Disclosure of Invention
The embodiment of the application provides an intravascular ultrasound imaging catheter and a system with forward-looking capability, which solve the problems that a large subintimal hematoma or interlayer is possibly caused when a guide wire is guided to penetrate through a traditional intravascular ultrasound imaging catheter, the guiding effect is influenced by serious calcification lesion, and the operation of guiding the guide wire to penetrate is complicated and time-consuming.
In a first aspect, there is provided an intravascular ultrasound imaging catheter with forward-looking capabilities, comprising: a sheath having a proximal portion and a distal portion;
a guidewire lumen disposed on an outer side of the distal portion;
a flexible drive shaft disposed within the sheath, the flexible drive shaft having a first end for electrically connecting to a drive device configured to drive the flexible drive shaft to rotate within the sheath;
a transducer module disposed at a second end of the flexible drive shaft, the transducer module including a lateral ultrasonic device and a forward ultrasonic device;
the lateral ultrasonic device and the forward ultrasonic device are both used for being electrically connected with an ultrasonic host so as to transmit the obtained imaging electric signal to the ultrasonic host or receive an excitation electric signal transmitted by the ultrasonic host.
According to the intravascular ultrasonic imaging catheter with the forward-looking capability, the lateral ultrasonic device and the forward ultrasonic device are arranged, so that the catheter can scan and image the lateral blood vessel of the catheter and the forward blood vessel of the catheter at the same time, a true cavity can be found and confirmed better, the quality of an image can be improved by multi-directional scanning imaging, and the guide wire can be guided to penetrate better by the guide wire; the guide wire cavity is arranged on the outer side of the distal end part of the sheath tube, so that the guide wire cavity and the catheter of the application are integrated into a whole body, the catheter of the application can enter an occluded blood vessel at the same time, and the guide wire penetrating operation is simple and quick.
In one possible design, the transducer module further includes:
a fixed member connected to a second end of the flexible drive shaft; the lateral ultrasonic device and the forward ultrasonic device are fixed on the fixing piece;
and the back lining is respectively fixed on the bottom surfaces of the side ultrasonic device and the front ultrasonic device and is used for eliminating ultrasonic interference signals transmitted from the bottom surfaces of the side ultrasonic device and the front ultrasonic device.
In one possible design, the surface of the backing has a saw-tooth like structure.
In one possible design, the fixing member is provided with an opening, and the opening is respectively opposite to the ultrasonic signal transmitting and receiving surfaces of the lateral ultrasonic device and the forward ultrasonic device.
In one possible design, the guidewire lumen includes a proximal section and a distal section;
an imaging window is arranged between the proximal section and the distal section and is used for reducing intravascular ultrasonic imaging artifacts;
the distal section is provided with a developing mark.
In one possible design, the lateral ultrasonic device and the forward ultrasonic device are both single-chip ultrasonic transducer array chips;
one end of the fixing piece, which is far away from the flexible driving shaft, is an inclined plane, and the inclined plane and the axial direction of the flexible driving shaft form an angle of 45 degrees;
the forward ultrasonic device is mounted on the inclined surface of the mount.
In one possible design, the transducer module further includes:
and the analog front-end receiving and sending chip is packaged into a whole with the lateral ultrasonic device and the forward ultrasonic device respectively through three-dimensional integration or a wafer-level fan-out packaging process.
In one possible design, the intravascular ultrasound imaging catheter with forward-looking capability further comprises:
a lead for electrically connecting the lateral ultrasonic device and the ultrasonic host, and for electrically connecting the forward ultrasonic device and the ultrasonic host;
the flexible drive shaft has an internal cavity along which the lead is disposed.
In a second aspect, there is provided an intravascular ultrasound imaging catheter system with forward-looking capability, comprising:
the intravascular ultrasound imaging catheter with forward viewing capability described above;
a drive device connected to the intravascular ultrasound imaging catheter with forward-looking capability for driving the flexible drive shaft to rotate within the sheath in a linear direction perpendicular to the flexible drive shaft;
the ultrasonic host is electrically connected with the driving device and used for transmitting excitation electric signals to the lateral ultrasonic device and the forward ultrasonic device through the driving device so as to drive the lateral ultrasonic device to emit ultrasonic signals in a linear direction perpendicular to the flexible driving shaft and drive the forward ultrasonic device to emit ultrasonic signals in a direction with an axial included angle of 45 degrees with the flexible driving shaft; or for receiving the imaging electrical signals it obtains sent by the lateral ultrasound device and the forward ultrasound device.
The invention has the following beneficial effects: the lateral ultrasonic device and the forward ultrasonic device are arranged to respectively transmit ultrasonic waves to the lateral direction and the forward direction of the catheter, so that the lateral direction and the forward direction of the catheter can be conveniently scanned and imaged, a real cavity can be conveniently and well searched and confirmed, the guide wire can be guided to penetrate, the imaging range of an image can be wider by scanning and imaging the lateral direction and the forward direction of the blood vessel, the catheter can better pass through a lesion of the blood vessel under correct guidance, and the guide wire penetrating capacity is improved; in addition, the guide wire cavity is arranged on the outer side surface of the distal end part of the sheath tube, so that the guide wire cavity and the catheter of the application form a whole body, the guide wire cavity and the catheter of the application can enter an occluded blood vessel at the same time, and the guide wire penetrating operation is simple and quick; in addition, the back lining with the sawtooth-shaped surface can eliminate ultrasonic interference signals transmitted from the bottom surfaces of the lateral ultrasonic device and the forward ultrasonic device; because the lateral ultrasonic device and the forward ultrasonic device are single-chip ultrasonic transducer array chips, the lateral ultrasonic device and the forward ultrasonic device are respectively integrated with the analog front end receiving and transmitting chip, so that the receiving and transmitting control of a plurality of transduction array elements contained in the lateral ultrasonic device and the forward ultrasonic device is facilitated, the signal-to-noise ratio of intravascular ultrasonic imaging electric signals obtained by the lateral ultrasonic device and the forward ultrasonic device is improved, the instantaneity and the resolution ratio of the intravascular ultrasonic imaging electric signals are improved, and the better guide wire penetration is facilitated.
Detailed Description
Reference will now be made in detail to embodiments of the present application, examples of which are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to the same or similar elements or elements having the same or similar function throughout. The embodiments described below with reference to the accompanying drawings are illustrative and are only for the purpose of explaining the present application and are not to be construed as limiting the present application.
In the description of the present application, it is to be understood that the terms "first", "second" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implying any number of technical features indicated. Thus, features defined as "first", "second", may explicitly or implicitly include one or more of the described features. In the description of the present application, "a plurality" means two or more unless specifically limited otherwise.
In the description of the present application, it is to be noted that, unless otherwise explicitly specified or limited, the terms "mounted" and "connected" are to be interpreted broadly, e.g., as being either fixedly connected, detachably connected, or integrally connected; may be mechanically connected, may be electrically connected or may be in communication with each other; either directly or indirectly through intervening media, either internally or in any other relationship. The specific meaning of the above terms in the present application can be understood by those of ordinary skill in the art as appropriate.
In the description of the present application, it is to be understood that the terms "upper", "lower", "side", "front", "rear", and the like indicate orientations or positional relationships based on installation, and are only for convenience in describing the present application and simplifying the description, but do not indicate or imply that the device or element referred to must have a particular orientation, be constructed in a particular orientation, and be operated, and thus should not be construed as limiting the present application.
It should be noted that the same reference numerals are used to denote the same components or parts in the embodiments of the present application, and for the same parts in the embodiments of the present application, only one of the parts or parts may be given the reference numeral, and it should be understood that the reference numerals are also applicable to the other same parts or parts.
The embodiment of the application provides an intravascular ultrasound imaging catheter with forward-looking capability, and solves the problems that a large subintimal hematoma or interlayer is possibly caused when a guide wire is guided to penetrate through a traditional intravascular ultrasound imaging catheter, the guiding effect is influenced by serious calcification lesion, and the operation of guiding the guide wire to penetrate is complex and time-consuming.
Fig. 1 is a schematic structural diagram of an intravascular ultrasound imaging catheter with forward-looking capability provided by an embodiment of the present application.
As shown in fig. 1, the intravascular ultrasound imaging catheter with forward-looking capability provided by the embodiments of the present application includes a sheath 10, a guidewire lumen 20, a flexible drive shaft 30, and a transducer module;
the sheath 10 has a proximal portion and a distal portion; the guidewire lumen 20 is disposed on the outer side of the distal portion; the flexible driving shaft 30 is arranged in the sheath 10, and the first end is used for being electrically connected with the driving device 100, and the driving device 100 is configured to drive the flexible driving shaft 30 to rotate in the sheath 10; a transducer module is provided at the second end of the flexible drive shaft 30, the transducer module comprising a lateral ultrasonic device 41 and a forward ultrasonic device 42; the lateral ultrasonic device 41 and the forward ultrasonic device 42 are both used for electrically connecting the ultrasonic mainframe 200 to transmit the obtained imaging electrical signal to the ultrasonic mainframe 200 or receive the excitation electrical signal transmitted by the ultrasonic mainframe 200.
According to the intravascular ultrasonic imaging catheter with the forward-looking capability provided by the embodiment of the application, the lateral ultrasonic device 41 and the forward ultrasonic device 42 are arranged, so that the catheter can scan and image the lateral blood vessel of the catheter and the forward blood vessel of the catheter at the same time, a real cavity can be found and confirmed better, the quality of an image can be improved by multi-directional scanning imaging, and the catheter can guide the guide wire penetration better; positioning the guidewire lumen 20 outside the distal portion of the sheath 10 allows the guidewire lumen 20 to be integrated with the catheter of the present application for simultaneous entry into the occluded vessel, allowing for simple and rapid guidewire penetration.
Optionally, the sheath 10 is used to establish a vessel access passageway while protecting the flexible drive shaft 30 from high speed rotation within the vessel. The inner wall of the sheath 10 is provided with a lubricating layer, which can reduce the friction between the flexible driving shaft 30 and the inner wall of the sheath 10 during rotation, and is beneficial to the uniform rotation of the flexible driving shaft 30 and further the uniform rotation of the transducer module arranged at the second end of the flexible driving shaft 30, wherein the lubricating layer can be one or more of polytetrafluoroethylene, high-density polyethylene, ultra-high molecular weight polyethylene and molybdenum disulfide. The sheath 10 may have a multi-layer structure, wherein the inner layer is made of PTFE (polytetrafluoroethylene), UHMWPE (ultra high molecular weight polyethylene), or the like.
Fig. 2 is a schematic structural diagram of a sheath according to an embodiment of the present application.
As shown in fig. 2, in the present application, the proximal end portion of the sheath tube 10 is provided with a proximal port 11, and the distal end portion is a tube body 13; the proximal interface 11 is connected with the driving device 100, and the conductive signals of the flexible driving shaft 30, the lateral ultrasonic device 41 and the forward ultrasonic device 42 are all input from the proximal interface; the flexible drive shaft 30 is disposed within the tube body 13 such that the tube body 13 protects the flexible drive shaft 30.
Further, since the presence of air may affect the imaging effect of the intravascular ultrasound imaging catheter and the safety of the patient, the flushing port 101 is provided on the proximal port 11 of the sheath 10, and the flushing port 101 is provided with a luer connector for flushing and exhausting the intravascular ultrasound imaging catheter before the operation.
It should be noted that the tube body 13 includes a proximal tube 131 and a distal tube 132, wherein the proximal tube 131 is connected to the proximal port 11, the diameter of the proximal tube 131 is larger than that of the distal tube 132, and the hardness of the proximal tube 131 is also larger than that of the distal tube 132, so as to achieve better pushing capability. The guidewire lumen 20 is provided on the outside surface of the distal tube 132.
In a preferred embodiment, the proximal tube 131 may have different diameters at different locations, with the larger diameter near the proximal hub 11 end and the smaller diameter near the distal tube 132 end; or the diameter decreases from the end near the proximal port 11 to the end near the distal tube 132, and the entire proximal tube 131 is tapered; or a partial region of the proximal tube 131 is a straight tube and a partial region is a conical tube. The distal tube 132 may have different diameters at different locations, with the end closer to the proximal tube 131 having a larger diameter and the end farther from the proximal tube 131 having a smaller diameter; or the diameter decreases from the end near the proximal tube 131 to the end far from the proximal tube 131, and the entire distal tube 132 is tapered; or a straight section of the distal tube 132 and a tapered section.
In a preferred embodiment, the proximal tube 131 may have different durometers at different locations, with the end near the proximal hub 11 having a greater durometer and the end near the distal tube 132 having a lesser durometer, or the durometer may decrease from the end near the proximal hub 11 to the end near the distal tube 132. The distal tube 132 may have different durometers at different locations, with the end proximal to the proximal tube 131 being stiffer and the end distal to the proximal tube 131 being stiffer, or the durometers decreasing from the end proximal to the proximal tube 131 to the end distal to the proximal tube 131.
The material of the proximal tube 131 may be nylon 12, nylon 11, Pebax (block polyether amide resin), or the like. The tubing properties of the distal tube 132 may allow for minimal energy attenuation, reflection, or refraction when the ultrasound is conducted between the lateral ultrasound device 41 and the vascular tissue and between the forward ultrasound device 42 and the vascular tissue, respectively, through the imaging window of the sheath 10, e.g., the tubing of the distal tube 132 may be PE (polyethylene), Pebax (block polyether amide resin), TPU (thermoplastic polyurethane), etc.
Since the guidewire lumen 20 is disposed on the outer side of the distal tube 132, the guidewire can extend from the guidewire port of the guidewire lumen 20 during operation of the guidewire lumen 20 of the present application, so that the distal tube 132 can drive the proximal tube 131 along the guidewire into the body. The guide wire is a medical guide wire, when the intravascular ultrasonic imaging catheter is used for entering a blood vessel, a puncture needle or other puncture devices can be used for puncturing the blood vessel, and then the guide wire is pushed into the blood vessel along the punctured position to reach a diseased blood vessel area. Because the guidewire lumen 20 is threaded over the guidewire, the catheter of the present invention can be smoothly advanced over the guide guidewire into the blood vessel.
The distal tube 132 and the exterior of the guidewire lumen 20 have a lubricious coating, such as PVP (polyvinylpyrrolidone), which reduces friction between the catheter of the present invention and the vessel and also facilitates better passage of the catheter of the present invention through tortuous lesions.
The flexible drive shaft 30 of the present application has a double-layer or multi-layer reverse spiral structure, has sufficient flexibility while maintaining the rigidity required for rotation, and can maintain the tightness of the flexible drive shaft 30 during high-speed rotation.
As shown in fig. 1, the transducer module further includes: a mount 43 and a backing 44, the mount 43 being attached to the second end of the flexible drive shaft 30; the side ultrasonic device 41 and the front ultrasonic device 42 are fixed to the mount 43; the backing 44 is fixed on the bottom surfaces of the lateral ultrasonic device 41 and the forward ultrasonic device 42, respectively, for eliminating the ultrasonic interference signals transmitted from the bottom surfaces of the lateral ultrasonic device 41 and the forward ultrasonic device 42.
In the above arrangement, the fixing member 43 may be a fixing shell, and in a preferred implementation, the fixing shell is cylindrical, and the wall thickness of the fixing shell is ultra-thin, and the outer diameter thereof is slightly larger than the diameter of the flexible driving shaft 30, so as to fit the sheath 10 more closely, thereby reducing the condition of uneven rotation; the fixing shell is provided with a mounting groove which is matched with the lateral ultrasonic device 41 and the forward ultrasonic device 42, and the lateral ultrasonic device 41 and the forward ultrasonic device 42 are mounted in the mounting groove so that the lateral ultrasonic device 41 and the forward ultrasonic device 42 are fixed in the fixing shell, so that when the flexible driving shaft 30 rotates at a high speed to drive the fixing shell to rotate, the lateral ultrasonic device 41 and the forward ultrasonic device 42 cannot be separated from the fixing shell, and the stability of the working performance of the fixing shell is ensured.
As shown in fig. 1, the surface of the backing 44 has a saw-toothed structure.
With the above arrangement, the saw-toothed structure on the surface of the backing 44 can eliminate the ultrasonic interference signals conducted from the bottom surfaces of the lateral ultrasonic device 41 and the forward ultrasonic device 42, and the saw-toothed structure on the surface of the backing 44 can be symmetrical or asymmetrical. The backing 44 is adhesively secured between the bottom surface of the lateral ultrasonic device 41 and the inner surface of the stationary case and between the bottom surface of the forward ultrasonic device 42 and the inner surface of the stationary case.
As shown in fig. 1, the fixing member 43 is provided with openings 430, and the openings 430 are opposed to the ultrasonic signal transmitting and receiving faces of the side ultrasonic device 41 and the front ultrasonic device 42, respectively.
In the above arrangement, the opening 430 of the stationary shell is slightly smaller than the cross-sectional diameter of the stationary shell, and an ultrasonic signal is emitted from the opening 430 of the stationary shell and an ultrasonic echo signal is received from the opening 430.
As shown in FIG. 3, the guidewire lumen 20 includes a proximal section 21 and a distal section 22; an imaging window 23 is arranged between the proximal end section 21 and the distal end section 22, and the imaging window 23 is used for reducing intravascular ultrasonic imaging artifacts; the distal segment 22 is provided with visualization indicia 24.
In the above arrangement, the development mark 24 provided on the distal end portion 22 of the guidewire cavity 20 is used for performing development positioning on the guidewire, specifically, the development mark 24 may be a positioning ring such as a platinum ring, a tantalum ring, or the like embedded in the tube wall of the guidewire cavity 20, or may be a development material doped in the tube material of the guidewire cavity 20, such as doped bismuth trioxide, tungsten, or the like, with a doping amount of 30 to 80%.
Optionally, the distal segment 22 of the guidewire lumen 20 has a length of 5-20 millimeters and the imaging window 23 has a length of 1-10 centimeters.
As shown in fig. 1, the lateral ultrasonic device 41 and the forward ultrasonic device 42 are both single-chip ultrasonic transducer array chips; the end of the fixing member 43 away from the flexible driving shaft 30 is an inclined surface, and the inclined surface forms an angle of 45 degrees with the axial direction of the flexible driving shaft 30; the forward ultrasonic device 42 is mounted on the inclined surface of the mount 43.
The lateral ultrasonic device 41 and the forward ultrasonic device 42 of the present application are single-chip ultrasonic transducer array chips, rectangular or circular, and can be directly coupled with liquid and prepared on a silicon substrate by a micro-electromechanical ultrasonic transducer PMUT manufacturing process. The ultrasonic frequency of the forward ultrasonic device 42 is lower than that of the lateral ultrasonic device 41, the ultrasonic frequency of the forward ultrasonic device 42 is 10-30MHz, the ultrasonic frequency of the lateral ultrasonic device 41 is 30-70MHz, the single-chip ultrasonic transducer array chip comprises a plurality of linear or annular transducer array elements, but all the transducer array elements share one control port, the control port is electrically connected with the ultrasonic host 200 through a metal wire, and the transducer array elements comprise a plurality of transducer units which are sequentially connected in parallel.
As shown in fig. 5-6, the transducer module further comprises: the analog front end receiving and sending chip 45 is packaged into a whole with the lateral ultrasonic device 41 and the forward ultrasonic device 42 respectively through three-dimensional integration or a wafer level fan-out packaging process.
In the above arrangement, the analog front end transceiver chip 45 includes a power management circuit module, a clock circuit module, a transmitting circuit module, a receiving circuit module, an analog-to-digital conversion circuit module, a BGR circuit module, and a Buffer circuit module; the simulation front end transceiver chip 45 is in the same place with side direction ultrasonic device 41 and preceding ultrasonic device 42 integration respectively, be favorable to adopting ultrasonic synthetic aperture control algorithm to carry out transceiver control respectively to a plurality of transduction array elements that side direction ultrasonic device 41 includes, and be favorable to adopting ultrasonic synthetic aperture control algorithm to carry out transceiver control respectively to a plurality of transduction array elements that preceding ultrasonic device 42 includes, receiving circuit module and transduction array element direct integration will make the ultrasonic imaging signal of telecommunication obtain higher SNR simultaneously, and then real-time and the resolution ratio of ultrasonic image have been promoted.
As shown in fig. 1, the intravascular ultrasound imaging catheter with forward-looking capability further comprises: a lead 50, the lead 50 is used for electrically connecting the lateral ultrasonic device 41 and the ultrasonic main machine 200, and is used for electrically connecting the forward ultrasonic device 42 and the ultrasonic main machine 200; the flexible drive shaft 30 has an internal cavity 31 with a lead 50 disposed along the internal cavity 31.
In the above arrangement, the conductor 50 is a metal conductor, and in order to reduce signal interference, the conductor 50 is a coaxial line with a shielding layer.
Fig. 4 is a schematic structural diagram of an intravascular ultrasound imaging catheter system with forward-looking capability provided by an embodiment of the present application.
As shown in fig. 4, the present application provides an intravascular ultrasound imaging catheter system with forward-looking capability, including the intravascular ultrasound imaging catheter 300 with forward-looking capability described above; a driving device 100, the driving device 100 being connected to the intravascular ultrasound imaging catheter 300 with forward looking capability for driving the flexible driving shaft 30 to rotate in a linear direction perpendicular to the flexible driving shaft 30 within the sheath 10; the ultrasonic main machine 200 is electrically connected with the driving device 100, and is used for transmitting excitation electric signals to the lateral ultrasonic device 41 and the forward ultrasonic device 42 through the driving device 100 so as to drive the lateral ultrasonic device 41 to emit ultrasonic signals in a linear direction perpendicular to the flexible driving shaft 30 and drive the forward ultrasonic device 42 to emit ultrasonic signals in a direction with an axial included angle of 45 degrees with the flexible driving shaft 30; or for receiving their acquired imaging electrical signals sent by the lateral ultrasonic device 41 and the forward ultrasonic device 42.
When the intravascular ultrasonic imaging catheter system with forward-looking capability provided by the embodiment of the application is used, firstly, the guide wire enters a vascular target area such as a lesion area through a vascular puncture position, and then the intravascular ultrasonic imaging catheter 300 with forward-looking capability is pushed to the vascular target area under the driving of the guide wire, and meanwhile, the lateral ultrasonic device 41 and the forward ultrasonic device 42 of the intravascular ultrasonic imaging catheter 300 with forward-looking capability are ensured to be at the far end of the vascular target area. In this way, a complete detection of the target region of the blood vessel can be ensured. The images of the vessel target region are then collated on the ultrasound mainframe 200.
The above description is only for the specific embodiments of the present application, but the scope of the present application is not limited thereto, and any person skilled in the art can easily conceive of the changes or substitutions within the technical scope of the present application, and shall be covered by the scope of the present application. Therefore, the protection scope of the present application shall be subject to the protection scope of the claims.