Fiber optic balloon catheter

Abstract

The present invention relates to the field of medical device technology, and provides a fiber optic balloon catheter comprising at least: a balloon body, the surface of which is coated with a drug that promotes vascular repair; and optical fibers, a plurality of which are evenly spaced on the outer surface of the balloon body along the circumferential direction of the balloon body. Compared to the prior art method of arranging the optical fibers inside the balloon body, the fiber optic balloon catheter provided by the present invention evenly arranges the optical fibers on the outer surface of the balloon body, thereby reducing the impact of the balloon body on the optical fiber light, allowing the light emitted by the optical fiber to evenly illuminate the surface of the balloon body or the blood vessel wall, thereby activating the drug that promotes vascular repair, inducing cross-linking of proteins in the blood vessel wall, forming a natural blood vessel stent, and maintaining the expanded blood vessel.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a fiber optic balloon catheter. Background Art

[0002] Among the many cardiovascular diseases, vascular stenosis is one of the more serious ones. Vascular intervention is an important treatment method for revascularization of vascular stenosis. For intravascular stenosis, balloon dilatation or stent implantation is usually used for treatment, but both methods have their own shortcomings: after balloon dilatation, the endothelium of the dilated artery segment is damaged and the elastic fibers are broken, leading to thrombosis and intimal hyperplasia; the balloon has a short inflation time during use and lacks long-term support, which leads to elastic retraction and remodeling of the vessel wall; the vascular stent will also act as a foreign body and produce a proliferative response in the body if placed for a long time, leading to restenosis in the vascular stent. To address the above problems, a fiber optic balloon catheter has been developed. The balloon is coated with a vascular repair material. After the balloon is expanded, the vascular repair material is released into the inner wall of the blood vessel. The optical fiber emits light of a specific wavelength to activate it, causing the amino acids in the inner wall of the blood vessel to form covalent cross-links, which has a supporting effect on the blood vessel, thereby avoiding the problem of vascular retraction.

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

[0004] Therefore, the present invention aims to solve the problem of fiber optic balloon catheters in the prior art, in which a single optical fiber is usually placed on one side of the outer wall of the inner tube inside the balloon. This design makes the light intensity received by the surface of the balloon close to the optical fiber side high, and the light intensity received by the surface of the balloon away from the optical fiber side relatively low, resulting in uneven light received by the entire balloon surface, thereby providing a fiber optic balloon catheter.

[0005] In order to solve the above technical problems, the technical solutions of the present invention are as follows:

[0006] The present invention provides a fiber optic balloon catheter, which at least comprises: a balloon body, the surface of which is coated with a drug promoting blood vessel repair; and optical fibers, a plurality of which are evenly spaced on the outer surface of the balloon body along the circumferential direction of the balloon body.

[0007] Furthermore, a plurality of accommodating grooves are evenly spaced on the outer surface of the balloon body along the circumferential direction of the balloon body, and the optical fiber is arranged in each of the accommodating grooves.

[0008] Furthermore, the optical fiber is an optical fiber that emits light only at the end face or an optical fiber that emits light at both the cylindrical surface and the end face.

[0009] Furthermore, when the optical fiber is an optical fiber that emits light only at its end face, along the radial direction of the optical fiber, a portion of the optical fiber is embedded in the accommodating groove, and another portion protrudes relative to the outer surface of the balloon body.

[0010] Furthermore, when the optical fiber is an optical fiber that emits light on both the cylindrical surface and the end face, along the radial direction of the optical fiber, the optical fiber is completely embedded in the accommodating groove and the optical fiber is bonded to the accommodating groove by glue with a high refractive index.

[0011] Furthermore, the vascular repair promoting drug is coated in the containing groove.

[0012] Furthermore, the outer surface of the balloon body except the area where the receiving groove is located is coated with anti-proliferative drugs.

[0013] Furthermore, it also includes a catheter seat and a catheter; the catheter seat is a hollow structure, and the catheter seat is provided with a guidewire outlet, a balloon filling interface and an optical fiber interface; the catheter includes a coaxially arranged inner tube and an outer tube, the outer tube is sleeved outside the inner tube, the inner cavity of the inner tube serves as a guidewire cavity and is connected to the guidewire outlet; the gap between the inner tube and the outer tube forms a balloon filling cavity, and the balloon filling cavity is connected to the balloon filling interface; the balloon body is located at the distal end of the inner tube and is connected to the balloon filling cavity, and fluid is filled into or extracted from the balloon body through the balloon filling interface to cause it to 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.

[0014] Furthermore, the proximal end of the optical fiber extends to the optical fiber interface through the outer surface of the outer tube.

[0015] Furthermore, an optical fiber channel is provided in the tube wall of the outer tube, and the proximal end of the optical fiber extends to the optical fiber interface through the optical fiber channel.

[0016] The technical solution of the present invention has the following advantages:

[0017] Compared with the prior art method of arranging the optical fiber inside the balloon body, the fiber optic balloon catheter provided by the present invention arranges the optical fiber evenly on the outer surface of the balloon body, which can reduce the influence of the balloon body on the optical fiber light, so that the light emitted by the optical fiber can be evenly irradiated to the surface of the balloon body or the blood vessel wall, so as to activate the vascular repair drug, trigger the cross-linking of the protein in the blood vessel wall, form a natural vascular stent, and maintain the expanded blood vessel; moreover, compared with placing multiple optical fibers outside the inner tube, or placing the optical fiber in a spiral manner, it will not reduce the filling gap, will not increase the time for filling and unloading the balloon, and will not increase the overall outer diameter of the balloon catheter, which is conducive to the balloon catheter entering the stenotic lesion area. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the specific embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0019] Figure 1 is a schematic diagram of a fiber optic balloon catheter in an embodiment of the present invention;

[0020] Figure 2 Schematic diagram of a balloon body in a fiber optic balloon catheter according to an embodiment of the present invention;

[0021] Figure 3 Schematic diagram of the outer tube of the fiber optic balloon catheter in an embodiment of the present invention;

[0022] Figure 4 for Figure 3 Side view of;

[0023] Figure 5 It is an enlarged schematic diagram of the receiving groove in the fiber optic balloon catheter in an embodiment of the present invention.

[0024] Description of reference numerals:

[0025] 1. Balloon body; 101. Accommodation slot;

[0026] 2. Optical fiber; 3. Inner tube; 4. Outer tube; 5. Catheter seat; 6. Balloon filling interface; 7. Guidewire outlet; 8. Optical fiber interface; 9. Glue; 10. Drugs that promote vascular repair. DETAILED DESCRIPTION

[0027] The technical solution of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

[0028] In the description of the present invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings and are intended solely to facilitate and simplify the description of the present invention. They are not intended to indicate or imply that the devices or components referred to must have, be constructed, or operate in a specific orientation, and therefore should not be construed as limitations on the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0029] In the description of the present invention, it should be noted that, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood in a broad sense. For example, they may refer to fixed, detachable, or integral connections; mechanical or electrical connections; direct or indirect connections through an intermediate medium; and internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on the specific circumstances.

[0030] In addition, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0031] like Figure 1 As shown, this embodiment provides a fiber optic balloon catheter, which at least includes: a balloon body 1, the surface of the balloon body 1 is coated with a vascular repair drug 10; for example, the vascular repair drug 10 can be a naphthalimide dimer and its derivatives. An optical fiber 2, a plurality of optical fibers 2 are evenly 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 bonding. For example, two, four, six, eight or more optical fibers 2 can be evenly spaced along the circumferential direction of the entire balloon body 1, or three, five, seven, nine or more optical fibers 2 can be evenly spaced along the circumferential direction of the entire balloon body 1. The specific number can be designed as needed. This arrangement makes the light irradiated by the optical fiber 2 more uniform in the circumferential direction of the entire balloon body 1.

[0032] For example, the optical fiber 2 can be a conventional optical fiber 2, including an internal core, a middle cladding and an external coating. The function of the cladding is to confine the light within the core through total reflection, so that the light is transmitted to the part where you want to emit light. The function of the coating is to provide mechanical protection to make the intensity of the optical fiber 2 higher. The optical fiber 2 of this structure only emits light at the end. At this time, along the axial direction of the balloon body 1, the axial length of the optical fiber 2 at different positions can be different. For example, a part of the optical fiber 2 is longer, and its distal end can extend to a position flush with the distal end of the balloon body 1; a part of the optical fiber 2 is of moderate length, and its distal end can extend to the middle position of the balloon body 1; and another part of the optical fiber 2 is shorter, and its distal end can extend to the proximal position of the balloon body 1. This arrangement makes the light irradiated by the optical fiber 2 more uniform in the entire axial direction of the balloon body 1. For example, the optical fiber 2 may also be an optical fiber 2 having only a core, and both the end face and the cylindrical surface of the optical fiber 2 can emit light. In this case, along the axial direction of the balloon body 1, the optical fibers 2 may all be relatively long, and the distal end of each optical fiber 2 may extend to a position flush with the distal end of the balloon body 1, so that the light irradiated by the optical fibers 2 is more uniform along the entire axial direction of the balloon body 1. It should be noted that the distal end in this application refers to the end of the device away from the operator, and the proximal end refers to the end of the device closer to the operator.

[0033] Compared with the prior art in which the optical fiber 2 is arranged inside the balloon body 1, the optical fiber 2 balloon catheter provided in this embodiment arranges the optical fiber 2 evenly on the outer surface of the balloon body 1, which can reduce the impact of the balloon body 1 on the light of the optical fiber 2, so that the light emitted by the optical fiber 2 can be evenly irradiated to the surface of the balloon body 1 or the blood vessel wall, so as to activate the vascular repair drug 10, trigger the cross-linking of proteins in the blood vessel wall, form a natural vascular stent, and maintain the expanded blood vessel.

[0034] like Figure 2 As shown, a plurality of accommodating grooves 101 are evenly spaced on the outer surface of the balloon body 1 along the circumferential direction of the balloon body 1 , and the optical fiber 2 is arranged in each of the accommodating grooves 101 .

[0035] The optical fiber 2 is an optical fiber 2 that emits light only on the end face, or an optical fiber 2 that emits light on both the cylindrical surface and the end face. For example, when the optical fiber 2 is an optical fiber 2 that emits light only on the end face, along the radial direction of the optical fiber 2, a portion of the optical fiber 2 is embedded in the receiving groove 101, and the other portion protrudes relative to the outer surface of the balloon body 1. For example, during the production process of the balloon body 1, a specific mold can be used to form the receiving groove 101 on the outer surface of the balloon body 1 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. In this arrangement, half of the optical fiber 2 is installed in the receiving groove 101, and the other 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 surface of the balloon without designing the receiving groove 101, this design can, on the one hand, increase the contact area between the optical fiber 2 and the balloon body 1, avoiding the loose bonding between the optical fiber 2 and the balloon body 1; on the other hand, it can reduce the folded outer diameter of the balloon body 1; and 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.

[0036] like Figure 5 As shown, when the optical fiber 2 is an optical fiber 2 that emits light both on the cylindrical surface and the end face, along 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 to the receiving groove 101 by glue 9 having a high refractive index. In this embodiment, since the optical fiber 2 has only a core and no cladding to restrict the light, the light can be more evenly scattered on the outer surface of the balloon body 1. Moreover, after the optical fiber 2 is bonded, there is still remaining space in the receiving groove 101. For example, the vascular repair drug 10 can be directionally coated in the receiving groove 101 by pipetting. After the balloon body 1 is folded, the optical fiber 2 and the drug are hidden in the folding wings, which can effectively reduce the loss of the drug.

[0037] The outer surface of the balloon body 1 is coated with an anti-proliferative drug on the remaining area except the area where the receiving groove 101 is located. The anti-proliferative drug is used to treat vascular stenosis and occlusion. For example, the anti-proliferative drug can be a macrolide immunosuppressant, a macrolide antibiotic, rapamycin, a structural derivative and functional analog of rapamycin, everolimus, a structural derivative and functional analog of everolimus, paclitaxel, a taxane, a temsirolimus compound, zotarolimus, everolimus, sirolimus, biolimus, tacrolimus, or temsirolimus or a temsirolimus compound, zotarolimus, everolimus, sirolimus, biolimus, tacrolimus, or a temsirolimus compound.

[0038] The catheter also includes a catheter seat 5 and a catheter; the catheter seat 5 is a hollow structure, and is provided with a guidewire outlet 7, a balloon filling interface 6, and an optical fiber interface 8; the catheter includes a coaxially arranged inner tube 3 and an outer tube 4, the outer tube 4 is sleeved outside the inner tube 3, and the inner cavity of the inner tube 3 serves as a guidewire cavity and is connected to the guidewire outlet 7; the gap between the inner tube 3 and the outer tube 4 forms a balloon filling cavity, and the balloon filling cavity is connected to the balloon filling interface 6; the balloon body 1 is located at the distal end of the inner tube 3 and is connected to the balloon filling cavity, and fluid is filled or extracted into the balloon body 1 through the balloon filling interface 6 to expand or contract it; 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 guidewire cavity, a balloon filling cavity, etc. The structure of the catheter is prior art and will not be introduced here.

[0039] The proximal end of the optical fiber 2 may extend to the optical fiber interface 8 through the outer surface of the outer tube 4 .

[0040] like Figure 3 、 Figure 4 As shown, a fiber channel is provided within the wall of the outer tube 4, through which the proximal end of the optical fiber 2 extends to the optical fiber interface 8. For example, a hollow outer tube 4 or catheter with an optical fiber 2 can be prepared by a sleeve method. The optical fiber 2 located within the catheter or outer tube 4 can be a core or a conventional optical fiber 2. The position of the optical fiber 2 extending from the outer tube 4 or catheter matches the position of the receiving groove 101 on the balloon body 1.

[0041] When the fiber optic balloon catheter in the present application is in use, the catheter is introduced into the diseased position of the blood vessel through the guide wire, and the balloon body 1 is delivered to the diseased position, and the balloon body 1 is filled so that it contacts the diseased tissue, and the vascular repair drug 10 reaches the diseased tissue; then the optical fiber 2 is connected to the external laser generator, so that the optical fiber 2 emits light with a wavelength of 400nm-500nm, activates the vascular repair drug 10, triggers the cross-linking of proteins in the blood vessel wall, forms a natural vascular stent, and maintains the expanded blood vessel; then the balloon body 1 is depressurized to make it shrink and be withdrawn from the body.

[0042] In summary, the fiber optic balloon catheter in the present application sets at least one receiving groove 101 on the outer wall of the balloon body 1, and places at least one optical fiber 2 in the receiving groove 101, so that the light emitted by the optical fiber 2 can be evenly irradiated to the surface of the balloon body 1, thereby activating the vascular repair drug 10, triggering the cross-linking of proteins in the blood vessel wall, forming a natural vascular stent, and maintaining the expanded blood vessel.

[0043] Obviously, the above embodiments are merely examples for clarity of explanation and are not intended to limit the implementation methods. Those skilled in the art will readily appreciate that other variations or modifications based on the above descriptions are possible. It is not necessary and impossible to enumerate all implementation methods here. Obvious variations or modifications arising therefrom remain within the scope of protection of the present invention.

Claims

1. A fiber optic balloon catheter, characterized in that: At least: A balloon body (1), wherein the surface of the balloon body (1) is coated with a vascular repair promoting drug (10); Optical fibers (2), a plurality of the optical fibers (2) being evenly spaced apart on the outer surface of the balloon body (1) along the circumferential direction of the balloon body (1); A plurality of accommodating grooves (101) are evenly spaced apart on the outer surface of the balloon body (1) along the circumferential direction of the balloon body (1), and the optical fiber (2) is arranged in each of the accommodating grooves (101); When the optical fiber (2) is an optical fiber (2) that emits light on both the cylindrical surface and the end surface, along the radial direction of the optical fiber (2), the optical fiber (2) is completely embedded in the accommodating groove (101) and the optical fiber (2) is bonded to the accommodating groove (101) by glue (9) having a high refractive index; It also includes a catheter, the catheter including 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; The gap between the inner tube (3) and the outer tube (4) forms a balloon filling cavity, and the balloon body (1) is located at the distal end of the inner tube (3) and communicates with the balloon filling cavity; The outer tube (4) with an inner hollow portion and an optical fiber (2) is prepared by a casing method, and the optical fiber (2) located in the outer tube (4) serves as a fiber core.

2. The fiber optic balloon catheter according to claim 1, characterized in that: The vascular repair promoting drug (10) is coated in the containing groove (101).

3. The fiber optic balloon catheter according to claim 2, characterized in that: The outer surface of the balloon body (1) is coated with anti-proliferative drugs in the remaining area except the area where the receiving groove (101) is located.

4. The fiber optic balloon catheter according to claim 1, characterized in that: Also included is a catheter seat (5); The catheter seat (5) is a hollow structure, and is provided with a guide wire outlet (7), a balloon filling interface (6), and an optical fiber interface (8); The guidewire outlet (7) is in communication with the guidewire cavity; The balloon filling interface (6) is in communication with the balloon filling cavity, and fluid is filled into or extracted from the balloon body (1) through the balloon filling interface (6) to cause the balloon body (1) 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.

5. The fiber optic balloon catheter according to claim 1, characterized in that: The proximal end of the optical fiber (2) extends through the outer surface of the outer tube (4) to the optical fiber interface (8).

6. The fiber optic balloon catheter according to claim 1, characterized in that: An optical fiber channel is provided in the 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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