Search

CN-121971143-A - Choledocholithiasis stone extraction device and control method thereof

CN121971143ACN 121971143 ACN121971143 ACN 121971143ACN-121971143-A

Abstract

The invention relates to the technical field of medical instruments and discloses a choledocholithiasis stone taking device which comprises a connecting seat, a flexible stone taking catheter and a compliance response balloon which are sequentially connected from right to left, wherein a micro-fluid displacement sensing unit and a stone taking propelling unit are arranged on the outer side of one end, close to the connecting seat, of the flexible stone taking catheter, a plurality of pressure micro-fluctuation collecting units are distributed on the upper surface of the cavity wall of the compliance response balloon, the flexible stone taking catheter is fixedly installed with the compliance response balloon, a micro-fluid deformation cavity communicated with the interior of the flexible stone taking catheter is arranged in the compliance response balloon, the micro-fluid displacement sensing unit is communicated with the micro-fluid deformation cavity through a micro-fluid connecting pipe, and the stone taking propelling unit, the pressure micro-wave motion collecting unit and the micro-fluid displacement sensing unit are all electrically connected with a controller. The invention achieves the aim of improving the accuracy in the whole stone extraction process.

Inventors

  • ZHAO CHENXI
  • ZHU YANAN
  • Hou Congran

Assignees

  • 保定市第一中心医院

Dates

Publication Date
20260505
Application Date
20260305

Claims (10)

  1. 1. The choledocholithiasis stone removing device is characterized by comprising a connecting seat (1), a flexible stone removing catheter (2) and a compliance response balloon (3) which are sequentially connected from right to left, wherein a microfluid displacement sensing unit (4) and a stone removing propelling unit (5) are arranged outside one end, close to the connecting seat (1), of the flexible stone removing catheter (2), and a plurality of pressure micro-fluctuation collecting units (6) for collecting transient pressure fluctuation signals of the compliance response balloon (3) in the working process are distributed on the upper surface of the cavity wall of the compliance response balloon (3); The flexible stone extraction catheter (2) is fixedly arranged with the compliant response balloon (3), and a micro-fluid deformation cavity communicated with the interior of the flexible stone extraction catheter (2) is arranged in the compliant response balloon (3); the microfluidic displacement sensing unit (4) is communicated with the microfluidic deformation cavity through a microfluidic connecting pipe and is used for detecting the volume displacement change of a working medium in the microfluidic deformation cavity; The stone extraction propulsion unit (5) is used for applying propulsion and retraction actions along the axial direction of the flexible stone extraction catheter to the flexible stone extraction catheter (2), and the stone extraction propulsion unit (5), the pressure micro-fluctuation acquisition unit (6) and the micro-fluid displacement sensing unit (4) are electrically connected with controllers, and are used for calculating the compliance of the common bile duct wall according to transient pressure fluctuation signals and working medium volume displacement change signals and generating propulsion control instructions for controlling the stone extraction propulsion unit according to the compliance of the common bile duct wall so as to draw the common bile duct stones to move towards the duodenum under the condition that the compliance of the common bile duct wall is matched.
  2. 2. A choledocholithiasis extraction device according to claim 1, characterized in that the compliant response balloon (3) comprises a distal detection section, a middle imaging section and a proximal traction section in sequence along the axial direction of the flexible extraction catheter 2, the distal detection section, the middle imaging section and the proximal traction section being separated by a membrane; The microfluidic displacement sensing unit (4) comprises a scale liquid storage chamber, an elastic diaphragm and a displacement sensor, wherein the scale liquid storage chamber is communicated with the microfluidic deformation cavity through a microfluidic connecting pipe, the elastic diaphragm is arranged at the outer end of the scale liquid storage chamber in a sealing manner, and the displacement sensor is used for detecting the deformation quantity of the elastic diaphragm and converting the deformation quantity of the elastic diaphragm into a working medium volume displacement change signal; the pressure micro-fluctuation acquisition unit (6) comprises a plurality of micro pressure sensors which are distributed at different positions in the axial direction of the compliant response balloon (3) and are used for acquiring transient pressure fluctuation distribution along the axial direction of the compliant response balloon; The stone extraction propulsion unit (5) comprises a reciprocating driving mechanism and is used for driving the flexible stone extraction catheter 2 to axially perform periodic propulsion and retraction under the action of propulsion control instructions output by the controller; The controller is internally provided with a compliance calculation module, a partition identification module and a propulsion strategy generation module, wherein the compliance calculation module is used for calculating the common bile duct wall compliance based on transient pressure fluctuation signals and working medium volume displacement change signals, the partition identification module is used for dividing the common bile duct wall compliance into a basic compliance area, an enhanced compliance area and a stiff risk area, and the propulsion strategy generation module is used for respectively generating different propulsion rhythm parameters and retraction control parameters for the basic compliance area, the enhanced compliance area and the stiff risk area.
  3. 3. A control method of a choledocholithiasis lithotomy device, implemented in a choledocholithiasis lithotomy device according to any one of claims 1-2, comprising: After the compliant response balloon (3) enters the common bile duct, injecting a working medium through the micro-fluid deformation cavity to enable the balloon to generate initial expansion, collecting transient pressure fluctuation signals and volume displacement change signals along the axial direction of the compliant response balloon (3), and constructing a compliant original data set through the transient pressure fluctuation signals and the volume displacement change signals; Filtering, normalizing and position registering the compliance original data set to obtain a compliance data set, calculating and counting the volume displacement variation corresponding to the transient pressure fluctuation of the biliary wall through the compliance data set to obtain a compliance distribution curve, and dividing the compliance distribution curve into a basic compliance area, an enhanced compliance area and a stiff risk area according to the amplitude and the variation trend of the compliance distribution curve; determining a propelling area based on the compliance distribution curve and the position of the stone, and setting rhythm parameters for the basic compliance area and the enhanced compliance area respectively, wherein the rhythm parameters comprise period propelling duration, propelling force and propelling and retracting time ratio; The stone taking propulsion unit (5) executes propulsion operation and retraction operation according to rhythm parameters, acquires new transient pressure fluctuation signals and new volume displacement change signals in real time and updates a compliance distribution curve during the propulsion operation and the retraction operation to obtain a new compliance distribution curve and a stone resistance change curve, and the controller updates the rhythm parameters in real time according to the new compliance distribution curve and the stone resistance curve; when the new compliance distribution curve has the condition that the compliance continuously decreases or the resistance continuously increases, the controller triggers a risk withdrawal strategy to enable the compliance response balloon (3) to rapidly exit from the stiff risk area and re-inject the working medium to reconstruct the compliance distribution curve; When the calculus resistance data suddenly drops and the transient pressure fluctuation signal is amplified, the controller judges that the slippage trend exists, and the controller reconstructs rhythm parameters according to the compliance distribution curve; When the new compliance distribution curve shows that the front part of the compliance response balloon (3) is continuously in the enhanced compliance area and the stone resistance data continuously decrease trend, the controller switches to a final steady-state traction mode, stones are sent to the duodenum by shortening the ratio of pushing and withdrawing time and pushing force, and when the transient pressure fluctuation signal is restored to the characteristic range of the basic compliance area and the stone resistance data approaches zero, the controller judges that the stone is led out and the pushing is stopped.
  4. 4. The control method of the choledocholithiasis lithotomy device according to claim 3, wherein the construction of the compliant raw data set comprises the steps of injecting a working medium into the micro-fluid deformation cavity in a volume increasing manner, respectively acquiring corresponding transient pressure fluctuation signals and volume displacement change signals at the beginning and the end of each injection, and arranging all the transient pressure fluctuation signals and the volume displacement change signals in time and axial positions to obtain the compliant raw data set.
  5. 5. The method for controlling the choledocholithiasis lithotomy device according to claim 4, wherein the method is characterized by comprising the steps of dividing a basic compliance area, an enhanced compliance area and a stiff risk area into a transient pressure fluctuation signal and a volume displacement change signal in a compliance original data set, carrying out filtering, normalization and position registration processing to obtain a compliance data set, calculating a volume displacement change amount corresponding to the transient pressure fluctuation at each axial position according to the compliance data set by a controller to obtain a local bile duct wall compliance index, connecting a plurality of local bile duct wall compliance indexes to obtain a compliance distribution curve, carrying out amplitude interval division and change trend analysis on the compliance distribution curve by the controller, marking an area with the compliance index at a medium amplitude and a gentle change trend as the basic compliance area, marking an area with the compliance index at a high amplitude and an ascending change trend along with the axial direction as the enhanced compliance area, and marking an area with the compliance index at a low amplitude and containing local sudden drop or abnormal change trend as the stiff risk area.
  6. 6. The method of claim 5, wherein the controller defines the basal compliance zone and the enhanced compliance zone as a propellable region and defines the stiff risk zone as a non-propellable region based on the compliance profile and the location of the stone; the controller sets a first set of rhythm parameters for the propulsive area in the basic compliance area, wherein the first set of rhythm parameters comprise period propulsion time length, propulsion force and propulsion and withdrawal time ratio, and the propulsion and withdrawal time ratio is larger than 1; The controller sets a second group of rhythm parameters for the propelled area in the enhanced compliance area, the period propulsion duration in the second group of rhythm parameters is shorter than that in the first group of rhythm parameters, the propulsion strength is greater than that in the first group of rhythm parameters, and the ratio of the propulsion time to the withdrawal time is close to 1; The controller does not set rhythm parameters for the non-propelled area in the stiff risk area, and only sets withdrawal instructions; The controller sequentially arranges the first group of rhythm parameters and the second group of rhythm parameters according to expected movement paths of the calculus to form a rhythm parameter execution sequence according to the axial position of the calculus in the bile duct and the arrangement sequence of the basic compliance area and the enhanced compliance area, and marks the non-propulsive area as a skip section in the rhythm parameter execution sequence.
  7. 7. The control method of the choledocholithiasis lithotomy device according to claim 6, wherein the lithotomy propulsion unit (5) drives the flexible lithotomy catheter (2) to propel or retract according to the propulsion force, the period propulsion time and the propulsion and retraction time ratio of the current rhythm parameters, and the controller acquires new transient pressure fluctuation signals and new volume displacement change signals in real time during the propulsion and retraction processes; The controller superimposes the new transient pressure fluctuation signal and the new volume displacement change signal on the compliance original data set to obtain a new compliance distribution curve, and constructs a calculus resistance change curve by analyzing the change trend of the new compliance distribution curve in the rhythm parameter execution sequence; and updating the rhythm parameters in real time according to the new compliance distribution curve and the calculus resistance change curve.
  8. 8. The method according to claim 7, wherein the controller continuously monitors the local bile duct wall compliance index of each axial region in the new compliance profile, and marks a stiff risk region when the local bile duct wall compliance index of a certain axial region is lower than the local bile duct wall compliance index of the base compliance region in two or more consecutive rhythm parameter execution sequences and has no recovery trend; The controller synchronously monitors a calculus resistance change curve, and confirms that the area where the current calculus is positioned is a stiff risk area when the calculus resistance change curve shows monotonic rising in more than three continuous rhythm parameter execution sequences and the rising amplitude exceeds a preset resistance rising threshold; when the new compliance distribution curve and the stone resistance change curve both indicate the stiff risk zone, the controller triggers a risk withdrawal strategy, the stone extraction propulsion unit (5) performs, and the compliance response balloon (3) is withdrawn into the adjacent basic compliance zone; after the risk retraction strategy is executed, the controller reconstructs compliance distribution curves of the front and rear areas of the stiff risk area at the adjacent basic compliance area positions, and adjusts the rhythm parameter execution sequence.
  9. 9. The control method of a choledocholithiasis removing device according to claim 8, wherein the controller updates a stone resistance change curve according to a new compliance distribution curve after a primary rhythm parameter execution sequence is finished, and determines the primary rhythm parameter execution sequence as having a slip trend when the stone resistance change curve is greatly reduced in the rhythm parameter execution sequence and simultaneously the peak amplitude of a transient pressure fluctuation signal in the rhythm parameter execution sequence is increased; The controller stops issuing instructions and searches the new compliance profile for a continuous path of the base compliance zone and the enhanced compliance zone in the advanceable area in front of the compliance response balloon (3); When the new compliance distribution curve shows that a path formed by a continuous basic compliance area and an enhanced compliance area exists, the controller takes the path as a corrected traction path, and reconstructs rhythm parameters according to the traction path; When the new compliance profile shows that there is no satisfactory base compliance zone and enhanced compliance zone continuous path in the advanceable area in front of the compliance response balloon (3), the controller triggers a risk retraction strategy to retract the compliance response balloon (3) to the adjacent base compliance zone, reconstruct the compliance profile, and determine a new traction path.
  10. 10. The method according to claim 9, wherein the controller is switched to a final steady-state traction mode when the new compliance profile shows that local biliary wall compliance indicators of a plurality of continuously advanceable areas in front of the compliance response balloon (3) are in the enhanced compliance zone and the stone resistance change profile exhibits a decreasing trend in the three continuous rhythmic parameter execution sequences; The controller sets the period pushing time length in the rhythm parameters to be smaller than the first group of rhythm parameters, sets the pushing force to be equal to the first group of rhythm parameters, and adjusts the pushing and withdrawing time ratio to be not more than 1; The controller continuously monitors a calculus resistance change curve and a transient pressure fluctuation signal in a final steady-state traction mode, and judges that the calculus is completely led out through a duodenal outlet when the tail end of the calculus resistance change curve is gradually close to zero and the amplitude of the transient pressure fluctuation signal is in the range of a basic compliance zone in a plurality of rhythm parameter execution sequences; after the calculus is judged to be exported, the controller stops the pushing action of the rhythm parameter execution sequence, and slowly releases the working medium through the micro-fluid deformation cavity, so that the compliance response saccule (3) gradually collapses and exits the common bile duct.

Description

Choledocholithiasis stone extraction device and control method thereof Technical Field The invention relates to the technical field of medical appliances, in particular to a choledocholithiasis stone removing device and a control method thereof. Background Choledocholithiasis is one of common diseases of digestive system, and the long-term existence of the choledocholithiasis is easy to cause bile drainage blockage, secondary acute suppurative cholangitis, cholangitis and other serious complications. The prior clinical common technology mainly comprises a device and a method for taking out stones after a natural channel is expanded by a nipple by adopting an expansion saccule, a device for taking out the bile duct stones after a passage is constructed by expanding the bile duct, a structured scraping device for scraping or cleaning stones on the inner wall of the bile duct by an endoscope, an in-vivo stone crushing and processing device for crushing the stones in the biliary duct and then discharging the stones together with a stone taking tool, and the like, wherein the technologies improve the stone taking and discharging efficiency to different degrees, lighten the trauma of patients and promote the application of minimally invasive stone taking. However, some common problems commonly exist in the specific implementation process of the technology, such as the devices of expanding a balloon for removing stones, expanding and removing stones through a gall bladder tube or scraping and removing stones from the inner wall, and the like, most of the devices only depend on single or small amount of pressure monitoring, or completely depend on hand experience of operators to judge the stress condition of the gall bladder tube wall and the resistance of stones, continuous and fine quantitative characterization on the compliance of the gall bladder tube wall is lacking, once the filling pressure or the traction force of the balloon is improperly grasped, complications such as tearing, bleeding and the like of the gall bladder tube wall or the nipple part are easily caused, the existing devices often adopt a constant force or a simple graded pressurizing mode in the expanding or traction process, the compliance difference of the gall bladder tube wall at different axial positions is difficult to identify local stiffness, fibrosis or past operation scar areas in time, so that stones are lack of a targeted propulsion strategy adjustment and a risk withdrawal mechanism when passing through the high risk areas, the conventional stone removal process is operated to be dominant, the conventional stone removal process usually depends on personal and the judgment of the rhythm, the self-regulation of the compliance condition of the gall bladder tube wall and the resistance change based on the image condition is difficult to realize in real-time, and the adaptive regulation of the state of the resistance of the characteristics of the gall bladder tube wall is difficult to realize. In addition, although the existing part of in-vivo calculus crushing device can crush calculus through energy striking, migration, convergence and final discharge of crushed fragments in a common bile duct still need to be realized by means of a traditional calculus removing balloon, a basket or a scraping and sweeping device, a compliance original data set and a compliance distribution curve which are established by combining transient pressure fluctuation of the common bile duct wall and volume displacement change of an internal working medium still are lacking, and the calculus resistance change curve and the common bile duct wall compliance partition cannot be combined, so that the dynamics, duration and the ratio of pushing and withdrawing time of each pushing period are guided, and the refinement degree of rhythm control in the whole calculus removing process is limited. In order to solve the above problems, a need exists for a control method and apparatus that combines a "stone resistance change curve" with a "common bile duct wall compliance zone". Disclosure of Invention The invention aims to provide a choledocholithiasis stone removing device and a control method thereof, so as to solve the problems and achieve the aim of improving the accuracy degree in the whole stone removing process. In order to achieve the above object, the present invention provides the following solutions: The choledocholithiasis stone removing device comprises a connecting seat transient pressure fluctuation, a flexible stone removing catheter transient pressure fluctuation and a compliance response saccule transient pressure fluctuation which are sequentially connected from right to left, wherein a micro-fluid displacement sensing unit transient pressure fluctuation and a stone removing propulsion unit transient pressure fluctuation are arranged outside one end, close to the connecting seat transient pressure fluctuation, of the flexible stone removing catheter