Luminescent guidewire, balloon catheter assembly and methods of use thereof

Abstract

The invention discloses a light-emitting guide wire, a balloon catheter assembly and a using method thereof. The light-emitting guide wire comprises an optical fiber, the optical fiber is provided with a near end and a far end which are opposite, the optical fiber comprises a core body and a wrapping layer wrapping the core body, and a part of the core body at the far end of the optical fiber is exposed and serves as a light-emitting working section; the pushing rod is of a hollow tubular structure, and the pushing rod is fixedly arranged on the periphery of the optical fiber in a sleeving mode and used for driving the optical fiber to move; the guide head is connected to the far end of the optical fiber; the supporting piece is located on the periphery of the light-emitting working section, and the two ends of the supporting piece are connected with the guiding head and the pushing rod respectively. The light-emitting guide wire can be combined with various balloon catheters for use and is easy to process, and the light-emitting guide wire can be switched and excited to emit different light to act on a vascular lesion section by replacing a light source of the balloon catheter assembly, so that vascular restenosis or neointimal proliferation is effectively prevented.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to a luminous guidewire, a balloon catheter assembly and a method of using the same. Background Art

[0002] Percutaneous intervention has become one of the commonly used treatment technologies in the world. For intravascular stenosis, balloon dilatation or stent implantation is usually used for treatment, but both methods have their own shortcomings. The use of bare balloon dilatation to treat intravascular stenosis has a high chance of restenosis after treatment. Although the use of bare metal stent catheter intervention to treat intravascular stenosis is not prone to restenosis, it is easy to cause neointimal proliferation (i.e. the process of scar tissue formation in the stent segment). Once vascular restenosis or neointimal proliferation occurs, interventional treatment is required again. Summary of the invention

[0003] In response to the problems of the prior art, the present application provides a luminous guidewire, a balloon catheter assembly and a method of using the same, which are applied to treat intravascular stenosis lesions and can effectively prevent vascular restenosis or neointimal proliferation.

[0004] The luminous guidewire provided in the present application comprises:

[0005] An optical fiber having a proximal end and a distal end opposite to each other, the optical fiber comprising a core and a coating coating 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;

[0006] The push rod is a hollow tubular structure, and the push rod is fixedly sleeved on the outer circumference of the optical fiber to drive the optical fiber to move;

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

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

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

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

[0011] Optionally, the support member is a coil 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 hollowing ratio of the hollowing section is at least 80%.

[0013] Optionally, the coil spring is wound with a metal wire, and the diameter of the metal wire is 0.04-0.1 mm;

[0014] The diameter of the coil spring is 0.2-0.5 mm;

[0015] The length of the hollow section is 2 to 4 cm.

[0016] Optionally, the light-emitting guide wire further comprises a connector having a guide channel therein, and the optical fiber extends through the guide channel;

[0017] The proximal end of the connecting member is sleeved and fixed on the distal end of the pushing rod, the distal end of the connecting member is a cone structure with a gradually reduced diameter, and the first supporting section of the coil spring is sleeved and fixed on the cone structure;

[0018] The guide head comprises a spherical crown portion at a distal end and a cylindrical portion at a proximal end of the spherical crown portion, and the second supporting section of the spiral spring is sleeved and fixed on the cylindrical portion.

[0019] Optionally, a radial gap is provided between the first supporting segment and the cone structure, and the radial gap gradually increases from the proximal end to the distal end.

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

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

[0022] The balloon catheter assembly in this application includes:

[0023] A first pipe having a guide wire passage inside;

[0024] A second pipe member is sleeved on the outer side of the first pipe member, and a radial gap between the first pipe member and the second pipe member is a fluid channel;

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

[0026] A light-emitting guidewire, which adopts any of the light-emitting guidewires, and the light-emitting guidewire is movably arranged in the guidewire channel, wherein the axial position of the light-emitting working section is within the balloon body;

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

[0028] The method for using the balloon catheter assembly in the present application includes:

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

[0030] Inserting the balloon catheter along the luminous guidewire until the balloon body in the balloon catheter matches the position of the luminous working section;

[0031] Light is applied to the designated location via a light-emitting guidewire.

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

[0033] (1) A single luminous guidewire can be combined with various balloons, making processing simpler and more convenient;

[0034] (2) By replacing the light source, the light-emitting guidewire can be flexibly driven to emit blue light or red light to prevent vascular restenosis or neointimal proliferation. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 This is a schematic diagram of the structure of a light-emitting guide wire in an embodiment;

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

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

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

[0039] Figure 5 is a schematic structural diagram of a balloon catheter assembly in one embodiment;

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

[0041] Figure 7 1 is a flow chart of a method for using a balloon catheter assembly in one embodiment.

[0042] The reference numerals in the figures are described as follows:

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

[0044] 200, first pipe fitting;

[0045] 300, second pipe fitting;

[0046] 400, balloon body;

[0047] 500, light source;

[0048] 600, optical fiber components;

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

[0050] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0051] It should be noted that when a component is referred to as being "connected" to another component, it may be directly connected to the other component or there may be a central component. When a component is referred to as being "disposed on" another component, it may be directly disposed on the other component or there may be a central component at the same time.

[0052] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art to which this application belongs. The terms used herein in the specification of this application are only for the purpose of describing specific embodiments and are not intended to limit this application. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0053] refer to Figures 1 to 4, a light-emitting guidewire 100 provided in an embodiment of the present application includes 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, and 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 light-emitting guidewire 100 to move in the lumen of human tissue; the support member 140 is located at the periphery of the light-emitting 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 be used as both a light source and a guide wire, integrating the two 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 includes a first support segment 141, a hollow segment 142, and a second support segment 143 from the proximal end to the distal end, wherein the first support segment 141 and the second support segment 143 are mesh dense segments, and the hollow segment 142 is a mesh sparse segment. 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, which is conducive to ensuring the support strength of the support member 140. The axial position of the light-emitting working segment 113 corresponds to the mesh sparse segment, which can ensure the effect of the light-emitting guide wire 100 emitting light.

[0055] refer to Figure 1 , 2 In another embodiment shown, the support member 140 is a spiral structure, such as a spiral spring, and the support member 140 includes a first support segment 141, a hollow segment 142, and a second support segment 143 from the proximal end to the distal end, wherein the pitch of the hollow segment 142 is greater than the pitch of the first support segment 141 and the second support segment 143, wherein the pitch of the first support segment 141 and the second support segment 143 is 0.04-0.1mm, for example, 0.05-0.06mm; the pitch of the hollow segment 142 is 0.1-0.4mm, for example, 0.2-0.35mm, and another example is 0.3mm. 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 provide sufficient support strength, and the axial position of the light-emitting working segment 113 corresponds to the hollow segment 142 to ensure the effect of light-emitting guide wire 100 emitting light. To ensure that the light transmittance of the light-emitting working section 113 after emitting light is above 80%, 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, the diameter of the metal wire is 0.04-0.1mm, and it is further preferably formed by spirally winding a metal wire with a diameter of 0.05-0.06mm. 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. If the diameter is too large, the radial size of the light-emitting guide wire will increase, and if the diameter is too small, the support strength of the coil spring will be affected. 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 guide wire can be adapted to the corresponding balloon body when used.

[0057] refer to Figure 4 In the illustrated embodiment, in order to fix the coil spring, the light guide wire 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 is a tapered structure 151 with a gradually reduced diameter, and the first support section 141 of the coil spring is fixed to the tapered structure 151. In addition, the guide head 130 includes a spherical crown portion 131 at the distal end and a cylindrical portion 132 located at the proximal end of the spherical crown portion 131, and the second support section 143 of the coil spring is sleeved and fixed to the cylindrical portion 132.

[0058] The distal end of the push rod 120 is a reduced diameter end 121, and the proximal end of the connector 150 is provided with a closing structure 152 for the reduced diameter end 121 to extend into, and the shape of the closing structure 152 is adapted to the reduced diameter end 121. During assembly, the reduced diameter end 121 of the push rod 120 is connected with the closing structure 152 of the connector 150; further, the connection parts of the push rod 120 and the connector 150 are flush, so that the structure of the light guide wire 100 is compact, which is conducive to the subsequent assembly with the balloon catheter assembly. After the above components are connected, they can be fixed by laser welding.

[0059] The cone structure 151 gradually decreases in diameter from the proximal end to the distal end, and a radial gap is provided between the first support section 141 and the cone structure 151, and the radial gap gradually increases from the proximal end to the distal end. The span of the radial gap in the axial direction of the optical fiber 110 is L1, and the span of the hollow section 142 in the axial direction of the optical fiber 110 is L2, and L1:L2=1:1.2 to 3 times, for example, 1:1.5 to 2.5, for example, 1:1.5 to 2, and further for example, 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, and the optical fiber 110 that has passed through the pushing rod 120 extends through the threading channel of the connector 150 .

[0061] In the optical fiber 110, the material of the core 111 can be plastic optical fiber 110 or quartz optical fiber 110, preferably 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, the radial size of the light-emitting guide wire 100 will be too large, affecting the subsequent application of the light-emitting guide wire. The periphery of the optical fiber 110 can also 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 fiber 110 cladding is stripped from the portion of the fiber 110 in the balloon body 400, and the stripping length of the fiber 110 cladding 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] refer to Figure 5The present application also provides a balloon catheter assembly, including a first tube 200, a second tube 300, a balloon body 400, a light-emitting guidewire 100 and a light source 500, wherein a guidewire channel is provided inside the first tube, the second tube 300 is sleeved on the outside of the first tube 200, and the radial gap between the first tube 200 and the second tube 300 is a fluid channel; the balloon body 400 is located at the outer periphery of the first tube 200 and is fixedly connected to the distal end of the second tube 300; the light-emitting guidewire 100 includes an optical fiber 110, a push rod 120, a guide head 130 and a support member 140, and the optical fiber 110 includes a core 111 and a The wrapping layer 112, a part of the core 111 at the distal end of the optical fiber 110 is exposed and serves as the light-emitting working section 113, the pushing rod 120 is a hollow tubular structure, and 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, the support member 140 is located at the periphery of the light-emitting working section 113, and the two ends of the support member 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 optically connected to the light-emitting guide wire 100. Different light sources 500 can make the light-emitting guidewire 100 emit different lights. By replacing the light source 500, the balloon catheter assembly can meet the various needs of application scenarios. For example, when used to promote the repair of cells and tissues, the light source 500 selects a red light source 500, which can excite the light-emitting guidewire to emit red light with a wavelength of 625 to 720 nm. Red light has a photobiomodulatory effect. It is produced by a photochemical effect rather than a thermal effect, and can promote the repair of cells and tissues. For example, when used to form a vascular microstent, the light source 500 selects a blue light source, which can excite the light-emitting guidewire to emit blue light with a wavelength of 400 to 550 nm. The blue light in this band reacts with the therapeutic substance to form a microstent on the blood vessel, which is beneficial for treating early vascular stenosis and preventing restenosis of the blood vessel.

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

[0065] See also Figure 6In another embodiment shown, an optical fiber assembly 600 is further provided in the balloon catheter, and the optical fiber assembly 600 includes an optical fiber 110 body, which is inserted in the radial gap between the first tube 200 and the second tube 300, and the optical fiber assembly 600 has a light-emitting portion extending into the balloon body 400. The balloon catheter is also provided with an additional light source for the optical fiber assembly 600 outside, which is used to drive the optical fiber assembly 600 to emit light of a specific wavelength band. In this embodiment, the balloon catheter itself has a set of optical fiber assemblies 600, which are combined with the light-emitting guidewire 100. When used, it is convenient to switch between the optical fiber assembly 600 and the light-emitting guidewire 100 according to the scene requirements. For example, the optical fiber assembly 600 alone completes red light irradiation, and the light-emitting guidewire 100 alone completes blue light irradiation.

[0066] refer to Figure 7 In the illustrated embodiment, the method for using the balloon catheter assembly includes:

[0067] Step S100, passing the light-inducing guide wire 100 along a predetermined path until the light-emitting working section 113 reaches a specified position;

[0068] Step S200, inserting the balloon catheter along the luminous guide wire 100 until the balloon body 400 in the balloon catheter matches the position of the luminous working section 113;

[0069] Step S300 , applying light to a designated position via the light-emitting guide wire 100 .

[0070] In another embodiment, in step S300 , a therapeutic substance is applied to a designated location via a balloon catheter, and then light is applied to the designated location via the light-emitting guidewire 100 .

[0071] Specifically, the designated position in step S100 is a vascular disease segment, where there is cell and tissue damage and / or vascular stenosis. In step S200, the balloon catheter is inserted into the vascular disease segment under the guidance of the luminous guidewire 100. In step S300, the balloon catheter can release the therapeutic substance through the balloon body 400 or the fluid carrying the therapeutic substance can be applied to the designated position through the balloon body 400. The therapeutic substance can be at least one of an anti-proliferative drug, a drug that induces collagen or elastin cross-linking, and an anti-vasospasm drug.

[0072] When repairing cells and tissues in the diseased segment of a blood vessel, the balloon catheter assembly is equipped with a red light source 500, which prompts the light-emitting guide wire 100 to emit red light with a wavelength of 625 to 720 nm. The red light has a photobiomodulatory effect. It is generated by a photochemical effect rather than a thermal effect, and can promote the repair of cells and tissues and prevent the proliferation of new intima. When treating vascular stenosis, the balloon catheter assembly is equipped with a blue light source 500. The therapeutic substance is a therapeutic substance that can form a vascular microstent. The blue light with a wavelength of 400 to 550 nm is applied to the designated position through the light-emitting guide wire 100, prompting the therapeutic substance to react with the blood vessel to form a microstent, which can effectively prevent the restenosis of the blood vessel.

[0073] The luminous guidewire of the present application can be used in combination with a variety of balloon catheters, is easy to process, and by replacing the light source of the balloon catheter assembly, the luminous guidewire can be switched to emit different lights to act on the diseased segment of the blood vessel, thereby effectively preventing vascular restenosis or neointimal proliferation.

[0074] The technical features of the above-mentioned embodiments can be combined arbitrarily. To make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification. When the technical features in different embodiments are embodied in the same figure, it can be regarded that the figure also discloses the combination examples of the various embodiments involved.

[0075] The above-described embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the present application. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the present application shall be subject to the attached claims.

Claims

1. A luminous guide wire, 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 coating 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 circumference of the optical fiber to drive the optical fiber to move; A guide head connected to the distal end of the optical fiber; The support member is located at the periphery of the light-emitting working section, and two ends of the support member are respectively connected to the guide head and the push rod.

2. The light-emitting guidewire according to claim 1, characterized in that: The support member is a mesh tube structure or a spiral structure, and the support member includes a first support section, a hollow section and a second support section from the proximal end to the distal end; The first supporting section and the second supporting section are fixedly connected to the pushing rod and the guiding head respectively, and the axial position of the light-emitting working section corresponds to the hollow section.

3. The light-emitting guidewire according to claim 2, characterized in that: The support member is a coil spring, 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%.

4. The light-emitting guidewire according to claim 3, characterized in that: The coil spring 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.

5. The light-emitting guidewire according to claim 2, characterized in that: The light-emitting guide wire also includes a connector having a threading channel therein, and the optical fiber extends through the threading channel; The proximal end of the connecting member is sleeved and fixed on the distal end of the pushing rod, the distal end of the connecting member is a cone structure with a gradually reduced diameter, and the first supporting section of the coil spring is sleeved and fixed on the cone structure; The guide head comprises a spherical crown portion at a distal end and a cylindrical portion at a proximal end of the spherical crown portion, and the second supporting section of the spiral spring is sleeved and fixed on the cylindrical portion.

6. The light-emitting guidewire according to claim 5, 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.

7. The light-emitting guidewire according to claim 6, 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 L1:L2=1:1.2 to 3 times is satisfied.

8. 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.

9. A balloon catheter assembly, characterized in that: include: A first pipe having a guide wire passage inside; A second pipe member is sleeved on the outer side of the first pipe member, and a radial gap between the first pipe member and the second pipe member is a fluid channel; A balloon body, located at the outer periphery of the first tube and fixedly connected to the distal end of the second tube; A light-emitting guidewire, comprising the light-emitting guidewire as claimed in any one of claims 1 to 8, wherein the light-emitting guidewire is movably arranged in the guidewire channel, wherein the axial position of the light-emitting working section is within the balloon body; A light source is connected to the light path of the light-emitting guide wire.

10. A method for using a balloon catheter assembly, characterized in that: include: Passing the light-emitting guide wire according to any one of claims 1 to 8 along a predetermined path until the light-emitting working section reaches a specified position; Inserting the balloon catheter along the luminous guidewire until the balloon body in the balloon catheter matches the position of the luminous working section; Light is applied to the designated location via a light-emitting guidewire.

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