Coronary artery intervention guide wire cannula based on optical fiber blood flow sensing and manufacturing method of coronary artery intervention guide wire cannula

Abstract

The invention discloses a coronary intervention guide wire sleeve based on optical fiber blood flow sensing, a sleeve is sleeved outside a push rod, a sensing optical fiber is arranged on the push rod and arranged along the push rod, the sensing optical fiber comprises a single-mode optical fiber section and a hollow optical fiber section which are connected in sequence, and a temperature sensitive material is arranged in the hollow optical fiber section. The temperature-sensitive material forms a temperature-sensitive cavity at one end of the hollow optical fiber section close to the single-mode optical fiber section, an elastic reflective film is arranged at one end of the hollow optical fiber section away from the single-mode optical fiber section, and an air cavity is formed between the elastic reflective film and the temperature-sensitive material. The sensing optical fiber is arranged on the pushing rod of the guide wire sleeve, the overall external shape of the currently-used coronary blood flow guide wire is not damaged, the two FP cavities are formed in the tail end sensing structure through the temperature sensitive material and the elastic light reflecting film, the pressure and temperature of blood in the coronary artery are synchronously measured, and stability and sensitivity are high. The invention further provides a manufacturing method of the guide wire sleeve.

Description

Technical Field

[0001] The present invention relates to the technical field of coronary intervention, and in particular to a coronary intervention guidewire cannula based on optical fiber blood flow sensing and a manufacturing method thereof. Background Art

[0002] Coronary artery blood flow reserve (Fractional flow reserve, FFR) refers to the ratio of the maximum blood flow that can be obtained in the myocardial area supplied by the blood vessel to the maximum blood flow that can be obtained in the same area under normal conditions in theory when there is a stenotic lesion in the coronary artery. It has important guiding significance for the treatment strategy of coronary heart disease. Revascularization guided by FFR can improve the prognosis of patients, reduce mortality, the incidence of myocardial infarction and surgical costs. The interventional treatment strategy guided by FFR is not only safe and economical, but also can improve the prognosis of patients.

[0003] Traditional FFR measurement requires rapid injection of large doses of adenosine and other drugs that dilate coronary arteries. However, the short efficacy of adenosine, high incidence of side effects, large individual response differences, and many related contraindications have also limited the widespread clinical application of FFR.

[0004] Among the existing FFR calculation methods, the FFR measurement technology is currently mainly based on blood flow velocity testing and pressure testing, and then the FFR is calculated. For example, Chinese patent CN202011233059.7 discloses a low-error coronary blood flow reserve fraction measurement method. It calculates the FFR value by combining CTA and DSA, but the blood flow velocity obtained is still estimated, and the obtained blood flow velocity values ​​have large errors, resulting in inaccurate calculated FFR values; Chinese patent CN202210330812.7 discloses a coronary artery FFR measurement method based on a blood flow velocity monitoring device. By setting a hot-wire blood flow velocity monitoring device at the target position of the blood vessel, the blood flow velocity can be obtained quickly and accurately, and the blood pressure is calculated according to the Navier-Stokes equation, and finally the target coronary FFR value is obtained. However, the hot-wire flow velocity monitoring device has a long response time, and the temperature of the sensor probe needs to be additionally controlled during practical use. The measurement is difficult and cannot be truly mass-produced and industrialized. Summary of the invention

[0005] In order to solve the technical problems existing in the background technology, the present invention proposes a coronary intervention guidewire cannula based on optical fiber blood flow sensing.

[0006] The present invention provides a guidewire cannula for coronary intervention based on optical fiber blood flow sensing, comprising: a cannula, a push rod and a sensing optical fiber;

[0007] The sleeve is sleeved on the outside of the push rod, the sensing optical fiber is set on the push rod and arranged along the push rod, the sensing optical fiber includes a single-mode optical fiber segment and a hollow optical fiber segment connected in sequence, a temperature-sensitive material is arranged inside the hollow optical fiber segment, the temperature-sensitive material forms a temperature-sensing cavity at one end of the hollow optical fiber segment close to the single-mode optical fiber segment, an elastic reflective film is arranged at one end of the hollow optical fiber segment away from the single-mode optical fiber segment, and an air cavity is formed between the elastic reflective film and the temperature-sensitive material.

[0008] Preferably, a side wall of the push rod is provided with an accommodating groove for accommodating the sensing optical fiber.

[0009] Preferably, the sensing optical fiber is fixedly connected to the push rod via UV curing glue.

[0010] Preferably, the sleeve is sleeved on the outside of the sensing optical fiber and connected to the pushing rod.

[0011] Preferably, the side wall of the sleeve is provided with at least one through hole, and the through hole is arranged corresponding to the hollow optical fiber segment.

[0012] Preferably, the elastic reflective film is made of a gold-graphene oxide composite film.

[0013] In the present invention, the proposed coronary intervention guidewire cannula based on optical fiber blood flow sensing is provided with a cannula sleeved on the outside of a push rod, a sensing optical fiber is provided on the push rod and arranged along the push rod, and the sensing optical fiber includes a single-mode optical fiber segment and a hollow optical fiber segment connected in sequence, a temperature-sensitive material is provided inside the hollow optical fiber segment, and the temperature-sensitive material forms a temperature-sensing cavity at one end of the hollow optical fiber segment close to the single-mode optical fiber segment, and an elastic reflective film is provided at one end of the hollow optical fiber segment away from the single-mode optical fiber segment, and an air cavity is formed between the elastic reflective film and the temperature-sensitive material. By providing a sensing optical fiber on the push rod of the guidewire cannula, the overall external shape of the currently used coronary blood flow guidewire is not destroyed, and two FP cavities are formed in the terminal sensing structure by the temperature-sensitive material and the elastic reflective film, and the synchronous measurement of blood pressure and temperature in the coronary artery has high stability and high sensitivity.

[0014] The present invention also provides a method for manufacturing the above-mentioned coronary intervention guidewire cannula based on optical fiber blood flow sensing, comprising the following steps:

[0015] The hollow-core optical fiber is fused with the single-mode optical fiber, and the temperature-sensitive material is injected into the hollow-core optical fiber to form a temperature-sensitive cavity at the end of the single-mode optical fiber. The end of the hollow-core optical fiber away from the single-mode optical fiber is then dipped in a graphene oxide solution to form a graphene oxide film at the opening of the hollow-core optical fiber. Finally, a gold film is deposited on the graphene oxide film to form a gold-graphene oxide composite film.

[0016] Preferably, the method further comprises the following steps: forming a receiving groove on the outer wall of the push rod by using femtosecond laser etching technology, and fixing the sensing optical fiber in the receiving groove by using ultraviolet curing glue.

[0017] Preferably, before dipping the end of the hollow-core optical fiber away from the single-mode optical fiber into the graphene oxide solution, the end of the hollow-core optical fiber away from the single-mode optical fiber is cut flat.

[0018] In the present invention, the method for manufacturing a coronary intervention guidewire cannula based on fiber optic blood flow sensing has a technical effect similar to that of the above-mentioned coronary intervention guidewire cannula based on fiber optic blood flow sensing, so it will not be described in detail. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 This is a structural schematic diagram of an implementation of a coronary intervention guidewire cannula based on fiber optic blood flow sensing proposed by the present invention.

[0020] Figure 2 This is a schematic partial cross-sectional view of a sensing optical fiber in one embodiment of a coronary intervention guidewire cannula based on optical fiber blood flow sensing proposed by the present invention.

[0021] Figure 3 This is a schematic diagram of the sheath structure of an implementation of a coronary intervention guidewire sheath based on fiber optic blood flow sensing proposed by the present invention. DETAILED DESCRIPTION

[0022] like Figures 1 to 3 As shown, Figure 1 This is a schematic structural diagram of an embodiment of a coronary intervention guidewire cannula based on optical fiber blood flow sensing proposed by the present invention. Figure 2 This is a partial cross-sectional schematic diagram of a sensing optical fiber in one embodiment of a coronary intervention guidewire cannula based on optical fiber blood flow sensing proposed by the present invention. Figure 3 This is a schematic diagram of the sheath structure of an implementation of a coronary intervention guidewire sheath based on fiber optic blood flow sensing proposed by the present invention.

[0023] Reference Figure 1 and 2 The present invention provides a guidewire cannula for coronary intervention based on optical fiber blood flow sensing, comprising: a cannula 1, a push rod 2 and a sensing optical fiber 3;

[0024] The sleeve 1 is sleeved on the outside of the push rod 2, the sensing optical fiber 3 is set on the pushing rod 2 and arranged along the pushing rod 2, the sensing optical fiber 3 includes a single-mode optical fiber segment 6 and a hollow optical fiber segment 8 connected in sequence, a temperature-sensitive material 7 is arranged inside the hollow optical fiber segment 8, and the temperature-sensitive material 7 forms a temperature-sensitive cavity at one end of the hollow optical fiber segment 8 close to the single-mode optical fiber segment 6, and an elastic reflective film 9 is provided at one end of the hollow optical fiber segment 8 away from the single-mode optical fiber segment 6, and an air cavity is formed between the elastic reflective film 9 and the temperature-sensitive material 7.

[0025] In the specific working process of the coronary intervention guidewire cannula based on optical fiber blood flow sensing of this embodiment, the end of the single-mode optical fiber is connected to the demodulator, and the sensing optical fiber is sent in along with the push rod, so that the sensing probe is placed in the liquid sample to be tested, so that the elastic reflective film at the end of the optical fiber microcavity is facing the liquid to be tested. After the light wave emitted by the laser in the demodulator is coupled to the single-mode optical fiber, it is emitted from the single-mode optical fiber to reach the microcavity inside the hollow optical fiber, and passes through the temperature sensing cavity and the air cavity between the temperature sensing cavity and the elastic reflective film in turn, and is transmitted and reflected in the temperature sensing cavity. After reaching the elastic reflective film, it is reflected, and a three-beam interference phenomenon occurs. When the liquid sample to be tested flows, an impact force is generated on the film, causing the film to deform; as the liquid flow rate increases, the impact force increases, the film deformation increases, and the air cavity length L1 in the terminal sensing structure decreases, causing the reflection spectrum to move. Therefore, the flow rate and pressure information of the liquid sample to be tested can be obtained by monitoring the drift of the interference peak in the demodulator spectrum.

[0026] In the specific calculation process of flow velocity, the resonance wavelength corresponding to the m-th order interference fringe trough of the optical fiber air microcavity can be expressed as:

[0027]

[0028] Among them, nair is the refractive index of the air in the air cavity, L1 is the length of the air cavity, and m is the order of the interference fringes. By differentiating the formula, the pressure sensitivity of the optical fiber sensor can be obtained, and the corresponding expression is:

[0029]

[0030] Wherein, P is the blood pressure in the pipe, and the blood pressure in the formula mainly depends on the physical properties and geometric dimensions of the elastic reflective film 9. The change in the length of the air cavity is and the change in ambient pressure The relationship between them is:

[0031]

[0032] Wherein, μ is Poisson's ratio, E is Young's modulus, and H is the thickness of the elastic reflective film 9 .

[0033] In the specific temperature calculation process, when the temperature of the liquid sample to be tested changes, the effective refractive index of the temperature sensitive material in the temperature sensing cavity changes, causing the phase difference of the light wave in the temperature sensing cavity to change, which is manifested as a change in the interference spectrum in the demodulator. Therefore, the drift of the interference spectrum of the temperature sensing cavity can obtain the temperature information of the liquid sample to be tested. Similarly, in the temperature sensing cavity, the resonance wavelength corresponding to the m-th order interference fringe trough corresponding to the temperature sensitive material can be expressed as:

[0034]

[0035] By taking the derivative of the formula, we can get the temperature sensitivity of the optical fiber sensor, and the corresponding expression is:

[0036]

[0037] in is the thermo-optical coefficient (TOC) value of the temperature-sensitive material, is the thermal expansion coefficient (TEC) value of the temperature-sensitive material, and T is the ambient temperature. As the temperature of the liquid changes, the refractive index of the temperature-sensitive material in the optical fiber microcavity changes, resulting in the movement of the reflection spectrum. Therefore, the temperature information of the liquid sample to be tested can be obtained by monitoring the drift of the interference peak in the demodulator spectrum.

[0038] In this embodiment, the proposed coronary intervention guidewire cannula based on fiber optic blood flow sensing is provided with a cannula sleeved on the outside of a push rod, a sensing optical fiber is provided on the push rod and arranged along the push rod, and the sensing optical fiber includes a single-mode optical fiber segment and a hollow optical fiber segment connected in sequence, a temperature-sensitive material is provided inside the hollow optical fiber segment, and the temperature-sensitive material forms a temperature-sensing cavity at one end of the hollow optical fiber segment close to the single-mode optical fiber segment, and an elastic reflective film is provided at one end of the hollow optical fiber segment away from the single-mode optical fiber segment, and an air cavity is formed between the elastic reflective film and the temperature-sensitive material. By providing a sensing optical fiber on the push rod of the guidewire cannula, the overall external shape of the currently used coronary blood flow guidewire is not destroyed, and two FP cavities are formed in the terminal sensing structure by the temperature-sensitive material and the elastic reflective film, and the synchronous measurement of blood pressure and temperature in the coronary artery has high stability and high sensitivity.

[0039] In a specific embodiment, the side wall of the push rod 2 is provided with a receiving groove for receiving the sensing optical fiber 3, so as to facilitate the installation of the sensing optical fiber. Furthermore, the sensing optical fiber 3 can be fixedly connected to the push rod 2 by ultraviolet curing glue.

[0040] In the specific design of the sleeve, the sleeve 1 is sleeved outside the sensing optical fiber 3 and connected to the push rod 2. During interventional surgery, the sleeve is located at the front end of the push rod and is sent to the detection position with the push rod to protect the sensing structure at the front end of the push rod.

[0041] In order to ensure the detection effect of the sensing structure, in a further specific embodiment, with reference to the figure, at least one through hole is provided on the side wall of the sleeve 1, and the through hole is arranged corresponding to the hollow optical fiber segment 8. The liquid to be tested can enter the sleeve through the through hole. In the specific design, the sleeve can be designed with two ends, and the front end portion corresponding to the sensing structure can be made of biocompatible materials. A plurality of through holes are provided on it, so as not to affect the blood pressure and temperature test.

[0042] In the specific selection of materials, the temperature sensitive material 7 adopts high thermo-optic coefficient materials such as dimethyl silicone oil and SU-8 curing glue, and the elastic reflective film 9 adopts gold-graphene oxide composite film.

[0043] This embodiment also provides a method for manufacturing the above-mentioned coronary intervention guidewire cannula based on optical fiber blood flow sensing, comprising the following steps:

[0044] Preparation of sensing optical fiber: The hollow-core optical fiber is fused with the single-mode optical fiber, and the temperature-sensitive material 7 is injected into the hollow-core optical fiber to form a temperature-sensitive cavity at the end of the single-mode optical fiber. Then, the end of the hollow-core optical fiber away from the single-mode optical fiber is dipped in the graphene oxide solution to form a graphene oxide film at the opening of the hollow-core optical fiber. Finally, a gold film is deposited on the graphene oxide film to form a gold-graphene oxide composite film.

[0045] In actual operation, before dipping the end of the hollow-core optical fiber away from the single-mode optical fiber into the graphene oxide solution, the end of the hollow-core optical fiber away from the single-mode optical fiber is cut flat. Specifically, after the fusion splicing is completed, the hollow-core optical fiber is cut to a preset length using a precision optical fiber cutting platform, while ensuring that the end face of the cut end of the hollow-core optical fiber is flat to form an open optical fiber microcavity.

[0046] Then, a preset amount of temperature-sensitive material is injected into the open optical fiber microcavity. Specifically, the temperature-sensitive material is capillary-entered into the hollow-core optical fiber using the capillary effect, and the temperature-sensitive material is injected into the bottom of the open optical fiber microcavity using a pressurizing device. When the temperature-sensitive material reaches a preset amount, the ultrafine hollow-core optical fiber is taken out.

[0047] Finally, the open fiber microcavity was sealed with a gold-graphene oxide film;

[0048] Specifically, a graphene oxide solution is dropped onto a glass slide, and a high-precision three-dimensional dispensing platform is used to bring the open optical fiber microcavity into contact with the graphene oxide droplet and then move it away. After the solvent evaporates, a graphene oxide film is formed at the opening of the optical fiber microcavity. An ion sputtering device is used to deposit a gold film on the graphene film at the opening of the optical fiber microcavity. The thickness of the gold film reaches a preset value, and the preparation of the gold-graphene oxide film is completed.

[0049] Fixing of the sensing optical fiber and the pushing rod: a receiving groove is formed on the outer wall of the pushing rod 2 by using femtosecond laser etching technology, and the sensing optical fiber 3 is fixed in the receiving groove by ultraviolet curing glue.

[0050] Specifically, the output power, scanning rate and focusing size of the femtosecond laser are controlled to perform hard etching on the front end of the push rod to etch a semicircular receiving groove. The fiber optic sensor probe is fixed in the microgroove using a high-precision five-dimensional displacement platform, and the ultra-fine tapered optical fiber is fixed by dispensing glue using UV curing glue, model NOA65.

[0051] In a specific embodiment, when the specific dimensions of the sensing optical fiber are designed, the length of the hollow core fiber segment is within the Fabry-Perot interference length. The outer diameter of the single-mode optical fiber segment is 125 μm, and the core diameter is 8.9 μm. The outer diameter of the hollow core fiber segment is 125 μm, and the diameter of the air core is 80 μm. The length of the microcavity in the hollow core fiber segment is 100 μm, and the length of the temperature sensitive material in the microcavity is 20 μm. The thickness of the gold film-graphene oxide film is 300 nm.

[0052] Correspondingly, the receiving groove of the push rod has a length of 2 cm and a diameter of 130 μm.

[0053] The above description is only a preferred specific implementation manner of the present invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field can make equivalent replacements or changes according to the technical scheme and inventive concept of the present invention within the technical scope disclosed by the present invention, which should be covered by the protection scope of the present invention.

Claims

1. A guidewire cannula for coronary intervention based on fiber optic blood flow sensing, characterized in that: include: A sleeve (1), a push rod (2) and a sensing optical fiber (3); The sleeve (1) is sleeved on the outside of the push rod (2), the sensing optical fiber (3) is arranged on the push rod (2) and arranged along the push rod (2), the sensing optical fiber (3) comprises a single-mode optical fiber segment (6) and a hollow optical fiber segment (8) connected in sequence, a temperature sensitive material (7) is arranged inside the hollow optical fiber segment (8), the temperature sensitive material (7) forms a temperature sensing cavity at one end of the hollow optical fiber segment (8) close to the single-mode optical fiber segment (6), an elastic reflective film (9) is arranged at one end of the hollow optical fiber segment (8) away from the single-mode optical fiber segment (6), and an air cavity is formed between the elastic reflective film (9) and the temperature sensitive material (7).

2. The coronary intervention guidewire cannula based on optical fiber blood flow sensing according to claim 1, characterized in that: The side wall of the pushing rod (2) is provided with a receiving groove for receiving the sensing optical fiber (3).

3. The coronary intervention guidewire cannula based on optical fiber blood flow sensing according to claim 1 or 2, characterized in that: The sensing optical fiber (3) is fixedly connected to the pushing rod (2) via ultraviolet curing glue.

4. The coronary intervention guidewire cannula based on optical fiber blood flow sensing according to claim 1, characterized in that: The sleeve (1) is sleeved on the outside of the sensing optical fiber (3) and is connected to the pushing rod (2).

5. The coronary intervention guidewire cannula based on optical fiber blood flow sensing according to claim 4, characterized in that: The side wall of the sleeve (1) is provided with at least one through hole, and the through hole is arranged corresponding to the hollow optical fiber segment (8).

6. The coronary intervention guidewire cannula based on optical fiber blood flow sensing according to claim 1, characterized in that: The elastic reflective film (9) is made of a gold-graphene oxide composite film.

7. A method for manufacturing a coronary intervention guidewire cannula based on optical fiber blood flow sensing according to any one of claims 1 to 6, characterized in that: The following steps are involved: The hollow-core optical fiber is fused with the single-mode optical fiber, and the temperature-sensitive material is injected into the hollow-core optical fiber to form a temperature-sensitive cavity at the end of the single-mode optical fiber. The end of the hollow-core optical fiber away from the single-mode optical fiber is then dipped in a graphene oxide solution to form a graphene oxide film at the opening of the hollow-core optical fiber. Finally, a gold film is deposited on the graphene oxide film to form a gold-graphene oxide composite film.

8. The method according to claim 7, characterized in that: The method further comprises the following steps: using femtosecond laser etching technology to form a receiving groove on the outer wall of the push rod (2), and fixing the sensing optical fiber (3) in the receiving groove by ultraviolet curing glue.

9. The manufacturing method according to claim 7, characterized in that: Before dipping the end of the hollow-core optical fiber away from the single-mode optical fiber into the graphene oxide solution, the end of the hollow-core optical fiber away from the single-mode optical fiber is cut flat.

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