Optical fiber balloon catheter

Abstract

The invention relates to the technical field of medical instruments, and provides an optical fiber balloon catheter which at least comprises a balloon body, and the surface of the balloon body is coated with vascular repair promoting medicine; a plurality of optical fibers are uniformly arranged on the outer surface of the balloon body at intervals in the circumferential direction of the balloon body. Compared with the prior art in which the optical fibers are arranged in the balloon body, the optical fiber balloon catheter provided by the invention has the advantages that the optical fibers are uniformly arranged on the outer surface of the balloon body, so that the influence of the balloon body on optical fiber light can be reduced; the light emitted by the optical fiber can be uniformly irradiated to the surface of the balloon body or the blood vessel wall, so that the blood vessel repair promoting medicine is activated, crosslinking of protein in the blood vessel wall is triggered, a natural blood vessel stent is formed, and the expanded blood vessel is maintained.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly relates to an optical fiber balloon catheter. Background Art

[0002] Among numerous cardiovascular diseases, vascular stenosis lesion is a relatively serious one. Vascular interventional therapy is an important treatment method for revascularization of vascular stenosis lesions. For intravascular stenosis lesions, balloon dilation or stent implantation is usually used for treatment, but both of these methods have their own deficiencies: After balloon dilation, the vascular endothelium of the dilated arterial segment is damaged and elastic fibers are broken, resulting in thrombosis and intimal hyperplasia; during the use of the balloon, the inflation time is short and the long-term supporting force is lacking, resulting in elastic recoil and remodeling of the blood vessel wall; long-term placement of a vascular stent will also cause a proliferation reaction of the body as a foreign body, leading to restenosis within the vascular stent. In view of the above problems, an optical fiber balloon catheter has emerged. A vascular repair promoting material is coated on the balloon. After the balloon is dilated, the vascular repair promoting material is released onto the inner wall of the blood vessel, and specific wavelength light is emitted through the optical fiber to activate and cause covalent cross-linking of amino acids on the inner wall of the blood vessel, providing a supporting effect on the blood vessel, thereby avoiding the problem of blood vessel retraction.

[0003] However, for existing optical fiber balloon catheters, usually a single optical fiber is placed on one side of the outer side wall of the inner tube inside the balloon. This design makes the light intensity received on the surface of the balloon near the optical fiber high, while the light intensity received on the surface of the balloon far from the optical fiber relatively low, and the light received on the entire balloon surface is uneven; moreover, if it is necessary to ensure uniform light reception on the balloon surface, multiple optical fibers need to be placed outside the inner tube or spirally placed, which will reduce the filling gap and increase the time for balloon inflation and deflation. If the filling gap is not affected, the outer tube size needs to be increased, making the overall outer diameter of the balloon catheter larger, which is not conducive to the balloon catheter entering the stenosis lesion area. Summary of the Invention

[0004] Therefore, the present invention aims to solve the problem that for existing optical fiber balloon catheters, usually a single optical fiber is placed on one side of the outer side wall of the inner tube inside the balloon. This design makes the light intensity received on the surface of the balloon near the optical fiber high, while the light intensity received on the surface of the balloon far from the optical fiber relatively low, and the light received on the entire balloon surface is uneven, and thus provides an optical fiber balloon catheter.

[0005] To solve the above technical problems, the technical solution of the present invention is as follows: The present invention provides an optical fiber balloon catheter, which at least includes: a balloon body, and a vascular repair promoting drug is coated on the surface of the balloon body; optical fibers, and a plurality of the optical fibers are evenly spaced on the outer surface of the balloon body along the circumferential direction of the balloon body.

[0006] Further, a plurality of receiving grooves are uniformly spaced on the outer surface of the balloon body along the circumferential direction of the balloon body, and the optical fiber is disposed in each receiving groove.

[0007] Further, the optical fiber is an optical fiber that emits light only from the end face or an optical fiber that emits light from both the cylindrical surface and the end face.

[0008] Further, when the optical fiber is an optical fiber that emits light only from the end face, along the radial direction of the optical fiber, a part of the optical fiber is embedded in the receiving groove, and the other part protrudes outward relative to the outer surface of the balloon body.

[0009] Further, when the optical fiber is an optical fiber that emits light from both the cylindrical surface and the end face, along the radial direction of the optical fiber, the optical fiber is entirely embedded in the receiving groove and the optical fiber is bonded in the receiving groove by a glue having a high refractive index.

[0010] Further, the pro-angiogenic repair drug is coated in the receiving groove.

[0011] Further, the remaining area of the outer surface of the balloon body except the area where the receiving groove is located is coated with an anti-proliferative drug.

[0012] Further, it further includes a catheter seat and a catheter; the catheter seat is a hollow structure, and a guide wire outlet, a balloon inflation interface and an optical fiber interface are provided on the catheter seat; the catheter includes an inner tube and an outer tube arranged coaxially, the outer tube is sleeved outside the inner tube, and the inner cavity of the inner tube serves as a guide wire cavity and is communicated with the guide wire outlet; the gap between the inner tube and the outer tube forms a balloon inflation cavity, and the balloon inflation cavity is communicated with the balloon inflation interface; the balloon body is located at the distal end of the inner tube and is communicated with the balloon inflation cavity, and fluid is filled into or withdrawn from the balloon body through the balloon inflation interface to make it expand or contract; the proximal end of the optical fiber extends to the optical fiber interface and is connected to an external laser generating device.

[0013] Further, the proximal end of the optical fiber extends to the optical fiber interface through the outer surface of the outer tube.

[0014] Further, an optical fiber channel is provided in the wall of the outer tube, and the proximal end of the optical fiber extends to the optical fiber interface through the optical fiber channel.

[0015] The technical solution of the present invention has the following advantages: The fiber optic balloon catheter provided by the present invention, compared with the prior art in which the optical fiber is arranged inside the balloon body, the optical fiber in the fiber optic balloon catheter of the present application is uniformly arranged on the outer surface of the balloon body, which can reduce the influence of the balloon body on the light of the optical fiber, so that the light emitted by the optical fiber can uniformly irradiate the surface of the balloon body or the blood vessel wall, so as to activate the blood vessel repair drug, trigger the cross-linking of proteins in the blood vessel wall, form a natural blood vessel stent, and maintain the dilated blood vessel; moreover, compared with placing multiple optical fibers outside the inner tube or arranging the optical fibers in a spiral manner, it will not reduce the filling gap, will not increase the time for balloon inflation and deflation, and will not increase the overall outer diameter of the balloon catheter, which is beneficial for the balloon catheter to enter the narrow lesion area. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following will briefly introduce the drawings required for the description of the specific embodiments or the prior art. Obviously, the drawings in the following description are some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0017] Figure 1 Schematic diagram of the fiber optic balloon catheter in the embodiment of the present invention; Figure 2 Schematic diagram of the balloon body in the fiber optic balloon catheter in the embodiment of the present invention; Figure 3 Schematic diagram of the outer tube in the fiber optic balloon catheter in the embodiment of the present invention; Figure 4 is Figure 3 side view of; Figure 5 Enlarged schematic diagram of the accommodation groove in the fiber optic balloon catheter in the embodiment of the present invention. Description of the reference numerals: 1. Balloon body; 101. Accommodation groove; 2. Optical fiber; 3. Inner tube; 4. Outer tube; 5. Catheter seat; 6. Balloon inflation interface; 7. Guide wire outlet; 8. Optical fiber interface; 9. Glue; 10. Blood vessel repair drug. DETAILED DESCRIPTION OF THE EMBODIMENTS The following will clearly and completely describe the technical solutions of the present invention with reference to the drawings. Obviously, the described embodiments are some, but not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts fall within the protection scope of the present invention.

[0018] In the description of the present invention, it should be noted that the orientation or positional relationship indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation to the present invention. In addition, the terms "first", "second", "third" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance.

[0019] In the description of the present invention, it should be noted that unless otherwise clearly specified and defined, the terms "installed", "connected", "coupled" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0020] In addition, the technical features involved in different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0021] As Figure 1 shown, this embodiment provides an optical fiber balloon catheter, which at least includes: a balloon body 1, and a pro-angiogenic repair drug 10 is coated on the surface of the balloon body 1; for example, the pro-angiogenic repair drug 10 can be naphthalimide dimer and its derivatives. An optical fiber 2, and a plurality of the optical fibers 2 are uniformly spaced on the outer surface of the balloon body 1 along the circumferential direction of the balloon body 1. For example, the optical fiber 2 can be fixed on the outer surface of the balloon body 1 by an adhesive method. For example, two, four, six, eight or more optical fibers 2 can be uniformly spaced along the entire circumferential direction of the balloon body 1, or three, five, seven, nine or more optical fibers 2 can be uniformly spaced along the entire circumferential direction of the balloon body 1, and the specific number can be designed according to needs. With such a setting, the light irradiated by the optical fiber 2 is more uniform in the circumferential direction of the entire balloon body 1.

[0022] For example, the optical fiber 2 can be a conventional optical fiber 2, including an internal core, an intermediate cladding, and an external coating. The function of the cladding is to confine light within the core by total internal reflection, enabling the light to be transmitted to the desired light-emitting site. The function of the coating is to provide mechanical protection, making the optical fiber 2 stronger. Such a structured optical fiber 2 emits light only at its ends. At this time, along the axial direction of the balloon body 1, the axial lengths of the optical fibers 2 at different positions can be different. For example, some of the optical fibers 2 are longer, and their distal ends can extend to a position flush with the distal end of the balloon body 1; some of the optical fibers 2 have a moderate length, and their distal ends can extend to the middle position of the balloon body 1; and some of the optical fibers 2 are shorter, and their distal ends can extend to the proximal position of the balloon body 1. With such an arrangement, the light irradiated by the optical fibers 2 is more uniform in the entire axial direction of the balloon body 1. For example, the optical fiber 2 can also be an optical fiber 2 with only a core, and both the end face and the cylindrical surface of this optical fiber 2 can emit light. At this time, along the axial direction of the balloon body 1, relatively long optical fibers 2 can be selected for all the optical fibers 2, and the distal end of each optical fiber 2 extends to a position flush with the distal end of the balloon body 1, making the light irradiated by the optical fibers 2 more uniform in the entire axial direction of the balloon body 1. It should be noted that in this application, the distal end refers to the end of the instrument away from the operator, and the proximal end refers to the end of the instrument close to the operator.

[0023] Compared with the prior art where the optical fiber 2 is disposed inside the balloon body 1, the optical fiber balloon catheter provided in this embodiment evenly disposes the optical fiber 2 on the outer surface of the balloon body 1, which can reduce the influence of the balloon body 1 on the light of the optical fiber 2, enabling the light emitted by the optical fiber 2 to evenly irradiate the surface of the balloon body 1 or the blood vessel wall, so as to activate the blood vessel repair drug 10, trigger the cross-linking of proteins in the blood vessel wall, form a natural blood vessel scaffold, and enable the dilated blood vessel to be maintained.

[0024] As Figure 2 shown, along the circumferential direction of the balloon body 1, a plurality of receiving grooves 101 are evenly spaced on the outer surface of the balloon body 1, and the optical fiber 2 is disposed in each of the receiving grooves 101.

[0025] Among them, the optical fiber 2 is an optical fiber 2 that emits light only from the end face or an optical fiber 2 that emits light from both the cylindrical surface and the end face. For example, when the optical fiber 2 is an optical fiber 2 that emits light only from the end face, in the radial direction of the optical fiber 2, a part of the optical fiber 2 is embedded in the receiving groove 101, and the other part protrudes outward relative to the outer surface of the balloon body 1. For example, during the production of the balloon body 1, the receiving groove 101 can be formed on the outer surface of the balloon body 1 by using a specific mold during blow molding, and the size and shape of the receiving groove 101 can be designed according to the size and shape of the optical fiber 2. The optical fiber 2 can be fixed in the receiving groove 101 with glue 9. For example, the wavelength range of the light emitted by the optical fiber 2 can be 400nm - 500nm. With such a setting, half of the optical fiber 2 is installed in the receiving groove 101, and half is exposed on the surface of the balloon body 1. Compared with the case where the optical fiber 2 is completely arranged on the balloon surface without designing the receiving groove 101, such a design can, on the one hand, increase the contact area between the optical fiber 2 and the balloon body 1, avoiding unreliable bonding between the optical fiber 2 and the balloon body 1. On the other hand, it can reduce the folding outer diameter of the balloon body 1. Moreover, the part of the optical fiber 2 exposed on the surface of the balloon body 1 can play an anchoring role to prevent the balloon body 1 from slipping in the blood vessel.

[0026] As Figure 5 shown, among them, when the optical fiber 2 is an optical fiber 2 that emits light from both the cylindrical surface and the end face, in the radial direction of the optical fiber 2, the optical fiber 2 is completely embedded in the receiving groove 101 and the optical fiber 2 is bonded in the receiving groove 101 with glue 9 having a high refractive index. In this embodiment, since the optical fiber 2 has only a core and no cladding to limit the light, the light can be more evenly scattered on the outer surface of the balloon body 1. Moreover, there is still remaining space in the receiving groove 101 after the optical fiber 2 is bonded. For example, the method of pipetting can be adopted to directionally coat the blood vessel repair promoting drug 10 in the receiving groove 101. After the balloon body 1 is folded, the optical fiber 2 and the drug are hidden in the folding wing, which can effectively reduce the loss of the drug.

[0027] Among them, the remaining area of the outer surface of the balloon body 1 except the area where the receiving groove 101 is located is coated with an anti - proliferation drug. The anti - proliferation drug is used to treat vascular stenosis and occlusion. For example, the anti - proliferation drug can be a macrolide immunosuppressant, a macrolide antibiotic, rapamycin, a structural derivative and functional analogue of rapamycin, everolimus, a structural derivative and functional analogue of everolimus, paclitaxel, taxanes, temsirolimus compound, zotarolimus, everolimus, sirolimus, biolimus, tacrolimus or temsirolimus or temsirolimus compound, zotarolimus, everolimus, sirolimus, biolimus, tacrolimus or temsirolimus compound.

[0028] Among them, it further includes a catheter seat 5 and a catheter; the catheter seat 5 is a hollow structure, and the catheter seat 5 is provided with a guide wire outlet 7, a balloon inflation interface 6 and an optical fiber interface 8; the catheter includes an inner tube 3 and an outer tube 4 arranged coaxially, the outer tube 4 is sleeved outside the inner tube 3, the inner cavity of the inner tube 3 serves as a guide wire cavity and is communicated with the guide wire outlet 7; the gap between the inner tube 3 and the outer tube 4 forms a balloon inflation cavity, and the balloon inflation cavity is communicated with the balloon inflation interface 6; the balloon body 1 is located at the distal end of the inner tube 3 and is communicated with the balloon inflation cavity, and fluid is filled into or drawn out of the balloon body 1 through the balloon inflation interface 6 to make it expand or contract; the proximal end of the optical fiber 2 extends to the optical fiber interface 8 and is connected to an external laser generating device. Of course, the catheter can also be a multi-lumen tube, including a guide wire cavity, a balloon inflation cavity, etc. The structure of the catheter is prior art and will not be introduced in detail here.

[0029] Among them, the proximal end of the optical fiber 2 can extend to the optical fiber interface 8 through the outer surface of the outer tube 4.

[0030] Such as Figure 3 , Figure 4 As shown, among them, an optical fiber channel is arranged in the tube wall of the outer tube 4, and the proximal end of the optical fiber 2 extends to the optical fiber interface 8 through the optical fiber channel. For example, the outer tube 4 or the catheter with a hollow interior and an optical fiber 2 can be prepared by the sleeve method. The optical fiber 2 located in the catheter or the outer tube 4 can be a fiber core or a conventional optical fiber 2. The position of the optical fiber 2 extending out of the outer tube 4 or the catheter is adapted to the position of the receiving groove 101 on the balloon body 1.

[0031] When the optical fiber balloon catheter in the present application is used, the catheter is introduced into the diseased position of the blood vessel through a guide wire, the balloon body 1 is transported to the diseased position, the balloon body 1 is inflated to make it contact with the diseased tissue, and the blood vessel repair drug 10 reaches the diseased tissue; then the optical fiber 2 is connected to an external laser generator, and the optical fiber 2 emits light with a wavelength of 400 nm - 500 nm to activate the blood vessel repair drug 10, trigger the cross-linking of proteins in the blood vessel wall, form a natural blood vessel stent, and maintain the expanded blood vessel; then the balloon body 1 is depressurized to make it contract and withdrawn from the body.

[0032] In summary, the optical fiber balloon catheter in the present application arranges at least one receiving groove 101 on the outer wall of the balloon body 1, places at least one optical fiber 2 in the receiving groove 101, so that the light emitted by the optical fiber 2 can evenly irradiate the surface of the balloon body 1, activate the blood vessel repair drug 10, trigger the cross-linking of proteins in the blood vessel wall, form a natural blood vessel stent, and maintain the expanded blood vessel.

[0033] Obviously, the above embodiments are merely examples given for clear illustration and not limitations on the implementation manners. For those of ordinary skill in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all implementation manners here. And the obvious changes or modifications derived therefrom still fall within the protection scope of the present invention.

Claims

1. An optical fiber balloon catheter, characterized in that, Comprising at least: A balloon body (1), the surface of the balloon body (1) being coated with a blood vessel repair promoting drug (10); Optical fibers (2), a plurality of the optical fibers (2) being uniformly spaced on the outer surface of the balloon body (1) along the circumferential direction of the balloon body (1); A plurality of receiving grooves (101) are uniformly spaced on the outer surface of the balloon body (1) along the circumferential direction of the balloon body (1), and each of the receiving grooves (101) is provided with the optical fiber (2); The optical fiber (2) is an optical fiber (2) that emits light only from its end face or an optical fiber (2) that emits light from both its cylindrical surface and end face; When the optical fiber (2) is an optical fiber (2) that emits light only from its end face, along the radial direction of the optical fiber (2), a part of the optical fiber (2) is embedded in the receiving groove (101), and the other part protrudes outward relative to the outer surface of the balloon body (1).

2. The optical fiber balloon catheter according to claim 1, wherein When the optical fiber (2) is an optical fiber (2) that emits light from both its cylindrical surface and end face, along the radial direction of the optical fiber (2), the optical fiber (2) is entirely embedded in the receiving groove (101) and the optical fiber (2) is bonded in the receiving groove (101) by a glue (9) having a high refractive index.

3. The optical fiber balloon catheter according to claim 2, wherein The blood vessel repair promoting drug (10) is coated in the receiving groove (101).

4. The optical fiber balloon catheter according to claim 3, wherein The remaining area of the outer surface of the balloon body (1) except for the area where the receiving groove (101) is located is coated with an anti-proliferative drug.

5. The optical fiber balloon catheter according to claim 1, wherein It further comprises a catheter seat (5) and a catheter; The catheter seat (5) is a hollow structure, and the catheter seat (5) is provided with a guide wire outlet (7), a balloon inflation interface (6) and an optical fiber interface (8); The catheter comprises an inner tube (3) and an outer tube (4) arranged coaxially, the outer tube (4) being sleeved outside the inner tube (3), and the inner cavity of the inner tube (3) serving as a guide wire cavity and being connected to the guide wire outlet (7); The gap between the inner tube (3) and the outer tube (4) forms a balloon inflation cavity, and the balloon inflation cavity is connected to the balloon inflation interface (6); The balloon body (1) is located at the distal end of the inner tube (3) and is connected to the balloon inflation cavity. Fluid is filled into or withdrawn from the balloon body (1) through the balloon inflation interface (6) to cause it to expand or contract; The proximal end of the optical fiber (2) extends to the optical fiber interface (8) and is connected to an external laser generating device.

6. The optical fiber balloon catheter according to claim 5, wherein The proximal end of the optical fiber (2) extends to the optical fiber interface (8) through the outer surface of the outer tube (4).

7. The optical fiber balloon catheter according to claim 5, wherein An optical fiber channel is provided in the tube wall of the outer tube (4), and the proximal end of the optical fiber (2) extends to the optical fiber interface (8) through the optical fiber channel.

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