Background
Mitral insufficiency (MR) is the most common valvular disease, with an incidence of about 1.7% in the general population, and severe MR will severely impair cardiac function, increase the risk of heart failure, and severely threaten health and longevity. The main treatment mode of severe MR patients is mitral valve repair or replacement under extracorporeal circulation, the method is mature in technology and accurate in effect, but the method has high risk and death rate for the elderly, patients with severe cardiac insufficiency or patients with severe complications, and the patients cannot be operated. For the patients, a safe, minimally invasive and quick-healing valve replacement means is lacked, and only drug conservative treatment is relied on, so that the prognosis is poor. Transcatheter Mitral Valve replacement (TMVI) is a minimally invasive Valve replacement technology emerging in recent years, which performs Valve replacement through cardiac apices or femoral arteries and the like, so that the Valve replacement is minimally invasive like a coronary stent, thereby avoiding trauma operations such as sternal cleft, extracorporeal circulation and the like, and having the characteristics of low risk, minimal invasion and quick recovery. TMVI will provide the elderly high-risk MR patients with valve replacement therapy opportunities, reduce the degree of regurgitation, avoid heart failure, and thus benefit.
Due to the complexity of the anatomy of the mitral valve, the stent delivery devices used at present are all manually released gradually, so that the stents cannot be automatically implanted according to different conditions of the stent and the patient, the operation process is complicated, the accuracy cannot be ensured, the requirements on the operating surgeon are high, and the operator is exposed to radiation during the whole operation process to cause injury to the body of the operating surgeon (the applicant has previously applied for patent documents of relevant aspects, application number: 2020109584189, application date 2020.9.14). The valve stent used for TMVI at present is still immature, the problems of difficult valve positioning, valve displacement, sudden valve release and the like exist in the application of TMVI, the controllability is low, the failure rate is high, the operation risk is high, and the complications such as perivalvular leakage, left ventricular outflow tract obstruction and the like are easily caused.
Chinese patent documents: CN201310417098.6, application date 2013.09.13, patent names: an artificial aortic valve stent implanted through a catheter and a delivery system thereof. The artificial aortic valve rack implanted via catheter includes rack and artificial valve, the rack is woven with elastic fiber material and has dumbbell-shaped structure, head, waist and tail, and the head of the rack has one layer of biocompatible film coated on its outer surface and the tail has installing anchor. The delivery system for delivering the stent is also provided and consists of an outer sheath, an inner core, a loader, a pushing rod and a fixing head, wherein a mounting anchor at the tail part of the stent is arranged on the fixing head, and the artificial aortic valve stent is delivered into the body by a puncture method.
Chinese patent documents: CN201721155153.9, application date 2017.09.11, patent names: an aortic valve stent delivery system and an aortic valve system. The utility model discloses an aortic valve support conveying system and aortic valve system, including the propelling movement release that is used for carrying aortic valve support, especially, aortic valve support conveying system is still including setting up the dysmorphism sacculus pipe at propelling movement release front end, and dysmorphism sacculus pipe includes the sacculus, and the sacculus has column connecting portion and the sacculus expansion portion that communicates with column connecting portion, and column connecting portion are connected with propelling movement release's front end, and the sacculus is designed to be: after the expansion, the balloon expansion part forms a positioning surface at one side close to the columnar connecting part, and when the aortic valve stent delivery system is used, the balloon expansion part of the balloon is positioned in the left ventricular outflow tract and is tightly attached to the bottom of the aortic valve of a human body through the positioning surface, so that the functions of positioning and reducing and/or preventing perivalvular leakage are achieved.
The artificial aortic valve stent implanted through the catheter and the delivery system thereof in the patent document CN201310417098.6, and the aortic valve stent delivery system and the aortic valve system in the patent document CN201721155153.9 can deliver the aortic valve, but both of them are manually delivered, so there are problems of complicated operation process and low precision.
In summary, there is a need for a remote control-based electric stent delivery system that can be used for solving the problems of complicated equipment operation, low accuracy and high failure rate of surgery in the existing mitral valve replacement technology, actually reduce the trauma of patients, reduce the difficulty of surgeons, improve the success rate of surgery, reduce the complications after surgery, simplify the operation process, ensure the accurate positioning and accurate release of the mitral valve implantation, improve the success rate of surgery, avoid the occurrence of secondary surgery, and contribute to the development of the mitral valve replacement technology, and there is no relevant report on the stent delivery system at present.
Disclosure of Invention
The invention aims to overcome the defects of the prior art, and provides the remote control-based electric stent conveying system which can be used for solving the problems of complex equipment operation, low accuracy and high operation failure rate in the existing mitral valve replacement technology, practically reduces the trauma of a patient, reduces the difficulty of a surgeon, improves the success rate of the operation, reduces postoperative complications, can simplify the operation process, ensures the accurate positioning and accurate release of the implantation of the mitral valve, improves the success rate of the operation, avoids the occurrence of secondary operations, and contributes to the development of the mitral valve replacement technology.
In order to achieve the purpose, the invention adopts the technical scheme that:
a remote control-based electric stent conveying system comprises a conveying device and a remote control device; the conveying device and the remote control device form an operation end; the remote control device consists of a control page and a control device; the conveying device comprises a guide head, an inner core, an outer sheath, a pushing rod, a paying-off device, a wire cutting device, a valve stent traction wire, a wire collecting device, a pushing rod pushing device, an inner core pushing device and a mounting seat; the guide head is arranged at the top end of the inner core; the inner core is arranged in the inner sheath; the pushing rod is arranged at the tail end of the sheath, and the tail end of the pushing rod is opposite to the pushing device; the inner core pushing device is arranged at the tail end of the inner core and is opposite to the inner core; the paying-off device, the wire cutting device, the valve stent traction wire and the wire collecting device are respectively connected with one another and are respectively arranged at the front end position in the conveying device; the mounting seat is arranged at the rear section of the conveying device, and the pushing rod, the pushing rod pushing device and the inner core pushing device are all arranged on the surface of the mounting seat; the control page is developed through a Microsoft Visual Studio C # platform and is matched with the whole operation end for use; the control page runs under a Windows system of a PC (personal computer), transmits individualized data of a patient to the operation end remotely, and controls the operation end to start, stop suddenly and reset; the control device consists of a main control board, a take-up motor drive, a tangent motor drive, a push rod motor drive and a power module; the control device adopts a 32-bit high-performance ARM Cortex-M3 processor; the control device is internally provided with a TCP connection management module, and establishes TCP connection with the remote control device through Wi-Fi to realize real-time response of data and instructions.
As a preferred technical solution, the conveying device comprises 5 motors and corresponding mechanisms, and can complete corresponding actions under the control of the control device.
As a preferred technical scheme, the push rod pushing device is composed of a push rod rack, a push rod gear and a push rod motor; the pushing rod rack is arranged at the tail end of the pushing rod, and the pushing rod gear is arranged on an output shaft of a motor of the pushing rod and meshed with the pushing rod rack.
As a preferred technical scheme, the inner core comprises an integrated inner core head and an inner core, and the inner core is of a hollow structure; the guide head is connected with the inner core head through threads; the inner core pushing device consists of an inner core pushing rack, an inner core gear and an inner core pushing motor.
As a preferable technical scheme, one end of the valve stent traction wire is connected with the tail end of the artificial valve and is a clip wire, the other end of the valve stent traction wire is connected with a wire collecting device controlled by the engine, and the control wire passes between the outer sheath and the push rod and is used for assisting the release of the stent.
As a preferred technical scheme, the thread cutting device consists of a thread cutting motor, a flat key, a thread cutting motor screw rod, a cutter holder, a cutter head, a thread cutting baffle and a thread cutting baffle; the device is arranged in a shell connected with the outer sheath, the tangent cutter head is arranged on the tangent cutter holder through threaded connection, and the tangent cutter holder is positioned through a key and a cutter holder guide rail; the tangent cutter seat is matched with a tangent screw rod motor shaft through a screw hole to form a screw rod sliding block device; after the wire winding action is finished, the wire cutting knife holder and the knife holder guide rail can move relatively by driving the screw rod wire cutting motor to rotate forwards or reversely, so that the wire cutting knife holder extends out and retracts, and a valve support traction wire tightly stretched on the wire winding pulley block is cut off.
As a preferred technical scheme, the take-up device consists of a take-up reel, a take-up pulley block and a take-up device, and the pay-off device consists of a pay-off reel and a pay-off pulley; when the wire take-up motor is driven to rotate to take up wires, the left and right take-up reels rotate, and the left and right paying-off reels are driven by the valve support traction wires until the valve support traction wires on the two sides are tensioned.
As a preferable technical scheme, the conveying system is further matched with a mechanical arm, and the mechanical arm is provided with two movable joints, so that the angle and the direction of the stretching arm can be adjusted.
The invention has the advantages that:
1. remote control: the manual gradual release of the valve delivery system is changed into electric automatic remote positioning control, so that the radiation is reduced.
2. Accurate release: the relevant data of the heart valve is input individually, and the accurate release step and the distance are automatically adjusted.
3. Staged release adjustments over time: the valve is released in stages and stages, the release step is preset, the coordination control is realized in multiple aspects, and the valve can be readjusted or recovered to release again in different stages.
4. The problems of complex equipment operation, low precision and high operation failure rate in the existing mitral valve replacement technology are solved, the trauma of a patient is practically reduced, the difficulty of an operator is reduced, the success rate of the operation is improved, the postoperative complications are reduced, the operation process can be simplified, the accurate positioning and accurate release of the mitral valve implantation are ensured, the success rate of the operation is improved, the occurrence of secondary operations is avoided, and the development of the mitral valve replacement technology is contributed.
Detailed Description
The invention is further described with reference to the following examples and with reference to the accompanying drawings.
The reference numerals and components referred to in the drawings are as follows:
100.guide head 200. inner core
201. 300 of inner core head and outer sheath
400.Push rod 401, push rod head
402. Pushing and cuttingdisc 500 paying-off mechanism
510. Paying-offreel 520 paying-off pulley block
600.Wire cutting mechanism 610. wire cutting motor
620. Wire cuttingmotor screw 630 flat key
640.Tool apron 650. tool bit
660.Tangent baffle plate 670, tangent baffle plate screw
700. Valvesupport pull wire 800 take-up mechanism
810. Take-up reel 820, take-up pulley block
830. Take-upmotor 900 push rod pushing mechanism
910. Pushrod rack 920, push rod gear
1000. Innercore pushing mechanism 1010. inner core pushing rack
1020.Inner core gear 1030 inner core pushing motor
1100. Mountingseat 1200. valve support
1201.Valve support hook 1300. casing
1400.Control unit 1410, main control panel
1420. Take-upmotor drive 1430, tangent motor drive
1440. Pusherrod motor drive 1450 power module
1451.3V power module 1452.3.3V power module
1453.5V power supply module
Example 1
The invention relates to an electric bracket conveying system based on remote control, which consists of a conveying device and a remote control device, wherein the remote control device consists of a control device and a control page, and an operation end consists of the control device and the conveying device; the control page is developed through a Microsoft Visual Studio C # platform, can run under a PC Windows system, remotely transmits individualized data of a patient to an operation end, and controls the operation end to start, stop suddenly, reset and other actions; the control device adopts a 32-bit high-performance ARM Cortex-M3 processor, and has higher data processing capacity; the conveying device comprises 5 motors and corresponding mechanisms and can complete corresponding actions under the control of the control device; Wi-Fi communication is adopted between the control page and the control device, so that the control device has the advantages of high transmission rate and long effective distance, and communication can be realized in the effective range covered by radio waves of the wireless router; the equipment has the appearance size of 45cmx20cmx7.75cm, can be installed on a six-axis mechanical arm and is connected with a common socket through a switching power supply, so that the continuous and stable power supply is ensured;
in order to make the technical scheme and advantages of the invention more clear, the invention is further described in detail by the following parameter drawings and examples:
referring to fig. 1, fig. 1 is a front view of a pushing device and a control device according to the present invention. The delivery device comprises aguide head 100, aninner core 200, anouter sheath 300, apush rod 400, awire releasing device 500, awire cutting device 600, a valvestent traction wire 700, awire collecting device 800, a pushrod pushing device 900, an innercore pushing device 1000 and a mountingseat 1100; the control device 1400 is composed of amain control panel 1410, a take-upmotor drive 1420, atangent motor drive 1430, a pushrod motor drive 1440 and apower module 1450; thepower module 1450 includes a3V power module 1451, a 3.3V power module 1452, and a5V power module 1453; the operation end consists of a control device and a conveying device; themain control board 1410, the wire take-upmotor drive 1420, the wire cuttingmotor drive 1430, the pushrod motor drive 1440 and thepower module 1450 are respectively arranged at the inner end of theouter sheath 300 of the pushing device in a symmetrical structure;
referring to fig. 2, fig. 2 is a schematic perspective view of the conveying device of the present invention. The delivery device comprises aguide head 100, aninner core 200, anouter sheath 300, apush rod 400, awire releasing device 500, awire cutting device 600, a valvestent traction wire 700, awire collecting device 800, a pushrod pushing device 900, an innercore pushing device 1000 and a mountingseat 1100; theguide head 100 is arranged at the top end of theinner core 200; theinner core 200 is arranged inside theinner sheath 300; the pushingrod 400 is arranged at the tail end of theouter sheath 300, and the tail end of the pushingrod 400 is opposite to the pushingrod pushing device 900; the innercore pushing device 1000 is arranged at the tail end of theinner core 200 and is opposite to theinner core 200; the paying-offdevice 500, thewire cutting device 600, the valvestent pull wire 700 and thewire collecting device 800 are respectively connected with one another and are respectively arranged at the front position in the conveying device; the mountingseat 1100 is arranged at the rear section of the conveying device, and the push rod, the pushrod pushing device 900 and the innercore pushing device 1000 are all arranged on the surface of the mountingseat 1100;
referring to fig. 3, fig. 3 is a front view of the conveying device of the present invention. The pushingrod pushing device 900 is composed of a pushingrod rack 910, a pushingrod gear 920 and a pushingrod motor 930; thepush rod rack 910 is arranged at the tail end of thepush rod 400, and thepush rod gear 920 is arranged on the output shaft of thepush rod motor 930 and meshed with thepush rod rack 910; the innercore pushing device 1000 comprises an innercore pushing rack 1010, aninner core gear 1020 and an innercore pushing motor 1030; an innercore pushing rack 1010 is arranged at the tail end of theinner core 200, and aninner core gear 1020 is arranged on an output shaft of an innercore pushing motor 1030 and meshed with the innercore pushing rack 1010; thepush rod motor 930 and the innercore push motor 1030 are both worm and worm gear motors, are connected through bolts, and are mounted on the mountingbase 1100; the pushingrod motor 930 and the innercore pushing motor 1030 are driven to drive the pushingrod gear 920 and theinner core gear 1020 to rotate, so that the pushingrod 400 and theinner core 200 respectively do reciprocating motion; the paying-offdevice 500 is composed of a paying-off drum 510 and a paying-offpulley 520;
referring to fig. 4, fig. 4 is a top view of the conveying device of the present invention. Thethread cutting device 600 is composed of athread cutting motor 610, a thread cuttingmotor screw 620, aflat key 630, atool apron 640, atool bit 650, athread cutting baffle 660 and a thread cuttingbaffle screw 670; thecutter holder 640 is arranged in the mountingframe 1100 and is positioned through the key 620, thethread cutting motor 610 drives the thread cuttingmotor lead screw 630 to rotate, so that thecutter holder 640 and thecutter head 650 make transverse feeding motion, thethread cutting baffle 660 and the thread cuttingbaffle screw 670 play a limiting role, and after the valvesupport traction line 700 is cut off, thethread cutting motor 610 drives thecutter head 650 to retract; the take-updevice 800 is composed of a take-upreel 810, a take-uppulley block 820 and a take-upmotor 830;
referring to fig. 5, fig. 5 is a schematic structural view of a guide head and a guide core according to the present invention. Theinner core head 201 and theinner core 200 are integrated, and theinner core 200 is of a hollow structure; thereplaceable guide head 100 is connected with theinner core head 201 through threads; theguide head 100 can be replaced together with the valve according to the operation requirement, so that the conveying device can be recycled;
referring to fig. 6, fig. 6 is a top view of the guide head and the pushing rod of the present invention. The valve support traction line 700 is divided into two strands at the left and right, four line holes are respectively distributed on the head part 401 and the push separating disc 402 of the valve support, when the push rod 400 pushes the valve support 1200 to be pushed out, the valve support traction line 700 is stressed to drive the left and right paying-off winding drums 510 to rotate, the valve support traction line is led into the outer sheath 300 through the paying-off pulley blocks 520 at the two sides, penetrates through the upper holes of the push separating disc 402 and the head part 401 of the push rod, hooks the left and right hook feet 1201 of the valve support, and penetrates out of the lower hole to form; the penetrated traction wire 700 passes through the outer sheath 300 and winds into the left and right wire-rewinding pulley blocks 820, and the tail part of the traction wire is connected into the left and right wire-rewinding reels 810; the driving wire take-up motor 830 is a double-headed worm gear motor; when the wire-rewinding motor 830 is driven to rewind wires in a rotating manner, the left and right wire-rewinding drums 810 rotate, and the left and right wire-rewinding drums 510 are driven by the valve support traction wires 700 until the valve support traction wires 700 on the two sides are tensioned;
referring to fig. 7, fig. 7 is a sectional view of the head of the push rod of the present invention. The guide head and the push rod are respectively provided with aguide head 100, avalve stent 1200, avalve stent hook 1201, aninner core 200, a valvestent pull wire 700, apush rod 400, apush separation disc 402, apush rod head 401 and anouter sheath 300; the side view of the head of the pushing rod is similar to the side view of the pushing separating disc in size and shape, and the position relationship is shown in figure 6;
referring to fig. 8, fig. 8 is a schematic diagram of a control page according to the present invention. The PC end is connected with the singlechip through the WIFI connection established by the control page;
the invention relates to a remote control-based electric stent conveying system, which comprises the following operation processes:
the invention provides a remote control mode, which enables a user to realize data input and device control in a remote control room and complete the whole operation process; before the operation starts, a user places the conveying system on a corresponding mechanical arm beside a bed and adjusts the posture of the mechanical arm; after the preparation work is finished, the user can exit the operating room and enter a remote control room; as shown in fig. 8, when the operation starts, the operating doctor starts the control page, firstly clicks the "connect" button, and the PC software establishes Wi-Fi connection with the single chip microcomputer; after the connection is successful, displaying a connected character in the connection status bar; if the connection is not successful, displaying 'connection failure', and clicking 'link' again after waiting for the network state to recover until the connection is successful;
the invention provides two control modes of 'automatic conveying' and 'manual conveying'; a user can select a control mode or switch the control mode in a drop-down frame at the upper right corner of the control page; the selection and switching of the control mode can be carried out before the operation is started or after the emergency stop in the operation; before the operation is started, if the 'automatic conveying' is selected, the conveying device automatically finishes the conveying process according to the input data and the designated program; if the manual conveying is selected, a user manually controls the motor selection button and the direction control button to complete the conveying process;
in the automatic control process, a user firstly needs to input previously measured heart anatomical data of a patient; the user inputs the patient heart anatomical data measured in advance through the keyboard and clicks a 'submit' button, and all the data are sequentially displayed in a submit preview frame; the user checks the data, and clicks 'confirm submit' after checking the data, the data can be sent to the control device through Wi-Fi; if the user finds that the data input is wrong when the data is checked, the user can re-input the data in the input box and click the 'submit' button again until the user checks that the data is correct and then click 'confirm submit'; after clicking 'confirmation submission', if the sending is successful, the sending status bar displays a 'sending success' word; otherwise, displaying 'failure of sending', and the user can repeatedly click 'confirmation submission' until the sending is successful;
in the automatic control mode, a user controls the state of the motor through three buttons of 'start operation', 'emergency stop' and 'reset'; the right state display column displays the current running state of the conveying device; when the control device finishes initialization and successfully receives an instruction sent by a PC (personal computer) end, the state is displayed as ready; the state is displayed as "running" when the motor starts running according to a specified program; after the execution is finished, the running state is 'execution finished'; if an error is encountered in the execution process, displaying an error word in the operation status column;
after the control device receives the patient data sent by the remote control page through the Wi-Fi module, themain control board 1410 calculates the respective running time of each motor in the current release process according to the data; after the user clicks 'start operation';
as shown in fig. 1/2/3/4, first, the entire robot arm brings the transportation system to the designated position (as shown in fig. 9 a); then, the motor driver 1440 drives the push rod motor 930 and the inner core push motor 1030 to start rotating at the same time, and drives the push rod gear 920 and the inner core gear 1020 to rotate, so that the push rod 400 and the inner core 200 move forward to release the valve distal end (see fig. 9 b); then, the motor driver 1440 controls the inner core pushing motor 1030 to stop rotating, the inner core 200 stops advancing, the motor driver 1440 drives the pushing rod motor 930 to rotate, and the pushing rod 400 continues advancing, so that the head 401 of the pushing rod abuts against the proximal end of the valve (see fig. 9 c); when the pushing action is completed, the motor drive 1420 controls the wire-taking-up motor 830 to start to take up wires, the left and right wire-taking-up reels 810 rotate, and the left and right wire-taking-up reels 510 are driven by the valve stent pull wires 700 until the valve stent pull wires 700 on both sides are tensioned (see fig. 9 d); then, the motor driver 1440 controls the push rod motor 930 to stop rotating, the push rod 400 stops advancing, the motor driver 1440 drives the inner core push motor 1030 to rotate, the inner core 200 continues advancing, and the proximal end of the valve is released (see fig. 9 e); after the wire-rewinding action is finished, the motor drives 1430 to drive the screw rod wire-cutting motor 610 to rotate, so that the wire-cutting knife holder 640 and the knife holder guide rail generate relative movement, the wire-cutting knife head 650 extends out, and the valve support traction wire 700 tightly stretched on the wire-rewinding pulley block is cut off (as shown in fig. 9 f); after cutting off the traction wire of the valve stent, the cutter head is driven to retract by the wire cutting motor; the release process is ended by this time; then the motor driver 1440 controls the push rod motor 930 and the inner core push motor 1030 to start to rotate reversely at the same time, so as to drive the push rod gear 920 and the inner core gear 1020 to rotate reversely until the push rod 400 returns to the initial position, and then the inner core push motor 1030 continues to rotate reversely until the inner core 200 returns to the initial position (as shown in fig. 9 g); when the whole conveying process is finished, stopping all motors, and displaying the running state as 'execution finished';
in the above automatic execution process, the "emergency stop" button is always active; when a user finds that an emergency occurs in the operation process, the conveying device can be controlled to suddenly stop through the emergency stop button at any time, and all motors stop rotating immediately at the moment; after the problem is solved, the conveying device can be controlled to return to the initial position through a reset button; clicking the 'start operation' again can operate according to the data submitted before the suspension; after the emergency stop, if the state of the conveying device needs to be adjusted or the manual control conveying device is selected to finish the rest process, mode switching can be performed, namely, the mode is changed from 'automatic conveying' to 'manual conveying';
in the manual control mode, a user can independently control any one motor to forward or reverse; when the manual control mode is switched, a user can click and select a motor to be controlled through a mouse and control the motor to rotate through a forward button and a backward button; when the button is pressed down, the motor rotates, and when the button is released, the motor stops rotating; through the manual control mode, the user can handle the special condition in the operation process, also can directly accomplish whole transportation process through the manual control mode.
The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and additions can be made without departing from the principle of the present invention, and these should also be considered as the protection scope of the present invention.