Vascular closure device

Abstract

The present invention relates to the field of interventional surgical instruments and provides a vascular occlusion device. [Solution] The vascular occluder according to the present invention includes a handle 100, a push-pull wire, an anchor member 20, a fixing catheter, an inflatable hemostatic plug, an inner support tube, and an outer occludable tube. The handle is fixed to the rear end of the fixing catheter, and the handle is provided with a first controller 107, a second controller 108, and a third controller 109. The rear end of the push-pull wire extends from the rear end opening of the fixing catheter, and its tip is fixedly connected to the anchor, so that the anchor member can be in a state of axial contraction / radial expansion / axial return / radial contraction. The inner support tube and the outer occludable tube are movably fitted onto the outer wall of the fixing catheter in order from the inside to the outside. The second controller is driveable to move the inner support tube, and the third controller is driveable to move the outer occludable tube.

Description

Technical Field

[0001] The present invention relates to the field of interventional treatment surgical instruments, and specifically to a vascular occluder.

Background Art

[0002] With the continuous development of modern medicine, the clinical application of vascular surgery and interventional treatment technology is becoming increasingly widespread. In interventional surgery, the occlusion of the femoral vein is a very important part.

[0003] At present, the occlusion of the femoral vein mainly adopts a pressing method. Doctors need to manually press the blood vessel to stop bleeding. Although this method seems simple, it has many drawbacks. First, the hemostasis time is long, usually requiring a compression time of 15 to 30 minutes. During this long time, edema and damage are likely to occur in the tissues around the blood vessel, and the incidence probability of complications such as infectious diseases and thrombosis will increase significantly. Second, this method requires the patient to stay in bed and rest for a long time, which will undoubtedly bring extremely great pain and inconvenience to the patient, and at the same time, it will also affect the patient's recovery process and quality of life.

[0004] With the continuous progress of medical technology, in order to assist doctors in performing vascular occlusion interventional surgery, more and more medical devices are being developed. The main purpose of these devices is to immediately stop bleeding after interventional surgery, shorten the operation time and the patient's time out of bed, and reduce the risk of complications associated with interventional surgery. However, at present, there is still a lack of efficient, safe and convenient femoral vein occlusion technology and devices.

Summary of the Invention

Problems to be Solved by the Invention

[0005] In view of the above situation, the present invention proposes a vascular occluder to shorten the hemostasis time and reduce complications.

Means for Solving the Problems

[0006] To achieve the above objective, the present invention employs the following technical approach. A vascular occluder including a handle, The system further includes a push-pull wire, an anchor member, a fixing catheter, an inflatable hemostatic plug, an inner support tube, and an outer occlusion tube. An axial through-hole is provided at the tip of the handle, the rear end of the fixing catheter is fixedly installed inside the handle, and the tip of the fixing catheter extends out through the through-hole. The push-pull wire is movably inserted into the fixing catheter, the rear end of the push-pull wire extends from the rear end of the fixing catheter, the handle is provided with a first controller capable of driving the push-pull wire to move along the axial direction of the fixing catheter, the anchor member is fitted onto the front of the push-pull wire, the tip of the anchor member is fixedly connected to the tip of the push-pull wire, the rear end of the anchor member is fixedly connected to the tip of the fixing catheter, and the anchor member can assume an axial contraction / radial expansion state / axial return / radial contraction state in conjunction with the forward and backward movement of the push-pull wire. The inner support tube is movably fitted onto the outer wall of the fixed catheter, the tip of the inner support tube is located behind the anchor member, the rear end of the inner support tube extends into the handle, and the handle is provided with a second controller that can drive the inner support tube to move along the axial direction of the fixed catheter. The outer occlusion tube is movably fitted onto the outside of the inner support tube, the tip of the outer occlusion tube is located behind the anchor member, the rear end of the outer occlusion tube extends into the handle, and the handle is provided with a third controller that can drive the outer occlusion tube to move axially with respect to the fixed catheter. The inflatable hemostatic plug is fitted between the anterior inner wall of the outer occlusion tube and the anterior outer wall of the inner support tube. The outer occlusion tube moves its outer circumferential wall to close / expose the inflatable hemostatic plug, and the inner support tube is movable in the axial direction of the fixed catheter so as to detach from the inflatable hemostatic plug or to be inserted into the inner circumferential wall of the inflatable hemostatic plug.

[0007] To better realize the above technical solution, the third controller, the second controller, and the first controller are optionally arranged on the surface of the handle in order from front to rear.

[0008] Optionally, a push handle is fixedly fitted to the rear end of the outer closure tube, and an elastic member is further fitted to the outer closure tube, the tip of the elastic member abutting against the rear end of the through hole, the rear end of the elastic member abutting against the front end of the push handle, and the inner end of the third controller abutting against the rear end of the push handle.

[0009] Optionally, an end cap is fixed to the tip of the anchor member, and the end cap is fixed to the tip of the push-pull wire by welding, laser welding, argon arc welding, or thermal welding.

[0010] Optionally, when the anchor member is in an axially contracted and radially expanded state, it takes on a petal-shaped, basket-stent-shaped, or balloon-shaped structure, and when the anchor member is in an axially returned and radially contracted state, it takes on a straight tubular structure.

[0011] Optionally, the material of the inflatable hemostatic plug may be collagen or polyglycolic acid.

[0012] As an option, a fixing seat is fixedly installed inside the handle, the fixing seat has a mounting groove coaxial with the through hole, and the rear end of the fixing catheter is fixedly installed in the mounting groove.

[0013] Optionally, the first and second controllers are push-pull buttons, each having a locking hook, a cardboard is fixedly installed inside the handle, and the cardboard has locking grooves arranged to engage with each locking hook.

[0014] Optionally, at least one mark is provided on the outer wall of the outer closure pipe. [Effects of the Invention]

[0015] The beneficial effects of this invention are as follows: First, a method is adopted that combines an anchor member and an inflatable hemostatic plug to seal and close the blood vessel. The shape of the anchor member is adjusted using the first controller and a push-pull wire, and the inflatable hemostatic plug is exposed using the third controller. The inflatable hemostatic plug rapidly absorbs blood and expands, achieving hemostasis. Compared to the conventional pressure hemostasis method, this significantly reduces hemostasis time, improves the efficiency of interventional surgery, reduces patient discomfort and nursing burden, and because hemostasis time is short, interventional surgeons can complete interventional surgery in a short time, shortening the patient's interventional surgery time and postoperative recovery time. In addition, because hemostasis is rapid, patients can get out of bed and become active in a short time, which is advantageous for the patient's postoperative recovery and quality of life.

[0016] Next, the inflatable hemostatic plug is made of a biodegradable material, which prevents it from remaining in the body for a long period of time and reduces the risk of complications. In contrast, conventional pressure hemostasis methods can cause edema and damage to the tissues surrounding blood vessels, potentially increasing the risk of complications such as infection and thrombosis. Therefore, the safety of the vascular occlusion device of the present invention is even higher.

[0017] Finally, the anchor components are flexible anchor forms such as petal-shaped, basket-stent-shaped, or balloon-shaped, which can adapt well to the morphology of the blood vessel, reduce vascular damage, decrease secondary damage to the blood vessels during interventional surgery, protect the integrity and function of the blood vessels, and provide strong assurance for the patient's postoperative recovery. [Brief explanation of the drawing]

[0018] [Figure 1] This is a schematic perspective view of a vascular occluder according to an embodiment of the present invention. [Figure 2] This is an enlarged view of the partial structure shown in Figure 1. [Figure 3] Figure 1 shows the explosion diagram. [Figure 4] It is a connection schematic diagram of a push-pull wire, an anchor member, and a fixed catheter in FIG. 3. [Figure 5] It is an internal schematic diagram of the partial structure of FIG. 1. [Figure 6] It is a perspective schematic diagram of various anchor members and different states in a vascular occluder according to an embodiment of the present invention. [Figure 7] It is a perspective schematic diagram of various anchor members and different states in a vascular occluder according to an embodiment of the present invention.

Mode for Carrying Out the Invention

[0019] Hereinafter, the technical solution of the present invention will be described in detail with reference to the accompanying drawings and specific embodiments. Here, the same reference numerals are assigned to the same parts.

[0020] Referring to FIGS. 1 to 7, in an embodiment of the present invention, a vascular occluder including a handle 100, a push-pull wire 10, an anchor member 20, a fixed catheter 30, an inflatable hemostatic plug 40, an inner support tube 50, and an outer occlusion tube 60 is disclosed.

[0021] As shown in FIGS. 1 and 3, the handle 100 has a pen-shaped structure in which a front cover 101, a rear cover 102, a first half case 103, and a second half case 104 are engaged, and an assembly cavity for assembling the above components is provided in the handle 100.

[0022] As shown in FIGS. 3 and 5, a through hole 1011 is axially opened at the tip of the handle 100. Specifically, the through hole 1011 is opened at the center of the front cover 101. A fixed seat 105 is fixedly installed in the assembly cavity. The fixed seat 105 has a mounting groove 1051 coaxial with the through hole 1011. The rear end of the fixed catheter 30 is fixedly installed in the mounting groove 1051. More precisely, the fixed catheter 30 is fixed in the mounting groove 1051 by adhesion, and the tip of the fixed catheter 30 extends out from the through hole 1011.

[0023] As shown in Figures 3 and 5, the push-pull wire 10 is movably inserted into the fixed catheter 30, the rear end of the push-pull wire 10 extends from the rear end of the fixed catheter 30, the handle 100 is provided with a first controller 107 which is fixedly connected to the rear end of the push-pull wire 10 and can drive the push-pull wire 10 to move along the axial direction of the fixed catheter 30, the anchor member 20 is fitted onto the front of the push-pull wire 10 and the tip of the anchor member 20 is fixedly connected to the tip of the push-pull wire 10, the rear end of the anchor member 20 is fixedly connected to the tip of the fixed catheter 30, and the anchor member 20 takes on an axial contraction / radial expansion state and an axial return / radial contraction state as the push-pull wire 10 moves back and forth.

[0024] As shown in Figure 2, in this embodiment, an end cap 201 is fixed to the tip of the anchor member 20, and the end cap 201 is fixed to the tip of the push-pull wire 10 by welding, laser, argon arc welding, or heat welding, and the rear end of the anchor member 20 is fixed to the tip of the fixed catheter 30 by heat welding or dot bonding.

[0025] In this embodiment, the first controller 107 is a push-pull button that moves back and forth. Moving the first controller 107 back and forth allows the push-pull wire 10 to reciprocate along the axial direction of the fixed catheter 30. As the push-pull wire 10 moves backward, the anchor member 20 can be driven to expand radially and contract axially, and as the push-pull wire 10 moves forward, the anchor member 20 can be driven to contract radially and return axially.

[0026] As shown in Figures 6 and 7, specifically, when the anchor member 20 is in an axially contracted and radially expanded state, it takes on a petal-shaped, basket-stent-shaped, or balloon structure, and when the anchor member 20 is in an axially returned and radially contracted state, it takes on a straight tubular structure. For example, when the anchor member 20 adopts a petal-shaped structure, it is manufactured from memory alloy material with a diameter of 5 mm and a length of 15 mm. When a basket stent is adopted, it is manufactured from memory alloy wire with a diameter of approximately 8 mm and a length of approximately 8 mm. When a balloon is adopted, a polyurethane or silicone adaptive balloon is selected with a diameter of approximately 8 mm and a length of approximately 10 mm. With such a design, an appropriate flexible anchor form such as a petal-shaped, basket-stent, or balloon can be selected based on factors such as the diameter, shape, and hardness of the blood vessel.

[0027] As shown in Figures 1, 3, and 5, the inner support tube 50 is movably fitted onto the outer wall of the fixed catheter 30, the tip of the inner support tube 50 is located behind the anchor member 20, the rear end of the inner support tube 50 extends into the handle 100, the handle 100 is provided with a second controller 108 which is fixedly connected to the rear end of the inner support tube 50 and can drive the inner support tube 50 to move along the axial direction of the fixed catheter 30.

[0028] Specifically, the second controller 108 is a push-pull button that moves back and forth, and by moving the second controller 108 back and forth, the inner support tube 50 can be moved back and forth along the axial direction of the fixed catheter 30.

[0029] As shown in Figure 5, both the push-pull buttons of the first controller 107 and the second controller 108 have locking hooks, and a cardboard 106 is fixedly installed inside the handle 100. The cardboard 106 has locking grooves arranged on it that engage with each locking hook. By using the same cardboard 106 in combination with the first controller 107 and the second controller 108, the structure is made more compact and production costs are reduced.

[0030] As shown in Figures 1, 3, and 5, the outer occlusion tube 60 is movably fitted to the outside of the inner support tube 50, the tip of the outer occlusion tube 60 is located behind the anchor member 20, the rear end of the outer occlusion tube 60 extends into the handle 100, and the handle 100 is provided with a third controller 109 that can drive the outer occlusion tube 60 to move axially with respect to the fixed catheter 30. Specifically, a push handle 601 is fixedly fitted to the rear end of the outer occlusion tube 60, and an elastic member 602 is further fitted to the outer occlusion tube 60, preferably the elastic member 602 is a linear spring. The tip of the elastic member 602 abuts against the rear end of the through hole 1011, the rear end of the elastic member 602 abuts against the front end of the push handle 601, and the inner end of the third controller 109 abuts against the rear end of the push handle 601, and the third controller 109 is a push-rotate button.

[0031] As shown in Figures 2 and 3, the inflatable hemostatic plug 40 is fitted between the front inner wall of the outer occlusion tube 60 and the front outer wall of the inner support tube 50. The outer occlusion tube 60 moves its outer circumferential wall to close / expose the inflatable hemostatic plug 40, and the inner support tube 50 is movable in the axial direction of the fixed catheter 30 so as to detach from the inflatable hemostatic plug 40 or be inserted into the inner circumferential wall of the inflatable hemostatic plug 40.

[0032] Specifically, the expandable hemostatic plug 40 is made of a biodegradable material such as collagen or polyglycolic acid, and has a diameter of approximately 2 mm and a length of approximately 15 mm. The expandable hemostatic plug 40 absorbs blood and expands, immediately stopping bleeding. By using biodegradable collagen or polyglycolic acid, the expandable hemostatic plug 40 is prevented from remaining in the body for a long period of time, reducing the risk of complications.

[0033] In this embodiment, to facilitate the physician's operation, the third controller 109, the second controller 108, and the first controller 107 are arranged sequentially on the surface of the handle 100 from front to back.

[0034] As shown in Figures 2 and 3, the outer wall of the outer closure pipe 60 is provided with at least one mark 603, but preferably two. The mark 603 can serve as a reference for the travel length of the outer closure pipe 60.

[0035] The procedure for using the vascular occluder according to the embodiment of the present invention is as follows: First, in the initial state of the vascular occluder, the tip surface of the inflatable hemostatic plug 40 and the tip surface of the outer occluding tube 60 are on the same plane, the outer circumferential surface of the inflatable hemostatic plug 40 is enclosed by the outer occluding tube 60, the anchor member 20 is in an axial return and radial contraction state, the rear end of the push handle 601 abuts against the inner end of the third controller 109, and the elastic member 602 is in a compressed state.

[0036] S10: The front part of the push-pull wire 10, the entire anchor member 20, the front part of the fixing catheter 30, the entire inflatable hemostatic plug 40, the front part of the inner support tube 50, and the front part of the outer occlusion tube 60 are all placed inside the blood vessel via the puncture sheath.

[0037] S20: The first controller 107 is pushed backward to move the push-pull wire 10 backward, deforming the anchor member 20 into an axially contracted and radially expanded state, thereby positioning the inflatable hemostatic plug 40 at the puncture point at the anchor position of the blood vessel.

[0038] S30: The third controller 109 is pressed to rotate its inner end and detach it from the push handle 601. After the push handle 601 is no longer restricted by the third controller 109, the return action of the elastic member 602 pushes the outer occlusion tube 60 backward until the inflatable hemostatic plug 40 is completely exposed inside the blood vessel. At this time, the inflatable hemostatic plug 40 can absorb blood and stop bleeding immediately.

[0039] S40: The second controller 108 is pressed backward to move the inner support tube 50 backward, and the inflatable hemostatic plug 40 absorbs blood and expands, so the outer diameter of the inflatable hemostatic plug 40 is larger than the outer diameter of the outer occlusion tube 60, and the outer occlusion tube 60 forms an obstruction to the inflatable hemostatic plug 40, and the inflatable hemostatic plug 40 elastically occludes the puncture site as the inner support tube 50 moves backward.

[0040] S50: After waiting for 3 minutes, the first controller 107 is pressed forward to move the push-pull wire 10 forward, returning the anchor member 20 to its axial return and radial contraction state, and then withdrawing from the blood vessel and retracting the device.

[0041] The following effects can be obtained by using the vascular occlusion device according to the embodiment of the present invention. First, a method is adopted in which an anchor member 20 and an inflatable hemostatic plug 40 are combined to seal and close the blood vessel. The shape of the anchor member 20 is adjusted using the first controller 107 and the push-pull wire 10, and the inflatable hemostatic plug 40 is exposed using the third controller 109. The inflatable hemostatic plug 40 rapidly absorbs blood and expands, achieving hemostasis. Compared to the conventional pressure hemostasis method, this significantly reduces the hemostasis time, improves the efficiency of interventional surgery, allows interventional surgeons to complete surgery in a shorter time, and shortens the patient's interventional surgery time and postoperative recovery time. At the same time, because hemostasis is rapid, patients can get out of bed and become active in a short time, which is extremely advantageous for the patient's postoperative recovery and quality of life.

[0042] Next, the inflatable hemostatic plug 40 is made of a biodegradable material, which prevents it from remaining in the body for a long period of time and reduces the risk of complications. In contrast, conventional pressure hemostasis methods can cause edema and damage to the tissues surrounding blood vessels, potentially increasing the risk of complications such as infection and thrombosis. Therefore, the safety of the vascular occlusion device of the present invention is even higher.

[0043] Finally, the anchor member 20 is a flexible anchor type such as a petal shape, basket stent shape, or balloon, which can be better adapted to the morphology of the blood vessel, reduce vascular damage, decrease secondary damage to the blood vessel during interventional surgery, protect the integrity and function of the blood vessel, and provide strong assurance for the patient's postoperative recovery.

[0044] The technical aspects of the present invention have been described in detail above with reference to specific embodiments. The specific embodiments described are intended to aid in understanding the concept of the present invention. Derivations and modifications made by those skilled in the art based on the specific embodiments of the present invention are also covered within the scope of the present invention. [Explanation of Symbols]

[0045] 100...Handle, 101...Front cover, 1011...Through hole, 102...Rear cover, 103...First half case, 104...Second half case, 105...Fixing base, 1051...Mounting groove, 106...Cardboard, 107...First controller, 108...Second controller, 109...Third controller, 10...Push-pull wire, 20...Anchor member, 201...End cap, 30...Fixing catheter, 40...Inflation hemostatic plug, 50...Inner support tube, 60...Outer occlusion tube, 601...Push handle, 602...Elastic member, 603...Mark.

Claims

1. A vascular occluder including a handle (100), The device further includes a push-pull wire (10), an anchor member (20), a fixing catheter (30), an inflatable hemostatic plug (40), an inner support tube (50), and an outer occlusion tube (60), An axial through-hole (1011) is provided at the tip of the handle (100), the rear end of the fixed catheter (30) is fixedly installed inside the handle (100), and the tip of the fixed catheter (30) extends out from the through-hole (1011). The push-pull wire (10) is movably inserted into the fixed catheter (30), the rear end of the push-pull wire (10) extends from the rear end of the fixed catheter (30), the handle (100) is provided with a first controller (107) capable of driving the push-pull wire (10) to move along the axial direction of the fixed catheter (30), the anchor member (20) is fitted onto the front part of the push-pull wire (10), the tip of the anchor member (20) is fixedly connected to the tip of the push-pull wire (10), the rear end of the anchor member (20) is fixedly connected to the tip of the fixed catheter (30), and the anchor member (20) can take an axial contraction / radial expansion state / axial return / radial contraction state in accordance with the forward and backward movement of the push-pull wire (10). The inner support tube (50) is movably fitted onto the outer wall of the fixed catheter (30), the tip of the inner support tube (50) is located behind the anchor member (20), the rear end of the inner support tube (50) extends into the handle (100), and the handle (100) is provided with a second controller (108) that can drive the inner support tube (50) to move along the axial direction of the fixed catheter (30). The outer occlusion tube (60) is movably fitted onto the outside of the inner support tube (50), the tip of the outer occlusion tube (60) is located behind the anchor member (20), the rear end of the outer occlusion tube (60) extends into the handle (100), and the handle (100) is provided with a third controller (109) that can drive the outer occlusion tube (60) to move in the axial direction of the fixed catheter (30). The inflatable hemostatic plug (40) is fitted between the anterior inner wall of the outer occlusion tube (60) and the anterior outer wall of the inner support tube (50), the outer occlusion tube (60) moves backward to completely expose the inflatable hemostatic plug (40), and the inner support tube (50) is movable in the axial direction of the fixed catheter (30) so as to detach from the inflatable hemostatic plug (40) during the backward movement, and the inflatable hemostatic plug (40) elastically occludes the puncture site during the backward movement of the inner support tube (50). When the anchor member (20) is in an axially contracted and radially expanded state, it takes on a petal-shaped, basket-stent-shaped, or balloon-shaped structure, and when the anchor member (20) is in an axially returned and radially contracted state, it takes on a straight tubular structure. A push handle (601) is fixedly fitted to the rear end of the outer closure tube (60), and an elastic member (602) is further fitted to the outer closure tube (60), the tip of the elastic member (602) abuts against the rear end of the through hole (1011), the rear end of the elastic member (602) abuts against the front end of the push handle (601), and the inner end of the third controller (109) abuts against the rear end of the push handle (601). The third controller (109) is a push-rotate button, and the elastic member (602) is in a compressed state in its initial state. When the third controller (109) is pressed and rotated, the inner end of the third controller (109) detaches from the push handle (601), and the return action of the elastic member (602) moves the outer closing pipe (60) backward. At least one mark (603) is provided on the outer wall of the outer closing pipe (60). A vascular occluder characterized by the following features.

2. The third controller (109), the second controller (108), and the first controller (107) are arranged sequentially on the surface of the handle (100) from front to rear. The vascular occluder according to feature 1.

3. An end cap (201) is fixed to the tip of the anchor member (20), and the end cap (201) is fixed to the tip of the push-pull wire (10) by welding, laser welding, argon arc welding, or heat welding. The vascular occluder according to feature 1.

4. The material of the inflatable hemostatic plug (40) is collagen or polyglycolic acid. The vascular occluder according to feature 1.

5. A fixing base (105) is fixedly installed inside the handle (100), and the fixing base (105) has a mounting groove (1051) coaxial with the through hole (1011), and the rear end of the fixing catheter (30) is fixedly installed in the mounting groove (1051). The vascular occluder according to feature 1.

6. The first controller (107) and the second controller (108) are push-pull buttons, each having a locking hook, and a cardboard (106) is fixedly installed inside the handle (100), with locking grooves arranged on the cardboard (106) that engage with each locking hook. The vascular occluder according to feature 1.

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