Control method for cavity fluid infusion device, flow limiting system and medium

Abstract

The invention relates to a control method for a cavity fluid infusion device, a flow limiting system and a medium, and belongs to the technical field of medical engineering and medical instruments. The method comprises the following steps: acquiring a physiological tolerance feature set of a target orifice 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 the maximum allowable volume flow rate; the actual output volumetric flow rate is physically limited not to exceed the maximum value in response to the parameter by a controller or a flow limiting mechanism. According to the method, through a feedforward control mode, the maximum output volume flow rate is locked based on preset physiological and physical parameters, dynamic adjustment is carried out without depending on real-time intracavity sensor signals, personalized fluid infusion of natural cavities such as rectum, vagina and bladder can still be safely and comfortably completed under the condition of no real-time feedback; the drug retention effect and the target object tolerance are effectively improved.

Description

Technical Field

[0001] This invention belongs to the field of medical engineering and medical device technology, specifically relating to a control method, flow limiting system and medium for a cavity fluid infusion device. Background Technology

[0002] In intracavitary drug delivery in gastroenterology, gynecology, and urology, the core challenge lies in balancing "effective drug retention" with "painlessness / absence of reflexes in the target patient." Existing technologies generally suffer from the following shortcomings: Empirical infusion lacks individualized adaptation: The widely used gravity infusion or simple constant-flow pumps rely heavily on operator experience for volumetric flow rate settings, failing to provide personalized adjustments based on the individualized physiological characteristics of the target population. For example, the initial rectal sensory threshold of individuals with outlet obstruction constipation (OOC) is significantly higher than that of healthy individuals, while the pain threshold of individuals with irritable bowel syndrome (IBS) is significantly lower. Current technologies fail to quantify and respond to these key physiological differences, leading to infusion procedures that easily cause discomfort or premature triggering of the emptying reflex, thus affecting treatment efficacy.

[0003] Closed-loop feedback systems have clinical limitations: while some high-end devices using intracavitary pressure sensors for closed-loop control can dynamically adjust, they face problems such as sensor contamination and blockage by cavity contents (e.g., feces, mucus), tissue encapsulation affecting measurement accuracy after long-term implantation, and high costs due to single-use, severely limiting their widespread clinical application. Therefore, there is an urgent need for a technical solution that does not rely on real-time intracavitary sensor feedback, can preset safety boundaries based on quantifiable physiological characteristics and fluid properties before infusion, and maintains stable constraints during infusion.

[0004] The influence of fluid physical properties is overlooked: existing technologies rarely systematically establish quantitative compensation relationships between fluid properties (such as viscosity, density, and temperature) and safe infusion parameters. Differences in the physical properties of different drug solutions can significantly affect flow resistance and cavity irritation, but existing methods lack corresponding standardized correction mechanisms.

[0005] In summary, existing technologies have not yet established a coupled quantitative model that integrates dynamic stimulation thresholds and optional cavity compliance and / or individual sensitivity, as well as other physiological tolerance characteristics and fluid properties. Nor have they been able to achieve safe, universal, and economically reliable cavity infusion volumetric flow rate setting based on this model using a feedforward control method that does not rely on real-time sensor feedback. Summary of the Invention

[0006] To address the aforementioned problems in the existing technology, this invention provides a cavity fluid infusion control method based on physiological tolerance characteristics. The objective of this invention can be achieved through the following technical solution: A control method for a cavity fluid delivery device includes: Acquire or determine a set of physiological tolerance features for characterizing the tolerance of a target cavity, the set of physiological tolerance features including at least dynamic stimulation thresholds; in some embodiments, the set of physiological tolerance features also includes compliance factors and / or sensitivity factors for modification; Obtain or determine a set of fluid properties of the fluid to be infused, wherein the set of fluid properties includes at least a fluid factor; Based on a preset mapping model, the maximum permissible volumetric flow rate is determined according to the physiological tolerance feature set and the fluid property set. During the infusion execution phase, by implementing electronic control strategies and / or employing mechanical flow-limiting structures, the actual volumetric flow rate of the cavity fluid infusion device is always kept less than or equal to the maximum permissible volumetric flow rate during the infusion process. The maximum permissible volumetric flow rate remains constant after the infusion begins. This constant state is ensured by the logic locking of the control system and / or the physical constraints of the mechanical structure, and is not based on real-time pressure, real-time flow rate or other real-time physiological signals within the cavity for dynamic closed-loop updates of the maximum permissible volumetric flow rate. The real-time signals can be used for monitoring, recording, and triggering alarms, and can trigger interruption of infusion and / or entry into a safety degradation mode when an anomaly is detected, but are not used to update or change the maximum permissible volumetric flow rate.

[0007] Specifically, in some embodiments, the mapping model is configured such that: the value of the maximum permissible volumetric flow rate is positively correlated with the dynamic stimulation threshold; when the physiological tolerance feature set includes a compliance factor, it is positively correlated with the compliance factor; when the physiological tolerance feature set includes a sensitivity factor, it is negatively correlated with the sensitivity factor; and it is negatively correlated with the fluid factor.

[0008] Specifically, the mapping model includes at least one of the following implementations: functional relationship, lookup table, rule base, fitting model, machine learning model, and / or equivalent mapping relationship solidified by mechanical current limiting structure based on calibration data.

[0009] In one implementation, the mapping model is implemented as a lookup table, which can be constructed using pre-calibrated data (e.g., segmented sampling and verification based on the dynamic stimulation threshold τ of the target cavity and the physical properties of the fluid to be infused), and stores the maximum permissible volumetric flow rate Q corresponding to different input combinations. limit Value or mechanical gear number.

[0010] Specifically, the sensitivity factor is determined based on at least one of the following: the target object's clinical diagnostic classification, symptom questionnaire grading results, pain / discomfort rating grading, and / or a preset target object type option.

[0011] Specifically, the fluid factor is determined based on at least one of the following: fluid viscosity, density, temperature, rheological type, and / or a preset fluid type option.

[0012] Specifically, the fluid factor and the maximum permissible volumetric flow rate are pre-associated with the container or packaging identifier of the fluid to be infused; the acquisition method includes reading the identifier and obtaining the associated fluid factor value, or directly obtaining the associated maximum permissible volumetric flow rate value or flow restriction setting.

[0013] Specifically, the methods by which the actual volumetric flow rate satisfies the constraint that the actual volumetric flow rate is less than or equal to the maximum permissible volumetric flow rate include: The maximum permissible volumetric flow rate is converted into electronic control parameters, and the cavity fluid delivery device executes the electronic control parameters to limit the maximum output volumetric flow rate; The maximum permissible volumetric flow rate is converted into a mechanical flow limiting setting, which is a specified position or a specified flow limiting state of the mechanical flow limiting valve, so as to limit the volumetric flow rate through physical flow resistance.

[0014] Furthermore, the mechanical flow restriction setting is achieved by a mechanical flow restriction valve with multiple preset flow restriction levels, and each level is a discrete level and corresponds to a different flow channel geometry, thereby forming different flow resistances to limit the volumetric flow rate.

[0015] Furthermore, the flow channel geometry includes, but is not limited to: slender straight pipe flow channels, labyrinthine flow channels, variable cross-section flow channels, non-circular cross-section flow channels, porous medium flow channels, and / or other equivalent flow resistance structures based on the fluid dynamics flow resistance principle.

[0016] Furthermore, the electronic control parameters include a maximum output volumetric flow rate limit parameter, and the cavity fluid delivery device is configured to limit the output volumetric flow rate to no more than the maximum output volumetric flow rate limit parameter during delivery.

[0017] Specifically, the cavity fluid delivery device includes a pressure sensor and / or a flow sensor. The sensor outputs are used to monitor, record, and / or trigger alarms, but not to update or change the maximum output volumetric flow rate. In some embodiments, when an abnormal signal is detected, the sensor outputs may also trigger an interruption of delivery and / or entry into a safety degradation mode, but again, this is not used for dynamic closed-loop updates of the maximum output volumetric flow rate.

[0018] A cavity fluid delivery flow restriction system, comprising: The parameter acquisition module is used to acquire or determine the physiological tolerance feature set and the fluid property set. The mapping execution module is used to determine the maximum allowable volumetric flow rate based on a preset mapping model. The flow limiting execution module is used to limit the flow through electronic control and / or mechanical means so that the actual volumetric flow rate of the system during infusion always meets the requirement that the actual volumetric flow rate is less than or equal to the maximum allowable volumetric flow rate. Cavity interface module, used to connect with the target cavity to complete fluid delivery; The system is configured to: after infusion begins, feedforward lock and maintain a constant maximum permissible volumetric flow rate, the constantness of which is guaranteed by logical locking and / or physical constraints, and not to use real-time intracavitary pressure, real-time flow rate or other real-time physiological signals as the basis for dynamic closed-loop updating of the maximum permissible volumetric flow rate; wherein, the real-time signals can be used for monitoring, recording, and triggering alarms, and can trigger interruption of infusion and / or entry into a safety degradation mode when an anomaly is detected, but are not used to update or change the maximum permissible volumetric flow rate.

[0019] Furthermore, the mapping execution module includes a local mapping execution unit; and the system may also optionally include a cloud service unit for model updates, parameter library updates, and / or data analysis; wherein, the local mapping execution unit can still independently determine the maximum allowable volumetric flow rate and complete the flow limiting execution even when the cloud service unit is absent.

[0020] Furthermore, it also includes a parameter comparison tool provided in conjunction with the mechanical flow limiting valve. The parameter comparison tool is specifically designed for the mechanical flow limiting valve, and the position markings recorded on it uniquely correspond to the markings on the valve body. The parameter comparison tool is used to determine and indicate the mechanical position and / or flow limiting setting that should be locked based on the physiological tolerance characteristic set and fluid property set.

[0021] Furthermore, it also includes a pre-filled fluid container, which is provided in a fixed combination with the flow limiting setting of the flow limiting execution module; the fixed combination corresponds to a pre-calibrated or preset fluid factor level and / or flow limiting setting, so that the system can determine the maximum allowable volumetric flow rate and / or lock the flow limiting setting without requiring the user to measure the fluid viscosity or select a fluid type option, and ensure that the actual volumetric flow rate during the infusion process is less than or equal to the maximum allowable volumetric flow rate.

[0022] Furthermore, the pre-filled fluid container and / or the flow-limiting structure fixedly combined with it are marked with identification information for identifying the fixed combination, including but not limited to color coding, barcodes, QR codes, RFID tags, pairing serial numbers and / or shape matching features.

[0023] The beneficial effects of this invention are as follows: This invention achieves safe, universal, and cost-effective cavity infusion volumetric flow rate setting based on feedforward control by integrating dynamic stimulation thresholds and a coupled quantitative model of physiological tolerance characteristics such as cavity compliance and / or individual sensitivity with fluid properties. Compared to existing technologies, this method not only allows for precise adaptation to individual differences in the target subject but also avoids reliance on real-time sensor feedback, significantly reducing equipment costs and operational complexity. Furthermore, by combining a cloud service module with physical control tools, this invention provides an offline-available hardware flow limiting solution while ensuring efficient computation and dynamic optimization, further enhancing clinical applicability and safety. The mechanical regulating valve design fully considers hydrodynamic characteristics, helping to reduce the risk of additional stimulation caused by fluid disturbances. Overall, this invention provides an innovative solution for cavity drug delivery in gastroenterology, gynecology, and urology, and has significant clinical application value. Attached Figure Description

[0024] To facilitate understanding by those skilled in the art, the present invention will be further described below with reference to the accompanying drawings.

[0025] Figure 1 This is a schematic flowchart of a control method for a cavity fluid infusion device according to the present invention; Figure 2 This is a core logic block diagram of the present invention; Figure 3 This is an example diagram of the parameter comparison tool in this invention, which shows the mapping relationship between physiological tolerance level and fluid factor to determine the flow limiting level; Figure 4 One example structure is shown (e.g., perforated disc type / rotary valve core type, etc.). Figure 5 This is a system overview diagram of the present invention; Figure 6 This is a schematic diagram of a scenario according to the present invention. Detailed Implementation

[0026] Example embodiments will now be described more fully with reference to the accompanying drawings. However, example embodiments can be implemented in many forms and should not be construed as limited to the examples set forth herein; rather, these embodiments are provided to make this disclosure more comprehensive and complete, and to fully convey the concept of example embodiments to those skilled in the art. Furthermore, the described features, structures, or characteristics can be combined in any suitable manner in one or more embodiments. In the following description, numerous specific details are provided to give a full understanding of embodiments of this disclosure. However, those skilled in the art will recognize that the technical solutions of this disclosure can be practiced without one or more of the specific details, or other methods, components, apparatuses, steps, etc., can be employed. In other instances, well-known methods, apparatuses, implementations, or operations are not shown or described in detail to avoid obscuring aspects of this disclosure. The blocks shown in the drawings are merely functional entities and do not necessarily correspond to physically independent entities. That is, these functional entities can be implemented in software, in one or more hardware modules or integrated circuits, or in different network and / or processor devices and / or microcontroller devices. The flowcharts shown in the drawings are merely illustrative and do not necessarily include all contents and operations / steps, nor do they necessarily have to be performed in the order described. For example, some operations / steps can be broken down, while others can be combined or partially combined. Therefore, the actual execution order may change depending on the actual situation.

[0027] In the exemplary descriptions of this specification, volumetric flow rate may be expressed in terms of mL / min, and pressure may be expressed in terms of mmHg. It should be understood that the above units are for illustrative purposes only and do not constitute a limitation on the scope of protection of this invention. To avoid ambiguity, the examples in this specification all use a consistent unit system.

[0028] Terminology definition: (1) Cavity: A cavity in the human body that can contain / drain fluids, including but not limited to the rectum, vagina, cervix, bladder, urethra, etc.

[0029] (2) Cavity fluid: fluid media that enter the cavity, including but not limited to drug solution, gel, suspension, flushing solution, etc.

[0030] (3) Physiological tolerance feature set: a set of parameters used to characterize the tolerance of the target cavity, including at least τ; and optionally including C and / or σ.

[0031] (4) Dynamic stimulation threshold τ: refers to the stimulation amount threshold corresponding to the target cavity reaching the preset sensory event point and / or reflex event point under the preset stimulation profile (e.g., step-by-step, ramp-by-ram, or pulse stimulation of balloon dilation); the stimulation amount threshold can be characterized by volume threshold, pressure threshold, pressure-volume combination threshold and / or equivalent threshold related to the stimulation change process, and can be derived from standardized measurement, rule base, historical data or graded option mapping.

[0032] In some embodiments, the preset sensory / reflex event points may correspond to event points commonly used in anorectal manometry or rectal balloon dilation tests, such as first sensation, initial urge to defecate, maximum tolerated, and / or the rectoanal inhibitory reflex (RAIR) trigger threshold. However, the present invention is not limited to the above event points, and other repeatable and quantifiable sensory or reflex event points may be selected as the basis for determining τ according to different cavities and application scenarios (such as natural cavities of the urinary or reproductive tracts).

[0033] (5) Compliance factor C: Characterizes the relationship between volume change and pressure change response, which can be derived from pressure measurement / curve testing / image inference or rule base mapping.

[0034] (6) Sensitivity factor σ: Characterizes the sensitivity of the target object to stimuli, which can be derived from diagnostic classification, questionnaire grading or preset target object type options.

[0035] (7) Fluid factor η: A comprehensive quantitative characterization of properties such as viscosity, density, temperature, and rheological type. It can be detected, looked up in tables, identified, preset, or implicitly contained by a fixed combination.

[0036] (8) Mapping model: Couples the physiological tolerance feature set with the fluid property set and outputs Q. limit The model can be implemented through functional relationships, lookup tables, rule bases, fitting models, machine learning models, calibration and / or other equivalent methods.

[0037] (9) Maximum allowable volumetric flow rate Q limit : The control boundary determined by the mapping model is used to limit the maximum allowable volumetric flow rate during the infusion execution phase.

[0038] (10) Feedforward locking: Q is determined before or at the start of infusion. limitThe maximum permissible volumetric flow rate remains constant after infusion begins; this constantness is guaranteed by control logic locking and / or mechanical physical constraints, and is not based on real-time signals for dynamic closed-loop updates of the maximum permissible volumetric flow rate; wherein, the real-time signals can be used to monitor, record, and trigger alarms, and can trigger interruption of infusion and / or entry into a safety degradation mode when an anomaly is detected, but are not used to update or change the maximum permissible volumetric flow rate.

[0039] (11) Parameter comparison tool: a special tool that is matched with the mechanical flow limiting valve. Its position mark corresponds uniquely to the valve body mark and is used to indicate and lock the flow limiting setting.

[0040] In scenarios involving intracavitary drug delivery (including but not limited to rectum, vagina, cervix, bladder, and urethra), clinicians need to strike a balance between "effective drug retention" and "target patient comfort and tolerance." Current infusion practices typically rely on operator experience to set volumetric flow rates or use signals such as intracavitary pressure / flow rate for closed-loop regulation. However, the tolerance of intracavitary tracts to fluid infusion is not determined by a single factor but is influenced by multiple heterogeneous factors: on the one hand, the physiological tolerance characteristics of intracavitary tissues (e.g., compliance, tolerance thresholds to pressure / volume stimuli and their changes, individual sensitivity differences) determine their reflexive trigger risk to volumetric disturbances; on the other hand, the physical properties of the infused fluid (e.g., viscosity, density, temperature, and the resulting changes in flow resistance) significantly alter the pressure change and volume accumulation processes under the same driving conditions. These factors have different sources and dimensions; without a coupled quantification mechanism, it is difficult to establish a stable, reproducible, and engineerable safety boundary based solely on experience or a single feedback signal.

[0041] This invention recognizes that the key control objective of cavity infusion is not to pursue rapid infusion at arbitrary speeds, but rather to obtain an executable safety boundary parameter that matches the individual's tolerance and fluid properties. To this end, this invention proposes a technical path of "physiological tolerance feature set - fluid physical property set - mapping model - maximum permissible volumetric flow rate boundary": by acquiring or determining the physiological tolerance feature set of the target object (at least including the dynamic stimulation threshold τ; and optionally including the compliance factor C and / or sensitivity factor σ) and the physical property set of the infusion fluid (at least including the fluid factor η), and outputting the maximum permissible volumetric flow rate Q according to a preset mapping relationship. limit The Q limit It is not a "set value", but rather a deterministic upper limit constraint on the infusion execution process, thereby transforming subjective judgments that originally relied on personal experience into objective technical rules that can be calculated, looked up in tables, and verified.

[0042] In some implementations, the physiological tolerance feature set may include only the dynamic stimulation threshold τ; the mapping model determines Q based on the dynamic stimulation threshold τ and the fluid factor η.limit This allows for the formation of a more individualized baseline safety boundary relative to fixed empirical values; in other implementations, a compliance factor C and / or a sensitivity factor σ may be further introduced to modify the baseline safety boundary.

[0043] Furthermore, this invention does not limit the above mapping model to a single mathematical form. The mapping relationship can be implemented through function models, rule bases, lookup tables, discretization hierarchies, fitting models, or machine learning models, or by a mechanical current-limiting structure in a calibration / fixed manner, as long as Q is satisfied. limit The technical essence is that Q is positively correlated with τ and C, and negatively correlated with σ and η. Therefore, Q limit This can be materialized as deterministic control commands of electronic systems (e.g., logical locking of the upper limit of volumetric flow rate by an infusion pump controller) or as insurmountable structural constraints of mechanical devices (e.g., physical flow restriction of a multi-stage mechanical flow limiter). Unlike schemes that rely on real-time intracavitary sensor feedback for dynamic correction, the feedforward locking mechanism of this invention enables Q to be locked after infusion begins. limit Maintaining constancy, its constancy is guaranteed by control logic locking or mechanical physical constraints; real-time signals (if present) can be used for monitoring, recording, or alarming, but do not participate in the control of Q. limit Updates or changes.

[0044] In some implementations, the "locking" in an electronic path can manifest as: the controller setting Q... limit Alternatively, the corresponding flow limiting setting may be written into an unchangeable operating parameter range or a protected register, and any instruction to modify the parameter may be rejected during the infusion execution phase; and / or the relevant settings may be grayed out, interlocked, or have access restrictions imposed on the user interface, thereby making the adjustment parameters used to set the volumetric flow rate during the infusion process unchangeable.

[0045] In some implementations, the "locking" in a mechanical path can manifest as follows: after the flow-limiting regulating component (e.g., a rotary disc, valve core, slider) rotates to the corresponding position, mechanical limiting, a check structure, a positioning mechanism, or a combination thereof ensures that the physical displacement is insurmountable, thereby ensuring that the actual volumetric flow rate will not exceed the preset Q due to misoperation or external disturbance. limit Upper limit.

[0046] Therefore, the essential contribution of this invention lies in establishing a new paradigm for safe control of cavity infusion: it is fundamentally different from "stress-based closed-loop control" that relies on real-time sensor feedback (remedial measures with safety dependent on sensor reliability); it is also fundamentally different from "extensive open-loop control" that relies on fixed empirical values ​​(difficult to adapt to individual differences and changes in fluid properties). This invention, through feedforward, personalized, and physically solidifiable safety boundary settings, forms a deterministic technical constraint on the device's output behavior, providing a universal and reliable underlying safety logic for various cavity drug delivery devices.

[0047] To further illustrate the technical means and effects of the present invention in achieving its intended purpose, the following detailed description of the specific implementation methods, structures, features, and effects of the present invention, in conjunction with the accompanying drawings and preferred embodiments, is provided.

[0048] Please see Figure 1-6 A control method for controlling the output volumetric flow rate of a cavity fluid delivery device, comprising: Acquire or determine a set of physiological tolerance features for characterizing the tolerance of a target cavity, the set of physiological tolerance features including at least dynamic stimulation thresholds; and optionally including compliance factors and / or sensitivity factors for modification; Obtain or determine a set of fluid properties of the fluid to be infused, wherein the set of fluid properties includes at least a fluid factor; Based on a preset mapping model, the maximum permissible volumetric flow rate is determined according to the physiological tolerance feature set and the fluid property set. During the infusion execution phase, by implementing electronic control strategies and / or employing mechanical flow-limiting structures, the actual volumetric flow rate of the cavity fluid infusion device is always kept less than or equal to the maximum permissible volumetric flow rate during the infusion process. The maximum permissible volumetric flow rate remains constant after the infusion begins. This constant state is ensured by the logic locking of the control system and / or the physical constraints of the mechanical structure, and the maximum permissible volumetric flow rate is not dynamically updated in a closed loop based on real-time signals. The real-time signals can be used to monitor, record, and trigger alarms, and can trigger an interruption of infusion and / or entry into a safety degradation mode when an anomaly is detected, but they are not used to update or change the maximum permissible volumetric flow rate.

[0049] Specifically, in some embodiments, the mapping model is configured such that: the value of the maximum permissible volumetric flow rate is positively correlated with the dynamic stimulation threshold; when the physiological tolerance feature set includes a compliance factor, it is positively correlated with the compliance factor; when the physiological tolerance feature set includes a sensitivity factor, it is negatively correlated with the sensitivity factor; and it is negatively correlated with the fluid factor.

[0050] Specifically, the mapping model includes at least one of the following implementations: functional relationship, lookup table, rule base, fitting model, machine learning model, and / or equivalent mapping relationship solidified by mechanical current limiting structure based on calibration data.

[0051] Specifically, the sensitivity factor is determined based on at least one of the following: the target object's clinical diagnostic classification, symptom questionnaire grading results, pain / discomfort rating grading, and / or a preset target object type option.

[0052] Specifically, the fluid factor is determined based on at least one of the following: fluid viscosity, density, temperature, rheological type, and / or a preset fluid type option.

[0053] Specifically, the fluid factor and the maximum permissible volumetric flow rate are pre-associated with the container or packaging identifier of the fluid to be infused; the acquisition method includes reading the identifier and obtaining the associated fluid factor value, or directly obtaining the associated maximum permissible volumetric flow rate value or flow restriction setting.

[0054] Specifically, the methods by which the actual volumetric flow rate satisfies the constraint that the actual volumetric flow rate is less than or equal to the maximum permissible volumetric flow rate include: The maximum permissible volumetric flow rate is converted into electronic control parameters, and the cavity fluid delivery device executes the electronic control parameters to limit the maximum output volumetric flow rate; The maximum permissible volumetric flow rate is converted into a mechanical flow limiting setting, which is a specified position or a specified flow limiting state of the mechanical flow limiting valve, so as to limit the volumetric flow rate through physical flow resistance.

[0055] Furthermore, the mechanical flow restriction setting is achieved by a mechanical flow restriction valve with multiple preset flow restriction positions. The mechanical flow restriction valve can be a rotary valve core type, a multi-hole disc type, a slider throttling type, a capillary flow channel component type, or a combination thereof, and each position is a discrete position and corresponds to different flow channel geometry, thereby forming different flow resistances to limit the volumetric flow rate.

[0056] Furthermore, the flow channel geometry includes, but is not limited to: slender straight pipe flow channels, labyrinthine flow channels, variable cross-section flow channels, non-circular cross-section flow channels, porous medium flow channels, and / or other equivalent flow resistance structures based on the fluid dynamics flow resistance principle.

[0057] Furthermore, the electronic control parameters include a maximum output volumetric flow rate limit parameter, and the cavity fluid delivery device is configured to limit the output volumetric flow rate to no more than the maximum output volumetric flow rate limit parameter during delivery.

[0058] Specifically, the cavity fluid delivery device includes a pressure sensor and / or a flow sensor. The sensor outputs are used to monitor, record, and / or trigger alarms, but not to update or change the maximum output volumetric flow rate. In some embodiments, when an abnormal signal is detected, the sensor outputs may also trigger an interruption of delivery and / or entry into a safety degradation mode, but again, they are not used for dynamic closed-loop updates of the safe volumetric flow rate / maximum permissible volumetric flow rate.

[0059] A cavity fluid delivery flow restriction system, comprising: The parameter acquisition module is used to acquire or determine the physiological tolerance feature set and the fluid property set. The mapping execution module is used to determine the maximum allowable volumetric flow rate based on a preset mapping model. The flow limiting execution module is used to limit the flow through electronic control and / or mechanical means so that the actual volumetric flow rate of the system during infusion always meets the requirement that the actual volumetric flow rate is less than or equal to the maximum allowable volumetric flow rate. Cavity interface module, used to connect with the target cavity to complete fluid delivery; The system is configured to: after infusion begins, feedforward lock the maximum permissible volumetric flow rate and keep it constant, the constantness being guaranteed by logical locking and / or physical constraints, and not using real-time signals as the basis for dynamic closed-loop updates of the maximum permissible volumetric flow rate; wherein the real-time signals can be used for monitoring, recording, and triggering alarms, and can trigger interruption of infusion and / or entry into a safety degradation mode when an anomaly is detected, but are not used to update or change the maximum permissible volumetric flow rate.

[0060] Furthermore, the mapping execution module includes a local mapping execution unit; and the system may also optionally include a cloud service unit for model updates, parameter library updates, and / or data analysis; wherein, the local mapping execution unit can still independently determine the maximum allowable volumetric flow rate and complete the flow limiting execution even when the cloud service unit is absent.

[0061] Furthermore, it also includes a parameter comparison tool provided in conjunction with the mechanical flow limiting valve. The parameter comparison tool is specifically designed for the mechanical flow limiting valve, and the position markings recorded on it uniquely correspond to the markings on the valve body. The parameter comparison tool is used to determine and indicate the mechanical position and / or flow limiting setting that should be locked based on the physiological tolerance characteristic set and fluid property set.

[0062] Furthermore, it also includes a pre-filled fluid container, which is provided in a fixed combination with the flow limiting setting of the flow limiting execution module; the fixed combination corresponds to a pre-calibrated or preset fluid factor level and / or flow limiting setting, so that the system can determine the maximum allowable volumetric flow rate and / or lock the flow limiting setting without requiring the user to measure the fluid viscosity or select a fluid type option, and ensure that the actual volumetric flow rate during the infusion process is less than or equal to the maximum allowable volumetric flow rate.

[0063] Furthermore, the pre-filled fluid container and / or the flow-limiting structure fixedly combined with it are marked with identification information for identifying the fixed combination, including but not limited to color coding, barcodes, QR codes, RFID tags, pairing serial numbers and / or shape matching features.

[0064] In some implementations, the current limiting gears can be distinguished using one or more of the following identifiers: numerical identifiers (e.g., gear 1 / 2 / 3 or gear I / II / III), color coding, pattern or texture identifiers, barcodes / QR codes, RFID identifiers, pairing serial numbers, or shape keying structures. It should be understood that gear identification and locking do not depend on any single identifier. Further, the parameter comparison tool is used to determine and indicate the gear or current limiting setting to be locked based on a set of physiological tolerance characteristics and a set of fluid properties. The tool outputs the corresponding / specified current limiting setting, used to form a feedforward constraint boundary.

[0065] In some implementations, the system can obtain the fluid factor η associated with the fluid to be infused by reading the container or packaging label, or directly obtain the associated Q. limit The identifier carries information such as the current limiting gear index or other current limiting settings. This information ensures accurate matching between the current limiting setting and the fluid's physical properties. Furthermore, if the identifier information is missing, invalid, cannot be recognized by the system, or cannot be paired, the mapping model cannot obtain valid input or complete consistency verification. The system will then prohibit infusion or force entry into the most conservative current limiting gear, thereby technically ensuring that the safety boundary is not circumvented. Furthermore, after the identifier is successfully read and the current limiting setting is locked, the system can provide clear visual, auditory, or tactile feedback (e.g., indicator lights, beeps, or tactile feedback of "gear locked") and display a locked Q on the user interface. limit This may include gear position information to reduce the risk of misoperation or unintentional changes during the preparation phase. It should be understood that the above feedback may take one or more forms and does not constitute a limitation of the present invention.

[0066] The above methods can be used individually or in combination, and all are equivalent implementations of "reading the identifier to obtain the associated parameters".

[0067] Specifically, the fluid factor can be comprehensively quantified based on one or more of fluid density, viscosity, temperature and / or rheological type to reflect the negative correlation between the maximum permissible volumetric flow rate and fluid properties.

[0068] Specifically, the sensitivity factor can be determined based on one or more of the target object's symptom grading results, pain / discomfort rating grading, target object type options, and / or preset risk level options; in some embodiments, when the above grading results or risk level characterizes as more sensitive or less tolerable, the value of the sensitivity factor is increased accordingly, thereby reducing the maximum allowable volumetric flow rate determined by the mapping model.

[0069] Specifically, the physiological tolerance feature set is configured differently according to the functional type and working mode of the target cavity. The differentiating configuration is based on the cavity's storage function, pain sensitivity, or reflex coupling characteristics, including but not limited to the following modes: when the system is configured as a storage cavity mode, the value of the sensitivity factor is associated with the emptying-related reflex trigger threshold; when the system is configured as a sensitive infusion mode, the value of the sensitivity factor is associated with the mechanical pain or discomfort trigger threshold, and the sensitivity factor is set higher than the baseline value; when the system is configured as a urethra-bladder coupling mode, the value of the sensitivity factor is associated with the urination-related reflex or discomfort threshold.

[0070] Specifically, the control boundary parameters also include one or more of the following: maximum permissible total infusion volume, maximum permissible single infusion time, or maximum permissible transmembrane pressure difference; the control boundary parameters are determined by the mapping model based on the physiological tolerance feature set and physical property set, and can be used individually or in combination to limit physiological tolerance-related risks during the infusion process.

[0071] In some implementations, the mapping model establishes τ, C, σ, η, and Q. limit When determining the mapping relationship, engineering safety margin, calibration margin, or risk conservatism requirements can be comprehensively considered. It should be understood that this invention does not limit the specific implementation form, quantity, or mathematical structure of the safety margin; as long as the mapping relationship can be achieved and Q is satisfied after the infusion begins... limit Maintaining a constant feedforward locking boundary is within the scope of protection of this invention.

[0072] Specifically, during the infusion process, cavity drug delivery is controlled through a mapping execution module, and the mapping execution module may take the form of, but is not limited to: Electronic computing module: A processor that stores lookup tables or calculation algorithms; Cloud service module: A server that remotely calculates and returns mapping results and / or parameters; Physical comparison tools and mechanical limit devices: physical charts and turntables that record the corresponding relationships of the above parameters, and mechanical regulating valves with corresponding scale markings.

[0073] In some implementations, the cloud service unit can be used to maintain and update data resources related to the mapping model, such as parameter libraries, rule libraries, lookup tables, fitting models, machine learning models, calibration datasets, or combinations thereof. The mapping model may include various model parameters (e.g., threshold parameters, reduction parameters, calibration parameters, or other mapping parameters) used to implement the mapping relationship; these parameters can be obtained through calibration, fitting, training, or rule setting.

[0074] Before this infusion begins, the system loads the mapping model and parameters required for this infusion from local storage or the cloud; once the infusion starts, Q is determined based on the loaded model and parameters. limit And enter the feedforward locking state. This invention does not limit the specific number, organization, or mathematical structure of the mapping model parameters; as long as "Q" can be achieved... limit The technical essence is that it is positively correlated with τ and C, and negatively correlated with σ and η, and satisfies Q after the infusion starts. limit Maintaining a constant feedforward locking boundary is within the scope of protection of this invention.

[0075] Furthermore, cloud updates can be used for parameter preparation for subsequent versions or the next infusion; after the current infusion begins, the Q... limit It remains constant and does not change due to cloud updates. Furthermore, to achieve this isolation, the system can employ one or more of the following methods: at infusion initiation, the loaded model parameters are compared with Q... limit The values ​​are written to a local operating parameter range on the device (e.g., non-volatile memory, read-only cache, protected RAM area, or other local storage structure), and the control logic of the infusion process is configured to read operating parameters only from this local storage range, thereby architecturally isolating the operating parameters from external communication during the infusion process. It should be understood that this "architectural isolation" can be achieved through hardware isolation, software logic isolation, communication protocol isolation, or a combination thereof, and this invention does not limit its specific implementation.

[0076] In some implementations, the mapping model can also be implemented using a machine learning model. For example, it can be based on historical infusion data (including infusion records corresponding to different combinations of τ, C, σ, and η, and the finally locked Q). limit (and / or gear settings and associated tolerance results) are used to train a regression or classification model to learn the input features (τ, C, σ, η) and the output target (Q). limit The mapping relationship between (or gear index) is established. After training, the model parameters can be fixed and deployed locally or in the cloud to determine Q before infusion begins. limitIt should be understood that this invention does not limit the specific algorithm type, model structure, training data scale, or training method of the machine learning model; as long as the mapping relationship can be realized and the Q condition is met after the infusion begins. limit Maintaining a constant feedforward locking boundary is within the scope of protection of this invention.

[0077] In some implementations, the system may also be configured to: record the associated container identification information and the finally determined Q at the start of each infusion. limit Information such as and / or rate limiting settings, timestamps, and operator identifiers forms an operational log for auditing and traceability. The log may employ integrity checks, signatures, hash chains, or other tamper-proof measures to enhance traceability. It should be understood that the log is only for recording, auditing, and traceability, and is not used to update or change the Q during the infusion execution phase. limit And its feedforward locking state.

[0078] Specifically, the physical comparison tool and mechanical limiting device include: Parameter reference card: Printed with a table showing the correspondence between cavity type, target object sensitivity rating, fluid type and corresponding volumetric flow rate level. The table is pre-calculated and discretized based on the mapping model. In some embodiments, the mechanical flow-limiting unit includes at least two flow-limiting channels with significantly different geometric characteristics. The channel design is based on the principle of fluid dynamics resistance, and different equivalent flow resistances are formed by adjusting the equivalent length, equivalent cross-sectional area, tortuosity, branching structure, and surface characteristics (such as roughness and texture) and / or porous media structure characteristics of the channels, thereby allowing different limits on the maximum permissible volumetric flow rate for each limit. The maximum permissible volumetric flow rate limit for each flow-limiting limit is determined and solidified through calibration, engineering verification, numerical simulation, or a combination thereof. It should be understood that this invention is not limited to closed expressions of specific fluid dynamics relationships, fixed constant values, or analytical calculation processes; any feedforward physical constraint that "the actual volumetric flow rate is limited by the maximum permissible volumetric flow rate" can be achieved and falls within the scope of protection of this invention.

[0079] Furthermore, the current limiting gear can be distinguished by one or more forms such as digital identification, color coding, pattern or texture identification, barcode / QR code, RFID identification, pairing serial number, shape keying structure, etc.; it should be understood that gear identification and locking do not depend on any single identification form.

[0080] In this embodiment, the safe volumetric flow rate is determined by constructing a mapping model. This mapping model can be calculated in real time or pre-discretized into a lookup table or mechanical scale correspondence; both are equivalent implementations of this invention.

[0081] "Cavity": Specifically refers to the natural cavities within the human pelvic cavity, such as the rectum, vagina, cervix, urethra, and bladder; excluding the oral cavity, nasal cavity, ear canal, or blood vessels. These cavities share common physiological characteristics of fluid storage and emptying, which can be quantified by one or more physiological parameters characterizing cavity tolerance. These physiological parameters include compliance factor C, sensitivity factor σ, and / or dynamic stimulation threshold τ, and therefore can all serve as target cavities suitable for this invention.

[0082] For ease of understanding, some embodiments in this specification are illustrated using the rectal cavity as an example, because the rectal cavity has relatively mature existing practices in obtaining relevant parameters (such as anorectal manometry, balloon dilation testing, etc.). However, the technical solution of the present invention is not limited to the rectal cavity, but is also applicable to other natural cavities with physiological characteristics of fluid containment and emptying. For different cavities, corresponding sensory event points, reflex event points, and testing schemes can be selected according to their physiological characteristics and existing practices. As long as the dynamic stimulation threshold τ used to characterize the tolerance of the cavity can be obtained, the technical solution of the present invention can be applied.

[0083] Mapping model: refers to coupling a set of physiological tolerance features with a set of fluid properties and outputting the maximum permissible volumetric flow rate (Q). limit The implementation models for (and / or) current limiting levels may include, but are not limited to, functional relationships, lookup tables, rule bases, fitting models, machine learning models, calibrated and fixed equivalent correspondences, and / or other equivalent methods.

[0084] "Feedforward control" refers to setting operating boundaries based on a pre-acquired set of parameters, without including the process of dynamically correcting control parameters using real-time acquired intracavity signals. The system of this invention may selectively include pressure, flow, or volumetric sensors for safety monitoring or data recording, but the signals from these sensors do not participate in the dynamic closed-loop correction of the safe volumetric flow rate or the volumetric flow rate setpoint, and therefore still fall under the category of feedforward control.

[0085] "Dynamic stimulation threshold (τ)": refers to the stimulation amount threshold corresponding to the cavity reaching a preset sensory event point and / or reflex event point under a preset stimulation profile (e.g., step-by-step, ramp-by-ramming, or pulse stimulation of balloon dilation); the stimulation amount can be pressure, volume, pressure-volume combination, and / or equivalent representations thereof. In some embodiments, the above-mentioned event point may correspond to the initial sensation, urge to defecate, maximum tolerance, and / or the trigger threshold of the rectoanal inhibitory reflex (RAIR), etc., but this is not a limitation.

[0086] The acquisition of all parameters described in this invention is based on standardized clinical procedures. The measurement results only need to achieve the purpose of relative quantification that can be used for mapping models, and absolute consistency is not required. Those skilled in the art can perform equivalent acquisition based on the accuracy of hospital equipment.

[0087] The scenarios, parameter levels, and descriptions in the following embodiments are only used to illustrate and explain the technical principles and beneficial effects of the present invention, to facilitate understanding of "multi-parameter feedforward mapping → determining Q". limit → The technology chain of "electronic / mechanical locking execution"; the following example illustrates a cavity fluid infusion scenario, but the present invention is not limited to this example scenario and is applicable to other cavity fluid infusion applications. It does not constitute a limitation on any operating parameters, application practices, or product performance. The scope of protection of the present invention is defined by the claims.

[0088] Example: Determination of infusion volumetric flow rate based on multi-parameter coupling mapping; The example scenario is set as the target object receiving fluid infusion into the rectal cavity.

[0089] 1. Parameter Acquisition: The dynamic stimulation threshold τ can be measured under a preset stimulation profile through balloon dilation testing, or determined based on historical data statistics, engineering verification, or pressure measurement statistics. In some embodiments, the balloon dilation test can adopt a step-by-step incremental mode (e.g., inflating / infusing water in preset increments, and recording the initial sensory threshold, initial urge threshold, maximum tolerance threshold, and / or pressure / volume threshold corresponding to the relevant inhibitory reflex trigger point at each level), or a ramp-up mode (e.g., continuously inflating / infusing water at a preset rate until the target event point is reached). The above increments, rates, and termination conditions can be preset according to different cavities and application scenarios, and do not constitute a limitation of the present invention.

[0090] Sensitivity factor σ: Based on symptom questionnaire or grading results, sensitivity can be divided into three levels: low, medium, and high, and a discrete level value (e.g., σ) can be assigned according to a preset grading rule. low σ mid σ high ); This example uses high-level values ​​(e.g., σ). high It should be understood that the grading rules may be established based on statistical data, engineering validation, or expert experience, and are not limited to specific questionnaire types or scoring thresholds; Fluid factor η: The fluid to be infused is a gel-like fluid with a viscosity higher than that of an aqueous solution.

[0091] 2. Mapping execution: Based on the preset mapping model and the above parameter combinations, the maximum allowable volumetric flow rate Q in this scenario is determined. limit .

[0092] 3. Implementation method: 3.1 Electronic Implementation: Q limit As an upper limit parameter input to the pump control system, the controller limits the motor speed or sets an insurmountable speed threshold to ensure that the actual output volumetric flow rate does not exceed Q.limit ; 3.2 Mechanical Implementation: The corresponding gear (e.g., gear 1) is determined using a parameter comparison tool. The flow channel structure corresponding to this gear is fixed with Q based on pre-calibrated flow resistance characteristics. limit The upper limit, after the operator places the valve core in this position, ensures that the physical constraints of the fluid passage guarantee that the actual volumetric flow rate does not exceed Q. limit .

[0093] 4. Technical effect: Before the infusion begins, the system sets personalized safety boundaries based on the physiological characteristics and fluid properties of the target object. The feedforward locking mechanism avoids the decrease in comfort or reflex triggering caused by fixed experience settings or real-time feedback delays.

[0094] The above scenarios, parameter acquisition methods, and implementation details are illustrative examples used to demonstrate the technical principles and implementation chain of the present invention, and do not constitute a limitation on any operating parameters or application practices.

[0095] In this embodiment, the limitations of the fixed current limiting setting method are explained as follows: To facilitate understanding of the technical advantages of the present invention's "multi-parameter coupling mapping → personalized security boundary," a hypothetical comparison scenario is used below: Comparison method: Fixed current limiting setting (without multi-parameter coupling mapping); Suppose that a system always locks the flow limit setting to "gear 2" regardless of changes in physiological tolerance characteristics or fluid properties.

[0096] Scenario A: Low sensitivity + fluid is a low-viscosity aqueous solution; • Fixed position: still gear 2; • The method of this invention: Determine the corresponding gear with a higher upper limit based on multi-parameter mapping; • Difference: Fixed methods may be too conservative, resulting in unnecessary extension of infusion time.

[0097] Scenario B: High sensitivity + fluid is a high-viscosity gel; • Fixed position: still gear 2; • The method of this invention: Determine the corresponding gear with a lower upper limit based on multi-parameter mapping; • Differences: The fixation method fails to respond to individual compliance differences and fluid property fluctuations. In the absence of a feedforward locking mechanism, the actual volumetric flow rate is more difficult to predict and constrain before the start of infusion, which poses a risk of exceeding the tolerance limit of the object.

[0098] The above comparative scenarios are illustrative and are only used to demonstrate the difference in trends regarding "whether or not multi-parameter coupling mapping is performed." They do not constitute a limitation on any operating method, numerical setting, or scope of application. The scope of protection of this invention is defined by the claims.

[0099] It should be noted that any numerical values, scenarios, and comparison methods described in this section are for illustration and explanation of the technical principles and beneficial effects of the present invention only, and do not constitute a limitation on any operating method, numerical setting, or scope of application. The scope of protection of the present invention is defined by the claims.

[0100] The computer storage medium of this invention can be any combination of one or more computer-readable media. A computer-readable medium can be a computer-readable signal medium or a computer-readable storage medium. Computer-readable storage media can be, for example, but not limited to, electrical, magnetic, optical, electromagnetic, infrared, or semiconductor systems, apparatuses, or devices, or any combination thereof. More specific examples (a non-exhaustive list) of computer-readable storage media include: electrical connections having one or more wires, portable computer disks, hard disks, random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), optical fiber, portable compact disk read-only memory (CD-ROM), optical storage devices, magnetic storage devices, or any suitable combination thereof. In this document, a computer-readable storage medium can be any tangible medium containing or storing a program that can be used by or in conjunction with an instruction execution system, apparatus, or device.

[0101] Computer-readable signal media may include data signals propagated in baseband or as part of a carrier wave, carrying computer-readable program code. Such propagated data signals may take various forms, including but not limited to electromagnetic signals, optical signals, or any suitable combination thereof. Computer-readable signal media may also be any computer-readable medium other than computer-readable storage media, capable of sending, propagating, or transmitting programs for use by or in connection with an instruction execution system, apparatus, or device.

[0102] The program code contained on the computer-readable medium can be transmitted using any suitable medium, including but not limited to wireless, wired, optical fiber, RF, etc., or any suitable combination thereof. The computer program code for performing the operations of this invention can be written in one or more programming languages ​​or a combination thereof, including object-oriented programming languages ​​such as Java, Smalltalk, and C++, and conventional procedural programming languages ​​such as "C" or similar programming languages. The program code can be executed entirely on the user's computer, partially on the user's computer, as a standalone software package, partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In cases involving a remote computer, the remote computer can be connected to the user's computer via any type of network, including a local area network (LAN) or a wide area network (WAN), or it can be connected to an external computer (e.g., via the Internet using an Internet service provider).

[0103] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications or alterations to the above-disclosed technical content to create equivalent embodiments without departing from the scope of the present invention. Any simple modifications, equivalent changes and alterations made to the above embodiments based on the technical essence of the present invention without departing from the scope of the present invention shall still fall within the scope of the present invention.

Claims

1. A control method for a cavity fluid infusion device, characterized in that, include: Acquire or determine a set of physiological tolerance features for characterizing the tolerance of a target cavity, wherein the set of physiological tolerance features includes at least dynamic stimulation thresholds; Obtain or determine a set of fluid properties of the fluid to be infused, wherein the set of fluid properties includes at least a fluid factor; Based on a preset mapping model, the maximum permissible volumetric flow rate is determined according to the physiological tolerance feature set and the fluid property set. During the infusion execution phase, by implementing electronic control strategies and / or employing mechanical flow-limiting structures, the actual volumetric flow rate of the cavity fluid infusion device is always kept less than or equal to the maximum permissible volumetric flow rate during the infusion process. The maximum permissible volumetric flow rate remains constant after the infusion begins. This constant state is ensured by the logic locking of the control system and / or the physical constraints of the mechanical structure, and is not based on real-time pressure, real-time flow rate or other real-time physiological signals within the cavity for dynamic closed-loop updates of the maximum permissible volumetric flow rate. The real-time signals can be used for monitoring, recording, and triggering alarms, and can trigger interruption of infusion and / or entry into a safety degradation mode when an anomaly is detected, but are not used to update or change the maximum permissible volumetric flow rate.

2. The method according to claim 1, characterized in that, The physiological tolerance feature set further includes compliance factors and / or sensitivity factors; the mapping model is configured such that: the value of the maximum permissible volumetric flow rate is positively correlated with the dynamic stimulation threshold and negatively correlated with the fluid factor; when the physiological tolerance feature set includes compliance factors, it is positively correlated with the compliance factors; when the physiological tolerance feature set includes sensitivity factors, it is negatively correlated with the sensitivity factors.

3. The method according to claim 2, characterized in that, The physiological tolerance feature set includes a dynamic stimulation threshold, compliance factor, and sensitivity factor; and 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 according to any one of claims 1 to 3, characterized in that, The mapping model includes at least one of the following implementations: functional relationship, lookup table, rule base, fitting model, machine learning model, and / or equivalent mapping relationship solidified by mechanical current limiting structure based on calibration data.

5. The method according to any one of claims 1 to 3, characterized in that, The physiological tolerance feature set also includes a sensitivity factor, which is determined based on at least one of the following: the target object's clinical diagnostic classification, symptom questionnaire grading results, pain / discomfort rating grading, and / or a preset target object type option.

6. The method according to claim 1, characterized in that, The dynamic stimulation threshold is determined by a balloon dilation test, which includes step-increase dilation and / or ramp-increase dilation; in some embodiments, when the target cavity is the rectum, the dynamic stimulation threshold corresponds to one or a combination of the following event points: first sensation threshold, initial urge to defecate threshold, maximum tolerance threshold and / or trigger threshold for inducing rectal anal inhibitory reflex.

7. The method according to claim 1, characterized in that, The fluid factors are determined based on at least one of the following: fluid viscosity, density, temperature, rheological type, and / or a preset fluid type option.

8. The method according to claim 1, characterized in that, The fluid factor and the maximum permissible volumetric flow rate are pre-associated with the container or packaging identifier of the fluid to be infused; the acquisition method includes reading the identifier and obtaining the associated fluid factor value, or directly obtaining the associated maximum permissible volumetric flow rate value or flow limit setting.

9. The method according to claim 1, characterized in that, The methods for ensuring that the actual volumetric flow rate is less than or equal to the maximum permissible volumetric flow rate include: The maximum permissible volumetric flow rate is converted into electronic control parameters, and the cavity fluid delivery device executes the electronic control parameters to limit the maximum output volumetric flow rate; The maximum permissible volumetric flow rate is converted into a mechanical flow limiting setting, which is a specified position or a specified flow limiting state of the mechanical flow limiting valve, so as to limit the volumetric flow rate through physical flow resistance.

10. The method according to claim 9, characterized in that, The mechanical flow restriction setting is achieved by a mechanical flow restriction valve with multiple preset flow restriction levels. Each level is a discrete level and corresponds to a different flow channel geometry, thereby forming different flow resistances to limit the volumetric flow rate.

11. The method according to claim 10, characterized in that, The flow channel geometry includes, but is not limited to: slender straight pipe flow channels, labyrinth flow channels, variable cross-section flow channels, non-circular cross-section flow channels, porous medium flow channels, and / or other equivalent flow resistance structures based on the fluid dynamics flow resistance principle.

12. The method according to claim 9, characterized in that, The electronic control parameters include a maximum output volumetric flow rate limit parameter, and the cavity fluid delivery device is configured to limit the output volumetric flow rate to no more than the maximum output volumetric flow rate limit parameter during delivery.

13. The method according to claim 1, characterized in that, The cavity fluid delivery device includes a pressure sensor and / or a flow sensor, the output of which is used to monitor, record and / or trigger alarms, but not to update or change the maximum output volumetric flow rate.

14. A cavity fluid delivery flow restriction system, characterized in that, include: The parameter acquisition module is used to acquire or determine the physiological tolerance feature set and the fluid property set. The mapping execution module is used to determine the maximum allowable volumetric flow rate based on a preset mapping model. The flow limiting execution module is used to limit the flow through electronic control and / or mechanical means so that the actual volumetric flow rate of the system during infusion always meets the requirement that the actual volumetric flow rate is less than or equal to the maximum allowable volumetric flow rate. Cavity interface module, used to connect with the target cavity to complete fluid delivery; The system is configured to: after infusion begins, feedforward lock and maintain a constant maximum permissible volumetric flow rate, the constantness of which is guaranteed by logical locking and / or physical constraints, and not to use real-time intracavitary pressure, real-time flow rate or other real-time physiological signals as the basis for dynamic closed-loop updating of the maximum permissible volumetric flow rate; wherein, the real-time signals can be used for monitoring, recording, and triggering alarms, and can trigger interruption of infusion and / or entry into a safety degradation mode when an anomaly is detected, but are not used to update or change the maximum permissible volumetric flow rate.

15. The system according to claim 14, characterized in that, The mapping execution module includes a local mapping execution unit; and the system may also optionally include a cloud service unit for model updates, parameter library updates and / or data analysis; wherein, the local mapping execution unit can still independently determine the maximum allowable volumetric flow rate and complete the flow limiting execution even when the cloud service unit is absent.

16. The system according to claim 14 or 15, characterized in that, It also includes a parameter comparison tool provided in conjunction with the mechanical flow limiting valve. The parameter comparison tool is specifically designed for the mechanical flow limiting valve, and the position markings recorded on it correspond uniquely to the markings on the valve body. The parameter comparison tool is used to determine and indicate the mechanical position and / or flow limiting setting that should be locked based on the physiological tolerance characteristic set and fluid property set.

17. The system according to any one of claims 15 to 16, characterized in that, It also includes a pre-filled fluid container, which is provided in a fixed combination with the flow limiting setting of the flow limiting execution module; the fixed combination corresponds to a pre-calibrated or preset fluid factor level and / or flow limiting setting, so that the system can determine the maximum allowable volumetric flow rate and / or lock the flow limiting setting without the user measuring the fluid viscosity or selecting the fluid type option, and ensure that the actual volumetric flow rate during the infusion process is less than or equal to the maximum allowable volumetric flow rate.

18. The system according to claim 17, characterized in that, The pre-filled fluid container and / or the flow-limiting structure fixedly combined with it are marked with identification information for identifying the fixed combination. The identification information includes, but is not limited to, color codes, barcodes, QR codes, RFID tags, pairing serial numbers and / or shape matching features.

19. A computer-readable storage medium having a computer program stored thereon, which, when executed by a processor, causes the processor to perform the method steps of any one of claims 1 to 13.

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