CN117617913A - Pressure guide wire - Google Patents

Pressure guide wire Download PDF

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Publication number
CN117617913A
CN117617913A CN202410112458.XA CN202410112458A CN117617913A CN 117617913 A CN117617913 A CN 117617913A CN 202410112458 A CN202410112458 A CN 202410112458A CN 117617913 A CN117617913 A CN 117617913A
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China
Prior art keywords
optical fiber
detection device
pressure
sensor
pressure guidewire
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CN202410112458.XA
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Chinese (zh)
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CN117617913B (en
Inventor
颜玉强
张晓晖
杜瑞林
贾二文
凌静
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Zhejiang Batai Medical Technology Co ltd
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Zhejiang Batai Medical Technology Co ltd
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Abstract

The application discloses a pressure guide wire, which comprises a tubular piece, a first optical fiber, a second optical fiber and a third optical fiber which are arranged in the tubular piece, and a first detection device and a second detection device which are respectively connected with the second optical fiber and the third optical fiber, wherein after incident light is transmitted from the first optical fiber and contacts with external substances, generated ultrasonic waves can be acquired by the first detection device and used for photoacoustic imaging; the tubular member is provided with an overflow hole at the position of the second detection device, and the second detection device is used for detecting the pressure of blood flow at the position of the second detection device. The pressure guide wire can realize both functional diagnosis and imaging diagnosis of the blood vessel stenosis degree.

Description

Pressure guide wire
Technical Field
The application relates to the field of medical instruments, in particular to a pressure guide wire.
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.
Limited for a number of reasons, a single FFR evaluation is limited in accuracy. In some special cases, it is still necessary to assist other means to accurately evaluate the stenosis degree of the blood vessel and understand the nature of the lesion at the stenosis, which makes the process of evaluating the stenosis degree of the blood vessel complicated.
Disclosure of Invention
The application provides a pressure guide wire, which can realize functional diagnosis and imaging diagnosis of the stenosis degree of a blood vessel through one pressure guide wire.
According to a first aspect of the present application, there is provided a pressure guidewire comprising a tubular member, a first optical fiber, a second optical fiber and a third optical fiber arranged within the tubular member, and first and second detection means connected to the second and third optical fibers, respectively, whereby after incident light is transmitted from the first optical fiber and contacts an external substance, generated ultrasonic waves can be acquired by the first detection means and used for photoacoustic imaging; the tubular member is provided with an overflow hole at the position of the second detection device, and the second detection device is used for detecting the pressure of blood flow at the position of the second detection device.
Further, the outer diameter of the tubular member is set to 357 μm and the inner diameter thereof is set to 150-170 μm.
Further, the first detection device and the second detection device are configured as an F-P cavity sensor, wherein: the F-P cavity sensor serving as the first detection device adopts light intensity demodulation; the F-P cavity sensor as the second detection device adopts wavelength demodulation or cavity length demodulation.
Further, the F-P cavity sensor as the first detecting means is set to 700 μm to 850 μm in thickness and 80 μm to 160 μm in cavity length.
Further, the F-P cavity sensor serving as the first detection device has the measuring range of 0.05Pa-0.5Pa, the sensitivity of 20mV/Pa-40mV/Pa and the resonance frequency of 40kHz-80kHz.
Further, the F-P cavity sensor as the second detecting means is set to a thickness of 260 μm to 320 μm and a cavity length of 18 μm.
Further, the F-P cavity sensor as the second detection device has a measuring range of-30 mmHg to 300mmHg, a resolution of 0.1mmHg, a zero drift of < 1mmHg, an overload pressure of > 4500mmHg and a temperature accuracy of 0.2 ℃.
Further, the diameters of the first optical fiber, the second optical fiber and the third optical fiber are all set to be 50 μm to 60 μm.
Further, the first optical fiber, the second optical fiber and the third optical fiber each sequentially comprise a fiber core, a cladding and a coating layer from inside to outside, wherein: the refractive index n1 of the core is greater than the refractive index n2 of the cladding.
Further, the wavelengths of the transmission light beams in the first optical fiber, the second optical fiber and the third optical fiber are respectively set to 600nm-900nm, 1550nm and 1550nm.
The technical scheme provided by the embodiment of the application can comprise the following beneficial effects:
compared with a catheter, the pressure guide wire has smaller radial size and better trafficability for some lesions with larger stenosis degree, so that the optical fiber is compounded in the pressure guide wire, and the application is wider; meanwhile, the first optical fiber in the application is used as incident light to be transmitted, the chromophore in the pathological change tissue in the blood vessel absorbs light energy and generates non-radiation transition, the tissue is heated instantly to generate thermal elastic expansion, and then the chromophore propagates outwards in an ultrasonic mode and is acquired by the first detection device, and the chromophore is transmitted out through the second optical fiber, so that the photoacoustic imaging in the blood vessel can be realized by matching the chromophore with the first optical fiber, the chromophore, the first optical fiber and the second optical fiber, compared with the photoacoustic imaging method which is adopted in the application, has higher imaging integration level and can be integrated in a guide wire, the indication is wider, the ultrasonic transducer is integrated in a guide pipe, and the cost is higher. At the same time, the third optical fiber and the second detection device are matched to realize the measurement of the pressure in the blood vessel, thereby realizing the functional detection of the stenosis degree in the blood vessel. Therefore, through one-time interventional operation of the pressure guide wire, the functional diagnosis and the imaging diagnosis of the blood vessel stenosis degree can be simultaneously realized, the pain of a patient and the complexity of operation are reduced, and a more comprehensive and accurate basis is provided for accurate diagnosis of doctors.
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 cross-sectional view of a pressure guidewire according to an embodiment of the present application;
FIG. 2 is a graph of sensitivity of an F-P cavity sensor as a function of cavity length.
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, the present application discloses a pressure guidewire comprising a tubular member 100, a first optical fiber 200, a second optical fiber 300 and a third optical fiber 400 disposed within the lumen of the tubular member 100, and a first detection device and a second detection device connected to the second optical fiber 300 and the third optical fiber 400, respectively.
Wherein: after the incident light is transmitted into the pressure guide wire from the first optical fiber 200 and contacts with an external substance such as plaque on the inner wall of a blood vessel, ultrasonic waves are generated, and the generated ultrasonic waves can be acquired by the first detection device and used for photoacoustic imaging; the tubular member 100 is provided with an overflow hole (not shown) at the position where the second detecting device is located, and the second detecting device can detect the blood flow pressure at the position after contacting the blood in the blood vessel through the overflow hole.
Therefore, the pressure in the blood vessel can be measured simultaneously by one intervention of the pressure guide wire, and the high-resolution imaging is carried out on the inner cavity of the blood vessel, so that the pressure guide wire can complete the two diagnoses of functional diagnosis and influence diagnosis of the stenosis degree of the blood vessel. Coronary atherosclerosis progresses faster and mortality is higher in patients with Diabetes Mellitus (DM) and Acute Coronary Syndrome (ACS). FFR is currently used in very low proportions in such patients. Meanwhile, vulnerable plaques in such patients are more common, imaging is required for detection and evaluation, and intracavity imaging can identify high-risk plaques. Through the pressure guide wire in the embodiment, an operator can combine FFR with imaging diagnosis to more efficiently and accurately judge what treatment strategy should be adopted by a patient.
Further, compared with interventional instruments such as micro-catheters, the radial dimension of the pressure guide wire is smaller, the application scene is wider, and the pressure guide wire has obvious advantages in the case that some catheters are difficult to intervene.
In one embodiment, the diameters of the first optical fiber 200, the second optical fiber 300, and the third optical fiber 400 are substantially the same and are all set to R, and the following relationship exists between the inner diameter R of the tubular member 100 and the diameters R of the three optical fibers:r. In this way, a sufficient wall thickness of the tubular member 100 can be ensured, while at the same time, by means of geometrical constraints, a relatively defined position of the three optical fibers can be obtained within the tubular member 100.
In one embodiment, the tubular member 100 has an outer diameter of 357 μm and an inner diameter R of 150-170 μm, typically 160 μm. The diameters of the first optical fiber 200, the second optical fiber 300, and the third optical fiber 400 are all set to 50 μm to 60 μm. Further, the first optical fiber 200, the second optical fiber 300 and the third optical fiber 400 have substantially the same structure and each include a core, a cladding and a coating layer from inside to outside, wherein: the refractive index n1 of the core is greater than the refractive index n2 of the cladding.
The wavelengths of the transmission light beams in the first optical fiber 200, the second optical fiber 300, and the third optical fiber 400 are set to 600nm to 900nm, 1550nm, and 1550nm, respectively. Wherein: the light beam transmitted in the first optical fiber 200 is used for interaction with the tissue and cells in the blood vessel, and the like, and attenuation and scattering of the tissue are less in a near infrared region wave band of 600-900nm, so that ultrasonic waves which can be obtained by the first detection device are generated. The second optical fiber 300 is used for transmitting the ultrasonic waves obtained by the first detection device to the corresponding position to form an image. And the third fiber 400 is used to measure blood pressure. The working requirements of the three optical fibers can be better met by selecting the light beams with the wavelengths, so that photoacoustic imaging and blood pressure measurement can be better realized.
In one embodiment, the first and second detection devices are each configured as an F-P chamber sensor. Wherein: the F-P cavity sensor as the first detection device adopts light intensity demodulation; the F-P cavity sensor as the second detection device 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; the light intensity demodulation has a faster response speed, and the image processing can be performed more timely; with wavelength demodulation or cavity length demodulation, higher resolution and a greater number of channels can be obtained.
Further, the F-P cavity sensor as the first detecting means is set to 700 μm to 850 μm in thickness and 80 μm to 160 μm in cavity length. Because the ultrasonic sound pressure intensity generated by the photoacoustic effect is lower, the measuring range is 0.05Pa-0.5Pa, so that the sensor sensitivity is required to be high, the sensor sensitivity is required to be kept at 20mV/Pa-40mV/Pa, the acquisition of a rear-end circuit is facilitated, and the measurement accuracy is improved. Referring to FIG. 2, there is a peak function relationship between the sensitivity and the cavity length of the F-P cavity sensor, that is, the sensitivity increases monotonically with the increase of the cavity length, and then decreases monotonically, when the sensitivity is 20mV/Pa-40mV/Pa, the cavity length is required to be set at 80 μm-160 μm, and the optimal cavity length is 120 μm. The resonance frequency is 40kHz-80kHz, and similar to the cavity length, the relation between the sensitivity and the resonance frequency is also a wave crest function relation, so that the resonance frequency is 40kHz-80kHz and the optimal value is 60kHz for ensuring certain sensitivity.
The F-P cavity sensor as the second detecting means is set to 260 μm to 320 μm in thickness and 18 μm in cavity length. Because of the large blood pressure range, the lumen length can be set smaller than in the first detection device without affecting the sensitivity and detection. The range is-30 mmHg-300mmHg, the resolution is 0.1mmHg, the zero drift is less than 1mmHg, the overload pressure is more than 4500mmHg, and the temperature precision is 0.2 ℃. The second detecting device is used for detecting the pressure in the blood vessel, 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 repeatability of batch manufacturing of the MEMS process is required, so that high repeatability and high consistency are realized, and therefore, the size of the F-P cavity is not suitable to be too small; at the same time, at least three optical fibers and two detection devices are integrated into the tubular member 100, and thus, the oversized F-P lumen may result in a mismatch with the guidewire or lumen size for integration. The F-P cavity sensor is selected from the range, so that the manufacturing and processing are facilitated on the premise of meeting the use requirement, and the integration is not influenced.
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, characterized in that it comprises a tubular member (100), a first optical fiber (200), a second optical fiber (300) and a third optical fiber (400) arranged inside the tubular member (100), and a first detection device and a second detection device connected to the second optical fiber (300) and the third optical fiber (400), respectively, wherein after incident light is transmitted from the first optical fiber (200) and contacts an external substance, the generated ultrasonic wave can be acquired by the first detection device and used for photoacoustic imaging; the tubular member (100) is provided with an overflow hole at the position of the second detection device, and the second detection device is used for detecting the pressure of blood flow at the position of the second detection device.
2. Pressure guidewire according to claim 1, characterized in that the tubular member (100) has an outer diameter of 357 μm and an inner diameter of 150-170 μm.
3. The pressure guidewire of claim 1, wherein the first and second sensing devices are each configured as an F-P lumen sensor, wherein: the F-P cavity sensor serving as the first detection device adopts light intensity demodulation; the F-P cavity sensor as the second detection device adopts wavelength demodulation or cavity length demodulation.
4. A pressure guidewire according to claim 3, characterized in that the F-P lumen sensor as the first detection means is set to a thickness of 700 μm-850 μm and a lumen length of 80 μm-160 μm.
5. A pressure guidewire as in claim 3, wherein said F-P cavity sensor as said first detection means has a range of 0.05Pa to 0.5Pa, a sensitivity of 20mV/Pa to 40mV/Pa, and a resonant frequency of 40kHz to 80kHz.
6. A pressure guidewire according to claim 3, characterized in that the F-P lumen sensor as the second detection means is set to a thickness of 260 μm-320 μm and a lumen length of 18 μm.
7. The pressure guidewire of claim 1, wherein the F-P lumen sensor as the second detection means has 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 ℃.
8. The pressure guidewire of claim 1, wherein the first optical fiber (200), the second optical fiber (300), and the third optical fiber (400) are each provided with a diameter of 50 μιη -60 μιη.
9. The pressure guidewire of claim 7, wherein the first optical fiber (200), the second optical fiber (300), and the third optical fiber (400) each comprise a core, a cladding, and a coating layer in order from inside to outside, wherein: the refractive index n1 of the core is greater than the refractive index n2 of the cladding.
10. The pressure guidewire of claim 1, wherein the wavelengths of the transmitted light beams in the first optical fiber (200), the second optical fiber (300), and the third optical fiber (400) are set to 600nm-900nm, 1550nm, and 1550nm, respectively.
CN202410112458.XA 2024-01-25 2024-01-25 Pressure guide wire Active CN117617913B (en)

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