Intravascular thrombectomy balloon catheter

Abstract

The invention discloses an intravascular thrombus removal balloon catheter, comprising a balloon catheter body and a thrombus removal sheath. The balloon catheter body is composed of a tube body, a balloon, and a Y-shaped catheter seat. The distal end of the tube body is provided with a head, a guidewire cavity and a balloon cavity are provided inside the tube body, a balloon hole is provided outside the balloon cavity, a balloon channel and a guidewire channel are provided inside the Y-shaped catheter seat, and a silicone ring and a stopcock are provided outside the guidewire channel. The distal end of the thrombus removal sheath is provided with a net bag, and the proximal end of the thrombus removal sheath is provided with a sheath seat. The net bag is fixed to the front end of the thrombus removal sheath by welding or bonding, and a developing ring is provided at the front end of the net bag, and a hole is provided in the middle of the developing ring. The balloon catheter of the invention increases the rigidity of the latex balloon, can maintain a certain shape in the blood vessel after filling, avoids the occurrence of balloon slippage, and is compatible with the guide wire, so that the balloon catheter can reach a farther lesion position under the guidance of the guide wire.

Description

Technical Field

[0001] The invention relates to a catheter, in particular to an intravascular thrombectomy balloon catheter. Background Art

[0002] The existing Fogarty thrombectomy balloon catheter is a balloon catheter with a closed front end. The balloon is made of latex material and both ends of the balloon can be visualized. After the balloon enters the target blood vessel, the balloon is filled and the thrombus in the occluded blood vessel is crushed. The small blood clots formed after the crushing flow to the distal blood vessels with the blood circulation and are slowly absorbed. Larger emboli or old flocculent thrombi will be dragged out of the body with the balloon. The cutting balloon catheter is a balloon catheter with a blade on the outer wall of the balloon, which is specially used to cut plaque tissue deposited on the blood vessel wall. It mainly benefits by squeezing plaques and slightly dilating the blood vessel wall.

[0003] The existing Fogarty thrombectomy balloon catheter is a single-lumen tube with poor pushing force. In the absence of a guide wire, it is difficult to reach the extremely fine blood vessels with complex bifurcations at the distal end. Small blood clots crushed by the balloon or small emboli that are not captured may block some distal blood vessels, causing some complications or even sudden death. Moreover, since the latex balloon is relatively soft, it is very easy for the balloon to slip or rupture in the calcified lesion blood vessel, thus losing the thrombectomy function.

[0004] The balloon of the cutting balloon catheter is made of nylon and has a cutting blade on its surface. It will expand to the rated outer diameter under the rated pressure. When the balloon diameter exceeds 1.1 times the normal inner diameter of the blood vessel, the blade on the balloon surface can easily cause cutting damage to the blood vessels in non-lesioned areas, causing damage to the blood vessel wall. When the balloon diameter is smaller than the inner diameter of the blood vessel, the embolus can easily slip out of the gap between the balloon and the blood vessel, causing the thrombus removal to fail or prolonging the operation time.

[0005] Therefore, those skilled in the art provide an intravascular thrombectomy balloon catheter to solve the problems raised in the above-mentioned background technology. Summary of the invention

[0006] The purpose of the present invention is to provide an intravascular thrombectomy balloon catheter to solve the problems raised in the above-mentioned background technology.

[0007] To achieve the above object, the present invention provides the following technical solutions:

[0008] An intravascular thrombus removal balloon catheter comprises a balloon catheter body and a thrombus removal sheath, wherein the balloon catheter body is composed of a tube body, a balloon, and a Y-shaped catheter seat, a net bag is arranged at the distal end of the thrombus removal sheath, and a sheath tube seat is arranged at the proximal end of the thrombus removal sheath;

[0009] A head is provided at the distal end of the tube body, a guidewire cavity and a balloon cavity are provided inside the tube body, and the guidewire cavity is coaxial with the tube body. The cross-sectional shape of the balloon cavity can be elliptical, rectangular or other shapes. A balloon hole is provided outside the balloon cavity, and the guidewire cavity passes through the head. The left and right ends of the balloon are respectively provided with a distal development mark and a proximal development mark;

[0010] A balloon channel and a guidewire channel are provided in the Y-shaped catheter seat, the guidewire channel is located below the balloon channel, and a silicone ring and a stopcock are provided outside the guidewire channel;

[0011] A sheath plugging channel is arranged in the sheath tube seat, a second cock is sleeved on the outer side of the sheath plugging channel, a second silicone ring is arranged at the front end of the second cock, and the second silicone ring is sleeved on the sheath plugging channel;

[0012] The net bag is fixed to the front end of the plug removal sheath by welding or bonding, and a developing ring is arranged at the front end of the net bag, and a hole is opened in the middle of the developing ring;

[0013] The outer surfaces of the tube body, the balloon and the embolism removal sheath are all coated with a hydrophilic lubricating coating, and the inner surfaces of the guide wire cavity and the embolism removal sheath are all coated with a silicone oil lubricating coating.

[0014] As a further embodiment of the present invention, the material of the head end is not limited to polyurethane (PU, TPU) containing barium sulfate or bismuth subcarbonate, polyetheramide elastomer (Pebax) containing barium sulfate or bismuth subcarbonate, low-density polyethylene (LDPE) containing barium sulfate or bismuth subcarbonate, polyvinyl chloride (PVC) containing barium sulfate or bismuth subcarbonate, nylon (PA) containing barium sulfate or bismuth subcarbonate, or other thermoplastic elastomer plastics.

[0015] As a further solution of the present invention, the material of the tube body is not limited to polyetheramide elastomer (Pebax), polyurethane (PU, TPU), low-density polyethylene (LDPE), polyvinyl chloride (PVC), nylon (PA), multi-layer composite tube or sea wave tube reinforced with metal wire braiding, PI tube, and the inner and outer layer materials of the composite tube reinforced with metal wire braiding are not limited to polyetheramide elastomer (Pebax), nylon (PA), polytetrafluoroethylene (PTFE) or other high-rigidity thermoplastic elastomers.

[0016] As a further embodiment of the present invention, the materials of the distal development mark and the proximal development mark are not limited to adhesives containing developers, coating materials containing developers, or stainless steel, pure gold, platinum-iridium alloy, nickel-titanium alloy, and gold-plated stainless steel or other metal and alloy materials.

[0017] As a further solution of the present invention, the material of the balloon is latex, and may also be modified polyurethane (TPU), highly elastic polyolefin (TPE) or other thermoplastic plastics, and the compliance of the balloon can reach 6-10.

[0018] As a further solution of the present invention, the materials of the Y-shaped catheter seat and the sheath seat are not limited to polycarbonate (PC), acrylonitrile-butadiene-styrene copolymer (ABS), polyoxymethylene (POM), polypropylene (PP) and their alloy plastics.

[0019] As a further solution of the present invention, the material of the embolism removal sheath is not limited to fluoroplastics such as FEP, PTFE, low-density polyethylene (LDPE), polyvinyl chloride (PVC), nylon (PA), multi-layer composite tubes or sea wave tubes, and PI tubes reinforced with metal wire braiding; the inner and outer layer materials of the composite tube reinforced with metal wire braiding are not limited to polyetheramide elastomer (Pebax), nylon (PA), polytetrafluoroethylene (PTFE) or other high-rigidity thermoplastic elastomers, and the coating of the embolism removal sheath can be an ultra-thin PTFE outer layer.

[0020] As a further solution of the present invention, the material of the net bag is not limited to nylon thread, polyester thread, nylon thread or other polymer threads, or nickel-titanium alloy mesh wire with memory function and hydrophilic coating, and the net bag is retracted into the thrombus removal sheath when not in use.

[0021] As a further solution of the present invention, the material of the developing ring is not limited to stainless steel, pure gold, platinum-iridium alloy, nickel-titanium alloy, and gold-plated stainless steel or other metal and alloy materials.

[0022] As a further solution of the present invention, the material of the silicone ring 1 and the silicone ring 2 can be silicone or rubber.

[0023] Compared with the prior art, the present invention has the following beneficial effects:

[0024] 1. The balloon catheter of the present invention increases the rigidity of the latex balloon, and can maintain a certain shape in the blood vessel after being filled, thereby avoiding the balloon from slipping off, and is compatible with the guide wire, so that the balloon catheter can reach a farther lesion location under the guidance of the guide wire.

[0025] 2. The balloon catheter of the present invention has a variable diameter of the balloon without replacement, so that the outer diameter of the balloon can adapt to the inner diameter of different blood vessels, so that the captured embolus will neither slip out from the gap between the balloon and the blood vessel nor cause additional cutting and high friction damage to the normal blood vessel wall.

[0026] 3. When the balloon catheter of the present invention is in use, the gap between the balloon and the blood vessel becomes smaller, which can prevent the thrombus from slipping out of the thrombus remover and preventing the thrombus from falling off and spreading to distant places, significantly improving the thrombus clearance rate, reducing the number of thrombus removals, shortening the time interval from onset to recanalization of the blood vessels, and buying precious rescue time for patients, which plays a vital role in saving patients' lives; the net bag can enhance the rigidity of the balloon, so that the balloon will not slip even in calcified and narrow blood vessels or complex branched blood vessels, and the uneven surface of the net bag is conducive to the deposition of emboli on the net bag and the balloon is taken out of the body. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 It is a schematic diagram of the structure of the present invention.

[0028] Figure 2 It is a cross-sectional view of the tube body in the present invention.

[0029] Figure 3 It is an enlarged view of the net bag in the present invention.

[0030] Figure 4 It is a schematic diagram of the structure of the coronary blood vessels in the present invention.

[0031] Figure 5 It is a schematic diagram of the structure of the balloon in the present invention located in the coronary blood vessel.

[0032] Figure 6 It is a schematic diagram of the structure of the balloon in the present invention located in an arterial blood vessel.

[0033] In the figure: 1-tube body; 11-head; 12-balloon cavity; 13-balloon hole; 14-guidewire cavity; 2-balloon; 21-distal development mark; 22-proximal development mark; 3-Y-type catheter seat; 31-balloon channel; 32-stopcock 1; 33-silicone ring 1; 34-guidewire channel; 4-sheath removal; 5-net bag; 51-developing ring; 6-sheath seat; 61-silicone ring 2; 62-sheath channel; 63-stopcock 2. DETAILED DESCRIPTION

[0034] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0035] See also Figures 1 to 3In an embodiment of the present invention, an intravascular thrombus removal balloon catheter comprises a balloon catheter body and a thrombus removal sheath 4, wherein the balloon catheter body comprises a tube body 1, a super-compliant low-pressure inflation balloon 2, and a Y-shaped catheter seat 3 with adjustable sealing degree, a net bag 5 is provided at the distal end of the thrombus removal sheath 4, and a sheath seat 6 with adjustable sealing degree is provided at the proximal end of the thrombus removal sheath 4;

[0036] A flexible and developable head 11 is provided at the distal end of the tube body 1, a guidewire cavity 14 and a balloon cavity 12 are provided inside the tube body 1, and the guidewire cavity 14 is coaxial with the tube body 1, the cross-sectional shape of the balloon cavity 12 can be elliptical, rectangular or other shapes, a balloon hole 13 is provided outside the balloon cavity 12 to achieve communication between the balloon 2 and the balloon cavity 12, the guidewire cavity 14 passes through the head 11, and a distal development mark 21 and a proximal development mark 22 are provided at the left and right ends of the ultra-compliant low-pressure filling balloon 2, respectively;

[0037] A balloon channel 31 and a guidewire channel 34 are provided in the Y-shaped catheter seat 3 with adjustable sealing degree. The guidewire channel 34 is located below the balloon channel 31. A silicone ring 33 and a plug 32 are provided outside the guidewire channel 34. Rotating the plug 32 can control the tightness of the silicone ring 33 and adjust the minimum inner diameter of the guidewire channel 34 to control the relative position of the guidewire and the balloon catheter or to seal the entire guidewire channel 34.

[0038] A net bag 5 is provided at the distal end of the plug sheath 4, and a sheath tube seat 6 with adjustable sealing degree is provided at the proximal end of the plug sheath 4. A plug sheath channel 62 is provided in the sheath tube seat 6. A second cock 63 is sleeved on the outer side of the plug sheath channel 62. A second silicone ring 61 is provided at the front end of the second cock 63. The second silicone ring 61 is sleeved on the plug sheath channel 62.

[0039] The net bag 5 is fixed to the front end of the plug removal sheath 4 by welding or bonding. A developing ring 51 is provided at the front end of the net bag 5. A hole is provided in the middle of the developing ring 51 to allow the guide wire to pass through.

[0040] The outer surfaces of the tube body 1, the balloon 2 and the embolism removal sheath 4 are all coated with a hydrophilic lubricating coating, and the inner surfaces of the guidewire cavity 14 and the embolism removal sheath 4 are all coated with a silicone oil lubricating coating.

[0041] The material of the head end 11 is not limited to polyurethane (PU, TPU) containing barium sulfate or bismuth subcarbonate, polyetheramide elastomer (Pebax) containing barium sulfate or bismuth subcarbonate, low-density polyethylene (LDPE) containing barium sulfate or bismuth subcarbonate, polyvinyl chloride (PVC) containing barium sulfate or bismuth subcarbonate, nylon (PA) containing barium sulfate or bismuth subcarbonate, or other thermoplastic elastomer plastics.

[0042] The material of the tube body 1 is not limited to polyetheramide elastomer (Pebax), polyurethane (PU, TPU), low-density polyethylene (LDPE), polyvinyl chloride (PVC), nylon (PA), multi-layer composite tube or sea wave tube reinforced with metal wire braiding, PI tube, and the inner and outer layer materials of the composite tube reinforced with metal wire braiding are not limited to polyetheramide elastomer (Pebax), nylon (PA), polytetrafluoroethylene (PTFE) or other high-rigidity thermoplastic elastomers.

[0043] The materials of the distal development mark 21 and the proximal development mark 22 are not limited to adhesives containing developers, coating materials containing developers, or stainless steel, pure gold, platinum-iridium alloy, nickel-titanium alloy, and gold-plated stainless steel or other metal and alloy materials.

[0044] The material of the balloon 2 is latex, and may also be modified polyurethane (TPU), highly elastic polyolefin (TPE) or other thermoplastic plastics. The compliance of the balloon 2 can reach 6-10.

[0045] The materials of the Y-shaped catheter seat 3 and the sheath seat 6 are not limited to polycarbonate (PC), acrylonitrile-butadiene-styrene copolymer (ABS), polyoxymethylene (POM), polypropylene (PP) and their alloy plastics.

[0046] The material of the embolism removal sheath 4 is not limited to fluoroplastics such as FEP, PTFE, low-density polyethylene (LDPE), polyvinyl chloride (PVC), nylon (PA), multi-layer composite tubes or sea wave tubes reinforced with metal wire braiding, and PI tubes; the inner and outer layer materials of the composite tube reinforced with metal wire braiding are not limited to polyetheramide elastomer (Pebax), nylon (PA), polytetrafluoroethylene (PTFE) or other high-rigidity thermoplastic elastomers, and the coating of the embolism removal sheath 4 can be an ultra-thin PTFE outer layer.

[0047] The material of the net bag 5 is not limited to nylon, polyester, nylon or other polymer wires, or nickel-titanium alloy mesh wire with memory function and hydrophilic coating, and the net bag 5 is retracted in the thrombus removal sheath 4 when not in use.

[0048] The material of the developing ring 51 is not limited to stainless steel, pure gold, platinum-iridium alloy, nickel-titanium alloy, gold-plated stainless steel or other metal or alloy materials.

[0049] The material of the silicone ring 1 33 and the silicone ring 2 61 can be silicone or rubber.

[0050] See also Figures 4 to 6 Taking the coronary thrombectomy as an example, the use of the thrombectomy balloon catheter of the present invention is described in detail. The inner diameters of the coronary and arterial vessels are shown below. Figure 4 As shown, it can be clearly seen that the coronary vessels are thinner than the arterial vessels.

[0051] When coronary thrombus removal is required, after the guide wire passes through the arterial blood vessel and enters the target coronary blood vessel, the thrombus removal sheath 4 is first sent along the guide wire to the blocked part of the coronary blood vessel. Under the guidance of the X-ray equipment, it is ensured that the developing ring 51 at the head end of the net bag 5 passes through the blocked part of the blood vessel, and then the balloon catheter is also sent into the coronary blood vessel along the guide wire. At this time, the balloon catheter is located in the thrombus removal sheath 4, and the net bag 5 retracted in the thrombus removal sheath 4 will be pushed open into the blood vessel, and the balloon 2 will be filled through the balloon channel 31 in the Y-shaped catheter seat 3. At this time, the status of the balloon 2, the thrombus removal sheath 4 and the net bag 5 is as shown in the figure. Figure 5 As shown;

[0052] Control the second stopcock 63 of the sheath seat 6 and the first stopcock 32 of the Y-shaped catheter seat 3 to ensure that no air enters the embolization sheath 4 and the guidewire lumen 14 of the balloon catheter, and drag the embolization sheath 4 and the balloon catheter out of the body along the guidewire;

[0053] Under the guidance of the X-ray device, when the proximal developing mark 22 of the balloon 2 is observed to be located in the arterial blood vessel, the stopcock 63 of the sheath seat 6 is slightly loosened, and the sheath seat 6 is pulled to reduce the relative distance between the developing ring 51 and the head end of the embolism removal sheath 4. At this time, the balloon 2 is deformed and its outer diameter increases. Under the guidance of the X-ray device, the outer diameter of the balloon is observed, and the balloon 2 is appropriately filled or released to make the gap between the outer diameter of the balloon 2 and the arterial blood vessel wall as small as possible to ensure that the embolus will not slip out of the gap. At this time, the status of the balloon 2, the embolism removal sheath 4 and the net bag 5 is as shown in FIG. Figure 6 As shown, it can be seen that the outer diameter of the balloon 2 increases;

[0054] During the process of withdrawing the balloon catheter and removing the embolism sheath 4, the relative positions of the embolism sheath 4 and the net bag 5, as well as the filling volume of the balloon 2 can be continuously adjusted so that the outer diameter of the balloon 2 always matches the inner diameter of the blood vessel, thereby ensuring that the embolus does not detach during the removal process.

[0055] The above description is only a preferred specific implementation manner of the present invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field can make equivalent replacements or changes according to the technical scheme and inventive concept of the present invention within the technical scope disclosed by the present invention, which should be covered by the protection scope of the present invention.

Claims

1. An intravascular thrombus removal balloon catheter, comprising a balloon catheter body and a thrombus removal sheath (4), characterized in that: The balloon catheter body is composed of a tube body (1), a balloon (2), and a Y-shaped catheter seat (3); a net bag (5) is provided at the distal end of the embolization sheath (4), and a sheath tube seat (6) is provided at the proximal end of the embolization sheath (4); A head (11) is provided at the distal end of the tube body (1), a guidewire cavity (14) and a balloon cavity (12) are provided inside the tube body (1), the guidewire cavity (14) is coaxial with the tube body (1), the cross-sectional shape of the balloon cavity (12) is elliptical or rectangular, a balloon hole (13) is provided outside the balloon cavity (12), the guidewire cavity (14) passes through the head (11), and a distal development mark (21) and a proximal development mark (22) are provided at the left and right ends of the balloon (2), respectively; A balloon channel (31) and a guidewire channel (34) are provided in the Y-shaped catheter seat (3), the guidewire channel (34) is located below the balloon channel (31), and a silicone ring (33) and a stopcock (32) are provided outside the guidewire channel (34); A sheath plugging channel (62) is provided in the sheath tube seat (6), a second cock (63) is sleeved on the outer side of the sheath plugging channel (62), a second silicone ring (61) is provided at the front end of the second cock (63), and the second silicone ring (61) is sleeved on the sheath plugging channel (62); The net bag (5) is fixed to the front end of the bolt removal sheath (4) by welding or bonding, and a developing ring (51) is provided at the front end of the net bag (5), and a hole is provided in the middle of the developing ring (51); The outer surfaces of the tube body (1), the balloon (2) and the embolism removal sheath (4) are all coated with a hydrophilic lubricating coating, and the inner surfaces of the guidewire cavity (14) and the embolism removal sheath (4) are all coated with a silicone oil lubricating coating.

2. The intravascular thrombectomy balloon catheter according to claim 1, characterized in that: The material of the head (11) is polyurethane (PU, TPU) containing barium sulfate or bismuth subcarbonate, polyether amide elastomer (Pebax) containing barium sulfate or bismuth subcarbonate, low-density polyethylene (LDPE) containing barium sulfate or bismuth subcarbonate, polyvinyl chloride (PVC) containing barium sulfate or bismuth subcarbonate, and nylon (PA) containing barium sulfate or bismuth subcarbonate.

3. The intravascular thrombectomy balloon catheter according to claim 1, characterized in that: The material of the tube body (1) is polyetheramide elastomer (Pebax), polyurethane (PU, TPU), low-density polyethylene (LDPE), polyvinyl chloride (PVC), nylon (PA), a multi-layer composite tube or a hypotube reinforced with metal wire braiding, or a PI tube. The inner and outer layer materials of the composite tube reinforced with metal wire braiding are polyetheramide elastomer (Pebax), nylon (PA) or polytetrafluoroethylene (PTFE).

4. The intravascular thrombectomy balloon catheter according to claim 1, characterized in that: The materials of the distal development mark (21) and the proximal development mark (22) are adhesive containing a developer, coating material containing a developer, or stainless steel, pure gold, platinum-iridium alloy, nickel-titanium alloy, and stainless steel that has been gold-plated.

5. The intravascular thrombectomy balloon catheter according to claim 1, characterized in that: The material of the balloon (2) is latex, modified polyurethane (TPU) or highly elastic polyolefin (TPE), and the compliance of the balloon (2) reaches 6-10.

6. The intravascular thrombectomy balloon catheter according to claim 1, characterized in that: The Y-shaped catheter seat (3) and the sheath tube seat (6) are made of materials such as polycarbonate (PC), acrylonitrile-butadiene-styrene copolymer (ABS), polyoxymethylene (POM), and polypropylene (PP).

7. The intravascular thrombectomy balloon catheter according to claim 1, characterized in that: The material of the embolism removal sheath (4) is fluoroplastic, low-density polyethylene (LDPE), polyvinyl chloride (PVC), nylon (PA), a multi-layer composite tube or a hypotube reinforced with metal wire braiding, or a PI tube; the inner and outer layer materials of the composite tube reinforced with metal wire braiding are polyetheramide elastomer (Pebax), nylon (PA) or polytetrafluoroethylene (PTFE), and the coating of the embolism removal sheath (4) is an ultra-thin polytetrafluoroethylene (PTFE) outer layer.

8. The intravascular thrombectomy balloon catheter according to claim 1, characterized in that: The material of the net bag (5) is nylon thread, polyester thread or nylon thread, or nickel-titanium alloy mesh thread with memory function and hydrophilic coating, and the net bag (5) is retracted into the plug removal sheath (4) when not in use.

9. The intravascular thrombectomy balloon catheter according to claim 1, characterized in that: The material of the developing ring (51) is stainless steel, pure gold, platinum-iridium alloy, nickel-titanium alloy and gold-plated stainless steel.

10. The intravascular thrombectomy balloon catheter according to claim 1, characterized in that: The materials of the silicone ring 1 (33) and the silicone ring 2 (61) are silicone or rubber.

Images