A pump-controlled dosing system for mesalazine enema formulations and a method of performing the same
By designing a pump-controlled drug delivery system, precise and personalized drug delivery of mesalazine enema formulations was achieved, solving the problem of not being able to directly connect to commercial packaging containers and execute parameterized outputs in existing technologies, thus improving the safety and controllability of drug delivery.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- YOUCHANGDA (WUHAN) MEDICAL TECH CO LTD
- Filing Date
- 2026-06-16
- Publication Date
- 2026-07-24
AI Technical Summary
Existing technologies cannot provide a pump-controlled drug delivery solution for mesalazine enemas that allows for direct connection to the pump, parameterized execution, local safety verification, and reusable execution templates, without transferring the drug solution or altering the original packaging.
A pump-controlled drug delivery system was designed, including a holding/adapter component, a drive component, a controller, and a user interaction unit. Through local security verification and user confirmation, a pre-filled commercial packaging container of a single-dose mesalazine enema formulation is directly connected to the output channel in a sealed manner. The system determines the target delivery parameters based on the identification information and user input, and the drive component outputs the drug solution according to the parameters.
It enables precise, personalized, and traceable management of mesalazine enema administration, avoiding the risks of administration caused by parameter missetting and abnormal external data, simplifying the operation process, and retaining room for individualized adjustments.
Smart Images
Figure CN122440927A_ABST
Abstract
Description
Technical Field
[0001] This invention belongs to the field of drug delivery systems and intelligent drug delivery control technology, specifically relating to a pump-controlled drug delivery system for mesalazine enema preparations and its execution method. Background Technology
[0002] Currently, mesalazine enemas (used for the local treatment of intestinal diseases such as ulcerative colitis) are mainly used in clinical and home settings through the following methods: (1) The patient directly squeezes the corrugated / pleated bottle with his hand to push the liquid into the rectum. This method depends on the individual's technique, and the output flow rate and total amount are difficult to control stably, which can easily lead to uneven drug administration, patient discomfort or waste of liquid.
[0003] (2) The enema solution is suspended and flows in naturally by gravity. However, mesalazine enema solution is usually a single-dose pre-filled bottle and is not designed as a hanging bag. The solution needs to be transferred, which increases the risk of contamination and the complexity of operation.
[0004] (3) In a few scenarios, conventional infusion pumps or micro-pumps were attempted, but the drug database of the general pump only supports coarse-grained "liquid / viscous liquid" selection. It cannot identify the specific commercial packaging container and its identification information of mesalazine enema, nor can it call up targeted output parameter templates (such as staged programs and safe flow rate boundaries). It also lacks the ability to adapt to "direct pumping from the original packaging". Users need to transfer the drug solution to the reservoir, which destroys the convenience and sealing of the original packaging.
[0005] Therefore, existing technologies cannot provide a pump-controlled drug delivery scheme for mesalazine enemas that allows for direct connection to the pump, parameterized execution, local safety verification, and reusable execution templates, without transferring the drug solution or altering the original packaging. Summary of the Invention
[0006] To address the aforementioned problems in the prior art, this invention provides a pump-controlled drug delivery system for mesalazine enema preparations and its execution method.
[0007] The objective of this invention can be achieved through the following technical solutions: A pump-controlled delivery system for mesalazine enema formulations includes a holding / adapting component, a drive component, a controller, and a user interaction unit for containing or adapting a pre-filled commercial packaging container for a single-dose mesalazine enema formulation.
[0008] The retaining / adapting component is used to position the commercial packaging container without transferring the drug solution, so that the commercial packaging container forms a sealed connection with the output passage and is within the driving range of the driving component; the driving component is used to apply an action to the commercial packaging container to output the drug solution.
[0009] The controller stores or can recall at least one set of candidate delivery parameters associated with the mesalazine enema formulation, the set of candidate delivery parameters including at least one of total output, target flow rate, total duration, or staged execution procedure.
[0010] The controller is configured to: determine a set of target delivery parameters from the candidate delivery parameter set based on the input received by the user interaction unit or the identification information obtained from the commercial packaging container; perform local security verification on the target delivery parameters; and after the local security verification is passed and the user actively confirms, control the drive component to apply an action to the commercial packaging container to output the mesalazine enema preparation in the commercial packaging container according to the target delivery parameters.
[0011] In some embodiments, the commercial packaging container pre-filled with a single-dose mesalazine enema formulation is directly loaded into the retaining / adapting component without drug transfer and forms a sealed connection with the output passage, with the drug solution being directly output by compression applied by the drive component.
[0012] In some embodiments, the controller is also configured to receive configuration suggestion data packets from an external information processing system; the external information processing system is only used to generate or distribute configuration suggestion data packets and does not directly control the system to perform drug administration.
[0013] The controller performs a digest fingerprint consistency comparison and / or audit reference ID tracing on the configuration suggestion data packet; if the verification passes, the controller updates or supplements the candidate delivery parameter set based on the configuration suggestion data packet; if the verification fails, the controller maintains the local preset parameters or falls back to conservative parameters.
[0014] In some implementations, the user interaction unit includes a device-side interface and / or a mobile terminal interface for selecting a drug delivery mode, wherein the target delivery parameter is associated with the selected drug delivery mode.
[0015] In some implementations, after the local security verification is passed, before the output operation is executed, the user interaction unit displays the target delivery parameters and allows the user to adjust at least one of the flow rate, total duration, and staged program within a preset security boundary; after the user actively confirms through the user interaction unit, the controller controls the drive component to execute the output operation.
[0016] In some implementations, the commercial packaging container may be a squeeze bottle with a compressible body; the controller may also record session information for each execution output and allow the recall of successful templates from historical sessions as candidate delivery parameter sets in subsequent use.
[0017] A pump-controlled drug delivery method for mesalazine enema formulations, the method being executed by a pump-controlled drug delivery system including a holding / adapter component, a user interaction unit, a controller, and a drive component, comprising: directly loading a commercially available container pre-filled with a single-dose mesalazine enema formulation into the holding / adapter component without transferring the drug solution, and sealing the commercially available container with the output pathway; acquiring identification information associated with the commercially available container pre-filled with the single-dose mesalazine enema formulation; determining a set of target delivery parameters from a set of candidate delivery parameters stored or accessible in the controller based on the identification information or input received through the user interaction unit; performing a local security check on the target delivery parameters; after the local security check passes and the user actively confirms, controlling the drive component to apply an action to the commercially available container to output the mesalazine enema formulation within the commercially available container according to the target delivery parameters; and recording session information of this execution output.
[0018] The beneficial effects of this invention are as follows: By standardizing and adapting the commercially available packaging containers for pre-filled single-dose mesalazine enemas to a pump-controlled drug delivery system, this invention achieves precise, personalized, and traceable management of the drug delivery process. The system employs a local security verification mechanism and limits external information processing systems to providing configuration suggestion data packages without directly controlling execution, effectively avoiding drug delivery risks caused by parameter misconfiguration or abnormal external data. The user interaction unit supports dual-interface operation on both the device and mobile terminals, combining a one-click drug delivery mode with fine-tuning functions within safety boundaries, simplifying the operation process while retaining necessary individualized adjustment space. By establishing parameter templates and historical session reuse logic for the pre-filled single-dose mesalazine enema packaging containers, this invention contributes to promoting the standardization and intelligent development of mesalazine enema drug delivery.
[0019] In particular, the present invention allows commercial packaging containers pre-filled with a single dose of mesalazine enema formulation to be directly loaded into the holding / adapter component without transferring the medication, and after forming a sealed connection with the output channel, the drive component applies the action to output the medication after passing local safety verification and active confirmation by the user. Attached Figure Description
[0020] To facilitate understanding by those skilled in the art, the present invention will be further described below with reference to the accompanying drawings.
[0021] Figure 1 This is a schematic diagram of the overall system of a pump-controlled drug delivery system for mesalazine enema formulation according to the present invention; Figure 2 This is a flowchart of the parameter template calling and local security verification process in this invention; Figure 3 This is a schematic diagram of user interaction in this invention; Figure 4 This is a schematic diagram of the direct connection path of the original packaging in this invention; Figure 5 This is a flowchart of the execution record and history reuse process in this invention. Detailed Implementation
[0022] 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.
[0023] 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.
[0024] Please see Figure 1-5 A pump-controlled delivery system for mesalazine enema formulations includes a holding / adapting component for containing or adapting a pre-filled commercial packaging container for single-dose mesalazine enema formulations, a drive component, a controller, and a user interaction unit.
[0025] The retaining / adapting component is used to position the commercial packaging container without transferring the drug solution, so that the commercial packaging container forms a sealed connection with the output passage and is within the driving range of the driving component; the driving component is used to apply an action to the commercial packaging container to output the drug solution.
[0026] The controller stores or can recall at least one set of candidate delivery parameters associated with the mesalazine enema formulation.
[0027] The controller is configured to: determine a set of target delivery parameters from the candidate delivery parameter set based on the input received by the user interaction unit or the identification information obtained from the commercial packaging container; perform local security verification on the target delivery parameters; and after the local security verification is passed and the user actively confirms, control the drive component to apply an action to the commercial packaging container to output the mesalazine enema preparation in the commercial packaging container according to the target delivery parameters.
[0028] In some embodiments, the controller is further configured to receive configuration suggestion data packets from an external information processing system; the external information processing system is only used to generate or distribute configuration suggestion data packets and does not directly control the system to perform drug administration.
[0029] Perform a digest fingerprint consistency comparison and / or audit reference ID tracing on the configuration suggestion data packet; if the verification passes, update or supplement the candidate delivery parameter set based on the configuration suggestion data packet; if the verification fails, maintain the local preset parameters or fall back to conservative parameters.
[0030] In some implementations, the user interaction unit includes a device-side interface and / or a mobile terminal interface for selecting a drug delivery mode, wherein the target delivery parameter is associated with the selected drug delivery mode.
[0031] In some implementations, after the local security verification is passed, before the output operation is executed, the user interaction unit displays the target delivery parameters and allows the user to adjust at least one of the flow rate, total duration, and staged program within a preset security boundary; after the user actively confirms through the user interaction unit, the controller controls the drive component to execute the output operation.
[0032] In some implementations, the commercial packaging container may be a squeeze bottle with a compressible body; the controller may also record session information for each execution output and allow the recall of successful templates from historical sessions as candidate delivery parameter sets in subsequent use.
[0033] The method is executed by a pump-controlled drug delivery system including a holding / adapter component, a user interaction unit, a controller, and a drive component. The method includes: directly loading a commercially available container pre-filled with a single-dose mesalazine enema formulation into the holding / adapter component without transferring the drug solution, and sealing the commercially available container with the output pathway; acquiring identification information associated with the commercially available container pre-filled with the single-dose mesalazine enema formulation; determining a set of target delivery parameters from a set of candidate delivery parameters stored or accessible in the controller based on the identification information or input received through the user interaction unit; performing a local security check on the target delivery parameters; after the local security check passes and the user actively confirms, controlling the drive component to apply force to the commercially available container to output the mesalazine enema formulation within the container according to the target delivery parameters; and recording session information for this execution.
[0034] Example 1: Existing pre-loaded mesalazine enema direct-connect pump platform; 1.1 This embodiment provides a pump-controlled drug delivery system for mesalazine enema formulations, comprising: Holding / Adapting Components: A universal clamp based on the shoulder positioning outer diameter, featuring a radially concentric positioning structure and an axial stop surface, is used to accommodate a 60 mL nominal volume commercial mesalazine enema corrugated squeeze bottle.
[0035] Drive components: include a linear stepper motor and a pusher plate. The pusher plate acts on the bottom of the bottle, and the controller controls the rotation angle of the motor to drive the pusher plate to move axially, compressing the corrugated bottle to output the medicine.
[0036] Controller: An embedded microcontroller with a set of candidate delivery parameters pre-stored in its internal non-volatile memory for the "Mesalazine Enema - 60mL Corrugated Bottle". This set of parameters includes: total output, target flow rate, total duration, and staged execution program.
[0037] Preferably, the default parameter template for the "Mesalazine Enema Preparation - 60mL Corrugated Bottle" can be set as follows: total output volume 50mL, first-stage target flow rate 2.0mL / min for 10min, second-stage target flow rate 1.5mL / min for 20min, total duration 30min. Users can make fine adjustments within the preset safety boundaries.
[0038] User interaction unit: The device is equipped with a 2.8-inch touchscreen and supports Bluetooth connection to mobile terminal APP.
[0039] 1.2 The operation procedure is as follows: The 60mL commercial mesalazine enema container is directly filled with the retainer / adapter without transferring the medication, and a sealed connection is formed with the output channel through the sealing connection at the bottle mouth.
[0040] The user inserts a 60mL mesalazine enema commercial packaging container into the retainer / adapter assembly to position the container. The bottle neck of the commercial packaging container is sealed to the output passage via a sealing connection structure.
[0041] When the user selects "Mesalazine Mode" on the touchscreen, the system automatically identifies the drug type as "Mesalazine Enema" and the container type as "60mL Commercial Packaging Container." The controller then retrieves the corresponding set of candidate delivery parameters from storage as the target delivery parameters.
[0042] In some implementations, the outer surface of the commercial packaging container is provided with at least one of the following: a QR code label, an RFID tag, or a color-coded identifier. The identification module reads the identifier and generates identification information for the commercial packaging container. The controller automatically matches and calls the corresponding candidate delivery parameter set based on this identification information. When the read identification information does not match the current drug type or container type, the output operation is refused, or the system reverts to conservative parameters and prompts the user for confirmation.
[0043] The controller performs local security checks: The total output of the verification target does not exceed the nominal volume of the container; Verify that the flow rate at each stage does not exceed the system's preset safety threshold; The total duration of the verification target shall not exceed the maximum allowed duration.
[0044] After successful verification, the touchscreen displays the default parameters and provides a "One-Click Execution" button and an "Advanced Adjustment" entry.
[0045] After the user clicks "One-Click Execution," the controller drives the pusher plate to compress the commercial packaging container according to the staged program, allowing the liquid medicine to be output through the output channel. During execution, the touchscreen displays the remaining volume, current flow rate, and elapsed time in real time; after the staged program is completed, the system stops outputting and records the session information.
[0046] After execution, the controller records the session information: session ID, timestamp, agent type, container type, actual execution parameters, and exception handling result. This session information is stored in local flash memory and can be synchronized to the mobile terminal.
[0047] 1.3 When the same user uses the service a second time, they can directly select the "Last Successful Template" through the mobile app. The system will automatically retrieve the parameter set from the historical session, repeat the above local security verification, and then execute the service with one click. Users can also make minor adjustments within the security boundaries: for example, by reducing the flow rate in the second stage, the system will accept the adjustment and execute it.
[0048] Example 2: Configuration suggestion data packets and parameter reuse; 2.1 Data Packet Generation and Distribution: The external information processing system generates configuration suggestion data packets based on historical execution data anonymously uploaded by multiple users, or based on multiple usage records of a specific user, resulting in a smoother output process and higher user compliance. The external information processing system is only used to generate or distribute configuration suggestion data packets and does not directly control the pump-controlled drug delivery system to administer medication. The configuration suggestion data packet includes at least: Drug type; container type; recommended parameters; summary fingerprint; audit citation ID.
[0049] Data packets are pushed to the user's mobile terminal APP via Bluetooth or Wi-Fi, and then transmitted to the pump controller.
[0050] 2.2 Terminal Local Security Verification: After receiving the configuration suggestion data packet, the controller does not adopt it directly, but instead performs the following local security checks: Digest fingerprint consistency comparison: The controller recalculates the data packet content and compares it with the digest fingerprint carried by the data packet. If they match, it indicates that the data packet has not been tampered with during transmission.
[0051] Audit reference ID tracing: The controller verifies the signature information of the external information processing system to confirm the trustworthiness of the data packet source.
[0052] Parameter range verification: The recommended stage flow rate is within the safety boundary, the recommended total output does not exceed the allowable output limit corresponding to the current commercial packaging container, and the stage duration is a positive value.
[0053] Compatibility check: It is recommended that the parameters match the type of commercial packaging container currently connected.
[0054] All validations passed. The controller stores the suggested parameters as a supplementary candidate parameter set and marks them as "external recommended template". The original default parameter set is retained.
[0055] 2.3 User Interaction and Execution: The next time the user uses the device, the touchscreen will display "New recommended parameter template found," listing the differences in parameters. The user can choose to "Accept and execute," "View details," or "Decline." If the user selects "Accept and execute," the system will execute the output according to the recommended parameters.
[0056] 2.4 Verification failure scenarios: If the flow rate of the second stage in the data packet sent by the external information processing system exceeds the security boundary, the local verification fails. The controller refuses to update the parameters, maintains the local preset parameters (or falls back to conservative parameters), and displays "Recommended parameters failed security verification and have been ignored" on the user interface. The abnormal event is also logged.
[0057] 2.5 Local reuse of historical successful templates: Without external information processing system intervention, the controller periodically analyzes locally stored session records. For the same drug and container type, if a set of parameters is successfully executed three times consecutively, it is automatically marked as a "local recommended template." The user can then directly select this template the next time they use the device, without needing to re-enter the information.
[0058] 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 pump-controlled delivery system for mesalazine enema formulations, characterized in that, Includes holding / adapting components, drive components, controllers, and user interaction units for containing or adapting pre-filled commercial packaging containers for single-dose mesalazine enema formulations; The holding / adapting component is used to position the commercial packaging container without transferring the drug solution, so that the commercial packaging container forms a sealed connection with the output passage and is within the driving range of the driving component. The drive component is used to apply force to the commercial packaging container to dispense the liquid medicine; The controller stores or can recall at least one set of candidate delivery parameters associated with the mesalazine enema formulation; The controller is configured to: Based on the input received by the user interaction unit or the identification information obtained from the commercial packaging container, a set of target delivery parameters is determined from the candidate delivery parameter set; A local security check is performed on the target delivery parameters; after the local security check passes and the user actively confirms through the user interaction unit, the drive component is controlled to perform an output operation on the mesalazine enema preparation in the commercial packaging container according to the target delivery parameters.
2. The system according to claim 1, characterized in that, The controller is also configured to: Receive configuration suggestion data packets from external information processing systems; Perform digest fingerprint consistency comparison and / or audit reference ID tracing on the configuration suggestion data packet; If the verification passes, the candidate delivery parameter set will be updated or supplemented based on the configuration suggestion data packet. If the verification fails, the local preset parameters will be maintained or the parameters will be rolled back to conservative parameters. The configuration suggestion data packet is only used to update or supplement the candidate transmission parameter set and does not directly control the driver component to perform output operations.
3. The system according to claim 1, characterized in that, The user interaction unit includes a device-side interaction interface and / or a mobile terminal interaction interface, used to select a drug delivery mode. The target delivery parameters are associated with the selected drug delivery mode, and the drug delivery mode includes a one-click drug delivery mode.
4. The system according to claim 1, characterized in that, After the local security verification is passed, before the output operation is executed, the user interaction unit displays the target delivery parameters and allows the user to adjust at least one of the flow rate, total duration, and staged program within the preset security boundaries; after the user actively confirms through the user interaction unit, the controller controls the drive component to execute the output operation.
5. The system according to claim 1, characterized in that, The candidate delivery parameter set includes at least one of the following: total output, target flow rate, total duration, and staged execution procedure.
6. The system according to claim 1, characterized in that, The identification information includes at least one of the following: drug identification, container identification, nominal volume, and packaging identification.
7. The system according to claim 1, characterized in that, The commercial packaging container is a compressible, pre-filled commercial packaging container for a single-dose mesalazine enema formulation.
8. The system according to claim 1, characterized in that, The controller is also configured to record session information for each execution output, the session information including at least one of session ID, timestamp, agent type, container type, actual execution parameters, and exception handling results, and to allow the use of successful templates from historical sessions as candidate delivery parameter sets in subsequent use.
9. The system according to claim 3, characterized in that, The one-click drug delivery mode displays the default parameters in the candidate delivery parameter set through the user interaction unit, and provides a one-click confirmation execution option after the local security verification is passed.
10. The system according to claim 4, characterized in that, The preset safety boundaries include: upper and lower limits for flow rate adjustment, maximum and minimum total duration, and constraint ranges for duration or flow rate of each stage in the staged program; the controller is configured to reject user input that exceeds the safety boundaries.
11. The system according to claim 2, characterized in that, The local security verification includes: verifying whether the target delivery parameters are within a preset security threshold range; verifying whether the target delivery parameters match the identification information; verifying whether the target delivery parameters are consistent with the selected delivery mode when the dosing mode is selected through the user interaction unit; and verifying the digest fingerprint and / or audit reference ID of the configuration suggestion data packet from the external information processing system.
12. The system according to claim 1, characterized in that, The system also includes: An identification module for identifying information about the commercial packaging container or pharmaceutical agent, the identification module including at least one of a QR code reader, an RFID reader, or a color-coded identifier, to prevent misconnection of commercial packaging containers of different sizes or different pharmaceutical agents.
13. The system according to claim 1, characterized in that, The controller is also configured to: determine a target delivery parameter from a set of candidate delivery parameters corresponding to the commercial packaging container based on the identification information obtained from the commercial packaging container; and refuse to perform an output operation or fall back to conservative parameters when the identification information does not match the set of candidate delivery parameters.
14. The system according to claim 1, characterized in that, The pre-filled single-dose mesalazine enema commercial packaging container is directly loaded into the retaining / adapting component without transferring the drug solution, and forms a sealed connection with the output passage through the sealing connection at the bottle mouth. The driving component directly applies compression to the original packaging container to output the drug solution.
15. A pump-controlled administration method for mesalazine enema formulations, characterized in that, The method is performed by a pump-controlled drug delivery system comprising a holding / adapting component for containing or adapting a pre-filled commercial packaging container for a single-dose mesalazine enema formulation, a user interaction unit, a controller, and a drive component, including: A commercially available container pre-filled with a single-dose mesalazine enema formulation is directly loaded into the retainer / fitting assembly without transferring the drug solution, and the commercially available container is sealed to the output passage. Obtain the identification information associated with commercial packaging containers pre-filled with a single-dose mesalazine enema formulation; Based on the identification information or the input received through the user interaction unit, a set of target transport parameters is determined from the candidate transport parameter set stored or available in the controller. Perform local security checks on the target delivery parameters; After the local security verification is passed and the user actively confirms through the user interaction unit, the control drive component applies an action to the commercial packaging container to output the mesalazine enema preparation in the commercial packaging container according to the target delivery parameters; Record the session information output during this execution.