Intravascular ultrasound imaging catheter probe assembly and assembly method thereof

Abstract

This invention discloses an intravascular ultrasound imaging catheter probe assembly, comprising a flexible drive shaft, an ultrasound transducer, a housing, and cables. The bifurcated portions of the positive and negative leads are bonded to the side of the ultrasound transducer near its open end, and the positive and negative leads are respectively attached to the sidewall of the ultrasound transducer and extend until they are respectively connected to two wiring terminals. This invention also provides an assembly method for the intravascular ultrasound imaging catheter probe assembly, used for assembling the aforementioned intravascular ultrasound imaging catheter probe assembly. By adopting the above technical solution, the bonding structure and bonding process between the ultrasound transducer and the cables are optimized, reducing the complexity of the process while improving the yield of the assembly process, and solving the problem of separation of the positive or negative leads from the ultrasound transducer when the ultrasound transducer is installed in the housing.

Description

Technical Field

[0001] The invention relates to an intravascular ultrasonic imaging catheter probe assembly and a manufacturing method thereof, belonging to the technical field of intravascular ultrasonic imaging. Background Art

[0002] Intravascular ultrasound (IVUS) is a new imaging technology. Through the ultrasonic transducer component installed at the tip of the catheter, it can rotate 360° in real time to collect cross-sectional images of the blood vessels, and there is basically no blind spot for observation. Accurately measuring the lumen area, plaque size, and judging the nature of plaques have important application value in the diagnosis and prediction of coronary heart disease, especially in the evaluation of critical lesions. The intravascular ultrasound imaging catheter generally includes an imaging core, an outer tube, and a host adapted for the imaging catheter. Its working principle is to send the catheter to the distal end of the target area through a guidewire, perform a 360° stereoscopic scan of the target area through the rotation and retraction of the imaging core, and transmit the signal to the host through the ultrasonic transducer component to form cross-sectional images at different positions, thereby guiding doctors to diagnose the lesions of this blood vessel.

[0003] The bonding of ultrasonic transducer components and cables is a relatively complex process in the manufacture of intravascular ultrasound imaging catheters, and the yield rate is relatively low. Figure 1 The figure shows the current process and method for bonding the ultrasonic transducer assembly and the cable, wherein the positive and negative electrodes of the cable are connected to the ultrasonic transducer assembly through conductive adhesive. In the assembly process, the cable 112a and the ultrasonic transducer assembly 112 are bonded and then installed in the housing. The ultrasonic transducer assembly 112 includes an ultrasonic transducer and a mounting seat. The positive and negative wires of the cable 112a are forked and respectively connected to the connection parts on both sides of the ultrasonic transducer assembly 112. In this process, the cable 112a and the ultrasonic transducer assembly 112 may be separated, causing damage to the catheter.

[0004] Since the imaging core in the intravascular ultrasound imaging catheter needs to be visible in the blood vessel based on X-rays, the existing technology is to plate the parts of the catheter probe with metal or non-metal coatings such as gold and tungsten with high X-ray absorption rates. The development effect is limited by the thickness of the coating. The thinner the coating thickness, the worse the development effect. The biggest disadvantage of coating is that the coating may fall off during the high-speed rotation of the probe in the outer sheath. After the detached coating enters the blood vessel, it will cause some serious lesions such as thrombosis. Another technology is to weld or bond metal rings such as platinum rings and gold rings with high X-ray absorption rates around the probe. The disadvantage of this technology is that due to the small matching gap between the imaging core and the outer sheath, adding a metal ring to the imaging core may cause the fluid to be blocked or cause the imaging core to rotate unevenly. Secondly, after adding an additional metal ring next to the probe on the core, the length of the probe part will increase, making it difficult for the catheter probe to pass or even damaged in the tortuous lesion environment, and this technology requires welding or bonding the metal ring to the imaging core, and its process is relatively cumbersome. Summary of the invention

[0005] Therefore, an object of the present invention is to provide an intravascular ultrasound imaging catheter probe assembly and an assembly method thereof, which solves the problem of the positive or negative electrode of the cable being separated from the ultrasound transducer assembly when the ultrasound transducer assembly is installed in a housing.

[0006] In order to achieve the above-mentioned purpose, an intravascular ultrasound imaging catheter probe assembly of the present invention comprises a flexible transmission shaft, an ultrasonic transducer assembly, a shell and a cable; the shell is cylindrical, one end of which is an open end, and the other end is provided with a head, the ultrasonic transducer assembly can enter the shell at the open end and be encapsulated in the shell; the side of the ultrasonic transducer assembly provided with an ultrasonic transducer is a working surface, and the side opposite to the working surface is an opposite surface, a first notch portion and a second notch portion are relatively provided on the side wall of the shell, the working surface of the ultrasonic transducer assembly faces the first notch portion, and the opposite surface faces the second notch portion, so that ultrasonic waves can pass through the first notch portion; the cable passes through the flexible transmission shaft and is connected to the ultrasonic transducer assembly, the cable comprises a positive wire and a negative wire, and wiring portions are respectively provided on the working surface and the opposite surface of the ultrasonic transducer assembly, the bifurcation portion of the positive wire and the negative wire is bonded to the side of the ultrasonic transducer assembly close to the open end, and the positive wire and the negative wire are respectively attached to the side wall of the ultrasonic transducer assembly and extend until they are respectively connected to the two wiring portions.

[0007] The positive electrode wire and the negative electrode wire are respectively bonded to the two connection parts by conductive adhesive.

[0008] The shell and / or the sealing head are made of X-ray developing material.

[0009] The X-ray development material includes platinum, tantalum, iridium, gold or tungsten, or an alloy material composed of at least two of platinum, tantalum, iridium, gold and tungsten.

[0010] The flexible transmission shaft is a spring tube.

[0011] The sealing head is a dome sealing head.

[0012] The flexible transmission shaft and the housing, as well as the housing and the head, are bonded or welded to each other and fixed.

[0013] The sealing head is a spherical sealing head, and a receiving groove is arranged at the end of the shell. The spherical sealing head is installed in the receiving groove and can rotate freely, and a part of the spherical sealing head protrudes to the outside of the shell.

[0014] The present invention also provides an assembly method of an intravascular ultrasound imaging catheter probe assembly, which is used to assemble the intravascular ultrasound imaging catheter probe assembly as described above, comprising:

[0015] After the cable passes through the flexible transmission shaft, separate the positive and negative wires of the cable, and then adhere the bifurcated portion of the positive and negative wires to the ultrasonic transducer assembly, insert the ultrasonic transducer assembly into the open end of the housing, and use glue to fix the ultrasonic transducer assembly in the housing;

[0016] The positive wire and the negative wire are respectively attached to the surface of the ultrasonic transducer assembly and extended to the two wiring parts, and the positive wire and the negative wire of the cable are respectively bonded to the two wiring parts of the ultrasonic transducer assembly using conductive glue;

[0017] The flexible transmission shaft is bonded or welded to the shell, and the ultrasonic transducer assembly is encapsulated in the shell by curing glue.

[0018] Cut off the excess parts of the positive and negative leads that extend beyond the connection parts.

[0019] By adopting the above technical solution, the intravascular ultrasound imaging catheter probe assembly and the assembly method thereof of the present invention have the following beneficial effects compared with the prior art:

[0020] 1. The present invention optimizes the bonding structure and bonding process of the ultrasonic transducer assembly and the cable, reduces the complexity of the process and improves the yield of the assembly process, and solves the problem of the positive or negative wire of the cable being separated from the ultrasonic transducer assembly when the ultrasonic transducer assembly is installed in the housing;

[0021] 2. The shell or the head is made of X-ray developing material, which can be developed under X-rays, and the manufacturing process is simple, which solves the problem of the developing coating of the catheter probe falling off under X-rays and the problem of uneven rotation of the imaging core in the prior art;

[0022] 3. By setting the head as a spherical head and installing the spherical head in the receiving groove at the end of the shell, the spherical head can rotate freely, so that the sliding friction between the probe and the inner wall of the casing can be converted into rolling friction. When the core component is bent, the resistance to axial movement in the casing can be reduced, which is conducive to passing through more tortuous lesions. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 The figure is a schematic diagram of a bonding mechanism for connecting an ultrasonic transducer assembly and a cable in the prior art.

[0024] Figure 2 Schematic diagram of the structure of the intravascular ultrasound imaging catheter.

[0025] Figure 3 A schematic diagram of the structure of the kernel components.

[0026] Figure 4 The figure is a schematic diagram of the assembly process of the first embodiment of the intravascular ultrasound imaging catheter probe assembly of the present invention.

[0027] Figure 5 This is a schematic diagram of the second assembly process of the first embodiment of the intravascular ultrasound imaging catheter probe assembly of the present invention.

[0028] Figure 6 FIG3 is a schematic diagram of the assembly process of the first embodiment of the intravascular ultrasound imaging catheter probe assembly of the present invention.

[0029] Figure 7 It is a structural schematic diagram of Embodiment 2 of the intravascular ultrasound imaging catheter probe assembly of the present invention.

[0030] Figure 8 It is a schematic structural diagram of the outer shell and the spherical head in the second embodiment of the intravascular ultrasound imaging catheter probe assembly of the present invention.

[0031] Fig. 9 for Figure 8 AA section view in.

[0032] Fig.10 It is a schematic diagram of the use state of the second embodiment of the intravascular ultrasound imaging catheter probe assembly of the present invention. DETAILED DESCRIPTION

[0033] The present invention is further described in detail below through the accompanying drawings and specific embodiments.

[0034] like Figure 2 , 3As shown, the intravascular ultrasound imaging catheter of the present invention includes a core component 1 and an outer tube component 2. The core component 1 includes a joint component 12 for connecting to the IVUS host and a flexible transmission shaft 111 connected to the joint component 12, a cable 112a is arranged in the flexible transmission shaft 111, and a probe 11 is arranged at the distal end of the flexible transmission shaft 111. The outer tube component 2 includes a sleeve 23, a water injection pipe 21 and a telescopic component 22, the distal end of the sleeve 23 is closed, and the flexible transmission shaft 111 of the core component is inserted into the sleeve 23. The telescopic component 22 can realize the relative movement of the flexible transmission shaft 111 in the sleeve 23 so as to withdraw the probe 11 component; physiological saline can be injected into the sleeve 23 through the water injection pipe 21, and the physiological saline is used as a medium for acoustic coupling to ensure the quality of imaging. The IVUS host drives the flexible transmission shaft 111 to rotate evenly through the joint component 12, and transmits the scanned signal to the IVUS host through the probe 11. After post-processing by the host, a complete intravascular ultrasound image is formed.

[0035] like Figure 4 , 6 As shown, the probe 11 includes an ultrasonic transducer assembly 112, a housing 113, and the cable 112a; the housing 113 is cylindrical, one end of which is open, and the other end is provided with a sealing head, and the ultrasonic transducer assembly 112 can enter the interior of the housing 113 at the open end and be encapsulated in the housing 113. In the first embodiment, the sealing head is a dome sealing head 114, and the flexible transmission shaft 111 is a spring tube.

[0036] The side of the ultrasonic transducer assembly 112 on which the ultrasonic transducer is provided is a working surface 112c, and the side opposite to the working surface 112c is an opposing surface. A first notch portion 113a and a second notch portion 113b are oppositely provided on the side wall of the shell 113. The working surface 112c of the ultrasonic transducer assembly 112 faces the first notch portion 113a, and the opposing surface faces the second notch portion 113b, so that ultrasonic waves can pass through the first notch portion 113a.

[0037] The cable 112a passes through the flexible transmission shaft 111 and is connected to the ultrasonic transducer assembly 112. The cable 112a includes a positive wire 112a1 and a negative wire, and wiring portions are respectively provided on the working surface 112c and the opposite surface of the ultrasonic transducer assembly 112, and the bifurcation portion of the positive wire 112a1 and the negative wire is bonded to one side of the ultrasonic transducer assembly 112 close to the open end, and the positive wire 112a1 and the negative wire are respectively attached to the side wall of the ultrasonic transducer assembly 112 and extend until they are respectively connected to the two wiring portions.

[0038] When assembling, Figure 4As shown, first, after the cable 112a passes through the flexible transmission shaft 111, the positive wire 112a1 and the negative wire 112a2 of the cable 112a are separated, and then the bifurcated portion of the positive wire 112a1 and the negative wire 112a2 are bonded to the ultrasonic transducer assembly 112, and the ultrasonic transducer assembly 112 is inserted into the open end of the housing 113, and the ultrasonic transducer assembly 112 is fixed in the housing 113 using glue. Then, the positive wire 112a1 and the negative wire 112a2 are respectively attached to the surface of the ultrasonic transducer assembly 112 and extended to the two wiring parts, and the positive wire 112a1 and the negative wire 112a2 of the cable 112a are respectively bonded to the two wiring parts of the ultrasonic transducer assembly 112 using conductive glue, the flexible transmission shaft 111 is bonded or welded to the shell 113, the shell 113 is bonded or welded to the dome head 114, and then the ultrasonic transducer assembly 112 is encapsulated in the shell 113 by curing glue, as shown in FIG. Figure 5 Then, the excess parts of the positive lead 112a1 and the negative lead 112a2 extending outside the connection part are cut off, and the assembly is completed, as shown in FIG. Figure 6 shown.

[0039] As a further improvement, the shell 113 or the head is made of an X-ray developing material, and the X-ray developing material includes platinum, tantalum, iridium, gold or tungsten, or an alloy material composed of at least two of platinum, tantalum, iridium, gold and tungsten. The processing technology can be processed by laser cutting the metal tube, omitting the process step of drilling holes at the mating part to ensure the coaxiality of the probe base. The thickness of the metal tube is much greater than the thickness of the developing coating, and the length of the probe part will not be increased.

[0040] In the second embodiment of the present invention, Figure 7-9 As shown, the sealing head is a spherical sealing head 115, and a receiving groove 116 is provided at the end of the shell 113. The spherical sealing head 115 is installed in the receiving groove and can rotate freely, and a part of the spherical sealing head 115 protrudes to the outside of the shell 113. An isolating member 117 is provided between the spherical sealing head 115 and the ultrasonic transducer assembly 112, which is used to isolate the spherical sealing head 115 from the ultrasonic transducer assembly 112. After the curing glue is injected into the shell 113, the isolating member 117 is stably fixed in the shell 113 to ensure the free rotation of the spherical sealing head 115. Fig.10 As shown, the spherical head 115 can rotate freely in the receiving groove 116. When passing through a tortuous blood vessel, after the spherical head 115 touches the inner wall of the sleeve 23 in a bent state, the sliding friction between the probe 11 and the inner wall of the sleeve 23 is converted into rolling friction through free rotation, thereby reducing the resistance to axial movement in the sleeve 23, which is conducive to passing through more tortuous lesions.

[0041] Obviously, the above embodiments are only examples for clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived from them are still within the protection scope of the invention.

Claims

1. An intravascular ultrasound imaging catheter probe assembly, characterized in that: The invention comprises a flexible transmission shaft, an ultrasonic transducer assembly, a shell and a cable; the shell is cylindrical, one end of which is an open end, and the other end is provided with a sealing head, the ultrasonic transducer assembly can enter the shell at the open end and be encapsulated in the shell; the side of the ultrasonic transducer assembly provided with the ultrasonic transducer is a working surface, and the side opposite to the working surface is an opposite surface, a first notch portion and a second notch portion are relatively provided on the side wall of the shell, the working surface of the ultrasonic transducer assembly faces the first notch portion, and the opposite surface faces the second notch portion, so that ultrasonic waves can pass through the first notch portion; the cable passes through the flexible transmission shaft and is connected to the ultrasonic transducer assembly, the cable comprises a positive wire and a negative wire, and wiring portions are respectively provided on the working surface and the opposite surface of the ultrasonic transducer assembly, the bifurcation portion of the positive wire and the negative wire is bonded to the side of the ultrasonic transducer assembly close to the open end, and the positive wire and the negative wire are respectively attached to the side wall of the ultrasonic transducer assembly and extend until they are respectively connected to the two wiring portions.

2. The intravascular ultrasound imaging catheter probe assembly according to claim 1, characterized in that: The positive electrode wire and the negative electrode wire are respectively bonded to the two connection parts by conductive adhesive.

3. The intravascular ultrasound imaging catheter probe assembly according to claim 1, characterized in that: The shell and / or the sealing head are made of X-ray developing material.

4. The intravascular ultrasound imaging catheter probe assembly according to claim 3, characterized in that: The X-ray development material includes platinum, tantalum, iridium, gold or tungsten, or an alloy material composed of at least two of platinum, tantalum, iridium, gold and tungsten.

5. The intravascular ultrasound imaging catheter probe assembly according to claim 1, characterized in that: The flexible transmission shaft is a spring tube.

6. The intravascular ultrasound imaging catheter probe assembly according to any one of claims 1 to 5, characterized in that: The sealing head is a dome sealing head.

7. The intravascular ultrasound imaging catheter probe assembly according to claim 6, characterized in that: The flexible transmission shaft and the housing, as well as the housing and the head, are bonded or welded to each other and fixed.

8. The intravascular ultrasound imaging catheter probe assembly according to any one of claims 1 to 5, characterized in that: The sealing head is a spherical sealing head, and a receiving groove is arranged at the end of the shell. The spherical sealing head is installed in the receiving groove and can rotate freely, and a part of the spherical sealing head protrudes to the outside of the shell.

9. An assembling method of an intravascular ultrasound imaging catheter probe assembly, used for assembling the intravascular ultrasound imaging catheter probe assembly according to any one of claims 1 to 8, characterized in that: include: After the cable passes through the flexible transmission shaft, separate the positive and negative wires of the cable, and then adhere the bifurcated portion of the positive and negative wires to the ultrasonic transducer assembly, insert the ultrasonic transducer assembly into the open end of the housing, and use glue to fix the ultrasonic transducer assembly in the housing; The positive wire and the negative wire are respectively attached to the surface of the ultrasonic transducer assembly and extended to the two wiring parts, and the positive wire and the negative wire of the cable are respectively bonded to the two wiring parts of the ultrasonic transducer assembly using conductive glue; The flexible transmission shaft is bonded or welded to the shell, and the ultrasonic transducer assembly is encapsulated in the shell by curing glue.

10. The method for assembling the intravascular ultrasound imaging catheter probe assembly according to claim 9, characterized in that: After the ultrasonic transducer assembly is encapsulated in the housing by curing the adhesive, the redundant portions of the positive and negative lead wires extending outside the wiring portions are cut off.

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