A balloon catheter with controllable blood flow occlusion amount

Abstract

The present invention discloses a balloon catheter with controllable blood flow blocking amount, including a balloon catheter body and a guide wire, the balloon catheter body is composed of a tube body, a balloon, and a Y-shaped catheter seat, the front end of the guide wire is provided with a head end and a spring coil, the tube body is composed of a flexible distal segment, a balloon segment, and a rigid push shaft segment, a guide wire cavity is provided inside the flexible distal segment, and an end of the balloon segment near the rigid push shaft segment is also provided with a developing marker ring, and a balloon channel and a guide wire channel are provided in the Y-shaped catheter seat. The present invention can adapt to a longer operation time, and can appropriately open a vascular access in an operation that requires a long-term blockage of an aneurysm or a blood vessel, control blood flow, avoid ischemia or metabolic disorders of downstream organs, and improve the survival rate of patients. In addition, due to the multi-cavity structure, the guide wire cavity and the balloon cavity are independent of each other, and the position of the catheter and the guide wire can be flexibly adjusted during the balloon filling period, which is convenient for the operator to operate and reduces the operation time.

Description

Technical Field

[0001] The invention relates to a catheter used in surgical operations, in particular to a balloon catheter with controllable blood flow blocking amount. Background Art

[0002] The existing occlusion balloon catheter system is a set product consisting of an occlusion balloon catheter and a 0.010-inch hydrophilic guidewire. The occlusion balloon catheter is a single-lumen, tapered, multifunctional catheter with a hydrophilic coating on the outer layer. The distal end is equipped with a non-detachable, highly compliant balloon that is inflated at low pressure and has two radiopaque marker bands. There is an overflow port at the front end of the catheter, and the balloon can only be inflated when the overflow port is blocked by the guidewire. The overflow port is made of heat-shrinkable polyester elastomer; the proximal and distal ends of the catheter are made of modified nylon and polyolefin elastomer, respectively; the catheter lining is made of polytetrafluoroethylene; the balloon is made of heat-shrinkable elastomer; and the proximal and distal radiopaque marker bands are both made of platinum-iridium alloy. The surface of the 0.010-inch guidewire is covered with a hydrophilic coating and is made of 304 stainless steel, and the X-ray development wire is made of platinum-tungsten alloy.

[0003] The existing blocking balloon catheter is a single-lumen tube. The balloon can only be filled when the guide wire completely blocks the overflow port. At this time (during the long period of time required for blocking), the relative position of the guide wire and the catheter cannot move, otherwise the balloon will fail to fill (lose the blocking effect or vascular support effect), or the balloon will leak, and the excess contrast agent will enter the blood vessel, causing unnecessary harm to the patient and increasing the operation time. In addition, the existing blocking balloon catheter system will completely block the blood flow in the blood vessel during the blood flow blockage period. When the blood flow is blocked for a long time, it is easy to cause long-term ischemia of the tissue near the downstream blood vessel and a sudden increase in blood pressure in the upstream blood vessel. Both of these situations will cause iatrogenic complications that are difficult to resolve during the operation. Data show that blood vessel blockage longer than 60 minutes will cause obvious metabolic disorders and organ damage, and the 24-hour survival rate is only 2 / 3. Therefore, those skilled in the art provide a balloon catheter with a controllable blood flow blockage amount to solve the problems raised in the above background technology. Summary of the Invention

[0004] The object of the present invention is to provide a balloon catheter with controllable blood flow blocking amount to solve the problems raised in the above background technology.

[0005] To achieve the above object, the present invention provides the following technical solutions:

[0006] A balloon catheter with controllable blood flow occlusion amount comprises a balloon catheter body and a guide wire. The balloon catheter body comprises a tube body, a balloon, and a Y-shaped catheter seat. The Y-shaped catheter seat is mounted on the rear end of the tube body, the balloon is sleeved on the front end of the tube body, the front end of the guide wire is provided with a head end and a spring coil, and the outer surface of the guide wire is coated with a hydrophilic lubricating coating.

[0007] The tube body is composed of a flexible distal section, a balloon section, and a rigid push shaft section. The flexible distal section, the balloon section, and the rigid push shaft section are arranged on the tube body in sequence from the front end to the rear end. A guidewire cavity 1 is provided inside the flexible distal section. The balloon section contains a balloon cavity and a guidewire cavity 2. A balloon hole is provided outside the balloon cavity. A blood inlet hole and a blood outlet hole are provided outside the guidewire cavity 2, which together with the guidewire cavity 2 form a blood passage. The blood inlet hole and the blood outlet hole are located at the rear end and the front end of the guidewire cavity 2, respectively.

[0008] A developing marker ring is also provided at one end of the balloon segment near the rigid pushing shaft segment. The relative position of the developing marker ring and the blood flow inlet hole is fixed. The outer surface of the tube body is coated with a hydrophilic lubricating coating, and the insides of the guidewire lumen 1 and the guidewire lumen 2 are both coated with a silicone oil lubricating coating.

[0009] The left and right ends of the balloon are respectively provided with a distal development marker ring and a proximal development marker ring, and the outer surface of the balloon is coated with a hydrophilic lubricating coating;

[0010] A balloon channel and a guidewire channel are provided in the Y-shaped catheter seat. The guidewire channel is located at the lower side of the balloon channel, and a silicone ring and a stopcock are provided outside the guidewire channel.

[0011] As a further embodiment of the present invention, the material of the flexible distal segment 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.

[0012] As a further embodiment of the present invention, the material of the balloon segment is not limited to polyurethane (PU, TPU), polyetheramide elastomer (Pebax), low-density polyethylene (LDPE), polyvinyl chloride (PVC), nylon (PA) or other thermoplastic elastomers.

[0013] As a further solution of the present invention, the material of the rigid push shaft segment is not limited to the multi-layer composite tube or sea wave tube, PI tube reinforced with metal wire braiding, 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.

[0014] As a further solution of the present invention, the distal development marker ring, the proximal development marker ring and the development marker ring materials are not limited to stainless steel, pure gold, platinum-iridium alloy, nickel-titanium alloy and gold-plated stainless steel or other metals and alloy materials.

[0015] 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.

[0016] As a further solution of the present invention, the material of the Y-shaped catheter seat is not limited to polycarbonate (PC), acrylonitrile-butadiene-styrene copolymer (ABS), polyoxymethylene (POM), polypropylene (PP) and their alloy plastics.

[0017] As a further solution of the present invention, the material of the guide wire is not limited to stainless steel, nickel-titanium alloy, and gold-plated stainless steel or other metal and alloy materials. The coating of the guide wire can be an ultra-thin PTFE outer layer.

[0018] As a further solution of the present invention, the material of the silicone ring can be silicone or rubber.

[0019] Compared with the prior art, the present invention has the following beneficial effects:

[0020] 1. The balloon catheter of the present invention increases the flexibility of balloon inflation, that is, the balloon can be inflated or released without being affected by the position of the guidewire, thereby increasing the safety during surgery. At the same time, the surgeon can adjust the position of the balloon in the blood vessel or the position of the guidewire at any time according to the balloon inflation situation, greatly improving the flexibility of the surgery to adapt to more complex vascular conditions and aneurysm occlusion in complex locations.

[0021] 2. The balloon catheter of the present invention realizes the control of blocked blood flow. Before completely blocking the blood flow, it slowly and gradually reduces the blood flow in the target blood vessel to increase the reaction time of the human body's hemodynamic mechanism adjustment; on the other hand, during long-term surgery, it reduces the organ damage caused by ischemia. When it is necessary to release the blocked blood flow to a certain extent, the amount of blood flow released can be adjusted at any time according to the actual situation.

[0022] 3. The balloon catheter of the present invention can achieve less vascular damage. The tip of the balloon catheter and the tip of the guide wire are soft, slender and pre-shaped, causing less damage to the blood vessels and having greater adaptability to the target blood vessels, especially complex aneurysms located at the vascular bifurcation.

[0023] 4. This invention can accommodate longer surgical procedures. During surgeries requiring prolonged occlusion of aneurysms or blood vessels, it can appropriately open vascular access, control blood flow, avoid ischemia or metabolic disturbances in downstream organs, and improve patient survival. Furthermore, due to its multi-lumen structure, the guidewire and balloon cavities are independent of each other, allowing for flexible adjustment of the catheter and guidewire positions during balloon inflation, facilitating operator manipulation and reducing surgical time. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 It is a structural schematic diagram of the present invention.

[0025] Figure 2 It is a structural schematic diagram of a second embodiment of the blood flow inlet hole and the blood flow outlet hole in the present invention.

[0026] Figure 3 The guide wire of the present invention is in the guide wire cavity. Figure 1 .

[0027] Figure 4 The guide wire of the present invention is in the guide wire cavity. Figure 2 .

[0028] Figure 5 This is a schematic structural diagram of the present invention taking the occlusion of aneurysms in complex intracranial locations as an example.

[0029] In the figure: 1-tube body; 11-flexible distal segment; 111-guidewire lumen 1; 12-balloon segment; 121-balloon hole; 122-blood flow outlet hole; 123-blood flow inlet hole; 124-development marker ring; 13-rigid push shaft segment; 14-balloon lumen; 15-guidewire lumen 2; 2-balloon; 21-distal development marker ring; 22-proximal development marker ring; 3-Y-type catheter seat; 31-balloon channel; 32-stopcock; 33-silicone ring; 34-guidewire channel; 4-guide wire; 41-head end; 42-spring coil. DETAILED DESCRIPTION

[0030] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. 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 making creative efforts are within the scope of protection of the present invention.

[0031] See also Figure 1In an embodiment of the present invention, a balloon catheter with controllable blood flow blocking amount includes a balloon catheter body and a guide wire 4. The balloon catheter body is composed of a multi-section, multi-lumen tube body 1, an ultra-compliant low-pressure inflation balloon 2, and a Y-shaped catheter seat 3 with adjustable sealing degree. The Y-shaped catheter seat 3 is installed at the rear end of the tube body 1, and the balloon 2 is sleeved on the front end of the tube body 1. The front end of the guide wire 4 is provided with a head end 41 with enhanced imaging effect and a spring coil 42 for increasing the flexibility of the front end of the guide wire. The head end 41 has a certain pre-shaping that can adapt to the direction of the blood vessel. The outer surface of the guide wire 4 is coated with a hydrophilic lubricating coating.

[0032] The multi-segment, gradually changing, multi-lumen tube body 1 is composed of a flexible distal segment 11, a balloon segment 12, and a rigid push shaft segment 13. The flexible distal segment 11, the balloon segment 12, and the rigid push shaft segment 13 are arranged in sequence from the front end to the rear end on the tube body 1. A guidewire cavity 111 is provided inside the flexible distal segment 11, and a balloon cavity 14 and a guidewire cavity 2 15 are provided inside the balloon segment 12. A balloon hole 121 is provided outside the balloon cavity 14 to achieve communication between the balloon 2 and the balloon cavity 14. A blood inlet hole 123 and a blood outlet hole 122 are provided outside the guidewire cavity 15 to form a blood passage together with the guidewire cavity 15. The blood inlet hole 123 and the blood outlet hole 122 are respectively located at the rear end and the front end of the guidewire cavity 15.

[0033] One end of the balloon segment 12 near the rigid push shaft segment 13 is further provided with a developing marker ring 124. The position of the developing marker ring 124 relative to the blood flow inlet hole 123 is a certain value. The flexible distal segment 11 has a certain pre-shaped shape that can adapt to the direction of the blood vessel. The outer surface of the tube body 1 is coated with a hydrophilic lubricating coating, and the guidewire lumen 111 and the guidewire lumen 2 15 are both coated with a silicone oil lubricating coating.

[0034] The left and right ends of the ultra-compliant low-pressure inflation balloon 2 are respectively provided with a distal development marker ring 21 and a proximal development marker ring 22, and the outer surface of the balloon 2 is coated with a hydrophilic lubricating coating;

[0035] 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 on the lower side of the balloon channel 31. A silicone ring 33 and a plug 32 are provided on the outside of the guidewire channel 34. The material of the silicone ring 33 can be silicone or rubber. 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 movement of the guidewire and the balloon catheter or to seal the entire guidewire channel 34.

[0036] The material of the flexible distal segment 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.

[0037] The material of the balloon segment 12 is not limited to polyurethane (PU, TPU), polyetheramide elastomer (Pebax), low-density polyethylene (LDPE), polyvinyl chloride (PVC), nylon (PA) or other thermoplastic elastomers.

[0038] The material of the rigid push shaft segment 13 is not limited to a multi-layer composite tube or a sea wave tube or a PI tube reinforced with metal wire braiding, 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.

[0039] The materials of the distal development marker ring 21, the proximal development marker ring 22 and the development marker ring 124 are not limited to stainless steel, pure gold, platinum-iridium alloy, nickel-titanium alloy, gold-plated stainless steel or other metals and alloy materials.

[0040] 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.

[0041] The material of the Y-shaped catheter seat 3 is not limited to polycarbonate (PC), acrylonitrile-butadiene-styrene copolymer (ABS), polyoxymethylene (POM), polypropylene (PP) and their alloy plastics.

[0042] The material of the guide wire 4 is not limited to stainless steel, nickel-titanium alloy, gold-plated stainless steel or other metal and alloy materials. The coating of the guide wire 4 can be an ultra-thin PTFE outer layer.

[0043] See also Figure 2 , Figure 2 This is the second embodiment of the blood inlet hole 123 and the blood outlet hole 122 in the present invention. The blood inlet hole 123 and the blood outlet hole 122 are arranged to be groove-shaped, that is, dense holes. The holes are connected to each other to form a completely open area, that is, a groove is opened in the guide wire cavity, so that blood enters the guide wire cavity through the groove-shaped opening.

[0044] In addition, the outer diameter of the guide wire 4 described in the present invention can also be set to a gradient type, or the inner diameters of the guide wire cavity 111 and the guide wire cavity 2 15 can be set to a gradient type, and the gap between the guide wire and the guide wire cavity can be coordinated to control the blood flow entering the gap, thereby controlling the blood flow.

[0045] The following example takes the occlusion of complex intracranial aneurysms as an example (e.g. Figure 5 ), specifically describing the use of the balloon catheter of the present invention.

[0046] First, after the guide wire 4 enters the target branch vessel, the balloon catheter is passed through the guide wire lumen of the catheter from the tail end of the guide wire 4. After successfully reaching the branch vessel along the path of the guide wire 4, the positions of the distal development marker ring 21 and the proximal development marker ring 22 at both ends of the balloon 2 are observed under the guidance of the X-ray equipment. After the balloon 2 of the balloon catheter is adjusted to an appropriate position, the tail end stopcock 34 is tightened to fix the position of the balloon catheter, and the balloon 2 is inflated through the balloon channel 31 of the Y-shaped catheter seat 3 to achieve the effect of occluding the blood vessel;

[0047] When the blood flow needs to be released, the cock 34 is unscrewed, the guide wire 4 is withdrawn, and the position of the tip 41 of the guide wire 4 is observed to be behind the imaging mark ring 124 under the guidance of the X-ray device (see Figure 3 ), blood can enter the blood flow inlet hole 123, pass through the guide wire lumen 15, and flow out from the blood flow outlet hole 122 to reach the branch blood vessel, and a blood channel can be formed. Furthermore, by controlling the position of the head end 41 of the guide wire 4 so that it is located at different positions of the blood flow inlet hole 122, it is possible to control the blood flow entering the blood flow inlet hole 122. When the head end 41 of the guide wire 4 is further away from the imaging marker ring 124, the blood flow entering the inlet hole is less; when the head end 41 of the guide wire 4 is further away from the imaging marker ring 124, the blood flow entering the inlet hole is more.

[0048] Furthermore, by controlling the position of the tip 41 of the guide wire 4 so that it is located in different areas of the blood flow inlet hole 123, the blood flow entering the inlet hole can be controlled. When the tip 41 of the guide wire 4 is further away from the imaging mark ring 124, the blood flow entering the blood flow inlet hole 123 is less; when the tip 41 of the guide wire 4 is further away from the imaging mark ring 124, the blood flow entering the blood flow inlet hole 123 is more. Figure 4 As shown, blood flow can be controlled to half of the maximum amount.

[0049] The above description is only a preferred specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any technician familiar with the technical field, within the technical scope disclosed by the present invention, who makes equivalent replacements or changes based on the technical solution and inventive concept of the present invention, should be covered by the scope of protection of the present invention.

Claims

1. A balloon catheter with controllable blood flow blocking amount, comprising a balloon catheter body and a guide wire (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); the Y-shaped catheter seat (3) is installed at the rear end of the tube body (1); the balloon (2) is sleeved on the front part of the tube body (1); the front end of the guide wire (4) is provided with a head end (41) and a spring coil (42); and the outer surface of the guide wire (4) is coated with a hydrophilic lubricating coating; The tube body (1) is composed of a flexible distal section (11), a balloon section (12), and a rigid push shaft section (13). The flexible distal section (11), the balloon section (12), and the rigid push shaft section (13) are arranged on the tube body (1) in sequence from the front end to the rear end. The flexible distal section (11) is provided with a guidewire cavity 1 (111). The balloon section (12) contains a balloon cavity (14) and a guidewire cavity 2 (15). The balloon cavity (14) is provided with a balloon hole (121) on the outside. The guidewire cavity 2 (15) is provided with a blood flow inlet hole (123) and a blood flow outlet hole (122) on the outside. Together with the guidewire cavity 2 (15), the guidewire cavity 2 (15) form a blood passage. The blood flow inlet hole (123) and the blood flow outlet hole (122) are located at the rear end and the front end of the guidewire cavity 2 (15), respectively. One end of the balloon section (12) near the rigid push shaft section (13) is also provided with a developing mark ring (124), and the relative position of the developing mark ring (124) and the blood flow inlet hole (123) is a certain value. The outer surface of the tube body (1) is coated with a hydrophilic lubricating coating, and the inside of the guide wire cavity 1 (111) and the guide wire cavity 2 (15) are both coated with a silicone oil lubricating coating; A distal development marking ring (21) and a proximal development marking ring (22) are respectively provided at the left and right ends of the balloon (2), and the outer surface of the balloon (2) is coated with a hydrophilic lubricating coating; A balloon channel (31) and a guidewire channel (34) are provided in the Y-shaped catheter seat (3), the guidewire channel (34) is located at the lower side of the balloon channel (31), and a silicone ring (33) and a stopcock (32) are provided outside the guidewire channel (34); The material of the flexible distal section (11) is one of polyurethane containing barium sulfate or bismuth subcarbonate, polyetheramide elastomer containing barium sulfate or bismuth subcarbonate, low-density polyethylene containing barium sulfate or bismuth subcarbonate, polyvinyl chloride containing barium sulfate or bismuth subcarbonate, and nylon containing barium sulfate or bismuth subcarbonate; The material of the balloon segment (12) is one of polyurethane, polyetheramide elastomer, low-density polyethylene, polyvinyl chloride, and nylon; The material of the rigid push shaft section (13) is a multi-layer composite tube or a hypo tube or a PI tube reinforced by metal wire braiding, and the inner and outer layer materials of the multi-layer composite tube reinforced by metal wire braiding are one of polyetheramide elastomer, nylon and polytetrafluoroethylene; The material of the distal development marker ring (21), the proximal development marker ring (22) and the development marker ring (124) is one of stainless steel, pure gold, platinum-iridium alloy, nickel-titanium alloy, and stainless steel that has been gold-plated; The material of the balloon (2) is one of latex, modified polyurethane, and highly elastic polyolefin, and the compliance of the balloon (2) reaches 6 to 10; The material of the guide wire (4) is one of stainless steel, nickel-titanium alloy, and stainless steel that has been gold-plated, and the coating of the guide wire (4) is an ultra-thin PTFE outer layer.

2. A balloon catheter with controllable blood flow blocking amount according to claim 1, characterized in that: The material of the Y-shaped catheter seat (3) is one of polycarbonate, acrylonitrile-butadiene-styrene copolymer, polyoxymethylene, polypropylene, and alloy plastic.

3. The balloon catheter with controllable blood flow blocking amount according to claim 1, characterized in that: The material of the silicone ring (33) is silicone or rubber.

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