CN222708284U - Vascular closure devices and delivery systems - Google Patents

Abstract

The utility model provides a vascular closure and a conveying system, wherein the conveying system comprises the vascular closure and a conveying pipe, and the conveying pipe is used for conveying the vascular closure to a preset position. The vascular closer comprises an anchoring assembly and a limiting assembly, wherein the anchoring assembly comprises a first anchoring member and a connecting pipe, the first anchoring member is sleeved outside the connecting pipe, the limiting assembly comprises a limiting foot fixedly connected with the connecting pipe, the first anchoring member is used for being placed at a first preset position outside a target pipeline, the connecting pipe is used for penetrating through a notch of the target pipeline so as to place the limiting foot in the target pipeline, the limiting foot is used for being anchored at the notch, and the first anchoring member is used for clamping the notch together with the limiting foot. The vascular closer is convenient to operate, the implant is not easy to shift, the risk of vascular complications can be reduced, and the vascular closer has better consistency when closing the blood vessels, so that the safety and the reliability of the operation are improved.

Description

Vascular occluder and delivery system

Technical Field

The utility model relates to the technical field of medical appliances, in particular to a vascular closer and a conveying system.

Background

In interventional procedures, how to treat an interventional puncture wound is a concern. It is currently common practice to press hemostasis in conjunction with a longer brake to close the puncture wound. However, this practice often presents physiological and living discomfort and inconvenience to the patient and may not be effective for patients undergoing anticoagulation treatment during surgery, and vascular occlusive devices dedicated to occluding vascular puncture wounds have therefore emerged.

In recent years, as interventional medicine continues to develop, many emerging surgical approaches require the use of large-caliber sheaths for the intervention, which presents new challenges for vascular occluders. The main solutions for implanting the large-caliber sheath into the puncture wound are two types, namely, suturing the puncture point by using two or more sets of suturing devices, wherein the mode is complex, a doctor learns a long curve and risks that the blood vessel is completely closed, and the mode is also complex, the mode is that the locking anchor sheet and the sponge are locked through the knot pusher to clamp the sandwich structure closing instrument for the wound, the pushed sponge is uncontrollable in form and easy to shift, and manual sponge pushing is seriously dependent on the doctor's skill, so that the consistency is poor and the risk of vascular complications is high.

It is desirable to provide a vascular closure that is simple to operate and does not rely on suturing or pushing procedures by the physician.

Disclosure of utility model

The utility model aims to provide a vascular closer and a delivery system, which are convenient to operate, the implant is not easy to shift, the risk of vascular complications can be reduced, and the vascular closer has better consistency when closing a blood vessel, so that the safety and the reliability of an operation are improved.

The vascular closer comprises an anchoring assembly and a limiting assembly, wherein the anchoring assembly comprises a first anchoring piece and a connecting pipe, the first anchoring piece is sleeved outside the connecting pipe, the limiting assembly comprises a limiting foot fixedly connected with the connecting pipe, the first anchoring piece is used for being placed at a first preset position outside a target pipeline, the connecting pipe is used for penetrating through a notch of the target pipeline to place the limiting foot in the target pipeline, the limiting foot is used for being anchored at the notch, and the first anchoring piece is used for clamping the notch together with the limiting foot.

Optionally, the anchoring assembly further comprises a second anchor, at least part of which is disposed inside the connecting tube, the second anchor being capable of compression and expansion, the expanded second anchor being for anchoring at a second predetermined location outside the target line.

Optionally, the first anchor is sleeved outside the connecting pipe in a cylindrical structure, or the first anchor is wound on the whole circumference of the connecting pipe in a sheet structure.

Optionally, the maximum size of the limiting foot is larger than the length of the notch in the axial direction of the target pipeline.

Optionally, the first anchor is coated with an adhesive for adhering the expanded first anchor to the first predetermined location,

And/or the second anchor is coated with an adhesive for adhering the expanded second anchor to the second predetermined location.

Optionally, the adhesive can be automatically degraded, and the material of the adhesive is one of hydrolyzed collagen, carboxymethyl chitosan, gelatin, polyvinyl alcohol or polyethylene glycol.

Optionally, the spacing assembly and the anchor assembly are each made of a degradable material.

Optionally, the first anchor and/or the second anchor are/is provided as a sponge, and the material of the sponge is one of collagen, chitosan, cross-linked gelatin and derivatives thereof.

Optionally, the connecting tube and/or the limiting foot is made of one of polylactide, polyglycolide, polydioxanone and polycaprolactone.

Optionally, one end of the connecting pipe far away from the limiting pin is provided with a cutting seam, the cutting seam extends along the axial direction of the connecting pipe, at least one end of the connecting pipe is separated by the cutting seam in the circumferential direction of the connecting pipe to form a plurality of parts, and the plurality of parts of the connecting pipe are driven to move towards the outside of the connecting pipe after the first anchoring piece is expanded, so that the position of the first anchoring piece is limited.

Optionally, an end of the first anchor facing away from the limiting leg extends out of the connecting tube, and a portion of the first anchor extending out of the connecting tube is configured to abut the second predetermined position after expansion.

Optionally, one end of the connecting pipe connected with the limiting pin is of a sheet structure, the sheet structure extends in the width direction of the limiting pin, and the connecting pipe is made of a deformable material and is used for correspondingly deforming when the limiting pin rotates.

Optionally, the limiting component further comprises a choke film, the choke film is fixed on the outer wall of the side, facing the connecting pipe, of the limiting foot, and the choke film is used for blocking the notch of the target pipeline.

Optionally, the choke film extends out of the limiting feet at two sides of the limiting feet along the width direction, can be folded along the edges of the limiting feet along the length direction when being bound, can be automatically unfolded after being unbound, and is used for being attached to the inner wall of the target pipeline.

To achieve the above object, the present utility model also provides a delivery system including a delivery tube for delivering the vascular closure to a notch of the target line, and any one of the vascular closures.

Optionally, the delivery system further comprises a control wire, wherein the control wire is connected with the vascular closer, and the control wire is used for driving the vascular closer to move.

Optionally, the spacing foot is provided with two at least through-holes at the interval in self length direction, one end of control silk is located the proximal end of vascular closure, and the other end is used for respectively passing all the through-holes back the proximal end of vascular closure.

The utility model provides a vascular closer and a conveying system, wherein the vascular closer comprises an anchoring assembly and a limiting assembly, the anchoring assembly comprises a first anchoring piece and a connecting pipe, the first anchoring piece is sleeved outside the connecting pipe, the limiting assembly comprises a limiting foot fixedly connected with the connecting pipe, the first anchoring piece is used for being placed at a first preset position outside a target pipeline, the connecting pipe is used for penetrating through a notch of the target pipeline so as to place the limiting foot in the target pipeline, the limiting foot is used for being anchored at the notch, and the first anchoring piece and the limiting foot are used for jointly clamping the notch.

The vascular closer provided by the utility model is convenient to operate, the expansion and anchoring of the first anchoring piece in the puncture cavity can be automatically completed only by pulling the conveying pipe, on one hand, the puncture cavity can be plugged, and on the other hand, the limiting feet in the implantation target pipeline are anchored at the notch and are not easy to shift, so that the risk of vascular complications is reduced. In addition, the first anchoring piece and the limiting feet after expansion can clamp and close the notch of the target pipeline after being anchored, so that the process of plugging the notch by the vascular closer does not depend on a doctor operation method, and the vascular closer has better consistency, thereby improving the safety and reliability of the operation.

Drawings

FIG. 1 is a schematic, cross-sectional, elevational view of a vascular closure in accordance with a preferred embodiment of the present utility model, wherein both the first anchor and the second anchor are in compression;

FIG. 2 is a schematic perspective view of a vascular closure in accordance with a preferred embodiment of the present utility model, wherein both the first anchor and the second anchor are in compression;

FIG. 3 is a schematic side view in axial cross-section of a vascular closure and control wire in accordance with a preferred embodiment of the present utility model, wherein both the first anchor and the second anchor are in compression;

FIG. 4 is a schematic axial cross-sectional elevational view of a vascular closure in accordance with a preferred embodiment of the present utility model, wherein both the first anchor and the second anchor are in an expanded state;

FIG. 5 is a schematic perspective view of a vascular closure in accordance with a preferred embodiment of the present utility model, wherein both the first anchor and the second anchor are in an expanded state;

FIG. 6a is a schematic top view of the end of the connecting tube according to a preferred embodiment of the present utility model;

FIG. 6b is a schematic top view of the end of the connecting tube according to another preferred embodiment of the present utility model;

FIG. 6c is a schematic top view of the end of a connecting tube according to another preferred embodiment of the present utility model;

FIG. 7a is a schematic view showing the structure of the slits on the connecting tube according to a preferred embodiment of the present utility model;

FIG. 7b is a schematic view showing the structure of the slits on the connecting tube according to another preferred embodiment of the present utility model;

FIG. 8 is a schematic axial cross-sectional elevational view of a vascular closure in accordance with another preferred embodiment of the present utility model, wherein both the first anchor and the second anchor are in compression;

FIG. 9 is a schematic perspective view of a vascular closure in accordance with another preferred embodiment of the present utility model wherein both the first anchor and the second anchor are in compression;

FIG. 10 is a schematic axial cross-sectional elevational view of a vascular closure in accordance with another preferred embodiment of the present utility model, wherein both the first anchor and the second anchor are in an expanded state;

FIG. 11 is a schematic perspective view of a vascular closure in accordance with another preferred embodiment of the present utility model, wherein both the first anchor and the second anchor are in an expanded state;

FIG. 12a is a simplified schematic illustration of an implantation scenario of a vascular closure in accordance with a preferred embodiment of the present utility model, wherein a guidewire is threaded into a puncture lumen;

FIG. 12b is a simplified schematic illustration of an implantation scenario of a vascular closure in accordance with a preferred embodiment of the present utility model wherein the guidewire, dilator and closure sheath all penetrate into the puncture lumen;

FIG. 12c is a simplified schematic illustration of an implantation scenario of a vascular closure in accordance with a preferred embodiment of the present utility model, wherein the closure sheath is threaded into the puncture lumen;

FIG. 12d is a simplified schematic illustration of an implantation scenario of a vascular closure in accordance with a preferred embodiment of the present utility model, wherein the vascular closure is threaded along a closure sheath into a puncture lumen and a target line;

FIG. 12e is a simplified schematic illustration of an implantation scenario of a vascular closure in accordance with a preferred embodiment of the present utility model wherein a stop foot is anchored at a notch and a delivery tube constrains a first anchor and a second anchor;

FIG. 12f is a simplified schematic illustration of an implantation scenario of a vascular closure in accordance with a preferred embodiment of the present utility model wherein a stop foot is anchored at a notch, a first anchor is unbound and expanded at a first predetermined location, and a second anchor is unbound and expanded at a second predetermined location;

FIG. 12g is a simplified schematic illustration of an implantation scenario of a vascular occluder in accordance with a preferred embodiment of the present utility model, wherein thrombus is formed in the anchor assembly;

FIG. 12h is a simplified schematic illustration of an implantation scenario of a vascular closure in accordance with a preferred embodiment of the present utility model, wherein the vascular closure is degraded in vivo;

FIG. 13a is an enlarged view of FIG. 12 e;

fig. 13b is an enlarged view of fig. 12 f.

In the figure:

The anchor assembly 1, the first anchor 11, the connecting pipe 12, the cutting seam 121, the sheet structure 122, the second anchor 13, the limiting assembly 2, the limiting foot 21, the choke film 22, the delivery pipe 3, the control wire 4, the guide wire 5, the closer sheath 6 and the expander 7;

The target line 10, the notch 20, the first predetermined location 30, the second predetermined location 40, and the soft tissue 50.

Detailed Description

The utility model is described in further detail below with reference to the drawings and the specific examples. The advantages and features of the present utility model will become more apparent from the following description. It should be noted that the drawings are in a very simplified form and are all to a non-precise scale, merely for convenience and clarity in aiding in the description of embodiments of the utility model.

The terms "center," "longitudinal," "transverse," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counter-clockwise," "axial," "radial," "circumferential," etc. refer to an orientation or positional relationship based on that shown in the drawings, merely for convenience of description and to simplify the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore should not be construed as limiting the utility model.

As used herein, "distal" generally refers to the end of the delivery system that is distal to the operator, and the term "proximal" is opposite "distal" generally refers to the end of the delivery system that is proximal to the operator.

In the present utility model, unless explicitly specified and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally formed, mechanically connected, electrically connected, or communicable with each other, directly connected, or connected via an intermediate medium, or in communication with each other, or in an interaction relationship between two elements, unless explicitly specified otherwise. The specific meaning of the above terms in the present utility model can be understood by those of ordinary skill in the art according to the specific circumstances.

Exemplary embodiments of the present application will be described in detail below with reference to the accompanying drawings. The following embodiments and features of the embodiments may be complemented or combined with each other without conflict.

As shown in fig. 1 to 3, a preferred embodiment of the present utility model provides a vascular occlusive device, which is used for anchoring in a puncture cavity to block a puncture wound in a blood vessel, so as to prevent fluid in the blood vessel from overflowing, and promote the growth and healing of the puncture wound on the blood vessel.

The vascular closer comprises an anchor assembly 1 and a limiting assembly 2 which are connected. The anchor assembly 1 includes a first anchor 11 and a connecting tube 12. The first anchor 11 is sleeved outside the connection pipe 12. The limiting assembly 2 comprises a limiting foot 21 fixedly connected with the connecting pipe 12. The first anchor 11 is adapted to be placed at a first predetermined location 30 (see fig. 13 b) outside the target circuit 10, and the connecting tube 12 is adapted to be passed through the notch 20 of the target circuit 10 to place the stop foot 21 within the target circuit 10. The stop legs 21 serve to anchor at the notch 20 as the anchor assembly 1 moves out of the target pipeline 10, thereby defining the anchoring position of the anchor assembly 1. The first anchoring element 11 is capable of being compressed and expanded, the expanded first anchoring element 11 is used for being anchored at a first preset position 30 outside the target pipeline 10 so as to define the implantation positions of the connecting pipe 12 and the limiting foot 21, the first anchoring element 11 is also used for clamping the notch 20 together with the limiting foot 21 (namely, the first anchoring element 11 is positioned outside the target pipeline 10, the limiting foot 21 is positioned inside the target pipeline 10, and the first anchoring element 11 and the limiting foot 21 are used for clamping the notch 20 together so as to enable the notch 20 to be basically closed), so that a puncture cavity is blocked, and a hemostatic effect is achieved.

It should be understood that the target line 10 is generally referred to as a vessel that the vascular closure is required to close, the incision 20 is generally referred to as a puncture wound formed in the vessel during surgery, and the first predetermined location 30 is referred to as an anchoring location of the first anchor 11 within the puncture lumen. Specifically, in the present application, the first anchor 11 is anchored in the soft tissue in the puncture lumen and the position of the stopper 21 near the outer wall of the connecting tube 12. It should also be understood that a puncture lumen generally refers to a passageway formed by a patient inside and outside of the target circuit 10 after puncturing and extending through the notch 20.

With continued reference to fig. 13a and 13b, a preferred embodiment of the present utility model also provides a delivery system comprising a vascular closure provided in any of the embodiments of the present utility model and a delivery tube 3, the delivery tube 3 being adapted to deliver the vascular closure to the target site of the breach 20 of the target vessel 10, the vascular closure being adapted to occlude and close the breach 20 after delivery in place.

The vascular closer provided by the utility model is convenient to operate, the expansion and anchoring of the first anchoring piece 11 in the puncture cavity can be automatically completed only by pulling the conveying pipe 3, on one hand, the puncture cavity can be plugged, and on the other hand, the limiting feet 21 implanted in the target pipeline 10 are anchored at the notch 20 and are not easy to shift, so that the risk of vascular complications is reduced. In addition, the first anchoring piece 11 and the limiting feet 21 after expansion can clamp and close the notch 20 of the target pipeline 10 after being anchored, so that the process of plugging the notch 20 by the vascular closer does not depend on the operation method of doctors, and the vascular closer has better consistency so as to improve the safety and reliability of operations.

With continued reference to fig. 1-3, and in combination with fig. 13a and 13b, the anchor assembly 1 also preferably includes a second anchor 13, at least a portion of the second anchor 13 being disposed within the connecting tube 12, i.e., the connecting tube 12 is sleeved over at least a portion of the outer surface of the second anchor 13. The second anchor 13 is capable of being compressed and expanded, the expanded second anchor 13 being used for anchoring at a second predetermined location 40 (see fig. 13 b) outside the target vessel 10, where the second predetermined location 40 at which the second anchor 13 is anchored refers to the anchoring location of the second anchor 13 within the puncture lumen, in particular, where the second anchor 13 is anchored at the soft tissue within the puncture lumen. So configured, the expanded second anchor 13 also serves to define the implantation position of the connection tube 12 and the stopper pin 21, i.e., the first anchor 11 and the second anchor 13 can jointly define the positions of the connection tube 12 and the stopper pin 21 after expansion, thereby better preventing the stopper pin 21 from being displaced.

The expanded second anchor 13 is anchored at the second predetermined position 40, and the outer wall of the second anchor 13 may directly contact the second predetermined position 40, and the second anchor 13 is directly anchored at the second predetermined position 40. Meanwhile, the second anchoring element 13 may be expanded to drive the connecting tube 12 to expand, so that the outer wall of the connecting tube 12 contacts the second predetermined position 40, and the second anchoring element 13 may be indirectly anchored at the second predetermined position 40 through the connecting tube 12.

In more detail, the vascular closer is actually implanted with the delivery tube 3 being sleeved outside the vascular closer to bind and compress the first and second anchors 11, 13. The conveying pipe 3 can drive the anchoring assembly 1 and the limiting assembly 2 to move, and convey the limiting feet 21 into the target pipeline 10. Then, the conveying pipe 3 drives the anchoring assembly 1 and the limiting assembly 2 to move towards the direction of moving out of the target pipeline 10 until the limiting feet 21 are abutted against the inner wall of the target pipeline 10, and then the limiting feet 21 are anchored at the notch 20. The delivery tube 3 is then withdrawn to move the delivery tube 3 relative to the first and second anchors 11, 13. As the delivery tube 3 is withdrawn, the first and second anchors 11, 13 sequentially un-tie the delivery tube 3 and gradually expand, the first anchor 11 being capable of anchoring at a first predetermined location 30 after expansion and the second anchor 13 being capable of anchoring at a second predetermined location 40 after expansion, the first and second anchors 11, 13 both compressing the surrounding soft tissue after anchoring to define the implantation location of the connecting tube 12 and the stop leg 21, preventing displacement of the connecting tube 12 and stop leg 21 after long term implantation. At the same time, the first anchor 13 outside the target line 10 and the stop leg 21 inside the target line 10 can jointly clamp the notch 20 to prevent the blood inside the blood vessel from overflowing from the notch 20.

The present application is not limited to the shape of the first anchor 11. In an alternative, the first anchor 11 is sleeved outside the connection pipe 12 in a cylindrical structure. In a further alternative, the first anchor 11 is wound around the entire circumference of the connecting tube 12 in a sheet-like structure, that is to say the first anchor 11 is connected after being enclosed on the outer wall of the connecting tube 12 for one revolution.

In practice, the first anchoring element 11 is placed around or wound around the connecting tube 12, and the first anchoring element 11 is gripped by a gripper, wherein the first anchoring element 11 is allowed to expand in the circumferential and/or axial direction of the connecting tube 12 after contacting blood or tissue fluid, and is anchored in the first predetermined position 30, so as to prevent uncontrolled displacement and loosening of the first anchoring element 11 on the connecting tube 12.

The connection manner of the connection tube 12 and the limit leg 21 is not limited in the present application, and for example, the connection tube 12 may be connected to the limit leg 21 by welding, hot pressing, integral molding, bonding, or other suitable manners.

In a preferred embodiment, the maximum dimension of the stop leg 21 is greater than the length of the notch 20 in the axial direction of the target line 10. It should be understood that when the spacing leg 21 is polygonal, the maximum dimension of the spacing leg 21 refers to the maximum side length of the spacing leg 21, and when the spacing leg 21 is circular or elliptical, the maximum dimension of the spacing leg 21 refers to the maximum inner diameter of the spacing leg 21.

So set up for can block to establish in breach 20 position when spacing foot 21 is leaned on the inner wall of target pipeline 10, and then make spacing foot 21 lean on the inner wall of target pipeline 10, so can avoid spacing foot 21 to shift out target pipeline 10, still can prevent the abundant spilling over of blood in the target pipeline 10.

Referring to fig. 12a to 13b, and referring to fig. 1, the first anchor 11 and the second anchor 13 are generally made of a self-expandable material such as sponge, and the materials for preparing the first anchor 11 and the second anchor 13 are not limited in the present application.

When both the first anchor 11 and the second anchor 13 are provided as a sponge, the first anchor 11 and/or the second anchor 13 may be expanded after rapid absorption of fluid (e.g., absorption of tissue fluid within soft tissue) after implantation and release of the tie, thereby achieving anchoring. In addition, the sponge can block the puncture lumen after absorbing the liquid, thereby preventing the blood in the target pipeline 10 from continuously exuding.

Preferably, the first anchoring element 11 and/or the second anchoring element 13 are coated with an adhesive for adhering the expanded first anchoring element 11 to the first predetermined position 30 and for adhering the second anchoring element 13 to the second predetermined position 40, so that, on the one hand, the notch 20 of the target line 10 can be sealed to further prevent the blood in the target line 10 from continuously overflowing in the puncture lumen, and on the other hand, the anchoring strength of the first anchoring element 11 and the second anchoring element 13 can be improved to further prevent the connecting tube 12 and the stopper 21 from being displaced.

In more detail, the outer walls of the first and second anchors 11, 13 are provided with an adhesive which dissolves upon contact with blood or interstitial fluid to form a gel of high viscosity, thereby effecting the bonding of the first anchor 11 at the first predetermined location 30 and the bonding of the second anchor 13 at the second predetermined location 40.

The application is not limited to the combination mode of the sponge and the adhesive. In a specific example, the sponge and the adhesive may be integrally lyophilized to provide the first anchor 11 or the second anchor 13, in which case the adhesive may be disposed on the outer surface of the sponge or on the interior of the sponge. In another specific example, the first anchor 11 or the second anchor 13 may also be obtained by freeze-drying to prepare a sponge frame, and then dipping, spraying or rolling an adhesive on the sponge frame, followed by secondary freeze-drying.

The operator can choose any combination to prepare the first anchor 11 and the second anchor 13 according to the actual clinical needs. After the first anchor 11 is prepared, the second anchor 13 is swaged using a swager so that it can be inserted into the connection tube 12.

When the sponge is contacted with blood or tissue fluid to absorb the fluid and expand, the adhesive can be separated out to the outer surface of the sponge so as to adhere the sponge to the preset position.

In the prior art, the vascular occlusive device can not be completely degraded, so that the vascular occlusive device forms interference and obstruction to the subsequent secondary puncture interventional operation.

In order to solve the above problems, the anchor assembly 1 and the limiting assembly 2 provided by the utility model are both made of degradable materials, so that the vascular closure can be completely degraded after the puncture cavity is self-healed, and further, the vascular closure is prevented from interfering or obstructing the human body or subsequent operations.

In order to enable the anchoring assembly 1 and the limiting assembly 2 to be completely degraded after being implanted in a body, the adhesive can be designed to be automatically degraded, and the material of the adhesive is preferably one of hydrolyzed collagen, carboxymethyl chitosan, gelatin, polyvinyl alcohol or polyethylene glycol, wherein the hydrolyzed collagen, carboxymethyl chitosan or gelatin is a water-soluble derivative, the polyvinyl alcohol or polyethylene glycol is a degradable synthetic water-soluble material, and the water-soluble derivative and the degradable synthetic water-soluble material are both soluble in liquid to form adhesive gel. In addition, the adhesive can also be prepared by using other water-soluble derivatives or soluble synthetic water-soluble materials.

Further, the first anchor 11 and the second anchor 13 are preferably provided as degradable sponges, and the sponges are made of one of collagen, chitosan, crosslinked gelatin and derivatives thereof. The second anchoring member 13 may have various shapes, for example, in some embodiments, the second anchoring member 13 is provided as a cylinder, a prism, a cone or a pyramid, and the anchoring effect is good.

In more detail, the connection tube 12 is a degradable polymeric tube including, but not limited to, a natural or synthetic polymeric degradable tube, and the connection tube 12 is made of one of polylactide, polyglycolide, polydioxanone, and polycaprolactone. The shape of the connecting pipe 12 is not particularly limited in the present application, for example, the connecting pipe 12 may be a square pipe or a round pipe.

Optionally, the limiting leg 21 is a hard degradable sheet, the shape of the limiting leg 21 is approximately arched, and the side of the limiting leg 21 facing the connecting tube 12 is preferably provided with a streamline shape or the like to reduce or even avoid the overflow of blood flow from the notch 20. The stopper leg 21 may be made of one of polylactide, polyglycolide, polydioxanone, and polycaprolactone.

The application does not limit the preparation mode of the connecting pipe 12 and/or the limiting pin 21, and the connecting pipe 12 and/or the limiting pin 21 can be prepared by adopting extrusion, blow molding, injection molding, 3D printing, electrostatic spinning and other modes. The connecting pipe 12 and/or the limiting pin 21 are preferably prepared in an electrostatic spinning mode, and the connecting pipe 12 and/or the limiting pin 21 prepared in the electrostatic spinning mode are rough in surface, have good thrombus forming performance and can help puncture wounds to be closed by coagulation as soon as possible. In addition, the connecting pipe 12 and/or the limiting feet 21 prepared in an electrostatic spinning mode are loose and porous in structure, so that the degradation speed of the connecting pipe 12 and/or the limiting feet 21 is increased, and meanwhile, the connecting pipe can also serve as a cytoskeleton to promote the growth and healing of wounds.

In order to meet the clinical demands of most patients, when the first anchoring piece 11 is of a cylindrical structure, the length of the first anchoring piece 11 in the axial direction is 2 mm-20 mm, and the diameter of the first anchoring piece 11 in the cross section is 0.5 mm-10 mm. When the first anchor 11 is of a sheet-like structure, the length of the first anchor 11 is 2 mm-300 mm, the width of the first anchor 11 is 2 mm-20 mm, and the thickness of the first anchor 11 is 10 um-2 mm.

In addition, the length of the second anchor 13 in the axial direction thereof is 2mm to 20mm, and the diameter or side length of the second anchor 13 in the cross section is 0.5mm to 10mm. The length of the connecting pipe 12 in the axial direction is 2 mm-20 mm, and the diameter or side length of the connecting pipe 12 in the cross section is 0.5 mm-10 mm. The length of the limiting pin 21 in the axial direction (i.e. the length direction L in FIG. 2) is 5 mm-50 mm, the length of the limiting pin 21 in the circumferential direction is 2 mm-50 mm, and the thickness of the limiting pin 21 in the radial direction is 20 um-2 mm.

However, it should be understood that the dimensions of the first anchor 11, the connecting tube 12, the second anchor 13 and the spacing leg 21 may be adapted according to the actual needs of the patient without limiting the scope of the disclosure of the above embodiments.

Referring to fig. 6a to 7b, the end of the connecting tube 12 away from the limiting leg 21 has a slit 121, and the slit 121 extends substantially along the axial direction of the connecting tube 12. The slits 121 divide at least one end of the connection pipe 12 in the circumferential direction of the connection pipe 12 to form a plurality of portions, for example, the slits 121 can bisect (see fig. 6 a), quarter (see fig. 6 b) or multiple halves (see fig. 6 c) the end of the connection pipe 12. The second anchor 13 is expanded to move portions of the connection tube 12 toward the outside, thereby defining the position of the first anchor 11.

Specifically, the connection tube 12 can be co-expanded with the second anchor 13 to increase the width of each slit 121 in the circumferential direction of the connection tube 12, and the connection tube 1 can press the inner wall of the first anchor 11 after expansion, thereby firmly anchoring the first anchor 11 at the first predetermined position 30.

It should be appreciated that the outer portion of the connection tube 12 refers to the direction of the connection tube 12 from inside to outside, i.e., the direction in which the connection tube 12 approaches the puncture lumen (i.e., the direction of the first predetermined position 30 or the second predetermined position 40).

In order to secure the first anchor 11 at the first predetermined position 30, the length of the slit 121 in the axial direction of the connection pipe 12 is preferably 2mm to 8mm.

The shape of the slit 121 is not limited in the present application, and for example, the slit 121 may be formed in a zigzag shape (see fig. 7 a) or a hairpin shape (see fig. 7 b), and the slit 121 may be formed in another shape as needed. The saw-tooth or hairpin shape of the slits 121 helps to deform the end of the connecting tube 12 when expanding together with the second anchor 13, thereby increasing the friction between the connecting tube 12 and the surrounding soft tissue and improving the anchoring strength of the anchor assembly 1.

After the second anchor 13 is inserted into the connecting tube 12, the second anchor 13 is firmly anchored to the connecting tube 12 without being loosened because the intermediate portion of the expanded second anchor 13 is disposed in the connecting tube and presses the inner wall of the connecting tube 12.

Referring back to fig. 1-4, in one embodiment, the end of the second anchor 13 facing away from the stop leg 21 extends out of the connecting tube 12, and the portion of the second anchor 13 extending out of the connecting tube 12 is adapted to abut the second predetermined location 40 after expansion (see fig. 13 b). So arranged, the second anchor 13 can be brought into direct contact with the second predetermined location 40, and the second anchor 13 and the second predetermined location 40 are bonded by the adhesive, so as to improve the anchoring strength of the second anchor 13.

In the case where the second anchor 13 extends out of the connection pipe 12, the slit 121 may be optionally provided at the end of the connection pipe 12. When no slit is provided in the connection tube 12, it is only necessary to satisfy the requirement that the second anchor 13 can be directly anchored at the second predetermined position 40 after being expanded.

With continued reference to fig. 1 to 3, one end of the connection tube 12 connected to the spacing leg 21 is a sheet structure 122 (i.e., a sheet), and the sheet structure 122 extends in the width direction W of the spacing leg 21, that is, after the connection tube 12 is connected to the spacing leg 21, the extending direction of the sheet structure 122 (i.e., the length direction of the sheet structure 122) is parallel to the width direction W of the spacing leg 21. The connecting tube 12 is made of a deformable material and is adapted to be deformed accordingly when the stopper leg 21 is rotated. Specifically, when the stopper pin 21 rotates around the own width direction, that is, both ends of the stopper pin 21 in the own length direction L rotate around the extending direction of the sheet structure 122, the connection pipe 12 can be deformed adaptively. Thus, the limit pin 21 can conveniently penetrate into the notch 20 of the target pipeline 10 and adjust the position in the target pipeline 10.

It should be noted that, after the limiting leg 21 is implanted into the target pipeline 10, the length direction L of the limiting leg 21 is the axial direction of the target pipeline 10, and the width direction W of the limiting leg 21 is the radial direction of the target pipeline 10.

The present application is not limited to the manner in which the ends of the connecting tube 12 are prepared, and the ends of the connecting tube 12 may be prepared in a sheet form by hot pressing, mechanical pressing, melting, solvent softening deformation, or other suitable means to form the sheet structure 122.

Referring to fig. 8 to 11, the limiting assembly 2 further includes a blocking film 22, where the blocking film 22 is fixed on an outer wall of the side of the limiting leg 21 facing the connecting pipe 12, and the blocking film 22 is used for blocking the notch 20 of the target pipeline 10. Specifically, when the choke film 22 is disposed on the vascular closer, the choke film 22 directly abuts against the inner wall of the target pipeline 10 after entering the target pipeline 10, so as to further prevent the blood in the target pipeline 10 from overflowing.

With continued reference to fig. 8 to 11, the choke film 22 extends out of the stopper leg 21 on both sides of the stopper leg 21 in the width direction W. The choke film 22 has a folded state and an unfolded state, and the choke film 22 can be folded along the edge of the limiting leg 21 in the length direction L when being bound, so as to form the folded state, and thus the limiting leg 21 and the choke film 22 can conveniently enter the target pipeline 10 at the notch 20. The blocker film 22 is also capable of automatically expanding upon unlatching, the expanded blocker film 22 being adapted to abut the inner wall of the target pipeline 10.

Specifically, the choke film 22 can be automatically unfolded after entering the target pipeline 10 and contacting the body temperature blood, the size of the unfolded choke film 22 in the width direction W of the limiting leg 21 is larger than the size of the notch 20 in the width direction W of the limiting leg 21, and at this time, the choke film 22 can block the notch 20 to reduce or even avoid the blood in the target pipeline 10 from flowing from the notch 20 to the soft tissue.

Preferably, the choke film 22 is a film made of a shape memory polymer, and the choke film 22 is made of one of polyglycolide, polylactide, copolymers and mixtures thereof.

The present application is not limited to the preparation method of the choke film 22, and the choke film 22 may be prepared by extrusion, blow molding, injection molding, 3D printing, electrostatic spinning, or the like, preferably by electrostatic spinning.

Alternatively, the blocker film 22 may have a variety of shapes, such as circular or oval. For better blocking the notch 20, the diameter of the choke film 22 is preferably 10 mm-100 mm, and the thickness of the choke film 22 is preferably 20 um-2 mm. The size of the choke film 22 can be adapted to the actual needs of the patient and is not limited to the scope disclosed in the preferred embodiment.

Referring back to fig. 2, the delivery system further comprises a control wire 4, the control wire 4 is connected with the vascular closer, and the control wire 4 is used for driving the vascular closer to move. Specifically, the control wire 4 is used for driving the vascular closer to move out of the target pipeline 10, and the limiting leg 21 can be anchored at the notch 20 of the target pipeline 10 in the moving process.

Further, the control wire 4 is preferably a polymer wire, and the polymer wire which can be degraded or not degraded in the body can be selected according to the requirement, and particularly can be selected from 7-0 wire to 1 wire.

Preferably, both ends of the control wire 4 are connected with a handle (not shown) of the conveying system, and the control wire 4 can be driven to move by controlling the handle.

Alternatively, the control wire 4 may be connected to the connection tube 12 and/or the limiting leg 21, and the control wire 4 may drive the whole vascular closer to move through the connection tube 12 and/or the limiting leg 21.

In a preferred embodiment, the limiting leg 21 or the connecting tube 12 is provided with at least two through holes (not numbered), and the control wire 4 is connected to the handle after passing through all the through holes in sequence.

Referring to fig. 2 and 3, the limiting leg 21 is preferably provided with at least two through holes at intervals along its length direction L, one end of the control wire 4 is located at the proximal end of the vascular closer, and the other end is used to pass through the two through holes and then pass back to the proximal end of the vascular closer.

In more detail, one end of the control wire 4 is placed at the proximal end of the connection tube 12, and the other end is adapted to pass through one of the through holes on the side of the connection tube 12 and to pass back through the proximal end of the connection tube 12 after passing through the other through hole on the side facing away from the connection tube 12. By such arrangement, the limiting leg 21 can be rotated relative to the connecting pipe 12 by pulling one end of the control wire 4, so as to adjust the rotation angle of the limiting leg 21 relative to the connecting pipe 12.

The relative positions of the control wire 4 and the anchor assembly 1 are not limited in the present application. In an example, two through holes are provided on the limiting leg 21, and the control wire 4 is disposed outside the first anchor 11 at both portions of the limiting leg 21 facing the connecting tube 12, at which time the control wire 4 may be withdrawn or the control wire 4 may be retained in the vascular closer. When the control wire 4 stays in the body, the first anchoring piece 11 expands to drive the control wire 4 to move, so that the control wire 4 is pressed and held between the first anchoring piece 11 and soft tissues.

In another example, two through holes are provided on the limiting leg 21, and the control wire 4 penetrates between the first anchor 11 and the connecting pipe 12 at both parts of the limiting leg 21 facing the connecting pipe 12, at which time the control wire 4 and the first anchor 11 can be commonly pressed and held on the connecting pipe 12. When the control wires 4 are withdrawn, one of the control wires 4 may be cut, and the control wire 4 may be pulled out by pulling the handle.

Referring to fig. 12 a-13 b, in one non-limiting embodiment, the vascular occluder implantation procedure is:

1) Referring to fig. 12a, after the interventional procedure is completed, the guide wire 5 is passed through the primary sheath, the primary sheath is withdrawn, and the guide wire is left in the puncture lumen.

2) Referring to fig. 12b, the dilator 7 and the closer sheath 6 are connected, the dilator 7 and the closer sheath 6 are implanted in the extending direction of the guide wire 5, and the surrounding soft tissue 50 is pressed by the dilator 7 so that one end of the closer sheath 6 protrudes into the target tube 10.

3) Referring to fig. 12c, the guidewire 5 and dilator 7 are withdrawn, leaving the occluder sheath 6 in the target tube 10.

4) Referring to fig. 12d, the delivery tube 3 is implanted along the lumen of the occluder sheath 6, and the delivery tube 3 moves the vascular occluder therein until the stop foot 21 is moved into the target vessel 10.

5) Referring to fig. 12e and fig. 13a, the delivery tube 3 and the closer sheath 6 are withdrawn simultaneously, the delivery tube 3 drives the vascular closer to move out of the target pipeline 10 until the closer sheath 6 and the delivery tube 3 are withdrawn integrally to reach an obvious resistance, and at this time, the limiting feet 21 abut against the inner wall of the target pipeline 10, so as to complete the anchoring of the limiting feet 21 at the notch 20. In the process, the delivery tube 3 is always sleeved outside the first anchoring member 11 and the second anchoring member 13.

In fig. 13a, the outer wall of the delivery tube 3 should always be in contact with the soft tissue 50 during implantation, and in order to clearly illustrate the implantation process of the vascular occlusive device, the delivery tube 3 and the soft tissue 50 are spaced apart by a certain distance in fig. 13 a.

6) Referring to fig. 12f and 13b, the control wire 4 is withdrawn, the delivery tube is withdrawn to move the delivery tube 3 relative to the vessel closer, thereby releasing the anchor assembly 1, the first anchor 11 and the second anchor 13 sequentially release the tether of the delivery tube 3 to self-expand, the first anchor 11 is compressed and anchored at the first predetermined position 30 after expansion, the second anchor 13 is compressed and anchored at the second predetermined position 40 after expansion, and the first anchor 11 is expanded and the stop legs 21 cooperate to clamp the notch 20.

It should be noted that, in fig. 13b, the outer walls of the first anchor 11, the connecting tube 12 and the second anchor 13 (i.e. the blank between the second anchor 13 and the stop leg 21) should be always abutted against the soft tissue 50 when being implanted, and in order to clearly illustrate the anchoring process of the first anchor 11 and the second anchor 13, the blank is left between the anchor assembly 1 and the soft tissue 50 in fig. 13 b.

7) Referring to fig. 12g, with the control wire 4 held in tension, one end of the control wire 4 is cut, and then the handle is withdrawn with the control wire 4, withdrawing the delivery tube 3 and the closer sheath 6, and the implant implantation is completed. Thrombus is formed in the anchoring component 1 of the vascular closer, so that the puncture cavity is blocked.

8) Referring to fig. 12h, the vascular occlusive device gradually degrades in the body to complete healing of the puncture lumen.

In summary, the vascular closer provided by the utility model is convenient to operate, and the expansion and anchoring of the first anchoring member 11 in the puncture cavity can be automatically completed only by pulling the conveying pipe 3, so that the puncture cavity can be plugged on one hand, and on the other hand, the limiting feet 21 implanted in the target pipeline 10 are anchored at the notch 20 and are not easy to shift, so that the risk of vascular complications is reduced. In addition, the first anchoring piece 11 and the limiting feet 21 after expansion can clamp and close the notch 20 of the target pipeline 10 after being anchored, so that the process of plugging the notch 20 by the vascular closer does not depend on the operation method of doctors, and the vascular closer has better consistency so as to improve the safety and reliability of operations.

The above description is only illustrative of the preferred embodiments of the present utility model and is not intended to limit the scope of the present utility model, and any alterations and modifications made by those skilled in the art based on the above disclosure shall fall within the scope of the present utility model.

Claims (17)

1. A vascular closure device, characterized in that it comprises an anchoring assembly and a limiting assembly; the anchoring assembly comprises a first anchoring member and a connecting tube; the first anchoring member is sleeved on the outside of the connecting tube; the limiting assembly comprises a limiting foot fixedly connected to the connecting tube; the first anchoring member is used to be placed at a first predetermined position outside a target pipeline; the connecting tube is used to pass through a notch in the target pipeline so as to place the limiting foot in the target pipeline, and the limiting foot is used to anchor at the notch; the first anchoring member is used to clamp the notch together with the limiting foot. 2. The vascular closure device according to claim 1, characterized in that the anchoring assembly further comprises a second anchoring member, at least a portion of which is disposed inside the connecting tube; the second anchoring member is capable of compression and expansion, and the expanded second anchoring member is used to anchor at a second predetermined position outside the target pipeline. 3. The vascular closure device according to claim 2, wherein the first anchoring member is sleeved on the outside of the connecting tube in a cylindrical structure, or the first anchoring member is wound around the entire circumference of the connecting tube in a sheet-like structure. 4. The vascular closure device according to claim 2, wherein the maximum dimension of the limiting foot is greater than the axial length of the notch in the target pipeline. 5. The vascular closure device according to claim 2, wherein the first anchoring member is coated with an adhesive, and the adhesive is used to bond the expanded first anchoring member to the first predetermined position. And/or, the second anchoring member is coated with an adhesive, and the adhesive is used to bond the expanded second anchoring member to the second predetermined position. 6. The blood vessel closure device according to claim 5, characterized in that the adhesive is self-degradable, and the material of the adhesive is one of hydrolyzed collagen, carboxymethyl chitosan, gelatin, polyvinyl alcohol or polyethylene glycol. 7. The vascular closure device according to any one of claims 2 to 6, characterized in that the limiting component and the anchoring component are both made of degradable materials. 8. The vascular closure device according to claim 7, characterized in that the first anchoring member and/or the second anchoring member is configured as a sponge, and a material of the sponge is one of collagen, chitosan, cross-linked gelatin and derivatives thereof. 9. The vascular closure device according to claim 7, wherein the connecting tube and/or the limiting pin are made of one of polylactide, polyglycolide, polydioxanone, polydioxanone and polycaprolactone. 10. The vascular closure device according to any one of claims 2 to 6, characterized in that the end of the connecting tube away from the limiting foot has a slit, the slit extends along the axial direction of the connecting tube, and the slit divides at least one end of the connecting tube into a plurality of parts in the circumferential direction of the connecting tube; after the second anchor is expanded, it is used to drive the plurality of parts of the connecting tube to move toward the outside of the connecting tube, thereby limiting the position of the first anchor. 11. The blood vessel closure device according to any one of claims 2 to 6, characterized in that one end of the second anchoring member away from the limiting leg extends out of the connecting tube, and the portion of the second anchoring member extending out of the connecting tube is used to abut against the second predetermined position after expansion. 12. The vascular closure device according to any one of claims 1 to 6, characterized in that one end of the connecting tube connected to the limiting foot is a thin sheet structure, and the thin sheet structure extends in the width direction of the limiting foot; the connecting tube is made of a deformable material and is used to deform accordingly when the limiting foot rotates. 13. The vascular closure device according to any one of claims 1 to 6, characterized in that the limiting assembly further comprises a flow-blocking membrane, the flow-blocking membrane is fixed on the outer wall of the limiting foot on a side facing the connecting tube, and the flow-blocking membrane is used to block the gap of the target pipeline. 14. The blood vessel closure device as described in claim 13 is characterized in that the blocking membrane extends out of the limiting foot on both sides of the limiting foot in the width direction; the blocking membrane can be folded along the edge of the limiting foot in the length direction when being restrained, and can be automatically unfolded after being released, and the unfolded blocking membrane is used to adhere to the inner wall of the target pipeline. 15. A delivery system, comprising a delivery tube and the vascular closure device according to any one of claims 1 to 14, wherein the delivery tube is used to deliver the vascular closure device to the breach of the target pipeline. 16. The delivery system according to claim 15, further comprising a control wire, wherein the control wire is connected to the vascular closure device, and the control wire is used to drive the vascular closure device to move. 17. The delivery system as claimed in claim 16, characterized in that the limiting foot is provided with at least two through holes at intervals in its length direction, one end of the control wire is located at the proximal end of the vascular closure device, and the other end is used to pass through the two through holes respectively and then pass back to the proximal end of the vascular closure device.