A vascular occluder

Abstract

The present invention relates to the field of interventional therapy surgical instruments, and discloses a vascular occluder, which includes a handle, a push-pull wire, an anchor, a fixed catheter, an expandable hemostatic plug, an inner support tube and an outer plug tube. The handle is fixed to the rear end of the fixed catheter. The handle is provided with a first controller, a second controller and a third controller. The rear end of the push-pull wire extends out of the rear port of the fixed catheter, and the front end is fixedly connected to the anchor, so that the anchor assumes a shape of axial contraction and radial expansion or axial reset and radial contraction. The inner support tube and the outer plug tube are movably sleeved on the outer wall of the fixed catheter in sequence from inside to outside. The second controller can drive the inner support tube to move, and the third controller can drive the outer plug tube to move. The expandable hemostatic plug is sleeved between the outer plug tube and the inner support tube. The outer plug tube can close or expose its outer ring wall, and the inner support tube can be disengaged from or sleeved inside its inner ring wall. The vascular occluder of the present invention can effectively shorten the hemostasis time and reduce the occurrence probability of complications.

Description

Technical Field

[0001] The present invention relates to the field of interventional treatment surgical instruments, and particularly to a vascular closure device. Background Art

[0002] With the continuous development of modern medicine, vascular surgery and interventional treatment technologies are increasingly widely used in clinical practice. In interventional surgeries, the closure of femoral vein blood vessels is a crucial step.

[0003] At present, the closure of femoral vein blood vessels mainly adopts the method of manual compression. Doctors need to manually compress the blood vessels to stop bleeding. Although this method seems simple, it has many drawbacks. First of all, the hemostasis time is relatively long, usually requiring 15 to 30 minutes of compression time. During this long period, the surrounding tissues of the blood vessels are prone to edema and damage, greatly increasing the incidence of complications such as infection and thrombosis. Secondly, this method requires patients to stay in bed for a long time, which undoubtedly brings great pain and inconvenience to patients, and also affects the rehabilitation process and quality of life of patients.

[0004] With the continuous progress of medical technology, more and more medical devices have been developed to assist doctors in performing interventional vascular closure surgeries. The main purpose of these devices is to stop bleeding immediately after interventional surgeries, reduce the operation time and the time for patients to get out of bed, and reduce the risk of complications in interventional surgeries. However, there is still a lack of an efficient, safe and convenient femoral vein blood vessel closure technology and device. Summary of the Invention

[0005] In view of this, the present invention provides a vascular closure device to shorten the hemostasis time and reduce complications.

[0006] To achieve the above object, the present invention adopts the following technical solutions:

[0007] A vascular closure device includes a handle, a push-pull wire, an anchor, a fixed catheter, an expandable hemostatic plug, an inner support tube and an outer plug tube;

[0008] A through hole is axially formed at the front end of the handle, and the rear end of the fixed catheter is fixed inside the handle, and the front end of the fixed catheter extends out from the through hole;

[0009] The push-pull wire is movably sleeved inside the fixed catheter, the rear end of the push-pull wire extends out from the rear port of the fixed catheter, and a first controller is provided on the handle, which is fixedly connected to the rear end of the push-pull wire and can drive the push-pull wire to move axially along the fixed catheter. The anchor is sleeved on the front part of the push-pull wire, and the front end of the anchor is fixedly connected to the front end of the push-pull wire, and the rear end of the anchor is fixedly connected to the front end of the fixed catheter. The anchor expands radially and contracts axially / contracts radially and resets axially as the push-pull wire moves back and forth;

[0010] The inner support tube is movably sleeved on the outer wall of the fixed catheter. The front end of the inner support tube is located at the rear side of the anchoring member, and the rear end of the inner support tube extends into the handle. A second controller is provided on the handle and is fixedly connected to the rear end of the inner support tube and can drive the inner support tube to move axially along the fixed catheter.

[0011] The outer plug tube is movably sleeved on the outside of the inner support tube. The front end of the outer plug tube is located at the rear side of the anchoring member, and the rear end of the outer plug tube extends into the handle. A third controller is provided on the handle and can drive the outer plug tube to move axially along the fixed catheter.

[0012] The expandable hemostatic plug is sleeved between the inner wall of the front part of the outer plug tube and the outer wall of the front part of the inner support tube. The outer wall of the expandable hemostatic plug is moved to be closed / exposed by the outer plug tube. The inner support tube can move axially along the fixed catheter to disengage from the expandable hemostatic plug or be sleeved inside the inner wall of the expandable hemostatic plug.

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

[0014] Optionally, a push handle is fixedly sleeved at the rear end of the outer plug tube. The outer plug tube is also sleeved with an elastic element. The front end of the elastic element abuts against the rear end of the perforation, the rear end of the elastic element abuts against the front end of the push handle, and the inner end of the third controller abuts against the rear end of the push handle.

[0015] Optionally, an end cap is fixedly provided at the front end of the anchoring member, and the end cap is fixed to the front end of the push-pull wire by welding, laser, argon arc welding, or hot melting.

[0016] Optionally, when the anchoring member is in an axially contracted and radially expanded state, it is in a petal shape, a basket stent, or a balloon structure, and when the anchoring member is in an axially reset and radially contracted state, it is in a straight tube structure.

[0017] Optionally, the material of the expandable hemostatic plug is collagen or polyglycolic acid.

[0018] Optionally, a fixed seat is fixedly provided inside the handle. The fixed seat has an installation groove coaxial with the perforation, and the rear end of the fixed catheter is fixedly arranged in the installation groove.

[0019] Optionally, the first controller and the second controller are push-pull buttons, and each push-pull button has a locking hook. A clamping plate is fixedly provided inside the handle, and locking grooves for cooperating with the respective locking hooks are arranged on the clamping plate.

[0020] Optionally, at least one mark is provided on the outer wall of the outer plug tube.

[0021] The beneficial effects of the present invention:

[0022] First, the closed blood vessel is blocked by the cooperation of the anchor and the expandable hemostatic plug. The shape of the anchor is adjusted by the first controller and the push-pull wire, and the expandable hemostatic plug is exposed by the third controller. The expandable hemostatic plug can quickly absorb blood and expand to achieve hemostasis. Compared with the existing method of pressing to stop bleeding, the hemostasis time is greatly shortened, the efficiency of interventional surgery is improved, the discomfort of the patient and the nursing burden are reduced. At the same time, due to the short hemostasis time, the interventional surgeon can complete the interventional surgery in a shorter time, reducing the interventional surgery time and the postoperative recovery time of the patient. In addition, due to the rapid hemostasis, the patient can get out of bed and move in a shorter time, which is beneficial to the postoperative recovery and quality of life of the patient.

[0023] Secondly, the expandable hemostatic plug is made of degradable material, which avoids the long-term presence of the expandable hemostatic plug in the body and reduces the risk of complications. In contrast, the existing method of pressing to stop bleeding may cause edema and damage of the tissues around the blood vessel, increasing the risk of complications such as infection and thrombosis. The vascular occluder of the present invention has higher safety.

[0024] Finally, the anchor is in a flexible anchor form such as a petal shape, a basket stent or a balloon, which can better adapt to the shape of the blood vessel, reduce blood vessel damage, reduce secondary damage to the blood vessel during interventional surgery, protect the integrity and function of the blood vessel, and provide a strong guarantee for the postoperative recovery of the patient. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 is a three-dimensional schematic diagram of a vascular occluder according to an embodiment of the present invention;

[0026] Figure 2 is Figure 1 an enlarged view of a partial structure;

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

[0028] Figure 4 is Figure 3 a connection schematic diagram of the push-pull wire, the anchor and the fixed catheter in...;

[0029] Figure 5 is Figure 1 an internal schematic diagram of a partial structure;

[0030] Figure 6 is a three-dimensional schematic diagram of various anchors and different states in a vascular occluder according to an embodiment of the present invention;

[0031] Figure 7 is a three-dimensional schematic diagram of various anchors and different states in a vascular occluder according to an embodiment of the present invention;

[0032] Reference Signs:

[0033] Handle 100, front cover 101, perforation 1011, rear cover 102, first half shell 103, second half shell 104, fixing base 105, installation groove 1051, clamping plate 106, first controller 107, second controller 108, third controller 109, push-pull wire 10, anchoring member 20, end cap 201, fixing catheter 30, expandable hemostatic plug 40, inner support tube 50, outer blocking tube 60, push handle 601, elastic element 602, identifier 603. Detailed implementation mode

[0034] The technical solution of the present invention will be described in detail below in conjunction with the accompanying drawings and specific embodiments. Among them, the same components are denoted by the same reference numerals.

[0035] Please refer to Figures 1 to 7 , an embodiment of the present invention discloses a vascular occluder, including a handle 100, a push-pull wire 10, an anchoring member 20, a fixing catheter 30, an expandable hemostatic plug 40, an inner support tube 50, and an outer blocking tube 60.

[0036] As Figure 1 and Figure 3 shown, the handle 100 has a pen-shaped structure and is formed by snapping together a front cover 101, a rear cover 102, a first half shell 103, and a second half shell 104. The handle 100 has an assembly cavity for assembling the above components.

[0037] As Figure 3 and Figure 5 shown, a perforation 1011 is axially formed at the front end of the handle 100. Specifically, the perforation 1011 is formed at the center of the front cover 101. A fixing base 105 is fixedly provided in the assembly cavity. The fixing base 105 has an installation groove 1051 coaxial with the perforation 1011. The rear end of the fixing catheter 30 is fixedly arranged in the installation groove 1051. More precisely, the fixing catheter 30 is fixedly installed in the installation groove 1051 by gluing. The front end of the fixing catheter 30 extends out from the perforation 1011.

[0038] As Figure 3 and Figure 5 shown, the push-pull wire 10 is movably sleeved inside the fixing catheter 30. The rear end of the push-pull wire 10 extends out from the rear port of the fixing catheter 30. A first controller 107 is provided on the handle 100 and is fixedly connected to the rear end of the push-pull wire 10 and can drive the push-pull wire 10 to move axially along the fixing catheter 30. The anchoring member 20 is sleeved on the front part of the push-pull wire 10. The front end of the anchoring member 20 is fixedly connected to the front end of the push-pull wire 10, and the rear end of the anchoring member 20 is connected to the front end of the fixing catheter 30. The anchoring member 20 moves forward and backward with the push-pull wire 10 and is in a state of axial contraction and radial expansion / axial reset and radial contraction;

[0039] As Figure 2As shown, in this embodiment, a end cap 201 is fixedly provided at the front end of the anchor 20. The end cap 201 is fixed to the front end of the push-pull wire 10 by welding, laser, argon arc welding or hot melting. The rear end of the anchor 20 is fixed to the front end of the fixed catheter 30 by hot melting or dispensing.

[0040] In this embodiment, the first controller 107 is a push-pull button that moves back and forth. When the first controller 107 is pushed back and forth, it can drive the push-pull wire 10 to reciprocate axially along the fixed catheter 30. During the backward movement of the push-pull wire 10, it can push the anchor 20 to expand radially and contract axially. During the forward movement of the push-pull wire 10, it can push the anchor 20 to contract radially and reset axially.

[0041] As Figure 6 and Figure 7 shown, specifically, when the anchor 20 is in the state of axial contraction and radial expansion, it is in a petal shape, a basket stent or a balloon structure. When the anchor 20 is in the state of axial reset and radial contraction, it is in a straight tube structure. For example, when the anchor 20 adopts a petal structure, it is made of a shape memory alloy material, with a diameter of 5 mm and a length of 15 mm. When a basket stent is adopted, it is made of shape memory alloy wire, with a diameter of about 8 mm and a length of about 8 mm. When a balloon is adopted, a polyurethane or silicone compliant balloon is selected, with a diameter of about 8 mm and a length of about 10 mm. Such a design can select a suitable flexible anchoring form such as a petal shape, a basket stent or a balloon according to factors such as the diameter, shape and hardness of the blood vessel.

[0042] As Figure 1 , Figure 3 and Figure 5 shown, the inner support tube 50 is movably sleeved on the outer wall of the fixed catheter 30. The front end of the inner support tube 50 is located at the rear side of the anchor 20. The rear end of the inner support tube 50 extends into the handle 100. A second controller 108 is provided on the handle 100, which is fixedly connected to the rear end of the inner support tube 50 and can drive the inner support tube 50 to move axially along the fixed catheter 30.

[0043] Specifically, the second controller 108 is a push-pull button that moves back and forth. When the second controller 108 is pushed back and forth, it can drive the inner support tube 50 to reciprocate axially along the fixed catheter 30.

[0044] As Figure 5 shown, the push-pull buttons of the first controller 107 and the second controller 108 both have locking hooks. A clamping plate 106 is fixedly provided in the handle 100. Locking grooves that cooperate with the respective locking hooks are arranged on the clamping plate 106. Using the same clamping plate 106 to cooperate with the first controller 107 and the second controller 108 makes the structure compact and reduces the production cost.

[0045] As Figure 1 , Figure 3 andFigure 5 As shown, the outer plugging tube 60 is movably sleeved on the outer wall of the inner support tube 50. The front end of the outer plugging tube 60 is located at the rear side of the anchoring member 20, and the rear end of the outer plugging tube 60 extends into the handle 100. A third controller 109 for driving the outer plugging tube 60 to axially move along the fixed catheter 30 is provided on the handle 100. Specifically, a push handle 601 is fixedly sleeved at the rear end of the outer plugging tube 60. An elastic element 602 is also sleeved on the outer plugging tube 60. The elastic element 602 is preferably a linear spring. The front end of the elastic element 602 abuts against the rear end of the perforation 1011, and the rear end of the elastic element 602 abuts against the front end of the push handle 601. 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 press-rotation type button.

[0046] As Figure 2 and Figure 3 shown, the expandable hemostatic plug 40 is sleeved between the front inner wall of the outer plugging tube 60 and the front outer wall of the inner support tube 50. The outer wall of the expandable hemostatic plug 40 is closed / exposed by the movement of the outer plugging tube 60. The inner support tube 50 can axially move along the fixed catheter 30 to disengage from the expandable hemostatic plug 40 or be sleeved inside the inner wall of the expandable hemostatic plug 40.

[0047] Specifically, the expandable hemostatic plug 40 is made of a biodegradable material, such as collagen, polyglycolic acid, etc. Its diameter is about 2 mm and its length is about 15 mm. The expandable hemostatic plug 40 can stop bleeding immediately after absorbing blood and expanding. Using biodegradable collagen and polyglycolic acid avoids the long-term retention of the expandable hemostatic plug 40 in the body and reduces the risk of complications.

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

[0049] As Figure 2 and Figure 3 shown, at least one identifier 603, preferably two, is provided on the outer wall of the outer plugging tube 60. The setting of the identifier 603 can be used as a reference for the moving length of the outer plugging tube 60.

[0050] The usage steps of the vascular occluder according to the embodiment of the present invention are as follows:

[0051] First of all, it should be noted that in the initial state of the vascular occluder, the front end faces of the expandable hemostatic plug 40 and the outer plugging tube 60 are coplanar. The outer peripheral surface of the expandable hemostatic plug 40 is wrapped by the outer plugging tube 60. The anchoring member 20 is in the axially reset and radially contracted state. The rear end of the push handle 601 abuts against the inner end of the third controller 109, and the elastic element 602 is in the compressed state.

[0052] S10. Insert the front part of the push-pull wire 10, the entire anchoring member 20, the front part of the fixed catheter 30, the entire expandable hemostatic plug 40, the front part of the inner support tube 50, and the front part of the outer plugging tube 60 into the blood vessel through the puncture sheath together;

[0053] S20. Push the first controller 107 backward to move the push-pull wire 10 backward, driving the anchoring member 20 to deform into an axially contracted and radially expanded state, so that at the blood vessel anchoring position, the expandable hemostatic plug 40 is located at the puncture point.

[0054] S30. Press the third controller 109 to rotate its inner end away from the push handle 601. After the push handle 601 loses the limitation of the third controller 109, under the reset action of the elastic element 602, push the outer plugging tube 60 backward until the expandable hemostatic plug 40 is completely exposed in the blood vessel. At this time, the expandable hemostatic plug 40 can suck blood to stop bleeding immediately;

[0055] S40. Push the second controller 108 backward to drive the inner support tube 50 to move backward. Because the expandable hemostatic plug 40 sucks blood and expands, the outer diameter of the expandable hemostatic plug 40 is greater than the outer diameter of the outer plugging tube 60, and the outer plugging tube 60 forms a blockage for the expandable hemostatic plug 40. During the backward movement of the inner support tube 50, drive the expandable hemostatic plug 40 to elastically seal the puncture point.

[0056] S50. After waiting for 3 minutes, push the first controller 107 forward to move the push-pull wire 10 forward, driving the anchoring member 20 to reset to an axially reset and radially contracted state, and then withdraw from the blood vessel and retract the instrument.

[0057] Using the vascular closure device of the embodiment of the present invention has the following effects:

[0058] First of all, the blood vessel is blocked and closed by the cooperation of the anchoring member 20 and the expandable hemostatic plug 40. The shape of the anchoring member 20 is adjusted by using the first controller 107 and the push-pull wire 10, and the expandable hemostatic plug 40 is exposed by using the third controller 109. The expandable hemostatic plug 40 can quickly suck blood and expand to achieve hemostasis. Compared with the pressing hemostasis method in the prior art, the hemostasis time is greatly shortened, the efficiency of interventional surgery is improved, the interventional surgeon can complete the surgery in a shorter time, and the interventional surgery time and postoperative recovery time of the patient are reduced. At the same time, due to the rapid hemostasis, the patient can get out of bed and move in a shorter time, which is extremely beneficial to the postoperative recovery and quality of life of the patient.

[0059] Secondly, the expandable hemostatic plug 40 is made of a biodegradable material, which avoids the long-term presence of the expandable hemostatic plug 40 in the body and reduces the risk of complications. In contrast, the existing pressing hemostasis method may cause edema and damage to the tissues around the blood vessel, increasing the risk of complications such as infection and thrombosis. The vascular closure device of the present invention has higher safety.

[0060] Finally, the anchor 20 is in a flexible anchoring form such as a petal shape, a wire basket stent or a balloon, which can better adapt to the shape of blood vessels, reduce blood vessel damage, minimize secondary damage to blood vessels during interventional surgery, protect the integrity and function of blood vessels, and provide strong guarantee for the postoperative recovery of patients.

[0061] The above is a detailed introduction to the technical solution of the present invention in combination with specific embodiments, and the described specific embodiments are used to help understand the idea of the present invention. The derivations and deformations made by those skilled in the art based on the specific embodiments of the present invention also fall within the protection scope of the present invention.

Claims

1. A vascular occluder, comprising a handle (100), characterized in that, It further includes a push-pull wire (10), an anchor (20), a fixed catheter (30), an expandable hemostatic plug (40), an inner support tube (50), and an outer plug tube (60); A perforation (1011) is axially formed at the front end of the handle (100). The rear end of the fixed catheter (30) is fixedly arranged inside the handle (100), and the front end of the fixed catheter (30) extends out from the perforation (1011); The push-pull wire (10) is movably sleeved inside the fixed catheter (30). The rear end of the push-pull wire (10) extends out from the rear port of the fixed catheter (30). A first controller (107) for driving the push-pull wire (10) to axially move along the fixed catheter (30) is arranged on the handle (100). The anchor (20) is sleeved on the front part of the push-pull wire (10), and the front end of the anchor (20) is fixedly connected to the front end of the push-pull wire (10). The rear end of the anchor (20) is fixedly connected to the front end of the fixed catheter (30). The anchor (20) can move back and forth with the push-pull wire (10) to be in an axially contracted and radially expanded state / an axially reset and radially contracted state; The inner support tube (50) is movably sleeved on the outer wall of the fixed catheter (30). The front end of the inner support tube (50) is located at the rear side of the anchor (20). The rear end of the inner support tube (50) extends into the handle (100). A second controller (108) for driving the inner support tube (50) to axially move along the fixed catheter (30) is arranged on the handle (100); The outer plug tube (60) is movably sleeved on the outside of the inner support tube (50). The front end of the outer plug tube (60) is located at the rear side of the anchor (20). The rear end of the outer plug tube (60) extends into the handle (100). A third controller (109) for driving the outer plug tube (60) to axially move along the fixed catheter (30) is arranged on the handle (100); The expandable hemostatic plug (40) is sleeved between the front inner wall of the outer plug tube (60) and the front outer wall of the inner support tube (50). The outer plug tube (60) moves to enclose / expose the outer ring wall of the expandable hemostatic plug (40). The inner support tube (50) can axially move along the fixed catheter (30) to be separated from the expandable hemostatic plug (40) or sleeved on the inner ring wall of the expandable hemostatic plug (40). Among them, during the process of the inner support tube (50) moving backward, it drives the expandable hemostatic plug (40) to elastically seal the puncture point; When the anchor (20) is in the axially contracted and radially expanded state, it is in a petal shape, a basket stent or a balloon structure. When the anchor (20) is in the axially reset and radially contracted state, it is in a straight tube structure; A push handle (601) is fixedly sleeved at the rear end of the outer plug tube (60). An elastic element (602) is also sleeved on the outer plug tube (60). The front end of the elastic element (602) abuts against the rear end of the perforation (1011), and the rear end of the elastic element (602) abuts against the front end of the push handle (601). The inner end of the third controller (109) abuts against the rear end of the push handle (601); At least one mark (603) is arranged on the outer wall of the outer plug tube (60).

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

3. The vascular occluder according to claim 1, wherein A end cap (201) is fixedly provided at the front end of the anchoring member (20), and the end cap (201) is fixed to the front end of the push-pull wire (10) by welding, laser, argon arc welding, or hot melting.

4. The vascular occluder according to claim 1, characterized in that, The material of the expandable hemostatic plug (40) is collagen or polyglycolic acid.

5. The vascular occluder according to claim 1, characterized in that, A fixing seat (105) is fixedly provided inside the handle (100), and the fixing seat (105) has a mounting groove (1051) coaxial with the perforation (1011), and the rear end of the fixed catheter (30) is fixedly arranged in the mounting groove (1051).

6. The vascular occluder according to claim 1, wherein, The first controller (107) and the second controller (108) are push-pull buttons, each push-pull button has a locking hook, and a clamping plate (106) is fixedly provided inside the handle (100), and locking grooves for cooperating with the respective locking hooks are arranged on the clamping plate (106).

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