CN117617927A - Pressure guide wire and manufacturing method thereof - Google Patents
Pressure guide wire and manufacturing method thereof Download PDFInfo
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- CN117617927A CN117617927A CN202410111435.7A CN202410111435A CN117617927A CN 117617927 A CN117617927 A CN 117617927A CN 202410111435 A CN202410111435 A CN 202410111435A CN 117617927 A CN117617927 A CN 117617927A
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- 238000004519 manufacturing process Methods 0.000 title claims abstract description 10
- 239000013307 optical fiber Substances 0.000 claims abstract description 84
- 238000001514 detection method Methods 0.000 claims abstract description 43
- 238000009530 blood pressure measurement Methods 0.000 claims abstract description 6
- 230000017531 blood circulation Effects 0.000 claims abstract description 3
- 238000000034 method Methods 0.000 claims description 12
- 238000005253 cladding Methods 0.000 claims description 9
- 229910052751 metal Inorganic materials 0.000 claims description 5
- 239000002184 metal Substances 0.000 claims description 5
- 239000010935 stainless steel Substances 0.000 claims description 5
- 229910001220 stainless steel Inorganic materials 0.000 claims description 5
- 239000003292 glue Substances 0.000 claims description 4
- 239000011247 coating layer Substances 0.000 claims description 3
- 238000010147 laser engraving Methods 0.000 claims description 3
- 229910001000 nickel titanium Inorganic materials 0.000 claims description 3
- 230000000149 penetrating effect Effects 0.000 claims description 3
- 238000007789 sealing Methods 0.000 claims description 3
- 238000005259 measurement Methods 0.000 description 10
- 210000004351 coronary vessel Anatomy 0.000 description 9
- 210000004204 blood vessel Anatomy 0.000 description 6
- 238000011161 development Methods 0.000 description 5
- 238000011156 evaluation Methods 0.000 description 5
- 201000000057 Coronary Stenosis Diseases 0.000 description 3
- 206010057469 Vascular stenosis Diseases 0.000 description 3
- 239000000835 fiber Substances 0.000 description 3
- 238000003384 imaging method Methods 0.000 description 3
- 230000035945 sensitivity Effects 0.000 description 3
- 230000005540 biological transmission Effects 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 230000036772 blood pressure Effects 0.000 description 2
- 239000002131 composite material Substances 0.000 description 2
- 230000003902 lesion Effects 0.000 description 2
- 229910052763 palladium Inorganic materials 0.000 description 2
- 238000013146 percutaneous coronary intervention Methods 0.000 description 2
- 208000024172 Cardiovascular disease Diseases 0.000 description 1
- 206010020565 Hyperaemia Diseases 0.000 description 1
- 238000002399 angioplasty Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
- 230000000004 hemodynamic effect Effects 0.000 description 1
- 230000010354 integration Effects 0.000 description 1
- 238000013152 interventional procedure Methods 0.000 description 1
- 238000000691 measurement method Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 208000010125 myocardial infarction Diseases 0.000 description 1
- HLXZNVUGXRDIFK-UHFFFAOYSA-N nickel titanium Chemical compound [Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni] HLXZNVUGXRDIFK-UHFFFAOYSA-N 0.000 description 1
- 230000035515 penetration Effects 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 230000008054 signal transmission Effects 0.000 description 1
- 238000012800 visualization Methods 0.000 description 1
Abstract
The application discloses a pressure guide wire and a method of manufacturing the same, the pressure guide wire comprising: the device comprises a tubular piece, wherein a first lumen and a second lumen which are arranged at intervals along the length direction of the tubular piece are arranged in the tubular piece, and a first overflow hole and a second overflow hole which are respectively used for communicating the first lumen and the second lumen to the outside are formed in the tubular piece; a first optical fiber and a second optical fiber disposed within the tubular member, and the ends of the first optical fiber and the second optical fiber are respectively received in the first lumen and the second lumen; and the first pressure detection device and the second pressure detection device are respectively connected to the tail ends of the first optical fiber and the second optical fiber, and can contact the blood flow at the first lumen and the second lumen through the first overflow hole and the second overflow hole to perform pressure measurement. The pressure guide wire can independently realize intravascular multipoint pressure measurement without the assistance of a guide catheter with a pressure measurement function.
Description
Technical Field
The present application relates to the field of medical devices, and in particular, to a pressure guidewire and a method of manufacturing the same.
Background
Vascular stenosis is a serious consequence of cardiovascular disease, such as coronary stenosis, which can lead to myocardial infarction. Percutaneous Coronary Intervention (PCI) is now widely used in clinical treatment, and prior to angioplasty or stent placement, a physician needs to evaluate the extent of vascular stenosis qualitatively or quantitatively to help him make a decision as to whether to perform stent placement and what size balloon or stent to choose.
Current methods used by physicians to assess the extent of vascular stenosis include both imaging and functional. Among them, functional evaluation is widely used because it can reflect the characteristics of a lesion more deeply than imaging evaluation. The existing functional evaluation is usually based on fractional flow reserve (FFR for short). FFR is a technique for measuring the pressure difference at a coronary stenosis, i.e. based on the ratio of the distal coronary average pressure Pd to the coronary ostial aortic average pressure Pa (Pd/Pa) when the coronary artery is at its maximum hyperemia.
Currently, in order to achieve the measurement of the distal coronary average pressure Pd and the coronary ostial aortic average pressure Pa, it is generally necessary to use a guide catheter and a pressure guidewire in combination for the measurement. Wherein: the guide catheter is connected with an external pressure sensor, and the pressure guide wire passes through the guide catheter and enters a blood vessel to be measured; the pressure value detected by the pressure guide wire at the coronary artery opening part is calibrated by referring to the detection value of the pressure sensor connected to the guide catheter, the pressure value of the coronary artery opening part measured by the guide catheter is Pa, and the formal measurement is carried out after the calibration and the balance are carried out for many times. The guide catheter measures the coronary artery ostial aortic average pressure Pa, and the distal coronary artery average pressure Pd after advancing the pressure guidewire, where ffr=pd/Pa.
In the above measurement method, before the formal measurement, the doctor needs to perform calibration and balancing many times, which has high operation complexity and needs to be improved.
Disclosure of Invention
The application provides a pressure guide wire and a manufacturing method thereof, which can realize multi-point pressure measurement through the pressure guide wire.
According to a first aspect of the present application, there is provided a pressure guidewire comprising:
the device comprises a tubular piece, wherein a first lumen and a second lumen which are arranged at intervals along the length direction of the tubular piece are arranged in the tubular piece, and a first overflow hole and a second overflow hole which are respectively used for communicating the first lumen and the second lumen to the outside are formed in the tubular piece;
a first optical fiber and a second optical fiber disposed within the tubular member, and the ends of the first optical fiber and the second optical fiber are respectively received in the first lumen and the second lumen;
and the first pressure detection device and the second pressure detection device are respectively connected to the tail ends of the first optical fiber and the second optical fiber, and can contact the blood flow at the first lumen and the second lumen through the first overflow hole and the second overflow hole to perform pressure measurement.
Further, the tubular member includes the core pipe and overlaps and locate the outer tubular member outside the core pipe, the outer tubular member includes interconnect fixed first pipe section and second pipe section, wherein: the first pipe section is set to be a woven pipe or a metal hypotube, the second pipe section is set to be a stainless steel pipe or a nickel-titanium alloy pipe, and the first pipe cavity and the second pipe cavity are both set to be in the second pipe section.
Further, a developing spring is arranged at one end, relatively far away from the first pipe section, of the second pipe section, and the length of the developing spring is set to be 30mm.
Further, the distance between the first lumen and the end of the developing spring is 35mm, and the distance between the first lumen and the second lumen is set to be 10mm-40mm.
Further, the length of the first pipe section is set to 1550mm, and the length of the second pipe section is set to 300mm.
Further, the outer diameter of the tubular member is 357 μm, the diameters of the first lumen and the second lumen are 110 μm to 170 μm, and the diameters of the first optical fiber and the second optical fiber are each set to 50 μm to 80 μm.
Further, the first optical fiber and the second optical fiber each sequentially comprise a fiber core, a cladding and a coating layer from inside to outside, wherein: the diameter of the core is set to 5-10 μm, and the total diameter of the core and the cladding is set to 10-20 μm.
Further, the refractive index n1 of the fiber core is greater than the refractive index n2 of the cladding, and the wavelength of the transmission light beam in the first optical fiber and the second optical fiber is 1550nm.
Further, the first pressure detection device and the second pressure detection device are both arranged as F-P cavity sensors, and the F-P cavity sensors adopt wavelength demodulation or cavity length demodulation.
According to a second aspect of the present application, there is provided a method of manufacturing the pressure guidewire described above, the method comprising the steps of:
s100, providing a core tube, and forming a cavity in the core tube by laser engraving;
s200, providing a first optical fiber, a second optical fiber, a first pressure detection device and a second pressure detection device, penetrating the first optical fiber and the second optical fiber into the cavity respectively, and ensuring that the tail ends of the first optical fiber and the second optical fiber are stopped at different positions;
s300, adhering and fixing the first pressure detection device and the second pressure detection device at the tail ends of the first optical fiber and the second optical fiber respectively;
s400, utilizing sealing glue to solidify and divide into a first pipe cavity and a second pipe cavity which respectively correspond to the first pressure detection device and the second pressure detection device in the cavity;
s500, assembling an outer pipe fitting outside the core pipe, and forming holes at the corresponding positions of the first pipe cavity and the second pipe cavity so as to communicate the first pipe cavity and the second pipe cavity to the outside;
s600, respectively assembling handles and developing springs at two ends of the outer pipe fitting.
The technical scheme provided by the embodiment of the application can comprise the following beneficial effects: the first lumen and the second lumen in the pressure guide wire are arranged at intervals, and the first overflow hole and the second overflow hole are respectively formed, so that after the pressure guide wire is inserted into a target blood vessel, the first lumen and the second lumen respectively correspond to the measuring positions of the far-end coronary artery average pressure Pd and the coronary artery port aortic average pressure Pa by controlling the extending position of the pressure guide wire, and therefore, the first pressure detection device and the second pressure detection device in the two lumens respectively contact with blood at the corresponding positions through the first overflow hole and the second overflow hole, and measurement and signal transmission of two pressure values are completed under the cooperation of the first optical fiber and the second optical fiber.
Compared with the prior art, the pressure guide wire provided by the embodiment of the application can independently complete two pressure values required by FFR evaluation without guiding a catheter. In addition, two required pressure values are values directly measured at corresponding positions in blood vessels, pa in the prior art is a value measured by a pressure sensor for extending a guide catheter to the outside of the body, and the measuring result of the pressure guide wire in the application is more accurate. In addition, compared with the method adopting a lead to perform electric power sensing, the method can reduce the sensitivity of the two pressure detection devices to the environment by using the first optical fiber and the second optical fiber as the sensing implementation means, thereby better ensuring the accuracy of the pressure detection result.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the application.
Drawings
FIG. 1 is a schematic structural view of a pressure guidewire according to an embodiment of the present application;
FIG. 2 is a schematic cross-sectional view of the structure of FIG. 1 illustrating the distribution of the first and second optical fibers within the tubular member;
fig. 3 is another cross-sectional view of the structure shown in fig. 1, illustrating a cross-section of the first/second flow-through hole opening.
Detailed Description
Reference will now be made in detail to exemplary embodiments, examples of which are illustrated in the accompanying drawings. When the following description refers to the accompanying drawings, the same numbers in different drawings refer to the same or similar elements, unless otherwise indicated. The manner described in the following exemplary embodiments does not represent all manners consistent with the present application. Rather, they are merely examples of apparatus and methods consistent with some aspects of the present application as detailed in the accompanying claims.
The terminology used in the present application is for the purpose of describing particular embodiments only and is not intended to be limiting of the present application. As used in this application and the appended claims, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It should also be understood that the term "and/or" as used herein refers to and encompasses any or all possible combinations of one or more of the associated listed items.
It should be understood that the terms "first," "second," and the like, as used in the specification and the claims herein, do not denote any order, quantity, or importance, but rather are used to distinguish one element from another. Likewise, the terms "a" or "an" and the like do not denote a limitation of quantity, but rather denote the presence of at least one. Unless otherwise indicated, the terms "front," "rear," "lower," and/or "upper" and the like are merely for convenience of description and are not limited to one location or one spatial orientation. The word "comprising" or "comprises", and the like, means that elements or items appearing before "comprising" or "comprising" are encompassed by the element or item recited after "comprising" or "comprising" and equivalents thereof, and that other elements or items are not excluded. The terms "connected" or "connected," and the like, are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect.
Embodiments of the present application will be described in detail below with reference to the accompanying drawings. Features of the embodiments described below may be combined with each other without conflict.
As shown in fig. 1, 2 and 3, the present application discloses a pressure guidewire comprising a tubular member 100, a first optical fiber 200, a second optical fiber 300, a first pressure detection device 400 and a second pressure detection device 500. Wherein: the inside of the tubular member 100 is provided with a first lumen 11 and a second lumen 12 arranged at intervals along the length direction thereof, and a first overflow hole and a second overflow hole are also respectively provided at positions on the tubular member 100 corresponding to the two lumens, and the first lumen 11 and the second lumen 12 are respectively communicated to the outside through the first overflow hole and the second overflow hole.
The first optical fiber 200 and the second optical fiber 300 are each disposed within the tubular member 100, and the ends of the first optical fiber 200 and the second optical fiber 300 are respectively terminated in the first lumen 11 and the second lumen 12. The first and second pressure detecting means 400 and 500 are connected to the ends of the first and second optical fibers 200 and 300, respectively.
After the pressure guide wire is inserted into the preset position of the target blood vessel, the first lumen 11 and the second lumen 12 respectively correspond to the measurement positions of the distal coronary average pressure Pd and the coronary ostial aortic average pressure Pa. The first pressure detecting means 400 and the second pressure detecting means 500 inside can directly detect Pd and Pa by contacting the blood at the corresponding positions through the first and second overflow holes, respectively.
When FFR evaluation is performed through a guide catheter in the conventional art, a sensor for measuring pressure is arranged outside the body, and Pa is measured only through extension of the conductive catheter, so that the measured Pa value always has a certain deviation from the actual pressure value of the coronary artery opening no matter how the measured Pa value is verified. At the same time, to measure the value of Pd, it is also necessary to advance the pressure guidewire after the calibration operation. In other words, in conventional FFR measurement, calibration and measurement of the guide catheter are a prerequisite for obtaining Pd. Therefore, the general improvement direction is focused on reducing the measurement error of the guide catheter, improving the calibration accuracy, and the like.
The pressure guide wire in this embodiment eliminates the matching and calibration of the guide catheter, and directly sets the first pressure detecting device 400 and the second pressure detecting device 500 in two lumens arranged at intervals, so that the two pressure detecting devices directly obtain two values Pa and Pd at a time without calibration. The operation of doctors is simpler, and repeated calibration is not needed. Meanwhile, in some lesion scenes, compared with a guide catheter, the pressure guide wire can better realize interventional operation, so that the pressure guide wire is wider in applicable scenes.
Compared with the first pressure detection device 400 and the second pressure detection device 500 which rely on an external pressure sensor to obtain detection results, the detection results are closer to the real pressure values when the pressure guide wire enters the blood vessel to directly measure the blood pressure at the corresponding position. Thus, FFR values obtained with the pressure guidewire of this example can most truly reflect hemodynamic occlusion.
In addition, the first optical fiber 200 and the second optical fiber 300 are used for transmitting light beams inwards, and the first pressure detecting device 400 and the second pressure detecting device 500 are correspondingly arranged as optical fiber pressure sensors, so that compared with a pressure sensor adopting electrical sensing, the optical fiber pressure sensor has higher detection sensitivity and is less sensitive to the environment, and the detection result is more accurate.
The first pressure detecting means 400 and the second pressure detecting means 500 may be provided as F-P cavity sensors, and the F-P cavity sensors have a range of-30 mmHg to 300mmHg, a resolution of 0.1mmHg, a zero drift < 1mmHg, an overload pressure > 4500mmHg, and a temperature accuracy of 0.2 ℃. Moreover, the thickness of the F-P cavity is 260-320 mu m, the cavity length is 18 mu m, and the oversize can cause that the F-P cavity is not matched with the guide wire or the inner cavity in size and cannot be integrated; in order to form a more accurate detection result on the blood pressure, the inner cavity of the F-P cavity sensor needs to form vacuum, namely, the finally formed sensor is an absolute pressure sensor, which is required to be manufactured by a micro-electromechanical process (MEMS), and the reproducibility of batch manufacturing of the MEMS process is also required, so that high repeatability and high consistency are realized, therefore, the size of the F-P cavity is not required to be too small, and the selection of the range can ensure that the manufacturing and the processing are facilitated on the premise of meeting the use requirement, and the integration is not influenced.
In addition, the F-P cavity sensor adopts wavelength demodulation or cavity length demodulation. Compared with other types of optical fiber sensors, the F-P cavity sensor has higher detection precision and lower environmental sensitivity, and can better meet the measurement requirement in blood vessels. The demodulation method of the F-P cavity sensor comprises light intensity demodulation, wavelength demodulation and cavity length demodulation, and higher resolution and more channel numbers can be obtained by adopting the wavelength demodulation or the cavity length demodulation.
The tubular member 100 includes a core tube and an outer tube member sleeved outside the core tube. The outer pipe comprises a first pipe section 13 and a second pipe section 14 which are connected and fixed with each other, and the first pipe cavity 11 and the second pipe cavity 12 are arranged on the core pipe at positions corresponding to the second pipe section 14. Wherein: the first tube section 13 is provided as a braided tube or a metallic hypotube and the second tube section is provided as a stainless steel tube or a nitinol tube. In one embodiment, the first tube section 13 is provided as a metallic hypotube and the second tube section 14 is provided as a stainless steel tube. Because the inner cavity is required to be formed in the core tube to meet the composite requirement of the first optical fiber 200 and the second optical fiber 300, the stainless steel tube is selected as the second tube section, the integral torsion and transmission performance of the pressure guide wire can be ensured, and meanwhile, the metal hypotube is selected as the first tube section 13, and the tube wall of the metal hypotube can be arranged to be very thin, so that the inner space of the metal hypotube is as large as possible, the inner core with larger diameter is accommodated, and the composite optical fiber in the inner core is facilitated.
The length of the first tube section 13 may be set to 1550mm and the length of the second tube section 14 to 300mm. In one embodiment, the first lumen 11 and the second lumen 12 are formed separately within the second tube section 14 by curing through glue filling within the second tube section 14.
The second tube section 14 is also fixedly provided with a developing spring 600 at an end relatively far from the first tube section 13, and the length of the developing spring 600 is set to 30mm. During interventional procedures, the visualization spring 600 can cooperate with imaging to feed back the penetration of the pressure guidewire to the operator. The distance between the first lumen 11 and the end of the developing spring 600 is 35mm, and the distance between the first lumen 11 and the second lumen 12 is set to 10mm-40mm. The distance between the two lumens may be set to 10mm, 15mm, 20mm, 25mm, 30mm, 35mm, 40mm, depending on the length of the coronary stenosis.
In addition to the development, the development spring 600 itself needs better operability, overstretching performance, etc. as the foremost end of the pressure guide wire, so the development spring 600 itself is actually of a tapered structure, on which the requirement of arranging the first pressure detecting device 400 is not satisfied, and therefore, the distance between the first lumen 11 and the end of the development spring 600 needs to be greater than the length of the development spring 600 itself; the coronary vessel has a limited length, and the effective working length of the pressure guide wire after entering the vessel is limited, so that the pressure detection device needs to be arranged as close to the front end of the pressure guide wire as possible, and the distance is comprehensively selected and set to be 35mm.
The outer diameter of the tubular member 100 is set to 357 μm and the diameter of its lumen is set to 110 μm-170 μm. Correspondingly, the diameters of the first optical fiber 200 and the second optical fiber 300 are set to be 50 μm to 80 μm. There is a certain degree of matching between the diameter of the lumen of the tubular member 100 and the diameters of the two optical fibers, for example, in one embodiment, the inner diameter of the tubular member 100 is set to 170 μm and the diameters of the first optical fiber 200 and the second optical fiber 300 are each set to 80 μm. In this way, just two optical fibers can be accommodated in the lumen of the tubular member 100 without excessive free space, enabling preliminary positioning of the two optical fibers.
The first optical fiber 200 and the second optical fiber 300 each include a core, a cladding, and a coating layer from inside to outside in this order, wherein: the diameter of the core is set to 5 μm to 10 μm, and the total diameter of the core and the cladding is set to 10 μm to 20 μm. The refractive index n1 of the core is greater than the refractive index n2 of the cladding. The wavelength of the transmitted beam in both fibers was 1550nm.
The second aspect of the present application also provides a method of manufacturing the pressure guidewire of any of the above embodiments, the method comprising the steps of:
s100, providing a core tube, and forming a cavity in the core tube by laser engraving;
s200, providing a first optical fiber 200, a second optical fiber 300, a first pressure detection device 400 and a second pressure detection device 500, penetrating the first optical fiber 200 and the second optical fiber 300 into the cavities respectively, and ensuring that the tail ends of the first optical fiber 200 and the second optical fiber 300 are received at different positions;
s300, adhering and fixing the first pressure detection device 400 and the second pressure detection device 500 at the tail ends of the first optical fiber 200 and the second optical fiber 300 respectively;
s400, utilizing sealing glue to solidify and divide and form a first pipe cavity 11 and a second pipe cavity 12 which respectively correspond to the first pressure detection device 400 and the second pressure detection device 500 in the cavity;
s500, assembling an outer pipe fitting outside the core pipe, and perforating the guide wire at the corresponding position of the first pipe cavity 11 and the second pipe cavity 12 to form a first overflow hole and a second overflow hole so as to communicate the first pipe cavity 11 and the second pipe cavity 12 to the outside;
s600 are respectively assembled with the handle 700 and the developing spring 600 at both ends of the outer tube.
In step S200, the first optical fiber 200 and the second optical fiber 300 are preferably threaded from the tail of the core tube and are respectively threaded to the first lumen 11 and the second lumen 12.
The foregoing description is not intended to limit the preferred embodiments of the present application, but is not intended to limit the scope of the present application, and any simple modification, equivalent variation and variation of the above embodiments according to the technical matter of the present application can be made by any person skilled in the art without departing from the scope of the technical solution of the present application.
Claims (10)
1. A pressure guidewire, the pressure guidewire comprising:
a tubular member (100), wherein a first lumen (11) and a second lumen (12) which are arranged at intervals along the length direction of the tubular member (100) are arranged in the tubular member (100), and a first overflow hole and a second overflow hole which are respectively used for communicating the first lumen (11) and the second lumen (12) to the outside are arranged on the tubular member (100);
a first optical fiber (200) and a second optical fiber (300) disposed within the tubular member (100), and the ends of the first optical fiber (200) and the second optical fiber (300) are respectively received in the first lumen (11) and the second lumen (12);
first and second pressure detection devices (400, 500) are connected to ends of the first and second optical fibers (200, 300), respectively, and are capable of contacting blood flow at the first and second lumens (11, 12) through the first and second flowthrough holes for pressure measurement.
2. The pressure guidewire of claim 1, wherein the tubular member (100) comprises a core tube and an outer tubular member sleeved outside the core tube, the outer tubular member comprising a first tube section (13) and a second tube section (14) secured to each other, wherein: the first pipe section (13) is a braided pipe or a metal hypotube, the second pipe section (14) is a stainless steel pipe or a nickel-titanium alloy pipe, and the first pipe cavity (11) and the second pipe cavity (12) are both arranged in the core pipe at the corresponding position of the second pipe section (14).
3. A pressure guidewire according to claim 2, characterized in that the second tube section (14) is provided with a developing spring (600) at an end relatively remote from the first tube section (13), the developing spring (600) being provided with a length of 30mm.
4. A pressure guidewire according to claim 3, characterized in that the distance of the first lumen (11) from the end of the developing spring (600) is 35mm, the distance between the first lumen (11) and the second lumen (12) being set to 10-40 mm.
5. A pressure guidewire according to claim 2, characterized in that the length of the first tube section (13) is set to 1550mm and the length of the second tube section (14) is set to 300mm.
6. The pressure guidewire of claim 1, wherein the tubular member (100) has an outer diameter of 357 μm, the first lumen (11) and the second lumen (12) have diameters of 110 μm-170 μm, and the first optical fiber (200) and the second optical fiber (300) each have a diameter of 50 μm-80 μm.
7. The pressure guidewire of claim 6, wherein the first optical fiber (200) and the second optical fiber (300) each comprise a core, a cladding, and a coating layer in order from inside to outside, wherein: the diameter of the core is set to 5-10 μm, and the total diameter of the core and the cladding is set to 10-20 μm.
8. The pressure guidewire of claim 7, wherein the refractive index n1 of the core is greater than the refractive index n2 of the cladding, and the wavelength of the transmitted light beam in both the first optical fiber (200) and the second optical fiber (300) is 1550nm.
9. The pressure guidewire of claim 1, wherein the first pressure detection device (400) and the second pressure detection device (500) are each configured as an F-P cavity sensor that employs wavelength demodulation or cavity length demodulation.
10. A method for manufacturing a pressure guidewire according to any one of claims 1-9, characterized in that the method comprises the steps of:
s100, providing a core tube, and forming a cavity in the core tube by laser engraving;
s200, providing a first optical fiber, a second optical fiber, a first pressure detection device and a second pressure detection device, penetrating the first optical fiber and the second optical fiber into the cavity respectively, and ensuring that the tail ends of the first optical fiber and the second optical fiber are stopped at different positions;
s300, adhering and fixing the first pressure detection device and the second pressure detection device at the tail ends of the first optical fiber and the second optical fiber respectively;
s400, utilizing sealing glue to solidify and divide into a first pipe cavity and a second pipe cavity which respectively correspond to the first pressure detection device and the second pressure detection device in the cavity;
s500, assembling an outer pipe fitting outside the core pipe, and forming holes at the corresponding positions of the first pipe cavity and the second pipe cavity so as to communicate the first pipe cavity and the second pipe cavity to the outside;
s600, respectively assembling handles and developing springs at two ends of the outer pipe fitting.
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| CN202410111435.7A CN117617927A (en) | 2024-01-25 | 2024-01-25 | Pressure guide wire and manufacturing method thereof |
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