ES2924574A1 - SENSITIVE DRAINAGE SYSTEM FOR ORGANIC FLUIDS PRESENT IN PATIENT WOUNDS OR STOMA - Google Patents

Abstract

Sensitive drainage system for organic fluids present in wounds or stomas. The present invention refers to a medical system or device for draining organic fluids present in wounds or stomas of the patient. In particular, the system is automated through a processing unit that manages the activation and deactivation of the system, based on the data taken by a sensor regarding different physical and/or chemical variables measured in the fluid. (Machine-translation by Google Translate, not legally binding)

Description

SENSITIVE DRAINAGE SYSTEM FOR ORGANIC FLUIDS PRESENT IN

PATIENT WOUNDS OR STOMA

FIELD OF THE INVENTION

The present invention belongs to the medical field. Particularly, the present invention refers to a medical system or device for draining organic fluids present in wounds or stomas of patients. In particular, the system is automated through a processing unit ( hardware) that executes a computer program ( software) to manage the activation and deactivation of the system based on the data obtained by a sensor regarding different physical variables and/or measured chemicals in the fluid.

STATE OF THE ART

Drains are devices used in medicine and surgery to favor the evacuation of organic fluids, excreted or secreted naturally or pathologically in different cavities or surgical wounds.

With the use of drains, it is possible to quantify the volume of fluid, assess its characteristics and prevent its accumulation, facilitating tissue healing. Therefore, drainage can be considered prophylactic, therapeutic and diagnostic.

There are currently two types of drainage: active (they have negative pressure) and passive, which in turn can be by capillarity or by gravity.

With regard to active drainage, continuous negative pressure (Jackson Pratt, Redon, Blake, Pleurevac systems) have traditionally been used. Devices are currently used for vacuum closure of complex VAC-type wounds, which have an electronic device that adjusts the pressure exerted on the wound, and even allows intermittent programming of aspiration.

In the treatment of complex wounds that present high-output enterocutaneous fistulas, healing is compromised. Active drains that suction continuously, used for the treatment of complex wounds (VAC therapies) can increase the flow of the fistula, causing discomfort to the patient and, by requiring a continuous vacuum, they can become saturated and it is difficult to prevent the system from leaking. have leaks. On the other hand, passive drains, commonly called "swimming pools" in these cases, cause fluids to intestinal accumulate on the wound altering healing. In addition, they end up filtering through the folds, preventing the proper adherence of the system and digesting healthy skin, causing discomfort and pain to the patient.

Therefore, there is an unmet medical need to generate drainage systems that are capable of being programmed to automatically determine and decide when their activation or deactivation is necessary, or even define the time interval for activating the system. , or the waiting time interval until its reactivation, depending on the physical or chemical characteristics of the fluid.

The present invention is aimed at solving this medical need and is therefore focused on a drainage system capable of executing previously programmed instructions.

DESCRIPTION OF THE INVENTION

Brief description of the invention

The present invention refers to a system (hereinafter system of the invention) or medical device for draining organic fluids present in wounds or stomas of the patient.

The system is automated through a processing unit ( hardware) that executes a computer program ( software) to manage its activation and deactivation, based on the data taken by a sensor regarding different physical and/or chemical variables measured in the fluid.

Particularly, the first aspect of the present invention refers to a system configured for the drainage and evacuation of organic fluids from a wound or stoma in the patient, characterized in that it comprises:

• Tubular structure with a plurality of holes (1),

• Sensor (2) configured to measure physical and/or chemical variables in the fluid, • Sealing bag (3) configured to prevent accidental fluid leaks,

• Vacuum generation system (4),

• Computer comprising a processor unit (hardware/software) (5) configured to:

o Continuously receive the data obtained by the sensor (2) regarding physical and/or chemical variables measured in the fluid,

o Process the data obtained by the sensor (2) for the identification of variations in the physical and/or chemical variables measured in the fluid that are significant with respect to a predetermined threshold value,

o Provide a signal to activate the vacuum generation system (4) when significant variations have been identified in the physical and/or chemical variables measured in the fluid,

• Fluid collection tank (6).

In a preferred aspect, the system of the invention is characterized in that it further comprises:

• Vacuum loss port (7),

• Solenoid valve (8) and

• Wound drainage lavage system (9).

In a preferred aspect, the system of the invention is characterized in that it comprises:

• Tubular structure with a plurality of holes (1),

• Sensor (2) configured to measure physical and/or chemical variables in the fluid, • Sealing bag (3) configured to prevent accidental fluid leaks,

• Vacuum generation system (4),

• Vacuum loss port (7),

• Solenoid valve (8),

• Computer comprising a processor unit (hardware/software) (5) configured to:

o Continuously receive the data obtained by the sensor (2) regarding the physical and/or chemical variables measured in the fluid,

o Process the data obtained by the sensor (2) for the identification of variations in the physical and/or chemical variables measured in the fluid that are significant with respect to a predetermined threshold value,

o Provide a signal to activate the solenoid valve (8) proceeding to close the vacuum loss orifice (7), and/or the vacuum generation system (4), when significant variations have been identified in the physical variables and/or measured chemicals in the fluid,

• Fluid collection tank (6).

• Drainage or wound lavage system (9).

In a preferred aspect, the system of the invention is characterized in that the tubular structure with a plurality of holes (1) has a circular shape.

In a preferred aspect, the system of the invention is characterized in that the tubular structure with a plurality of holes (1) have a diameter between 3 and 6 mm.

In a preferred aspect, the system of the invention is characterized in that the tubular structure with a plurality of holes (1) is made of semi-rigid plastic.

In a preferred aspect, the system of the invention is characterized in that the sensor (2) is configured to measure physical and/or chemical variables in the fluid selected from the group comprising: pH, liquid level, color, flow or percentage moisture.

In a preferred aspect, the system of the invention is characterized in that a processor unit (hardware/software) (5) is also configured to define the system activation time interval, or the waiting time interval until system reactivation. system, based on the data generated by the sensor (2).

In a preferred aspect, the system of the invention is characterized in that a processing unit (hardware/software) (5) is also configured to activate or deactivate the washing system (9).

In a preferred aspect, the system of the invention is characterized in that the sealing bag (3) is reinforced with insulating paste.

In particular, the system of the invention comprises a board with integrated circuits (hardware) capable of executing instructions that have been programmed for it through a computer software interface. It has a variety of devices both input (sensors) and output (actuators). Among the input devices we can find pH, humidity, color, flow, water level detectors, etc. As for actuators (output devices), servo motors are a frequently used option.

The second aspect of the invention refers to a computer program (software) that includes instructions for the activation or deactivation of the system of the invention, based on the data obtained by the sensor (2). In particular the computer program comprises instructions for:

• Continuously receive the data obtained by the sensor (2) regarding the physical and/or chemical variables measured in the fluid,

• Process the data obtained by the sensor (2) for the identification of variations in the physical and/or chemical variables measured in the fluid that are significant with respect to a predetermined threshold value,

• Provide a signal to activate the solenoid valve (8) proceeding to close the vacuum loss orifice (7), and/or the vacuum generation system (4), when significant variations have been identified in the physical variables and/or measured chemicals in the fluid.

The third aspect of the invention relates to a computer readable medium comprising the above defined computer program (software).

The fourth aspect of the present invention refers to a method for draining organic fluids present in wounds or stomas of the patient that comprises the use of the system of the invention.

Description of the figures

Figure 1 and Figure 2. Preferred arrangement of the system of the invention showing the different modules.

The elements characterized in the figures are the following:

Detailed description of the invention

The system of the invention comprises a tubular structure (1), preferably made of semi-rigid plastic, comprising a plurality of holes. The tubular structure (1) is preferably circular.

Adjacent to the tubular structure (1), there is a sensor (2) configured to measure physical and/or chemical variables in the fluid, for example: pH, humidity, color, liquid level or flow, in contact with the region of the patient to be treated.

In a preferred aspect, the sensor (2) is a direct current analog water level sensor, with an input voltage requirement of 5V, given by the microcontroller, an operating current of less than 20mA, with a detection area of 40mmx16mm and a humidity resistance of between 10 and 90%. Like this sensor, pH, humidity or heat sensors can be used, all of them configured to measure physical and/or chemical variables in the fluid. These sensors would all have characteristics very similar to those of the water level sensor.

The variables measured by the sensor can indicate the presence of excess fluid by increasing the humidity index above a certain threshold (or changing the pH or changing color) which will determine that the fluid must be drained.

In one embodiment of the invention, the sensor (2) measures the values of said physical and/or chemical variables in the fluid and sends the data taken to the processing unit (5). Said processing unit (5) continuously receives the data obtained by the sensor (2) regarding the physical and/or chemical variables measured in the fluid, processes the data obtained by the sensor (2) for the identification of variations in the physical and/or chemical variables measured in the fluid that are significant with respect to a predetermined threshold value and provides a signal to activate or deactivate the vacuum generation system (4) (which has the ability to modulate the negative pressure exerted), depending on the significance of the variations in the physical and/or chemical variables measured in the fluid.

In another embodiment of the invention, the sensor (2) measures the values of said physical and/or chemical variables in the fluid and sends the data taken to the processing unit (5). Said processing unit (5) continuously receives the data obtained by the sensor (2) regarding the physical and/or chemical variables measured in the fluid, processes the data obtained by the sensor (2) for the identification of variations in the physical and/or chemical variables measured in the fluid that are significant with respect to a predetermined threshold value and provide a signal to activate the system but, in this case, the pressure exerted by the vacuum generation system (4) is not transmitted directly to the patient, since, away from the area to be treated, the system preferably comprises a vacuum loss orifice (7) on which an electrovalve (8) with the capacity to block it is located. Thus, when the sensor (2) detects a variation in the physical and/or chemical variables measured in the fluid, it sends the signal to the processing unit (5) and, if the variation in the physical and/or chemical variables measured in the fluid are significant with respect to a predetermined threshold value, the solenoid valve (8) will be activated, closing the vacuum loss orifice (7) and sucking in the fluids for the programmed time (depending on the patient's needs). That is, while the system is idle, vacuum pressure is lost through the vacuum loss port (7). When the system is activated, the pressure is transmitted to the system by closing the vacuum loss hole (7) by means of the solenoid valve (8).

In both embodiments, the sensor (2) measures different physical and/or chemical variables in the fluid, preferably: humidity, pH, color, liquid level or flow. In a preferred aspect, the variables used are pH or fluid level, for the purpose of draining intestinal fluids.

In both embodiments, the drained liquid continues to a fluid collection tank (6), which in turn connects to the vacuum generation system (4), whose pressure can be adjusted with a regulator.

The processing unit (5), in addition to giving instructions to activate or deactivate the system based on the average variables measured by the sensor (2), determines the activation threshold of the sensor, the activation time of the solenoid valve (8), the wait until reactivation and activation sequence of the washing system (9).

The system also comprises a sealing bag (3) around the tubular structure (1) to prevent accidental liquid leakage, especially when the system is applied to wounds with high-flow secretions. Thus, the sealing bag (3) seals the area of the wound, in such a way that, if very rapid fluid outflows occur, they are collected in the bag until the drainage is activated (or reactivated), avoiding leaks.

In addition, the system may include a drainage or wound washing system (9) that helps to increase the sensitivity of the sensor, achieving a more precise aspiration. The drainage or wound washing system (9) can be activated sequentially at the end of the aspiration.

Through the processing unit (5) it is also possible to establish a minimum time until the new detection and, therefore, the new aspiration. In this way, the system of the invention is completely programmable for each specific case.

Claims (1)

1. System configured for the drainage and evacuation of organic fluids from a wound or stoma in a patient, characterized in that it comprises: • Tubular structure with a plurality of holes (1), • Sensor (2) configured to measure physical and/or chemical variables in the fluid, • Sealing bag (3) configured to prevent accidental leaks of the fluid, • Vacuum generation system (4), • Computer comprising a processor unit (5) configured to: Yo. Continuously receive the data obtained by the sensor (2) regarding the physical and/or chemical variables measured in the fluid, ii. Process the data obtained by the sensor (2) for the identification of variations in the physical and/or chemical variables measured in the fluid that are significant with respect to a predetermined threshold value, iii. Provide a signal to activate the vacuum generation system (4) when significant variations have been identified in the physical and/or chemical variables measured in the fluid, • Fluid collection tank (6). 2. System, according to claim 1, characterized in that it further comprises: • Vacuum loss port (7), • Solenoid valve (8) and • Wound drainage lavage system (9). 3. System, according to any of the preceding claims, characterized in that it comprises: • Tubular structure with a plurality of holes (1), • Sensor (2) configured to measure physical and/or chemical variables in the fluid, • Sealing bag (3) configured to prevent accidental leaks of the fluid, • Vacuum generation system (4), • Vacuum loss port (7), • Solenoid valve (8), • Computer comprising a processor unit (5) configured to: Yo. Continuously receive the data obtained by the sensor (2) regarding the physical and/or chemical variables measured in the fluid, ii. Process the data obtained by the sensor (2) for the identification of variations in the physical and/or chemical variables measured in the fluid that are significant with respect to a predetermined threshold value, iii. Provide a signal to activate the solenoid valve (8) proceeding to close the vacuum loss orifice (7), and the vacuum generation system (4), when significant variations have been identified in the physical and/or chemical variables measured in the fluid, • Fluid collection tank (6). • Drainage or wound lavage system (9). 4. System according to any of the preceding claims, characterized in that the tubular structure with a plurality of holes (1) has a circular shape. 5. System, according to any of the preceding claims, characterized in that the tubular structure with a plurality of holes (1) has a diameter between 3 and 6 mm. 6. System, according to any of the preceding claims, characterized in that the tubular structure with a plurality of holes (1) is semi-rigid plastic. 7. System, according to any of the preceding claims, characterized in that the sensor (2) is configured to measure physical and/or chemical variables in the fluid selected from the group comprising: pH, liquid level, color, flow or percentage moisture. 8. System, according to any of the preceding claims, characterized in that a processing unit (5) is also configured to define the system activation time interval, or the waiting time interval until system reactivation, depending on the data generated by the sensor (2). 9. System, according to any of the preceding claims, characterized in that a processing unit (5) is also configured to activate or deactivate the washing system (9). 10. System according to any of the preceding claims, characterized in that the sealing bag (3) is reinforced with insulating paste. 11. Computer program comprising instructions for activating or deactivating the system of claims 1 to 10. 12. A computer readable medium comprising the program of claim 11.