CN-121983273-A - Control method, flow limiting system and medium for cavity fluid infusion device

CN121983273ACN 121983273 ACN121983273 ACN 121983273ACN-121983273-A

Abstract

The invention relates to a control method, a flow limiting system and a medium for a lumen fluid infusion device, and belongs to the technical fields of medical engineering and medical instruments. The method comprises the steps of obtaining a physiological tolerance feature set of a target cavity and a physical attribute set of fluid to be infused, converting the feature set into control boundary parameters of the infusion device based on a preset mapping model, wherein the control boundary parameters comprise a maximum allowable volume flow rate, and responding to the parameters through a controller or a flow limiting mechanism, and physically limiting the actual output volume flow rate not to exceed the maximum value. According to the method, the maximum output volume flow rate is locked based on preset physiological and physical parameters in a feedforward control mode, dynamic adjustment is not performed by depending on real-time intracavity sensor signals, personalized fluid infusion of natural channels such as rectum, vagina, bladder and the like can be safely and comfortably finished under the condition of no real-time feedback, and the drug retaining effect and the tolerance of a target object are effectively improved.

Inventors

YAN GE
CAO ZHIYI
Huang Canchen

Assignees

艾格立特(武汉)科技有限公司
优畅达(武汉)医疗科技有限公司

Dates

Publication Date: 20260505
Application Date: 20260403

Claims (19)

1. A control method for a lumen fluid infusion device, comprising: Obtaining or determining a set of physiological tolerance features for characterizing a target luminal tolerance, the set of physiological tolerance features comprising at least a dynamic stimulation threshold; acquiring or determining a fluid property set of a fluid to be infused, the fluid property set comprising at least a fluid factor; determining a maximum allowable volumetric flow rate from the set of physiological tolerance characteristics and the set of fluid properties based on a preset mapping model; In the infusion execution stage, the actual volume flow rate of the cavity fluid infusion device always meets the requirement that the actual volume flow rate is smaller than or equal to the maximum allowable volume flow rate in the infusion process by executing an electronic control strategy and/or adopting a mechanical flow limiting structure; Wherein the maximum allowable volumetric flow rate is kept constant after the infusion is started, the constant state is ensured by logic locking of a control system and/or physical constraint of a mechanical structure, and real-time pressure, real-time flow or other real-time physiological signals in a cavity are not used as the basis for dynamically updating the maximum allowable volumetric flow rate in a closed loop, wherein the real-time signals can be used for monitoring, recording and triggering an alarm, and can trigger the interruption of the infusion and/or enter a safety degradation mode when an abnormality is detected, but are not used for updating or changing the maximum allowable volumetric flow rate.
2. The method of claim 1, wherein the set of physiological tolerance features further comprises a compliance factor and/or a sensitivity factor, wherein the mapping model is configured such that the value of the maximum allowable volumetric flow rate is positively correlated with the dynamic stimulation threshold and negatively correlated with the fluid factor, wherein the set of physiological tolerance features comprises a compliance factor and wherein the set of physiological tolerance features comprises a sensitivity factor.
3. The method of claim 2, wherein the set of physiological tolerance features includes a dynamic stimulation threshold, a compliance factor, and a sensitivity factor at the same time, and wherein the mapping model is configured to determine the maximum allowable volumetric flow rate by integrating the dynamic stimulation threshold, the compliance factor, and the sensitivity factor.
4. The method of any of claims 1 to 3, wherein the mapping model comprises at least one implementation of a functional relationship, a look-up table, a rule base, a fitting model, a machine learning model, and/or an equivalent mapping relationship cured by a mechanocuity based on calibration data.
5. The method of any one of claims 1 to 3, wherein the set of physiological tolerance characteristics further comprises a sensitivity factor determined based on at least one of a clinical diagnostic classification of the subject, a symptom questionnaire classification result, a pain/discomfort score classification, and/or a preset subject type option.
6. The method of claim 1, wherein the dynamic stimulation threshold is determined by a balloon dilation test comprising a stepwise incremental dilation and/or a ramp incremental dilation, and wherein in some embodiments, the dynamic stimulation threshold corresponds to one or a combination of a first sensation threshold, an initial stool threshold, a maximum tolerance threshold, and/or a trigger threshold that induces a rectal anal suppression reflex when the target lumen is the rectum.
7. The method of claim 1, wherein the fluid factor is determined based on at least one of fluid viscosity, density, temperature, rheology, and/or preset fluid type options.
8. The method of claim 1, wherein the fluid factor and the maximum allowable volumetric flow rate are pre-associated with a container or package identifier of the fluid to be infused, and wherein the acquiring means comprises reading the identifier and acquiring a fluid factor value associated therewith, or directly acquiring a maximum allowable volumetric flow rate value or a restriction setting associated therewith.
9. The method of claim 1, wherein the limiting of the actual volumetric flow rate to a maximum allowable volumetric flow rate or less includes: Converting the maximum allowable volumetric flow rate to an electronically controlled parameter and executing the electronically controlled parameter by the lumen fluid infusion device to define a maximum output volumetric flow rate; the maximum allowable volumetric flow rate is converted to a mechanical restriction setting that is a specified gear or a specified restriction state of the mechanical restriction valve to define the volumetric flow rate through a physical flow resistance.
10. The method of claim 9, wherein the mechanical restriction setting is achieved by a mechanical restriction valve having a plurality of preset restriction steps, and each step is a discrete step and corresponds to a different flow path geometry, thereby creating a different flow resistance to define the volumetric flow rate.
11. The method of claim 10, wherein the flow channel geometry includes, but is not limited to, an elongated straight tube flow channel, a labyrinth flow channel, a variable cross-section flow channel, a non-circular cross-section flow channel, a porous media flow channel, and/or other equivalent flow resistance structures based on hydrodynamic flow resistance principles.
12. The method of claim 9, wherein the electronically controlled parameter comprises a maximum output volume flow rate upper limit parameter, and the lumen fluid infusion device is configured to limit the volume flow rate at which the output does not exceed the maximum output volume flow rate upper limit parameter during the infusion.
13. The method of claim 1, wherein the lumen fluid infusion device comprises a pressure sensor and/or a flow sensor, the sensor output being used to monitor, record and/or trigger an alarm, but not to update or change the maximum output volumetric flow rate.
14. A lumen fluid infusion flow-limiting system, comprising: the parameter acquisition module is used for acquiring or determining a physiological tolerance characteristic set and a fluid attribute set; the mapping execution module is used for determining the maximum allowable volume flow rate based on a preset mapping model; The flow limiting execution module is used for enabling the actual volume flow rate of the system to always meet the actual volume flow rate smaller than or equal to the maximum allowable volume flow rate in the infusion process through electronic control and/or mechanical flow limiting; the cavity channel interface module is used for communicating with the target cavity channel to complete fluid infusion; Wherein the system is configured to feed-forward lock and maintain a constant said maximum allowable volumetric flow rate after infusion has begun, the constancy being ensured by logical locking and/or physical constraints and not subject to dynamic closed loop updates of said maximum allowable volumetric flow rate by intra-luminal real-time pressure, real-time flow or other real-time physiological signals, wherein said real-time signals may be used to monitor, record, trigger alarms and trigger interruption of infusion and/or entry into a safe degradation mode upon detection of an abnormality but are not used to update or change said maximum allowable volumetric flow rate.
15. The system of claim 14, wherein the map execution module comprises a local map execution unit, and further optionally comprising a cloud service unit for model updating, parameter library updating, and/or data analysis, wherein the local map execution unit is still capable of independently determining the maximum allowable volumetric flow rate and completing flow limiting execution in the absence of the cloud service unit.
16. The system according to claim 14 or 15, further comprising a parameter comparison means provided in connection with the mechanical restriction valve, said parameter comparison means being dedicated to the mechanical restriction valve, wherein the gear identification recorded thereon uniquely corresponds to the identification on the valve body, said parameter comparison means being adapted to determine and indicate the mechanical gear and/or restriction setting to be locked based on the physiological tolerance feature set and the fluid property set.
17. The system of any one of claims 15 to 16, further comprising a prefilled fluid container provided in a fixed combination with the flow restriction setting of the flow restriction execution module, the fixed combination corresponding to a pre-calibrated or pre-set fluid factor level and/or flow restriction setting, such that the system completes the determination of the maximum allowable volumetric flow rate and/or locking of the flow restriction setting without requiring a user to determine fluid viscosity or select a fluid type option, and such that the actual volumetric flow rate during infusion satisfies the actual volumetric flow rate being equal to or less than the maximum allowable volumetric flow rate.
18. The system of claim 17, wherein the prefilled fluid container and/or a flow restricting structure in fixed combination therewith is identified with identification information for identifying the fixed combination, including but not limited to color coding, bar codes, two-dimensional codes, RFID tags, mating serial numbers, and/or shape matching features.
19. A computer readable storage medium having stored thereon a computer program which, when executed by a processor, causes the processor to perform the method steps of any of claims 1 to 13.

Description

Control method, flow limiting system and medium for cavity fluid infusion device Technical Field The invention belongs to the technical field of medical engineering and medical appliances, and particularly relates to a control method, a flow limiting system and a medium for a cavity fluid infusion device. Background In the treatment of digestive, gynecological and urinary cavity administration, the core challenge is to balance "drug effective retention" with "no pain/no reflex in the target subject". The prior art scheme has the following defects: The empirical infusion is lack of individual adaptation, namely the widely used gravity infusion or a simple constant flow pump, the volume flow rate setting of the pump depends on the experience of an operator, and the physiological characteristics of aberration differentiation cannot be individually adjusted according to the target. For example, the rectal initial sensation threshold of an Outlet Obstruction Constipation (OOC) target subject is significantly higher than that of a healthy population, while the pain threshold of an Irritable Bowel Syndrome (IBS) target subject is significantly lower. The prior art fails to quantify and respond to such critical physiological differences, resulting in an infusion process that is prone to discomfort to the target subject or premature triggering of emptying reflex, affecting the therapeutic effect. The closed-loop feedback system has clinical limitations that high-end equipment which is partially subjected to closed-loop control by adopting an intra-cavity pressure sensor can be dynamically adjusted, but the problems that the sensor is easy to be polluted and blocked by cavity contents (such as feces and mucus), the accuracy of measurement is influenced by tissue wrapping after long-term implantation, the cost is high due to disposable use and the like are faced, and the popularization and the application of the sensor in clinic are severely limited. Therefore, there is a need for a solution that does not rely on real-time intra-luminal sensor feedback, can preset safety boundaries by quantifiable physiological characteristics and fluid properties prior to infusion, and maintains stable constraints during infusion. The impact of fluid physical properties is ignored as little prior art systematically establishes quantitative compensation relationships between fluid properties (e.g., viscosity, density, temperature) and safe infusion parameters. The physical characteristic difference of different liquid medicines can obviously influence the flow resistance and the cavity stimulation, but the existing method lacks a corresponding standardized correction mechanism. In summary, the prior art has not established a quantitative model for coupling physiological tolerance characteristics and fluid properties, such as dynamic stimulation threshold, and optionally channel compliance and/or individual sensitivity, and has not been able to implement safe, universal, and economical and reliable channel infusion volumetric flow rate setting in a feedforward control manner independent of real-time sensor feedback based on the model. Disclosure of Invention In order to solve the problems in the prior art, the invention provides a method for controlling the infusion of a channel fluid based on physiological tolerance characteristics, and the purpose of the invention can be realized by the following technical scheme: A control method for a lumen fluid infusion device, comprising: Obtaining or determining a set of physiological tolerance features for characterizing a target luminal tolerance, the set of physiological tolerance features including at least a dynamic stimulation threshold; acquiring or determining a fluid property set of a fluid to be infused, the fluid property set comprising at least a fluid factor; determining a maximum allowable volumetric flow rate from the set of physiological tolerance characteristics and the set of fluid properties based on a preset mapping model; In the infusion execution stage, the actual volume flow rate of the cavity fluid infusion device always meets the requirement that the actual volume flow rate is smaller than or equal to the maximum allowable volume flow rate in the infusion process by executing an electronic control strategy and/or adopting a mechanical flow limiting structure; Wherein the maximum allowable volumetric flow rate is kept constant after the infusion is started, the constant state is ensured by logic locking of a control system and/or physical constraint of a mechanical structure, and real-time pressure, real-time flow or other real-time physiological signals in a cavity are not used as the basis for dynamically updating the maximum allowable volumetric flow rate in a closed loop, wherein the real-time signals can be used for monitoring, recording and triggering an alarm, and can trigger the interruption of the infusion and/or enter a safety degradation mode when an abnormali