A magnetic control balloon catheter guide wire for microvessel revascularization and a manufacturing method thereof

Abstract

This invention discloses a magnetically controlled balloon guidewire for microvascular revascularization and its manufacturing method. The magnetically controlled balloon guidewire for microvascular revascularization includes a magnetically controlled tip, a phase-change balloon, and a guidewire connected in sequence. This magnetically controlled balloon guidewire for microvascular revascularization can precisely navigate and flexibly steer, and the phase-change balloon can accurately navigate to the stenotic lesion site of the microvessel.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a magnetically controlled balloon guidewire for microvascular revascularization and its manufacturing method. Background Technology

[0002] Cerebral artery occlusion can lead to fatal diseases such as stroke. Currently, the mainstream treatment for occlusion involves using a guidewire and balloon catheter to access the lesion and perform angioplasty to restore blood flow. However, due to limitations in the navigation capabilities of the pre-bent guidewire and the relatively large size of the balloon catheter itself, this method is difficult to handle lesions occurring in narrow and tortuous small blood vessels in the brain. Summary of the Invention

[0003] The technical problem to be solved by the present invention is to provide a magnetically controlled balloon guidewire for microvascular revascularization and its manufacturing method.

[0004] To solve the above-mentioned technical problems, the technical solution adopted by the present invention is: a magnetically controlled balloon guidewire for microvascular revascularization, comprising a magnetically controlled end, a phase-change balloon and a guidewire connected in sequence.

[0005] To solve the above-mentioned technical problems, the present invention also adopts the following technical solution: a method for manufacturing a magnetically controlled balloon guidewire for microvascular revascularization, wherein a magnetically controlled tip and a phase change balloon are prepared respectively, and a guidewire is obtained, and then the magnetically controlled tip, the phase change balloon and the guidewire are assembled.

[0006] The beneficial effects of this invention are as follows:

[0007] 1. Precise navigation and flexible steering: An external magnetic field can act on the magnetically controlled tip, enabling the tip to deflect and navigate in all directions. The magnetically controlled balloon guidewire, combined with its sub-millimeter size, can effectively traverse narrow, tortuous, and complex blood vessels, and precisely navigate to the stenotic lesions in microvessels.

[0008] 2. Immediate and Controllable Vasodilation: Upon reaching the stenotic lesion, the phase change balloon absorbs microwave energy and generates heat, causing the low-boiling-point phase change fluid inside the balloon to rapidly vaporize and expand, physically dilating the blood vessels at the stenotic site. This method achieves immediate and controllable vasodilation without leaving a permanent implant in the patient's body.

[0009] 3. Compatibility with existing commercial guidewires: This magnetically controlled balloon guidewire adopts a modular design. The combined module consisting of the magnetically controlled tip and the phase-change balloon is compatible with various existing commercial guidewires. Existing surgical procedures can be upgraded through simple integration, eliminating the need to purchase a large number of new devices. This design not only reduces medical costs but also greatly improves the product's usability and clinical acceptance. Attached Figure Description

[0010] Figure 1 This is a front view of the magnetically controlled balloon guidewire (with the phase change balloon not inflated).

[0011] Figure 2 This is a cross-sectional view of the magnetically controlled balloon guidewire.

[0012] Figure 3 A cross-sectional view of the magnetically controlled tip of a magnetically controlled balloon guidewire;

[0013] Figure 4 A cross-sectional view of the phase change balloon in the magnetically controlled balloon guidewire;

[0014] Figure 5 Schematic diagram of the assembly of the magnetically controlled tip and the phase change balloon. Figure 1 ;

[0015] Figure 6 Schematic diagram of the assembly of the magnetically controlled tip and the phase change balloon. Figure 2 ;

[0016] Figure 7 This is a front view of the magnetically controlled balloon guidewire (after the phase change balloon is inflated).

[0017] Label Explanation:

[0018] 1. Magnetically controlled end; 11. Blind hole;

[0019] 2. Phase change balloon; 21. Central fixation wire; 22. Anchor point; 23. Composite silicone tube; 24. Receiving cavity;

[0020] 3. Guidewire;

[0021] 4. Thin-walled heat shrink tubing. Detailed Implementation

[0022] To explain in detail the technical content, objectives, and effects of the present invention, the following description is provided in conjunction with the embodiments and accompanying drawings.

[0023] Please refer to Figure 1 and Figure 2 A magnetically controlled balloon guidewire for microvascular revascularization includes a magnetically controlled tip 1, a phase-change balloon 2, and a guidewire 3 connected in sequence.

[0024] As described above, the beneficial effects of this invention are as follows: This magnetically controlled balloon guidewire has a novel structure, enabling precise control and flexible steering using an external magnetic field. Combined with its sub-millimeter size, it effectively traverses narrow, tortuous, and complex blood vessels, accurately navigating to the stenotic lesion site in microvessels. Once the phase-change balloon 2 reaches the stenotic lesion, it absorbs microwave energy and generates heat, causing the low-boiling-point phase-change liquid inside the balloon to rapidly vaporize and expand, physically dilating the blood vessel at the stenotic lesion site. This method achieves immediate and controllable vascular dilation without leaving a permanent implant in the patient's body. This magnetically controlled balloon guidewire adopts a modular design, which helps reduce medical costs and improves the product's practicality and clinical acceptance.

[0025] Furthermore, one end of the phase change balloon 2 is connected to the magnetron end 1 via a thin-walled heat shrink tubing 4, and the other end of the phase change balloon 2 is connected to the guide wire 3 via another thin-walled heat shrink tubing 4.

[0026] As can be seen from the above description, the connection between the phase change balloon 2, the magnetic control end 1, and the guide wire 3 is simple and reliable. The modular design of the magnetic control end 1, the phase change balloon 2, and the guide wire 3 allows for the rapid removal of defective products during the production of the magnetic control balloon guide wire, avoiding the use of defective products in the assembly process and facilitating the control of production costs.

[0027] Furthermore, the magnetron end 1 is made of a soft polymer doped with hard magnetic particles.

[0028] As can be seen from the above description, the magnetically controlled terminal 1 can be precisely controlled by an external magnetic field.

[0029] Furthermore, the phase change balloon 2 includes a central fixing wire 21, an anchor point portion 22, and a composite silicone tube 23. At least two anchor points 22 are sleeved on the central fixing wire 21, and the composite silicone tube 23 is sleeved on the anchor point portion 22. Two adjacent anchor points 22 and the composite silicone tube 23 together form a receiving cavity 24, and the receiving cavity 24 is filled with phase change fluid. The composite silicone tube 23 includes an inner silicone tube layer, a carbon nanotube layer, and an outer silicone tube layer connected sequentially from the inside to the outside.

[0030] As can be seen from the above description, the anchor point part 22 is formed in a simple and reliable manner.

[0031] Furthermore, the central fixing wire 21 is a nickel-titanium alloy wire, iron wire, or stainless steel wire.

[0032] As described above, the central fixing wire 21 is used for assembly and utilizes the standing wave effect in synergy with the carbon nanotube layer to increase heat generation.

[0033] Please refer to Figures 1 to 7A method for manufacturing a magnetically controlled balloon guidewire for microvascular revascularization involves preparing a magnetically controlled tip 1 and a phase-change balloon 2, obtaining a guidewire 3, and then assembling the magnetically controlled tip 1, the phase-change balloon 2, and the guidewire 3.

[0034] As can be seen from the above description, the manufacturing method of magnetically controlled balloon guidewire is simple and the manufacturing efficiency is high.

[0035] Furthermore, the fabrication of the magnetron tip 1 includes the following steps:

[0036] The monomer solution A of polydimethylsiloxane and the crosslinking agent B are mixed at a mass ratio of 10:1 to obtain the first mixture.

[0037] Neodymium iron boron particles with a diameter of 5 nm were added to the first mixture at a volume fraction of 20% to obtain a second mixture, which was then stirred and mixed thoroughly.

[0038] The second mixture, after being stirred and mixed, is injected into a tube mold pre-inserted with a pre-inserted filament and cured to obtain a cured end.

[0039] The cured end is demolded and magnetized to obtain a magnetized end 1 with a blind hole 11 at one end.

[0040] As can be seen from the above description, the production process of the magnetron end 1 is simple, and the function of the pre-placed wire is to give one end of the magnetron end 1 a blind hole 11.

[0041] Furthermore, the preparation of the phase change balloon 2 includes the following steps:

[0042] To prepare the composite silicone tube 23, Ecoflex 30 solution A and solution B, along with n-hexane, were mixed in a mass ratio of 1:1:3 and stirred until homogeneous to obtain a silicone solution. Carbon nanotubes were mixed with anhydrous ethanol at a volume ratio of 15% and stirred until homogeneous to obtain a carbon nanotube solution. A portion of the silicone solution was sprayed onto the outer peripheral wall of a needle mold rotating axially to obtain a uniform inner silicone tube layer. The carbon nanotube solution was then sprayed onto the outer peripheral wall of the inner silicone tube layer rotating axially to obtain a uniform carbon nanotube layer. Another portion of the silicone solution was sprayed onto the outer peripheral wall of the carbon nanotube layer rotating axially to obtain a uniform outer silicone tube layer, thus completing the preparation of the composite silicone tube 23.

[0043] Take a section of central fixing wire 21 and anchor multiple anchor point heat shrink tubes for forming anchor point part 22 on the central fixing wire 21. Then, put the composite silicone tube 23 onto the anchor point heat shrink tube so that the composite silicone tube 23 and two adjacent anchor point heat shrink tubes surround and form a receiving cavity 24.

[0044] The phase change fluid is injected into the receiving cavity 24 to obtain the phase change balloon 2.

[0045] As described above, the carbon nanotube layer absorbs external energy (such as microwave energy) and converts it into heat, thereby heating the phase change liquid to vaporize it, which in turn causes the composite silicone tube 23 to expand to support the blood vessel. The central fixing wire 21 can work synergistically with the carbon nanotube layer to increase heat generation, thereby increasing the expansion rate of the phase change balloon 2. The central fixing wire 21 includes, but is not limited to, nickel-titanium alloy wire, iron wire, and stainless steel wire.

[0046] Furthermore, assembling the magnetically controlled end 1, the phase change balloon 2, and the guide wire 3 includes the following steps: connecting the magnetically controlled end 1 and the phase change balloon 2 using a thin-walled heat shrink tubing 4, and connecting the phase change balloon 2 and the guide wire 3 using another thin-walled heat shrink tubing 4.

[0047] As can be seen from the above description, the connection between the magnetically controlled end 1, the phase change balloon 2, and the guidewire 3 is simple and reliable.

[0048] Furthermore, before connecting the magnetic control end 1 and the phase change balloon 2 using the thin-walled heat shrink tubing 4, the central fixing wire 21 exposed at one end of the phase change balloon 2 is inserted into the blind hole 11 of the magnetic control end 1.

[0049] As can be seen from the above description, the cooperation between the central fixing wire 21 and the blind hole 11 of the magnetic control end 1 can facilitate the positioning and assembly of the central fixing wire 21 and the magnetic control end 1. More importantly, it can better guide the phase change balloon 2 to follow the magnetic control end 1 to turn.

[0050] Please refer to Figures 1 to 7 The first embodiment of the present invention is as follows: Please refer to... Figure 1 and Figure 2 A magnetically controlled balloon guidewire for microvascular revascularization includes a magnetically controlled end 1, a phase change balloon 2, and a guidewire 3 connected in sequence. One end of the phase change balloon 2 is connected to the magnetically controlled end 1 through a thin-walled heat-shrink tubing 4, and the other end of the phase change balloon 2 is connected to the guidewire 3 through another thin-walled heat-shrink tubing 4. The thin-walled heat-shrink tubing 4 can be a medical thin-walled heat-shrink tubing.

[0051] The magnetron 1 is made of a soft polymer doped with hard magnetic particles. In one or more embodiments, the hard magnetic particles are neodymium iron boron with a diameter of 5 nm, and the soft polymer is polydimethylsiloxane (PDMS).

[0052] The phase change balloon 2 includes a central fixing wire 21, anchor points 22, and a composite silicone tube 23. At least two anchor points 22 are fitted onto the central fixing wire 21. The composite silicone tube 23 is fitted onto the anchor points 22, and two adjacent anchor points 22 and the composite silicone tube 23 together form a receiving cavity 24. The receiving cavity 24 is filled with a phase change fluid, which can be Novec 7000 fluorinated liquid, etc. The phase change fluid has a low boiling point and vaporizes upon heating, thereby causing the phase change balloon 2 to expand to support the blood vessel. The composite silicone tube 23 includes an inner silicone tube layer, a carbon nanotube layer, and an outer silicone tube layer connected sequentially from the inside out. In this embodiment, the anchor point 22 is formed by fixing a heat-shrinkable anchor point tube with a smaller inner diameter and a thicker thickness onto the central fixing wire 21. That is, the heat-shrinkable anchor point tube refers to the heat-shrinkable tube used to form the anchor point 22.

[0053] Preferably, the central fixing wire 21 is a nickel-titanium alloy wire. In other embodiments, the central fixing wire 21 may also be made of other materials, such as iron wire or stainless steel wire.

[0054] One end of the central fixing wire 21 in the phase change balloon 2 extends out of the phase change balloon 2, and the magnetic control end 1 connected to the phase change balloon 2 is provided with a blind hole 11 that matches the area where the central fixing wire 21 extends out.

[0055] Please combine Figure 1 and Figure 2 This embodiment also provides a method for manufacturing a magnetically controlled balloon guidewire for microvascular revascularization. The manufacturing method includes the following steps: preparing a magnetically controlled tip 1 and a phase change balloon 2, obtaining a guidewire 3, and then assembling the magnetically controlled tip 1, the phase change balloon 2, and the guidewire 3.

[0056] The fabrication of the magnetron tip 1 includes the following steps:

[0057] The monomer solution A of polydimethylsiloxane (PDMS) and the crosslinking agent solution B are mixed at a mass ratio of 10:1 to obtain the first mixture.

[0058] Neodymium iron boron particles with a diameter of 5 nm are added to the first mixture at a volume fraction of 20% to obtain a second mixture, and the second mixture is stirred and mixed evenly; optionally, when stirring and mixing the second mixture, the second mixture is placed in a planetary mixer and stirred and mixed at a speed of 2000 revolutions per minute.

[0059] The second mixture, after being stirred and mixed, is injected into a tube mold pre-inserted with a pre-inserted wire and cured to obtain a cured end; the pre-inserted wire can be a nickel-titanium alloy wire with a diameter of 0.15mm, etc., and the tube mold is preferably made of polytetrafluoroethylene (PTFE), as PTFE tube molds facilitate the subsequent demolding of the cured end; during curing, the tube mold is placed in an oven at 50 degrees Celsius and heated for 12 hours.

[0060] The cured end is demolded and magnetized to obtain a magnetized end 1 with a blind hole 11 at one end, as shown below. Figure 3 As shown, the diameter of the blind hole 11 is the same as the diameter of the pre-placed wire. After demolding, the pre-placed wire detaches from the cured end, thereby forming the blind hole 11 at the end of the magnetized magnetic control end 1.

[0061] The preparation of the phase change balloon 2 includes the following steps:

[0062] To prepare the composite silicone tube 23, Ecoflex 30 solution A and solution B, along with n-hexane, were mixed in a mass ratio of 1:1:3 and stirred until homogeneous to obtain a silicone solution. Carbon nanotubes were mixed with anhydrous ethanol at a volume ratio of 15% and stirred until homogeneous to obtain a carbon nanotube solution (CNT solution). A portion of the silicone solution was sprayed onto the outer peripheral wall of a needle mold rotating axially to obtain a uniform inner silicone tube layer. Next, the carbon nanotube solution was sprayed onto the outer peripheral wall of the inner silicone tube layer rotating axially to obtain a uniform carbon nanotube layer. Finally, another portion of the silicone solution was sprayed onto the outer peripheral wall of the carbon nanotube layer rotating axially to obtain a uniform outer silicone tube layer, thus completing the preparation of the composite silicone tube 23. It is easy to understand that the composite silicone tube 23 is a three-layer tubular structure of silicone-CNT-silicone.

[0063] Take a section of central fixing wire 21 and anchor multiple heat-shrinkable tubes for forming anchor points 22 onto the central fixing wire 21. Then, utilizing the elasticity and tension of the composite silicone tube 23 itself, fit the composite silicone tube 23 onto the heat-shrinkable tubes, so that the composite silicone tube 23 and two adjacent heat-shrinkable tubes enclose and form a receiving cavity 24. Specifically, when anchoring multiple heat-shrinkable tubes for forming anchor points 22, multiple heat-shrinkable tubes with small inner diameters and large wall thicknesses are fitted onto the central fixing wire 21, and the position of the heat-shrinkable tubes on the central fixing wire 21 is adjusted. Then, the heat-shrinkable tubes are heated and shrunk, thus fixing them onto the central fixing wire 21, acting as anchor points 22, and providing fixing points for the subsequent fixing of the composite silicone tube 23. The central fixing wire 21 includes, but is not limited to, nickel-titanium alloy wire, iron wire, stainless steel wire, etc.

[0064] Injecting phase change fluid into the receiving cavity 24 yields the phase change balloon 2, as shown below. Figure 4As shown. The specific operation method for injecting phase change fluid into the receiving cavity 24 is as follows: First, insert the needle of the syringe loaded with phase change fluid into the sealed receiving cavity 24, then draw out the air in the receiving cavity 24 (the air that was originally in the receiving cavity 24 enters the syringe and is located above the phase change fluid), then inject the phase change fluid into the receiving cavity 24. After the phase change fluid is injected, seal the tiny holes left by the needle by applying fast-curing silicone adhesive (Sil-poxy).

[0065] Assembling the magnetically controlled end cap 1, the phase change balloon 2, and the guide wire 3 includes the following steps: connecting the magnetically controlled end cap 1 and the phase change balloon 2 using a thin-walled heat shrink tubing 4, and connecting the phase change balloon 2 and the guide wire 3 using another thin-walled heat shrink tubing 4. Before connecting the magnetically controlled end cap 1 and the phase change balloon 2 using the thin-walled heat shrink tubing 4, the exposed central fixing wire 21 at one end of the phase change balloon 2 is inserted into the blind hole 11 of the magnetically controlled end cap 1, as shown below. Figure 5 and Figure 6 As shown.

[0066] When using a magnetically controlled balloon guidewire intended for microvascular revascularization, an external magnetic field is used to control the magnetically controlled tip 1, which in turn drives the phase-change balloon 2. Once the phase-change balloon 2 reaches the lesion site, the temperature of the balloon 2 is adjusted by controlling the application of external energy (such as microwaves), thereby controlling the vaporization and liquefaction of the phase-change fluid inside, ultimately achieving the expansion and recovery of the phase-change balloon 2. Figure 1 and Figure 7 As shown.

[0067] The above description is merely an embodiment of the present invention and does not limit the patent scope of the present invention. Any equivalent modifications made based on the content of the present invention specification and drawings, or direct or indirect applications in related technical fields, are similarly included within the patent protection scope of the present invention.

Claims

1. A magnetically controlled balloon guidewire for microvascular revascularization, characterized in that, The device includes a magnetically controlled end, a phase-change balloon, and a guidewire connected in sequence. The phase-change balloon includes a central fixing wire, anchor points, and a composite silicone tube. At least two anchor points are sleeved on the central fixing wire, and the composite silicone tube is sleeved on the anchor points. Two adjacent anchor points and the composite silicone tube together form a receiving cavity, which is filled with phase-change fluid. The composite silicone tube includes an inner silicone tube layer, a carbon nanotube layer, and an outer silicone tube layer connected in sequence from the inside to the outside. One end of the phase change balloon is connected to the magnetron end via a thin-walled heat shrink tubing, and the other end of the phase change balloon is connected to the guidewire via another thin-walled heat shrink tubing. The magnetron tip is made of a soft polymer doped with hard magnetic particles; The central fixing wire is a nickel-titanium alloy wire, iron wire, or stainless steel wire.

2. A method for manufacturing a magnetically controlled balloon guidewire for microvascular revascularization, characterized in that, The magnetically controlled tip and phase-change balloon are fabricated separately, and the guidewire is obtained. Then, the magnetically controlled tip, phase-change balloon, and guidewire are assembled. The fabrication of the phase-change balloon includes the following steps: To prepare a composite silicone tube, Ecoflex 30 solution A and solution B, along with n-hexane, are mixed in a mass ratio of 1:1:3 and stirred until homogeneous to obtain a silicone solution. Carbon nanotubes are mixed with anhydrous ethanol at a volume ratio of 15% and stirred until homogeneous to obtain a carbon nanotube solution. A portion of the silicone solution is sprayed onto the outer peripheral wall of an axially rotating needle mold to obtain a uniform inner silicone tube layer. The carbon nanotube solution is then sprayed onto the outer peripheral wall of the axially rotating inner silicone tube layer to obtain a uniform carbon nanotube layer. Another portion of the silicone solution is sprayed onto the outer peripheral wall of the axially rotating carbon nanotube layer to obtain a uniform outer silicone tube layer, thus completing the preparation of the composite silicone tube. A section of central fixing wire is taken, and multiple anchor point heat-shrinkable tubes for forming anchor points are anchored onto the central fixing wire. The composite silicone tube is then fitted onto the anchor point heat-shrinkable tubes so that the composite silicone tube and two adjacent anchor point heat-shrinkable tubes enclose a receiving cavity. A phase change fluid is injected into the receiving cavity to obtain the phase change balloon.

3. The method for manufacturing a magnetically controlled balloon guidewire for microvascular revascularization according to claim 2, characterized in that, The fabrication of the magnetron tip includes the following steps: The monomer solution A of polydimethylsiloxane and the crosslinking agent B are mixed at a mass ratio of 10:1 to obtain a first mixture; neodymium iron boron particles with a diameter of 5 nm are added to the first mixture at a volume fraction of 20% to obtain a second mixture, and the second mixture is stirred and mixed evenly. The second mixture, after being stirred and mixed, is injected into a tube mold pre-inserted with a pre-inserted filament and cured to obtain a cured end. The cured end is demolded and magnetized to obtain a magnetized end with a blind hole at one end.

4. A method for manufacturing a magnetically controlled balloon guidewire for microvascular revascularization according to claim 2, characterized in that, Assembling the magnetron end, phase change balloon and guidewire includes the following steps: connecting the magnetron end and the phase change balloon with a thin-walled heat shrink tubing, and connecting the phase change balloon and the guidewire with another thin-walled heat shrink tubing.

5. A method for manufacturing a magnetically controlled balloon guidewire for microvascular revascularization according to claim 4, characterized in that, Before connecting the magnetron end to the phase change balloon using thin-walled heat shrink tubing, insert the exposed central fixing wire at one end of the phase change balloon into the blind hole of the magnetron end.

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