Lighted guidewire, balloon catheter assembly, and methods of use thereof

Abstract

The application discloses a light-emitting guide wire, a balloon catheter assembly and a use method thereof. The light-emitting guide wire comprises a fiber with opposite proximal and distal ends, the fiber comprising a core and a cladding layer wrapping the core, a part of the core of the distal end of the fiber being exposed and serving as a light-emitting working section; a push rod in a hollow tubular structure, the push rod being fixedly sleeved on the outer periphery of the fiber for driving the fiber to move; a guide head connected to the distal end of the fiber; and a support at the periphery of the light-emitting working section, two ends of the support being connected to the guide head and the push rod respectively. The light-emitting guide wire can be used in combination with various balloon catheter assemblies, is simple to process, and can switch the light-emitting guide wire to emit different light irradiation on a vascular lesion section by replacing the light source of the balloon catheter assembly, thereby effectively preventing vascular restenosis or neointimal proliferation.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a light-emitting guide wire, a balloon catheter assembly and a method of using the same. BACKGROUND

[0002] Percutaneous intervention has become one of the commonly used treatment technologies worldwide. For intravascular stenosis, balloon dilation or stent implantation is usually used for treatment, but both methods have their own shortcomings. The use of bare balloon dilation to treat intravascular stenosis has a high probability of restenosis after treatment. The use of bare metal stent catheter intervention to treat intravascular stenosis is not prone to restenosis, but is prone to neointimal proliferation (i.e., the process of scar tissue formation in the stent segment). Once restenosis or neointimal proliferation occurs, intervention treatment needs to be performed again. SUMMARY

[0003] To solve the problems in the prior art, the present application provides a light-emitting guide wire, a balloon catheter assembly and a method of using the same, which are applied to treat intravascular stenosis and can effectively prevent restenosis or neointimal proliferation.

[0004] The light-emitting guide wire provided by the present application comprises:

[0005] An optical fiber having opposite proximal and distal ends, the optical fiber comprising a core and a cladding layer wrapping the core, and a part of the core of the distal end of the optical fiber being exposed and serving as a light-emitting working section;

[0006] A push rod in a hollow tubular structure, the push rod being fixedly sleeved on the outer periphery of the optical fiber and being used to drive the optical fiber to move;

[0007] A guide head connected to the distal end of the optical fiber;

[0008] A support member at the periphery of the light-emitting working section, the two ends of the support member being connected to the guide head and the push rod, respectively.

[0009] Optionally, the support member is in a mesh tube structure or a spiral structure, and the support member comprises, in sequence from the proximal end to the distal end, a first support section, a hollow section and a second support section;

[0010] The first support section and the second support section are fixedly connected to the push rod and the guide head, respectively, and the axial position of the light-emitting working section corresponds to the hollow section.

[0011] Optionally, the support member is a spiral spring, and the pitch of the hollow section is greater than the pitch of the first support section and the second support section.

[0012] The hollow ratio of the hollow section is at least 80%.

[0013] Optionally, the helical spring is made of a wire, and a diameter of the wire is 0.04-0.1mm;

[0014] A diameter of the helical spring is 0.2-0.5mm;

[0015] A length of the hollow section is 2-4cm.

[0016] Optionally, the light-emitting guide wire further comprises a connecting piece with a through channel inside, and the optical fiber extends through the through channel;

[0017] A proximal end of the connecting piece is fixedly sleeved to a distal end of the push rod, a distal end of the connecting piece is a taper structure with gradually reduced diameter, and the first supporting section of the helical spring is fixedly sleeved to the taper structure;

[0018] The guide head comprises a spherical cap portion at the distal end and a cylindrical portion at the proximal end of the spherical cap portion, and the second supporting section of the helical spring is fixedly sleeved to the cylindrical portion.

[0019] Optionally, the radial gap between the first supporting section and the taper structure gradually increases from the proximal end to the distal end.

[0020] Optionally, a span of the radial gap in the axial direction of the optical fiber is L1, a span of the hollow section in the axial direction of the optical fiber is L2, and L1:L2=1:1.2-3.

[0021] Optionally, the outer periphery of the optical fiber is further wrapped with a protective tube.

[0022] In the application, the balloon catheter assembly comprises:

[0023] A first tube with a guide wire channel inside;

[0024] A second tube fixedly sleeved outside the first tube, and a radial gap between the first tube and the second tube is a fluid channel;

[0025] A balloon body at the outer periphery of the first tube and fixedly connected to the distal end of the second tube;

[0026] A light-emitting guide wire, which is any one of the light-emitting guide wires, and the light-emitting guide wire is movably arranged in the guide wire channel, wherein an axial position of the light-emitting working section is in the balloon body;

[0027] A light source connected to an optical path of the light-emitting guide wire.

[0028] In the application, a method for using the balloon catheter assembly comprises:

[0029] threading the light-emitting guide wire along a predetermined path until the light-emitting working section reaches a designated position;

[0030] threading a balloon catheter along the light-emitting guide wire until a balloon body in the balloon catheter matches the position of the light-emitting working section;

[0031] applying light to the designated position via the light-emitting guide wire.

[0032] Compared with the prior art, the present application has at least the following beneficial effects:

[0033] (1) The separate light-emitting guide wire can be combined with various balloons, and the processing is simpler and more convenient;

[0034] (2) The light-emitting guide wire emits blue light or red light by replacing the light source, so as to prevent vascular restenosis or neointimal proliferation. BRIEF DESCRIPTION OF DRAWINGS

[0035] Figure 1 is a structural schematic view of the light-emitting guide wire in an embodiment;

[0036] Figure 2 is an exploded view of the light-emitting guide wire in an embodiment;

[0037] Figure 3 is a structural schematic view of the optical fiber in an embodiment;

[0038] Figure 4 is a sectional view of the light-emitting guide wire in an embodiment;

[0039] Figure 5 is a structural schematic view of the balloon catheter assembly in an embodiment;

[0040] Figure 6 is a structural schematic view of the balloon catheter assembly in another embodiment;

[0041] Figure 7 is a flowchart of the use method of the balloon catheter assembly in an embodiment.

[0042] The reference signs in the drawings are explained as follows:

[0043] 100, light-emitting guide wire; 110, optical fiber; 111, core; 112, cladding layer; 113, light-emitting working section; 120, push rod; 121, reduced-diameter end; 130, guide head; 131, spherical crown; 132, cylindrical portion; 140, support; 141, first support section; 142, hollow section; 143, second support section; 150, connecting piece; 151, cone structure; 152, closing structure; 160, protective tube;

[0044] 200, first tube;

[0045] 300, second tube;

[0046] 400, balloon body;

[0047] 500, light source;

[0048] 600, optical fiber assembly;

[0049] L1, span of the radial gap in the optical fiber axial direction; L2, span of the hollowed-out section in the optical fiber axial direction. DETAILED DESCRIPTION

[0050] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work fall within the scope of protection of the present application.

[0051] It should be noted that when an assembly is referred to as being "connected" with another assembly, it can be directly connected with the other assembly or there can be a middle assembly. When an assembly is referred to as being "disposed on" another assembly, it can be directly disposed on the other assembly or there can be a middle assembly.

[0052] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0053] Reference Figures 1-4, an embodiment of the present application provides a luminous guidewire 100, including an optical fiber 110, a push rod 120, a guide head 130 and a support member 140; wherein the optical fiber 110 has a relative proximal end and a distal end, the optical fiber 110 includes a core 111 and a wrapping layer 112, the wrapping layer 112 wraps the core 111, plays a role in protecting the optical fiber and reducing the energy loss of the optical fiber, a part of the core 111 at the distal end of the optical fiber 110 is exposed and serves as a working section; the push rod 120 is a hollow tubular structure, which is fixedly sleeved on the outer periphery of the optical fiber 110 and is used to drive the optical fiber 110 to move; the guide head 130 is connected to the distal end of the optical fiber 110, and is used to guide the luminous guidewire 100 to move in the lumen of human tissue; the support member 140 is located on the periphery of the luminous working section 113, and the two ends of the support member 140 are respectively connected to the guide head 130 and the push rod 120 to provide corresponding support strength. In this embodiment, the optical fiber 110 can serve as both a light source and a guide wire, integrating the two major functions of emitting light and interventional guidance. A separate light-emitting guide wire 100 can be combined with various balloon bodies 400, making the processing of the balloon catheter assembly simpler and more convenient.

[0054] In one embodiment, the support member 140 may be a mesh tube structure, which, from proximal to distal, comprises a first support segment 141, a hollow segment 142, and a second support segment 143. The first support segment 141 and the second support segment 143 are densely meshed segments, while the hollow segment 142 is a sparsely meshed segment. The first support segment 141 and the second support segment 143 are fixedly connected to the push rod 120 and the guide head 130, respectively, to ensure the support strength of the support member 140. The axial position of the light-emitting working segment 113 corresponds to the sparsely meshed segment, ensuring that the light-emitting guidewire 100 emits light effectively.

[0055] refer to Figure 1 、 2 In another embodiment shown, the support member 140 is a helical structure, such as a coil spring. The support member 140 includes, from proximal to distal, a first support segment 141, a hollow segment 142, and a second support segment 143. The pitch of the hollow segment 142 is greater than the pitch of the first support segment 141 and the second support segment 143. The pitch of the first support segment 141 and the second support segment 143 is 0.04-0.1 mm, for example, 0.05-0.06 mm; the pitch of the hollow segment 142 is 0.1-0.4 mm, for example, 0.2-0.35 mm, or another example, 0.3 mm. The first support segment 141 and the second support segment 143 are respectively fixedly connected to the push rod 120 and the guide head 130 to provide sufficient support strength. The axial position of the light-emitting working segment 113 corresponds to the hollow segment 142 to ensure that the light-emitting guidewire 100 emits light. To ensure that the light transmittance of the light-emitting working section 113 is above 80% after emitting light, the hollowing ratio of the hollow section 142 is at least 80%, such as at least 90%, and for example at least 95%.

[0056] The support strength of the support member 140 and the light transmittance after the light-emitting working section 113 is allowed to emit light are related to the specific structure of the coil spring. The coil spring can be made of metal wire with a diameter of 0.04-0.1mm, and is more preferably made of a metal wire with a diameter of 0.05-0.06mm wound in a spiral. The material of the metal wire is one of platinum tungsten, platinum iridium, stainless steel, gold, and nickel titanium. The diameter of the coil spring should be moderate. A diameter that is too large will increase the radial size of the light-emitting guidewire, and a diameter that is too small will affect the support strength of the coil spring. The coil spring can be 0.2-0.5mm, for example, 0.2-0.4mm, and another example is 0.35mm. In addition, the length of the hollow section 142 is 2-4cm, for example, 2-3cm, and another example is 3cm, so that the light-emitting guidewire can adapt to the corresponding balloon body when used.

[0057] refer to Figure 4 In the illustrated embodiment, to secure the coil spring, the illuminated guidewire 100 further includes a connector 150. The proximal end of the connector 150 is sleeved and fixed to the distal end of the push rod 120. The distal end comprises a tapered structure 151 with a gradually decreasing diameter. The first support segment 141 of the coil spring is fixed to the tapered structure 151. Furthermore, the guide head 130 includes a spherical crown 131 at the distal end and a cylindrical portion 132 proximal to the spherical crown 131. The second support segment 143 of the coil spring is sleeved and fixed to the cylindrical portion 132.

[0058] The distal end of push rod 120 is a reduced diameter end 121. The proximal end of connector 150 features a closed structure 152 into which reduced diameter end 121 extends. The shape of closed structure 152 matches that of reduced diameter end 121. During assembly, reduced diameter end 121 of push rod 120 mates with closed structure 152 of connector 150. Furthermore, the flush connection between push rod 120 and connector 150 creates a compact structure for illuminated guidewire 100, facilitating subsequent assembly with a balloon catheter assembly. All of these components can be secured using laser welding.

[0059] The cone structure 151 gradually decreases in diameter from the proximal end to the distal end. A radial gap is defined between the first support segment 141 and the cone structure 151, and the radial gap gradually increases from the proximal end to the distal end. The radial gap has a span L1 in the axial direction of the optical fiber 110, and the hollow segment 142 has a span L2 in the axial direction of the optical fiber 110. The ratio L1:L2 is 1:1.2 to 3 times, for example, 1:1.5 to 2.5, 1:1.5 to 2, or 1:1.8.

[0060] To facilitate the threading of the optical fiber 110 , the connector 150 is connected to the pushing rod 120 of the hollow tubular structure. The optical fiber 110 that has passed through the pushing rod 120 extends through the threading channel of the connector 150 .

[0061] The material of the core 111 in the optical fiber 110 can be a plastic optical fiber 110 or a quartz optical fiber 110, and is preferably a plastic optical fiber 110, which has good flexibility and elasticity and is suitable for use as a guide wire. The diameter of the optical fiber 110 can be 0.1-0.3 mm, for example, 0.125-0.25 mm, and for example, 0.125 mm. If the optical fiber 110 is too thin, it is easy to break during use. If the optical fiber 110 is too thick, it will result in an excessively large radial size of the light-emitting guide wire 100, which will affect the subsequent application of the light-emitting guide wire. The outer periphery of the optical fiber 110 can be wrapped with a protective tube 160 to protect the optical fiber.

[0062] The light-emitting guide wire 100 can be used in combination with different balloon bodies 400. According to the axial length of the balloon body 400, the part of the optical fiber 110 in the balloon body 400 is stripped of the cladding of the optical fiber 110. The stripping length of the cladding of the optical fiber 110 is equal to the axial length of the balloon body 400. The stripping method can be physical stripping (for example, sandblasting, grinding, scraping, etc.) or chemical stripping. The surface of the light-emitting working section 113 is ground to make the surface more uniform and improve the uniformity of light emission.

[0063] Reference Figure 5The application also provides a balloon catheter assembly, which comprises a first tube 200, a second tube 300, a balloon body 400, a light-emitting guide wire 100 and a light source 500. The first tube 200 is internally provided with a guide wire channel. The second tube 300 is sleeved on the outside of the first tube 200. The radial gap between the first tube 200 and the second tube 300 is a fluid channel. The balloon body 400 is located on the periphery of the first tube 200 and is fixedly connected to the distal end of the second tube 300. The light-emitting guide wire 100 comprises an optical fiber 110, a pushing rod 120, a guide head 130 and a support 140. The optical fiber 110 comprises a core 111 and a cladding layer 112 wrapping the core 111. A part of the core 111 at the distal end of the optical fiber 110 is exposed and serves as a light-emitting working section 113. The pushing rod 120 is a hollow tubular structure and is fixedly sleeved on the periphery of the optical fiber 110 for driving the optical fiber 110 to move. The guide head 130 is connected to the distal end of the optical fiber 110. The support 140 is located on the periphery of the light-emitting working section 113, and the two ends of the support 140 are respectively connected to the guide head 130 and the pushing rod 120. The light-emitting guide wire 100 is movably arranged in the guide wire channel, and the axial position of the light-emitting working section 113 is located in the balloon body 400. The light source 500 is connected to the light path of the light-emitting guide wire 100. Different light sources 500 can make the light-emitting guide wire 100 emit different light. By replacing the light source 500, the balloon catheter assembly can meet the multiple requirements of application scenarios. For example, when applied to promote the repair of cells and tissues, the light source 500 selects a red light source 500, which can stimulate the light-emitting guide wire to emit red light with a wavelength of 625-720 nm. The red light has a photobiomodulation effect, which is generated by a photochemical effect rather than a thermal effect, and can promote the repair of cells and tissues. For another example, when applied to form a vascular microstent, the light source 500 selects a blue light source, which can stimulate the light-emitting guide wire to emit blue light with a wavelength of 400-550 nm. The blue light in this wavelength band can react with a treatment substance to form a microstent on the blood vessel, which is beneficial to the treatment of pre-stenosis and prevention of restenosis.

[0064] The material of the first tube can be selected from block polyether amide resin (PEBAX), nylon or thermoplastic polyurethane elastomer rubber (TPU), and the color is colorless and transparent, which is beneficial to the light transmission of the light-emitting guide wire. The material of the second tube can be selected from PEBAX or nylon.

[0065] Referring to Figure 6In another embodiment, the balloon catheter further comprises a fiber assembly 600, which comprises a fiber 110 body, is inserted into the radial gap between the first tube 200 and the second tube 300, and has a light emitting part extending into the balloon body 400. The balloon catheter further comprises a light source for the fiber assembly 600 outside the balloon catheter, which is used to drive the fiber assembly 600 to emit light of a specific wavelength. In this embodiment, the balloon catheter itself has a set of fiber assemblies 600, which can be used in combination with the light emitting guide wire 100. When used, the fiber assembly 600 and the light emitting guide wire 100 can be switched according to the scene requirements, for example, the fiber assembly 600 can be used for red light irradiation, and the light emitting guide wire 100 can be used for blue light irradiation.

[0066] Reference Figure 7 In the embodiment shown, the method for using the balloon catheter assembly comprises:

[0067] Step S100: The light emitting guide wire 100 is inserted along a predetermined path until the light emitting working section 113 reaches a specified position.

[0068] Step S200: The balloon catheter is inserted along the light emitting guide wire 100 until the balloon body 400 in the balloon catheter matches the position of the light emitting working section 113.

[0069] Step S300: Light is applied to the specified position through the light emitting guide wire 100.

[0070] In another embodiment, in step S300, a therapeutic substance is applied to the specified position through the balloon catheter, and then light is applied to the specified position through the light emitting guide wire 100.

[0071] Specifically, the specified position in step S100 is a vascular lesion section, where there is cell and tissue damage and / or vascular stenosis. In step S200, the balloon catheter is inserted into the vascular lesion section under the guidance of the light emitting guide wire 100. In step S300, the balloon catheter can release a balloon body 400 carrying a therapeutic substance or a fluid carrying a therapeutic substance through the balloon body 400 to apply the therapeutic substance to the specified position. The therapeutic substance can be at least one of an anti-proliferative drug, a drug for inducing collagen or elastin cross-linking, and an anti-vasospasm drug.

[0072] When the cells and tissues of the vascular lesion segment are repaired, the balloon catheter assembly is configured with a red light source 500, prompting the light emitting guide wire 100 to emit red light with a wavelength of 625-720 nm, which has a photobiomodulation effect, which is generated by photochemical effect rather than thermal effect, and can promote the repair of cells and tissues and prevent neointimal proliferation. When treating vascular stenosis, the balloon catheter assembly is configured with a blue light source 500, and the treatment material is a treatment material that can form a vascular microstent. The light emitting guide wire 100 applies blue light with a wavelength of 400-550 nm to the designated location, prompting the treatment material to react with the blood vessels to form a microstent, which can effectively prevent vascular restenosis.

[0073] The light emitting guide wire of the present application can be used in combination with various balloon catheters, is simple to process, and can switch the light emitting guide wire to emit different light by replacing the light source of the balloon catheter assembly, so as to effectively prevent vascular restenosis or neointimal proliferation.

[0074] The technical features of the above-mentioned embodiments can be combined in any way. In order to make the description concise, all possible combinations of the technical features in the above-mentioned embodiments are not described, but as long as the combination of the technical features does not exist contradictory, it should be considered as the scope of the present application. When the technical features in different embodiments are embodied in the same figure, it can be considered that the figure also discloses the combination of each embodiment involved.

[0075] The above-mentioned embodiments only express several embodiments of the present application, and the description is more specific and detailed, but it should not be understood as a limitation on the scope of the patent of the present application. It should be pointed out that for ordinary skilled in the art, without departing from the concept of the present application, a number of modifications and improvements can be made, which are within the scope of protection of the present application. Therefore, the scope of protection of the present application should be subject to the appended claims.

Claims

1. A luminous guidewire, characterized in that: include: An optical fiber having a proximal end and a distal end opposite to each other, the optical fiber comprising a core and a coating surrounding the core, wherein a portion of the core at the distal end of the optical fiber is exposed and serves as a light-emitting working section; The push rod is a hollow tubular structure, and the push rod is fixedly sleeved on the outer periphery of the optical fiber to drive the optical fiber to move; a guide head connected to the distal end of the optical fiber; A support member is located outside the light-emitting working section, and two ends of the support member are respectively connected to the guide head and the push rod; The support member includes a first support section, a hollow section and a second support section in sequence from the proximal end to the distal end; The first supporting segment and the second supporting segment are fixedly connected to the pushing rod and the guiding head respectively, and the axial position of the luminous working segment corresponds to the hollow segment.

2. The light-emitting guidewire according to claim 1, characterized in that The support member is a mesh tube structure or a spiral structure.

3. The light-emitting guidewire according to claim 2, characterized in that The support member is a mesh tube structure, the first support segment and the second support segment are mesh dense segments, and the hollow segment is a mesh sparse segment.

4. The light-emitting guidewire according to claim 2, characterized in that The support member is a spiral structure, and the pitch of the hollow section is greater than the pitch of the first support section and the second support section; The hollowing ratio of the hollowing section is at least 80%.

5. The light-emitting guidewire according to claim 4, characterized in that: The spiral structure is a coil spring, which is made of a metal wire, and the diameter of the metal wire is 0.04-0.1 mm; The diameter of the coil spring is 0.2-0.5 mm; The length of the hollow section is 2 to 4 cm.

6. The light-emitting guidewire according to claim 1, characterized in that The light-emitting guidewire also includes a connector with a guide channel inside, and the optical fiber extends through the guide channel; the proximal end of the connector is sleeved and fixed to the distal end of the push rod, and the distal end of the push rod is a reduced diameter end. The proximal end of the connector is internally provided with a closing structure for the reduced diameter end to extend into, and the shape of the closing structure is adapted to the reduced diameter end.

7. The light-emitting guidewire according to claim 1, characterized in that: The light-emitting guidewire further includes a connector having a guide channel therein, and the optical fiber extends through the guide channel; The proximal end of the connecting member is sleeved and fixed to the distal end of the pushing rod. The distal end of the connecting member is a cone structure with a gradually decreasing diameter. The supporting member is a coil spring. The first supporting section of the coil spring is sleeved and fixed to the cone structure. The guide head includes a spherical crown portion at the distal end and a cylindrical portion at the proximal end of the spherical crown portion, and the second supporting section of the coil spring is sleeved and fixed on the cylindrical portion.

8. The light-emitting guidewire according to claim 7, characterized in that: A radial gap is provided between the first supporting section and the cone structure, and the radial gap gradually increases from the proximal end to the distal end.

9. The light-emitting guidewire according to claim 8, characterized in that: The span of the radial gap in the axial direction of the optical fiber is L1, and the span of the hollow section in the axial direction of the optical fiber is L2, and the relationship L1:L2=1:1.2~3 times is satisfied.

10. The light-emitting guidewire according to claim 1, characterized in that: The outer periphery of the optical fiber is also wrapped with a protective tube.

11. A balloon catheter assembly, characterized in that: include: a first tube having a guide wire channel therein; a second pipe fitting, sleeved on the outside of the first pipe fitting, wherein a radial gap between the first pipe fitting and the second pipe fitting serves as a fluid channel; a balloon body, located on the outer periphery of the first tube and fixedly connected to the distal end of the second tube; A luminous guidewire, comprising the luminous guidewire according to any one of claims 1 to 10, wherein the luminous guidewire is movably arranged in the guidewire channel, wherein the axial position of the luminous working section is within the balloon body; A light source is connected to the light path of the light-emitting guide wire.

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