CN118680638B - Intravascular ultrasonic vibration auxiliary rotary grinding device - Google Patents
Intravascular ultrasonic vibration auxiliary rotary grinding device Download PDFInfo
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- CN118680638B CN118680638B CN202410786946.9A CN202410786946A CN118680638B CN 118680638 B CN118680638 B CN 118680638B CN 202410786946 A CN202410786946 A CN 202410786946A CN 118680638 B CN118680638 B CN 118680638B
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- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
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- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B17/22004—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
- A61B17/22012—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B17/22004—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
- A61B17/22012—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
- A61B17/2202—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being inside patient's body at the distal end of the catheter
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/08—Accessories or related features not otherwise provided for
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22001—Angioplasty, e.g. PCTA
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22038—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with a guide wire
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22079—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with suction of debris
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22082—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance
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Abstract
本发明提供一种血管内超声振动辅助旋磨装置，涉及医用磨削设备领域，针对目前钙化组织旋磨过程中振动作用和磨削作用结合效果差的问题，将超声换能器嵌入磨头内部，超声换能器产生的振动能够直接驱动磨头振动，省去了通过传动轴将远端振动源传递至磨头的过程，利用旋磨和超声振动有效合理结合后的双重作用对钙化组织进行磨削，提高了振动磨削操作过程中的可控性，从而提高振动磨削的精度。
The present invention provides an intravascular ultrasonic vibration-assisted atherectomy device, which relates to the field of medical grinding equipment. Aiming at the problem that the combination of vibration and grinding in the current calcified tissue atherectomy process is poor, an ultrasonic transducer is embedded in a grinding head, and the vibration generated by the ultrasonic transducer can directly drive the grinding head to vibrate, thereby eliminating the process of transmitting a remote vibration source to the grinding head through a transmission shaft. The calcified tissue is ground by utilizing the dual effects of atherectomy and ultrasonic vibration after an effective and reasonable combination, thereby improving the controllability of the vibration grinding operation process, thereby improving the accuracy of vibration grinding.
Description
Technical Field
The invention relates to the field of medical grinding equipment, in particular to an intravascular ultrasonic vibration auxiliary rotary grinding device.
Background
Calcified tissue is a substance harmful to human body due to the deposition of fat, thrombus, connective tissue and calcium carbonate on the inner wall of arterial blood vessel, and is usually treated by Percutaneous Coronary Intervention (PCI) during treatment. Percutaneous coronary intervention refers to a minimally invasive intervention treatment means for dredging the lumen of a blood vessel by using a percutaneous catheter technology, and an expansion saccule or a rotational grinding instrument is sent into the blood vessel of the artery by using a percutaneous puncture technology, so that the purpose of expanding the effective vascular flow lumen or modifying part of calcified tissues is achieved, and further the blood flow supply of cardiac muscle is improved. The PCI treatment means mainly comprise Percutaneous Transluminal Angioplasty (PTA), rotational Atherectomy (RA) and stent implantation, wherein rotational atherectomy is a typical processing technology for removing materials by internal grinding, and the principle is that a micro cutter with rough surface (which is olive-shaped and has tiny diamond particles attached to the surface) is used, and the main clinical access mode is femoral artery or radial artery nitro. The guide wire is used as a guiding instrument in the operation of gyratory grinding, firstly, the guide wire is required to move to the far end through calcified tissues so as to more accurately position the lesion, then, a gyratory knife tool is delivered to the near end of the calcified tissues along the guide wire, and a flexible transmission shaft drives the knife tool to rotate at a high speed and simultaneously to reciprocate in a pecking shape to advance until the knife tool passes through the lesion.
Chinese patent application (publication No. CN 116807568A) discloses a multifunctional compound operation device suitable for removing cardiovascular calcified tissues and application, and combines a rotary grinding and ultrasonic vibration technology to realize the control of the small-range high-frequency reciprocating motion of a rotary grinding tool in the rotary grinding process so as to achieve the purposes of reducing the interaction degree of the tool and the calcified tissues and reducing the incarceration probability of the rotary grinding tool. Although the ultrasonic element is arranged at the position of the rotary grinding tool, in order to realize ultrasonic imaging, the adopted ultrasonic vibration module is positioned inside the external operation handle, only axial reciprocating vibration motion can be transmitted through the flexible transmission shaft, and auxiliary vibration in other directions cannot be formed, so that the problem that the vibration effect is difficult to be effectively applied to the position of calcified tissues exists, the single vibration direction affects the rotary grinding effect on the calcified tissues, meanwhile, the vibration source is far away from the rotary grinding tool, the vibration loss is large in the transmission process, and the control difficulty of the working position of the tail end rotary grinding tool can be increased by increasing the related parameters of the vibration source, so that the operation accuracy of the rotary grinding process is affected.
Disclosure of Invention
Aiming at the defects of the prior art, the invention provides an intravascular ultrasonic vibration auxiliary rotary grinding device, an ultrasonic transducer is embedded into a grinding head, vibration generated by the ultrasonic transducer can directly drive the grinding head to vibrate, the process of transmitting a remote vibration source to the grinding head through a transmission shaft is omitted, calcified tissues are ground by utilizing the dual functions of rotary grinding and ultrasonic vibration, and the controllability in the vibration grinding operation process is improved, so that the vibration grinding precision is improved.
In order to solve the problems, the invention adopts the following scheme:
an intravascular ultrasound vibration assisted rotational atherectomy device comprising:
One end of the grinding head is connected with a rotary flexible driving shaft, the other end of the grinding head is used as a rotary grinding part, an ultrasonic transducer is embedded and fixed in the side wall between the two ends of the grinding head, and a wire of the ultrasonic transducer is connected with an ultrasonic generator along the flexible driving shaft;
The guide pipe is sleeved outside the flexible driving shaft and forms a running fit with the flexible driving shaft;
The guide wire sequentially penetrates through the flexible driving shaft and the grinding head along the axial direction, the guide wire is in rotary and sliding connection with the flexible driving shaft, and the guide wire is in rotary and sliding connection with the grinding head.
Further, the ultrasonic transducer is two fan-shaped piezoelectric ceramic plates which are symmetrically distributed relative to the axis of the grinding head, and the piezoelectric ceramic plates are bent to form conical surfaces.
Further, two symmetrical and spaced-apart mounting grooves are formed in the side wall between the two ends of the grinding head, and the piezoelectric ceramic plates are embedded and fixed in the mounting grooves and plug the openings of the mounting grooves through fillers.
Further, the grinding head and the flexible driving shaft are internally provided with continuously distributed wire channels, and wires are led out of the flexible driving shaft after passing through the wire channels.
Further, the lead is connected to the ultrasonic generator through the conductive sliding ring, and the lead channel is separated from the distribution position of the lead.
Further, guide wire channels which are distributed along the axial direction are arranged in the grinding head and the driving shaft, guide wires penetrate through the guide wire channels, and one end of each guide wire can be led out of the guide wire channels or retracted into the guide wire channels.
Further, a slag discharging channel is arranged in the pipe wall of the guide pipe, an inlet of the slag discharging channel is arranged on the outer side wall of the guide pipe, and an outlet of the slag discharging channel is open.
Further, the guide pipe is sleeved with a check ring, the check ring is positioned between the inlet and the outlet of the slag discharge channel, the check ring is conical, and the outer ring of the check ring is close to the grinding head compared with one end of the check ring, which is attached to the guide pipe, of the check ring.
Further, the flexible driving shaft is a spring ring formed by spiral winding of wires, and an antifriction coating is arranged on the outer side wall of the flexible driving shaft.
Further, a cooling channel for conveying cooling liquid is formed between the flexible driving shaft and the inner wall of the guide pipe.
Compared with the prior art, the invention has the advantages and positive effects that:
(1) The ultrasonic transducer is embedded into the grinding head, and vibration generated by the ultrasonic transducer can directly drive the grinding head to vibrate, so that the process of transmitting a remote vibration source to the grinding head through a transmission shaft is omitted, the calcified tissue is ground by utilizing the dual effects of the rotational grinding and the ultrasonic vibration after being effectively and reasonably combined, and the controllability in the vibration grinding operation process is improved, so that the vibration grinding precision is improved.
(2) The ultrasonic transducer is designed and installed in the grinding head, the piezoelectric ceramic plate is used as the ultrasonic transducer to be embedded and fixed in the grinding head, and the piezoelectric ceramic plate is utilized to generate two-dimensional high-frequency ultrasonic vibration, so that the grinding head forms an elliptical motion track, and the grinding efficiency of calcified tissues is improved under the dual actions of spin grinding and ultrasonic vibration.
(3) The grinding head utilizes differential spin grinding to selectively remove fibrotic or calcified arteriosclerosis plaques, and elastic vascular tissues can be naturally sprung out when the grinding head vibrating at high speed passes through, so that the spin grinding contact between the elastic tissues and normal vascular walls can be reduced, the safety of the spin grinding process is improved, and healthy tissues are protected.
(4) The method has the advantages that the posture of the piezoelectric ceramic plates arranged in the mounting groove can be changed according to requirements, the piezoelectric ceramic plates are configured to form a set included angle with the axis of the grinding head, different two-dimensional ultrasonic high-frequency vibration can be generated due to the difference of included angle angles formed between the two piezoelectric ceramic plates, further different vibration combining directions are generated, the movement track of abrasive particles relative to calcified tissues in the grinding head rotating grinding process is changed, the included angle of the piezoelectric ceramic plates can be adjusted according to different calcification conditions before rotating grinding, and the grinding efficiency is improved.
(5) The inlet of the slag discharging channel is arranged on the outer circumferential surface of the near end of the guide pipe close to the grinding head, and the slag discharging channel is arranged in the guide pipe, so that abrasive dust and cooling liquid sucked into the grinding area at the inlet position can be discharged out of the guide pipe, and then led out of the guide pipe, and the cooling liquid is circulated, so that the temperature of the grinding area is effectively reduced, and the grinding efficiency is effectively prevented from being influenced by abrasive dust accumulation.
Drawings
The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the invention.
FIG. 1 is a schematic view of an intravascular ultrasound vibration assisted rotational atherectomy device according to embodiment 1 of the present invention;
FIG. 2 is a view showing the structure of a grinding head in embodiment 1 of the present invention;
FIG. 3 is a schematic view of the grinding head of example 1 of the present invention in full section;
FIG. 4 is a schematic cross-sectional view at A-A of FIG. 2;
FIG. 5 is a schematic diagram showing the distribution of ultrasonic transducers inside a grinding head in embodiment 1 of the present invention;
FIG. 6 is a schematic view showing the structure of an ultrasonic transducer inside a grinding head in embodiment 1 of the invention;
FIG. 7 is a schematic view of the drive shaft outer wrap wire in accordance with example 1 of the present invention;
FIG. 8 is a schematic cross-sectional view of a drive shaft in accordance with embodiment 1 of the present invention;
FIG. 9 is a schematic view showing the structure of a catheter in embodiment 1 of the present invention;
FIG. 10 is a schematic cross-sectional view of a catheter according to example 1 of the present invention;
FIG. 11 is a schematic radial cross-sectional view of a catheter according to example 1 of the present invention;
FIG. 12 is a schematic radial cross-sectional view of another axial position of the catheter of example 1 of the present invention;
FIG. 13 is a schematic view showing the structure of a retainer ring and a catheter according to embodiment 1 of the present invention;
FIG. 14 is a schematic cross-sectional view of a catheter and a retainer ring according to example 1 of the present invention;
FIG. 15 is a schematic view of the structure of the included angle formed by the ultrasonic transducer in embodiment 1 of the present invention;
FIG. 16 is a schematic view showing the operation state of the intravascular ultrasound vibration assisted rotational atherectomy device of embodiment 1 of the present invention;
FIG. 17 is a schematic view showing the operation state of the intravascular ultrasound vibration assisted rotational atherectomy device of embodiment 1 of the present invention;
fig. 18 is a flow chart of a process for manufacturing the grinding head in embodiment 1 of the invention.
The ultrasonic transducer comprises a 1-guide wire, 2-abrasive particles, a 3-grinding head smooth surface, a 4-grinding head, a 5-retainer ring, a 6-catheter, a 7-blood vessel, an 8-flexible driving shaft, a 9-cooling channel, a 10-ultrasonic transducer, an 11-guide wire, a 12-vibration damping pad, a 13-wire, a 14-guide wire inner core, a 15-electrode wire, a 16-electrode plate, a 17-catheter wall, a 18-metal vibrating piece, a 19-screw, a 20-screw hole and a 21-ultrasonic generator.
Detailed Description
Example 1
In an exemplary embodiment of the present invention, as shown in fig. 1-18, an intravascular ultrasound vibration-assisted rotational atherectomy device is provided.
When calcified tissue and the like in the blood vessel 7 are removed, although the traditional rotary grinding and rotary cutting are assisted with ultrasonic vibration to improve the removal effect, the coupling effect between the vibration and the rotary grinding is poor, so that the removal effect is poor, and the effective grinding removal of the completely occluded calcified lesions is difficult to realize. Based on this, this embodiment provides a two-dimensional ultrasonic vibration auxiliary rotary grinding device in the blood vessel 7, the grinding head 4 is used as a rotary grinding tool piece and also is used as a carrier of the ultrasonic transducer 10 for generating vibration, the grinding head 4 is driven by the rotating flexible driving shaft 8 to perform high-speed rotary grinding, and simultaneously the ultrasonic transducer 10 embedded in the interior generates two-dimensional high-frequency ultrasonic vibration when excited, so that calcified tissues and thicker superficial calcified rings of the vestibule which are not completely closed and completely closed can be cleared.
The calcified tissue is ground by utilizing the dual functions of high-speed rotary grinding and high-frequency ultrasonic vibration, and healthy tissues such as the wall of an elastic blood vessel 7 and the like can be sprung out when encountering the grinding head 4 vibrating at high speed, so that the safety of rotary grinding on the calcified part is ensured, and the efficiency and safety of rotary grinding for removing the calcified tissue are improved.
Referring to fig. 1, the two-dimensional ultrasonic vibration auxiliary rotary grinding device in the blood vessel 7 mainly comprises a grinding head 4, a sleeve, a guide wire 1 and a control assembly, one end of the grinding head 4 is connected with a rotary flexible driving shaft 8, the other end of the grinding head is used as a rotary grinding part, the flexible driving shaft 8 can be connected with a rotary driving element of the control assembly, the rotary driving element is used for driving the flexible driving shaft 8 and the grinding head 4 to rotate, and the requirement of executing rotary grinding work is met. An ultrasonic transducer 10 is embedded and fixed in the side wall between the two ends of the grinding head 4, a wire 11 of the ultrasonic transducer 10 is connected with an ultrasonic generator 21 of the control assembly along the flexible driving shaft 8, and the ultrasonic generator 21 transmits an electric signal through the wire 11, so that the ultrasonic transducer 10 is excited to generate vibration acting on the grinding head 4, and the grinding head 4 forms rotary grinding under the vibration effect. The guide wire 1 sequentially passes through the flexible driving shaft 8 and the grinding head 4 along the axial direction, and can play a guiding role, the guide wire 1 and the flexible driving shaft 8 form a rotating and sliding connection, so that the guide wire 1 can keep a guiding effect when the flexible driving shaft 8 rotates, the guide wire 1 and the grinding head 4 form a rotating and sliding connection, and the requirements of relative rotation and direction adjustment of the grinding head 4 during working are met.
As shown in fig. 2, the guide wire 1 comprises a guide wire inner core 14 and a soft silica gel protective sleeve covered on the end of the guide wire inner core 14, so as to prevent the guide wire 1 from damaging the inner wall of the blood vessel 7. The grinding head 4 consists of a rotary grinding part and a grinding head smooth surface 3, one end of the grinding head 4 acting on calcified tissues is the rotary grinding part, the other end is the grinding head smooth surface 3, the grinding head is connected with a flexible driving shaft 8, the transmitted torque is acquired from the flexible driving shaft 8, the base material of the grinding head 4 is tungsten carbide, and the whole body is olive-shaped. Taking the working state as an example, the rotary grinding part is positioned at the front half part of the grinding head 4 and is positioned at one end of the grinding head 4 away from the flexible driving shaft 8, and diamond abrasive particles 2 are uniformly distributed on the rotary grinding part.
It is understood that other particles than diamond, such as particles made of metal, may be used as the abrasive particles 2 distributed on the spin-grinding portion. The rotary grinding part of the grinding head 4 for rotary grinding operation is electroplated by adopting an ultrasonic sand burying method, so that the uniform plating of the abrasive particles 2 on the surface of the grinding head 4 is ensured, and the grinding efficiency and the safety are improved.
As shown in fig. 3, the ultrasonic transducer 10 is formed by two fan-shaped piezoelectric ceramic plates which are symmetrically distributed with respect to the axis of the grinding head 4, and the piezoelectric ceramic plates are bent to form a conical surface so as to be distributed around the axis of the grinding head 4. Two symmetrical and spaced apart mounting grooves are formed in the side wall between the two ends of the grinding head 4, the strength of the grinding head 4 can be guaranteed through an isolation structure between the two mounting grooves, the piezoelectric ceramic plates are embedded and fixed in the mounting grooves, openings of the mounting grooves are plugged through fillers, the strength of the grinding head 4 after being embedded in the piezoelectric ceramic plates is guaranteed, and the influence of the mounting grooves on the structural strength of the grinding head 4 is reduced. Referring to fig. 15, the included angle of the warp lines at symmetrical positions on the two piezoelectric ceramic plates is alpha, and alpha is more than or equal to 0 and less than or equal to 180 degrees.
Wherein, as shown in fig. 4 and 5, the ultrasonic transducer 10 is composed of two piezoelectric ceramic plates, the ultrasonic transducer 10 is embedded in the grinding head 4, and is fixed inside the grinding head 4 by a screw 19, and the shape thereof is as shown in fig. 4 and 5. Screw holes 20 are reserved on the grinding head 4 and are used for being matched with screws 19, so that the piezoelectric ceramic plates are fixed inside the grinding head 4 through the screws 19 to ensure the stability of spin grinding, after the screws 19 fix the piezoelectric ceramic plates, the removable insulating filler is filled in the mounting groove for accommodating the ultrasonic transducer 10 and covers the mounting positions of the screws 19, and the surface of the whole grinding head 4 is covered with the insulating waterproof coating.
In order to drive the piezoelectric ceramic plate, continuously distributed wire channels are arranged in the grinding head 4 and the flexible driving shaft 8, wires 11 penetrate through the wire channels and then are led out of the flexible driving shaft 8, and the wires 11 can transmit electric signals output by the ultrasonic generator 21 to the piezoelectric ceramic plate so as to excite the piezoelectric ceramic plate. Referring to fig. 3, an ultrasonic signal transmission wire 11 has one end connected to the ultrasonic transducer 10 and one end connected to an ultrasonic generator 21 outside the catheter 6, and the wire 11 is used to transmit a high-frequency ultrasonic electric signal to the ultrasonic transducer 10, thereby exciting the ultrasonic transducer 10 and generating two-dimensional high-frequency ultrasonic vibrations acting on the grinding head 4.
As shown in fig. 5 and 6, the piezoelectric ceramic plate and the metal vibration plate 18 work cooperatively, the piezoelectric ceramic plate is located on the upper side of the metal vibration plate 18, wherein the piezoelectric ceramic plate and the metal vibration plate 18 are connected and fixed in a bonding manner by using epoxy resin and the like, meanwhile, electrode wires 15 are uniformly distributed on the piezoelectric ceramic plate, and one end of a wire 11 is connected with the electrode plate 16 on the piezoelectric ceramic plate in a bonding manner by welding, so that signal transmission is realized. And an insulating coating is coated on the piezoelectric ceramic sheet and the metal vibration plate 18.
As shown in fig. 7, the flexible driving shaft 8 is a spring coil formed by spirally winding a wire 13, and an antifriction coating is provided on the outer side wall of the flexible driving shaft 8. In this embodiment, the flexible driving shaft 8 is a flexible driving shaft, which can transmit torque rotating around the axis direction, and can bend at the same time, so as to realize transmission of rotation from one end to the other end in a non-coaxial direction. The flexible driving shaft 8 is a spring ring formed by spirally winding one or more strands of wires 13, and a guide wire channel for the guide wire inner core 14 to pass through is formed inside the flexible driving shaft, so that the torque is large and the flexibility is good. The inner and outer surfaces of the flexible drive shaft 8 are covered with a coating having a low coefficient of friction, such as a PTFE polymer coating or the like, so as to reduce friction between the inner surface of the flexible drive shaft 8 and the guidewire 1, and to reduce friction between the outer surface of the flexible drive shaft 8 and the inner wall of the catheter 6, thereby reducing frictional heat.
As shown in fig. 8, the grinding head 4 and the flexible driving shaft 8 are provided with continuously distributed wire passages, and the wires 11 are led out of the flexible driving shaft 8 after passing through the wire passages. Meanwhile, the grinding head 4 and the flexible driving shaft 8 can be connected by adopting laser welding, and a vibration damping gasket 12 is further arranged at the connecting position of the grinding head 4 and the flexible driving shaft 8, so that the transmission of vibration of the grinding head 4 along the flexible driving shaft 8 is reduced, and the stable rotation of the flexible driving shaft is ensured. Wherein the wire channels are distributed in the side walls of the flexible drive shaft 8 corresponding to the coils for the passage of wires 11 for transmitting ultrasonic signals.
In order to realize the motion decoupling of the rotation of the flexible driving shaft 8 and the connection of the lead 11 to the ultrasonic generator 21, the lead 11 is connected to the ultrasonic generator 21 through the conductive sliding ring, so that the lead 11 can still be connected to the ultrasonic generator 21 when the flexible driving shaft 8 rotates, the flexible driving shaft 8 can be externally provided with a gear, a worm wheel and other structures, the rotation is realized under the driving of an external gear or worm, the rotation requirement of the flexible driving shaft 8 is met, the lead channel is separated from the distribution position of the lead 1, and the interference between the lead 1 and the lead 11 is avoided.
The grinding head 4 and the driving shaft are internally provided with guide wire channels which are distributed along the axial direction, the guide wire 1 is arranged in the guide wire channels in a penetrating way, and one end of the guide wire 1 can be led out of the guide wire channels or retracted into the guide wire channels.
As shown in FIG. 9, the conduit 6 may be a pvc hose, or other hose that meets the requirements of medical operation may be used, and the conduit 6 is a hollow tube with a channel in the middle.
Meanwhile, the laser calcification ablation device in the prior art adopts short-range pulse laser to clean calcified areas, so that the volume of calcified tissues after being destroyed can be reduced, and calcified fragments generated after spin grinding treatment are difficult to treat. In this embodiment, as shown in fig. 10 and 11, a slag discharging channel is provided in the pipe wall 17 of the pipe, the inlet of the slag discharging channel is opened at the outer side wall of the pipe 6, and the outlet of the slag discharging channel is opened.
As shown in fig. 12, a cooling channel 9 for conveying cooling liquid is formed between the flexible driving shaft 8 and the inner wall of the guide tube 6, the cooling channel 9 can also be used for conveying liquid medicine, and the cooling liquid can be output from one end of the guide tube 6 close to the grinding head 4, so that the effects of cleaning grinding dust on the grinding head 4 and reducing the temperature of a rotary grinding operation area are achieved.
The cooling liquid is output through the one end that pipe 6 is close to bistrique 4, and in order to avoid the cooling liquid to be taken out by the sediment passageway when not being used for the position of grinding soon after the evacuation, set up the sediment entry at the lateral wall of pipe 6 to with the one end interval distribution that pipe 6 is close to bistrique 4, separate the position of arranging sediment entry and cooling channel 9 output cooling liquid, improve the cooling effect, form one-way flow path between cooling liquid output position, the work position of grinding soon and sediment entry, improve cooling effect and sediment effect.
After the cooling liquid acts on the rotary grinding position, grinding scraps at the grinding head 4 are led in by utilizing the inlet of the slag discharging channel and then led out from the outlet of the slag discharging channel, so that the accumulation amount of the grinding scraps in the blood vessel 7 is reduced. It can be understood that the outlet of the slag discharging channel can be connected with suction components such as a suction component, so that negative pressure is formed in the slag discharging channel, the process of discharging grinding scraps carried by cooling liquid is realized, and secondary damage to human bodies caused by blockage of blood vessels 7 due to massive accumulation of the grinding scraps is reduced.
As shown in fig. 13 and 14, in order to increase the discharge amount of the abrasive dust passing through the cavity, a retainer ring 5 is sleeved outside the guide pipe 6, the retainer ring 5 is positioned between the inlet and the outlet of the slag discharging channel, the retainer ring 5 is conical, and the outer ring of the retainer ring 5 is closer to the grinding head 4 than the end of the retainer ring 5, which is attached to the guide pipe 6. The outer surface of the guide pipe 6 is provided with a flexible retainer ring 5 shown in fig. 1, the retainer ring 5 is in a cone shape to form a horn-shaped structure, one side of the large diameter of the horn-shaped structure faces to a rotary grinding position, as shown in fig. 16 and 17, abrasive dust can generate a countercurrent trend along the guide pipe 6 under the impact of cooling liquid, namely, the abrasive dust has a trend of flowing to an external ultrasonic generator 21, the retainer ring 5 can block the movement paths of the washed cooling liquid and abrasive dust, and at the moment, the cooling liquid carries the abrasive dust to flow to an inlet of a slag discharge channel along the retainer ring 5 and is discharged out of the body along the slag discharge channel, so that the discharge amount of the abrasive dust is increased.
It can be understood that when the rotational grinding acts on calcified tissues, if the temperature of the rotational grinding area is too high or the rotational grinding area is raised too fast, the flow of the cooling liquid can be increased, the temperature is reduced and the discharge amount of the grinding dust passing through the slag discharge channel is increased, so that the cooling effect is improved. The flexible retainer ring 5 may be made of the same material as the conduit 6, and may be integrally formed during the processing of the conduit 6, or the retainer ring 5 may be connected to the conduit 6 by gluing at a later stage.
Referring to fig. 1, the grinding head 4 is connected to an end of the driving shaft away from the control assembly and the ultrasonic generator 21, the guide wire 1 is penetrated through the grinding head 4 and the driving shaft, the driving shaft and the grinding head 4 can move along the axial direction of the guide wire 1, and the driving shaft and the grinding head 4 can move rotationally around the guide wire 11. In the rotational grinding operation, the guide wire 1 and the driving shaft can be operated to realize the back-and-forth movement of the grinding head 4, wherein the axial movement refers to the movement along the axial direction of the guide wire 1 to the direction close to the ultrasonic generator 21 or the direction of the ultrasonic generator 21 according to the principle, so that the position of the blood vessel 7 needing the rotational grinding is rotationally ground to dredge the lumen.
When the severely calcified or completely calcified blood vessel 7 is grinded, the diamond abrasive particles 2 at the front end of the grinding head 4 grind the calcified tissue firstly, and meanwhile, the lead 11 transmits an in-vitro ultrasonic signal to the ultrasonic transducer 10, so that the calcified tissue which generates high-frequency ultrasonic vibration is easier to clean under the double functions of the diamond abrasive particles 2 and the ultrasonic vibration, and the follow-up whole grinding head 4 and the guide pipe 6 can enter a designated position for follow-up treatment.
As shown in fig. 18, the grinding head 4 machining process includes machining the shape of the grinding head 4 and electroplating the grinding head 4.
The grinding head 4 is processed into an ellipsoidal section by utilizing a turning mode. The embedded ultrasound transducer 10 is partially machined by milling. The wire 11 and the passing path of the guide wire 1 are processed by drilling to obtain corresponding wire channels and guide wire channels.
The electroplating process of the grinding head 4 mainly comprises the steps of grinding head 4 matrix cleaning, nickel preplating, diamond abrasive preparation and nickel-diamond codeposition, wherein the grinding head 4 matrix cleaning adopts alcohol or acetone reagent to remove oil and clean the grinding head 4 matrix in an ultrasonic cleaning machine, the grinding head 4 matrix preplating is carried out on a water bath heating test bed, and the diamond abrasive preparation is carried out on an ultrasonic vibration test bed. Nickel-diamond co-deposition was also performed on an ultrasonic vibration bench.
The nickel plating on the surface of the grinding head 4 is carried out by taking a nickel block as an anode, taking a base body of the grinding head 4 as a cathode, and taking a watt liquid as an electroplating liquid under the conditions of 15mA current, 0.8-1.1V voltage and 55 ℃ temperature, wherein the electroplating liquid comprises nickel sulfamate, nickel chloride, boric acid, sodium dodecyl sulfate and saccharin.
The preparation process of the diamond abrasive particles 2 comprises the steps of firstly, placing the abrasive particles 2 in an alcohol or acetone solution to form a mixed solution, placing the mixed solution on an ultrasonic vibration experiment table to perform ultrasonic vibration dispersion, taking upper liquid, obtaining preliminary abrasive particles 2 through suction filtration, and cleaning and drying the preliminary abrasive particles 2 to obtain the finally prepared abrasive particles 2.
The working process of the two-dimensional ultrasonic vibration auxiliary rotary grinding device in the blood vessel 7 is described as follows:
The guide wire 1 is inserted into the calcified region at a proper arterial position close to the calcified lesion region, and the end part of the guide wire 1 is coated with soft materials so as to prevent the guide wire 1 from damaging the inner wall of the blood vessel 7. After the guide wire 1 reaches a designated position, the guide wire 1 is penetrated into the catheter 6 in vitro, so that the catheter 6 is penetrated into a calcified region along the guide wire 1, then the guide wire 1 is conveyed into the grinding head 4 and the flexible driving shaft 8 through the catheter 6 and the guide wire 1, the guide wire 1 is conveyed to the far end of a coronary artery through calcified lesions, and then the grinding head 4 and the flexible driving shaft 8 are conveyed to the near end of the calcified lesions along the guide wire 1.
When the grinding head 4 and the guide pipe 6 reach the designated positions, the flexible driving shaft 8 is enabled to rotate at high speed with the grinding head 4 through the rotary grinding control console of the external control assembly, meanwhile, high-frequency ultrasonic electric signals are generated through the external ultrasonic sound generator, and the electric signals are transmitted to the ultrasonic transducer 10 embedded in the grinding head 4 through the lead 11, so that the high-frequency ultrasonic electric signals are converted into high-frequency ultrasonic vibration.
The ultrasonic transducer 10 is fixed inside the grinding head 4 by two piezoelectric ceramic plates at a certain angle to generate two-dimensional high-frequency ultrasonic vibration. Meanwhile, the silica gel gasket 2 is arranged at the joint of the grinding head 4 and the flexible driving shaft 8, so that the influence of vibration of the grinding head 4 on the flexible driving shaft 8 can be effectively reduced. Aiming at the complex conditions of different calcified areas, the grinding heads 4 with different angles clamped between the two piezoelectric ceramic plates can be selected, so that different two-dimensional vibration tracks are generated to correspond to each other, different grinding effects are realized, and the spin grinding efficiency is improved.
As shown in fig. 15, when the two piezoelectric ceramic plates are located on the same plane and perpendicular to the axis of the grinding head 4, the ultrasonic vibration generated by the piezoelectric ceramic plates is in the same direction and coincides with the central axis of the grinding head 4, the abrasive particles 2 of the grinding head 4 form a reciprocating linear motion track parallel to the axis relative to the calcified tissue, and when the two piezoelectric ceramic plates coincide and are parallel to the axis of the grinding head 4, the ultrasonic vibration generated by the piezoelectric ceramic plates is perpendicular to the central axis of the grinding head 4, and the abrasive particles 2 of the grinding head 4 form a reciprocating linear motion perpendicular to the axis relative to the calcified tissue. When the two piezoelectric ceramic plates are positioned between the two conditions, the abrasive particles 2 of the grinding head 4 form elliptic motion tracks relative to calcified tissues. The distribution mode of the piezoelectric ceramic plates can be configured according to the requirements.
When the grinding head 4 works, physiological saline is used as cooling liquid to be conveyed to the grinding head 4 from outside along the cooling channel 9, so that the purpose of reducing the temperature of a grinding area is achieved, and when the temperature of the grinding area is higher, the flow rate of the physiological saline can be increased to accelerate the temperature reduction. The normal saline cools down and washes the grinding dust of the grinding head 4 at the same time, and the washed grinding dust and the normal saline flow to the inlet of the slag discharging channel due to the difference of the liquid pressure in the grinding area, and are discharged outside the body through the slag discharging channel, and the retainer ring 5 outside the guide pipe 6 can play a role in blocking and guiding the washed waste dust and the normal saline.
The grater 4 with diamond abrasive particles 2 can be retracted to the proximal end of the lesion during the rotational milling process, and the rotational milling is repeated until the grater 4 is pushed and retracted until the resistance disappears to clear the calcified lesion. After the spinning is completed, the external spinning control console and the ultrasonic generator 21 are turned off to stop the rotation and vibration of the grinding head 4, the flexible driving shaft 8 and the guide tube 6 are firstly moved out of the body along the guide wire 1, then the guide wire 1 is moved out of the body, and the device is sterilized.
The above description is only of the preferred embodiments of the present invention and is not intended to limit the present invention, but various modifications and variations can be made to the present invention by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
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| CN109394307A (en) * | 2018-11-19 | 2019-03-01 | 储新 | A kind of intravascular calcified plaque or calcification ring ultrasonic grinding device |
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