Double balloon occlusion catheter and method for peripheral vascular injury

Abstract

A double-balloon blocking catheter and method for peripheral vascular injury relate to the technical field of vascular surgical instruments. The double-balloon blocking catheter for peripheral vascular injury comprises a catheter, on the outer wall of which a blood inlet hole connected to a guidewire lumen and a blood outlet hole connected to the guidewire lumen are arranged at intervals, and a first balloon and a second balloon are arranged at intervals on the tube section between the blood inlet hole and the blood outlet hole. A method for treating a damaged common carotid artery is based on a double-balloon blocking catheter for peripheral vascular injury. The advantage of the present invention is that, as a surgical treatment tool after peripheral vascular injury, it combines the advantages of traditional vascular repair schemes and stent implantation schemes, blocks the blood flow of the target blood vessel by the first and second balloons, and performs closure treatment on the proximal and distal ends of the target blood vessel. In the process of repairing the blood vessel, the section of the guidewire lumen between the blood inlet hole and the blood outlet hole can provide temporary blood circulation to avoid necrosis of the terminal organs due to prolonged hypoxia and ischemia.

Description

Technical Field

[0001] The invention relates to the technical field of vascular surgical instruments, in particular to a double-balloon blocking catheter and method for peripheral vascular injury. Background Art

[0002] Peripheral blood vessels mainly refer to all blood vessels except the coronary arteries, thoracic and abdominal aortas, and intracranial arteries, mainly including visceral blood vessels, neck blood vessels, and limb blood vessels. Among the peripheral blood vessels, the common carotid artery is the main arterial trunk in the head and neck, with a large blood flow and a superficial location. It is used to supply blood and oxygen to the brain. Once the common carotid artery ruptures and is injured, the situation is the most dangerous and requires immediate pressure to stop bleeding. However, pressing to stop bleeding also blocks the blood and oxygen supply to the brain. Since the brain has a poor tolerance to hypoxia, if the injury cannot be treated and blood circulation cannot be restored in a short period of time, it will cause irreversible damage to the brain.

[0003] There are two options for dealing with common carotid artery rupture injury, one is to repair the blood vessels, and the other is to implant stents. When repairing blood vessels, it is necessary to first peel off a length of the proximal and distal ends of the ruptured blood vessels, and then clamp the proximal and distal ends of the blood vessels with vascular clamps respectively, and finally perform anastomosis repair on the ruptured blood vessels. After the repair is completed, remove the vascular clamps to restore blood supply and oxygen supply to the brain. The cost of repairing blood vessels is relatively low, the postoperative recovery is relatively fast, and the postoperative effect is relatively better. When implanting a stent, an interventional surgery is performed through the femoral artery, and the stent is delivered to the ruptured blood vessel. The proximal and distal ends of the blood vessel are connected through the stent, thereby restoring blood circulation in the common carotid artery. The stent implantation method does not require the repair of damaged blood vessels, the operation is efficient, and the blood supply to the brain can be restored more quickly, with a relatively low risk of brain damage.

[0004] The above two solutions have the following shortcomings: 1. During the process of repairing blood vessels, the proximal and distal ends of the blood vessels need to be clamped until the repair is completed and blood circulation can be restored. As the repair time increases, the risk of brain damage will continue to increase; 2. After the implantation of the stent, some patients will experience severe rejection reactions, and there is also the risk of the stent falling out of the blood vessel in the later stage, causing secondary bleeding at the ruptured blood vessel. Summary of the invention

[0005] The purpose of the present invention is to overcome the shortcomings of the prior art and provide a double-balloon occluding catheter and method for peripheral vascular injury, which solves the problem that in the current solutions for treating common carotid artery rupture injury, the intraoperative risk of repairing blood vessels is relatively large, and the postoperative risk of implanting stents is relatively large.

[0006] The technical solution of the present invention is: a double-balloon blocking catheter for peripheral vascular injury, comprising a catheter, wherein a guidewire cavity, a first air path channel and a second air path channel which are not connected to each other are arranged inside the catheter, a front guidewire port connected to the guidewire cavity, a first air port connected to the front end of the first air path channel and a second air port connected to the front end of the second air path channel are arranged at the front end of the catheter, a rear guidewire port connected to the guidewire cavity is arranged at the rear end of the catheter, a blood inlet hole connected to the guidewire cavity and a blood outlet hole connected to the guidewire cavity are arranged at intervals on the outer wall of the catheter, a first balloon and a second balloon are arranged at intervals on the tube section of the catheter located between the blood inlet hole and the blood outlet hole, the first balloon is connected to the rear end of the first air path channel, and the second balloon is connected to the rear end of the second air path channel.

[0007] A further technical solution of the present invention is: multiple blood inlet holes are evenly distributed around the outer wall of the catheter, the diameter of the blood inlet holes is 0.9-1.1mm, and the distance between any two adjacent blood inlet holes is greater than 2mm; multiple blood outlet holes are evenly distributed around the outer wall of the catheter, the diameter of the blood outlet holes is 0.9-1.1mm, and the distance between any two adjacent blood outlet holes is greater than 2mm.

[0008] A further technical solution of the present invention is: the first balloon is attached to the outer wall of the catheter in a surrounding manner, and is in a deflated state when the interior is not inflated, and expands into a cylindrical shape when the interior is filled with gas; the second balloon is attached to the outer wall of the catheter in a surrounding manner, and is in a deflated state when the interior is not inflated, and expands into a cylindrical shape when the interior is filled with gas.

[0009] A further technical solution of the present invention is: the catheter is provided with a circle of first developing marks on the outer wall of the tube at both ends of the first balloon, a circle of second developing marks on the outer wall of the tube at both ends of the second balloon, and a circle of third developing marks on the outer wall of the tube at the blood outlet and the blood inlet.

[0010] A further technical solution of the present invention is: the first development mark, the second development mark and the third development mark are all circular rings made of gold, and accordingly, the catheter is provided with a first positioning ring groove, a second positioning ring groove and a third positioning ring groove on the pipe section where the first development mark, the second development mark and the third development mark are located, respectively; the first development mark is installed in the first positioning ring groove and is flush with the outer wall of the catheter without a gap, the second development mark is installed in the second positioning ring groove and is flush with the outer wall of the catheter without a gap, and the third development mark is installed in the third positioning ring groove and is flush with the outer wall of the catheter without a gap.

[0011] A further technical solution of the present invention is: the axis line of the blood inlet hole forms an acute angle a with respect to the axis line of the guide wire cavity, and the axis line of the blood outlet hole forms an acute angle b with respect to the axis line of the guide wire cavity, the corner point of the acute angle a is relatively close to the rear end of the catheter, and the corner point of the acute angle b is relatively close to the front end of the catheter.

[0012] A further technical solution of the present invention is that the acute angle a and the acute angle b are both 25-45 degrees.

[0013] A further technical solution of the present invention is that the acute angle a and the acute angle b are both 35°.

[0014] The technical scheme of the present invention is: a method for treating a damaged common carotid artery, based on the above-mentioned double-balloon occluding catheter for peripheral vascular injury; the method acts on a human body model, the human body model is provided with a trunk of a human abdomen, chest, neck and head, the trunk is provided with a simulated epidermis on the outside, and the trunk is provided with simulated muscles and simulated blood vessels on the inside, and colored liquid is injected into the simulated blood vessels, and the simulated epidermis, simulated muscles and simulated blood vessels are all made of repairable materials;

[0015] Here’s how:

[0016] S01, first puncture the puncture sheath through the body surface into the femoral artery, then send the rear end of the guide wire into the femoral artery through the inner hole of the puncture sheath, and then push the guide wire deep into the blood vessel with the assistance of the DSA machine until the rear end of the guide wire reaches the distal end of the damaged common carotid artery, and the front end of the guide wire extends out of the body through the inner hole of the puncture sheath;

[0017] S02, passing the rear guide wire port at the rear end of the catheter through the front end of the guide wire, and then, with the assistance of the DSA machine, pushing the catheter along the path defined by the guide wire into the deep part of the blood vessel until the first balloon on the outer wall of the catheter reaches the distal end of the damaged common carotid artery and the second balloon on the outer wall of the catheter reaches the proximal end of the damaged common carotid artery, and then stopping pushing;

[0018] S03, inflating the first airbag through the first air port, and inflating the second airbag through the second air port, so that the first airbag and the second airbag expand and press against the inner wall of the common carotid artery, thereby temporarily fixing the catheter inside the common carotid artery; in this step, the air pressure inside the first airbag and the second airbag is controlled not to exceed 12Mpa;

[0019] S04, the guidewire is completely withdrawn from the guidewire lumen of the catheter. The blood at the inlet end of the common carotid artery then passes through the blood inlet hole, the guidewire lumen and the blood outlet hole in sequence under the action of blood pressure and enters the distal end of the common carotid artery, thereby ensuring smooth blood flow to the brain.

[0020] S05, the proximal and distal ends of the ruptured common carotid artery are peeled off 2-3 cm respectively, and then the blood vessel is repaired. After the blood vessel repair is completed, the puncture sheath and catheter are withdrawn, and the surface wound is sutured.

[0021] Compared with the prior art, the present invention has the following advantages:

[0022] 1. As a surgical treatment tool after peripheral vascular injury, it combines the advantages of traditional vascular repair schemes and stent implantation schemes. On the one hand, the first airbag and the second airbag block the blood flow of the target blood vessel, and the proximal and distal ends of the target blood vessel are closed to meet the prerequisites for vascular repair. On the other hand, during the process of vascular repair, the section of the guidewire cavity between the blood inlet and the blood outlet, as well as the section of the guidewire cavity between the blood inlet and the rear guidewire port, can provide temporary blood circulation, thereby maintaining smooth blood circulation and avoiding necrosis of terminal organs due to prolonged hypoxia and ischemia.

[0023] 2. Both the blood inlet and the blood outlet are designed with small aperture, multiple holes and uniform annular distribution, which can reduce the influence of the opening on the structural strength of the catheter to a large extent, offset the lateral force generated when the blood flows in or out, and make the catheter better centered in the blood vessel, avoiding the catheter sticking to the inner wall of the blood vessel under the action of lateral force, resulting in poor blood inflow or outflow.

[0024] 3. There are multiple developing marks on the catheter. During interventional surgery, the DSA machine (C-arm machine) can accurately locate the positions of the first balloon, the second balloon, the blood inlet hole and the blood outlet hole, which is convenient for the interventional surgery.

[0025] 4. The axis line of the blood inlet hole and the axis line of the blood outlet hole form an acute angle with respect to the axis line of the guide wire cavity. Based on this design, it can achieve the effect of draining blood into the guide wire cavity through the blood inlet hole, and draining blood out of the guide wire cavity through the blood vessel outlet hole.

[0026] The present invention is further described below in conjunction with the figures and embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 It is a structural schematic diagram of the present invention;

[0028] Figure 2 for Figure 1 AA section view;

[0029] Figure 3 for Figure 1 BB cross-sectional view;

[0030] Figure 4 for Figure 1 Enlarged view of part C;

[0031] Figure 5 for Figure 1 A magnified view of the D portion;

[0032] Figure 6 This is a usage state diagram of the present invention.

[0033] Legend: catheter 1; guidewire cavity 11; first air passage 12; second air passage 13; front guidewire port 14; first air port 15; second air port 16; blood inlet 17; blood outlet 18; first development mark 191; second development mark 192; third development mark 193; rear guidewire port 10; first balloon 2; second balloon 3. DETAILED DESCRIPTION

[0034] Embodiment 1:

[0035] like Figure 1-6 As shown, a double-balloon occluding catheter for peripheral vascular injury includes a catheter 1, wherein a guidewire cavity 11, a first air path channel 12, and a second air path channel 13 which are not connected to each other are provided inside the catheter 1, a front guidewire port 14 connected to the guidewire cavity 11, a first air port 15 connected to the front end of the first air path channel 12, and a second air port 16 connected to the front end of the second air path channel 13 are provided at the front end of the catheter 1, a blood inlet hole 17 connected to the guidewire cavity 11 and a blood outlet hole 18 connected to the guidewire cavity 11 are arranged at intervals on the outer wall of the catheter 1, and a rear guidewire port 10 connected to the guidewire cavity is provided at the rear end of the catheter 1.

[0036] The catheter 1 is provided with a first balloon 2 and a second balloon 3 at intervals on the outside of the tube section located between the blood inlet hole 17 and the blood outlet hole 18. The first balloon 2 is connected to the rear end of the first gas channel 12 and is attached to the outer wall of the catheter 1 in a surrounding manner. When the interior is not inflated, it is in a deflated state, and when the interior is filled with gas, it expands into a ring-shaped column. The second balloon 3 is connected to the rear end of the second gas channel 13, and is attached to the outer wall of the catheter 1 in a surrounding manner. When the interior is not inflated, it is in a deflated state, and when the interior is filled with gas, it expands into a ring-shaped column.

[0037] Preferably, multiple blood inlet holes 17 are evenly distributed around the outer wall of the catheter 1, the diameter of the blood inlet holes 17 is 0.9-1.1mm, and the distance between any two adjacent blood inlet holes 17 is greater than 2mm. Multiple blood outlet holes 18 are evenly distributed around the outer wall of the catheter, the diameter of the blood outlet holes 18 is 0.9-1.1mm, and the distance between any two adjacent blood outlet holes 18 is greater than 2mm. Based on the above-mentioned design of reducing the aperture, increasing the number of holes, and all holes being evenly distributed in a ring shape, the influence of the openings on the catheter structure strength can be reduced to a large extent, the lateral force generated when blood flows in or out can be offset, so that the catheter can be better centered in the blood vessel, and the catheter can be prevented from sticking to the inner wall of the blood vessel under the action of the lateral force, resulting in poor blood flow in or out.

[0038] Preferably, the catheter 1 is provided with a circle of first development mark 191 on the outer wall of the tube at both ends of the first balloon 2, a circle of second development mark 192 on the outer wall of the tube at both ends of the second balloon 3, and a circle of third development mark 193 on the outer wall of the tube at the blood outlet 18 and the blood inlet 17. The first development mark 191, the second development mark 192 and the third development mark 193 are all circular rings made of gold. Correspondingly, the catheter 1 is provided with a first positioning ring groove, a second positioning ring groove and a third positioning ring groove on the tube section where the first development mark 191, the second development mark 192 and the third development mark 193 are located, respectively. The first development mark 191 is installed in the first positioning ring groove and is flush with the outer wall of the catheter 1 without a gap. The second development mark 192 is installed in the second positioning ring groove and is flush with the outer wall of the catheter 1 without a gap. The third development mark 193 is installed in the third positioning ring groove and is flush with the outer wall of the catheter 1 without a gap. The above-mentioned development mark setting can accurately locate the positions of the first balloon 2, the second balloon 3, the blood inlet 17 and the blood outlet 18 through the DSA machine (C-arm machine) during interventional surgery, which is convenient for the implementation of interventional surgery.

[0039] Preferably, the axis of the blood inlet hole 17 forms an acute angle a relative to the axis of the guidewire cavity 11, and the axis of the blood outlet hole 18 forms an acute angle b relative to the axis of the guidewire cavity 11, and the corner point of the acute angle a is relatively close to the rear end of the catheter, and the corner point of the acute angle b is relatively close to the front end of the catheter. The acute angle a and the acute angle b are both 35°. Based on this angle setting, the effect of draining blood into the guidewire cavity 11 through the blood inlet hole 17 and draining blood to the outside of the guidewire cavity 11 through the blood vessel outlet hole 18 can be achieved.

[0040] Briefly describe the method for treating a damaged common carotid artery using the present invention:

[0041] 1. First, puncture the puncture sheath through the body surface into the femoral artery, then send the rear end of the guide wire into the femoral artery through the inner hole of the puncture sheath, and then push the guide wire deep into the blood vessel with the assistance of the DSA machine until the rear end of the guide wire reaches the distal end of the damaged common carotid artery, and the front end of the guide wire extends out of the body through the inner hole of the puncture sheath.

[0042] 2. Pass the rear guide wire port at the rear end of the catheter through the front end of the guide wire, and then, with the assistance of the DSA machine, push the catheter along the path defined by the guide wire into the deep part of the blood vessel until the first balloon 2 on the outer wall of the catheter reaches the distal end of the damaged common carotid artery and the second balloon 3 on the outer wall of the catheter reaches the proximal end of the damaged common carotid artery, and then stop pushing. In this step, during the process of pushing the catheter, the guide wire cavity of the catheter forms a sliding fit with the guide wire.

[0043] 3. Inflate the first airbag through the first air port and inflate the second airbag through the second air port, so that the first airbag and the second airbag expand and press against the inner wall of the common carotid artery, thereby temporarily fixing the catheter inside the common carotid artery. In this step, the air pressure inside the first airbag and the second airbag is controlled not to exceed 12Mpa.

[0044] 4. Completely withdraw the guide wire from the guide wire lumen of the catheter. Under the action of blood pressure, the blood at the inlet end of the common carotid artery will then pass through the blood inlet hole, guide wire lumen and blood outlet hole in sequence and enter the distal end of the common carotid artery, thus ensuring smooth blood flow to the brain.

[0045] 5. Peel off 2-3 cm of the proximal and distal ends of the ruptured common carotid artery respectively, and then perform vascular repair. After the vascular repair is completed, withdraw the puncture sheath and catheter 1, and suture the surface wound.

[0046] The method is applied to a human body model, which is used to help trainees quickly become familiar with the (surgical) treatment process of common carotid artery rupture. The human body model is provided with a torso of the abdomen, chest, neck and head of the human body, the outside of the torso is provided with a simulated epidermis, the inside of the torso is provided with simulated muscles and simulated blood vessels, and colored liquids are injected into the simulated blood vessels. The simulated epidermis, simulated muscles and simulated blood vessels are all made of repairable materials.

Claims

1. Double balloon occlusion catheter for peripheral vascular injury, characterized by: The invention comprises a catheter, wherein a guidewire cavity, a first air passage and a second air passage which are not connected to each other are arranged inside the catheter, a front guidewire port connected to the guidewire cavity, a first air port connected to the front end of the first air passage and a second air port connected to the front end of the second air passage are arranged at the front end of the catheter, a rear guidewire port connected to the guidewire cavity is arranged at the rear end of the catheter, a blood inlet hole connected to the guidewire cavity and a blood outlet hole connected to the guidewire cavity are arranged at intervals on the outer wall of the catheter, a first balloon and a second balloon are arranged at intervals on the tube section of the catheter between the blood inlet hole and the blood outlet hole, the first balloon is connected to the rear end of the first air passage, and the second balloon is connected to the rear end of the second air passage; Multiple blood inlet holes are evenly distributed around the outer wall of the catheter, the diameter of the blood inlet holes is 0.9-1.1mm, and the distance between any two adjacent blood inlet holes is greater than 2mm; multiple blood outlet holes are evenly distributed around the outer wall of the catheter, the diameter of the blood outlet holes is 0.9-1.1mm, and the distance between any two adjacent blood outlet holes is greater than 2mm; The axis of the blood inlet hole forms an acute angle a with respect to the axis of the guidewire cavity, and the axis of the blood outlet hole forms an acute angle b with respect to the axis of the guidewire cavity. The corner point of acute angle a is relatively close to the rear end of the catheter, and the corner point of acute angle b is relatively close to the front end of the catheter.

2. The double-balloon occluding catheter for peripheral vascular injury as claimed in claim 1, characterized in that: The first balloon is attached to the outer wall of the catheter in a surrounding manner. It is in a deflated state when it is not inflated, and expands into a cylindrical shape when it is filled with gas; the second balloon is attached to the outer wall of the catheter in a surrounding manner. It is in a deflated state when it is not inflated, and expands into a cylindrical shape when it is filled with gas.

3. The double-balloon occluding catheter for peripheral vascular injury as claimed in claim 2, characterized in that: The catheter has a circle of first developing marks on the outer wall of the first balloon at both ends, a circle of second developing marks on the outer wall of the second balloon at both ends, and a circle of third developing marks on the outer wall of the blood outlet and blood inlet.

4. The double-balloon occluding catheter for peripheral vascular injury as claimed in claim 3, characterized in that: The first development mark, the second development mark and the third development mark are all circular rings made of gold. Correspondingly, the catheter is provided with a first positioning ring groove, a second positioning ring groove and a third positioning ring groove on the pipe sections where the first development mark, the second development mark and the third development mark are located, respectively. The first development mark is installed in the first positioning ring groove and is flush with the outer wall of the catheter without a gap, the second development mark is installed in the second positioning ring groove and is flush with the outer wall of the catheter without a gap, and the third development mark is installed in the third positioning ring groove and is flush with the outer wall of the catheter without a gap.

5. The double-balloon occluding catheter for peripheral vascular injury as claimed in claim 4, characterized in that: The acute angle a and the acute angle b are both 25-45 degrees.

6. The double-balloon occluding catheter for peripheral vascular injury as claimed in claim 5, characterized in that: The acute angle a and the acute angle b are both 35°.

7. A method for treating a damaged common carotid artery, based on the double-balloon occluding catheter for peripheral vascular injury according to any one of claims 1 to 6; the method is applied to a human model, the human model having a trunk of a human abdomen, chest, neck and head, a simulated epidermis on the outside of the trunk, simulated muscles and simulated blood vessels on the inside of the trunk, colored liquids injected into the simulated blood vessels, and the simulated epidermis, simulated muscles and simulated blood vessels are all made of repairable materials; Here’s how: S01, first puncture the puncture sheath through the body surface into the femoral artery, then send the rear end of the guide wire into the femoral artery through the inner hole of the puncture sheath, and then push the guide wire deep into the blood vessel with the assistance of the DSA machine until the rear end of the guide wire reaches the distal end of the damaged common carotid artery, and the front end of the guide wire extends out of the body through the inner hole of the puncture sheath; S02, passing the rear guide wire port at the rear end of the catheter through the front end of the guide wire, and then, with the assistance of the DSA machine, pushing the catheter along the path defined by the guide wire into the deep part of the blood vessel until the first balloon on the outer wall of the catheter reaches the distal end of the damaged common carotid artery and the second balloon on the outer wall of the catheter reaches the proximal end of the damaged common carotid artery, and then stopping pushing; S03, inflating the first airbag through the first air port, and inflating the second airbag through the second air port, so that the first airbag and the second airbag expand and press against the inner wall of the common carotid artery, thereby temporarily fixing the catheter inside the common carotid artery; in this step, the air pressure inside the first airbag and the second airbag is controlled not to exceed 12Mpa; S04, the guidewire is completely withdrawn from the guidewire lumen of the catheter. The blood at the inlet end of the common carotid artery then passes through the blood inlet hole, the guidewire lumen and the blood outlet hole in sequence under the action of blood pressure and enters the distal end of the common carotid artery, thereby ensuring smooth blood flow to the brain. S05, the proximal and distal ends of the ruptured common carotid artery are peeled off 2-3 cm respectively, and then the blood vessel is repaired. After the blood vessel repair is completed, the puncture sheath and catheter are withdrawn, and the surface wound is sutured.

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