WO2018170789A1

WO2018170789A1 - Blood vessel optical fiber catheter

Info

Publication number: WO2018170789A1
Application number: PCT/CN2017/077680
Authority: WO
Inventors: 尚华
Original assignee: 尚华
Priority date: 2017-03-22
Filing date: 2017-03-22
Publication date: 2018-09-27

Abstract

A blood vessel optical fiber catheter (1), comprising at least one optical fiber core wire (10), a sealing layer (17) for preventing drug and light leakage, and a hydrophilic coating (18). The optical fiber core wire (10) is disposed at the central axis of the blood vessel optical fiber catheter (1), and the periphery of the optical fiber core wire (10) is provided with a cavity (16) surrounded by the sealing layer (17) and capable of containing delivered drug. The periphery of the sealing layer (17) is coated with the hydrophilic coating (18) capable of improving body fluid compatibility and reducing resistance. The blood vessel optical fiber catheter (1) can lead light into and out of a lesion portion so as to achieve treatment and diagnosis effects; the blood vessel optical fiber catheter (1) can deliver and release drug to the lesion portion; the blood vessel optical fiber catheter (1) has multiple effects, is easy to use, and provides great convenience for tumor photodynamic therapy, and improving drug and lesion portion combining precision.

Description

Vascular fiber catheter

Technical field

The present invention relates to the field of medical device technology, and in particular to a blood vessel fiber catheter.

Background technique

At present, the Seldinger arterial intubation technique is very mature. Under the guidance of clinical imaging medicine (X-ray, CT, MR, B-us, etc.), the technique is to insert a special device such as a catheter or a guide wire into the lesion through a percutaneous puncture vascular approach or an original human orifice. Diagnostic imaging and treatment. The technique uses a metal catheter to percutaneously puncture a blood vessel into a blood vessel to reach a lesion. The method is simple in operation, small in damage, and does not require suturing a blood vessel, and completely replaces the method of surgically cutting open blood vessels, and becomes a basic operation technique of modern interventional radiology. In the tumor for thrombus plug and drug perfusion, intra-arterial irradiation, prevention of radiation damage, chemotherapy, preoperative embolization of tumor blood vessels, vasoactive drugs and alcohol, etc. have achieved good results.

However, due to the limitations of the treatment mode, the tissue is mainly caused by embolization caused by ischemia-anoxic necrosis or perfusion of drugs to inhibit cell growth or release of implanted medical devices to change the shape of organs, and it is impossible to introduce light into blood vessels and the body or Lead to blood vessels and in vitro. Compared with conventional treatments such as surgery, chemotherapy and radiotherapy, tumor photodynamic therapy has many advantages such as small trauma, low toxicity, good targeting and good applicability, but the illumination method is limited to the body surface or thicker channels due to Limited by the laser emission mechanism and the performance of the photosensitizer, its photodynamic power is only a few millimeters, which greatly limits its application in the medical field.

The invention comprises an optical fiber and an interventional catheter constituting a vascular fiber catheter of various lengths and diameters, and the device is used to enter the blood vessel, and the light is introduced into and taken out of the blood vessel through the optical fiber core wire, and more importantly, can pass simultaneously. The effect of catheter delivery of drugs makes the photodynamic therapy of tumors more convenient and precise, and can meet the needs of biological, medical and other fields to introduce and simultaneously introduce drugs into and out of blood vessels.

Summary of the invention

The guidewire for the Seldinger arterial cannulation technique is unable to deliver light energy and tumor photodynamic drugs to the vascular lesion site. It is an object of the present invention to provide a vascular fiber catheter.

The object of the invention is achieved by the following technical solutions:

A vascular fiber catheter comprising at least one fiber core wire, a sealing layer for preventing drug and light leakage, and a hydrophilic coating, the fiber core wire being disposed at a central axis of the fiber tube, the fiber core and the closure A hollow body capable of containing a drug for transport is provided between the layers, and the periphery of the sealing layer is coated with a hydrophilic coating capable of improving body fluid compatibility and reducing resistance.

Further, a tip of the fiber catheter that is introduced into one end of the blood vessel is provided with a delivery portion capable of releasing a drug.

Further, a conveying hole that communicates with the hollow body is provided on an outer side surface of the conveying portion.

Further, the fiber optic conduit further includes a winding layer, the winding layer being composed of at least one winding wrapped around a periphery of the optical fiber core; the hollow body is disposed on the winding layer and the sealing layer Between or between the wire layer and the core of the fiber.

Further, one end of the optical fiber catheter left outside the body is provided with a coupling portion to which a laser capable of emitting laser light and a drug injection device capable of supplying a drug are connected.

Further, the coupling portion is a multi-channel coupler.

Further, the top end of the transport portion is provided with a light exiting portion that can couple light into/out of the optical fiber core, and the light exiting portion is preferably a microlens.

Further, the optical fiber core wire includes a core and a cladding applied to a periphery of each of the cores, the cladding having a light conductivity less than the core.

Further, one or more metal wires or polymer wires may be added to the core in parallel with the core to increase the strength thereof.

Further, the material of the sealing layer comprises stainless steel, platinum, titanium alloy, synthetic fiber, carbon fiber, polytetrafluoroethylene, polyethylene, polyvinyl chloride, silicone rubber, fluorocarbon polymer. And polyurethane.

Further, the hydrophilic coating is made of a chemically stable material including at least at least one of polytetrafluoroethylene, silicone rubber, polyethylene, polyvinyl chloride, fluorocarbon polymer, and polyurethane. One.

Further, the core is a single-mode core or a multi-mode core; the core is made of at least one of a quartz core, a polymer core or a metal hollow core.

Further, the fiber optic conduit includes two or more fiber core wires, the fiber core wire including a first core capable of introducing light and a second core capable of deriving light.

Further, the diameter of the fiber conduit is from 90 μm to 2000 μm, preferably from 100 μm to 1000 μm; and the length of the fiber conduit is from 1 m to 2 m.

The invention has at least the following beneficial effects:

The fiber optic catheter of the present invention can enter the body through a blood vessel or the like, that is, the fiber optic catheter enters a predetermined lesion position in the blood vessel, and introduces and extracts light to the lesion portion to serve therapeutic and diagnostic effects; more importantly, the fiber optic catheter can The drug is transported through the cavity in the catheter and then released to the lesion through the delivery hole of the delivery portion. Therefore, the catheter has multiple functions and is convenient to use, which brings great convenience and treatment for tumor photodynamic therapy. The accuracy of the combination with the lesion has an extremely important clinical application value.

In addition, the diameter of the fiber guide is only a few hundred micrometers and a maximum of about 2 millimeters, but the length can reach 1-2 meters, so the structure of the fiber conduit is very high, and the invention can not only make it complete by the specific structure. It reaches the strength of use and can penetrate the skin very often and travel through the blood vessels. The specific structural arrangement of its delivery section makes it extremely convenient to release the drug and to derive the required light. The coupling portion at one end of the body can be connected to the drug injection device to deliver the photodynamic tumor drug into the catheter to the lesion.

DRAWINGS

1 is a schematic view showing the overall structure of a fiber optic conduit according to an embodiment of the present invention;

Figure 2 is a cross-sectional view of a fiber optic catheter in accordance with an embodiment of the present invention;

Figure 3 is a cross-sectional view showing a conveying portion according to an embodiment of the present invention;

4 is a partial structural schematic view showing one end of a fiber optic catheter introduced into a blood vessel according to an embodiment of the present invention;

Figure 5 is a cross-sectional view showing a conveying portion according to another embodiment of the present invention;

6 is a schematic cross-sectional view of a fiber optic catheter according to another embodiment of the present invention;

7 is a schematic structural view of a shape of a hypotube at a T0 temperature according to an embodiment of the present invention;

8 is a schematic structural view of a hypotube wrapped optical fiber guide wire at a T1 temperature according to an embodiment of the present invention;

Fig. 9 is a view showing the relationship between the inner diameter of the hypotube and the number of turns according to the embodiment of the present invention.

1. Fiber guide, 10, fiber core wire, 11, conveying part, 12, coupling part, 13, core, 14, cladding, 15, wire layer, 16, hollow body, 17, closed layer, 18, Hydrophilic coating, 19, conveying hole, 20, light guiding hole, 21, light exiting portion.

detailed description

The technical solutions in the embodiments of the present invention are clearly and completely described below. It is obvious that the described embodiments are a part of the embodiments of the present invention, and not all of the embodiments. The detailed description of the embodiments of the invention, which are set forth below, are not intended to limit the scope of the claimed invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative efforts are within the scope of the present invention.

Example 1

A vascular fiber catheter, as shown in Figures 1-3, comprising at least one fiber core wire 10, a wire-wound layer 15 capable of enhancing strength, a sealing layer 17 for preventing drug and light leakage, and capable of improving fluid compatibility and reducing drag Hydrophilic coating 18. The optical fiber core wire 10 is disposed at a central axis of the optical fiber conduit 1. The outer periphery of the optical fiber core wire 10 is wrapped with a winding wire layer 15 wound around the outer periphery of the optical fiber core wire 10 to improve the optical fiber core wire 10. Toughness and strength, the winding layer 15 is provided with a hollow body 16 formed by the sealing layer 17 and capable of containing a drug for transporting, that is, a hollow body 16 is disposed between the winding layer 15 and the sealing layer 17, and the sealing layer 17 is peripherally It is coated with a hydrophilic coating 18. The wire layer 15 may be formed by at least one wire wrapped around the periphery of the fiber core wire 10, that is, the wire is wound around a plurality of spiral coils disposed in the fiber conduit, and the wire layer 15 may be integrally formed.

The fiber core wire 10 includes a core 13 (i.e., an optical fiber) for conducting light and a cladding 14 coated on the periphery of the core 13, and the core 13 is a single-mode core or a multi-mode core. The core 13 is made of at least one of a quartz core, a polymer core, and a metal hollow core. The optical conductivity of the cladding 14 is less than the optical conductivity of the core 13, and therefore, the cladding 14 has a certain binding force to the light in the core 13.

The end of the fiber guide 1 into which one end of the blood vessel is introduced is provided with a delivery portion 11 capable of releasing a drug. The outer side surface of the conveying portion 11 is provided with a conveying hole 19 which communicates with the hollow body 16 and can release the medicine, that is, the conveying hole 19 penetrates through the sealing layer 17 and the hydrophilic coating layer 18. The number of the conveying holes 19 can be determined according to the actual situation. Preferably, a plurality of delivery holes 19 are evenly disposed on the outer circumference of the delivery end, so that drug release is more convenient and more efficient. The shape of the conveying hole 19 may be a circle, a square, a strip, a ring, or the like.

One end of the fiber-optic conduit 1 remaining outside the body is provided with a coupling portion 12 to which a laser capable of emitting laser light and a drug injection device capable of supplying a drug are connected.

The coupling portion 12 is preferably a multi-pass coupler, ie the fiber-optic conduit 1 can be connected to the laser by means of a multi-pass coupler, and the drug in the drug injection device can be injected into the hollow body 16 by the multi-pass coupler.

The top end of the conveying portion 11 (that is, the tip end of the fiber guide 1 is introduced into one end of the human blood vessel) is provided with a light exiting portion 21 (that is, capable of coupling out/into the fiber conduit) capable of coupling light out/into the optical fiber core 10, and the optical fiber core The wire 10 extends from the main body portion of the optical fiber conduit 1 to the conveying portion 11, and then the light guided in the optical fiber core wire 10 is collected from the microlens 15 and transmitted out of the optical fiber conduit 1 and irradiated at a portion where light is required. The light exit portion 21 is preferably a microlens. The microlens 15 is a circular, hemispherical or the like structure, and it is easy to concentrate light or heat, and the arrangement of the microlens 15 further reduces the resistance of the fiber guide 1 to travel through the blood vessel. Of course, the microlens 15 can also be of other construction types.

The length of the delivery portion 11 is generally from 1 to 4 cm, preferably from 2 to 3 cm, which contributes to the treatment and advancement of the fiberoptic catheter 1 in the blood vessel.

The material of the sealing layer 17 includes stainless steel, platinum, titanium alloy, synthetic fiber, carbon fiber, polytetrafluoroethylene, polyethylene, polyvinyl chloride, silicone rubber, fluorocarbon polymer and polyurethane, and the sealing layer 17 can be among these materials. Made of any one of them.

The hydrophilic coating 18 is configured to increase fluid compatibility and reduce resistance of the fiber conduit 1 in the body, such as improving blood compatibility and reducing resistance in the blood. The hydrophilic coating 18 is a chemically stable material. production. Specifically, the material of the hydrophilic coating 18 includes, but is not limited to, polytetrafluoroethylene, silicone rubber, polyethylene, polyvinyl chloride, fluorocarbon polymer and polyurethane, and the hydrophilic coating 18 may be formed of any of the above materials. It may be composed of two or more kinds of mixtures. The hydrophilic coating 18 may be disposed outside the wound layer 15 by coating, coating or heat shrinking.

In a further preferred embodiment, the conveying portion 11 is further provided with a plurality of light guiding holes 20 penetrating the winding layer 15, the sealing layer 17 and the hydrophilic coating layer 18 and perpendicular to the optical fiber core wire 10. The optical fiber core wires 10 can be exposed through the light guiding holes 20, that is, the optical fiber core wires 10 can be directly seen through the holes, and a small portion of the light in the core 13 passes through the cladding layer 14 and is transmitted from the light guiding holes 20 Out. The shape of the light guiding hole 20 may be a circle, a square, a strip, a ring, or the like. It should also be noted that, in addition to the light guiding holes 20, the light in the optical fiber is mainly outputted from the tip end of the catheter into one end of the blood vessel, that is, the normal output along the axial direction of the optical fiber.

As a further preferred embodiment, one or more metal guide wires or polymer guide wires can be added to the core 13 in parallel with the core 13 to increase the strength thereof.

Example 2

The structure of the fiber-optic conduit 1 in the first embodiment may also be as shown in FIGS. 4-5. The cavity body 16 is disposed between the wire-wound layer 15 and the optical fiber core wire 10, that is, the wire-wound layer 15 is disposed. On the inner wall of the sealing layer 17. Then, at the conveying portion 11, a certain gap between two adjacent spiral coils of the winding layer 15 can be used as the conveying hole 19 to release the medicine, and the conveying hole 19 can also guide part of the light side surface, and the sealing layer Also provided on the hydrophilic coating 18 is a large or small opening to allow the drug of the cavity 16 to be released from the delivery hole 19 in the present embodiment to the lesion.

In the present embodiment, the light guiding hole 20 can be omitted, and the conveying hole 19 can be used instead.

Example 3

As shown in FIG. 6, in the first embodiment or the second embodiment, the number of the optical fiber core wires 10 may be two or more and arranged side by side at the axial center of the optical fiber conduit 1, and the optical fiber core wire 10 includes the core 13 and the coating. The cladding 14 covering the periphery of each of the cores 13 is wound around the periphery of all the optical fiber cores 10 around the filaments 15 to improve its toughness and strength.

If the fiber optic conduit 1 contains a plurality of cores 13, the core 13 can include both a first core capable of introducing light and a second core capable of deriving light, that is, in the case of a plurality of cores 13, One or more cores can be used to introduce light, and at the same time, one or more cores can be used to derive light, and the core of the derived light can be derived by using a computer or the like by deriving the light that acts inside the blood vessel. Analysis of the spectrum, etc., to help understand the treatment or condition, and take appropriate treatments for diagnosis and treatment.

Example 4

In the embodiment 1, the winding layer 15 is preferably a hypotube, the hypotube is a hypotube containing a plurality of spiral coils, and the through hole 3 in the middle of the hypotube can be inserted into the optical fiber core 10. The hypotube is preferably made of a shape memory alloy, and the hypotube is different in diameter at different temperatures so as to be able to closely wrap around the optical fiber core 10 disposed in the hypotube. The preparation method of the hypotube having the shape memory function wrapped around the periphery of the optical fiber core 10 is as follows:

1 The material of the shape memory alloy is Nitinol 51Ni-Ti, the martensite transformation temperature Ms is -20 ° C, and the reverse phase transformation temperature As is -12 ° C. The shape memory alloy material is first used to make the metal. Thin tube, then the metal thin tube is laser cut to make a hypotube (multiple spiral tube) with multiple spiral coils, if the inner diameter of the hypotube is 300μm, the length H is 5cm, and the number of turns is 10 ;

2 immersing the hypotube tube containing the plurality of spiral coils prepared in step 1 in a dry ice-alcohol solution to cool to T0=-40 ° C, at which time the temperature is lower than Ms;

3 When the temperature of the hypotube drops to T0=-40°C, that is, below Ms, the opposite torque rotation is applied at both ends of the hypotube to reduce the number of turns of the hypotube and increase the diameter, such as application. Torque rotation causes the hypotube to rotate 4 turns (ie 6 turns of spiral), at which point the diameter D is expanded to 500 Μm, due to the metal memory effect, the shape of the hypotube 1 at the temperature lower than Ms is preserved at the T0 temperature;

4 Restoring the hypotube to room temperature T1, at which time the temperature is higher than As, and by applying opposite torques at both ends of the hypotube to reduce the inner diameter d of the hypotube 1 to 300 μm, the hypotube is due to the metal memory effect. The shape at the T1 temperature is preserved;

5 Select the optical fiber core wire 10 having an outer diameter Di of 300 μm, and the axial wire cannot pass through the hypotube having an inner diameter of 300 μm at room temperature; soak the sea wave tube of the shape memory function obtained in step 4 in the dry ice-alcohol solution When the medium is cooled to T0 = -40 ° C, the inner diameter D is expanded to 500 μm, and the optical fiber core wire 10 can be easily passed through, as shown in FIG.

Then insert the optical fiber core wire 10 into the hypotube, and then return the temperature of the hypotube inserted into the optical fiber core 10 to room temperature, at which time the inner diameter of the hypotube is reduced, due to the inner diameter d of the hypotube and the core of the optical fiber at the T1 temperature. The outer diameter Di of 10 is uniform, so the hypotube is tightly bound to the periphery of the optical fiber core 10, as shown in FIG.

In the above steps, when a reverse moment is applied to both ends of the hypotube, the diameter thereof is enlarged or reduced because the hypotube can be simplified to a spiral structure, assuming that the helix height is H and the helix diameter is D, if the number of turns is N, the cylindrical surface on which it is located is expanded into a straight line. According to the Pythagorean theorem, the length L of the spiral can be calculated as:

Express the diameter in the above equation as a function of the number of turns N:

Fig. 9 is a relationship between N and D. As can be seen from the figure, when a moment is applied to both ends of the hypotube, the number of turns is reduced and the diameter is increased.

In the present embodiment, the ratio of dry ice to alcohol can be referred to the prior art as long as the temperature of the present invention can be attained. Of course, the cooling method of the present invention can also select other of the prior art. method.

In specific implementation, for example, in photodynamic tumor therapy, if a liver tumor is intervened, it is necessary to enter a blood vessel in the liver tumor. First, the laser is connected to the fiber guide 1 through a multi-pass coupler to pass through the blood vessel light, and is connected to the drug injection device. One end of the fiber catheter 1 with the microlens is punctured into the blood vessel, and under the guidance of the clinical image, the hand-held end is rotated to gradually screw the fiber catheter 1 into the lesion of the blood vessel in the liver tumor. The sensitizer is delivered through the hollow body of the fiber optic catheter and introduced into the tumor site through the delivery port. The laser is turned on, and the laser is guided through the optical fiber core wire 10 to irradiate the tumor tumor body which has been injected with the photosensitive drug, so that the photochemical reaction of the photosensitive drug in the tumor produces singlet oxygen, which in turn causes necrosis and apoptosis of the tumor tumor body, thereby achieving treatment. The purpose of the tumor.

In the specific implementation, the fiber guide 1 of the present invention has a diameter of only one hundred micrometers, generally has a maximum diameter of about 2 mm, and a minimum diameter of only about 100 μm. Therefore, it can be inserted into a human body through a blood vessel or the like for interventional treatment. The length of the fiber optic catheter 1 is generally 1.5 to 2 m, and the light source can be transmitted to almost any lesion in the human body, and 0.4 to 1 m is generally reserved in vitro.

In a specific implementation, the multi-channel coupler in this embodiment can directly use the coupler in the prior art, and then a hole can be provided on the coupler to the cavity body 16, and then the drug injection device directly passes through the hole. The drug is input into the hollow body 16, or the needle in the drug injection device is directly inserted into the hollow body 16 through the coupler. In any case, as long as the function can be achieved, the drug injection device of the present invention can be For ordinary syringes.

The above description is only a preferred embodiment of the present invention, and is not intended to limit the present invention, and various modifications and changes can be made to the present invention. Any modifications, equivalents, improvements, etc. made within the spirit and scope of the invention are intended to be included within the scope of the invention.

Claims

A vascular fiber catheter comprising at least one fiber core wire, a sealing layer for preventing drug and light leakage, and a hydrophilic coating, wherein the fiber core wire is disposed at a central axis of the fiber conduit, A hollow body capable of containing a drug to be transported is disposed between the optical fiber core and the sealing layer, and the outer periphery of the sealing layer is coated with a hydrophilic coating capable of improving body fluid compatibility and reducing resistance.
The vascular fiber catheter according to claim 1, wherein a tip of one end of the fiber catheter introduced into the blood vessel is provided with a delivery portion capable of releasing a drug.
The vascular fiber guide according to claim 2, wherein a conveying hole that communicates with the hollow body is provided on an outer side surface of the conveying portion.
The vascular fiber conduit according to claim 3, wherein said fiber optic conduit further comprises a wrap layer, said wrap layer being comprised of at least one wrap around a periphery of said fiber core;

The cavity body is disposed between the wire winding layer and the sealing layer or between the wire layer and the fiber core wire.
The vascular fiber catheter according to claim 1, wherein a distal end of the fiber catheter is provided with a coupling portion, and a laser capable of emitting laser light and a drug injection device capable of supplying a drug are connected to the coupling portion.
The vascular fiber optic catheter of claim 5 wherein said coupling portion is a multi-channel coupler.
The vascular fiber catheter according to claim 3, wherein a tip end of the transport portion is provided with a light exiting portion capable of coupling light out into/into the optical fiber core, and the light exiting portion is preferably a microlens.
The vascular fiber conduit according to claim 1, wherein said fiber guide comprises two or more optical fiber cores, said optical fiber core simultaneously comprising a first core capable of introducing light and a second fiber capable of deriving light core.
A vascular fiber catheter according to any one of claims 1 to 7, wherein: The optical fiber core wire includes a core and a cladding layer coated on a periphery of each of the cores, the cladding layer having a light conductivity lower than the core;

One or more metal guide wires or polymer guide wires can also be added to the core in parallel with the core to increase its strength.
The vascular fiber catheter according to claim 8, wherein the material of the sealing layer comprises stainless steel, platinum, titanium alloy, synthetic fiber, carbon fiber, polytetrafluoroethylene, polyethylene, polyvinyl chloride, silicone rubber, fluorine. Carbon polymer and polyurethane.

The hydrophilic coating is made of a chemically stable material, and the material of the hydrophilic coating comprises at least one of polytetrafluoroethylene, silicone rubber, polyethylene, polyvinyl chloride, fluorocarbon polymer, and polyurethane;

The core is a single-mode core or a multi-mode core; the core is made of at least one of a quartz core, a polymer core or a metal hollow core;

The diameter of the fiber conduit is from 90 μm to 2000 μm, preferably from 100 μm to 1000 μm;

The length of the fiber conduit is 1 m to 2 m.