Blocking balloon micro-catheter with adjustable bent head end

Abstract

The invention discloses a blocking balloon micro-catheter with a bent head end, and belongs to the technical field of medical instruments. The balloon catheter is sequentially composed of a balloon catheter head end, a catheter far-end bending adjusting section, a near-end supporting section and a handle from far to near, the catheter far-end bending adjusting section is provided with a far-end balloon, the near end of the balloon catheter head end is connected with the far end of a driving wire a, and the catheter far-end bending adjusting section is connected with the far end of a driving wire c at the position corresponding to the far end of the far-end balloon. The near ends of the driving wire a and the driving wire b are connected with a driving device a, and the near end of the driving wire c is connected with a driving device b. The three functions of active bending adjustment, balloon plugging and drug delivery are integrated in one micro catheter, surgical operation is simplified, instrument replacement during surgery is reduced, and surgical risk and cost are reduced.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a balloon microcatheter with an adjustable bendable tip for occlusion. Background Technology

[0002] In interventional radiology, microcatheters are key devices for superselective endovascular therapy. Occlusive balloon microcatheters, based on traditional microcatheters, have a repeatedly inflatable balloon positioned at a certain distance from the catheter tip. Once inflated, the balloon anchors proximal to the target vessel, blocking blood flow and preventing reflux of embolic material. This allows for precise embolization, improving treatment outcomes and reducing complications. These devices are widely used in hepatic artery chemoembolization, bronchial artery embolization for hemoptysis, and prostate artery embolization.

[0003] Chinese patent CN222033348U discloses a super-compliant occlusion balloon catheter, whose tip is passive and relies on pre-shaping or guidewire guidance to pass through tortuous and complex vascular pathways. In clinical practice, operators often face challenges such as highly tortuous vessels, tricky branching angles, and atherosclerotic plaques. The passivity of existing catheters results in insufficient maneuverability, passability, and directionality when navigating such complex anatomical structures, often leading to prolonged operation time, increased fluoroscopy time, increased surgical risks, and even surgical failure. Therefore, existing microcatheters have many shortcomings, one of the biggest being the lack of active tip control.

[0004] Therefore, there is an urgent clinical need for an occlusion balloon microcatheter that can provide active tip-end steering control in order to cope with complex vascular anatomy and improve the success rate and efficiency of the procedure. Summary of the Invention

[0005] Therefore, the purpose of this invention is to provide a tip-adjustable occlusion balloon microcatheter that integrates three major functions—active bending, balloon occlusion, and drug delivery—into a single microcatheter, simplifying surgical procedures, reducing intraoperative instrument changes, and lowering surgical risks and costs.

[0006] To achieve the above objectives, the present invention provides the following technical solution: This invention provides a tip-adjustable occlusion balloon microcatheter, which consists of a balloon catheter tip, a distal bending section, a proximal support section, and a handle, arranged from distal to proximal. The distal bending section has a distal balloon. The proximal end of the balloon catheter tip is connected to the distal end of drive wire a. The distal bending section is connected to the distal end of drive wire c at the corresponding distal end of the distal balloon. The proximal ends of drive wire a and drive wire b are connected to drive device a, and the proximal end of drive wire c is connected to drive device b.

[0007] Based on the above technical solution, further, both the driving device a and the driving device b include a rotating column a and a rotating column groove a, the proximal end of the driving wire a or the driving wire c is wound on the rotating column a, and the rotating column a is located in the rotating column groove a; The swivel groove a in the driving device a is disposed on the top of the swivel a, the swivel b is wound around the near end of the driving wire b, and the swivel b is located in the swivel groove b.

[0008] Based on the above technical solution, both the rotating column a and the rotating column b are provided with limiting grooves in the axial direction, and both the rotating column groove a and the rotating column groove b are provided with locking mechanisms that match the limiting grooves; both the rotating column a and the rotating column b are threaded structures.

[0009] Among them, the threaded column a and column b mainly act as winding wheels, winding the drive wire around the column. The drive wire can be extended or retracted by rotating the column, thereby achieving the bending of the head end.

[0010] The limiting groove and the locking mechanism are interlocked. When the rotating column a or the rotating column b rotates exactly to the position where the limiting groove corresponds to the locking mechanism, the corresponding drive wire is locked, thereby preventing the tip from rebounding due to vascular pulsation or external force during the operation.

[0011] Among them, the operation module that controls more than one drive wire has an internal structure including two or more rotating columns. The multiple rotating columns are arranged in a structure surrounded by the same center, and can control the corresponding drive wires respectively.

[0012] Based on the above technical solution, the top of the rotating column a (12-6-1) is provided with a display mark (12-4) and a display indicator mark (12-3). The extension and retraction range of the drive wire a (9-1), the drive wire b (9-2) and the drive wire c (9-3) is 0-50mm, corresponding to the bending angle of the catheter is 0-90 degrees.

[0013] Among them, the indicator and the pointer indicator are used to indicate the angle of the head bend when the rotating indicator corresponds to the pointer indicator, so that the surgeon can keep track of the head bend in time.

[0014] Based on the above technical solution, the distal balloon is adjacent to or partially covers the distal bending section of the catheter, and the distal balloon is a super-compliant balloon made of polyurethane or medical-grade silicone rubber.

[0015] The distal balloon is a super-compliant balloon, making it more flexible and expandable into different shapes to meet the requirements of distal catheter flexibility and better adapt to various vascular conditions.

[0016] Based on the above technical solution, the proximal support section and the distal bending section of the catheter are composite multi-lumen tubes, which include an inner liner, a reinforcing layer and an outer tube arranged coaxially from the inside to the outside.

[0017] Among them, the composite multi-lumen tube design of the inner liner, outer tube and reinforcement layer reduces the filling dead space and improves the balloon response speed; makes the overall structure of the catheter more symmetrical, and improves the transmission of pushing force and torque; and avoids the risk of the annular channel being blocked due to bending or compression.

[0018] Based on the above technical solution, the inner liner is further provided with a guide wire / drug delivery channel; The outer tube in the proximal support section of the catheter is provided with an inflatable balloon channel, a drive wire channel a, a drive wire channel b, and a drive wire channel c. The drive wire a, the drive wire b, and the drive wire c are respectively located in the drive wire cavity a, the drive wire cavity b, and the drive wire cavity c; The hardness of the outer tube gradually decreases from the proximal end to the distal end; The reinforcing layer is provided with a reinforcing structure, which is a coiled wire, a braided wire, or a combination of coiled wire and braided wire.

[0019] Only a single drive wire can be accommodated in the drive wire cavity.

[0020] The guidewire / drug delivery channel is the central channel that runs through the catheter. Its proximal end connects to the drug delivery channel opening at the proximal handle, and its distal end opens at the very tip of the catheter, used to deliver drugs through the guidewire.

[0021] Based on the above technical solution, further, the outer surface of the reinforcing layer of the distal bending section of the catheter is provided with a fixing ring / marking ring for the proximal end of the balloon and a fixing ring / marking ring for the distal end of the balloon, and the tip of the balloon catheter is provided with a fixing ring / marking ring for the tip of the catheter. The drive wire a and the drive wire b are connected to the fixing ring / marking ring at the tip of the catheter, and the drive wire c is connected to the fixing ring / marking ring at the distal end of the balloon.

[0022] The drive assembly consists of drive wire a, drive wire b, and the fixing / marking ring at the catheter tip. Another drive assembly consists of drive wire c and the fixing / marking ring at the distal end of the balloon. Each drive assembly can be controlled independently, which not only allows the distal end of the catheter to bend into different angles or even S-bends in the axial direction, but also allows the drive wire c of one drive assembly to bend the proximal end of the catheter's bending segment at an angle to hook onto the main blood vessel. Then, the drive wires a and b of the other drive assembly can be controlled to finely adjust the distal end of the bending segment to enter the branch. This significantly improves the ability to pass through complex and tortuous blood vessels. A set of independent drive components can consist of a single or several drive wires and a retaining ring, enabling the same drive component to control the bending of the distal bending section of the conduit in different directions at the same axial position.

[0023] Among them, the fixation ring / marking ring at the catheter tip, the fixation ring / marking ring at the distal end of the balloon, and the fixation ring / marking ring at the catheter tip are platinum-iridium alloy rings or coatings. They not only serve to fix the drive wire, but also can be visualized under X-ray fluoroscopy, thus clearly locating the catheter tip and balloon position.

[0024] Based on the above technical solution, the outer surface of the catheter is further coated with a lubricating coating, and the inner walls of the guidewire / drug delivery channel, the inflation balloon channel, the drive wire channel a, the drive wire channel b, and the drive wire channel c are all coated with a coating.

[0025] The outer surface of the conduit is coated with a lubricating coating, which can significantly reduce the resistance to passage.

[0026] The inner walls of the guidewire / drug delivery channel, the inflation balloon channel, the drive wire channel a, the drive wire channel b, and the drive wire channel c are all coated with a coating to prevent drug adhesion or blockage of the guidewire channel and to reduce the frictional resistance between the drive wire and the inner wall of the channel to prevent jamming.

[0027] Based on the above technical solution, the proximal end of the handle is provided with a balloon inflation interface and a guidewire / drug delivery interface. The balloon inflation interface is connected to the inflation balloon cavity, and the guidewire / drug delivery interface is connected to the guidewire / drug delivery cavity.

[0028] Compared with the prior art, the present invention has the following beneficial effects: 1. This invention allows the operator to precisely control the bending angle and direction of the distal end of the catheter in real time outside the body to smoothly pass through tortuous blood vessels and selectively enter target branch vessels; by inflating the distal balloon, blood flow in the target vessel is temporarily blocked to achieve precise embolization treatment; it has an independent cavity for delivering embolic agents, chemotherapy drugs or contrast agents; it integrates the three major functions of active bending adjustment, balloon occlusion and drug delivery into a single microcatheter, simplifying the surgical procedure, reducing intraoperative instrument changes, and lowering surgical risks and costs.

[0029] 2. The active tip bending function of the present invention enables the catheter to "turn" and easily cope with complex vascular anatomy, significantly improving the success rate of entering the target blood vessel and shortening the operation time.

[0030] 3. This invention allows the operator to control the direction of the catheter tip in real time outside the body, achieving precise "point-and-shoot" control. Even with the balloon inflated and blood flow blocked, the tip position can still be finely adjusted via the bending function to ensure accurate drug delivery.

[0031] 4. The multiple cavities of this invention are independent of each other, arranged in parallel, do not interfere with each other, and can work simultaneously, ensuring the reliability and efficiency of each function. Attached Figure Description

[0032] To more clearly illustrate the embodiments of the present invention, the accompanying drawings involved in the embodiments will be briefly described below.

[0033] Figure 1 This is a schematic diagram of the overall structure of the balloon dilation catheter of the present invention; Figure 2 for Figure 1 Schematic diagram of the cross-section of the conduit at section AA; Figure 3 This is a magnified schematic diagram of the distal end of the catheter (including the balloon) and a schematic diagram of its state after dilation in different blood vessels; Figure 4 This is a structural schematic diagram of the drive mechanism at the handle and a detailed view of a single module. Figure 5 A schematic diagram showing the bent position of the balloon catheter tip; Figure 6 This is an enlarged view of the display indicator and its portion; In the diagram: 1. Balloon catheter tip; 2. Distal balloon; 3. Distal catheter bend section; 4. Proximal support section; 5. Handle; 6. Balloon inflation port; 7. Guidewire / drug delivery port; 8. Fixing ring / marking ring; 8-1. Fixing ring / marking ring at the catheter tip; 8-2. Fixing ring / marking ring at the distal end of the balloon; 8-3. Fixing ring / marking ring at the proximal end of the balloon; 9. Drive wire; 9-1. Drive wire a; 9-2. Drive wire b; 9-3. Drive wire c; 10. Distal balloon fixation point; 11. Proximal balloon fixation point; 12. Drive wire Device; 12-1, Drive device a; 12-2, Drive device b; 12-3, Indicator; 12-4, Indicator; 12-5, Locking mechanism; 12-6, Rotating column; 12-6-1, Rotating column a; 12-6-2, Rotating column b; 12-7, Limiting groove; 13, Inner liner; 13-1, Guidewire / drug delivery channel; 13-2, Inflatable balloon channel; 14, Reinforcing layer; 15, Outer tube; 15-1, Drive wire channel a; 15-2, Drive wire channel b; 15-3, Drive wire channel c; 16, Blood vessel. Detailed Implementation

[0034] The present invention will be described in detail below with reference to the embodiments. However, the implementation of the present invention is not limited thereto. Obviously, the embodiments described below are only some embodiments of the present invention. For those skilled in the art, other similar embodiments can be obtained without creative effort and all fall within the protection scope of the present invention.

[0035] To avoid ambiguity, the orientation is defined as follows: the part of the product device that is closer to the operator is the proximal end, and the part that is farther away from the operator is the distal end. Example

[0036] like Figure 1 As shown, the present invention provides an adjustable-tip occlusion balloon microcatheter, which mainly includes a distal balloon 2, a distal adjustable section 3, a proximal support section 4, and a handle 5. Example

[0037] like Figure 2 As shown, both the proximal support section 4 and the distal bending section 3 of the catheter are composite multi-lumen tubes, which include an inner liner 13, an outer tube 15, and a reinforcing layer 14. The composite multi-lumen tube design reduces the filling dead space, improves balloon response speed, makes the overall catheter structure more symmetrical, and optimizes push force and torque transmission; it also avoids the risk of occlusion of the annular channel due to bending or compression. The composite multi-lumen tube includes a guidewire / drug delivery channel 13-1 between the inner liner 13 and the outer tube 15, which is the central lumen of the catheter. Its proximal end connects to the drug delivery channel opening at the proximal handle, and its distal end opens at the very tip of the catheter for guiding the guidewire or delivering drugs. Between the reinforcing layer 14 and the outer tube 15, there is a balloon inflating channel 13-2 and several drive wire channels a15-1, b15-2, and c15-3, all of which are independent of each other. The inflating channel 13-2 is connected proximally to the balloon inflating channel opening of the proximal handle and distally to the inner lumen of the balloon. The drive wire channels a15-1, b15-2, and c15-3 are connected proximally to the proximal drive device 12 and distally terminate at the distal bending section 3 of the catheter. A drive wire 9 is inserted into the channel, with its distal end fixed to the fixing ring / marking ring 8-1 at the catheter tip or the fixing ring / marking ring 8-2 at the distal end of the balloon, and its proximal end fixed to the rotating column 12-6 of the drive device 12. The bending of the catheter tip can be controlled externally through the rotating column drive device module. The outer tube 15 gradually decreases in stiffness from the proximal support section to the distal bending section. The reinforcing layer 14 has a reinforcing structure, which is one or more of the following: a coiled wire, a braided wire, or a combination of coiled and braided wire. Example

[0038] like Figure 3 As shown, the distal balloon 2 is adjacent to or partially covers the distal bending section 3 of the catheter, and the balloon is a super-compliant balloon made of polyurethane or medical-grade silicone rubber, which makes the balloon more flexible and expandable into different shapes to meet the conditions of flexible distal catheter and better adapt to various vascular conditions.

[0039] In addition, such as Figure 3 As shown, the distal bending section 3 of the catheter contains at least two independent drive wires 9 and a drive assembly consisting of a fixing ring / marker ring 8-1 at the catheter tip or a fixing ring / marker ring 8-2 at the distal end of the balloon. For example, drive wires a9-1 and b9-2 together with the fixing ring / marker ring 8-1 at the catheter tip form one drive assembly, and drive wire c9-3 together with the fixing ring / marker ring 8-2 at the distal end of the balloon form another drive assembly. This design not only allows the distal end of the catheter to bend into different angles or even S-bends in the axial direction, but also allows the drive wire c9-3 of one drive assembly to bend the proximal end of the bending section into an angle to hook the main blood vessel, and then the drive wires a9-1 or b9-2 of the other drive assembly to fine-tune the distal end of the bending section into the branch. This significantly improves the ability to pass through complex and tortuous blood vessels.

[0040] One of the independent drive components can consist of a single or several drive wires 9 and a fixing ring / marking ring 8-1 at the tip of the catheter or a fixing ring / marking ring 8-2 at the distal end of the balloon, so that the same drive component can control the same axial position of the catheter bending section 3 to bend in different directions; wherein, one end of the drive wire 9 is connected to the fixing ring 8-1 or 8-2, and the other end is connected to the drive device 12 of the handle.

[0041] The fixation ring / marking ring 8-1 at the catheter tip or the fixation ring / marking ring 8-2 at the distal end of the balloon is made of platinum-iridium alloy or has a coating. It not only serves to fix the drive wire but also can be visualized under X-ray fluoroscopy, thus clearly locating the catheter tip and balloon.

[0042] The fixing ring / marking ring 8-1 at the tip of the catheter or the fixing ring / marking ring 8-2 at the distal end of the balloon is located on the reinforcing layer 14 of the composite multi-lumen tube. The drive wire a9-1, drive wire b9-2 or drive wire c9-3 are located in the drive wire channels a15-1, b15-2 and c15-3 between the reinforcing layer 14 and the outer tube 15 of the composite multi-lumen tube. Each channel can only accommodate a single drive wire. Example

[0043] like Figure 4 As shown, the handle 5 is equipped with a drive device 12, which controls the extension and retraction of the drive wire 9 and the bending angle of its tip. The extension and retraction range of each drive wire is 0-50mm, corresponding to a bending angle of 0-90 degrees at the tip of the catheter. The drive device 12 consists of drive units 12 that control different drive components. Each drive unit 12 includes a threaded column 12-6, a locking mechanism 12-5, a display indicator 12-4, and a display indication indicator 12-3.

[0044] The threaded column 12-6 mainly acts as a winding wheel, winding the drive wire around the column. The drive wire can be extended or retracted by rotating the column, thereby achieving head bending.

[0045] In addition, the threaded structure has a limiting groove 12-7 designed axially upward on the rotating column. This limiting groove 12-7 fits perfectly with the locking mechanism 12-5. When the rotating column rotates to the point where the limiting groove 12-7 corresponds to the locking mechanism 12-5, the drive wire is locked, thus preventing the tip from rebounding due to vascular pulsation or external force during surgery. For operation modules that only control a single drive wire 9, such as the drive device b12-2, its structure only includes one set of rotating columns 12-6. However, for the drive device ba12-1 that controls more than one drive wire 9, its internal structure includes two or more rotating columns 12-6. The multiple rotating columns form a structure with rotating columns a12-6-1 and b12-6-2 surrounding the same center, which can control the corresponding drive wires a9-1 and b9-2 respectively.

[0046] In addition, each drive unit 12 has a display mark 12-4 and a display indicator mark 12-3. When the rotation display mark corresponds exactly to the display indicator mark 12-3, it indicates the angle of the head bend, which makes it convenient for the surgeon to keep track of the head bend. Example

[0047] The distal end of the catheter, balloon 2, is fixed to the outer tube 15 by bonding or welding at both ends. The inner lumen of balloon 2 communicates with the balloon inflation channel 13-2. Balloon 2 has a distal fixation ring / marker ring 8-2 and a proximal fixation ring / marker ring 8-3, respectively. The very tip of the catheter also has a catheter tip fixation ring / marker ring 8-1, which not only serves to fix the drive wire 9 but also facilitates imaging and observation under X-ray. Example

[0048] During the procedure, the microcatheter is first advanced to the vicinity of the target area under the guidance of a guidewire. When selective access to branch vessels with tricky angles is required, the operator controls the extension and retraction of the drive wire via the drive device 12 on the handle 5, causing the catheter tip to bend as needed. Figure 5 The catheter is positioned at the required angle to smoothly enter the target blood vessel. Once in position, a syringe is connected to the balloon inflation port 6, and inflation medium is injected into the balloon cavity 13-2 to inflate the distal balloon 2 and occlude the blood vessel. Subsequently, an embolic agent or chemotherapy drug is injected into the guidewire / drug delivery cavity 13-1 through the guidewire / drug delivery port 7 for precise release. After treatment, the fluid in the distal balloon 2 is aspirated, and the catheter is withdrawn. Example

[0049] refer to Figures 1 to 5This embodiment provides a tip-adjustable bendable balloon microcatheter for hepatic artery chemoembolization. The total length of the microcatheter is approximately 1300 mm, and its outer diameter ranges from 1.2 Fr0.40 mm to 3.0 Fr1.0 mm.

[0050] The handle 5 is injection molded from medical-grade polycarbonate material and consists of several drive devices 12. The overall structure is ergonomically designed, and the surface has anti-slip textures. The handle connects to two channels, leading to: The balloon inflation port 6 is equipped with a rotary valve with a Luer connector for connecting a 1 mL balloon-specific syringe.

[0051] The guidewire / drug delivery port 7 is equipped with a standard medical Luer connector for connecting a syringe to deliver chemotherapy drugs or embolic agents.

[0052] The distal balloon 2 is made of compliant medical-grade silicone or polyurethane, with a working length of approximately 8 mm, low working pressure, and a maximum inflation volume of 0.22 ml. When fully inflated, its diameter can expand to approximately 4 mm, effectively occluding most of the hepatic artery branches. The distal balloon 2 is welded to the outer tube 15 using a laser welding machine.

[0053] The drive wire 9 is made of highly elastic nickel-titanium alloy wire with a diameter of approximately 0.2 mm. Its distal end is fixed to the fixing rings / marking rings 8-1 and 8-2 by laser welding. This material selection ensures that the drive wire 9 can return to its original shape after repeated bending, providing reliable performance.

[0054] Three fixing rings / marking rings are provided: 8-1 at the catheter tip, 8-2 at the distal end of the balloon, and 8-3 at the proximal end of the balloon. All are made of platinum-iridium alloy (Pt-90%, Ir-10%). The first one, the tip fixing ring / marking ring 8-1, is tightly fixed to the catheter 2mm from the tip. It can be used not only for precise positioning of the catheter tip under X-ray but also as a fixing position for the drive wire 9.

[0055] The other two are located inside the balloon. The distal fixation ring / marker ring 8-2 of the balloon near the distal end serves not only for visualization but also to fix another drive wire 9. The proximal fixation ring / marker ring 8-3 of the balloon near the proximal end serves for visualization. The setting of these fixation rings / marker rings allows the surgeon to clearly identify the position and length of the balloon.

[0056] Working process and usage, taking transarterial chemoembolization (TACE) as an example: Establishing access: Using the Seldinger technique, puncture the femoral or radial artery and insert a sheath. Guiding catheter / long sheath placement: Under the guidance of a standard guidewire, place the guiding catheter into the common hepatic artery.

[0057] Microcatheter introduction and navigation: Insert a 0.016-inch microguidewire into the drug delivery channel 5, with its tip slightly protruding from the microcatheter tip. Guided by the microguidewire and X-ray fluoroscopy, advance the microcatheter of this invention. When encountering a sharp bend in the blood vessel, where the guidewire cannot provide sufficient support and direction, the operator pauses advancement. By controlling the drive device 12 on the handle 5, slowly pull the drive wires a9-1, b9-2, and c9-3, causing the flexible bend at the distal end of the catheter to bend in accordance with the direction of the blood vessel. Figure 5 As shown. Release the microguidewire, use the bend at the catheter tip to "hook" the vascular branch, and then gently push the entire system to smoothly enter the target blood vessel, such as the tumor feeding artery.

[0058] Balloon occlusion and drug infusion: After confirming that the catheter tip is in the ideal position, connect the syringe through the balloon inflation port 6 and slowly inject about 0.6 mL of half-concentration contrast agent to slightly inflate the balloon 2 and block blood flow.

[0059] Pre-mixed chemotherapy drugs and embolization microspheres are slowly injected through a syringe connected to the guidewire / drug delivery port 7. With the balloon occluded, blood flow is blocked, and the drugs and microspheres are "trapped" within the target vessel, effectively targeting the tumor tissue and significantly reducing the risk of reflux and off-target embolization. If adjustment of the perfusion position is needed, the balloon tip can be finely adjusted using the bend adjustment function after the balloon is emptied, and then the balloon can be re-inflated.

[0060] End of procedure: After perfusion is completed, the balloon is aspirated, and after confirming that there are no residual emboli, the microcatheter is withdrawn.

[0061] In summary, this invention, through its ingenious multi-cavity design and drive wire bending mechanism, successfully integrates active guidance, blood flow occlusion, and drug delivery functions, providing an efficient and safe instrument solution for addressing the challenges of complex vascular interventional procedures. Those skilled in the art can substitute and adjust the specific materials and dimensions based on the above description, and all such modifications fall within the scope of protection of this invention. Example

[0062] During use, the operator first controls the drive device to allow the distal curved section of the catheter to bend freely to pass through the tortuous lesion. At this time, the balloon is not inflated. When the catheter reaches the target lesion, the balloon is inflated to block the blood vessel. At this time, the inflated balloon adheres tightly to the blood vessel wall and acts as an anchor to stabilize the bent tip and prevent it from shifting. Then, the medication is injected through the guidewire lumen to achieve the purpose of precise drug delivery.

[0063] Because the drive wire 9 is wound around the rotating column 12-6, and the indicator 12-4 is also directly connected to the rotating column 12-6, when the base of 12-6 with the indicator 12-4 is rotated by hand, the rotating column 12-6 also rotates together. At this time, the drive wire 9 will be wound or unwound, thereby controlling the bending angle of the head end.

[0064] For example, to achieve a 25-degree bend angle at the head end, calculations show that the drive wire 9 needs to be shortened by 4mm to achieve the exact 25-degree bend angle. The radius of the rotating column 12-6 is designed to be 1.3mm. When the rotating column 12-6 rotates half a turn, corresponding to the 25-degree mark, the drive wire 9 has shortened by exactly 4mm, and the bend angle at the head end perfectly matches the reading on the 12-4 mark.

[0065] In addition, because there are multiple imaging rings at the tip of the catheter, the bending of the catheter can be observed on the surgical computer, further confirming the angle of the bending and the position of the catheter.

[0066] The above description is merely a specific embodiment of this invention, but the scope of protection of this invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in this invention should be included within the scope of protection of this invention.

[0067] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A tip-adjustable occlusion balloon microcatheter, comprising, from distal to proximal, a balloon catheter tip (1), a distal bending section (3), a proximal support section (4), and a handle (5), wherein the distal bending section (3) is provided with a distal balloon (2), characterized in that, The proximal end of the balloon catheter tip (1) is connected to the distal end of the drive wire a (9-1), and the distal bending section (3) of the catheter is connected to the distal end of the drive wire c (9-3) at the distal end of the distal balloon (2). The proximal ends of the drive wire a (9-1) and drive wire b (9-2) are connected to the drive device a (12-1), and the proximal end of the drive wire c (9-3) is connected to the drive device b (12-2).

2. The adjustable-tip occlusion balloon microcatheter according to claim 1, characterized in that, Both the driving device a (12-1) and the driving device b (12-2) include a swivel column a (12-6-1) and a swivel column groove a. The proximal end of the driving wire a (9-1) or the driving wire c (9-3) is wound around the swivel column a (12-6-1), and the swivel column a (12-6-1) is located in the swivel column groove a. The swivel groove a in the driving device a (12-1) is disposed at the top of the swivel a (12-6-1), and the swivel b (12-6-1) is wound around the proximal end of the driving wire b (9-2), and the swivel b (12-6-1) is located in the swivel groove b.

3. The adjustable-tip occlusion balloon microcatheter according to claim 2, characterized in that, Both the swivel column a (12-6-2) and the swivel column b (12-6-1) are provided with a limiting groove (12-7) in the axial direction. Both the swivel column groove a and the swivel column groove b are provided with a locking mechanism (12-5) that matches the limiting groove (12-7). Both the swivel column a (12-6-2) and the swivel column b (12-6-1) are threaded structures.

4. The adjustable-tip occlusion balloon microcatheter according to claim 2, characterized in that, The top of the rotating column a (12-6-1) is provided with a display mark (12-4) and a display indicator mark (12-3). The extension and retraction range of the drive wire a (9-1), drive wire b (9-2) and drive wire c (9-3) is 0-50mm, corresponding to the bending angle of the catheter is 0-90 degrees.

5. The adjustable-tip occlusion balloon microcatheter according to claim 1, characterized in that, The distal balloon (2) is adjacent to or partially covers the distal bending section (3) of the catheter. The distal balloon (2) is a super-compliant balloon made of polyurethane or medical-grade silicone rubber.

6. The adjustable-tip occlusion balloon microcatheter according to claim 1, characterized in that, The proximal support section (4) and the distal bending section (3) of the catheter are composite multi-lumen tubes, which include an inner liner (13), a reinforcing layer (14) and an outer tube (15) arranged coaxially from the inside to the outside.

7. The adjustable-tip occlusion balloon microcatheter according to claim 6, characterized in that, The inner liner (13) is provided with a guidewire / drug delivery channel (13-1). The outer tube (15) of the proximal support section (4) of the catheter is provided with an inflatable balloon channel (13-2), a drive wire channel a (15-1), a drive wire channel b (15-2) and a drive wire channel c (15-3). The drive wire a (9-1), the drive wire b (9-2), and the drive wire c (9-3) are respectively located in the drive wire cavity a (15-1), the drive wire cavity b (15-2), and the drive wire cavity c (15-3); The hardness of the outer tube (15) gradually decreases from the proximal end to the distal end; The reinforcing layer (14) is provided with a reinforcing structure, which is a coiled wire, a braided wire, or a combination of coiled wire and braided wire.

8. The adjustable-tip occlusion balloon microcatheter according to claim 6, characterized in that, The outer surface of the reinforcing layer (14) of the distal bending section (3) of the catheter is provided with a fixing ring / marking ring (8-3) for the proximal end of the balloon and a fixing ring / marking ring (8-2) for the distal end of the balloon, and the tip of the balloon catheter (1) is provided with a fixing ring / marking ring (8-1) for the tip of the catheter. The drive wire a (9-1) and the drive wire b (9-2) are connected to the fixing ring / marking ring (8-1) at the tip of the catheter, and the drive wire c (9-3) is connected to the fixing ring / marking ring (8-2) at the distal end of the balloon.

9. The adjustable-tip occlusion balloon microcatheter according to claim 7, characterized in that, The outer surface of the catheter is coated with a lubricating coating, and the inner walls of the guidewire / drug delivery channel (13-1), the inflatable balloon channel (13-2), the drive wire channel a (15-1), the drive wire channel b (15-2), and the drive wire channel c (15-3) are also coated.

10. The adjustable-tip occlusion balloon microcatheter according to claim 1, characterized in that, The handle (5) is provided with a balloon inflation port (6) and a guidewire / drug delivery port (7) at its proximal end. The balloon inflation port (6) is connected to the inflation balloon cavity (13-2), and the guidewire / drug delivery port (7) is connected to the guidewire / drug delivery cavity (13-1).

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