Manufacturing method of PVDF micro-force sensor and application method of PVDF micro-force sensor in surgical instrumentTechnical Field
The invention relates to the technical field of sensors, in particular to a manufacturing method of a PVDF micro-force sensor and an application method of the PVDF micro-force sensor in a surgical instrument.
Background
The piezoelectric film sensor is a dynamic strain sensor, the sensitive element is made of piezoelectric materials, and the piezoelectric film sensor is a sensor based on piezoelectric effect and is commonly used for monitoring vital signals on the surface of human skin or implanted in a human body.
PVDF (polyvinylidene fluoride) is an organic piezoelectric material, has the characteristics of small volume, light weight, flexible material, low impedance, high piezoelectric voltage constant, wide frequency band response, small influence on the mechanical property of a structure and the like, and is suitable for being used as a sensitive element of a piezoelectric sensor. Piezoelectric PVDF was developed by shanghai chemical institute of chinese academy of sciences as early as 1977, and is now widely used in almost all fields including hydrophones and sonars, medical sensing, and ignition and detonation. The PVDF piezoelectric film surface will generate polarization phenomenon after stress, thereby generating electric charge on two surfaces, after being amplified by a charge amplifier and a measuring circuit and transformed into impedance, the electric charge is output in direct proportion to the external force, the quantity of the electric charge generated by the film is related to the piezoelectric coefficient and the stress magnitude of the film, therefore, under the condition of controlling the piezoelectric coefficient and the area of the film to be unchanged, the piezoelectric film sensor is calibrated, and the stress magnitude can be obtained by measuring the output electric charge of the PVDF piezoelectric film sensor.
The rotational atherectomy (CRA) of coronary artery plaque utilizes the principle of differential cutting, selectively removes calcified or fibrous arteriosclerosis plaque by a physical rotational atherectomy method, is mainly suitable for highly calcified lesions of coronary artery, and is a means for removing the atherosclerosis plaque which is more clinically applied. Early coronary atherectomy is assisted by balloon dilatation or stenting for plaque ablation purposes. In recent years, with the development of interventional therapy, rotational atherectomy has focused more on plaque modification, and the risk of vascular injury is reduced by using a rotational atherectomy head to abrade calcified plaque to form a new passageway.
However, the rotational atherectomy described above still involves the risk of complications such as coronary spasm, coronary dissection, slow/no coronary flow, broken rotationally abraded guide wire, rotational atherectomy, coronary perforation or cardiac tamponade. In the operation, factors such as too fast propelling speed of the rotational grinding head, long time of single rotational grinding and the like can cause coronary artery spasm and dissection; the factors such as the manipulation of the rotating/grinding head may also cause serious complications such as the incarceration of the rotating/grinding head.
Disclosure of Invention
The invention provides a manufacturing method of a PVDF micro-force sensor and an application method of the PVDF micro-force sensor in a surgical instrument, which can measure the stress of the surgical instrument in a blood vessel in real time with high sensitivity, can be used for measuring the micro-grinding force of a rotary grinding head colliding with a calcified tissue or a cardiovascular wall in rotational atherectomy, and can increase the safety of removing the calcified tissue.
The invention adopts the following technical scheme.
The manufacturing method of the PVDF micro-force sensor is used for preparing the sensor capable of detecting the stress data of the cardiovascular interventional surgical instrument in a blood vessel, the micro-force sensor is an elastic sandwich structure packaged by a waterproof and insulating protective film, and comprises a piezoelectric film serving as the middle layer of the elastic sandwich structure and two electrodes respectively connected with the top surface and the bottom surface of the piezoelectric film; the elastic sandwich structure is embedded in the installation groove of the surgical instrument, the bottom surface or the top surface of the elastic sandwich structure is positioned on the outer surface of the surgical instrument, and when the stress of the surgical instrument in a blood vessel is conducted to the micro-force sensor, the piezoelectric film of the micro-force sensor generates a detection electric signal.
The piezoelectric film is a PVDF piezoelectric film subjected to polarization treatment; the protective film is a PET release film; and the upper surface and the lower surface of the PVDF piezoelectric film are covered with electrodes.
The electrode is a red copper layer with the thickness of 10 mu m; the thickness of the PVDF piezoelectric film is 28 micrometers; the thickness of the PET release film is 100 mu m.
The PET release film is subjected to heat sealing treatment to form a closed insulating layer around the micro force sensor, the PET release film is subjected to thermoplastic treatment to enable the thermoplastic force of the PET release film to bend and mold the micro force sensor until the micro force sensor can be basically matched with the shape of the outer surface of a surgical instrument and can be attached to a mounting groove in the outer surface of the surgical instrument, and the arc shapes of the top surface and the bottom surface of the micro force sensor are matched with the surface of the surgical instrument.
The application method of the PVDF micro-force sensor in the surgical instrument adopts the PVDF micro-force sensor, and the surgical instrument is a rotary grinding head of a cardiovascular calcified tissue removing device; one side or two sides of the outer surface of the rotary grinding head are provided with installation grooves for installing the PVDF micro-force sensor; the micro-force sensor is arranged on one side of the rotary grinding head or symmetrically arranged on two sides of the rotary grinding head.
A radial through hole and an axial center hole which are communicated are arranged in the rotary grinding head; a transmission shaft for driving the rotary grinding head is fixed in an axial central hole in the rotary grinding head, and the transmission shaft and the axial central hole have the same axle center; when the rotary grinding head grinds the calcified tissue/cardiovascular wall, the generated rotary grinding force acts on the PVDF piezoelectric film of the PVDF micro-force sensor, so that the PVDF piezoelectric film is polarized, the upper surface and the lower surface of the PVDF piezoelectric film generate stress detection charges, and the stress detection charges are transmitted to an external data acquisition instrument through an electrode and an insulating wire harness; the insulation wire harness is arranged in a radial through hole and an axial central hole of the rotary grinding head.
The rotary grinding head is driven by a motor through a flexible transmission shaft; the flexible transmission shaft is arranged in the hollow shaft at the motor support and is in interference fit with the hollow shaft, and the motor drives the flexible transmission shaft to rotate to drive the rotary grinding head when driving the hollow shaft to rotate; a sensor wiring with one end connected with a data acquisition instrument is arranged in the hollow shaft; the insulating wire harness penetrates out of the rotary grinding head and then enters the transmission sheath, and reaches the rotary joint through the transmission sheath and is connected with the other end of the wiring of the sensor in the hollow shaft; the rotary joint is connected with the hollow shaft through a coupler.
The sensor wiring is connected with the charge amplifier and the measuring circuit, and the stress detection charge received by the sensor wiring from the insulated wire harness is amplified and impedance-transformed to form an electrical detection signal of the PVDF micro-force sensor which is in direct proportion to the rotational abrasion force applied to the PVDF micro-force sensor and then sent to the upper computer.
The upper computer determines calibration associated data between the rotational grinding force between the rotational grinding head and the calcified tissue/cardiovascular wall and the electric detection signal of the PVDF micro-force sensor through calibrating the relation between the stress of the PVDF micro-force sensor and the electric detection signal;
and the upper computer measures the electrical detection signal of the PVDF micro-force sensor by using the voltage detection module, retrieves corresponding stress data from the calibrated associated data according to the measurement result, and uses the stress data as the rotational grinding force data between the current rotational grinding head and the calcified tissue/cardiovascular wall measured by the PVDF micro-force sensor.
When the rotational grinding head is used for rotational grinding of the coronary plaque, the upper computer monitors the grinding force between the rotational grinding head and the plaque or the coronary artery wall through measured rotational grinding force data, and displays the real-time rotating speed and the grinding force of the rotational grinding head on a TJC screen of rotational grinding equipment, so that an operator can evaluate whether the current rotational grinding head can seriously stimulate the coronary artery wall in real time.
Compared with the prior art, the invention has the following advantages:
1. under the condition of less influence on the mechanical property of the cardiovascular interventional surgical instrument structure, a micro-force sensor with higher sensitivity is arranged in a groove on the outer surface of the rotary grinding head.
2. In the rotational atherectomy of coronary artery plaques, the PVDF micro-force sensor can feed back the grinding force between the rotational head and the plaques or the coronary artery walls in real time, so that the condition in the operation can be observed in real time conveniently, the stimulation of the rotational head to the coronary arteries is reduced, and the risk of postoperative complications is reduced.
3. Because the micro-force sensor has high sensitivity, whether the current grinding part of the rotary grinding head is a lesion spot or a normal blood vessel can be quickly judged from monitoring data, and an alarm can be quickly given when the blood vessel grinding phenomenon occurs.
Drawings
The invention is described in further detail below with reference to the following figures and detailed description:
FIG. 1 is a schematic layered view of a micro-force sensor according to the present invention;
FIG. 2 is a schematic view of a micro-force sensor of the present invention disposed on a rotational atherectomy head;
FIG. 3 is another schematic view of the micro-force sensor of the present invention disposed on a rotational atherectomy head;
FIG. 4 is a schematic perspective view of a micro-force sensor of the present invention mounted on a rotational atherectomy head;
FIG. 5 is a schematic diagram of a wiring harness layout of the micro-force sensor;
FIG. 6 is a schematic flow chart of the present invention for rotational atherectomy of coronary artery plaque;
in the figure: 1-a piezoelectric film; 2-an electrode; 3-protective film; 4-micro force sensor; 5-axial center hole; 6-radial through holes; 7-a rotary grinding head; 8-an insulated wire harness; 9-a flexible transmission shaft; 10-a hollow shaft; 11-a motor support; 12-a coupling; 13-sensor wiring; 14-a rotary joint; 15-driving sheath.
Detailed Description
As shown in the figure, the manufacturing method of the PVDF micro-force sensor is used for preparing the sensor capable of detecting the stress data of the cardiovascular interventional surgical instrument in the blood vessel, themicro-force sensor 4 is an elastic sandwich structure packaged by a waterproof and insulatingprotective film 3, and comprises a piezoelectric film 1 serving as the middle layer of the elastic sandwich structure and twoelectrodes 2 respectively connected with the top surface and the bottom surface of the piezoelectric film; the elastic sandwich structure is embedded in the installation groove of the surgical instrument, the bottom surface or the top surface of the elastic sandwich structure is positioned on the outer surface of the surgical instrument, and when the stress of the surgical instrument in a blood vessel is conducted to the micro-force sensor, the piezoelectric film of the micro-force sensor generates a detection electric signal.
The piezoelectric film is a PVDF piezoelectric film subjected to polarization treatment; the protective film is a PET release film; and the upper surface and the lower surface of the PVDF piezoelectric film are covered with electrodes.
The electrode is a red copper layer with the thickness of 10 mu m; the thickness of the PVDF piezoelectric film is 28 micrometers; the thickness of the PET release film is 100 mu m.
The PET release film is subjected to heat sealing treatment to form a closed insulating layer around the micro force sensor, the PET release film is subjected to thermoplastic treatment to enable the thermoplastic force of the PET release film to bend and mold the micro force sensor until the micro force sensor can be basically matched with the shape of the outer surface of a surgical instrument and can be attached to a mounting groove in the outer surface of the surgical instrument, and the arc shapes of the top surface and the bottom surface of the micro force sensor are matched with the surface of the surgical instrument.
The application method of the PVDF micro-force sensor in the surgical instrument adopts the PVDF micro-force sensor, and the surgical instrument is arotary grinding head 7 of a cardiovascular calcified tissue removing device; one side or two sides of the outer surface of the rotary grinding head are provided with installation grooves for installing the PVDF micro-force sensor; the micro-force sensor is arranged on one side of the rotary grinding head or symmetrically arranged on two sides of the rotary grinding head.
A radial throughhole 6 and anaxial center hole 5 which are communicated are arranged in the rotary grinding head; a transmission shaft for driving the rotary grinding head is fixed in an axial central hole in the rotary grinding head, and the transmission shaft and the axial central hole have the same axle center; when the rotary grinding head grinds the calcified tissue/cardiovascular wall, the generated rotary grinding force acts on the PVDF piezoelectric film of the PVDF micro-force sensor, so that the PVDF piezoelectric film is polarized, the upper surface and the lower surface of the PVDF piezoelectric film generate stress detection charges, and the stress detection charges are transmitted to an external data acquisition instrument through an electrode and aninsulating wire harness 8; the insulation wire harness is arranged in a radial through hole and an axial central hole of the rotary grinding head.
The rotary grinding head is driven by a motor through a flexible transmission shaft 9; the flexible transmission shaft is arranged in thehollow shaft 10 at the position of themotor support 11 and is in interference fit with the hollow shaft, and when the motor drives the hollow shaft to rotate, the flexible transmission shaft is driven to rotate so as to drive the rotary grinding head; asensor wiring 13 with one end connected with a data acquisition instrument is arranged in the hollow shaft; the insulated wire harness penetrates out of the rotary grinding head, enters thetransmission sheath 15, reaches therotary joint 14 through the transmission sheath, and is connected with the other end of the wiring of the sensor in the hollow shaft; the swivel joint is connected to the hollow shaft via acoupling 12.
The sensor wiring is connected with the charge amplifier and the measuring circuit, and the stress detection charge received by the sensor wiring from the insulated wire harness is amplified and impedance-transformed to form an electrical detection signal of the PVDF micro-force sensor which is in direct proportion to the rotational abrasion force applied to the PVDF micro-force sensor and then sent to the upper computer.
The upper computer determines calibration associated data between the rotational grinding force between the rotational grinding head and the calcified tissue/cardiovascular wall and the electric detection signal of the PVDF micro-force sensor through calibrating the relation between the stress of the PVDF micro-force sensor and the electric detection signal;
and the upper computer measures the electrical detection signal of the PVDF micro-force sensor by using the voltage detection module, retrieves corresponding stress data from the calibrated associated data according to the measurement result, and uses the stress data as the rotational grinding force data between the current rotational grinding head and the calcified tissue/cardiovascular wall measured by the PVDF micro-force sensor.
When the rotational grinding head is used for rotational grinding of the coronary plaque, the upper computer monitors the grinding force between the rotational grinding head and the plaque or the coronary artery wall through measured rotational grinding force data, and displays the real-time rotating speed and the grinding force of the rotational grinding head on a TJC screen of rotational grinding equipment, so that an operator can evaluate whether the current rotational grinding head can seriously stimulate the coronary artery wall in real time.
In the embodiment, the piezoelectric film in the PVDF micro-force sensor generates polarization after being subjected to stress generated by the rotational grinding head and the calcified tissue/cardiovascular wall, positive and negative charges are generated on the upper surface and the lower surface, and the charges are transferred to the wire harness by the red copper electrode material and then are transmitted to the outside of the body by the insulating wire harness.
In this embodiment, the insulating wire harness will successively pass through the inside of the rotary grinding head and the inside of the transmission sheath to reach the outside of the body, and then pass through the inside of the motor transmission shaft, the motor transmission shaft will be connected with the rotary joint through the coupler, and the wire harness will pass through the rotary joint and finally reach a static state.
In this embodiment, after reaching a static state, the wire harness is amplified by the charge amplifier and the measuring circuit and transforms impedance, and then outputs electric quantity proportional to the external force, and is connected to the voltage detection module for electric quantity measurement.
In the embodiment, the relationship between the stress generated by the spin grinding head and the calcified tissue/cardiovascular wall spin grinding and the output electric quantity is determined by calibrating the PVDF micro-force sensor.
The above embodiments are merely illustrative of the technical ideas and features of the present invention, and the purpose thereof is to enable those skilled in the art to understand the contents of the present invention and implement the present invention, and not to limit the protection scope of the present invention. All equivalent changes and modifications made according to the spirit of the present invention should be covered within the protection scope of the present invention.