Vascular closure devices and delivery systems

Abstract

The utility model provides a vascular closure device and a delivery system; the delivery system includes a vascular closure device and a delivery tube, and the delivery tube is used to deliver the vascular closure device to a predetermined position. The vascular closure device includes an anchoring assembly and a limiting assembly; the anchoring assembly includes a first anchor and a connecting tube; the first anchor is sleeved on the outside of the connecting tube, and the limiting assembly includes a limiting foot fixedly connected to the connecting tube; the first anchor 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 anchor is used to clamp the gap together with the limiting foot. The vascular closure device is easy to operate, and the implant is not easy to shift, which can reduce the risk of vascular complications, and has better consistency when closing the blood vessel, so as to improve the safety and reliability of the operation.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, in particular to a blood vessel closure device and a delivery system. Background Art

[0002] In interventional surgery, how to deal with interventional puncture wounds is an issue worthy of attention. The current common practice is to press to stop bleeding and apply braking for a long time to close the puncture wound. However, this practice usually brings physical and life discomfort and inconvenience to patients, and may not be effective for patients who have undergone anticoagulation during surgery. Therefore, vascular closure devices specifically used to close vascular puncture wounds have emerged.

[0003] In recent years, with the continuous development of interventional medicine, many emerging procedures require the use of large-caliber sheaths for intervention, which poses new challenges to vascular closure devices. For large-caliber sheath implantation puncture wounds, there are two mainstream solutions: one is to use two or more sets of suturing devices to suture the puncture point. This method is more complicated, the doctor has a long learning curve, and there is a risk of complete closure of the blood vessel; the other is a sandwich structure closure device that clamps the wound with a knot pusher to lock the anchor plate and sponge. This method is also more cumbersome. Not only is the shape of the sponge being pushed uncontrollable and prone to displacement, but the manual push of the sponge is heavily dependent on the doctor's technique, with poor consistency and a greater risk of vascular complications.

[0004] Therefore, there is an urgent need to provide a vascular closure device that is simple to operate and does not rely on the doctor's suturing or pushing techniques. Utility Model Content

[0005] The utility model aims to provide a vascular closure device and a delivery system. The vascular closure device is easy to operate, and the implant is not easily displaced, which can reduce the risk of vascular complications and has better consistency when closing the blood vessel, so as to improve the safety and reliability of the operation.

[0006] To achieve the above-mentioned purpose, the utility model provides a blood vessel closure device, including 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 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.

[0007] Optionally, 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.

[0008] Optionally, 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 structure.

[0009] Optionally, the maximum dimension of the limiting foot is greater than the axial length of the notch in the target pipeline.

[0010] Optionally, 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.

[0011] 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.

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

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

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

[0015] Optionally, the connecting tube and / or the limiting foot are made of one of polylactide, polyglycolide, polydioxanone, polydioxanone and polycaprolactone.

[0016] Optionally, 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 separates at least one end of the connecting tube into a plurality of parts in the circumferential direction of the connecting tube; after the first 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.

[0017] Optionally, one end of the first anchoring member facing away from the limiting foot extends out of the connecting tube, and the portion of the first anchoring member extending out of the connecting tube is used to abut against the second predetermined position after expansion.

[0018] Optionally, 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.

[0019] Optionally, 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 of the target pipeline.

[0020] Optionally, the blocking membrane extends out of the limiting feet on both sides of the limiting feet along 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 automatically unfold after being released, and the unfolded blocking membrane is used to adhere to the inner wall of the target pipeline.

[0021] To achieve the above-mentioned object, the utility model further provides a delivery system, comprising a delivery tube and any one of the vascular closure devices, wherein the delivery tube 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, 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.

[0023] Optionally, 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 all the through holes and then pass back to the proximal end of the vascular closure device.

[0024] The utility model provides a vascular closure device and a delivery system, wherein the vascular closure device 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 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 notch; the first anchoring member is used to clamp the notch together with the limiting foot.

[0025] The vascular closure device provided by the utility model is easy to operate. It can automatically complete the expansion and anchoring of the first anchoring member in the puncture cavity by only pulling the delivery tube. On the one hand, it can block the puncture cavity, and on the other hand, the limiting foot implanted in the target pipeline is anchored at the gap and is not easy to shift, so as to reduce the risk of vascular complications. In addition, the expanded first anchoring member and the limiting foot can clamp the gap of the target pipeline after anchoring, so that the process of blocking the gap by the vascular closure device does not rely on the doctor's operation technique, and has better consistency, so as to improve the safety and reliability of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 It is a schematic diagram of the axial cross-section front view of the vascular closure device in a preferred embodiment of the utility model, wherein the first anchoring member and the second anchoring member are both in a compressed state;

[0027] Figure 2 This is a schematic diagram of the three-dimensional structure of a blood vessel closure device in a preferred embodiment of the utility model, wherein the first anchoring member and the second anchoring member are both in a compressed state;

[0028] Figure 3 It is a schematic diagram of the axial cross-section side view of the vascular closure device and the control wire in a preferred embodiment of the utility model, wherein the first anchoring member and the second anchoring member are both in a compressed state;

[0029] Figure 4 It is a schematic diagram of the axial cross-section front view of the vascular closure device in a preferred embodiment of the utility model, wherein the first anchoring member and the second anchoring member are both in an expanded state;

[0030] Figure 5 This is a schematic diagram of the three-dimensional structure of a blood vessel closure device in a preferred embodiment of the utility model, wherein the first anchoring member and the second anchoring member are both in an expanded state;

[0031] Figure 6a This is a schematic diagram of the top view of the end of the connecting pipe in a preferred embodiment of the utility model;

[0032] Figure 6b This is a schematic diagram of the top view of the end of the connecting pipe in another preferred embodiment of the utility model;

[0033] Figure 6c This is a schematic diagram of the top view of the end of the connecting pipe in another preferred embodiment of the utility model;

[0034] Figure 7a This is a structural schematic diagram of the slit on the connecting pipe in a preferred embodiment of the utility model;

[0035] Figure 7b This is a schematic diagram of the structure of the slit on the connecting pipe in another preferred embodiment of the utility model;

[0036] Figure 8 It is a schematic diagram of an axial cross-section front view of a vascular closure device in another preferred embodiment of the utility model, wherein the first anchoring member and the second anchoring member are both in a compressed state;

[0037] Fig. 9 This is a schematic diagram of the three-dimensional structure of a blood vessel closure device in another preferred embodiment of the utility model, wherein the first anchoring member and the second anchoring member are both in a compressed state;

[0038] Fig.10 It is a schematic diagram of an axial cross-section front view of a vascular closure device in another preferred embodiment of the utility model, wherein the first anchoring member and the second anchoring member are both in an expanded state;

[0039] Fig.11 This is a schematic diagram of the three-dimensional structure of a blood vessel closure device in another preferred embodiment of the utility model, wherein the first anchoring member and the second anchoring member are both in an expanded state;

[0040] Fig.12a This is a simplified schematic diagram of an implantation scene of a vascular closure device in a preferred embodiment of the utility model, wherein a guide wire is inserted into the puncture cavity;

[0041] Figure 12b This is a simplified schematic diagram of the implantation scene of the vascular closure device in a preferred embodiment of the utility model, wherein the guide wire, the dilator and the closure device sheath are all inserted into the puncture cavity;

[0042] Fig.12c This is a simplified schematic diagram of the implantation scene of the vascular closure device in a preferred embodiment of the utility model, wherein the closure device sheath is inserted into the puncture cavity;

[0043] Fig.12d This is a simplified schematic diagram of an implantation scenario of a vascular closure device in a preferred embodiment of the utility model, wherein the vascular closure device is inserted into the puncture cavity and the target pipeline along the closure device sheath;

[0044] Fig.12e It is a simplified schematic diagram of an implantation scene of a vascular closure device in a preferred embodiment of the utility model, wherein the limiting foot is anchored at the notch, and the delivery tube constrains the first anchor and the second anchor;

[0045] Fig.12f It is a simplified schematic diagram of the implantation scene of the vascular closure device in a preferred embodiment of the utility model, wherein the limiting foot is anchored at the notch, the first anchor is untied and expanded at the first predetermined position, and the second anchor is untied and expanded at the second predetermined position;

[0046] Figure 12g It is a simplified schematic diagram of an implantation scenario of a vascular closure device in a preferred embodiment of the utility model, wherein a thrombus is formed in the anchoring component;

[0047] Figure 12h This is a simplified schematic diagram of an implantation scenario of a vascular closure device in a preferred embodiment of the utility model, wherein the vascular closure device degrades in the body;

[0048] Fig.13a for Fig.12e A magnified image of

[0049] Fig.13b for Fig.12f Magnified image of .

[0050] In the figure:

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

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

[0053] The utility model is further described in detail below in conjunction with the accompanying drawings and specific embodiments. According to the following description, the advantages and features of the utility model will become clearer. It should be noted that the drawings are all in a very simplified form and are not in precise proportions, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the utility model.

[0054] The orientation or position relationship indicated by the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. are based on the orientation or position relationship shown in the drawings, and are only for the convenience of describing the utility model and simplifying the description, and do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the utility model.

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

[0056] In the present invention, unless otherwise clearly defined and specified, the terms "installation", "connection", "fixation" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection, an electrical connection, or communication with each other; it can be a direct connection, or a connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0057] The exemplary embodiments of the present application are described in detail below in conjunction with the accompanying drawings. In the absence of conflict, the following embodiments and features in the embodiments may complement or be combined with each other.

[0058] like Figure 1 to Figure 3 As shown, a preferred embodiment of the utility model provides a blood vessel closure device, which is used to be anchored in the puncture cavity to seal the puncture wound in the blood vessel, on the one hand to prevent the fluid in the blood vessel from overflowing, and on the other hand to promote the growth and healing of the puncture wound on the blood vessel.

[0059] The vascular closure device includes an anchoring assembly 1 and a stop assembly 2 connected to each other. The anchoring assembly 1 includes a first anchor 11 and a connecting tube 12. The first anchor 11 is sleeved on the outside of the connecting tube 12. The stop assembly 2 includes a stop foot 21 fixedly connected to the connecting tube 12. The first anchor 11 is used to be placed at a first predetermined position 30 (refer to Fig.13b ), the connecting tube 12 is used to pass through the notch 20 of the target pipeline 10 to place the limiting foot 21 in the target pipeline 10. The limiting foot 21 is used to anchor at the notch 20 when the anchor assembly 1 is moved out of the target pipeline 10, thereby defining the anchoring position of the anchor assembly 1. The first anchor 11 is capable of compression and expansion, and the expanded first anchor 11 is used to anchor at a 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 clamp the notch 20 together with the limiting foot 21 (that is, the first anchor 11 is located outside the target pipeline 10, the limiting foot 21 is located inside the target pipeline 10, and the first anchor 11 and the limiting foot 21 clamp the notch 20 together to make the notch 20 basically closed) to block the puncture cavity, thereby achieving a hemostatic effect.

[0060] It should be understood that the target conduit 10 generally refers to the blood vessel to be closed by the vascular closure device, the gap 20 generally refers to the 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 cavity. Specifically, in the present application, the first anchor 11 is anchored at the soft tissue in the puncture cavity and the position where the limit foot 21 is close to the outer wall of the connecting tube 12. It should also be understood that the puncture cavity generally refers to the channel formed inside and outside the patient's target conduit 10 after puncture and passing through the gap 20.

[0061] Continue to refer to Fig.13a and Fig.13b A preferred embodiment of the present invention further provides a delivery system, which includes the vascular closure device and the delivery tube 3 provided in any embodiment of the present invention. The delivery tube 3 is used to deliver the vascular closure device to the gap 20 of the target pipeline 10. After the vascular closure device is delivered to the target pipeline 10, it is used to block and close the gap 20.

[0062] The vascular closure device provided by the utility model is easy to operate. It can automatically complete the expansion and anchoring of the first anchor 11 in the puncture cavity by only pulling the delivery tube 3. On the one hand, it can block the puncture cavity, and on the other hand, the limiting foot 21 implanted in the target pipeline 10 is anchored at the gap 20 and is not easy to shift, so as to reduce the risk of vascular complications. In addition, after the expansion of the first anchor 11 and the limiting foot 21 are anchored, the gap 20 of the target pipeline 10 can be clamped, so that the process of the vascular closure device blocking the gap 20 does not rely on the doctor's operation technique, and has better consistency, so as to improve the safety and reliability of the operation.

[0063] Continue to refer to Figure 1 to Figure 3 As shown, combined with Fig.13a and Fig.13b The anchor assembly 1 preferably further includes a second anchor 13, at least part of which is disposed 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 to anchor at a second predetermined position 40 (refer to Fig.13b ), the second predetermined position 40 where the second anchor 13 is anchored refers to the anchor position of the second anchor 13 in the puncture cavity. 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 to limit the implantation position of the connecting tube 12 and the limiting foot 21, that is, the first anchor 11 and the second anchor 13 can jointly limit the position of the connecting tube 12 and the limiting foot 21 after expansion, so as to better prevent the limiting foot 21 from shifting.

[0064] It should be noted that the expanded second anchor 13 is anchored at the second predetermined position 40, and the outer wall of the second anchor 13 may be directly in contact with the second predetermined position 40, in which case the second anchor 13 is directly anchored at the second predetermined position 40. At the same time, the second anchor 13 may also expand to drive the connecting tube 12 to expand, so that the outer wall of the connecting tube 12 is in contact with the second predetermined position 40, in which case the second anchor 13 may be indirectly anchored at the second predetermined position 40 through the connecting tube 12.

[0065] In more detail, when the vascular closure device is actually implanted, the delivery tube 3 is sleeved on the outside of the vascular closure device 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 stop assembly 2 to move, and deliver the stop foot 21 into the target pipeline 10. Then, the delivery tube 3 drives the anchor assembly 1 and the stop assembly 2 to move in the direction of moving out of the target pipeline 10, until the stop foot 21 is attached to the inner wall of the target pipeline 10, and then the stop foot 21 is anchored at the notch 20. Then, withdraw the delivery tube 3 so that the delivery tube 3 moves relative to the first anchor 11 and the second anchor 13. As the delivery tube 3 is withdrawn, the first anchor 11 and the second anchor 13 successively release the restraint of the delivery tube 3 and gradually expand. After the expansion, the first anchor 11 can be anchored at the first predetermined position 30, and the second anchor 13 can be anchored at the second predetermined position 40. After anchoring, the first anchor 11 and the second anchor 13 squeeze the surrounding soft tissue to limit the implantation position of the connecting tube 12 and the limiting foot 21 to prevent the connecting tube 12 and the limiting foot 21 from shifting 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 the blood in the blood vessel from overflowing from the gap 20.

[0066] The present application does not limit the shape of the first anchor 11. In one optional solution, the first anchor 11 is sleeved on the outside of the connecting tube 12 in a cylindrical structure. In another optional solution, the first anchor 11 is wrapped around the entire circumference of the connecting tube 12 in a sheet-like structure, that is, the first anchor 11 surrounds the outer wall of the connecting tube 12 for one circle before being connected.

[0067] During actual preparation, after the first anchor 11 is sleeved or wrapped around the connecting tube 12, a crimping machine is used to crimp the first anchor 11. At this time, the first anchor 11 can expand circumferentially and / or axially in 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 uncontrollably shifting and loosening on the connecting tube 12.

[0068] The present application does not limit the connection method between the connecting tube 12 and the limiting foot 21. For example, the connecting tube 12 can be connected to the limiting foot 21 by welding, hot pressing, integral molding, bonding or other suitable methods.

[0069] In a preferred embodiment, the maximum size of the limiting foot 21 is greater than the length of the notch 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] Such a configuration enables the limiting foot 21 to be stuck in the notch 20 position when it is against the inner wall of the target pipeline 10, thereby making the limiting foot 21 against the inner wall of the target pipeline 10, thereby preventing the limiting foot 21 from moving out of the target pipeline 10 and preventing a large amount of blood in the target pipeline 10 from overflowing.

[0071] Reference Figure 12a to Figure 13b , and combined with Figure 1 The first anchor 11 and the second anchor 13 are usually self-expanding materials such as sponges. The present application does not limit the preparation materials of the first anchor 11 and the second anchor 13.

[0072] When the first anchor 11 and the second anchor 13 are both configured as sponges, the first anchor 11 and / or the second anchor 13 can be made to rapidly absorb liquid (e.g., absorb tissue fluid in soft tissue) and then expand after being implanted and released, thereby achieving anchoring. In addition, the sponge can block the puncture cavity after absorbing liquid, preventing blood in the target pipeline 10 from continuously leaking out.

[0073] In a preferred case, an adhesive is coated on the first anchor 11 and / or the second anchor 13, and the adhesive is used to bond the expanded first anchor 11 to the first predetermined position 30, and to bond the second anchor 13 to the second predetermined position 40. This can, on the one hand, seal the gap 20 of the target pipeline 10 to further prevent the blood in the target pipeline 10 from continuously overflowing in the puncture cavity; on the other hand, it can improve the anchoring strength of the first anchor 11 and the second anchor 13, and further avoid displacement of the connecting tube 12 and the limit foot 21.

[0074] In more detail, the outer walls of the first anchor 11 and the second anchor 13 are both provided with an adhesive, which can dissolve after contacting blood or tissue fluid to form a high-viscosity gel, thereby achieving the bonding of the first anchor 11 at the first predetermined position 30 and the bonding of the second anchor 13 at the second predetermined position 40.

[0075] The present application does not limit the combination of the sponge and the adhesive. In a specific example, the sponge and the adhesive can be freeze-dried as a whole to obtain the first anchor 11 or the second anchor 13, and the adhesive can be set on the outer surface of the sponge or inside the sponge. In another specific example, the sponge frame can be freeze-dried first, and then the adhesive is dipped, sprayed or rolled on the sponge frame and then freeze-dried again to obtain the first anchor 11 or the second anchor 13.

[0076] The operator can select any combination to prepare the first anchor 11 and the second anchor 13 according to actual clinical needs. After the first anchor 11 is prepared, a crimping machine is used to crimp the second anchor 13 so that it can be inserted into the connecting tube 12.

[0077] It should be noted that if the adhesive is placed inside the sponge during preparation, when the sponge contacts blood or tissue fluid and absorbs the liquid and expands, the adhesive can precipitate to the outer surface of the sponge to bond the sponge to the predetermined position.

[0078] In the prior art, since vascular closure devices are not completely degradable, they interfere with and hinder subsequent secondary puncture interventional surgery.

[0079] To solve the above problems, the anchoring component 1 and the limiting component 2 provided by the present invention are both made of degradable materials, so that the vascular closure device can be completely degraded after the puncture cavity heals itself, thereby avoiding the vascular closure device from interfering with or hindering the human body or subsequent surgery.

[0080] In order to make the anchoring component 1 and the limiting component 2 completely degraded after implantation in the body, the adhesive can be designed to be self-degradable, and the material of the adhesive is preferably one of hydrolyzed collagen, carboxymethyl chitosan, gelatin, polyvinyl alcohol or polyethylene glycol, wherein hydrolyzed collagen, carboxymethyl chitosan or gelatin are water-soluble derivatives, polyvinyl alcohol or polyethylene glycol are degradable synthetic water-soluble materials, and water-soluble derivatives and degradable synthetic water-soluble materials can be dissolved in liquid to form an adhesive gel. In addition, the adhesive can also be prepared using other water-soluble derivatives or degradable synthetic water-soluble materials.

[0081] Furthermore, the first anchor 11 and the second anchor 13 are preferably both configured as degradable sponges, and the material of the sponge is one of collagen, chitosan, cross-linked gelatin and derivatives thereof. The second anchor 13 can have a variety of shapes. For example, in some embodiments, the second anchor 13 is configured as 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 of polylactide, polyglycolide, polydioxanone, polydioxanone and polycaprolactone. The present application does not make any special requirements on the shape of the connecting tube 12. For example, the connecting tube 12 can be a square tube or a round tube.

[0083] Optionally, the limiting foot 21 is a hard degradable sheet, and the shape of the limiting foot 21 is approximately an arch, and the limiting foot 21 is preferably set to a streamlined shape or the like to reduce the influence of hemodynamics on the side facing the connecting tube 12, so as to reduce or even avoid blood flow overflowing from the notch 20. The limiting foot 21 can be prepared from one of polylactide, polyglycolide, polydioxanone, polydioxanone and polycaprolactone.

[0084] The present application does not limit the preparation method of the connecting tube 12 and / or the limiting foot 21. 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 are preferably prepared by electrospinning, because the surface of the connecting tube 12 and / or the limiting foot 21 prepared by electrospinning is relatively rough, has good thrombogenicity, and can help the puncture wound to coagulate and seal 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 helps to accelerate the degradation rate of the connecting tube 12 and / or the limiting foot 21, and can also act as a cytoskeleton to promote the growth and healing of the wound.

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

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

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

[0088] Reference Figure 6a to Figure 7b As shown, the end of the connecting tube 12 away from the limiting foot 21 has a slit 121, and the slit 121 extends substantially along the axial direction of the connecting tube 12. The slit 121 divides at least one end of the connecting tube 12 into a plurality of parts in the circumferential direction of the connecting tube 12. For example, the slit 121 can divide the end of the connecting tube 12 into two equal parts (see Figure 6a ), quartered (see Figure 6b ) or multiple equal parts (see Figure 6c After the second anchor 13 expands, it is used to drive 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 circumferential width of each slit 121 in the connecting tube 12 . After expansion, the connecting tube 13 can squeeze the inner wall of the first anchor 11 , so that the first anchor 11 is firmly anchored at the first predetermined position 30 .

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

[0091] In order to ensure that the first anchoring member 11 is firmly anchored at the first predetermined position 30, the length of the slit 121 in the axial direction of the connecting tube 12 is preferably 2 mm to 8 mm.

[0092] The present application does not limit the shape of the slit 121. For example, the slit 121 may be set to be sawtooth-shaped (see Figure 7a ) or hairpin-shaped (refer to Figure 7b ), and the slit 121 can also be designed into other shapes as needed. Setting the slit 121 in a sawtooth or hairpin shape helps the end of the connecting tube 12 and the second anchor 13 to deform when they expand together, thereby increasing the friction between the connecting tube 12 and the surrounding soft tissues and improving the anchoring strength of the anchor 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 in the connecting tube and squeezes 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] Return to reference Figure 1 to Figure 4In one embodiment, the end of the second anchor 13 away from the limiting foot 21 extends out of the connecting tube 12, and the portion 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 Fig.13b ). With such a configuration, the second anchor 13 can be directly in contact with the second predetermined position 40, and then the second anchor 13 and the second predetermined position 40 are 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 end of the connecting tube 12 may or may not be provided with a slit 121. When the connecting tube 12 is not provided with a slit, it is only necessary that the second anchor 13 can be directly anchored at the second predetermined position 40 after expansion.

[0096] Continue to refer to Figure 1 to Figure 3 As shown, one end of the connecting tube 12 connected to the limiting foot 21 is a thin sheet structure 122 (i.e., a thin sheet), and the thin sheet structure 122 extends in the width direction W of the limiting foot 21, that is, after the connecting tube 12 is connected to the limiting foot 21, the extension direction of the thin sheet structure 122 (i.e., the length direction of the thin 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 accordingly when the limiting foot 21 rotates. Specifically, when the limiting foot 21 rotates around its own width direction, that is, when the two ends of the limiting foot 21 in its own length direction L rotate around the extension direction of the thin sheet structure 122, the connecting tube 12 can be adaptively deformed. In this way, it is convenient for the limiting foot 21 to penetrate into the notch 20 of the target pipeline 10 and adjust its position in the target pipeline 10.

[0097] It should be explained that after the limiting foot 21 is implanted in 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. The end of the connecting tube 12 can be prepared into a thin sheet by hot pressing, mechanical pressing, melting, solvent softening deformation or other suitable methods to form a thin sheet structure 122.

[0099] Reference Figure 8 to Figure 11 As shown, the limiting assembly 2 further includes a flow-blocking membrane 22, which is fixed on the outer wall of the limiting foot 21 facing the connecting tube 12, and is used to block the gap 20 of the target pipeline 10. Specifically, when the flow-blocking membrane 22 is provided on the vascular closure device, the flow-blocking membrane 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] Continue to refer to Figure 8 to Figure 11 , the blocking film 22 extends out of the limiting feet 21 on both sides of the limiting feet 21 in the width direction W. The blocking film 22 has a folded state and an unfolded state. The blocking film 22 can be folded along the edge of the limiting feet 21 in the length direction L when being restrained to form a folded state, thereby facilitating the limiting feet 21 and the blocking film 22 to enter the target pipeline 10 at the notch 20. The blocking film 22 can also be automatically unfolded after being released from the restraint, and the unfolded blocking film 22 is used to abut against the inner wall of the target pipeline 10.

[0101] Specifically, the baffle film 22 can automatically unfold after entering the target pipeline 10 and contacting body temperature blood. The dimension of the unfolded baffle film 22 in the width direction W of the limiting foot 21 is larger than the dimension of the notch 20 in the width direction W of the limiting foot 21. At this time, the baffle film 22 can block the notch 20 to reduce or even prevent the blood in the target pipeline 10 from flowing from the notch 20 to the soft tissue.

[0102] Preferably, the flow-blocking film 22 is a film made of shape memory polymer, and the material of the flow-blocking film 22 is one of polyglycolide, polylactide, and copolymers and mixtures thereof.

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

[0104] Optionally, the flow-blocking film 22 may have a variety of shapes, such as a circular or elliptical shape. To better block the gap 20, the diameter of the flow-blocking film 22 is preferably 10 mm to 100 mm, and the thickness of the flow-blocking film 22 is preferably 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 scope disclosed in the above preferred embodiment.

[0105] Return to reference Figure 2 The delivery system further includes a control wire 4, which is connected to the vascular closure device and 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 notch 20 of the target pipeline 10 during the movement.

[0106] Furthermore, the control wire 4 is preferably a polymer wire, and a polymer wire that can be degraded in vivo or not can be selected according to needs, and specifically, it can be selected between 7-0 wire and 1 wire.

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

[0108] Optionally, the control wire 4 may be connected to the connecting tube 12 and / or the limiting pin 21 , and in this case, the control wire 4 may drive the entire vascular closure device to move through the connecting tube 12 and / or the limiting pin 21 .

[0109] In a preferred embodiment, at least two through holes (not numbered) are provided on the limiting foot 21 or the connecting tube 12, and the control wire 4 passes through all the through holes in sequence and is connected to the handle.

[0110] Reference Figure 2 and Figure 3 As shown, the limiting foot 21 is preferably provided with at least two through holes spaced apart in its length direction L, 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 and then pass back to the proximal end of the vascular closure device.

[0111] In more detail, one end of the control wire 4 is placed at the proximal end of the connecting tube 12, and the other end is used to pass through one of the through holes on one side of the connecting tube 12, and to pass through another 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 arrangement, the limit foot 21 can be rotated relative to the connecting tube 12 by pulling one end of the control wire 4, thereby adjusting the rotation angle of the limit foot 21 relative to the connecting tube 12.

[0112] The present application does not limit the relative positions of the control wire 4 and the anchor assembly 1. In one example, two through holes are provided on the limit foot 21, and the two parts of the control wire 4 at the limit foot 21 facing the connecting tube 12 are both provided outside the first anchor 11, at which time the control wire 4 can be withdrawn or retained in the vascular closure device. When the control wire 4 is retained in the body, the first anchor 11 expands and drives the control wire 4 to move, thereby pressing the control wire 4 between the first anchor 11 and the soft tissue.

[0113] In another example, two through holes are provided on the limit foot 21, and the two parts of the control wire 4 at the limit foot 21 facing the connecting tube 12 are both inserted between the first anchor 11 and the connecting tube 12, and at this time, the control wire 4 and the first anchor 11 can be pressed and gripped on the connecting tube 12. When withdrawing the control wire 4, one of the control wires 4 can be cut off, and the control wire 4 can be pulled out by pulling the handle.

[0114] Reference Figure 12a to Figure 13b As shown, in a non-limiting embodiment, the implantation process of the vascular closure device is:

[0115] 1)Reference Fig.12a After completing the interventional surgery, the guide wire 5 is passed through the original sheath, the original sheath is pulled out, and the guide wire is left in the puncture cavity.

[0116] 2)Reference Figure 12b, connect the dilator 7 and the closure sheath 6, and implant the dilator 7 and the closure sheath 6 along the extension direction of the guide wire 5; squeeze the surrounding soft tissue 50 through the dilator 7 so that one end of the closure sheath 6 extends into the target pipeline 10.

[0117] 3)Reference Fig.12c , withdraw the guide wire 5 and the dilator 7, leaving the occluder sheath 6 retained in the target conduit 10.

[0118] 4)Reference Fig.12d The delivery tube 3 is implanted along the inner cavity of the closure sheath 6 , and the delivery tube 3 drives the vascular closure device therein to move until the limiting foot 21 moves into the target pipeline 10 .

[0119] 5)Reference Fig.12e and Fig.13a , the delivery tube 3 and the occluder sheath 6 are synchronously withdrawn, and the delivery tube 3 drives the vascular occluder to move out of the target pipeline 10, until the occluder sheath 6 and the delivery tube 3 are withdrawn as a whole to an obvious resistance, at which time the limit pin 21 is attached to the inner wall of the target pipeline 10 to complete the anchoring of the limit pin 21 at the position of the notch 20. In this process, the delivery tube 3 is always sleeved on the outside of the first anchor 11 and the second anchor 13.

[0120] It should be noted that in Fig.13a In the embodiment, the outer wall of the delivery tube 3 should always be close to the soft tissue 50 during implantation. To clearly explain the implantation process of the vascular closure device, Fig.13a The delivery tube 3 and the soft tissue 50 are spaced a certain distance apart.

[0121] 6)Reference Fig.12f and Fig.13b , withdraw the control wire 4, withdraw the delivery tube, so that the delivery tube 3 moves relative to the vascular closure device, and then release the anchor assembly 1; the first anchor 11 and the second anchor 13 successively release the restraint of the delivery tube 3 and expand themselves, the first anchor 11 is squeezed and anchored at the first predetermined position 30 after expansion, and the second anchor 13 is squeezed and anchored at the second predetermined position 40 after expansion; the first anchor 11 cooperates with the limiting foot 21 after expansion to clamp the gap 20.

[0122] It should be noted that in Fig.13b In the embodiment, the outer walls of the first anchor 11, the connecting tube 12 and the second anchor 13 (i.e., the blank portion between the second anchor 13 and the limiting foot 21) should always be close to the soft tissue 50 during implantation. To clearly explain the anchoring process of the first anchor 11 and the second anchor 13, Fig.13b A blank portion is left between the anchor component 1 and the soft tissue 50.

[0123] 7)Reference Figure 12gWhile keeping the control wire 4 taut, cut one end of the control wire 4, then withdraw the handle together with the control wire 4, withdraw the delivery tube 3 and the closure sheath 6, and the implant is completed. Thrombus is formed in the anchoring component 1 of the vascular closure device, thereby blocking the puncture cavity.

[0124] 8)Reference Figure 12h The vascular closure device gradually degrades in the body to complete the healing of the puncture cavity.

[0125] In summary, the vascular closure device provided by the utility model is easy to operate. It can automatically complete the expansion and anchoring of the first anchor 11 in the puncture cavity by only pulling the delivery tube 3. On the one hand, it can block the puncture cavity, and on the other hand, the limiting foot 21 implanted in the target pipeline 10 is anchored at the gap 20 and is not easy to shift, so as to reduce the risk of vascular complications. In addition, after the expansion of the first anchor 11 and the limiting foot 21 are anchored, the gap 20 of the target pipeline 10 can be clamped, so that the process of the vascular closure device blocking the gap 20 does not rely on the doctor's operation technique, and has better consistency, so as to improve the safety and reliability of the operation.

[0126] The above description is only a description of the preferred embodiment of the utility model, and is not any limitation to the scope of the utility model. Any changes and modifications made by ordinary technicians in the field of the utility model based on the above disclosure shall fall within the protection scope of the utility model.

Claims

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, characterized in that: 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 structure.

4. The vascular closure device according to claim 2, characterized in that: The maximum size 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, characterized in that: The first anchor is coated with an adhesive, and the adhesive is used to bond the expanded first anchor 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, characterized in that: The adhesive can be 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 anchor and / or the second anchor is configured as a sponge, and the material of the sponge is one of collagen, chitosan, cross-linked gelatin and derivatives thereof.

9. The vascular closure device according to claim 7, characterized in that: The connecting pipe and / or the limiting foot 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 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 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 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 foot 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, which is fixed on the outer wall of the limiting foot on a side facing the connecting pipe, and is used for blocking the gap of the target pipeline.

14. The vascular closure device according to claim 13, characterized in that: The blocking membrane extends out of the limiting feet on both sides of the limiting feet along 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, and the unfolded blocking membrane is used to adhere 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, characterized in that It also includes a control wire, which is connected to the vascular closure device and is used to drive the vascular closure device to move.

17. The delivery system according to 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.

Images