Vascular closure device and delivery system

Abstract

A vascular closure device and a delivery system. The delivery system comprises the vascular closure device and a delivery tube. The delivery tube is used to deliver the vascular closure device to a predetermined position. The vascular closure device comprises an anchoring assembly and a limiting assembly. The anchoring assembly comprises a first anchoring member and a connecting tube, with the first anchoring member 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 configured to be positioned at a first predetermined position outside a target vessel. The connecting tube is configured to pass through a gap in the target vessel, so as to position the limiting foot inside the target vessel. The limiting foot is configured to anchor at the gap. The first anchoring member is configured to cooperate with the limiting foot to clamp and close the gap. The vascular closure device is easy to operate, minimizes implant displacement, reduces the risk of vascular complications, and exhibits excellent consistency during vessel closure, thereby enhancing surgical safety and reliability.

Description

Vascular closure device and delivery system TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a vascular closure device and delivery system. BACKGROUND

[0002] In interventional surgery, how to deal with the interventional puncture wound is a problem worth attention. The current common practice is to press the hemostatic device to close the puncture wound for a long time. However, this method usually brings physiological and life discomfort and inconvenience to the patient, and the effect may not be good for the patient who has been treated with anticoagulation during the operation, so the vascular closure device for closing the vascular puncture wound emerges as the times require.

[0003] In recent years, with the continuous development of interventional medicine, many emerging procedures need to use large-diameter sheath tubes for interventional treatment, which poses new challenges to the vascular closure device. For large-diameter sheath tube implantation puncture wound, the mainstream solution is two categories; one is to use two or more sets of suture devices to suture the puncture point, which is more complex, and the doctor's learning curve is long, and there is a risk of completely closing the blood vessel; the other is to use a sandwich structure closure device to lock the anchor piece and sponge to close the wound, which is also more cumbersome, not only the shape of the sponge pushed is uncontrollable, and it is easy to shift, but also the manual pushing of the sponge depends heavily on the doctor's technique, and the consistency is poor, and there is a high risk of vascular complications.

[0004] Therefore, it is urgent to provide a vascular closure device which is simple to operate and does not depend on the doctor's suture or pushing technique. SUMMARY

[0005] The purpose of the present application is to provide a vascular closure device and delivery system, which is convenient to operate, and the implant is not easy to shift, can reduce the risk of vascular complications, and has better consistency when closing the blood vessel, to improve the safety and reliability of the operation.

[0006] To achieve the above purpose, the present application provides a vascular closure device, comprising an anchor assembly and a limiting assembly; the anchor assembly comprises a first anchor and a connecting pipe; the first anchor is sleeved outside the connecting pipe; the limiting assembly comprises a limiting foot fixedly connected with the connecting pipe; the first anchor is used to be placed at a first predetermined position outside a target pipeline; the connecting pipe is used to pass through a gap of the target pipeline, so as to place the limiting foot in the target pipeline, and the limiting foot is used to be anchored at the gap; the first anchor is used to close the gap together with the limiting foot.

[0007] Optionally, the anchoring component further comprises a second anchor, at least a portion of the second anchor is disposed inside the connecting pipe; the second anchor is capable of compression and expansion, the expanded second anchor is used to anchor at a second predetermined position outside the target pipeline.

[0008] Optionally, the first anchor is sleeved on the outside of the connecting pipe in a cylindrical structure, or the first anchor is wound on the entire circumference of the connecting pipe in a sheet structure.

[0009] Optionally, the maximum size of the limiting foot is greater than the length of the gap in the axial direction of the target pipeline.

[0010] Optionally, the first anchor is coated with an adhesive, the adhesive is used to adhere the expanded first anchor to the first predetermined position,

[0011] and / or, the second anchor is coated with an adhesive, the adhesive is used to adhere the expanded second anchor to the second predetermined position.

[0012] Optionally, the adhesive is capable of self-degradation, the material of the adhesive is one or more combinations of hydrolyzed collagen, carboxymethyl chitosan, gelatin, polyvinyl alcohol, or polyethylene glycol.

[0013] Optionally, the limiting component and the anchoring component are both made of degradable materials.

[0014] Optionally, the first anchor and / or the second anchor is provided as a sponge, the material of the sponge is one or more combinations of collagen, chitosan, cross-linked gelatin, and derivatives thereof.

[0015] Optionally, the connecting pipe and / or the limiting foot is made of one or more mixtures or copolymers of poly-lactide, poly-glycolide, poly-dioxanone, poly-p-dioxanone, and poly-caprolactone.

[0016] Optionally, the end of the connecting pipe away from the limiting foot has a slit, the slit extends along the axial direction of the connecting pipe, the slit separates at least one end of the connecting pipe in the circumferential direction of the connecting pipe to form multiple parts; the expanded first anchor is used to move the multiple parts of the connecting pipe towards the outside of the connecting pipe, thereby limiting the position of the first anchor.

[0017] Optionally, the end of the first anchor away from the limiting foot protrudes out of the connecting pipe, the part of the first anchor protruding out of the connecting pipe is used to abut against the second predetermined position after expansion.

[0018] Optionally, one end of the connecting pipe connected with the limiting leg is a sheet structure, which extends in the width direction of the limiting leg; the connecting pipe is made of a deformable material and is used to deform correspondingly when the limiting leg rotates.

[0019] Optionally, the limiting assembly further comprises a flow blocking film, which is fixed on the outer wall of the limiting leg on the side facing the connecting pipe, and is used to block the gap of the target pipeline.

[0020] Optionally, the flow blocking film extends out of the limiting leg on both sides in the width direction of the limiting leg; the flow blocking film can be folded along the edge in the length direction of the limiting leg when being bound, and can automatically unfold after being unbound, and the unfolded flow blocking film is used to abut against the inner wall of the target pipeline.

[0021] To achieve the above-mentioned purposes, the application further provides a delivery system, which comprises a delivery pipe and any one of the vascular closure devices, and the delivery pipe is used to deliver the vascular closure device to the gap of the target pipeline.

[0022] Optionally, the delivery system further comprises a control wire, which is connected with the vascular closure device, and is used to drive the vascular closure device to move.

[0023] Optionally, the limiting leg is provided with at least two through holes in the length direction of the limiting leg, 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 all the through holes and then pass back to the proximal end of the vascular closure device.

[0024] The application provides a vascular closure device and a delivery system, the vascular closure device comprising an anchoring assembly and a limiting assembly; the anchoring assembly comprises a first anchor and a connecting pipe; the first anchor is sleeved outside the connecting pipe; the limiting assembly comprises a limiting leg fixedly connected with the connecting pipe; the first anchor is used to be placed at a first predetermined position outside a target pipeline; the connecting pipe is used to pass through a gap of the target pipeline, so as to place the limiting leg in the target pipeline, and the limiting leg is used to be anchored at the gap; the first anchor is used to clamp the gap together with the limiting leg.

[0025] The vascular closure device provided by the application is convenient to operate, and the inflation and anchoring of the first anchor in the puncture cavity can be automatically completed by pulling the delivery tube, which can block the puncture cavity and anchor the limiting foot in the gap of the target pipeline, thereby reducing the risk of vascular complications. In addition, the first anchor and the limiting foot after inflation can clamp the gap of the target pipeline, so that the process of blocking the gap by the vascular closure device is not dependent on the operation method of the doctor, and has better consistency, thereby improving the safety and reliability of the operation. BRIEF DESCRIPTION OF DRAWINGS

[0026] Fig. 1 is a schematic diagram of the axial cross-sectional front view structure of the vascular closure device in an optional embodiment of the application, wherein the first anchor and the second anchor are in a compressed state;

[0027] Fig. 2 is a schematic diagram of the three-dimensional structure of the vascular closure device in an optional embodiment of the application, wherein the first anchor and the second anchor are in a compressed state;

[0028] Fig. 3 is a schematic diagram of the axial cross-sectional side view structure of the vascular closure device and the control wire in an optional embodiment of the application, wherein the first anchor and the second anchor are in a compressed state;

[0029] Fig. 4 is a schematic diagram of the axial cross-sectional front view structure of the vascular closure device in an optional embodiment of the application, wherein the first anchor and the second anchor are in an inflated state;

[0030] Fig. 5 is a schematic diagram of the three-dimensional structure of the vascular closure device in an optional embodiment of the application, wherein the first anchor and the second anchor are in an inflated state;

[0031] Fig. 6a is a schematic diagram of the top view structure of the end portion of the connecting tube in an optional embodiment of the application;

[0032] Fig. 6b is a schematic diagram of the top view structure of the end portion of the connecting tube in another optional embodiment of the application;

[0033] Fig. 6c is a schematic diagram of the top view structure of the end portion of the connecting tube in another optional embodiment of the application;

[0034] Fig. 7a is a schematic diagram of the structure of the cut seam on the connecting tube in an optional embodiment of the application;

[0035] Fig. 7b is a schematic diagram of the structure of the cut seam on the connecting tube in another optional embodiment of the application;

[0036] Fig. 8 is a schematic diagram of the axial cross-sectional front view structure of the vascular closure device in another optional embodiment of the application, wherein the first anchor and the second anchor are in a compressed state;

[0037] Figure 9 is a perspective view of a vascular closure device in another alternative embodiment of the present application, wherein both the first anchor and the second anchor are in a compressed state;

[0038] Figure 10 is an axial cross-sectional view of a vascular closure device in another alternative embodiment of the present application, wherein both the first anchor and the second anchor are in an expanded state;

[0039] Figure 11 is a perspective view of a vascular closure device in another alternative embodiment of the present application, wherein both the first anchor and the second anchor are in an expanded state;

[0040] Figure 12a is a simplified view of a vascular closure device in an implantation scenario in one embodiment of the present application, wherein a guidewire is inserted into a puncture tract;

[0041] Figure 12b is a simplified view of a vascular closure device in an implantation scenario in one alternative embodiment of the present application, wherein a guidewire, a dilator, and a closure sheath are inserted into a puncture tract;

[0042] Figure 12c is a simplified view of a vascular closure device in an implantation scenario in one alternative embodiment of the present application, wherein a closure sheath is inserted into a puncture tract;

[0043] Figure 12d is a simplified view of a vascular closure device in an implantation scenario in one alternative embodiment of the present application, wherein a vascular closure device is inserted into a puncture tract and a target vessel along a closure sheath;

[0044] Figure 12e is a simplified view of a vascular closure device in an implantation scenario in one alternative embodiment of the present application, wherein a retaining foot is anchored at a gap, and a delivery tube restrains the first anchor and the second anchor;

[0045] Figure 12f is a simplified view of a vascular closure device in an implantation scenario in one alternative embodiment of the present application, wherein a retaining foot is anchored at a gap, the first anchor is released and expanded at a first predetermined location, and the second anchor is released and expanded at a second predetermined location;

[0046] Figure 12g is a simplified view of a vascular closure device in an implantation scenario in one alternative embodiment of the present application, wherein a thrombus is formed within an anchor assembly;

[0047] Figure 12h is a simplified view of a vascular closure device in an implantation scenario in one alternative embodiment of the present application, wherein a vascular closure device is degraded in vivo;

[0048] Figure 13a is an enlarged view of Figure 12e;

[0049] Figure 13b is an enlarged view of Figure 12f.

[0050] In the figures:

[0051] Anchoring assembly 1; first anchor 11; connecting tube 12; slit 121; sheet structure 122; second anchor 13; limiting assembly 2; limiting foot 21; flow-blocking membrane 22; delivery tube 3; control wire 4; guide wire 5; closure sheath 6; dilator 7;

[0052] Target vessel 10; gap 20; first predetermined position 30; second predetermined position 40; soft tissue 50. DETAILED DESCRIPTION

[0053] The present application will be further described with reference to the drawings and specific examples. The advantages and features of the present application will be more apparent from the following description. It should be noted that the drawings are in very simplified form and are not drawn to precise scale, and are merely intended to facilitate the understanding of the present application and to illustrate its principles.

[0054] The terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are merely intended to facilitate the description of the present application and simplify the description, and therefore cannot be understood as indicating or implying that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application.

[0055] As used in this specification, "distal" generally refers to the end of a delivery system that is farthest from an operator; the term "proximal" is opposite "distal" and generally refers to the end of a delivery system that is closest to an operator.

[0056] In the present application, unless otherwise explicitly specified and limited, the terms "mounting", "connecting", "fixing" and the like should be understood broadly, for example, can be fixed connection, can also be detachable connection, or integral; can be mechanical connection, can also be electrical connection or communication with each other; can be directly connected, or connected through an intermediate medium, can be the internal communication of two elements or the interaction relationship between two elements, unless otherwise explicitly limited. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0057] The exemplary embodiments of the present application will be described in detail below with reference to the drawings. In the case of no conflict, the embodiments described below and the features in the embodiments can be complementary or combined with each other.

[0058] As shown in FIGS. 1-3, an optional embodiment of the present application provides a vascular closure device for anchoring in a puncture tract to seal a puncture wound in a blood vessel, on one hand to prevent the leakage of fluid in the blood vessel, and on the other hand to promote the growth and healing of the puncture wound on the blood vessel.

[0059] The vascular closure device comprises an anchoring assembly 1 and a limiting assembly 2 connected together. The anchoring assembly 1 comprises a first anchor 11 and a connecting tube 12. The first anchor 11 is sleeved outside the connecting tube 12. The limiting assembly 2 comprises a limiting foot 21 fixedly connected with the connecting tube 12. The first anchor 11 is used to be placed at a first predetermined position 30 outside the target pipeline 10 (see FIG. 13b), and the connecting tube 12 is used to pass through the gap 20 of the target pipeline 10 to place the limiting foot 21 inside the target pipeline 10. The limiting foot 21 is used to be anchored at the gap 20 when the anchoring assembly 1 moves out of the target pipeline 10, thereby defining the anchoring position of the anchoring assembly 1. The first anchor 11 can be compressed and expanded. The expanded first anchor 11 is used to be anchored at the first predetermined position 30 outside the target pipeline 10, thereby defining the implantation position of the connecting tube 12 and the limiting foot 21; the first anchor 11 is also used to jointly close the gap 20 with the limiting foot 21 (i.e., the first anchor 11 is located outside the target pipeline 10, and the limiting foot 21 is located inside the target pipeline 10, the first anchor 11 and the limiting foot 21 jointly hold the gap 20 to make the gap 20 substantially closed), so as to seal the puncture tract and thereby play a hemostatic role.

[0060] It should be understood that the target pipeline 10 generally refers to a blood vessel that needs to be closed by the vascular closure device, the gap 20 generally refers to a puncture wound formed on the blood vessel during surgery, and the first predetermined position 30 refers to the anchoring position of the first anchor 11 in the puncture tract. Specifically, in the present application, the first anchor 11 is anchored in the soft tissue inside the puncture tract, and the limiting foot 21 is located close to the outer wall of the connecting tube 12. It should also be understood that the puncture tract generally refers to a channel formed inside and outside the target pipeline 10 after puncture and passing through the gap 20.

[0061] Continuing to refer to FIGS. 13a and 13b, an optional embodiment of the present application further provides a delivery system comprising the vascular closure device provided by any embodiment of the present application and a delivery tube 3, the delivery tube 3 being used to deliver the vascular closure device to the gap 20 of the target pipeline 10, and the vascular closure device being used to seal and close the gap 20 after being delivered in place.

[0062] The blood vessel closure device provided by the application is convenient to operate, and the inflation and anchoring of the first anchor 11 in the puncture cavity can be automatically completed by pulling the delivery tube 3. On the one hand, the puncture cavity can be plugged, and on the other hand, the limiting foot 21 implanted in the target pipeline 10 is anchored at the notch 20 and is not easy to displace, so as to reduce the risk of blood vessel complications. In addition, the first anchor 11 after inflation and the limiting foot 21 after anchoring can clamp the notch 20 of the target pipeline 10, so that the process of plugging the notch 20 by the blood vessel closure device is not dependent on the operation method of the doctor, has better consistency, and improves the safety and reliability of the operation.

[0063] With reference to FIGS. 1-3, and in combination with FIGS. 13a and 13b, the anchoring assembly 1 can further include a second anchor 13, and at least part of the second anchor 13 is arranged inside the connecting tube 12, that is, the connecting tube 12 is sleeved with at least part of the outer surface of the second anchor 13. The second anchor 13 can be compressed and expanded, and the expanded second anchor 13 is used for anchoring at a second predetermined position 40 (see FIG. 13b) outside the target pipeline 10. At this time, the second predetermined position 40 where the second anchor 13 is anchored refers to the anchoring position of the second anchor 13 in the puncture cavity, and specifically, the second anchor 13 is anchored at the soft tissue in the puncture cavity. In this way, the expanded second anchor 13 is also used for limiting the implantation position of the connecting tube 12 and the limiting foot 21, that is, the first anchor 11 and the second anchor 13 after expansion can jointly limit the position of the connecting tube 12 and the limiting foot 21, and better prevent the displacement of the limiting foot 21.

[0064] It should be noted that the expanded second anchor 13 is anchored at the second predetermined position 40, which can be that the outer wall of the second anchor 13 directly contacts the second predetermined position 40, and at this time, the second anchor 13 is directly anchored at the second predetermined position 40. At the same time, it can also be that the second anchor 13 expands 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 at this time, the second anchor 13 can be indirectly anchored at the second predetermined position 40 through the connecting tube 12.

[0065] In detail, the blood vessel closer is implanted, the delivery tube 3 is sleeved outside the blood vessel closer to bind and compress the first anchor 11 and the second anchor 13. The delivery tube 3 can drive the anchor assembly 1 and the limiting assembly 2 to move and deliver the limiting foot 21 into the target pipeline 10. Then, the delivery tube 3 drives the anchor assembly 1 and the limiting assembly 2 to move away from the target pipeline 10 until the limiting foot 21 abuts against the inner wall of the target pipeline 10, and then the limiting foot 21 is anchored at the gap 20. Then, the delivery tube 3 is withdrawn to move the delivery tube 3 relative to the first anchor 11 and the second anchor 13. With the withdrawal of the delivery tube 3, the first anchor 11 and the second anchor 13 are gradually inflated after being released from the binding of the delivery tube 3. The first anchor 11 is inflated to be anchored at the first predetermined position 30, and the second anchor 13 is inflated to be anchored at the second predetermined position 40. The first anchor 11 and the second anchor 13 are inflated to press the surrounding soft tissue to limit the implantation position of the connecting tube 12 and the limiting foot 21, so as to prevent the connecting tube 12 and the limiting foot 21 from being displaced after long-term implantation. At the same time, the first anchor 13 outside the target pipeline 10 and the limiting foot 21 inside the target pipeline 10 can jointly clamp the gap 20 to prevent blood in the blood vessel from overflowing from the gap 20.

[0066] The shape of the first anchor 11 is not limited in the present application. In an optional embodiment, the first anchor 11 is sleeved outside the connecting tube 12 in a cylindrical structure. In another optional embodiment, the first anchor 11 is wound on the entire circumference of the connecting tube 12 in a sheet structure, that is, the first anchor 11 is connected after being enclosed on the outer wall of the connecting tube 12.

[0067] In actual production, after the first anchor 11 is sleeved or wound on the connecting tube 12, a pressing machine is used to press the first anchor 11. At this time, the first anchor 11 can be inflated in the circumferential direction and / or the axial direction of the connecting tube 12 after contacting blood or tissue fluid, and then anchored at the first predetermined position 30 to prevent the first anchor 11 from being displaced and detached from the connecting tube 12 uncontrollably.

[0068] The connection mode of the connecting tube 12 and the limiting foot 21 is not limited in the present application. For example, the connecting tube 12 can be connected with the limiting foot 21 by fusion, hot pressing, integral molding, adhesion or other suitable modes.

[0069] In an optional embodiment, the maximum size of the limiting foot 21 is greater than the length of the gap 20 in the axial direction of the target pipeline 10. It should be understood that when the limiting foot 21 is a polygon, the maximum size of the limiting foot 21 refers to the maximum side length of the limiting foot 21; when the limiting foot 21 is a circle or an ellipse, the maximum size of the limiting foot 21 refers to the maximum inner diameter of the limiting foot 21.

[0070] In this way, when the limiting leg 21 abuts against the inner wall of the target pipeline 10, it can be clamped at the position of the gap 20, and then abut against the inner wall of the target pipeline 10, so as to avoid the displacement of the limiting leg 21 out of the target pipeline 10, and prevent the blood in the target pipeline 10 from continuously overflowing.

[0071] Referring to FIGS. 12a-13b, and in combination with FIG. 1, the first anchor 11 and the second anchor 13 are generally sponge or other self-expandable materials, and the preparation materials of the first anchor 11 and the second anchor 13 are not limited in the present application.

[0072] When the first anchor 11 and the second anchor 13 are both sponge, the first anchor 11 and / or the second anchor 13 can expand rapidly after absorbing liquid (e.g., absorbing tissue fluid in soft tissue) after being implanted and released from restraint, so as to achieve anchoring. In addition, the sponge can block the puncture cavity after absorbing liquid, so as to prevent the blood in the target pipeline 10 from continuously leaking out.

[0073] In an optional case, the first anchor 11 and / or the second anchor 13 are coated with an adhesive, which is used to adhere the expanded first anchor 11 to the first predetermined position 30, and is used to adhere the second anchor 13 to the second predetermined position 40. In this way, on the one hand, the gap 20 of the target pipeline 10 can be sealed to further prevent the blood in the target pipeline 10 from continuously overflowing in the puncture cavity; on the other hand, the anchoring strength of the first anchor 11 and the second anchor 13 can be improved, so as to further avoid the displacement of the connecting pipe 12 and the limiting leg 21.

[0074] More specifically, the outer wall of the first anchor 11 and the second anchor 13 is provided with an adhesive, which can dissolve after contacting with blood or tissue fluid to form a high-viscosity gel, so as to achieve the adhesion of the first anchor 11 at the first predetermined position 30 and the adhesion of the second anchor 13 at the second predetermined position 40.

[0075] The present application does not limit the combination of sponge and adhesive. In a specific example, the sponge and the adhesive can be integrally freeze-dried to obtain the first anchor 11 or the second anchor 13, and at this time, the adhesive can be arranged on the outer surface of the sponge or the inside of the sponge. In another specific example, the sponge frame can be first freeze-dried, and then the adhesive can be immersed, sprayed or roller coated on the sponge frame to obtain the first anchor 11 or the second anchor 13 after secondary freeze-drying.

[0076] The operator can select any one of the combination methods to prepare the first anchor 11 and the second anchor 13 according to actual clinical needs. After the first anchor 11 is prepared, the second anchor 13 is pressed by a pressing machine so as to be inserted into the connecting pipe 12.

[0077] It should be noted that if the adhesive is placed inside the sponge during preparation, the adhesive can be precipitated to the outer surface of the sponge when the sponge absorbs liquid and swells after contacting blood or tissue fluid, so as to play a role in bonding the sponge to the predetermined position.

[0078] In the prior art, since the vascular closure device cannot be completely degraded, the vascular closure device interferes with and hinders subsequent secondary puncture intervention surgery.

[0079] To solve the above problems, the anchor assembly 1 and the limiting assembly 2 are both made of degradable materials, so that the vascular closure device can be completely degraded after the puncture cavity is self-healed, thereby avoiding interference or obstruction of the vascular closure device to the human body or subsequent surgery.

[0080] To enable the anchor assembly 1 and the limiting assembly 2 to be completely degraded after being implanted in the body, the adhesive can be designed to be self-degradable, and the material of the adhesive can be selected from one or a combination of hydrolyzed collagen, carboxymethyl chitosan, gelatin, polyvinyl alcohol, or polyethylene glycol. Among them, the hydrolyzed collagen, carboxymethyl chitosan or gelatin is a water-soluble derivative, and the polyvinyl alcohol or polyethylene glycol is a degradable synthetic water-soluble material. Both the water-soluble derivative and the degradable synthetic water-soluble material can be dissolved in liquid to form an adhesive gel. In addition, the adhesive can also be prepared from other water-soluble derivatives or degradable synthetic water-soluble materials.

[0081] Further, the first anchor 11 and the second anchor 13 can be selected to be degradable sponges, and the material of the sponge is one or a combination of collagen, chitosan, cross-linked gelatin and derivatives thereof. The second anchor 13 can have various shapes, for example, in some embodiments, the second anchor 13 is provided in the shape of a cylinder, a prism, a cone or a pyramid, and the anchoring effect is good.

[0082] In more detail, the connecting tube 12 is a degradable polymer tube, including but not limited to a natural or synthetic polymer degradable tube, and the connecting tube 12 is made of one or a mixture or copolymer of polypropylene lactone, polyglycolide, polydioxanone, polydioxanone and polylactide. The shape of the connecting tube 12 is not specially required in the present application, for example, the connecting tube 12 is a square tube or a circular tube.

[0083] Optionally, the limiting foot 21 is a hard degradable sheet, and the shape of the limiting foot 21 is approximately arched. The side of the limiting foot 21 facing the connecting tube 12 can be optionally provided in a streamlined shape or the like to reduce the influence on blood flow dynamics, so as to reduce or even avoid blood flow from overflowing from the gap 20. The limiting foot 21 can be made of one or a mixture or copolymer of polypropylene lactone, polyglycolide, polydioxanone, polydioxanone and polylactide.

[0084] The preparation method of the connecting tube 12 and / or the limiting foot 21 is not limited in the present application. The connecting tube 12 and / or the limiting foot 21 can be prepared by extrusion, blow molding, injection molding, 3D printing or electrospinning. The connecting tube 12 and / or the limiting foot 21 can be prepared by electrospinning. The surface of the connecting tube 12 and / or the limiting foot 21 prepared by electrospinning is rough, has good thrombogenicity, and can help the puncture wound to clot and close as soon as possible. In addition, the connecting tube 12 and / or the limiting foot 21 prepared by electrospinning has a loose and porous structure, which can help to speed up the degradation of the connecting tube 12 and / or the limiting foot 21, and also can act as a cell skeleton to promote the growth and healing of the wound.

[0085] To adapt to the clinical needs of most patients, when the first anchor 11 is a cylindrical structure, the length of the first anchor 11 in the axial direction thereof is 2mm-20mm, and the diameter of the first anchor 11 in the cross section thereof is 0.5mm-10mm. When the first anchor 11 is a sheet structure, the length of the first anchor 11 is 2mm-300mm, the width of the first anchor 11 is 2mm-20mm, and the thickness of the first anchor 11 is 10um-2mm.

[0086] In addition, the length of the second anchor 13 in the axial direction thereof is 2mm-20mm, and the diameter or side length of the second anchor 13 in the cross section thereof is 0.5mm-10mm. The length of the connecting tube 12 in the axial direction thereof is 2mm-20mm, and the diameter or side length of the connecting tube 12 in the cross section thereof is 0.5mm-10mm. The length of the limiting foot 21 in the axial direction thereof (i.e., the length direction L in FIG. 2) is 5mm-50mm, the length of the limiting foot 21 in the circumferential direction thereof is 2mm-50mm, and the thickness of the limiting foot 21 in the radial direction thereof is 20um-2mm.

[0087] However, it should be understood that the size of the first anchor 11, the connecting tube 12, the second anchor 13 and the limiting foot 21 can be adjusted adaptively according to the actual needs of the patient, and is not limited to the range disclosed in the above embodiments.

[0088] As shown in FIGS. 6a-7b, the end of the connecting tube 12 away from the limiting foot 21 has a slit 121, which extends substantially along the axial direction of the connecting tube 12. The slit 121 separates at least one end of the connecting tube 12 in the circumferential direction of the connecting tube 12 to form multiple parts. For example, the slit 121 can bisect (see FIG. 6a), quarter (see FIG. 6b) or multiple (see FIG. 6c) the end of the connecting tube 12. The second anchor 13 expands to drive the multiple parts of the connecting tube 12 to move outward, thereby limiting the position of the first anchor 11.

[0089] Specifically, the connecting tube 12 can expand together with the second anchor 13 to increase the width of each slit 121 in the circumferential direction of the connecting tube 12, and the connecting tube 1 can press the inner wall of the first anchor 11 after expansion, so that the first anchor 11 is firmly anchored in the first predetermined position 30.

[0090] It should be understood that the outside of the connecting tube 12 refers to the direction from the inside to the outside of the connecting tube 12, i.e. the direction of the connecting tube 12 close to the puncture cavity (i.e. the direction of the first predetermined position 30 or the second predetermined position 40).

[0091] In order to firmly anchor the first anchor 11 in the first predetermined position 30, the length of the slit 121 in the axial direction of the connecting tube 12 can be selected to be 2mm-8mm.

[0092] The shape of the slit 121 is not limited in the present application, for example, the slit 121 can be set to be sawtooth-shaped (see Figure 7a) or hairpin-shaped (see Figure 7b), and the slit 121 can also be designed to other required shapes. Setting the slit 121 to be sawtooth-shaped or hairpin-shaped can help the end of the connecting tube 12 to deform 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 anchoring assembly 1.

[0093] It should be noted that after the second anchor 13 is inserted into the connecting tube 12, the middle part of the expanded second anchor 13 is arranged inside the connecting tube and presses the inner wall of the connecting tube 12, so that the second anchor 13 can be firmly anchored on the connecting tube 12 without loosening.

[0094] Referring back to Figures 1-4, in a specific embodiment, the end of the second anchor 13 away from the limiting foot 21 extends out of the connecting tube 12, and the part of the second anchor 13 extending out of the connecting tube 12 is used to abut against the second predetermined position 40 after expansion (see Figure 13b). In this way, the second anchor 13 can directly contact the second predetermined position 40, and then the second anchor 13 and the second predetermined position 40 can be bonded by an adhesive to improve the anchoring strength of the second anchor 13.

[0095] It should be noted that when the second anchor 13 extends out of the connecting tube 12, the slit 121 can be selected to be arranged or not arranged at the end of the connecting tube 12. When the slit 121 is not arranged on the connecting tube 12, it only needs to meet the requirement that the second anchor 13 can be directly anchored in the second predetermined position 40 after expansion.

[0096] Continuing to refer to FIGS. 1-3, the end of the connecting tube 12 connected with the limiting foot 21 is a sheet structure 122 (i.e., a sheet), which extends in the width direction W of the limiting foot 21, that is, after the connecting tube 12 is connected with the limiting foot 21, the extension 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 limiting foot 21. The connecting tube 12 is made of a deformable material and is used to deform correspondingly when the limiting foot 21 rotates. Specifically, when the limiting foot 21 rotates around the width direction thereof, that is, the two ends of the limiting foot 21 in the length direction L thereof rotate around the extension direction of the sheet structure 122, the connecting tube 12 can deform adaptively. In this way, the limiting foot 21 can be conveniently inserted into the gap 20 of the target pipeline 10 and adjusted in position within the target pipeline 10.

[0097] It needs to be explained that after the limiting foot 21 is implanted into the target pipeline 10, the length direction L of the limiting foot 21 is the axial direction of the target pipeline 10, and the width direction W of the limiting foot 21 is the radial direction of the target pipeline 10.

[0098] The present application does not limit the preparation method of the end of the connecting tube 12, and the end of the connecting tube 12 can be prepared into a sheet shape by hot pressing, mechanical pressing, melting, solvent softening deformation or other suitable methods to form the sheet structure 122.

[0099] Referring to FIGS. 8-11, the limiting assembly 2 further comprises a flow-blocking film 22, which is fixed on the outer wall of the limiting foot 21 on the side facing the connecting tube 12, and is used to block the gap 20 of the target pipeline 10. Specifically, when the flow-blocking film 22 is provided on the blood vessel closure device, the flow-blocking 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.

[0100] Continuing to refer to FIGS. 8-11, the flow-blocking film 22 extends out of the limiting foot 21 on both sides of the limiting foot 21 in the width direction W. The flow-blocking film 22 has a folded state and an unfolded state, and can be folded along the edge in the length direction L of the limiting foot 21 when being constrained, so as to form the folded state, thereby facilitating the limiting foot 21 and the flow-blocking film 22 to enter the target pipeline 10 at the gap 20. The flow-blocking film 22 can also automatically unfold after being released from the constraint, and the unfolded flow-blocking film 22 is used to abut against the inner wall of the target pipeline 10.

[0101] Specifically, the flow-blocking film 22 can automatically unfold after entering the target pipeline 10 and contacting the body temperature blood, and the size of the unfolded flow-blocking film 22 in the width direction W of the limiting foot 21 is greater than the size of the gap 20 in the width direction W of the limiting foot 21, at which time the flow-blocking film 22 can block the gap 20, so as to reduce or even avoid the blood in the target pipeline 10 from flowing to the soft tissue from the gap 20.

[0102] Optionally, the flow blocking film 22 is a thin film made of a shape memory polymer, and the material of the flow blocking film 22 is a combination of one or more of polyglycolide, polylactide, and copolymers and mixtures thereof.

[0103] The application does not limit the preparation method of the flow blocking film 22. The flow blocking film 22 can be prepared by extrusion, blow molding, injection molding, 3D printing, or electrospinning. Optionally, the flow blocking film 22 is prepared by electrospinning.

[0104] Optionally, the flow blocking film 22 can have various shapes, such as a circular shape or an elliptical shape. To better block the gap 20, the diameter of the flow blocking film 22 can be selected to be 10 mm to 100 mm, and the thickness of the flow blocking film 22 can be selected to be 20 um to 2 mm. The size of the flow blocking film 22 can be adaptively adjusted according to the actual needs of the patient, and is not limited to the range disclosed in the above embodiments.

[0105] Referring back to FIG. 2, the delivery system further includes a control wire 4 connected with the vascular closure device, and the control wire 4 is used to drive the vascular closure device to move. Specifically, the control wire 4 is used to drive the vascular closure device to move out of the target pipeline 10, and the limiting foot 21 can be anchored at the gap 20 of the target pipeline 10 during the movement.

[0106] Further, the control wire 4 can be a polymer wire. The polymer wire can be selected to be degradable or non-degradable in the body according to the needs. Specifically, the polymer wire can be selected between a 7-0 wire and a 1 wire.

[0107] In an optional case, both ends of the control wire 4 are connected with a handle (not shown) of the delivery system, and the control wire 4 can be driven to move by controlling the handle.

[0108] Optionally, the control wire 4 can be connected with the connecting pipe 12 and / or the limiting foot 21. At this time, the control wire 4 can drive the entire vascular closure device to move through the connecting pipe 12 and / or the limiting foot 21.

[0109] In an optional solution, at least two through holes (not numbered) are provided on the limiting foot 21 or the connecting pipe 12, and the control wire 4 is connected with the handle after sequentially passing through all the through holes.

[0110] Referring to FIGS. 2 and 3, the limiting foot 21 can be provided with at least two through holes at intervals in the length direction L thereof. One end of the control wire 4 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.

[0111] More specifically, one end of the control wire 4 is arranged at the proximal end of the connecting tube 12, and the other end is arranged to pass through one of the through holes on one side of the connecting tube 12 and then pass back through the other through hole on the side away from the connecting tube 12 and then pass back to the proximal end of the connecting tube 12. In this way, the limiting foot 21 can be rotated relative to the connecting tube 12 by pulling one end of the control wire 4, and the rotation angle of the limiting foot 21 relative to the connecting tube 12 can be adjusted.

[0112] The present application does not limit the relative position of the control wire 4 and the anchoring assembly 1. In one example, two through holes are arranged on the limiting foot 21, and the control wire 4 is arranged outside the first anchor 11 on both sides of the limiting foot 21 towards the connecting tube 12. At this time, the control wire 4 can be pulled out or retained in the blood vessel closure device. When the control wire 4 is retained in the body, the first anchor 11 expands and moves the control wire 4, thereby clamping the control wire 4 between the first anchor 11 and the soft tissue.

[0113] In another example, two through holes are arranged on the limiting foot 21, and the control wire 4 is arranged between the first anchor 11 and the connecting tube 12 on both sides of the limiting foot 21 towards the connecting tube 12. At this time, the control wire 4 and the first anchor 11 can be clamped together on the connecting tube 12. When the control wire 4 is withdrawn, one of the control wires 4 can be cut and pulled out by pulling the handle.

[0114] Referring to FIGS. 12a-13b, in a non-limiting embodiment, the implantation process of the blood vessel closure device is as follows:

[0115] 1) Referring to FIG. 12a, after the intervention surgery is completed, the guide wire 5 is inserted through the original sheath, and the original sheath is pulled out, leaving the guide wire in the puncture cavity.

[0116] 2) Referring to FIG. 12b, the dilator 7 and the closure sheath 6 are connected, and the dilator 7 and the closure sheath 6 are implanted along the extension direction of the guide wire 5; the surrounding soft tissue 50 is pressed by the dilator 7, so that one end of the closure sheath 6 extends into the target pipeline 10.

[0117] 3) Referring to FIG. 12c, the guide wire 5 and the dilator 7 are withdrawn, and the closure sheath 6 is retained in the target pipeline 10.

[0118] 4) Referring to FIG. 12d, the delivery tube 3 is implanted along the inner cavity of the closure sheath 6, and the blood vessel closure device is moved along with the delivery tube 3 until the limiting foot 21 moves into the target pipeline 10.

[0119] 5) Refer to Fig. 12e and Fig. 13a, the delivery tube 3 and the closure sheath tube 6 are retracted synchronously, the delivery tube 3 drives the vascular closure device out of the target vessel 10 until the closure sheath tube 6 and the delivery tube 3 are retracted as a whole to a significant resistance, at this time the limiting foot 21 is in contact with the inner wall of the target vessel 10 to complete the anchoring of the limiting foot 21 at the position of the notch 20. In this process, the delivery tube 3 is always sleeved outside the first anchor 11 and the second anchor 13.

[0120] It should be noted that in Fig. 13a, the outer wall of the delivery tube 3 should always be in contact with the soft tissue 50 during implantation, in order to clearly show the implantation process of the vascular closure device, the delivery tube 3 and the soft tissue 50 are spaced apart in Fig. 13a.

[0121] 6) Refer to Fig. 12f and Fig. 13b, the control wire 4 is withdrawn, and the delivery tube is retracted to move the delivery tube 3 relative to the vascular closure device, thereby releasing the anchoring assembly 1; the first anchor 11 and the second anchor 13 are sequentially released from the restraint of the delivery tube 3 and self-expand, the first anchor 11 is expanded to press and anchor at the first predetermined position 30, and the second anchor 13 is expanded to press and anchor at the second predetermined position 40; the first anchor 11 is expanded to cooperate with the limiting foot 21 to clamp the notch 20.

[0122] 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 part between the second anchor 13 and the limiting foot 21) should always be in contact with the soft tissue 50 during implantation, in order to clearly show the anchoring process of the first anchor 11 and the second anchor 13, the blank part between the anchoring assembly 1 and the soft tissue 50 is left in Fig. 13b.

[0123] 7) Refer to Fig. 12g, while the control wire 4 is kept tensioned, one end of the control wire 4 is cut off, and then the handle is withdrawn together with the control wire 4, the delivery tube 3 and the closure sheath tube 6 are retracted, and the implant is implanted. The anchoring assembly 1 of the vascular closure device forms a thrombus, thereby sealing the puncture tract.

[0124] 8) Refer to Fig. 12h, the vascular closure device gradually degrades in the body to complete the healing of the puncture tract.

[0125] In summary, the blood vessel closure device provided by the application is convenient to operate, and the inflation and anchoring of the first anchor 11 in the puncture cavity can be automatically completed by pulling the delivery tube 3. On the one hand, the puncture cavity can be plugged, and on the other hand, the limiting foot 21 implanted in the target pipeline 10 is anchored at the notch 20 and is not easy to shift, so as to reduce the risk of blood vessel complications. In addition, the inflated first anchor 11 and the limiting foot 21 after anchoring can clamp the notch 20 of the target pipeline 10, so that the process of plugging the notch 20 by the blood vessel closure device is not dependent on the operation method of the doctor, has better consistency, and can improve the safety and reliability of the operation.

[0126] The above description is only a description of the preferred embodiments of the application, and does not limit the scope of the application in any way. Any modification or change made by a person skilled in the art according to the above disclosure is within the protection scope of the application.

Claims

1. A vascular closure device, characterized in that: It includes an anchoring assembly and a limiting assembly; the anchoring assembly includes a first anchoring member and a connecting tube; the first anchoring member is sleeved on the outside of the connecting tube; the limiting assembly includes a limiting foot fixedly connected to the connecting tube; the first anchoring member is used to be placed at a first predetermined position outside the target pipeline; the connecting tube is used to pass through the gap of the target pipeline to place the limiting foot in the target pipeline, and the limiting foot is used to anchor at the gap; the first anchoring member is used to clamp the gap together with the limiting foot.

2. The vascular closure device according to claim 1, wherein: The anchoring assembly further includes 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 size of the limiting foot is greater than the length of the notch in the axial direction of 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 vascular closure device according to claim 5, wherein: The adhesive can be self-degradable, and the material of the adhesive is a combination of one or more 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, wherein: The first anchoring member and / or the second anchoring member is configured as a sponge, and the material of the sponge is a combination of one or more of collagen, chitosan, cross-linked gelatin and derivatives thereof.

9. The vascular closure device according to claim 7, wherein: The connecting pipe and / or the limiting foot are prepared from one or more mixtures or copolymers 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 connecting tube has a slit at one end away from the limiting foot, and the slit extends along the axial direction of the connecting tube. The slit divides at least one end of the connecting tube into multiple parts in the circumferential direction of the connecting tube; after the second anchor is expanded, it is used to drive the multiple parts of the connecting tube to move toward the outside of the connecting tube, thereby limiting the position of the first anchor.

11. The vascular closure device according to any one of claims 2 to 6, characterized in that: One end of the second anchoring member facing 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 includes a flow-blocking membrane, which is fixed on the outer wall of the limiting foot on a side facing the connecting pipe, and is used to block the gap in the target pipeline.

14. The vascular closure device according to claim 13, wherein: The blocking membrane extends out of the limiting feet on both sides of the limiting feet in the width direction; the blocking membrane can be folded along the edges in the length direction of the limiting feet when being constrained, and can be automatically unfolded after being released. The unfolded blocking membrane is used to stick to the inner wall of the target pipeline.

15. A conveying system, characterized in that: The invention comprises 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, wherein: The device further comprises a control wire connected to the vascular closure device, and configured to drive the vascular closure device to move.

17. The delivery system according to claim 16, wherein: The limiting leg is provided with at least two through holes spaced apart along 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 and then pass back to the proximal end of the vascular closure device.

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