CN116115197A

CN116115197A - OCT balloon catheter and preparation method thereof

Info

Publication number: CN116115197A
Application number: CN202310409087.7A
Authority: CN
Inventors: 刘坤; 郭伟; 张忠涛
Original assignee: Beijing Friendship Hospital
Current assignee: Beijing Friendship Hospital
Priority date: 2023-04-18
Filing date: 2023-04-18
Publication date: 2023-05-16
Anticipated expiration: 2043-04-18
Also published as: CN116115197B

Abstract

The invention discloses an OCT balloon catheter, a preparation method and application thereof, which comprises an OCT optical fiber, an OCT spring tube outside the optical fiber and a guide wire coaxially coated outside the OCT spring tube, wherein the guide wire sequentially comprises a directional guide wire, a bearing guide wire and a supporting guide wire from the head end to the tail end. The outer parts of the bearing guide wire and the supporting guide wire are respectively coated with a garment layer, and the outer garment layers of the bearing guide wire are inflated to form the saccule. The invention realizes the integration of the balloon and the OCT optical fiber, can be applied to diagnosis of biliary tract diseases, fills the biliary tract lumen with the inflatable balloon and fixes the biliary tract lumen to be adhered when in use, and realizes better examination effect after being combined with the OCT imaging technology in the balloon, and the balloon size can be designed according to different types of target biliary tract diameters and lesion lengths.

Description

OCT balloon catheter and preparation method thereof

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to an OCT balloon catheter and a preparation method thereof.

Background

The diagnosis of bile duct cancer has two difficulties at present, namely, the preoperative diagnosis is difficult, and the bile duct cancer belongs to a weak and small target in imaging, so that the accurate diagnosis is difficult to realize by a non-invasive means; secondly, the diagnosis in the operation is difficult, although the oral choledochoscope can realize direct vision and biopsy of the bile duct, the oral choledochoscope lacks the exploration capability of the Z axis (vertical depth) of the biliary tract; the commercially available intrabiliary ultrasound, while having a degree of Z-axis exploration capability, lacks the X, Y axis (direct view imaging) exploration capability. Therefore, there is a great clinical need for a biliary tract disease diagnosis apparatus that can have X, Y, Z axis examination capability at the same time.

The optical coherence tomography (optical coherence tomography, OCT) technology is to measure optical weak coherence reflection and back scattering, and to use super heterodyne detection technology to improve signal to noise ratio to obtain biological tissue tomographic image, which is a biological tissue imaging method independent of X-ray, ultrasound, CT and nuclear magnetism, and has the advantages of high resolution, low penetrating power and small volume. OCT is optical fiber imaging, the outer diameter of the optical fiber is generally 125-140um, the core diameter is generally 3-100um, the diameter of the optical fiber after being packaged by a spring tube can be still smaller than 800um, and the optical fiber can pass through any type of sheath tube. OCT imaging can be clearly imaged within the range of 3-10mm of a Z axis (vertical depth), the resolution can reach 10-50um, and the OCT imaging is also called as 'optical biopsy', and has been well applied to coronary artery and ophthalmic imaging. Coronary OCT is a catheter OCT technology, and the successful application of the coronary OCT technology indicates that the OCT technology has potential clinical significance in combination with an endoscopic catheter tumor examination method.

For example CN204169825U discloses an esophageal OCT system comprising an OCT engine, a probe interface unit, a balloon catheter, an OCT guidewire with a probe, a high-speed acquisition device and an image processing and display device connected in sequence. The method can solve the problems of low return rate, delayed diagnosis, error sampling and the like of the existing barrett's esophagus diagnosis equipment, has the advantages of high imaging speed, high resolution, high contrast, easy image identification and the like, and can meet the actual medical work needs of clinicians for observing esophageal tissue characteristics and the like.

However, the above design adopts an assembled balloon design, and has the following disadvantages: the required saccule has larger size, can only be used for diagnosing esophageal lesions, and can only be operated through a gastroscope with a large aperture; the assembled saccule also has the problems of tightness, fitting degree and diopter, because the assembled saccule needs a certain assembly clearance, the tightness and fitting degree are poor, the optical signal after the light rays pass through the incapable medium is unstable, the imaging quality is poor, and in addition, the OCT optical fiber and the probe are rough.

In recent years, research at home and abroad proves that the choledochoscope combined OCT imaging can have X, Y, Z axis examination capability at the same time, can solve the diagnosis problem of biliary tract tumors, and has more urgent and clear research and development requirements of biliary tract OCT.

Disclosure of Invention

In order to solve the problems, the invention provides an OCT balloon catheter and a preparation method thereof, which realize the integration of the balloon and the OCT optical fiber. The invention fills the biliary tract lumen and fixes the wall after the balloon is inflated, and realizes better examination effect after combining with OCT technology.

In order to at least achieve one of the above purposes, the present invention adopts the following technical scheme:

the invention provides an OCT balloon catheter, which comprises an OCT optical fiber, an OCT spring tube outside the OCT optical fiber and a coaxial guide wire coated outside the OCT spring tube, wherein the head end to the tail end of the guide wire are a direction guide wire, a bearing guide wire and a supporting guide wire in sequence; the outer parts of the bearing guide wire and the supporting guide wire are respectively coated with a garment layer, and the outer garment layers of the bearing guide wire can be inflated to form a balloon.

Further, the OCT balloon catheter tail end further includes an OCT rotational coupler interface and a fluid-intake branch interface.

Further, the OCT rotary coupler interface is arranged at the tail end of the outside of the OCT spring tube, and the outer garment layer supporting the tail end of the guide wire extends to a direction away from the OCT optical fiber to form a liquid inlet branch interface.

Further, the directional guide wire, the bearing guide wire, the supporting guide wire and the OCT rotary coupler interface are integrally formed, and lubricating liquid is filled in the tube cavity of the directional guide wire, the bearing guide wire, the supporting guide wire and the OCT rotary coupler interface and used for reducing friction between the OCT spring tube and the inner wall of the rigid guide wire.

Further, the diameter of the direction guide wire is smaller, and the direction guide wire is made of soft elastic materials and is used for guiding the direction under the endoscope; the bearing guide wire is made of a rigid transparent material and is used for bearing the saccule and the probe; the supporting guide wire is also made of rigid materials, and is a main power transmission stabilizer and a main conveyer.

Further, a valve is connected to the liquid inlet branch interface, and the tail end of the liquid inlet branch interface is connected with an injector, so that inflation liquid can be injected into the balloon.

Further, the refractive index of the lubricating liquid is consistent with that of the expansion liquid, so that the stability and uniformity of the optical signal are ensured.

Further, the outer garment layer is made of high polymer materials.

Further, the head end of the OCT optical fiber is integrally connected with a probe containing an optical lens.

Further, the OCT spring tube passes through the OCT rotary coupler interface and is connected with a rotary coupler device, and the rotary coupler device drives the OCT spring tube to rotate, instead of directly rotating the OCT optical fiber, and the OCT spring tube rotates and retracts to drive the probe to retract.

Further, the body shape of the balloon after inflation is a regular cylinder.

Further, the working distance of the probe is 4-16mm, the imaging depth is 3-10mm, the transverse resolution is 10-50um, and the water medium is optimized.

Further, the diameter of the balloon is 4-16mm, which may be any value or any range of the above-mentioned numerical ranges, for example, 4, 5.3, 6.7, 8, 10.3, 11, 12, 16mm, etc., or 4.3-5.5, 4.9-8, 5.6-7, 7.8-9.9, 8.9-10.1, 10.9-12mm, 15.1-16mm, etc.

Further, the length of the balloon is 10-30mm, which may be any of the above numerical ranges or any range, e.g., 10, 13, 15, 16.7, 19.8, 30mm, etc., or 10-10.5, 10-12, 15-15.8, 10-18, 28-29.7mm, etc.

The invention also provides a preparation method of the OCT balloon catheter, which comprises the following steps:

s1, embedding an OCT optical fiber with a coating layer into an OCT spring tube, and integrating the head end of the OCT optical fiber with a 90-degree side scanning out optical probe with an optical lens;

s2, embedding the OCT spring tube and the probe into the transparent bearing guide wire and the supporting guide wire, pouring lubricating liquid and packaging.

Preferably, the preparation method of the OCT balloon catheter further comprises:

s3, manufacturing the tail end into a liquid inlet branch interface and an OCT rotary coupler interface.

More preferably, the preparation method of the OCT balloon catheter further comprises:

and installing a valve and a syringe on the liquid inlet branch interface, pre-filling special expansion liquid in the syringe, and connecting the OCT rotary coupler interface with an external rotary coupler device.

The invention also provides application of the OCT balloon catheter in preparing biliary tract disease diagnosis equipment.

Further, the working distance of the probe is 4-16mm, the imaging depth is 3-10mm, the transverse resolution is 10-50um, and the aqueous medium is optimized.

Further, the diameter of the balloon is 4-16mm, which may be any value or any range of the above-mentioned numerical ranges, for example, 4, 5.3, 6.7, 8, 10.3, 11, 12, 16mm, etc., or 4.3-5.5, 4.9-8, 5.6-7, 7.8-9.9, 8.9-10.1, 10.9-12mm, 15.1mm-16mm, etc.

Compared with the prior art, the invention has the following beneficial effects:

1) According to the invention, the balloon is filled with the expansion liquid to form a regular cylinder, the OCT device can be well attached in bile ducts with different shapes and different tensions due to the balloon design, the imaging effect is better, the size of the balloon is smaller, the balloon can be compatible with the existing choledochoscope and duodenum scope, and the problem of OCT circular scanning focusing is well solved.

2) In the invention, the balloons with different types can be used for bile duct examination of different parts and different anatomical structures, and can be used under direct vision as long as the biliary tract can reach the parts, so as to obtain X, Y, Z three axial image information.

3) The invention is provided with the independent liquid inlet branch interface, has strong operability, accords with clinical operation habit, and does not need a learning curve.

4) In the invention, the direction guide wire is arranged in front of the OCT probe and used for guiding the direction under the endoscope, and the OCT probe is made of softer material, so that the damage to the bile duct is prevented.

Drawings

FIG. 1 is a schematic diagram of the overall structure of the present invention;

FIG. 2 is an enlarged view of the invention at A in FIG. 1;

FIG. 3 is a cross-sectional view of a balloon structure of the present invention;

the components in the figures are labeled as follows: 1-OCT optical fiber, 11-probe, 2-OCT spring tube, 3-direction guide wire, 4-bearing guide wire, 5-supporting guide wire, 6-outer coat layer, 61-saccule, 7-OCT rotary coupler interface, 8-liquid inlet branch interface and 81-valve.

Detailed Description

The advantages and features of the present invention will become more apparent from the following description when taken in conjunction with the accompanying drawings. It should be understood that the embodiments are illustrative only and should not be taken as limiting the scope of the invention.

It should be noted that all directional indicators (such as up, down, left, right, front, and rear … …) in the embodiments of the present invention are merely used to explain the relative positional relationship, movement conditions, etc. between the components in a specific posture (as shown in the drawings), and if the specific posture is changed, the directional indicators are correspondingly changed.

In the present invention, unless explicitly specified and limited otherwise, the terms "fixedly attached," "connected," and the like are to be construed broadly and, for example, as a fixed connection, as a removable connection, or as a unit; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communicated with the inside of two elements or the interaction relationship of the two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.

Fig. 1 shows the overall structure of the present invention, and fig. 2 and 3 show the specific structure of the balloon structure in the present invention. The biliary tract OCT balloon catheter shown in fig. 1 mainly comprises an OCT optical fiber 1 and an OCT spring tube 2 coated outside the OCT optical fiber 1, wherein the head end of the OCT optical fiber 1 is integrally connected with a probe 11.

The outside of the OCT spring tube 2 is nested with a direction guide wire 3, a bearing guide wire 4, a supporting guide wire 5 and an OCT rotary coupler interface 7 from the head end to the tail end in sequence, the OCT spring tube 2 passes through the OCT rotary coupler interface 7 to be connected with an external rotary coupler device, and the rotary coupler device drives the OCT spring tube 2 to rotate instead of directly rotating the OCT optical fiber 1.

The directional guide wire 3, the bearing guide wire 4, the supporting guide wire 5 and the OCT rotary coupler interface 7 are integrally formed, and lubricating liquid is filled in the tube cavity of the OCT rotary coupler interface, so that friction between the OCT spring tube 2 and the inner wall of the rigid guide wire is reduced. The diameter of the direction guide wire 3 is smaller, and the direction guide wire is made of soft elastic materials and is used for guiding the endoscope in the lower direction; the bearing guide wire 4 is made of a rigid transparent material and is used for bearing the balloon 61 and the probe 11; the support wire 5 is also made of rigid material and is the main power transmission stabilizer and conveyor.

The outer parts of the bearing guide wire 4 and the supporting guide wire 5 are respectively coated with a garment layer 6, the garment layer 6 outside the bearing guide wire 4 is inflated to form a balloon 61, and the balloon 61 is inflated to form a regular cylinder.

The outer garment layer 6 supporting the tail end of the guide wire 5 extends away from the OCT optical fiber 1 to form an independent fluid-feeding branch interface 8. The valve 81 is connected to the liquid inlet branch interface 8, the tail end of the liquid inlet branch interface 8 is connected with the injector, the expansion liquid is injected into the balloon 61, the refractive index of the lubrication liquid is consistent with that of the expansion liquid, and the stability and uniformity of the optical signals are ensured.

In this embodiment, the balloon 61 has a diameter of 12mm and a length of 20mm. The working distance of the probe 11 is 12mm, the imaging depth is 5mm, the transverse resolution is 10um, and the aqueous medium is optimized. The invention combines the saccule and the OCT technology, has X, Y, Z shaft inspection capability, reduces the size of the saccule, realizes the integration of the saccule and the OCT optical fiber, and overcomes the key problem in bile duct cancer diagnosis through the designs of independent liquid inlet branch interfaces and the like.

The preparation method of the biliary tract OCT balloon catheter provided by the embodiment of the invention comprises the following steps:

s1, integrating the head end of an OCT optical fiber 1 with a resin protective coating layer with a 90-degree side scanning optical probe 11 with an optical lens and embedding the probe into an OCT spring tube 2;

s2, the OCT optical fiber 1, the probe 11 and the OCT spring tube 2 are integrally embedded into the transparent bearing guide wire 4 and the supporting guide wire 5, and are filled with lubricating liquid, so that the OCT optical fiber can pass through a 2.2mm operation duct of a commercial choledochoscope with the outer diameter of 5mm and/or a 1.7mm operation duct of a commercial choledochoscope with the outer diameter of 3mm and/or a 1.2mm operation duct of a commercial choledochoscope with the outer diameter of 2.5mm after encapsulation.

S3, manufacturing the tail end of the device into an independent liquid inlet branch interface 8 and an OCT rotary coupler interface 7, installing a valve and a syringe in the liquid inlet branch interface 8, pre-filling special expansion liquid in the syringe, and connecting the OCT rotary coupler interface 7 with an external rotary coupler device.

The foregoing has shown and described the basic principles, principal features and advantages of the invention. It will be understood by those skilled in the art that the present invention is not limited to the foregoing examples, and that the foregoing description and description are merely illustrative of the principles of this invention, and various changes and modifications may be made without departing from the spirit and scope of the invention, which is defined in the appended claims.

Claims

1. An OCT balloon catheter, characterized by: the OCT optical fiber comprises an OCT optical fiber (1) and an OCT spring tube (2) outside the OCT optical fiber (1), wherein a coaxial guide wire is coated outside the OCT spring tube (2), and the guide wire sequentially comprises a direction guide wire (3), a bearing guide wire (4) and a supporting guide wire (5) from the head end to the tail end; the outer parts of the bearing guide wire (4) and the supporting guide wire (5) are respectively coated with a garment layer (6), the garment layers (6) outside the bearing guide wire (4) can be inflated to form a balloon (61), and the diameter of the balloon (61) is 4-16mm, and the length of the balloon is 10-30mm.

2. The OCT balloon catheter of claim 1, wherein: the tail end of the OCT balloon catheter also comprises an OCT rotary coupler interface (7) and a liquid inlet branch interface (8).

3. The OCT balloon catheter of claim 2, wherein: the OCT rotary coupler interface (7) is arranged at the tail end of the outside of the OCT spring tube (2), and the outer garment layer (6) supporting the tail end of the guide wire (5) extends to a direction far away from the OCT optical fiber (1) to form a liquid inlet branch interface (8).

4. The OCT balloon catheter of claim 3, wherein: the liquid inlet branch interface (8) is connected with a valve (81), and the tail end of the liquid inlet branch interface (8) can be connected with a syringe.

5. The OCT balloon catheter of claim 3, wherein: the directional guide wire (3), the bearing guide wire (4), the supporting guide wire (5) and the OCT rotary coupler interface (7) are integrally formed, and a lubricating liquid is filled in a lumen of the directional guide wire.

6. The OCT balloon catheter of claim 3, wherein: the head end of the OCT optical fiber (1) is integrally connected with a probe (11).

7. The OCT balloon catheter of claim 3, wherein: the OCT spring tube (2) is connected through the OCT power (7) interface with a rotary coupler device that drives the OCT spring tube (2) in rotation and translation.

8. The OCT balloon catheter of claim 3, wherein: the main body of the balloon (61) after inflation is in the shape of a regular cylinder.

9. The OCT balloon catheter of claim 3, wherein: the diameter of the direction guide wire (3) is smaller than that of the supporting guide wire (5), and the direction guide wire (3) is made of soft elastic materials.

10. The method of preparing an OCT balloon catheter according to any one of claims 1-9, comprising the steps of:

integrating a 90-degree side scanning optical probe (11) containing an optical lens at the head end of an OCT optical fiber (1) containing a resin protective coating layer and embedding the optical probe into an OCT spring tube (2);

and then the OCT optical fiber (1), the probe (11) and the OCT spring tube (2) are integrally embedded into the transparent bearing guide wire (4) and the supporting guide wire (5), and are filled with lubricating liquid and packaged.

11. Use of an OCT balloon catheter according to any one of claims 1-9 for the preparation of a biliary diagnosis device.