascular closure system comprising the vascular closure device 10 as described above, and as shown in fig. 7-11b, the vascular closure system further comprises a conveyor 70 for receiving and conveying the vascular closure device 10 as described above, the conveyor 70 comprising a sheath 71, a mandrel 73 and a handle assembly 74, wherein the sheath 71 is sleeved on the outer side of the mandrel 73 and the proximal ends thereof extend into the handle assembly 74, and the vascular closure device 10 is received in a space reserved between the sheath 71 and the mandrel 73 at the distal end.

The handle assembly 74 includes a housing 741, a first push block 742, a locking knob 744 and a release knob 745, wherein the first push block 742 is fixedly connected to the proximal end of the sheath 71 in the housing 741, and a corresponding position of the housing 741 is provided with a recess for allowing a portion of the first push block 742 to be exposed outside the housing 741 and to be pushed in an axial direction, so as to facilitate the axial operation, and the first push block 742 is used for controlling the sheath 71 to be retracted, so that the vascular occlusion device 10 retracted at the distal end of the delivery device 70 is exposed to the sheath 71, thereby releasing the vascular occlusion device 10, as shown in fig. 7-8.

As shown in fig. 8, the handle assembly 74 further includes a locking member 746, the locking member 746 is sleeved outside the mandrel 73, and the locking member 746 includes a fixing portion 7461, a straight threaded section 7462, and a locking portion 7463 extending obliquely toward the proximal end from the distal end to the proximal end, the locking portion 7463 is an elastic member with three flaps disposed around the mandrel, and is integrally in a cone-shaped structure, the locking portion can tightly hold the mandrel under the action of radial external force, a groove portion is disposed at the distal end of the locking knob 744, and the shape of the groove portion is adapted to the shape of the integral threaded section 7462 and the locking portion 7463. When the locking knob 744 is rotated circumferentially, the locking member 746 moves axially relative to the locking knob 744 such that the slot portion of the locking knob 744 is diagonally partially radially compressed against the locking portion 7463, causing the locking portion 7463 to hug the spindle 73 and thereby causing the locking member 746 to secure the spindle 73; or when the locking knob 744 is unscrewed in the circumferential direction in the opposite direction, the locking portion 7463 is unlocked from the mandrel 73, so that the mandrel 73 can move axially relative to the housing 741, and the mandrel 73 is locked to avoid that the connection relationship between the mandrel 73 and the vascular sealing device 10 is released in advance due to the mistaken touching of the release knob 745, and further help to fix the direction of the vascular sealing device relative to the first push block, so that the direction of the vascular sealing device relative to the blood vessel when entering the puncture hole can be conveniently determined. In the present embodiment, the straight portion of the groove portion of the locking knob 744 is provided with an internal thread corresponding to the thread section, and the locking knob 744 is axially fixed and circumferentially rotatable; the thread section 7462 of the locking member 746 is provided with external threads, and the locking member 746 is circumferentially fixed by an internal limiting member of the housing 741 and axially movable relative to the mandrel 73; when the locking knob 744 is rotated circumferentially, the locking member 746 moves proximally to radially compress the mandrel 73 by the locking portion 7463, so that the mandrel 73 is locked, and the vascular closure device 10 is released in a directional manner because the first disc surface 11 (inner sheet) and the second disc surface 13 (outer sheet) of the vascular closure device 10 conform to the shape of the blood vessel, and the circumferential locking of the mandrel 73 prevents the position of the vascular closure device 10 relative to the blood vessel from changing due to the rotation of the mandrel 73 during the delivery or release of the delivery device 70.

A release knob 745 is provided at the proximal end of the handle assembly 74 for rotating the mandrel 73 to disengage the vascular occlusion device 10 from the conveyor 70. After the locking knob 744 is adjusted to unlock the mandrel 73, the release knob 745 may be rotated to disengage the threaded connection between the distal end of the mandrel 73 and the proximal end of the vascular occlusion device 10.

After the percutaneous arterial puncture operation, as shown in fig. 7-11b in conjunction with fig. 3-4, the vascular sealing device 10 is conveyed into the blood vessel 83 through the puncture hole by using the conveyer 70 (since the vascular sealing device needs to be released in a directional manner, the first push block is used as a directional mark, and the directional release of the vascular sealing device during loading can be realized by determining the direction of the vascular sealing device relative to the first push block), and the mandrel 73 is in a locking state. As shown in fig. 10a-10b, first pushing block 742 is controlled to withdraw sheath 71 to expand first disc 11 into vessel 83, and after first disc 11 is released, conveyor 70 is moved proximally until first disc 11 is tightly attached to the inner wall of vessel, and then the distal end of sheath is located outside the vessel wall; as shown in fig. 11a-11b, the first pushing block 742 is continuously controlled to move the sheath 71 towards the proximal end, so that the second disk surface 13 is unfolded outside the blood vessel, and since one side of the skeleton 131 of the second disk surface 13 far away from the center of the second disk surface 13 exceeds the covering film 132, the part of the skeleton 131 exceeding the covering film 132 forms a pushing force on tissues on the outer wall of the blood vessel, so that a buffer area is formed between the covering film 132 and the tissues, tissues met by the covering film 132 on an unfolding path can be reduced, namely, the possibility that the tissues are extruded on the unfolding path of the covering film 132 is reduced, the extrusion influence of the tissues on the unfolding process of the covering film 132 is reduced, the unfolding of the covering film 132 is driven when the skeleton 131 of the second disk surface 13 is helped, so that the covering film 132 is unfolded as much as possible, the covering film can be better attached to the outer wall of the blood vessel, and the sealing effect of the covering film 132 on puncture holes is increased; finally, the locking knob 744 is controlled to unlock the spindle 73, and then the release knob 745 is rotated to disengage the spindle 73 from the extension 122 of the connector 12 and withdraw the carrier 70 from the person.

Example 2

Example 2 proposes another vascular occlusion device 20 and vascular occlusion system. As shown in fig. 12-19, the vascular sealing device 20 and the vascular sealing system of embodiment 2 are the same as or similar to the vascular sealing device 10 and the vascular sealing system of embodiment 1, and the feature parts that can be used in the vascular sealing device are not described in detail herein, and the main difference is that, in the vascular sealing device 20 of embodiment 2, as shown in fig. 12-13, the skeleton 231 of the second disk surface 23 includes two adjacent trunks 2311 radially distributed from the center of the second disk surface 23, branches 2312 are respectively provided on the two adjacent trunks 2311, and the branches 2312 extend from the trunks 2311 along the second disk surface 23 toward between the two trunks 2311 and beyond the covering film 232.

In this embodiment, branches are disposed between any two adjacent trunks 2311, so that the branches play a role in reducing the influence of tissues on the expansion of the covering film along the disk surface in all directions of the whole disk surface, thereby playing a better role in sealing.

The edge of the covering film 232 divides the disk surface formed by the framework 231 into a first area 23a and a second area 23b, the covering film 232 covers the first area 23a, the trunk 2311 comprises an inner section 2311a close to the center of the disk surface and an outer section 2311b far away from the center of the disk surface, the inner section 2311a is positioned in the first area 23a, the outer section 2311b is positioned in the second area 23b, and the branches 2312 extend from the outer section 2311b in a bending manner along the direction between the second disk surface 23 and the two trunks 2311 far away from the center of the disk surface. In the present embodiment, the branch 2312 includes a blocking portion 23121 and a piercing portion 23123, the blocking portion 23121 is located in the second region 23b, the blocking portion 23121 includes a start end and a connection end opposite to the start end, the start end is connected to the trunk 2311, and the piercing portion 23123 extends from the connection end along the second disk surface 23 in a direction away from the center of the disk surface. The shielding part 23121 is arranged in the second area 23b, so that when the second disk surface 23 is restored to the natural state to be unfolded, the shielding part 23121 is always positioned between the tissue and the covering film 232, the shielding part 23121 contacts the tissue before the covering film 232, the covering film 232 is helped to shield the tissue, the tissue is reduced to squeeze the covering film 232 along the direction of the disk surface towards the center of the disk surface, the covering film 232 is more favorable to be unfolded along the disk surface, and the covering film 232 cannot be unfolded or is not completely unfolded in the process of being unfolded when the tissue squeezes the covering film 232 along the direction of the disk surface towards the center of the disk surface to restore the second disk surface 23 to the natural state, so that the covering film 232 of the second disk surface 23 cannot further play a sealing role.

The puncture portion 23123 is located the central line position between two trunks 2311, and the trunk 2311 of puncture portion 23123 both sides is connected respectively to the symmetrical setting of relative puncture portion 23123 of shielding portion 23121, is provided with the starting end of shielding portion 23121 on two adjacent trunks 2311 respectively, and the link of two extends from the starting end and gathers to same puncture portion 23123 for shielding portion 23121 sets up along incessantly between two adjacent trunks 2311, and the position of two shielding portion 23121 tie points forms a folding angle alpha simultaneously, and folding angle alpha is defined as: the included angle formed between the tangent lines of the two shielding parts at the connecting points respectively, as shown in fig. 13, the folding angle alpha meets the requirement of not being equal to 180 degrees, so that the arrangement of the shielding parts 23121 does not influence the radial compression or the constriction of the whole vascular sealing device 20, and meanwhile, better unfolding force can be provided for the trunk, and the skeleton is more beneficial to driving the tectorial membrane to unfold.

In other embodiments, the fold angle α satisfies: alpha is more than or equal to 20 degrees and less than or equal to 135 degrees, wherein when alpha meets the following conditions: when alpha is more than or equal to 45 degrees and less than or equal to 90 degrees, the arrangement of the branches does not influence the radial compression or folding of the whole vascular sealing device, so that the vascular sealing device is convenient to be converged in the conveyor; simultaneously, can also provide better unfolding force to the trunk, more do benefit to the skeleton and drive the tectorial membrane to expand.

In other embodiments, the puncture portion 23123 may be located at a non-midline position between two trunks, and the shielding portions 23121 may be located on opposite sides of the puncture portion 23123 in the second region 23b, so long as the shielding portions 23121 are located at the front ends of the films 232 in the deployment direction, so as to shield the tissues and prevent the tissues from pressing the films 232 along the extension direction of the second disc surface 23 against the deployment of the films 232.

In other embodiments, as shown in fig. 14, the branch 2312 further includes a supporting portion 23122, where the supporting portion 23122 is at least partially located in the first area 23a, and is used to support a part of the covering film in the first area 23a, which is not located at the trunk 2311, so as to support the covering film 232, and help the covering film 232 to be deployed. The supporting portions 23122 between two adjacent trunks 2311 may be symmetrically disposed with respect to a central line between the two adjacent trunks, and another folding angle β is formed between the two supporting portions 23122, where the folding angle β is not equal to 180 degrees, so that the disposition of the supporting portions 23122 does not affect the overall radial compression or constriction of the vascular closure device.

The feature parts of the transporter provided in this embodiment, which are the same as or can be used as the transporter in the vascular occlusion system of embodiment 1, are not described in detail herein, and the main difference is that, as shown in fig. 15, the handle assembly 74 further includes a middle tube 72 and a second push block 743, the second push block 743 is disposed at a proximal end of the first push block 742, the sheath tube 71, the middle tube 72 and the mandrel 73 are sequentially sleeved from outside to inside, and the proximal ends of the sheath tube 71, the middle tube 72 and the mandrel 73 all extend into the handle assembly 74, the second push block 743 is fixedly connected with a proximal end of the middle tube 72 in the housing 741, and a corresponding housing 741 is provided with a avoiding groove so that the second push block 743 is partially exposed outside the housing 741 and can be pushed axially at the same time, so as to facilitate axial operation.

As shown in fig. 15-17 and fig. 12-13, the second disc surface 23 and the connecting piece 22 can be connected in a sliding manner along the axial direction, a sliding portion 233 is disposed at the proximal end of the second disc surface 23, the sliding portion 233 is sleeved on the outer side of the extending portion 222, a protruding clamping piece 2331 is disposed at the inner side of the sliding portion 233, a sliding groove 2221 is axially disposed at the extending portion 222 of the connecting piece 22, and the clamping piece 2331 is connected with the proximal end of the extending portion 222 in a snap-in manner, so that the clamping piece 2331 is clamped into the sliding groove 2221 and can move along the axial direction in the sliding groove 2221. Meanwhile, a sealant 25 is further disposed between the distal end of the middle tube 72 and the proximal end of the vascular sealing device 20, the sealant 25 is disposed at the proximal end of the sliding portion, when the first disc surface 21 and the second disc surface 23 of the vascular sealing device 20 are released, the second pushing block 743 is pushed towards the distal end along the axial direction, so that the sealant 25 at the distal end of the middle tube 72 pushes the sliding portion 233 towards the distal end, the clamping piece 2331 moves towards the distal end along the sliding groove 2221, thereby driving the second disc surface 23 to move towards the direction close to the first disc surface 21, so that the inner wall and the outer wall of a blood vessel are clamped after the first disc surface 21 and the second disc surface 23 are released, the sealing performance of the first disc surface 21 and the second disc surface 23 is increased, and patients with different vascular wall thicknesses can be adapted at the same time, as shown in fig. 17-18. The sealant 25 expands and becomes soft after meeting the tissue fluid, and continues to push the second pushing block 743 so that the sealant is attached to the second disc surface, as shown in fig. 19, further increasing the sealing property.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.

Claims (10)

1. The vascular sealing device is characterized by comprising a first disc surface, a second disc surface and a connecting piece for connecting the first disc surface and the second disc surface, wherein the first disc surface is used for being attached to the inner wall of a blood vessel for release, the second disc surface is used for being covered on the outer wall of the blood vessel for release, the second disc surface comprises a framework and a coating film which is coated on the framework, and one side, far away from the center of the second disc surface, of the framework exceeds the coating film.

2. The vascular occlusion device of claim 1, wherein the skeleton comprises stems radially extending from a center of the second disk surface along the second disk surface, and wherein branches are disposed between two adjacent stems, and extend from the stems in a direction away from the center of the disk surface toward the two stems.

3. The vascular occlusion device of claim 2, wherein the edge of the cover divides a second disc surface formed by the frame into a first region and a second region, the cover covers the first region, the stem includes an inner section and an outer section, the inner section is located in the first region, the outer section is located in the second region, and the branches extend from the outer section in a curved manner away from the center of the disc surface between the two stems.

4. A vascular occlusion device as in claim 3, wherein the branch includes a shielding portion and a piercing portion, the shielding portion being located in the second region, the shielding portion including a beginning end connected to the trunk and a connecting end opposite the beginning end, the piercing portion extending from the connecting end in a direction away from a center of the second disc surface.

5. The vascular occlusion device of claim 4, wherein the branch further comprises a support portion at least partially located in the first region.

6. The vascular occlusion device of claim 4, wherein the shield is disposed uninterrupted between adjacent stems.

7. The vascular occlusion device of claim 4, wherein two adjacent trunks are provided with respective beginning ends of the shielding portions, and wherein the connection ends of the two trunks extend and converge to the same puncture portion, and wherein the two shielding portions form a folding angle α at the connection point of the two trunks, the folding angle α satisfying: alpha is not equal to 180 degrees.

8. The vascular occlusion device of claim 1, wherein the second disc surface is slidably coupled to the connector member in an axial direction.

9. The vascular occlusion device of claim 1, wherein the first disc face, the connector and the second disc face are each comprised of a degradable shape memory polymer material.

10. A vascular closure system comprising a vascular closure device according to any one of claims 1-9, and a conveyor for conveying the vascular closure device.