Title of Invention:

[0001] Bladder irrigation monitoring system

Technical Field:

[0002] The invention is related to the field of human needs under the health sector. Specifically, the invention is related to medical equipment.

Background Art:

[0003] Bladder irrigation is usually done in a simple and traditional manner based on gravity, meaning that liquid comes from a source above the body level of patient and enters the body due to gravity ln the end, the liquid enters the liquid collection tank, which is placed at a level lower than the body level of the patient.

[0004] Today, there are some devices designed for automatic and smart irrigation of bladder, which merely facilitate the bladder irrigation process but contains no mechanism to monitor and detect possible dysfunctions in the process. Therefore, it is possible that some complications occur due to the high pressure of liquid injected into the bladder in case of an occurrence of the mentioned dysfunctions in bladder irrigation procedure.

[0005] Therefore, there is a general need for the design of a device to monitor and detect possible dysfunctions in the bladder irrigation process.

Summary of The Invention:

[0006] One of the essential treatments for patients with severe urinary bleeding from the source of the bladder or prostate is bladder irrigation process. This procedure is performed when there is an active bleeding inside the bladder. As a result, it is crucial to establish a continuous flow of fluid to the point that there is no blood flow or clots in the bladder.

[0007] The use of a bladder irrigation process blindly and without information about possible events that could occur in the bladder and prostate space after rinsing leads to severe and sometimes deadly complications in patients, causing difficulties in performing bladder and prostate surgery, increased the duration of disease and even mortality. Now, bladder irrigation is merely monitored and assessed by personal observations. Therefore, an inadequate number of nurses or assigning the process to companions of patients will lead to a high rate of neglect and error. Lack of detection of possible abnormalities in the bladder irrigation system (even for a short time) can have irreparable consequences for the patient.

[0008] The invented device can provide accurate and momentous information on the inaccessible conditions and environment of the bladder and prostate, announcing any change in the environment to physicians and nurses and preventing the occurrence of complications in patients.

[0009] The invented device just monitors the irrigation process and has no involvement in the bladder irrigation method ln addition, this device can be used in both manual and automatic techniques. Application of this device leads to constant control of bladder irrigation process, recognition of any dysfunction in the irrigation system through detecting sensors and announcing any errors by its alarm system ln addition to local alarms, the device also uses other warning mechanisms, including wireless monitors and mobile S1M cards.

[0010] Some of the advantages of this device include low weight and usability in any location or time, prevention of complications caused by dysfunction in bladder irrigation process, such as rupture of bladder, intense bleeding and occurrence of hemodynamic shock, decreased need to direct individual monitoring, reduced need to nurses for evaluation of patients, decreased costs and dependence on companions of patients and other non-experts for monitoring of patients during the process. Moreover, the device instantly shows the irrigation process in the monitor on the device itself as well as the nursing station monitor, simultaneously recording all information, especially alarms, in its memory for probable future readout.

Brief Description of Drawings:

The structure of the invention is shown in maps to better comprehend the invention. However, the invention is not limited to a specific method and structure in this project. Various sections of the invention are presented on the map with specific numbers, which are explained in the invention description section.

[0011] Figure 1. An image of the bladder irrigation monitoring system along with bladder washing tools

[0012] Figure 2. An image of the bladder irrigation monitoring system

Detailed Description Of The Invention:

[0013] According to Figure 1, the present patent is a bladder irrigation monitoring system. This device and irrigation system encompasse of bladder irrigation fluid source (101], liquid guiding tubes (102, 104, 105, 107, 111, 113, 114, 115, 117], connector of liquid guiding tubes (103, 106, 112, 116], inlet of washing liquid inside the three-way catheter (108], body of the three-way urinary catheterization (109], outlet of washing liquid of bladder from the three-way urinary catheter (110], bladder fluid collector tank (118], sensor determining the amount of fluid flow into the bladder (119], sensor determining the amount of fluid flow out of the bladder (120], sensor detecting fluid discoloration coming out of the bladder (121], the monitor showing the instantaneous information of the irrigation system (122], central processor of information (123], system for sending irrigation information to nursing station monitor (124, 127], alarm system, which send text messages to cellphone (125, 129], rechargeable battery (126], local alarm system (128], body of device (130], location of device battery (131], on-off switch (132], memory card (133] and setting switches (134].

[0014] The central information processor (123] includes two software and hardware sections, used to obtain and analyze the information received from sensors (119, 120, 121] and detect default defects in irrigation process and send alarms and informations (122, 124, 125, 128] required by information delivery systems.

[0015] Sensitivity level of three sensors (119, 120, 121] can be adjusted by setting switches (134] of the device ln addition, color detection sensor (121] has the ability to be turned on and off, so that the device could be adjusted based on the opinion of the surgeon and patient condition if required. [0016] Body (130) of the device is produced from aluminum or compressed plastic and is generally water resistant ln addition, liquid guiding tubes (102, 104, 105, 107, 111, 113, 114, 115, 117) are made of silicon or of medical grade type materials ln addition, they can be sterilized. Sensors (119, 120, 121) are of medical grade types and can be sterilized. Moreover, disposable sensors or those that have no direct contact with the liquid can be used. The software and hardware systems related to receiving, analyzing and delivering information through text messages and alarms (123) are water resistance and can be sterilized. The battery of the device (126) is made of lithium and has the ability to supply electricity to the device for a minimum of 24-48 hours ln addition, the battery can be charged by the adaptor and via urban electricity. The device is also able to work with municipal power. Antenna sending information to mobile phones and nursing monitors (127, 129) and the alarm installed on the device (128) can be sterilized and are water resistant. Connectors of tubes that guide the liquid (103, 106, 112, 116) are made of medical-grade compressed plastic and can be disinfected. The most efficient manufacturing technique in order to have a sterilizable device and avoid possible damages to electronic components is embedding the sensors and tubes in a separate box, that can be installed in the device. By doing so, the mentioned box can be separated sterilized and there is no need for complete sterilization of the device.

[0017] The irrigation liquid inside the source (101) is entered into the entry (103) of the device through guiding tubes (102). From there, the liquid is guided to the sensor that determines the flow rate of liquid entering the bladder (119) through another tube (104), so that the speed of liquid entering the body of patient is determined and delivered to the centeral data processor (123). Following that, the liquid is guided by another tube (105) to the relevant exit (106) and to the entry of the three-way catheter (108) by another tube (107). The irrigation liquid enters the bladder of patient by a three-way catheter (109). After washing the inside of the bladder, the liquid re-enters the device through the exit head of the catheter (110) and a special entry (112). The liquid exited from bladder of patient, which contains blood and other washing liquids, enters the detection sensor for fluid color change (121) via a tube (113). By doing so, an excess level of colorful compounds in the liquid is informed to the data center systems of the device (122, 124, 125, 128) through the central processor (123).The sensitivity level of the color detection sensor (121) is adjustable, in a way that color change is not reported to a specific limit ln the next stage, the exiting liquid enters the flow rate sensor for bladder outlet (120) through a tube (114), so that the flow rate of liquid exiting the body of the patient is determined and delivered to the central data processor (123). The central processor compares the informed received from the two sensors (119, 120) and instantly evaluates the irrigation process inside the body to deliver information about any dysfunction, including discontinuation of entry of fluid in the body or significant reduction of exit of liquid from the body, compared to liquid entering the body, to the information systems of the device (122, 124, 125, 128). ln the end, the liquid is guided toward the exit of the device (116) by another tube (115) and to the liquid collector tank (118) by another tube (117).

[0018] information related to the two flow rate determining sensors (119, 120) and color change detection sensor (121) is delivered to the central data processor (123) through the wires and are analyzed by a software, sending specific messages to sms sending systems:

[0019] discontinued or significantly lowered flow of liquid to the sensor (119) leads to the sending of a message with the title of“bladder irrigation flow is discontinued”. The limitation of liquid flow entering the bladder can be adjusted for sending the mentioned message.

[0020] excess or lower level of flow instantaneously detected in the sensor (120) based on the determined level in the entry sensor (119) results in sending a message with the title of“there is a problem in the exit of liquid from the body”. However, the level of difference in the flows recorded in two sensors (119, 120) can be adjusted for sending relevant messages.

[0021] instant information about the color of liquid exiting the bladder is collected by the sensor (121) and delivered to the central data processor (123) through a wire. Excessive amounts of colored materials more than the expected level in the liquid exiting the bladder leading to the sending of a message with the title of“the patient is bleeding”. However, the concentration level of liquid color for sending this message can be adjusted. [0022] the central processor (123) receives and analyzes the informations obtained from the three sensors (119, 120, 121), informing any pre-defined dysfunction in the bladder irrigation process through sending messages by four methods, including the local monitor that shows instant information on the device (122), data delivery system to the nursing station monitor through wireless (124, 127), local alarm on the device (128) and sending text messages to the cellphone of physicians and nurses through a S1M card (125, 129) to inform the physicians and nurses.

[0023] This device is designed to monitor bladder irrigation process, which is applied in cases of active bleeding inside the bladder. Therefore, it is necessary to have a sustainable and proper flow of liquid with the ability of preventing any remaining and clotting of blood in the bladder ln this invented device, monitoring is carried out based on the momentary flow of liquid, which is evaluated by flowmeters sensors (119, 120). The amount of liquid entering and exiting the bladder is estimated and color of the exited liquid is assessed. The software and hardware system of the device is able to analyze the mentioned information and send alarm, if required.

[0024] This device can be used after performing prostate surgeries in order to empty the bladder and prostate environments from blood clots that cause severe and even fatal complications in patients. To this end, the irrigation process is initiated after surgery, using the device to evaluate the level of entrance and exit and change of color of the liquid. Any change in this regard is interpreted as dysfunction in the irrigation process, which can be followed up by performing proper medical actions to prevent the associated complications. The device can be easily installed and displaced due to its significantly low volume and weight and does not intervene in the irrigation system of the bladder and just reports the existing dysfunctions occurring in the irrigation process on its monitors.

[0025] ln order to use the device, the entry tube of bladder irrigation liquid (102) is connected to the entrance of the device (103). ln addition, the tube (117) is connected to the exit of the device (116). The catheter (109) is sent to and fixed in the bladder of the patient. Following that, two entry (108) and exit (110) heads of the catheter are connected to the area related to the other side of the device. The start button of the device (132) is pushed. The flow of liquid and all of the other information are instantly shown on the monitor of the device (122) and nursing station monitor.

[0026] This device can be used for any process that requires monitoring of fluid flow or change in the color of the fluid, such as urban water and sewage and oil company.