Vascular closure device

Abstract

A vascular closure device, comprising a handle 100, characterized in that it also comprises a push-pull wire 10, an anchor 20, a fixed catheter 30, an expandable hemostatic plug 40, an inner support t

Description

TECHNICAL FIELD

[0001] The present invention relates to the field of interventional therapy surgical instruments, and specifically to a vascular closure device. BACKGROUND

[0002] With the continuous advancement of modern medicine, vascular surgery and interventional therapy techniques are being applied increasingly widely in clinical practice. In interventional procedures, femoral vein closure is a critical step.

[0003] Currently, femoral vein closure is predominantly achieved through manual compression. This method requires physicians to apply sustained manual pressure to the vessel to achieve hemostasis. While seemingly straightforward, this approach has several significant drawbacks. Primarily, it entails a prolonged hemostasis time, often requiring 15 to 30 minutes of continuous compression. During this extended period, the perivascular tissues are prone to edema and injury, substantially increasing the risk of complications such as infection and thrombosis. Furthermore, this method mandates that patients remain in prolonged bed rest, which inevitably causes considerable distress and inconvenience, ultimately impeding the recovery process and diminishing the quality of life.

[0004] With the continuous advancement of medical technology, an increasing number of medical devices have been developed to assist physicians in performing vascular closure during interventional procedures. Primary objectives of these devices are to achieve immediate hemostasis post-intervention, reduce procedure duration and patient time to ambulation, and lower the risk of complications associated with interventional surgery. However, there remains a lack of highly efficient, safe, and convenient techniques and devices specifically for femoral vein closure. SUMMARY

[0005] In view of the foregoing, the present invention provides a vascular closure device to achieve significantly reduced hemostasis time and a lower complication rate.

[0006] To realize the above objective, the present invention employs the following technical solutions:

[0007] a vascular closure device includes a handle, a push-pull wire, an anchor, a fixation catheter, an expandable hemostatic plug, an inner support tube, and an outer occlusion tube, in which:

[0008] a through-hole is axially disposed at a front end of the handle, a rear end of the fixation catheter is fixedly arranged in the handle, and a front end of the fixation catheter extends out from the through-hole;

[0009] the push-pull wire is movably sleeved in the fixation catheter, a rear end of the push-pull wire extends out from a rear port of the fixation catheter, and a first controller fixedly connected to the rear end of the push-pull wire is arranged on the handle and is configured to drive the push-pull wire to move axially along the fixation catheter; the anchor is sleeved over a front portion of the push-pull wire, a front end of the anchor is fixedly connected to a front end of the push-pull wire, and a rear end of the anchor is fixedly connected to a front end of the fixation catheter; and the anchor is configured to transition, in response to forward or rearward movement of the push-pull wire, between an axially-contracted and radially-expanded state and an axially-reset and radially-contracted state;

[0010] the inner support tube is movably sleeved over an outer wall of the fixation catheter, a front end of the inner support tube is located on a rear side of the anchor, and a rear end of the inner support tube extends into the handle; and a second controller fixedly connected to the rear end of the inner support tube is arranged on the handle and is configured to drive the inner support tube to move axially along the fixation catheter;

[0011] the outer occlusion tube is movably sleeved over an outer wall of the inner support tube, a front end of the outer occlusion tube is located on the rear side of the anchor, and a rear end of the outer occlusion tube extends into the handle; and a third controller is arranged on the handle and is configured to drive the outer occlusion tube to move axially along the fixation catheter; and

[0012] the expandable hemostatic plug is sleeved between an inner wall of a front portion of the outer occlusion tube and an outer wall of a front portion of the inner support tube; when the outer occlusion tube moves, an outer circumferential surface of the expandable hemostatic plug is enclosed or exposed; and the inner support tube moves axially along the fixation catheter to disengage from the expandable hemostatic plug or to sleeve an inner circumferential surface of the expandable hemostatic plug.

[0013] To better implement the above technical solution, alternatively, the third controller, the second controller, and the first controller are arranged on a surface of the handle sequentially from front to back.

[0014] Alternatively, a push collar is fixedly sleeved over a rear end of the outer occlusion tube, and an elastic element is further sleeved over the outer occlusion tube; and a front end of the elastic element is abutted against a rear end of the through-hole, a rear end of the elastic element is abutted against a front end of the push collar, and an inner end of the third controller is abutted against a rear end of the push collar.

[0015] Alternatively, an end cap is fixedly arranged at the front end of the anchor, and the end cap is fixed to the front end of the push-pull wire by a process including welding, laser welding, argon arc welding, or thermal fusion.

[0016] Alternatively, in the axially-contracted and radially-expanded state, the anchor is configured as a petal-like structure, a basket stent structure, or a balloon structure; and in the axially-reset and radially-contracted state, the anchor is configured as a straight tubular structure.

[0017] Alternatively, the expandable hemostatic plug is made of collagen or polyglycolic acid.

[0018] Alternatively, a fixing base is fixedly arranged in the handle, the fixing base has a mounting groove that is coaxial with the through-hole, and the rear end of the fixation catheter is fixedly arranged in the mounting groove.

[0019] Alternatively, the first controller and the second controller are push-pull buttons, with each having a locking hook; and a clamping plate is fixedly arranged in the handle, and a series of locking slots that match the corresponding locking hooks are arranged on the clamping plate.

[0020] Alternatively, at least one marking is arranged on an outer wall of the outer occlusion tube.

[0021] The present invention has the following beneficial effects.

[0022] 1. The vessel is sealed and closed by employing a cooperative manner between the anchor and the expandable hemostatic plug. The configuration of the anchor is adjusted using the first controller and the push-pull wire, and the expandable hemostatic plug is exposed using the third controller. The expandable hemostatic plug can rapidly absorb blood and expand to achieve hemostasis. Compared with conventional manual compression techniques, hemostasis time is significantly shortened, and the efficiency of interventional procedures is enhanced, thereby alleviating patient discomfort and nursing burden. Furthermore, due to the reduced hemostasis time, interventional physicians can complete procedures faster, thereby decreasing total interventional time and promoting quicker postoperative recovery for patients. Additionally, owing to the rapid hemostasis, patients can ambulate within a significantly shorter period, thereby facilitating postoperative recovery and enhancing the quality of life.

[0023] 2. The expandable hemostatic plug is made of a biodegradable material, which prevents its long-term retention in the body and reduces the risk of complications. In contrast, conventional manual compression techniques may lead to edema and injury in the perivascular tissues, increasing the risk of complications such as infection and thrombosis. The vascular closure device of the present invention demonstrates a superior safety profile.

[0024] 3. The anchor employs flexible configurations such as a petal-like structure, a basket stent, or a balloon. These configurations can better conform to the vascular anatomy, thereby minimizing vascular damage, reducing the risk of secondary damage during the interventional procedures, and preserving vascular integrity and function. This comprehensive protection provides a solid foundation for enhanced patient recovery. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] FIG. 1 is a perspective schematic diagram of a vascular closure according to an embodiment of the present invention;

[0026] FIG. 2 is an enlarged view of a local structure in FIG. 1;

[0027] FIG. 3 is an exploded view of FIG. 1;

[0028] FIG. 4 is a connection schematic diagram of a push-pull wire, an anchor, and a fixation catheter in FIG. 3;

[0029] FIG. 5 is an internal schematic diagram of a local structure in FIG. 1;

[0030] FIG. 6 is a perspective schematic diagram showing various anchors and different states thereof in the vascular closure device according to an embodiment of the present invention; and

[0031] FIG. 7 is a perspective schematic diagram showing various anchors and different states thereof in the vascular closure device according to an embodiment of the present invention.

[0032] Reference numerals and denotations thereof:

[0033] 100-handle; 101-front cover; 1011-through-hole; 102-rear cover; 103-first half-shell; 104-second half-shell; 105-fixing base; 1051-mounting groove; 106-clamping plate; 107-first controller; 108-second controller; 109-third controller; 10-push-pull wire; 20-anchor; 201-end cap; 30-fixation catheter; 40-expandable hemostatic plug; 50-inner support tube; 60-outer occlusion tube; 601-push collar; 602-elastic element; and 603-marking. DETAILED DESCRIPTION

[0034] The technical solutions of the present invention are described in detail below in combination with the accompanying drawings and specific embodiments. Corresponding components are designated by the same reference numerals.

[0035] Referring to FIGS. 1-7, an embodiment of the present invention provides a vascular closure device, including a handle 100, a push-pull wire 10, an anchor 20, a fixation catheter 30, an expandable hemostatic plug 40, an inner support tube 50, and an outer occlusion tube 60.

[0036] Referring to FIG. 1 and FIG. 3, the handle 100 features a pen-like structure, assembled by fastening a front cover 101, a rear cover 102, a first half-shell 103, and a second half-shell 104. An assembly cavity is disposed in the handle 100 for assembling the above components.

[0037] Referring to FIG. 3 and FIG. 5, a through-hole 1011 is axially disposed at a front end of the handle 100. Specifically, the through-hole 1011 is disposed at a center of the front cover 101. A fixing base 105 is fixedly arranged in the assembly cavity, the fixing base 105 has a mounting groove 1051 that is coaxial with the through-hole 1011, and a rear end of the fixation catheter 30 is fixedly arranged in the mounting groove 1051. More precisely, the fixation catheter 30 is fixed in the mounting groove 1051 by adhesive bonding, with a front end of the fixation catheter 30 extending out from the through-hole 1011.

[0038] Referring to FIG. 3 and FIG. 5, the push-pull wire 10 is movably sleeved in the fixation catheter 30, a rear end of the push-pull wire 10 extends out from a rear port of the fixation catheter 30, and a first controller 107 fixedly connected to the rear end of the push-pull wire 10 is arranged on the handle 100 and is configured to drive the push-pull wire 10 to move axially along the fixation catheter 30. The anchor 20 is sleeved over a front portion of the push-pull wire 10, a front end of the anchor 20 is fixedly connected to a front end of the push-pull wire 10, and a rear end of the anchor 20 is connected to the front end of the fixation catheter 30. The anchor 20 is configured to transition, in response to forward or rearward movement of the push-pull wire 10, between an axially-contracted and radially-expanded state and an axially-reset and radially-contracted state.

[0039] Referring to FIG. 2, in this embodiment, an end cap 201 is fixedly arranged at the front end of the anchor 20, and the end cap 201 is fixed to the front end of the push-pull wire 10 by a process including welding, laser welding, argon arc welding, or thermal fusion. The rear end of the anchor 20 is fixed to the front end of the fixation catheter 30 by thermal fusion or adhesive dispensing.

[0040] In this embodiment, the first controller 107 is a push-pull button for forward and rearward movement. During forward and rearward movement, the first controller 107 can drive the push-pull wire 10 to reciprocate axially along the fixation catheter 30. During the rearward movement of the push-pull wire 10, the anchor 20 is pushed to radially expand and axially contract. Conversely, during forward movement of the push-pull wire 10, the anchor 20 is pushed to radially contract and axially reset.

[0041] Referring to FIG. 6 and FIG. 7, in the axially-contracted and radially-expanded state, the anchor 20 is configured as a petal-like structure, a basket stent structure, or a balloon structure, while in the axially-reset and radially-contracted state, the anchor 20 is configured as a straight tubular structure. For instance, when the anchor 20 is configured as a petal-like structure, it is fabricated from a shape memory alloy with a diameter of 5 mm and a length of 15 mm. When implemented as the basket stent, it is fabricated from shape memory alloy wires, having an approximate diameter of 8 mm and a length of about 8 mm. In the balloon configuration, a compliant balloon made of materials such as polyurethane or silicone is selected, with a diameter of approximately 8 mm and a length of about 10 mm. In this design, according to the diameter, shape, hardness, and other factors of the blood vessel, appropriate flexible anchoring forms such as a petal-like structure, a basket stent, or a balloon can be selected.

[0042] Referring to FIG. 1, FIG. 3, and FIG. 5, the inner support tube 50 is movably sleeved over an outer wall of the fixation catheter 30, a front end of the inner support tube 50 is located on a rear side of the anchor 20, and a rear end of the inner support tube 50 extends into the handle 100. A second controller 108 fixedly connected to the rear end of the inner support tube 50 is arranged on the handle 100 and is configured to drive the inner support tube 50 to move axially along the fixation catheter 30.

[0043] Specifically, the second controller 108 is a push-pull button for forward and rearward movement. During forward and rearward movement, the second controller 108 drives the inner support tube 50 to reciprocate axially along the fixation catheter 30.

[0044] Referring to FIG. 5, the push-pull buttons of the first controller 107 and the second controller 108 have locking hooks. A clamping plate 106 is fixedly arranged in the handle 100, and a series of locking slots that match the corresponding locking hooks are arranged on the clamping plate 106. The first controller 107 and the second controller 108 share a common clamping plate 106 for engagement, resulting in a compact design and reduced manufacturing costs.

[0045] Referring to FIG. 1, FIG. 3, and FIG. 5, the outer occlusion tube 60 is movably sleeved over an outer wall of the inner support tube 50, a front end of the outer occlusion tube 60 is located on the rear side of the anchor 20, and a rear end of the outer occlusion tube 60 extends into the handle 100. A third controller 109 is arranged on the handle 100 and is configured to drive the outer occlusion tube 60 to move axially along the fixation catheter 30. Specifically, a push collar 601 is fixedly sleeved over a rear end of the outer occlusion tube 60, and an elastic element 602 is further sleeved over the outer occlusion tube 60. The elastic element 602 is preferably a linear spring. A front end of the elastic element 602 is abutted against a rear end of the through-hole 1011, a rear end of the elastic element 602 is abutted against a front end of the push collar 601, and an inner end of the third controller 109 is abutted against a rear end of the push collar 601. Furthermore, the third controller 109 is a press-and-rotate button.

[0046] Referring to FIG. 2 and FIG. 3, the expandable hemostatic plug 40 is sleeved between an inner wall of a front portion of the outer occlusion tube 60 and an outer wall of a front portion of the inner support tube 50. When the outer occlusion tube 60 moves, an outer circumferential surface of the expandable hemostatic plug 40 is enclosed or exposed. Moreover, the inner support tube 50 moves axially along the fixation catheter 30 to disengage from the expandable hemostatic plug 40 or to sleeve an inner circumferential surface of the expandable hemostatic plug 40.

[0047] Specifically, the expandable hemostatic plug 40 is made of a biodegradable material, such as collagen or polyglycolic acid, with a diameter of approximately 2 mm and a length of about 15 mm. Upon contact with blood, the expandable hemostatic plug 40 rapidly expands to achieve immediate hemostasis. The use of biodegradable materials like collagen and polyglycolic acid can prevent long-term retention of the expandable hemostatic plug 40 within the body, thereby reducing the risk of complications.

[0048] In this embodiment, the third controller 109, the second controller 108, and the first controller 107 are arranged on a surface of the handle 100 sequentially from front to back to facilitate the physician's operation.

[0049] Referring to FIG. 2 and FIG. 3, at least one marking 603 is arranged on an outer wall of the outer occlusion tube 60, preferably two. These markings 603 serve as a reference for gauging a displacement length of the outer occlusion tube 60.

[0050] Operational steps for the vascular closure device according to the embodiment of the present invention are as follows.

[0051] It is to be noted that in an initial state of the vascular closure device: a front end face of the expandable hemostatic plug 40 is flush with a front end face of the outer occlusion tube 60; the outer circumferential surface of the expandable hemostatic plug 40 is enclosed by the outer occlusion tube 60; the anchor 20 is in an axially-reset and radially-contracted state; the rear end of the push collar 601 is abutted against the inner end of the third controller 109; and the elastic element 602 is in a compressed state.

[0052] In S10, an assembly including a front portion of a push-pull wire 10, an entire anchor 20, a front portion of the fixation catheter 30, an entire expandable hemostatic plug 40, a front portion of the inner support tube 50, and a front portion of the outer occlusion tube 60 is introduced into the blood vessel via an introducer sheath.

[0053] In S20, a first controller 107 is moved rearward to retract the push-pull wire 10, causing the anchor 20 to deform into an axially-contracted and radially-expanded state, thereby anchoring at the vascular site and positioning the expandable hemostatic plug 40 at a puncture site.

[0054] In S30, a third controller 109 is depressed and rotated, causing its inner end to disengage from a push collar 601. After the push collar 601 loses the restraint of the third controller 109, an elastic element 602 drives the outer occlusion tube 60 rearward under its restoring force until the expandable hemostatic plug 40 is fully deployed within the blood vessel. At this point, the expandable hemostatic plug 40 rapidly expands upon contact with blood, achieving immediate hemostasis.

[0055] In S40, a second controller 108 is moved rearward, driving the inner support tube 50 backward. As the expandable hemostatic plug 40 has absorbed blood and expanded, its outer diameter exceeds that of the outer occlusion tube 60, causing the outer occlusion tube 60 to restrain the expandable hemostatic plug 40. During rearward movement, the inner support tube 50 drives the expandable hemostatic plug 40 to elastically seal the puncture site.

[0056] In S50, after waiting for 3 minutes, the first controller 107 is moved forward, advancing the push-pull wire 10 and causing the anchor 20 to revert to its axially-reset and radially-contracted state. The anchor is withdrawn from the blood vessel, and the entire device is retracted.

[0057] The vascular closure device according to the embodiment of the present invention has the following effects.

[0058] 1. The vessel is sealed and closed by employing a cooperative manner between the anchor 20 and the expandable hemostatic plug 40. The configuration of the anchor 20 is adjusted using the first controller 107 and the push-pull wire 10, and the expandable hemostatic plug 40 is exposed using the third controller 109. The expandable hemostatic plug 40 can rapidly absorb blood and expand to achieve hemostasis. Compared with conventional manual compression techniques, hemostasis time is significantly shortened, and the efficiency of interventional procedures is enhanced. Furthermore, interventional physicians can complete procedures faster, thereby decreasing total interventional time and promoting quicker postoperative recovery for patients. Additionally, owing to the rapid hemostasis, patients can ambulate within a significantly shorter period, thereby facilitating postoperative recovery and enhancing the quality of life.

[0059] 2. The expandable hemostatic plug 40 is made of a biodegradable material, which prevents its long-term retention in the body and reduces the risk of complications. In contrast, 5 conventional manual compression techniques may lead to edema and injury in the perivascular tissues, increasing the risk of complications such as infection and thrombosis. The vascular closure device of the present invention demonstrates a superior safety profile.

[0060] 3. The anchor 20 employs flexible configurations such as a petal-like structure, a basket stent, or a balloon. These configurations can better conform to the vascular anatomy, thereby 10 minimizing vascular damage, reducing the risk of secondary damage during the interventional procedures, and preserving vascular integrity and function. This comprehensive protection provides a solid foundation for enhanced patient recovery.

[0061] In conclusion, the technical solutions of the present invention have been described in detail above with reference to specific embodiments. These specific embodiments are intended to 15 aid in understanding the core principles of the present invention. It is to be understood that any derivations or modifications made by those skilled in the art based on these specific embodiments also fall within the scope of protection of the present invention.

Claims

1. Avascular closure device, comprising a handle (100), a push-pull wire (10), an anchor (20), a fixation catheter (30), an expandable hemostatic plug (40), an inner support tube (50), and an outer occlusion tube (60), wherein:a through-hole (1011) is axially disposed at a front end of the handle (100), a rear end of the fixation catheter (30) is fixedly arranged in the handle (100), and a front end of the fixation catheter (30) extends out from the through-hole (1011);the push-pull wire (10) is movably sleeved in the fixation catheter (30), a rear end of the push-pull wire (10) extends out from a rear port of the fixation catheter (30), and a first controller (107) is arranged on the handle (100) and is configured to drive the push-pull wire (10) to move axially along the fixation catheter (30); the anchor (20) is sleeved over a front portion of the push-pull wire (10), a front end of the anchor (20) is fixedly connected to a front end of the push-pull wire (10), and a rear end of the anchor (20) is fixedly connected to a front end of the fixation catheter (30); and the anchor (20) is configured to transition, in response to forward or rearward movement of the push-pull wire (10), between an axially-contracted and radially-expanded state and an axially-reset and radially-contracted state;the inner support tube (50) is movably sleeved over an outer wall of the fixation catheter (30), a front end of the inner support tube (50) is located on a rear side of the anchor (20), and a rear end of the inner support tube (50) extends into the handle (100); and a second controller (108) is arranged on the handle (100) and is configured to drive the inner support tube (50) to move axially along the fixation catheter (30);the outer occlusion tube (60) is movably sleeved over an outer wall of the inner support tube (50), a front end of the outer occlusion tube (60) is located on the rear side of the anchor (20), and a rear end of the outer occlusion tube (60) extends into the handle (100); and a third controller (109) is arranged on the handle (100) and is configured to drive the outer occlusion tube (60) to move axially along the fixation catheter (30);the expandable hemostatic plug (40) is sleeved between an inner wall of a front portion of the outer occlusion tube (60) and an outer wall of a front portion of the inner support tube (50); when the outer occlusion tube (60) moves, an outer circumferential surface of the expandable hemostatic plug (40) is enclosed or exposed; the inner support tube (50) moves axially along the fixation catheter (30) to disengage from the expandable hemostatic plug (40) or to sleeve an inner circumferential surface of the expandable hemostatic plug (40); and during rearward movement, theinner support tube (50) drives the expandable hemostatic plug (40) to elastically seal a puncture site;in the axially-contracted and radially-expanded state, the anchor (20) is configured as a petal-like structure, a basket stent structure, or a balloon structure; and in the axially-reset and radially-contracted state, the anchor (20) is configured as a straight tubular structure;a push collar (601) is fixedly sleeved over a rear end of the outer occlusion tube (60), and an elastic element (602) is further sleeved over the outer occlusion tube (60); and a front end of the elastic element (602) is abutted against a rear end of the through-hole (1011), a rear end of the elastic element (602) is abutted against a front end of the push collar (601), and an inner end of the third controller (109) is abutted against a rear end of the push collar (601); andat least one marking (603) is arranged on an outer wall of the outer occlusion tube (60).

2. The vascular closure device according to claim 1, wherein the third controller (109), the second controller (108), and the first controller (107) are arranged on a surface of the handle (100) sequentially from front to back.

3. The vascular closure device according to claim 1, wherein an end cap (201) is fixedly arranged at the front end of the anchor (20), and the end cap (201) is fixed to the front end of the push-pull wire (10) by a process comprising welding, laser welding, argon arc welding, or thermal fusion.

4. The vascular closure device according to claim 1, wherein the expandable hemostatic plug (40) is made of collagen or polyglycolic acid.

5. The vascular closure device according to claim 1, wherein a fixing base (105) is fixedly arranged in the handle (100), the fixing base (105) has a mounting groove (1051) that is coaxial with the through-hole (1011), and the rear end of the fixation catheter (30) is fixedly arranged in the mounting groove (1051).

6. The vascular closure device according to claim 1, wherein the first controller (107) and the second controller (108) are push-pull buttons, with each having a locking hook; and a clamping plate (106) is fixedly arranged in the handle (100), and a series of locking slots that match the corresponding locking hooks are arranged on the clamping plate (106).A

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