TECHNICAL FIELD

The invention relates to a programmable fluid drainage system that provides controlled drainage of chronic and I or acute accumulated fluid in body cavities due to various diseases.

The invention pertains in essence to the biomedical technical area/state of art.

PRIOR ART

It is possible to be accumulated “congenital” and/or “secondary” acute and/or chronic excess fluids in human corporeal cavities such as intracranial, lungs, chest cavities, heart, abdomen, due to various diseases (cancer, infection, inflammation, reactional, cirrhosis, etc.).

Malign pleural effusion (abbreviated as MPE) is a frequently encountered complication. It is estimated that annual incidence of pleural fluid is more than 150.000 (lung cancer, mammary cancer and lymphoma, mesothelioma, and such similar). However, it is reported that most of the malignities cause MPE. Following diagnosis, median survival duration is between 3 to 12 months, which depends on the type of underlying malignity, characteristics of the tumor, degree/level of the sickness, comorbidities as well as composition of the pleural effusion. Notwithstanding such a limited prognosis, it is hard to forecast the remaining life expectancy of the individual.

Accumulation of more than normal pathological fluid in the intraperitoneal cavity is called ascites. It is observed that nearly 85% of ascites incidents arise from cirrhosis of the liver, whereas roughly 10% of ascites occurs as a side effect of cancer treatment. Although this phenomenon is prevalent in peritoneal mesothelioma patients, this cancer is in general a rare cause for peritoneal effusion.

About 50% of malign peritoneal effusions are caused by “peritoneal carcinomatosis”. This results when several small sized cancer foci accumulate on the peritoneal surface of the abdominal cavity.

As it is encountered with the aforesaid fluid accumulations in the day-to-day clinic practice, the applications made by the physician on the patient comprise of detailed physical examination, analyses and inspections, laboratory tests and imaging/visualization procedures. If any disease, organ failure/dysfunction, organ function disorder is/are detected, it is initially started with the treatment process therefor. At the same time, it is ideal to determine the character of the accumulated fluid and thus it could be made “puncture with needle (thorasynthesis, parasynthesis, lumbar puncture, etc.)” with the aim of discharging/draining some of the fluid. Analysis, culture and pathological survey of the fluid taken are performed to make more accurate diagnosis.

Those patients diagnosed or otherwise in the technique could possibly be commenced with medication administration (antibiotics, anti-inflammatory medications, chemotherapy, radiotherapy, immunotherapy, target-oriented oncologic treatment, surgical practices, etc.). In the course of such treatment process, depending on the preference and decision of the physician as well as the response of the patient to the treatment, in order to drain-off and discharge the fluid accumulating, not decreasing and/or increasing, including eliminating or stopping the adverse consequences caused thereby, it could possibly be used either puncture or single-use passive drainage catheters and vacuum bottles. Such systems are called intrapleural systems depending on the place of usage within the body. In general, all of the foregoing systems comprise of a drainage catheter placed temporarily in the body and passive vacuum drainage bottles to be connected to such catheter in the course of discharge at home ambience. In the relevant technical field, all of the existing catheter and drainage systems consist of passive elements, not comprising of any systems towards feedback to either the patient and/or the physician.

Invention number US20070265647 A1 is related to providing an advanced atherectomy system where treatment of undesired sediments in the vasculature, ranging from soft clots/thrombi to harder plaques. Yet another potential application of the present invention is removing organized clots resistant to traditional thrombectomy catheter treatment.

Invention number WO2011116393 A1 is in respect of equipment, systems and methods for draining-off excessive corporeal fluids. Corporeal fluid drainage system included in the invention is placed in any patient between the area of excessive corporeal fluid and a second position capable of collecting the excessive mass and/or re-absorbing the same. Corporeal fluid drainage system comprises of a valve device applying increasing forces to the exterior part of the catheter in order to regulate the drainage speed of the corporeal fluid. Corporeal fluid drainage system included in the invention is providing for enforced flow of the corporeal fluid through the catheter, both to avoid any impediments as well as enable diagnosis on the system. By means of the system acquired by the invention, it becomes possible to drain-off and discharge various excessive body fluids such as peritoneal fluid, blood, water and/or such other corporeal fluids.

Invention number US9814807 is in general related to medical drainage systems and more specifically with thoracic drainage systems. Thoracic drainage system acquired by means of the invention is so structured and organized as to revert the lungs and pulmonary physiology to their normal condition by removing and disposing of air and/or other fluids to assist re-generation of normal vacuum pressures, lung inflation and respiratory dynamics; it is used in order to discharge any pool fluid and/or air after open heart surgery, thoracic surgery or thoracic trauma and/or facilitating collection of autologous blood from the patient’s pleural cavity or mediastinal area with the purpose of reinfusion in post-operative or trauma exsanguination administration. In conclusion, in order to eliminate any and all problems referred to hereinbefore as well as the disadvantages, it has become necessary to make a renovation in the technical field.

BRIEF DESCRIPTION OF THE INVENTION

Present invention is related to a programmable fluid drainage system devised in order to eliminate the aforesaid disadvantages and bring forth new advantages to the relevant technical area.

An objective of the invention is setting forth a programmable fluid drainage device that can be adjusted in the course of operation so as to provide the most convenient position for removing the body fluid without any requirement for detaching it from the area of application.

An objective of the invention is setting forth a programmable fluid drainage system that eliminates such complications which might possibly develop in the patient such as edema in the organs, function loss, infection and such similar, by means of continuous control of the drainage values.

An objective of the invention is setting forth a programmable fluid drainage system that makes the process instantly controllable and sustainable in a more effective way by means of the warning messages received, minimizing the requirement for physical proximity for both the physician as well as the patient.

In order to achieve and realize any and all purposes and objectives referred to hereinbefore and to be derived from the detailed description to be provided hereinbelow, the existing invention is related to a fluid drainage equipment enabling controlled drainage and discharge of any excess fluid accumulating either acutely or chronically in the corporeal cavities depending on and as a consequence of various diseases in order to achieve and realize any and all objectives to arise and originate from the detailed narration given hereinbelow. Accordingly, the drainage device referred to hereinbefore is characterized by incorporating the following elements/components; • a drainage catheter made of biocompatible materials that allow for shortterm use in the body and having a catheter distal tip that allows the position of optimal body fluid removal during operation to be adjusted without the need to remove it from the application site;

• Static application zone by generating acoustic waves in certain frequency ranges depending on the acoustic impedance specified in the microprocessor of the said drainage catheter component and providing continuous microscopic mobility at the end of the drainage catheter by means of the transmission of these acoustic waves to the drainage catheter at least one ultrasonic transducer that allows the liquid to hold onto the surface of the drainage catheter and thus avoid the risk of clogging of the catheter drainage holes;

• Application of body fluid drainage connected with at least one microprocessor that enables the transfer of the information determined by the doctor and use in the system of parameters such as drainage flow rate, duration, drainage intervals, fluid volume to be collected, which are necessary for the smooth operation of the system a programmable drainage compartment having at least one peristaltic pump that allows it to be withdrawn from the area.

In a potential set-up/modeling of the invention, the fluid drainage catheter is made of medical silicon or such other biocompatible thermoplastic materials of low durometer. Thereby, it is possible to achieve a drainage catheter enabling usage in the body as a short-term implant.

Catheter distal tip referred to under a potential set-up/modeling of the invention, is capable of changing distal positioning by means of deflecting at clinically acceptable angles downwards, upwards, to the right or to the left so as to attain the most convenient position for intake and receiving of the fluid. Thereby, it is possible to achieve a drainage catheter enabling adjustment of the best position for removing the corporeal fluid in the course of operation, without any requirement for detaching it from the area of application. In a potential set-up/modeling of the invention, the catheter distal tip is manufactured as modular or one-piece with the drainage catheter. Thereby, it is possible to specify the most suitable catheter distal tip for the area of application.

In a potential set-up/modeling of the invention, the catheter distal tip is manufactured either as flat or in pigtail form according to the target application. Thereby, it is possible to specify the most suitable catheter distal tip form for the area of application.

In a potential set-up/modeling of the invention, it is contained in the structure of the drainage catheter a deflection mechanism located at the proximal end of the catheter for positioning of the catheter distal tip at desired angles and orientations.

In a potential set-up/modeling of the invention, comprises of incorporating at least one drainage catheter connection hub enabling connection of the drainage catheter with the other elements/components and ensuring that the fluid coming from the area of application is drained.

In a potential set-up/modeling of the invention, the ultrasonic transducer clipped on the drainage catheter shaft being positioned thereon. Thereby, it is enabled that together with the data received directly from the microprocessor, desired acoustic vibrations are conveyed and transmitted to the catheter to prevent clogging of the distal drainage holes.

In the possible embodiment of the invention, the peristaltic pump includes several sensors that allow the measurement of fluid flow rate, pressure, and volume during drainage and can change the drainage rate or stop the drainage depending on the program set by the physician. The drainage system includes rechargeable battery to power the peristaltic pump and overall controller. It provides automated continuous drainage while providing mobility to the patient. Depending on the application area and the characteristics of the drainage catheter used, if any set values go out of the range, it activates an alarm and informs the patient with audible and visual warnings. The programmable drainage system can detect sudden pressure changes and flow resistance and intervene the drainage program accordingly. Thus, the Programmable drainage system can be connected to a simple internet environment for home use and the drainage parameters (accumulated fluid pressure, drainage speed, drained fluid volume, etc.) can be monitored or changed by the physician on the internet. When necessary, the physician can intervene the ongoing program by connecting to the device or make the necessary changes by talking to the patient. The process can be controlled instantly with more effective and incoming warnings, and a sustainable drainage device can be obtained, which eliminates complications such as edema, loss of function, infection, etc., and allows effective treatment remotely.

BRIEF EXPLANATION OF THE FIGURES

In Figure 1 , the representative view of the catheter element of the subject programmable drainage system is given.

In Figure 2, a representative view of the subject matter programmable drainage system is given.

In Figure 3, a representative view of the subject programmable drainage system on the body is given.

REFERENCE NUMBERS GIVEN ON THE FIGURES

1 Programmable Drainage System

10 Drainage Catheter

11 Body

12 Catheter Distal Tip

13 Deflection Button

14 Drainage Catheter Connection Hub

20 Ultrasonic Transducer

21 Ultrasonic Transducer Connection Point

30 Programmable Drainage Compartment

31 Microprocessor

32 Peristaltic Pump

33 Pressure Sensors

34 Air Bubble Detector

35 Fluid Flow Control Sensor

36 Wireless Transceiver

37 Rechargable Battery

40 Drainage Bags

41 Manual Fluid Control System DETAILED DESCRIPTION OF THE INVENTION

In this detailed description, the subject of the invention is related to a programmable drainage system (1 ) that provides controlled discharge of chronic and I or acute accumulated fluid due to various diseases in the body cavities; it is only explained with examples that do not have any limiting effect for a better understanding of the subject.

The fluid flow frequently mentioned in the detailed description is the movement of the excess fluid in the body to the drainage bag (40) by means of the device. On the contrary, liquid flow is the situation where the peristaltic pump (32) is discharged with the other movement of the liquid before it reaches the drainage bag (40).

Subject matter of the invention is in essence related to a biomedical device included in the drainage systems used in the present technique/state of the art and incorporating active elements/components towards resolving/settling problems frequently encountered. Accordingly, the device referred to hereunder comprises of three basic components, all of which components possess elements ensuring and enabling the device exhibit best possible performance.

Programmable drainage system (1 ), comprises of three components, namely the drainage catheter (10), ultrasonic transducer (20) and programmable drainage compartment (30) parts.

Programmable drainage system (1 ), representative view provided under Figure 1 , essentially comprising of body (11 ); catheter distal tip (12); deflection button (13) elements and a deflectable drainage catheter (10) that can be used in the body (11 ) as an implant for specific durations.

The body (11 ) part of the drainage catheter (10) can be in different diameters and lengths depending on the application area. The body (11 ) part can be extruded from medical silicone or biocompatible thermoplastic (polyurethane, polyethylene, pebax etc.) materials with low durometer (for example 33D) and used as short-term implant in the body (11 ). The drainage catheter distal tip (12) is not a rigid material; Due to its flexible and directional structure, it does not cause tissue damage in the body. The body (11 ) part is in the form of a hollow tube, and inside there is at least one catheter lumen that enables the catheter distal tip (12) to perform its functions, and the pull wire that advances with in the catheter shaft to the distal end and fluoroscopy device wires that enable the application area to be shown.

The main function of the body (11 ) is to provide support for the application area of the drainage catheter (10) and to ensure that the fluids drained from the target area safely and transferred to other components with the elements on it. The body (11 ) element plays an important role in the safe operation of the system as well as being the main part where the operations are carried out. Its design can be produced differently from the ones described here, especially in forms customized to the application area.

As shown in Figure 1 , the drainage catheter (10) contains a catheter distal tip (12), which ensures that the fluids in the application area are transmitted to the body (11 ) in the best possible way. The catheter distal tip (12) can be in one piece or modular structure with the body (11 ) part. The catheter distal tip (12) is located at the far end of the body (11 ) and provides its connection with the application area.

As shown in Figure 1 , the catheter distal tip (12) can also be turned into a coiled state by deflecting the tip in order to be positioned to remain in the body (11 ) as a short term implant while it is straight during the insertion and removal from the body (11 ). Thus, the catheter distal tip (12) is in an adjustable position in order to obtain the best position to drain the excess fluid in the target area effectively. The potential catheter distal tip (12) positions are shown in Figure 1 .

Due to its deflectability, the desired position of the catheter distal tip (12) can be adjusted so that the distal drainage holes stay within the excess fluid without moving/removing the drainage catheter (10) from its location.

In addition, the catheter distal tip (12) vibrates in micro scale to prevent adherence of particles within the excess fluid to the catheter shaft in close vicinity of drainage holes through the ultrasonic transducers (20) which are mechanically coupled to the body (11 ).

The basic function of the deflection button (13) mentioned before and positioned at the proximal end of the body (11 ); the aim is to adjust the position of the catheter distal tip (12) according to the application area eliminating the need of repositioning the whole leaving the drainage catheter (10). The deflection button (13) is connected to the catheter distal tip (12) via pulling wires. Figure 1 shows its position clearly. As mentioned before, the element that enables the catheter distal tip (12) to take its desired position in Figure 1 is the deflection button (13). The deflection button element (13) is mechanically associated with the catheter distal tip (12) element; it allows adjustment of the catheter distal tip (12) to obtain the highest efficiency.

As demonstrated on Figure 2, under structure of the programmable drainage system (1 ) there is contained at least one drainage catheter connection hub (14) providing for interconnection of the drainage catheter (10) with the other components and enabling conveyance of the fluid coming from the area of application up to the drainage bag (40).

As exhibited on Figure 1 and Figure 2, the programmable drainage system (1 ), comprises mainly of at least one ultrasonic transducer (20) placed inside an encasing of medical silicone so as to be positioned in “U” form to mount over the catheter shaft . The ultrasonic transducer (20) generates acoustic waves in the frequency range of 80 to 120 kHz (modulated in the frequency range of 30 to 50 Hz) depending on the acoustic impedance of the drainage catheter (10) component and by means of such acoustic waves being transmitted to the shaft of the drainage catheter (10) and conveyance thereof alongside the entire shaft, enabling perpetual microscopic mobility at the distal end of the drainage catheter, adherence of the static drain fluid to the surface of the drainage catheter (10) and thereby ensuring avoidance/prevention of blocking risk of the catheter holes. Ultrasonic transducer (20) is interconnected to the programmable drainage compartment (30), operating in coordination with the data arriving from such part. And it is providing for formation of an impact of the sound vibrations generated thereunder, on the body (11 ).

Although the main position of the ultrasonic transducer (20) is on the body (11 ), it can also be located in various polymer parts of the programmable drainage system (1 ) if preferred. For example, an ultrasonic transducer (20) can be placed on the drainage catheter connection hub (14). If preferred, the number of ultrasonic transducer (20) can be more than one.

The programmable drainage system (1 ) incorporates a programmable drainage compartment (30) as exhibited on Figure 2 and Figure 3. Whereas the smart drainage compartment (30) contains a peristaltic pump (32) and a microprocessor (31 ).

One side of the peristaltic pump (32) is interconnected to the drainage catheter (10) component while the other end with the drainage bag (40). Peristaltic pump (32) is of such form and structure as to incorporate ultrasonic transducers (20) enabling measurement of fluid flow rate, pressure, volume in the course of drainage to be adjusted and aligned by the physician depending on the area of application as well as the characteristics of the drainage catheter (10) used, capable of changing the drainage rate in parallel to these values and/or halting the same, in the event of extending beyond the prescribed value interval, activating the alarm and notifying the patient via vocal as well as visual warning signals/messages; instantly detecting any sudden pressure changes and flow resistances, adjusting the drainage speed/rate accordingly.

The function of the peristaltic pump (32) is to ensure that the excess fluid in the target area is removed from the catheter distal tip (12) and conveyed to the drainage bag (40), thanks to the pressure created by synchronously squeezing and loosening it by the rotor connected to the electric motor. The peristaltic pump (32) can also provide reverse operation for very short periods of time to prevent potential blockage within the catheter lumen when required (unlike fluid intake). Whereas the microprocessor (31 ) incorporated in the programmable drainage compartment (30) including the software loaded thereto are enabling the physician set and adjust such parameters like drainage flow rate/speed, duration, drainage intervals, volume of fluid to be collected from over the software on the device or by connecting the device to a computer.

The programmable drainage system (1 ) can contain additional elements to ensure the safe clinical operation of the drainage device and the system. One of the additional elements mentioned is the pressure sensor (33) located on the drainage catheter connection hub (14) as shown in Figure 2. Said pressure sensor (33) serves to measure the pressure of the fluid in the area (in the working area) where the drainage catheter (10) is placed. If the pressure sensor (33) reading is out of the set interval that the physician has previously set to the microprocessor (31 ), the fluid drainage can be stopped or the drainage speed can be adjusted accordingly.

The programmable drainage compartment (30) includes an air bubble detector (34) that can stop the drainage procedure immediately if the drained liquid includes air bubbles.

The programmable drainage compartment (30) includes a fluid flow control sensor (35) in the form of a three-way valve located on the liquid flow line (air bubble or water) in order to eliminate any adverse effects within the device. Thanks to the said fluid flow control sensor (35), it will be possible to remove the air bubble or liquid that is evaluated negatively by performing a reverse operation (opposite to the liquid flow) manually or automatically.

The programmable drainage compartment (30) includes a programmable Wi-Fi transceiver that allows the patient to reach the physician (by phone, mail or message) remotely.

The programmable drainage component (30) is powered by an internal rechargeable battery (37). In this way, the drainage patient does not have to stay in bed. The programmable drainage compartment (30) obtained with the invention has a modular structure that can be connected to other catheter distal tips (12).

The drainage device also includes a manual fluid control system (41 ) that allows manual operation in order to eliminate the previously mentioned problems on the device. Thanks to the manual fluid control system (41 ), the solution of instant crises can be addressed.

Operating principle of the device acquired as a result of implementation of the invention starts initially after advancing the catheter in place and the catheter distal tip (12) is positioned by the deflection button (13) according to the excess fluid location within the body. First, the fluid dispensing program parameters are entered into the microprocessor (31 ), data and particulars specific to the area of application. After receiving the aforesaid data from the microprocessor (31 ), ultrasonic transducers (20) generate ultrasonic waves with predetermined time intervals. Thereafter, by means of the specific values transmitted to the microprocessor (31 ) under control of the physician, enable the system to operate in such a manner so as to take the fluid from the area of application by means of the peristaltic pump (32) and convey the same to the drainage bag (40).

By means of using all elements and components together, throughout the course of the drainage procedure, patient visits to the hospital are minimized. Thanks to the device, risk of replacement of the catheter due to catheter blockages and infection are likewise minimized and in parallel to automatic drainage, life quality of the patient is substantially upgraded. Further, since the programmable drainage system (1 ) shall be checking the drainage resistance continuously, any blockage problem that might occur in the catheter would be detected much earlier, it is also eliminated such complications which might develop in the patient such as edema, function loss, infection and the like are eliminated.

Possessing such features like being remotely controllable and adjustable by the physician minimizes the requirement for both the patient as well as the physician towards being at close proximity, enabling the process to be more effective and instantly controlled by the alert signals/messages arriving, thereby enhancing sustainability.

SAMPLE APPLICATION

Application of a programmable drainage system (1 ) to the patient basically consists of four main procedures. The mentioned process steps are detailed below. It is thought that the invention can be understood more clearly with this sample flow.

1 . Patient Assesment by the Physician (Clinical, Radiological, etc).

• Diagnosis is done

• The catheter drainage is decided.

2. Drainage Catheter Insertion: Deflectable catheter distal tip (12) is inserted into the body space (head, chest, around heart, abdomen) which is filled with fluid and positioned according to the disease and the patient by the physician.

• The physician might decide to use the proposed deflectable pigtail catheter distal tip (12) which is more compatible with the programmable drainage compartment (30).

3. The Programmable Drainage Compartment Connection: The universal connection hub of the box is connected to the proposed deflectable drainage catheter (10) or commercial catheters during use.

• Detachable ultrasonic transducer (20) probe is attached to the proximal end of the drainage catheter (10) (proposed deflectable catheter or commercially available drainage catheters) to prevent potential occlusion of drainage holes and lumen during use.

• Drainage program (time interval, drainage volume, drainage speed etc.) will be set by the physician. The patient can interfere the program (i.e. pause, cancel) if necessary. • The real time drainage parameters such as liquid pressure, drainage flow rate, volume can be monitored by patient (through the display of the box) and physician (through a cloud server) when needed.

• If critical parameters go out of range or a critical failure is detected then warning message is sent automatically to the physician cell phone. And physician can change the drainage parameters remotely.

• If air bubble is detected in the catheter the drainage is stopped and notify the patient immediately to check the catheter connection.

• The drainage begins automatically when the set parameter values come again in between the set ranges (min/max) to keep the above mentioned parameters at the desired values.

• The programmable box alerts the patient when the disposable drainage bag is full.

• If the drainage stops suddenly while drainage pointing to a possible obstruction, the smart box stops draining and flushes back the one-way valve for a few seconds with a small amount of water and send alert to the physician.

• If the back flush works, the drainage process re-starts, and alerts the physician.

4. Removing/replacing the drainage catheter (10): Upon reaching the desired clinical results, the physician could decide to remove the catheter and disconnect from the box and also, if necessary, a new catheter is reinserted and continue the drainage process with the programmable drainage compartment (30) safely.