CN116115197B - OCT balloon catheter and preparation method thereof - Google Patents

Abstract

The invention discloses an OCT balloon catheter and its preparation method and application. It includes an OCT optical fiber, an OCT spring tube outside the optical fiber, and a coaxial guide wire wrapped outside the OCT spring tube. The guide wire runs from the head end to the tail end. The order is directional guide wire, load-bearing guide wire, and support guide wire. The outer parts of the load-bearing guide wire and the supporting guide wire are covered with a coat layer, and the outer coat layer of the load-bearing guide wire forms a balloon after expansion. The present invention realizes the integration of balloon and OCT optical fiber, and can be applied to the diagnosis of biliary tract diseases. When used, the balloon is inflated to fill the biliary lumen and fixed to the wall, and then combined with the OCT imaging technology in the balloon to achieve better results. To check the effect, the balloon size can be designed in different models according to the diameter of the target bile duct and the length of the lesion.

Description

An OCT balloon catheter and its preparation method

Technical field

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

Background technique

There are currently two difficulties in the diagnosis of cholangiocarcinoma. First, it is difficult to diagnose preoperatively. Cholangiocarcinoma is a weak target in imaging, so it is difficult to achieve accurate diagnosis through non-invasive means; second, it is difficult to diagnose intraoperatively, and transoral choledochoscopy is not required. Although it can achieve direct vision and biopsy of the bile duct, it lacks the ability to explore the Z-axis (vertical depth) of the bile duct; although the intrabiliary ultrasound that has been approved for marketing has a certain degree of Z-axis exploration ability, it lacks the ability to explore the X, Y-axis (vertical depth). imaging) detection capabilities. Therefore, there is an urgent clinical need for a biliary disease diagnostic equipment that can simultaneously perform X, Y, and Z axis examinations.

Optical coherence tomography (OCT) technology refers to obtaining tomographic images of biological tissues by measuring optical weak coherent reflection and backscattering, and using superheterodyne detection technology to improve the signal-to-noise ratio. It is a method that is independent of X-ray, Biological tissue imaging methods other than ultrasound, CT, and MRI have the advantages of high resolution, low penetration, and small size. OCT is optical fiber imaging. The outer diameter of the optical fiber is generally 125-140um, and the core diameter is generally 3-100um. After being packaged in a spring tube, the diameter can still be less than 800um, and can pass through any type of sheath. OCT imaging can clearly image in the Z-axis (vertical depth) range of 3-10mm, with a resolution of 10-50um. It is also called "optical biopsy" and has been well clinically used in coronary artery and ophthalmic imaging. Coronary OCT is a catheter OCT technology, and its successful application reminds us that OCT technology combined with endoscopic catheter tumor detection methods has potential clinical significance.

For example, CN204169825U discloses an esophageal OCT system, which includes 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. It can solve the problems of low return rate, delayed diagnosis and sampling error of existing equipment for diagnosing Barrett's esophagus. It also has the advantages of fast imaging speed, high resolution, high contrast and easy image recognition, and can meet clinical needs. Doctors observe the characteristics of esophageal tissue and other practical medical work needs.

However, the above design adopts an assembled balloon design, which has the following disadvantages: the required balloon size is relatively large, which can only be used to diagnose esophageal lesions and can only be operated through a large-aperture gastroscope; the assembled balloon also has airtightness , The problem of fit and refractive index. Because it requires assembly, a certain assembly gap is required, and the sealing and fit will be poor. The optical signal after the light passes through the impotent medium will be unstable, and the imaging quality will be poor. In addition, OCT The fiber optics and probes are both on the thick side.

In recent years, domestic and foreign studies have confirmed that choledochoscopy combined with OCT imaging can have X, Y, and Z-axis inspection capabilities at the same time, and can solve the diagnosis problem of biliary tumors. The need for research and development of biliary OCT has become increasingly urgent and clear.

Contents of the invention

In order to solve the above problems, the present invention provides an OCT balloon catheter and a preparation method thereof, which realizes the integration of the balloon and the OCT optical fiber. The present invention uses a balloon to inflate the bile duct cavity to fill it and fix it to the wall, and achieves better inspection results when combined with OCT technology.

In order to achieve at least one of the above objectives, the technical solution adopted by the present invention is:

The invention provides an OCT balloon catheter. The OCT balloon catheter includes an OCT optical fiber, an OCT spring tube outside the OCT optical fiber, and a coaxial guide wire wrapped outside the OCT spring tube. The first end of the guide wire From end to end, there are direction guide wires, load-bearing guide wires, and support guide wires in order; the load-bearing guide wires and the support guide wires are covered with a coat layer, and the outer coat layer of the load-bearing guide wire can be expanded to form a ball. bag.

Further, the tail end of the OCT balloon catheter also includes an OCT rotary coupler interface and a liquid inlet branch interface.

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

Further, the direction guide wire, load-bearing guide wire, support guide wire, and OCT rotary coupler interface are integrally formed, and the lumen is filled with lubricating liquid to reduce friction between the OCT spring tube and the inner wall of the rigid guide wire. .

Furthermore, the direction guide wire has a smaller diameter and is made of soft elastic material for guiding the direction under the endoscope; the load-bearing guide wire is made of rigid transparent material and is used for carrying the balloon. and probe; the support guide wire is also made of rigid material and is the main power transmission stabilizer and conveyor.

Further, a valve is connected to the liquid inlet branch interface, and a tail end of the liquid inlet branch interface is connected to a syringe, which can inject expansion liquid into the balloon.

Furthermore, the refractive index of the lubricating liquid and the expansion liquid are consistent, ensuring the stability and uniformity of the optical signal.

Further, the outer coat layer is made of polymer material.

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 to a rotary coupler device. The rotary coupler device drives the OCT spring tube to rotate instead of directly rotating the OCT optical fiber. The OCT spring tube rotates and retreats, driving the probe to retreat.

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

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

Further, the diameter of the balloon is 4-16mm, which can be any value or any range in the above numerical range, such as 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 can be any value or range of the above numerical range, such as 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 method for preparing an OCT balloon catheter, which includes the following steps:

S1. Embed the coated OCT optical fiber into the OCT spring tube, and then integrate the 90° side-scanning light probe with an optical lens at its head end;

S2. Embed the OCT spring tube and probe into the transparent load-bearing guide wire and support guide wire, fill them with lubricating liquid, and encapsulate them.

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

S3. Make 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 includes:

A valve and a syringe are installed on the liquid inlet branch interface, and the syringe is prefilled with a special expansion liquid, and the OCT rotary coupler interface is connected to an external rotary coupler device.

The present invention also provides the application of the OCT balloon catheter in preparing diagnostic equipment for biliary tract diseases.

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

Further, the diameter of the balloon is 4-16mm, which can be any value or any range in the above numerical range, such as 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.

Further, the length of the balloon is 10-30mm, which can be any value or range of the above numerical range, such as 10, 13, 15, 16.7, 19.8, 30mm, etc., or 10-10.5, 10-12 , 15-15.8, 10-18, 28-29.7mm, etc.

Compared with the prior art, the beneficial effects of the present invention are as follows:

1) In the present invention, the balloon forms a regular cylindrical shape after injecting expansion liquid. The balloon design enables the OCT device to achieve good adhesion in bile ducts of different shapes and different tensions, with better imaging effects, and the size of the balloon It is smaller, compatible with existing choledochoscopes and duodenoscopes, and better solves the problem of OCT ring scan focusing.

2) In the present invention, different types of balloons can be used for bile duct examination in different parts and different anatomical structures. As long as the choledochoscope can reach the part, the balloon can be used under direct vision to obtain the three axes of X, Y, and Z. oriented image information.

3) The present invention is equipped with an independent liquid inlet branch interface, which is highly maneuverable and conforms to clinical operating habits, without the need for a learning curve.

4) In the present invention, a direction guide wire is provided in front of the OCT probe for guiding the direction under the endoscope, and is made of softer material to prevent damage to the bile duct.

Description of the drawings

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

Figure 2 is an enlarged view of position A in Figure 1 of the present invention;

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

The components in the figure are marked as follows: 1-OCT optical fiber, 11-probe, 2-OCT spring tube, 3-directional guide wire, 4-loading guide wire, 5-support guide wire, 6-coat layer, 61-balloon, 7-OCT rotary coupler interface, 8-liquid inlet branch interface, 81-valve.

Detailed ways

The technical solution of the present invention will be further described below in conjunction with the accompanying drawings. The advantages and features of the present invention will become clearer with the description. However, it should be understood that the embodiments are only exemplary and do not limit the scope of the present invention.

It should be noted that all directional indications (such as up, down, left, right, front, back...) in the embodiments of the present invention are only used to explain the relationship between each component in a specific posture (as shown in the accompanying drawings). The relative positional relationship, movement conditions, etc., if the specific posture changes, the directional indication will also change accordingly.

In the present invention, unless otherwise clearly stated and limited, terms such as "fixed" and "connected" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integrated connection; it can be a mechanical connection. , or it can be an electrical connection; it can be a direct connection, or it can be an indirect connection through an intermediary, it can be an internal connection between two elements or an interaction between two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

Figure 1 shows the overall structure of the present invention, and Figures 2 and 3 show the specific structure of the balloon structure in the present invention. As shown in Figure 1, a biliary OCT balloon catheter is mainly composed of an OCT optical fiber 1 and an OCT spring tube 2 wrapped outside the OCT optical fiber 1. 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 load-bearing guide wire 4, a support guide wire 5, and an OCT rotary coupler interface 7 from the head end to the tail end. The OCT spring tube 2 passes through the OCT rotary coupler interface 7. Connected to an external rotary coupler device, the rotary coupler device drives the OCT spring tube 2 to rotate instead of directly rotating the OCT optical fiber 1.

The direction guide wire 3, the load-bearing guide wire 4, the support guide wire 5, and the OCT rotary coupler interface 7 are integrally formed, and the lumen is filled with lubricating liquid to reduce friction between the OCT spring tube 2 and the inner wall of the rigid guide wire. . The direction guide wire 3 has a smaller diameter and is made of soft elastic material, which is used to guide the direction under the endoscope; the carrying guide wire 4 is made of a rigid transparent material and is used to carry the balloon 61 and the probe 11; the supporting guide wire 3 is made of a soft elastic material. Wire 5 is also made of rigid material and is the main power transfer stabilizer and conveyor.

The outer portions of the load-bearing guide wire 4 and the support guide wire 5 are covered with a coat layer 6. The outer coat layer 6 of the load-bearing guide wire 4 is expanded to form a balloon 61. The expanded shape of the balloon 61 is a regular cylinder.

The coat layer 6 supporting the tail end of the guide wire 5 extends in a direction away from the OCT optical fiber 1 to form an independent liquid inlet branch interface 8 . A valve 81 is connected to the liquid inlet branch interface 8, and the tail end of the liquid inlet branch interface 8 is connected to a syringe to inject expansion liquid into the balloon 61. The refractive index of the lubricating liquid and the expansion liquid are consistent, ensuring the stability and uniformity of the optical signal. .

In this embodiment, the diameter of the balloon 61 is 12 mm and the length is 20 mm. The working distance of the probe 11 is 12mm, the imaging depth is 5mm, the lateral resolution is 10um, and the water medium is optimized. The present invention combines the balloon and OCT technology to have X, Y, and Z-axis inspection capabilities at the same time, reduces the size of the balloon and realizes the integration of the balloon and OCT optical fiber. It overcomes the problems through independent liquid inlet branch interface and other designs. Key issues in the diagnosis of cholangiocarcinoma.

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

S1. Integrate the first end of the OCT optical fiber 1 containing the resin protective coating layer with the 90° side-scanning light probe 11 containing the optical lens and embed it into the OCT spring tube 2;

S2. Embed the OCT optical fiber 1, probe 11 and OCT spring tube 2 into the transparent load-bearing guide wire 4 and support guide wire 5, and infuse the lubricating liquid. After the packaging is completed, they can pass through the commercial choledochoscope with an outer diameter of 5mm. 2.2mm operating channel and/or 1.7mm operating channel of a commercial choledochoscope with an outer diameter of 3mm and/or a 1.2mm operating channel of a commercial choledochoscope with an outer diameter of 2.5mm.

S3. Make the end of the device into an independent liquid inlet branch interface 8 and an OCT rotary coupler interface 7. Install a valve and a syringe on the liquid inlet branch interface 8. The syringe is prefilled with a special expansion liquid, and connect the OCT rotary coupler to the end of the device. The interface 7 is connected to an external rotary coupler device.

The basic principles, main features and advantages of the present invention have been shown and described above. Those skilled in the industry should understand that the present invention is not limited to the above embodiments. The above descriptions of the embodiments and descriptions only illustrate the principles of the present invention. Without departing from the spirit and scope of the present invention, the present invention will also be There are various changes and improvements which fall within the scope of the invention.

Claims (8)

1. An OCT balloon catheter, characterized in that: it contains an OCT optical fiber (1) and an OCT spring tube (2) outside the OCT optical fiber (1), and the outside of the OCT spring tube (2) is covered with a coaxial Guide wire, the guide wire is a direction guide wire (3), a load-bearing guide wire (4), and a support guide wire (5) in order from the head end to the tail end; the load-bearing guide wire (4), the support guide wire (5) ) are covered with a coat layer (6). The coat layer (6) outside the load-bearing guide wire (4) can be expanded to form a balloon (61). The diameter of the balloon (61) is 4- 12mm, with a length of 10-30mm; the tail end of the OCT balloon catheter also includes an OCT rotary coupler interface (7), the direction guide wire (3), the load-bearing guide wire (4), the support guide wire (5), The OCT rotary coupler interface (7) is integrally formed; the first end of the OCT optical fiber (1) is integrally connected with a probe (11); the diameter of the direction guide wire (3) is smaller than the support guide wire (5 ); the tail end of the OCT balloon catheter also includes a liquid inlet branch interface (8); The OCT balloon catheter preparation method includes the following steps: Integrate the first end of the OCT optical fiber (1) containing the resin protective coating layer with the 90° side-scanning light probe (11) containing the optical lens and embed it into the OCT spring tube (2); Then, the OCT optical fiber (1), probe (11) and OCT spring tube (2) are embedded into a transparent carrying guide wire (4) and supporting guide wire (5), and are filled with lubricating liquid and packaged. 2. The OCT balloon catheter according to claim 1, characterized in that: the OCT rotary coupler interface (7) is provided at the outer tail end of the OCT spring tube (2), and the support guide wire (5) The outer coat layer (6) at the tail end extends in a direction away from the OCT optical fiber (1) to form a liquid inlet branch interface (8). 3. The OCT balloon catheter according to claim 2, characterized in that: 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 to a syringe. . 4. The OCT balloon catheter according to claim 2, characterized in that: the direction guide wire (3), the load-bearing guide wire (4), the support guide wire (5), and the OCT rotary coupler interface (7) The lumen is filled with lubricating liquid. 5. The OCT balloon catheter according to claim 2, characterized in that: the OCT spring tube (2) passes through the OCT rotary coupler interface (7) and is connected to a rotary coupler device, and the rotary coupler device The coupler device drives the OCT spring tube (2) to rotate and translate. 6. The OCT balloon catheter according to claim 2, characterized in that the expanded main body shape of the balloon (61) is a regular cylinder. 7. The OCT balloon catheter according to claim 2, characterized in that the direction guide wire (3) is made of soft elastic material. 8. Application of the OCT balloon catheter according to any one of claims 1 to 7 in the preparation of biliary tract diagnostic equipment.