WO2016145966A1

WO2016145966A1 - Ultrasonic developing catheter

Info

Publication number: WO2016145966A1
Application number: PCT/CN2016/074167
Authority: WO
Inventors: 刘政; 陈重; 朱贤胜; 曾凡兵; 高顺记
Original assignee: 刘政; 陈重; 朱贤胜; 曾凡兵; 高顺记
Priority date: 2015-03-13
Filing date: 2016-02-19
Publication date: 2016-09-22

Abstract

An ultrasonic developing catheter, comprising a hollow tube body (1), wherein the tube body (1) is a medical soft catheter, high-molecular material fiber yarns (5) are arranged in the wall of the tube body (1), and the high-molecular material fiber yarns (5) are mutually crossed and overlapped to form a netted woven mesh layer, so that ultrasonic developing areas of different densities are formed between the tube body (1) and the woven mesh layer. Due to the structure, the catheter is simple in structure, wide in application range, and capable of decreasing the manufacturing cost, improving the ultrasonic developing capacity and facilitating the developing at the tip of the catheter.

Description

Ultrasound developing catheter

Technical field

The present invention relates to medical devices, and more particularly to an ultrasound developing catheter having a simple structure, a wide range of applications, reduced manufacturing costs, improved ultrasonic development capability, and facilitates catheter tip development.

Background technique

Minimally invasive interventional therapy is a new treatment method developed in the medical field in recent decades. Compared with traditional surgery, it has the characteristics of small incision, small trauma, less bleeding, quick recovery and less pain. Drainage catheters and other interventional catheters involved in minimally invasive interventional therapy should be guided by X-ray machine, CT, ultrasound and other electronic equipment. Because the strong ionizing radiation generated by X-ray machine and CT endangers human health, the application is simple and safe. Monitoring and positioning of ultrasound imaging equipment has become the primary consideration for clinicians. However, the existing interventional catheter is mainly made of medical grade plastic, and there is a problem that the ultrasonic development capability is not strong, especially the ultrasound development of the catheter tip is not ideal, which affects the safety and success rate of the ultrasound-guided minimally invasive interventional treatment, and limits the limitation. The method is applied clinically.

Conventional catheters for ultrasonic imaging, such as the utility model disclosed in CN201840755U, are a super-visible drainage catheter, which is a spiral wire inserted in the wall of the catheter tube. This method significantly enhances the reflection and scattering of the catheter wall. The signal, but due to the significant attenuation of the sound beam, forms an acoustic shadow behind it, causing the imaging of the catheter wall to be discontinuous. In addition, the method has the disadvantages of complicated processing process, high cost, bending resistance of the forming conduit but no tensile resistance, and the prior art can not realize the implantation of the wire at the tapered tip of the catheter, which is not conducive to the development of the tip.

The invention discloses an ultrasonic ultrasonic puncture needle of CN101227862B, and an invention patent of CN103623493A, an ultrasonic developing catheter and a molding process, which are roughened on the surface of the needle body or in the inner and outer surfaces of the hose tube, and are provided with a concave hole or Etching to enhance the ultrasonic reflection and scattering signals of the needle or catheter wall, but this method is complicated, and reduces the strength of the catheter wall, increases the resistance of the puncture and extubation, and the rough surface is easy to stick. Attaching substances such as blood clots increases the risk of treatment.

The invention patent puncture needle disclosed in CN101040790B is used for roughening the surface of the inner needle, which avoids the disadvantages of roughening the outer needle body or the wall surface of the catheter tube, but the ultrasonic wave caused by the outer cylinder needle is twice attenuated, partially offset The reflected and scattered signals increased by the roughening of the inner needle surface, so that the quality of the ultrasonic imaging is not substantially improved.

In summary, in the prior art, different catheters or different medical uses are required to produce different catheters. The above-mentioned disclosed technical solutions have problems in that the scope of application is limited, the manufacturing cost is high, the ultrasonic developing capability is low, and The catheter tip has low developing power.

Summary of the invention

SUMMARY OF THE INVENTION An object of the present invention is to provide an ultrasonic developing catheter which is simple in structure, wide in application range, low in manufacturing cost, improved in ultrasonic developing ability, and advantageous in development of a catheter tip.

The technical solution adopted for achieving the above object of the present invention is: an ultrasonic developing catheter comprising a hollow tubular body; wherein: the tubular body is a medical soft conduit, and a polymer material fiber is disposed in a tube wall of the tubular body The filaments of the polymer material and the filaments of the polymer material overlap each other to form a mesh-like woven mesh layer, so that an ultrasonic development zone of different density is formed between the tube body and the woven mesh layer.

Due to the above structure, the catheter of the present invention has a simple structure, a wide application range, a low manufacturing cost, an improved ultrasonic developing capability, and a catheter tip development.

DRAWINGS

The invention may be further illustrated by the non-limiting examples given in the accompanying drawings.

1 is a schematic structural view of a needle cannula (with a metal inner needle) according to an embodiment of the present invention;

2 is a schematic cross-sectional structural view of a pipe body of the present invention;

3 is a schematic perspective view showing the structure of a needleless cannula (guided by a guide wire) according to an embodiment of the present invention;

4 is a schematic cross-sectional structural view of a polymer material fiber filament in the tube body of the present invention;

Figure 5 is a schematic longitudinal sectional view of a polymer material fiber filament in the tube body of the present invention;

Figure 6 is a schematic view showing a photomicrograph of a polymer material fiber filament having microbubbles in a tube;

Figure 7 is a comparison view of ultrasonic imaging of a common plastic catheter (a) in water and a braided catheter (b) of the present invention in a convex probe, abdominal mode;

Figure 8 is a comparison diagram (d) of the measured values of the fundamental wave (c) and the second harmonic signal of the braided catheter and the ordinary plastic catheter of the present invention;

In the figure: 1, the tube body; 2, the catheter joint; 3, the metal needle sheath; 4, the inner needle; 5, the polymer material fiber filament; 6, microbubbles.

detailed description

The present invention will be further described below in conjunction with the accompanying drawings and embodiments:

Referring to Figures 1 to 8, the ultrasonic developing catheter comprises a hollow tube body 1; wherein: the tube body 1 is a medical soft tube, and a polymer material fiber filament 5 is disposed in the tube wall of the tube body 1. The polymer material fiber filaments 5 overlap each other to form a mesh-like woven mesh layer, so that an ultrasonic development zone having a density of different density is formed between the pipe body 1 and the woven mesh layer. In this embodiment, a woven mesh layer composed of a polymer material fiber 5 is implanted in the wall of the soft pipe body 1, so that an ultrasonic reflection and scattering interface is formed in the pipe body 1 made of plastic, which is advantageous. The position of the entire ultrasonic developing catheter and any portion of the ultrasonic developing catheter is determined by medical ultrasound imaging.

In order to further enhance the ultrasonic reflection, backscattering and side scatter signals of the tube wall, in the above embodiment, it is preferred to have microbubbles 6 at the intersections between the polymer material filaments 5.

In order to further enhance the ultrasonic reflection, backscattering and side scatter signals of the tube wall, in the above embodiment, preferably, the microbubbles 6 have a diameter of 0.005 mm to 0.2 mm. In the actual production process, it is achieved by controlling the injection pressure.

In order to ensure that the ultrasonic developing catheter is suitable for different medical catheters during use, in the above embodiment, preferably, the diameter of the polymeric material filament 5 is 0.05 mm to 0.8 mm. The vertical distance between the two polymer material filaments 5 parallel to each other in the polymer material filament 5 is 0.1 mm to 2 mm. The outer diameter of the pipe body 1 is from 0.6 mm to 10 mm, and the outer diameter is the outer diameter of the pipe section on the pipe body 1 near the joint end of the pipe joint. The tube wall thickness of the tube 1 is 0.0762 mm - 2 mm. In particular use, the ultrasonic developing catheter of the present invention can be used as a plurality of medical catheters that require ultrasound image localization and monitoring, such as: external drainage catheter, internal drainage catheter, needle cannula, needleless cannula (internal configurable Guide wire and broken body), balloon push rod and other interventional catheters for ultrasound.

For ease of use, in the above embodiment, preferably, one end of the tubular body 1 has a tapered portion that forms the tip end of the tubular body 1, and the other end of the tubular body 1 is a pipe joint connecting end. The pipe joint connection end of the pipe body 1 is fixed with a pipe joint 2, and a metal needle sheath 3 is set in the pipe joint 2, the metal needle sheath 3 extends into the inner cavity of the pipe body 1; the inner needle 4 is sheathed from the metal needle Insert 3 into the tip of the tube 1 until it is inserted. Of course, according to the actual use needs, the guide wire and other structures can also be used to replace the metal inner needle to achieve the guiding or only the tube body itself is used for guiding.

In order to ensure the use effect of the ultrasonic developing catheter of the present invention, in the above embodiment, preferably, the tube body 1 is made of one or more of silica gel, polyurethane, polyethylene, polyvinyl chloride or other composite materials. to make. The polymer material fiber 5 is made of polyamide, polyethylene or polypropylene.

As a result of the acoustic test, as shown in Fig. 8, after the ultrasonic waves are respectively emitted from the sound source to the braided catheter and the ordinary plastic catheter, the probe type hydrophone is received at various angles ranging from 30 degrees to 180 degrees with the ultrasonic emission direction. The distribution of the fundamental (8c) and second harmonic (8d) signals after the catheter is applied. The red line in the figure shows the braided catheter, and the blue line shows the ordinary plastic catheter. The results show that after the acoustic wave acts on the braided catheter, the fundamental wave and the second harmonic signal received by the hydrophone are evenly distributed after being applied to the ordinary plastic catheter; especially the signal received by the braided catheter is obviously strong in the range of 30 degrees to 90 degrees. In ordinary plastic catheters, the distribution is more uniform, so as shown in Fig. 7b, a substantially continuous and complete ultrasound image of the braided catheter loop can be observed, especially the angle between the incident sound beam and the parallel duct sidewall. No obvious echo loss, clear and complete imaging, which is difficult to achieve in ordinary plastic catheters (Figure 7a). Therefore, the dependence of the ultrasound on the angle during the interventional puncture monitoring or the postoperative observation of the braided catheter is reduced, and it is easier to obtain a clear continuous and complete catheter image, thereby improving the safety and success rate of the puncture.

In addition, in this study, the ultrasonic image 7a (general plastic) is obtained under the same setting parameters of the ultrasonic instrument. The rubber catheter ring) and 7b (woven catheter ring) were observed by two experienced sonographers to compare the ultrasound development. The results showed that the percentage of the circumference of the braided catheter wall was 92.4%, and that of the ordinary plastic catheter was 43.8%. The percentage of the echo of the braided catheter wall was 4.5% of the circumference and 15.6% of the ordinary plastic catheter. The wall of the catheter tube is incomplete and discontinuous due to multiple reflection artifacts. The "equal-like" weak echo range is 3.1% of the circumference, and the ordinary plastic catheter is 40.6%. In addition, the echo strength of the braided catheter is stronger than that of the ordinary plastic catheter. .

Because the above two experimental conditions and equipment are completely consistent, the inner diameter of the two conduits, the thickness of the pipe wall and the main plastic material of the pipe wall used are the same. The only difference in the experiment is that the polymer material fiber 5 is disposed in the wall of the braided conduit and the fiber is crossed. The microbubbles 6 existing around the point, so the experiment can obtain the following conclusion: the polymer material fiber 5 disposed in the wall of the braided catheter tube and the microbubbles 6 present around the intersection of the fiber filaments are the imaging quality of the braided catheter compared with the ordinary plastic catheter. The root cause of the apparent improvement is also the core of the present invention. The polymeric material filaments 5 disposed in the wall of the braided catheter tube and the microbubbles 6 present around the intersection of the filaments increase the density of the ultrasound developing zone within the wall of the catheter, thereby enabling greater backscattering and lateral orientation. The scatter signal makes it possible to display the braided catheter ultrasound image more clearly and continuously on the ultrasound instrument, which is significantly better than the ordinary plastic catheter imaging quality.

It is apparent that all of the embodiments described above are part of the embodiments of the invention, and not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative efforts are within the scope of the present invention.

In summary, the present invention has a simple structure, a wide application range, reduced manufacturing cost, improved ultrasonic developing capability, and facilitates catheter tip development.

Claims

An ultrasonic developing catheter comprises a hollow tube body (1); characterized in that: the tube body (1) is a medical soft tube, and a polymer material fiber filament is arranged in the tube wall of the tube body (1) ( 5) The polymer material fiber filaments (5) overlap each other to form a mesh-like woven mesh layer, so that an ultrasonic development zone of different density is formed between the pipe body (1) and the woven mesh layer.
The ultrasonic developing catheter according to claim 1, characterized in that the microbubbles (6) are present at the intersection between the polymer material fibers (5).
The ultrasonic developing catheter according to claim 2, characterized in that the microbubbles (6) have a diameter of 0.005 mm to 0.2 mm.
The ultrasonic developing catheter according to claim 1 or 2, wherein the fibrous material fiber (5) has a diameter of 0.05 mm to 0.8 mm.
The ultrasonic developing catheter according to claim 1 or 2, characterized in that the vertical distance between the two polymer material filaments (5) parallel to each other in the polymer material fiber filament (5) is 0.1 mm - 2mm.
The ultrasonic developing catheter according to claim 1, characterized in that the outer diameter of the tubular body (1) is from 0.6 mm to 10 mm, and the outer diameter is the outer diameter of the tubular portion of the tubular body (1) adjacent to the joint end of the pipe joint.
The ultrasonic developing catheter according to claim 1 or 6, wherein the tube body (1) has a tube wall thickness of 0.0762 mm to 2 mm.
The ultrasonic developing catheter according to claim 1, characterized in that one end of the tubular body (1) has a tapered portion which forms the tip end of the tubular body (1) and the other end of the tubular body (1) It is the pipe joint connection end.
The ultrasonic developing catheter according to claim 8, characterized in that the pipe joint connection end of the pipe body (1) is fixed with a pipe joint (2), and a metal needle sheath (3) is set in the pipe joint (2). The metal needle sheath (3) projects into the lumen of the tubular body (1); the inner needle (4) is inserted from the metal needle sheath (3) until it exits the tip end of the tubular body (1).
The ultrasonic developing catheter according to claim 1, wherein said tube body (1) is made of one or a mixture of silica gel, polyurethane, polyethylene, polyvinyl chloride or other composite material; The polymer material fiber yarn (5) is made of polyamide, polyethylene or polypropylene.