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Title:
METHODS, SYSTEMS, APPARATUSES, AND DEVICES FOR FACILITATING MAINTAINING PATENCY OF A MEDICAL CATHETER
Document Type and Number:
WIPO Patent Application WO/2023/230015
Kind Code:
A1
Abstract:
A device for facilitating maintaining patency of a medical catheter. The device includes a housing, a fluid reservoir comprising a fluid, a tube fluidly coupled with the fluid reservoir, a pumping assembly operatively coupled with the fluid reservoir and configured for forcing the fluid from the fluid reservoir to the medical catheter through the tube for performing an operation for the maintaining of the patency of the medical catheter, a sensor for generating sensor data by detecting a fluid parameter of the fluid moving through the tube, a processing device for analyzing the sensor data and generating a notification, and a communication interface for transmitting the notification to at least one device.

Inventors:
MEGAHED AHMED (US)
BHATTI ZAGUM ABID (US)
Application Number:
PCT/US2023/023162
Publication Date:
November 30, 2023
Filing Date:
May 23, 2023
Export Citation:
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Assignee:
MEGAHED AHMED (US)
BHATTI ZAGUM ABID (US)
International Classes:
A61M5/142; A61M5/172; A61M25/00; A61M27/00
Domestic Patent References:
WO2020146454A12020-07-16
Foreign References:
US20050171512A12005-08-04
US20100022988A12010-01-28
US5584671A1996-12-17
Attorney, Agent or Firm:
JINDAL, Dhiraj (US)
Download PDF:
Claims:
CLAIMS

What is claimed is: A device for facilitating maintaining patency of a medical catheter, the device comprising: a housing; at least one fluid reservoir disposed within the housing, wherein the at least one fluid reservoir comprising at least one fluid; at least one tube fluidly coupled with the at least one fluid reservoir, wherein the at least one tube comprises a first open end and a second open end, wherein the first open end is fluidly coupled with an outlet of the at least one fluid reservoir, wherein the second open end is configured to be fluidly coupled with a hub of the medical catheter; at least one pumping assembly disposed within the housing, wherein the at least one pumping assembly is electrically powered, wherein the at least one pumping assembly is operatively coupled with the at least one fluid reservoir, wherein the at least one pumping assembly is configured for forcing at least one amount of the at least one fluid with at least one force from the at least one fluid reservoir for moving the at least one amount of the at least one fluid to the medical catheter through the at least one tube for performing at least one operation for the maintaining of the patency of the medical catheter; at least one sensor configured for generating at least one sensor data based on detecting at least one flow parameter of the at least the amount of the at least one fluid moving from the at least one fluid reservoir to the medical catheter through the at least one tube; a processing device disposed within the housing, wherein the processing device is communicatively coupled with the at least one sensor, wherein the processing device is configured for: analyzing the at least one sensor data based on at least one criterion associated with the performing of the at least one operation; and generating at least one notification based on the analyzing; and a communication interface disposed within the housing, wherein the communication interface is communicatively coupled with the processing device, wherein the communication interface is configured for transmitting the at least one notification to at least one device. The device of claim 1, wherein the at least one fluid reservoir is at least one fluid cartridge, wherein the at least one fluid cartridge is removably disposed in the housing, wherein the at least one tube is removably and fluidly coupled with the at least one fluid cartridge, wherein the at least one pumping assembly is removably and operatively coupled with the at least one fluid cartridge. The device of claim 2, wherein the processing device is further configured for: determining a first amount of the at least one fluid outflowed from the at least one fluid cartridge based on the analyzing; determining a second amount of the at least one fluid remaining in the at least one fluid cartridge based on the determining of the first amount of the at least one fluid and at least cartridge information; and determining a requirement for replacing the at least one fluid cartridge based on the determining of the second amount of the at least one fluid remaining in the at least one fluid cartridge, wherein the generating of the at least one notification is further based on the determining of the requirement for the replacing of the at least one fluid cartridge. The device of claim 1, wherein the processing device is further configured for: determining a required amount of the at least one fluid and a required force needed for the moving of the at least one fluid to the medical catheter through the at least one tube for the performing of the at least one operation based on the analyzing of the at least one sensor data, wherein the at least one amount comprises the required amount and the at least one force comprises the required force; and generating at least one command for the at least one pumping assembly based on the determining, wherein the processing device is communicatively coupled with the at least one pumping assembly, wherein the forcing of the at least one amount of the at least one fluid with the at least one force comprises forcing the required amount of the at least one fluid with the required force based on the at least one command. The device of claim 4, wherein the processing device is further configured for determining at least one catheter characteristic associated with the medical catheter based on the analyzing of the at least one sensor data, wherein the determining of the required amount of the at least one fluid with the required force is further based on the at least one catheter characteristic. The device of claim 4, wherein the at least one sensor is further configured for generating at least one catheter data based on detecting a characteristic of the medical catheter fluidly coupled to the at least one tube, wherein the processing device is further configured for analyzing the at least one catheter data, wherein the determining of the required amount of the at least one fluid with the required force is further based on the analyzing of the at least one catheter data. The device of claim 1, wherein the communication interface is configured for receiving at least one input from the at least one device, wherein the processing device is further configured for: analyzing the at least one input; determining the at least one amount of the at least one fluid and the at least one force for the forcing of the at least one amount of the at least one fluid with the at least one force based on the analyzing of the at least one input; and generating at least one command for the at least one pumping assembly based on the determining, wherein the processing device is communicatively coupled with the at least one pumping assembly, wherein the forcing of the at least one amount of the at least one fluid with the at least one force is based on the at least one command. The device of claim 1, wherein the processing device is further configured for: determining a fluid movement characteristic associated with the moving of the at least one amount of the at least one fluid based on the analyzing; and comparing the fluid movement characteristic with an optimal fluid movement characteristic associated with the moving of the at least one amount of the at least one fluid for the performing of the at least one operation, wherein the generating of the at least one notification is further based on the comparing. The device of claim 1, wherein the processing device is further configured for determining a dysfunction associated with the medical catheter based on the analyzing of the at least one sensor data, wherein the generating of the at least one notification is further based on the determining of the dysfunction associated with the medical catheter. The device of claim 9, wherein the processing device is further configured for generating at least one recommendation for the medical catheter based on the dysfunction, wherein the communication interface is further configured for transmitting the at least one recommendation to the at least one device. The device of claim 1, wherein the processing device is further configured for determining a status of the at least one operation based on the analyzing of the at least one sensor data, wherein the generating of the at least one notification is further based on the status, wherein the at least one notification comprises at least one operation information associated with the at least one operation. The device of claim 11 further comprising a storage device disposed within the housing, wherein the storage device is communicatively coupled with the processing device, wherein the storage device is configured for storing the at least one operation information. The device of claim 1 further comprising a storage device communicatively coupled with the processing device, wherein the storage device is configured for retrieving at least one schedule for the performing of the at least one operation, wherein the processing device is further configured for generating at least one command for the at least one pumping assembly based on the at least one schedule, wherein the forcing of the at least one amount of the at least one fluid with the at least one force is based on the at least one command. The device of claim 14, wherein the communication interface is further configured for receiving at least one input from the at least one device, wherein the processing device is further configured for: analyzing the at least one input; and generating the at least one schedule based on the analyzing of the at least one input, wherein the storage device is further configured for storing the at least one schedule. The device of claim 1, wherein the at least one pumping assembly comprises at least one pumping mechanism and at least one actuator, wherein the at least one pumping mechanism is operatively coupled with the at least one fluid reservoir, wherein the at least one pumping mechanism is configured to be transitioned between a plurality of states for the forcing of the at least one amount of the at least one fluid with the at least one force, wherein the at least one actuator is operatively coupled with the at least one pumping mechanism, wherein the at least one actuator is configured for transitioning the at least one pumping mechanism between the plurality of states, wherein the forcing of the at least one amount of the at least one fluid with the at least one force is further based on the transitioning. A device for facilitating maintaining patency of a medical catheter, the device comprising: a housing; at least one fluid reservoir disposed within the housing, wherein the at least one fluid reservoir comprising at least one fluid; at least one tube fluidly coupled with the at least one fluid reservoir, wherein the at least one tube comprises a first open end and a second open end, wherein the first open end is fluidly coupled with an outlet of the at least one fluid reservoir, wherein the second open end is configured to be fluidly coupled with a hub of the medical catheter; at least one pumping assembly disposed within the housing, wherein the at least one pumping assembly is electrically powered, wherein the at least one pumping assembly is operatively coupled with the at least one fluid reservoir, wherein the at least one pumping assembly is configured for forcing at least one amount of the at least one fluid with at least one force from the at least one fluid reservoir for moving the at least one amount of the at least one fluid to the medical catheter through the at least one tube for performing at least one operation for the maintaining of the patency of the medical catheter; at least one sensor configured for generating at least one sensor data based on detecting at least one flow parameter of the at least the amount of the at least one fluid moving from the at least one fluid reservoir to the medical catheter through the at least one tube; a processing device disposed within the housing, wherein the processing device is communicatively coupled with the at least one sensor, wherein the processing device is configured for: analyzing the at least one sensor data based on at least one criterion associated with the performing of the at least one operation; determining a fluid movement characteristic associated with the moving of the at least one amount of the at least one fluid based on the analyzing; comparing the fluid movement characteristic with an optimal fluid movement characteristic associated with the moving of the at least one amount of the at least one fluid for the performing of the at least one operation; and generating at least one notification based on the comparing; and a communication interface disposed within the housing, wherein the communication interface is communicatively coupled with the processing device, wherein the communication interface is configured for transmitting the at least one notification to at least one device. The device of claim 16, wherein the processing device is further configured for determining a status of the at least one operation based on the analyzing of the at least one sensor data, wherein the generating of the at least one notification is further based on the status, wherein the at least one notification comprises at least one operation information associated with the at least one operation. The device of claim 16, wherein the at least one fluid reservoir comprises at least one fluid cartridge, wherein the at least one fluid cartridge is removably disposed in the housing, wherein the at least one tube is removably and fluidly coupled with the at least one fluid cartridge, wherein the at least one pumping assembly is removably and operatively coupled with the at least one fluid cartridge. The device of claim 18, wherein the processing device is further configured for: determining a first amount of the at least one fluid outflowed from the at least one fluid cartridge based on the analyzing; determining a second amount of the at least one fluid remaining in the at least one fluid cartridge based on the determining of the first amount of the at least one fluid and at least cartridge information; and determining a requirement for replacing the at least one fluid cartridge based on the determining of the second amount of the at least one fluid remaining in the at least one fluid cartridge, wherein the generating of the at least one notification is further based on the determining of the requirement for the replacing of the at least one fluid characteristic. A device for facilitating maintaining patency of a medical catheter, the device comprising: a housing; at least one fluid reservoir disposed within the housing, wherein the at least one fluid reservoir comprising at least one fluid; at least one tube fluidly coupled with the at least one fluid reservoir, wherein the at least one tube comprises a first open end and a second open end, wherein the first open end is fluidly coupled with an outlet of the at least one fluid reservoir, wherein the second open end is configured to be fluidly coupled with a hub of the medical catheter; at least one pumping assembly disposed within the housing, wherein the at least one pumping assembly is electrically powered, wherein the at least one pumping assembly is operatively coupled with the at least one fluid reservoir, wherein the at least one pumping assembly is configured for forcing at least one amount of the at least one fluid with at least one force from the at least one fluid reservoir for moving the at least one amount of the at least one fluid to the medical catheter through the at least one tube for performing at least one operation for the maintaining of the patency of the medical catheter; at least one sensor configured for generating at least one sensor data based on detecting at least one flow parameter of the at least the amount of the at least one fluid moving from the at least one fluid reservoir to the medical catheter through the at least one tube; a processing device disposed within the housing, wherein the processing device is communicatively coupled with the at least one sensor, wherein the processing device is configured for: analyzing the at least one sensor data based on at least one criterion associated with the performing of the at least one operation; and determining a required amount of the at least one fluid and a required force needed for the moving of the at least one fluid to the medical catheter through the at least one tube for the performing of the at least one operation based on the analyzing of the at least one sensor data, wherein the at least one amount comprises the required amount and the at least one force comprises the required force; generating at least one command for the at least one pumping assembly based on the determining, wherein the processing device is communicatively coupled with the at least one pumping assembly, wherein the forcing of the at least one amount of the at least one fluid with the at least one force comprises forcing the required amount of the at least one fluid with the required force based on the at least one command; and generating at least one notification based on the analyzing; and a communication interface disposed within the housing, wherein the communication interface is communicatively coupled with the processing device, wherein the communication interface is configured for transmitting the at least one notification to at least one device.

Description:
METHODS, SYSTEMS, APPARATUSES, AND DEVICES FOR FACILITATING MAINTAINING PATENCY OF A MEDICAL CATHETER

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional Patent Application No. 63345010, titled “METHODS, SYSTEMS, APPARATUSES, AND DEVICES CONFIGURED TO MAINTAIN PATENCY OF MEDICAL CATHETERS BY MEANS OF A SALINE FLUSH SYSTEM”, filed 23-MAY-2022, which is incorporated by reference herein in its entirety.

FIELD OF THE INVENTION

Generally, the present disclosure relates to the field of medical and laboratory equipment. More specifically, the present disclosure relates to methods, systems, apparatuses, and devices for facilitating maintaining patency of a medical catheter.

BACKGROUND OF THE INVENTION

The field of medical and laboratory equipment is technologically important to several industries, business organizations, and/or individuals. In particular, the use of medical and laboratory equipment is prevalent for surgeons, doctors, and healthcare workers.

Percutaneous drainage catheters are placed by Interventional Radiologists for a variety of indications. Further, the catheters are placed through the skin surface and into their intended location within the body via a minimally invasive surgical procedure using imaging guidance. Further, the catheters are generally composed of silicone and are comprised of a distal component (i.e., residing within the fluid collection requiring drainage) containing sideholes through which fluid enters the catheter, travels through a lumen of the catheter and exits the catheter at a hub which is external to the body. The hub is typically connected to a gravity drainage bag or a vacuum- suction bulb.

Drainage catheter management is just as important as device placement.

Unfortunately, drainage catheters may be subject to dysfunction from partial or complete occlusion. This may occur when the catheter is draining high-viscosity fluid, such as pus, bile, or other debris-containing fluid. For example, drainage catheters placed within the kidney for the purposes of urinary diversion in the setting of ureteral obstruction are subject to the formation of biofilm and encrustations within the lumen (or catheter lumen) and sideholes. This commonly results in catheter dysfunction as the catheter becomes occluded over time. Catheter occlusion occurs via other mechanisms depending on the location within the body and the type of fluid being drained. The current standard method utilized to retain normal catheter function and prevent occlusion is by means of frequent manual irrigation of the catheter with a sterile saline solution; this is accomplished by injecting saline through the hub of the catheter with a syringe by hand. It is generally accepted practice that flushing is performed with 10 mL of sterile saline at least twice per day (i.e., every 12 hours) for standard bore catheters (8.5-12 French). Failure to irrigate or flush the catheter at regular intervals can result in significant complications as the rate of fluid drainage slows or the catheter becomes completely occluded. For example, nephrostomy catheter occlusion can result in kidney failure or urosepsis, a potentially life-threatening condition. Treatment of infections related to indwelling nephrostomy catheters costs approximately $40,000 per episode and the average cost to exchange these catheters (due to dysfunction or as part of preventative maintenance) is $3,000 (1). Further, current technologies do not provide a non- obtrusive automated system, wherein a cartridge containing saline sufficient for several days' worth of flushes is injected through the drainage catheter at preset intervals. Furthermore, the current technologies do not alert the patient and interventional radiologist when the catheter’ s intraluminal pressure exceeds a certain threshold pressure.

Common barriers to catheter flushing as a part of preventative maintenance include patient compliance, lack of information provided to the patient on proper care of their catheter, limited access to nursing or family support, and difficulty in flushing the catheterbased on anatomic location. Patients with indwelling drainage catheters require clinical follow-up to ensure that any problems with the catheter may be promptly addressed. In the case of an intra- abdominal abscess, if the drainage catheter is partially or completely occluded or if the catheter becomes inadvertently mispositioned such that it is no longer effectively draining the abscess, the interventional radiologist must know this information so that the catheter can be exchanged in the procedure lab. Failure to recognize these scenarios may result in worsening the patient’s clinical condition. Typically, difficulty in performing manual flushing of a drainage catheter may indicate partial or complete occlusion of the catheter or mispositioning of the catheter. Further, current technologies do not allow for the automated flushing of a drainage catheter without user intervention and also provide feedback to the patient and physician when catheter evaluation is necessary. When a percutaneous drainage catheter has blockage leading to failure, there can be complications such as infection (localized, which can progress to sepsis), organ failure, inability to remove the catheter due to encrustation (i.e., nephrostomy tube), and death. Therefore, there is a tremendous need for a reliable method to ensure nonvascular drainage catheters remain patent and functional.

Therefore, there is a need for improved methods, systems, apparatuses, and devices for facilitating maintaining patency of a medical catheter that may overcome one or more of the above-mentioned problems and/or limitations.

SUMMARY OF THE INVENTION

This summary is provided to introduce a selection of concepts in a simplified form, that are further described below in the Detailed Description. This summary is not intended to identify key features or essential features of the claimed subject matter. Nor is this summary intended to be used to limit the claimed subject matter’s scope.

Disclosed herein is a device for facilitating maintaining patency of a medical catheter, in accordance with some embodiments. Accordingly, the device may include a housing, at least one fluid reservoir, at least one tube, at least one pumping assembly, at least one sensor, a processing device, and a communication interface. Further, the at least one fluid reservoir may be disposed within the housing. Further, the at least one fluid reservoir may include at least one fluid. Further, the at least one tube may be fluidly coupled with the at least one fluid reservoir. Further, the at least one tube may include a first open end and a second open end. Further, the first open end may be fluidly coupled with an outlet of the at least one fluid reservoir. Further, the second open end may be configured to be fluidly coupled with a hub of the medical catheter. Further, the at least one pumping assembly may be disposed within the housing. Further, the at least one pumping assembly may be electrically powered. Further, the at least one pumping assembly may be operatively coupled with the at least one fluid reservoir. Further, the at least one pumping assembly may be configured for forcing at least one amount of the at least one fluid with at least one force from the at least one fluid reservoir for moving the at least one amount of the at least one fluid to the medical catheter through the at least one tube for performing at least one operation for the maintaining of the patency of the medical catheter. Further, the at least one sensor may be configured for generating at least one sensor data based on detecting at least one flow parameter of the at least the amount of the at least one fluid moving from the at least one fluid reservoir to the medical catheter through the at least one tube. Further, the processing device may be disposed within the housing. Further, the processing device may be communicatively coupled with the at least one sensor. Further, the processing device may be configured for analyzing the at least one sensor data based on at least one criterion associated with the performing of the at least one operation. Further, the processing device may be configured for generating at least one notification based on the analyzing. Further, the communication interface may be disposed within the housing. Further, the communication interface may be communicatively coupled with the processing device. Further, the communication interface may be configured for transmitting the at least one notification to at least one device.

Further disclosed herein is a device for facilitating maintaining patency of a medical catheter, in accordance with some embodiments. Accordingly, the device may include a housing, at least one fluid reservoir, at least one tube, at least one pumping assembly, at least one sensor, a processing device, and a communication interface. Further, the at least one fluid reservoir may be disposed within the housing. Further, the at least one fluid reservoir may include at least one fluid. Further, the at least one tube may be fluidly coupled with the at least one fluid reservoir. Further, the at least one tube may include a first open end and a second open end. Further, the first open end may be fluidly coupled with an outlet of the at least one fluid reservoir. Further, the second open end may be configured to be fluidly coupled with a hub of the medical catheter. Further, the at least one pumping assembly may be disposed within the housing. Further, the at least one pumping assembly may be electrically powered. Further, the at least one pumping assembly may be operatively coupled with the at least one fluid reservoir. Further, the at least one pumping assembly may be configured for forcing at least one amount of the at least one fluid with at least one force from the at least one fluid reservoir for moving the at least one amount of the at least one fluid to the medical catheter through the at least one tube for performing at least one operation for the maintaining of the patency of the medical catheter. Further, the at least one sensor may be configured for generating at least one sensor data based on detecting at least one flow parameter of the at least the amount of the at least one fluid moving from the at least one fluid reservoir to the medical catheter through the at least one tube. Further, the processing device may be disposed within the housing. Further, the processing device may be communicatively coupled with the at least one sensor. Further, the processing device may be configured for analyzing the at least one sensor data based on at least one criterion associated with the performing of the at least one operation. Further, the processing device may be configured for determining a fluid movement characteristic associated with the moving of the at least one amount of the at least one fluid based on the analyzing. Further, the processing device may be configured for comparing the fluid movement characteristic with an optimal fluid movement characteristic associated with the moving of the at least one amount of the at least one fluid for the performing of the at least one operation. Further, the processing device may be configured for generating at least one notification based on the comparing. Further, the communication interface may be disposed within the housing. Further, the communication interface may be communicatively coupled with the processing device. Further, the communication interface may be configured for transmitting the at least one notification to at least one device.

Further disclosed herein is a device for facilitating maintaining patency of a medical catheter, in accordance with some embodiments. Accordingly, the device may include a housing, at least one fluid reservoir, at least one tube, at least one pumping assembly, at least one sensor, a processing device, and a communication interface. Further, the at least one fluid reservoir may be disposed within the housing. Further, the at least one fluid reservoir may include at least one fluid. Further, the at least one tube may be fluidly coupled with the at least one fluid reservoir. Further, the at least one tube may include a first open end and a second open end. Further, the first open end may be fluidly coupled with an outlet of the at least one fluid reservoir. Further, the second open end may be configured to be fluidly coupled with a hub of the medical catheter. Further, the at least one pumping assembly may be disposed within the housing. Further, the at least one pumping assembly may be electrically powered. Further, the at least one pumping assembly may be operatively coupled with the at least one fluid reservoir. Further, the at least one pumping assembly may be configured for forcing at least one amount of the at least one fluid with at least one force from the at least one fluid reservoir for moving the at least one amount of the at least one fluid to the medical catheter through the at least one tube for performing at least one operation for the maintaining of the patency of the medical catheter. Further, the at least one sensor may be configured for generating at least one sensor data based on detecting at least one flow parameter of the at least the amount of the at least one fluid moving from the at least one fluid reservoir to the medical catheter through the at least one tube. Further, the processing device may be disposed within the housing. Further, the processing device may be communicatively coupled with the at least one sensor. Further, the processing device may be configured for analyzing the at least one sensor data based on at least one criterion associated with the performing of the at least one operation. Further, the processing device may be configured for determining a required amount of the at least one fluid and a required force needed for the moving of the at least one fluid to the medical catheter through the at least one tube for the performing of the at least one operation based on the analyzing of the at least one sensor data. Further, the at least one amount may include the required amount and the at least one force may include the required force. Further, the processing device may be configured for generating at least one command for the at least one pumping assembly based on the determining. Further, the processing device may be communicatively coupled with the at least one pumping assembly. Further, the forcing of the at least one amount of the at least one fluid with the at least one force may include forcing the required amount of the at least one fluid with the required force based on the at least one command. Further, the processing device may be configured for generating at least one notification based on the analyzing. Further, the communication interface may be disposed within the housing. Further, the communication interface may be communicatively coupled with the processing device. Further, the communication interface may be configured for transmitting the at least one notification to at least one device.

Both the foregoing summary and the following detailed description provide examples and are explanatory only. Accordingly, the foregoing summary and the following detailed description should not be considered to be restrictive. Further, features or variations may be provided in addition to those set forth herein. For example, embodiments may be directed to various feature combinations and sub-combinations described in the detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute a part of this disclosure, illustrate various embodiments of the present disclosure. The drawings contain representations of various trademarks and copyrights owned by the Applicants. In addition, the drawings may contain other marks owned by third parties and are being used for illustrative purposes only. All rights to various trademarks and copyrights represented herein, except those belonging to their respective owners, are vested in and the property of the applicants. The applicants retain and reserve all rights in their trademarks and copyrights included herein, and grant permission to reproduce the material only in connection with reproduction of the granted patent and for no other purpose.

Furthermore, the drawings may contain text or captions that may explain certain embodiments of the present disclosure. This text is included for illustrative, non-limiting, explanatory purposes of certain embodiments detailed in the present disclosure.

FIG. 1 is a schematic diagram of a device 100 for facilitating maintaining patency of a medical catheter (such as a medical catheter 204), in accordance with some embodiments.

FIG. 2 is a schematic diagram of the device 100 connected to the human body 206 using the medical catheter 204 for allowing transferring of the at least one fluid to the human body 206, in accordance with some embodiments.

FIG. 3 is a schematic diagram of the device 100 connected to the human body 206 using the medical catheter 204 for restricting transferring of the at least one fluid to the human body 206, in accordance with some embodiments.

FIG. 4 is a schematic diagram of a device 400 for facilitating maintaining patency of medical catheters by means of a saline flush system, in accordance with some embodiments.

FIG. 5 is a block diagram of a system 500 for maintaining patency of medical catheters by means of a saline flush system, in accordance with some embodiments.

FIG. 6 is a schematic diagram of a device 600 for facilitating maintaining patency of a medical catheter, in accordance with some embodiments.

FIG. 7 is a schematic diagram of a device 700 for facilitating maintaining patency of a medical catheter, in accordance with some embodiments.

FIG. 8 is an illustration of an online platform consistent with various embodiments of the present disclosure. FIG. 9 is a block diagram of a computing device for implementing the methods disclosed herein, in accordance with some embodiments.

DETAIL DESCRIPTIONS OF THE INVENTION

As a preliminary matter, it will readily be understood by one having ordinary skill in the relevant art that the present disclosure has broad utility and application. As should be understood, any embodiment may incorporate only one or a plurality of the above-disclosed aspects of the disclosure and may further incorporate only one or a plurality of the abovedisclosed features. Furthermore, any embodiment discussed and identified as being “preferred” is considered to be part of a best mode contemplated for carrying out the embodiments of the present disclosure. Other embodiments also may be discussed for additional illustrative purposes in providing a full and enabling disclosure. Moreover, many embodiments, such as adaptations, variations, modifications, and equivalent arrangements, will be implicitly disclosed by the embodiments described herein and fall within the scope of the present disclosure.

Accordingly, while embodiments are described herein in detail in relation to one or more embodiments, it is to be understood that this disclosure is illustrative and exemplary of the present disclosure, and are made merely for the purposes of providing a full and enabling disclosure. The detailed disclosure herein of one or more embodiments is not intended, nor is to be construed, to limit the scope of patent protection afforded in any claim of a patent issuing here from, which scope is to be defined by the claims and the equivalents thereof. It is not intended that the scope of patent protection be defined by reading into any claim limitation found herein and/or issuing here from that does not explicitly appear in the claim itself.

Thus, for example, any sequence(s) and/or temporal order of steps of various processes or methods that are described herein are illustrative and not restrictive. Accordingly, it should be understood that, although steps of various processes or methods may be shown and described as being in a sequence or temporal order, the steps of any such processes or methods are not limited to being carried out in any particular sequence or order, absent an indication otherwise. Indeed, the steps in such processes or methods generally may be carried out in various different sequences and orders while still falling within the scope of the present disclosure. Accordingly, it is intended that the scope of patent protection is to be defined by the issued claim(s) rather than the description set forth herein.

Additionally, it is important to note that each term used herein refers to that which an ordinary artisan would understand such term to mean based on the contextual use of such term herein. To the extent that the meaning of a term used herein — as understood by the ordinary artisan based on the contextual use of such term — differs in any way from any particular dictionary definition of such term, it is intended that the meaning of the term as understood by the ordinary artisan should prevail.

Furthermore, it is important to note that, as used herein, “a” and “an” each generally denotes “at least one,” but does not exclude a plurality unless the contextual use dictates otherwise. When used herein to join a list of items, “or” denotes “at least one of the items,” but does not exclude a plurality of items of the list. Finally, when used herein to join a list of items, “and” denotes “all of the items of the list.”

The following detailed description refers to the accompanying drawings. Wherever possible, the same reference numbers are used in the drawings and the following description to refer to the same or similar elements. While many embodiments of the disclosure may be described, modifications, adaptations, and other implementations are possible. For example, substitutions, additions, or modifications may be made to the elements illustrated in the drawings, and the methods described herein may be modified by substituting, reordering, or adding stages to the disclosed methods. Accordingly, the following detailed description does not limit the disclosure. Instead, the proper scope of the disclosure is defined by the claims found herein and/or issuing here from. The present disclosure contains headers. It should be understood that these headers are used as references and are not to be construed as limiting upon the subjected matter disclosed under the header. The present disclosure includes many aspects and features. Moreover, while many aspects and features relate to, and are described in the context of methods, systems, apparatuses, and devices for facilitating maintaining patency of a medical catheter, embodiments of the present disclosure are not limited to use only in this context.

Overview:

The present disclosure describes methods, systems, apparatuses, and devices for facilitating maintaining patency of a medical catheter. A medical system for administering a medical fluid to a patient is described in, for example, U.S. patent application Ser. No. 16/422,668, filed May 24, 2019, published as U.S. Patent Publication No. 2019/0368484, the full disclosure of which is incorporated herein by reference in its entirety for all purposes. Further, the disclosed device overcomes the disadvantages of the conventional established procedure for ensuring catheter patency, namely the requirement for the manual attachment and injection of a saline syringe into a percutaneous drainage catheter by the patient, family member, or care provider at regular time intervals. The disclosed device may reduce the time and inconvenience of the maintenance process for the drainage catheters and decrease the number of complications patients suffer from suboptimal care of the drainage catheters, which carries a large financial burden to the healthcare system. Further, common medical applications of the percutaneous drainage catheter may include relief of obstruction of the kidney or bladder secondary to benign or malignant process, drainage of bile duct occlusion, drainage of abscesses within the abdominal or pelvic cavities or associated organs, drainage of thoracic cavity fluid secondary to an infection, trauma, or the postoperative state, drainage of post operative superficial incision-related fluid collections as seromas or abscesses, diversion of stool from the colon, etc.

Further, the device may include a wallet-sized housing containing a microprocessor, a motorized pumping mechanism, a pressure sensor, a battery, and a saline cartridge. Further, saline may be expelled by means of the motorized pumping mechanism driven by a motor through a tubing apparatus containing a one-way valve that allows the saline to travel from the device to the drainage catheter but does not allow for reflux of the saline into the device or the catheter drainage bag or bulb. In addition, the tubing apparatus may include the oneway valve to prevent the excursion of bodily fluids into the device. Further, the injection of the saline from the device into the drainage catheter may be optimized for a lumen of the drainage catheter, that may be of different sizes. Further, the lumen of the drainage catheter (or catheter) may be designed to achieve a sufficient velocity of the fluid through each of the side holes at the distal end of the catheter to keep these side holes free of debris and precipitations. For 8.5, 10, and 12 French-sized catheters, a recommended default volume of 10 mL of saline may be injected at a rate of 10 mL/second. For larger catheters, the injected volume and rate of saline may be modified. Further, parameters such as the frequency and volume of saline flushes desired may be programmed onto a device’s LED screen comprised in the device. Furthermore, a caliber of the catheter, its drainage location within the body, and the LED screen, in addition to which also provide feedback to at least one user regarding catheter flushing history and when a replacement saline cartridge is necessary. In addition, the LED screen may alert the at least one user when the pressure in the lumen of the drainage catheter is consistently high. Further, when the force of injection of fluid may be consistently insufficient to achieve a desired volume or velocity of flow through the catheter, the pressure sensor within the device may be triggered. Further, BluetoothTM and Wi-Fi capabilities send automated alerts to both a patient and an interventional radiology provider.

Further, in some embodiments, the device may be wearable and may be placed in a patient’s pocket or clipped to clothing. Additionally, the device may be secured to a patient’s existing gravity drainage bag by means of an adhesive pouch to simplify the drainage system for the patient and to be less obtrusive.

The novel features of this invention, including details of the combination of parts, will now be described in detail. Those with expertise in the art will note that there may be possible variations to the described embodiments, however, those would remain within the scope of the present invention. The following is, therefore, not intended to limit the scope of the invention which will be defined by the claims.

Further, percutaneous drainage catheters (or drainage catheters) may be typically placed by Interventional Radiologists (IR). Further, the drainage catheters (or catheters) are used to treat various infectious processes (for example, peri colonic abscess secondary to ruptured diverticulitis) or organ dysfunction (such as kidney failure secondary to an obstructing stone within the ureter). Given a large number of applications of percutaneous drainage, several different medical specialties manage patients with the drainage catheters. Such specialties include internal medicine, general surgery, urology, obstetrics and gynecology, and emergency medicine, to name a few. IR physicians and Advanced Practice Providers (APPs) primarily coordinate and manage the maintenance of the catheters in the hospital setting for inpatients. Further, the IR and APP may perform saline flushing for patients in the hospital, or registered nurses may be primarily responsible for administering saline flushes as part of the tracking of patient fluid inputs and outputs. For patients who require continued drainage outside of the hospital, other physicians and the APPs from these specialties may also be involved in the flushing of the drainage catheters. Further, skilled nursing and home nursing services may also be involved in the care of the drainage catheters. However, the majority of the day-to-day maintenance and care of the percutaneous drainage catheters is the responsibility of the patient. Historically, the patient and/or family member perform drainage catheter flushes manually with a saline syringe. This may pose significant challenges, as described previously, due to the location of the catheter in the body and the need for specialized supplies. The disclosed device may solve many of these challenges by simplifying and automating the process of drainage catheter flushing. The disclosed device may address these issues by providing a non-obtrusive automated system wherein a cartridge containing saline sufficient for several days' worth of flushes is injected through the drainage catheter at preset intervals. Furthermore, the disclosed device may be configured for alerting the patient and interventional radiologist when the catheter’s intraluminal pressure exceeds a certain threshold pressure.

Further, the present disclosure describes a device designed to maintain patency of medical catheters by means of a saline flush system. More specifically, the present disclosure describes an automated device intended to ensure nonvascular catheters remain free of occlusion, thereby preserving their function and reducing complications in patients. Additionally, the device may measure the pressure within the catheter and alert the patient to potential catheter dysfunction.

FIG. 1 is a schematic diagram of a device 100 for facilitating maintaining patency of a medical catheter (such as a medical catheter 204), in accordance with some embodiments. Accordingly, the device 100 may include a housing 102, at least one fluid reservoir 104, at least one tube 106, at least one pumping assembly 108, at least one sensor 110, a processing device 112, and a communication interface 114.

Further, the housing 102 may be a wallet-sized housing.

Further, the at least one fluid reservoir 104 may be disposed within the housing 102. Further, the at least one fluid reservoir 104 may include at least one fluid. Further, the at least one fluid reservoir 104 may be a saline cartridge. Further, the at least one fluid may include a saline solution.

Further, the at least one tube 106 may be fluidly coupled with the at least one fluid reservoir 104. Further, the at least one tube 106 may be a tubing apparatus. Further, the tubing apparatus may include a one-way valve 202, as shown in FIG. 2. Further, the at least one tube 106 may include a first open end 120 and a second open end 122. Further, the first open end 120 may be fluidly coupled with an outlet of the at least one fluid reservoir 104. Further, the second open end 122 may be configured to be fluidly coupled with a hub of the medical catheter 204. Further, the medical catheter 204 may be placed inside a human body 206. Further, the medical catheter 204 may be fluidly coupled with the a waste connection unit 208. Further, the waste collection unit 208 may include a drainage bag (such as a gravity drainage bag), a bulb (such as a vacuum-suction bulb), etc. Further, a waste (such as bodily fluids) from the human body 206 may move to the waste collection unit 208 after the moving of the at least one fluid into the medical catheter 204 for injecting the at least one fluid in the human body 206. Further, the one-way valve 202 may be transitionable between an open state and a closed state. Further, the one-way valve 202 may allow the moving of the at least one fluid into the medical catheter 204 in the open state by closing an inlet to the waste collection unit 208. Further, the one-way valve 202 may restrict an incursion of the waste in the at least one tube 106 by closing the second open end 122 in the closed state and diverting the waste to the waste collection unit 208.

Further, the at least one pumping assembly 108 may be disposed within the housing 102. Further, the at least one pumping assembly 108 may include a motorized pumping mechanism. Further, the at least one pumping assembly 108 may be electrically powered. Further, the at least one pumping assembly 108 may be operatively coupled with the at least one fluid reservoir 104. Further, the at least one pumping assembly 108 may be configured for forcing at least one amount of the at least one fluid with at least one force from the at least one fluid reservoir 104 for moving the at least one amount of the at least one fluid to the medical catheter 204 through the at least one tube 106 for performing at least one operation for the maintaining of the patency of the medical catheter 204. Further, the moving of the at least one amount of the at least one fluid with the at least one force may include expelling the at least one amount of the at least one fluid with the at least one force. Further, the moving of the at least one amount of the at least one fluid with the at least one force may include injecting the at least one amount of the at least one fluid with the at least one force from the at least one fluid reservoir 104 into the medical catheter 204 using the at least one tube 106. Further, the at least one operation may include flushing the medical catheter 204, irrigating the medical catheter 204, removing blockage from the medical catheter 204, preventing debris buildup in the medical catheter 204, etc. Further, the medical catheter 204 may include a drainage catheter comprising a percutaneous drainage catheter.

Further, the at least one sensor 110 may be configured for generating at least one sensor data based on detecting at least one flow parameter of the at least the amount of the at least one fluid moving from the at least one fluid reservoir 104 to the medical catheter 204 through the at least one tube 106. Further, the at least one sensor 110 may include a pressure sensor, a flow sensor, a temperature sensor, a mass flow sensor, etc. Further, the at least one flow parameter may include a mass flow rate, a flow rate, a pressure, a temperature, etc., associated with the at least one amount of the at least one fluid moving through the at least one tube 106.

Further, the processing device 112 may be disposed within the housing 102. Further, the processing device may include a processing unit of a computing device. Further, the processing device 112 may be communicatively coupled with the at least one sensor 110. Further, the processing device 112 may be configured for analyzing the at least one sensor data based on at least one criterion associated with the performing of the at least one operation. Further, the at least one criterion may include a criterion for establishing a completion of the performing of the at least one operation, a criterion for maintaining the performing of the at least one operation, etc. Further, the criterion for establishing the completion may include a moving of a required volume of the at least one fluid, an uninterrupted moving of the required volume of the at least one fluid, a required duration for moving the at least one fluid, etc. Further, the criterion for the maintaining of the performing of the at least one operation may include a required flow rate, a required mass flow rate, a required pressure, a required amount of the at least one fluid, etc. for the performing of the at least one operation. Further, the processing device 112 may be configured for generating at least one notification based on the analyzing.

Further, the communication interface 114 may be disposed within the housing 102. Further, the communication interface 114 may be a communication connection of a computing device. Further, the communication interface 114 may be communicatively coupled with the processing device 112. Further, the communication interface 114 may be configured for transmitting the at least one notification to at least one device. Further, the transmitting may include transmitting the at least one notification over at least one of a wired communication channel and a wireless communication channel. Further, the wireless communication channel may include Bluetooth, WiFi, etc. Further, the at least one device may include an output device (LED screen), a computing device, a user device, etc. Further, the user device may be associated with a user (such as a patient, a medical practitioner, a medical professional, etc.)

Further, in some embodiments, the at least one fluid reservoir 104 may be at least one fluid cartridge. Further, the at least one fluid cartridge may include a saline cartridge. Further, the at least one fluid cartridge may be removably disposed in the housing 102. Further, the at least one tube 106 may be removably and fluidly coupled with the at least one fluid cartridge. Further, the at least one pumping assembly 108 may be removably and operatively coupled with the at least one fluid cartridge.

Further, in an embodiment, the processing device 112 may be configured for determining a first amount of the at least one fluid outflowed from the at least one fluid cartridge based on the analyzing. Further, the processing device 112 may be configured for determining a second amount of the at least one fluid remaining in the at least one fluid cartridge based on the determining of the first amount of the at least one fluid and at least cartridge information. Further, the processing device 112 may be configured for determining a requirement for replacing the at least one fluid cartridge based on the determining of the second amount of the at least one fluid remaining in the at least one fluid cartridge. Further, the generating of the at least one notification may be based on the determining of the requirement for the replacing of the at least one fluid cartridge.

Further, in some embodiments, the processing device 112 may be configured for determining a required amount of the at least one fluid and a required force needed for the moving of the at least one fluid to the medical catheter 204 through the at least one tube 106 for the performing of the at least one operation based on the analyzing of the at least one sensor data. Further, the at least one amount may include the required amount and the at least one force may include the required force. Further, the processing device 112 may be configured for generating at least one command for the at least one pumping assembly 108 based on the determining. Further, the processing device 112 may be communicatively coupled with the at least one pumping assembly 108. Further, the forcing of the at least one amount of the at least one fluid with the at least one force may include forcing the required amount of the at least one fluid with the required force based on the at least one command.

Further, in an embodiment, the processing device 112 may be configured for determining at least one catheter characteristic associated with the medical catheter 204 based on the analyzing of the at least one sensor data. Further, the at least one catheter characteristic may include a size of a lumen of the medical catheter 204, a diameter of the lumen, a length of the lumen, etc. Further, the determining of the required amount of the at least one fluid with the required force may be further based on the at least one catheter characteristic.

Further, in an embodiment, the at least one sensor 110 may be configured for generating at least one catheter data based on detecting a characteristic of the medical catheter 204 fluidly coupled to the at least one tube 106. Further, the characteristic of the medical catheter 204 may include a size of a lumen of the medical catheter 204, a diameter of the lumen, a length of the lumen, a caliber of the medical catheter 204, etc. Further, the at least one sensor 110 may include an imaging sensor, a measurement sensor, etc. Further, the processing device 112 may be further configured for analyzing the at least one catheter data. Further, the determining of the required amount of the at least one fluid with the required force may be further based on the analyzing of the at least one catheter data.

Further, in some embodiments, the communication interface 114 may be configured for receiving at least one input from the at least one device. Further, the at least one input may include information associated with the injecting of the saline solution such as an amount of the saline solution, a flow rate of the saline solution, etc. Further, the processing device 112 may be configured for analyzing the at least one input. Further, the processing device 112 may be configured for determining the at least one amount of the at least one fluid and the at least one force for the forcing of the at least one amount of the at least one fluid with the at least one force based on the analyzing of the at least one input. Further, the processing device 112 may be configured for generating at least one command for the at least one pumping assembly 108 based on the determining. Further, the processing device 112 may be communicatively coupled with the at least one pumping assembly 108. Further, the forcing of the at least one amount of the at least one fluid with the at least one force may be based on the at least one command.

Further, in some embodiments, the processing device 112 may be configured for determining a fluid movement characteristic associated with the moving of the at least one amount of the at least one fluid based on the analyzing. Further, the fluid movement characteristic may include an impedance to the moving of the at least one fluid, a resistance to the moving of the at least one fluid, a pressure build up during the moving of the at least one fluid, etc. Further, the processing device 112 may be configured for comparing the fluid movement characteristic with an optimal fluid movement characteristic associated with the moving of the at least one amount of the at least one fluid for the performing of the at least one operation. Further, the optimal fluid movement characteristic may include an optimal impedance to the moving of the at least one fluid, an optimal resistance to the moving of the at least one fluid, an optimal pressure build-up during the moving of the at least one fluid, etc. Further, the generating of the at least one notification may be based on the comparing.

Further, in some embodiments, the processing device 112 may be configured for determining a dysfunction associated with the medical catheter 204 based on the analyzing of the at least one sensor data. Further, the generating of the at least one notification may be based on the determining of the dysfunction associated with the medical catheter 204.

Further, in an embodiment, the processing device 112 may be configured for generating at least one recommendation for the medical catheter 204 based on the dysfunction. Further, the communication interface 114 may be configured for transmitting the at least one recommendation to the at least one device. Further, the at least one recommendation may include a recommendation for replacing the medical catheter 204, a type of a replacing medical catheter 204, etc.

Further, in some embodiments, the processing device 112 may be configured for determining a status of the at least one operation based on the analyzing of the at least one sensor data. Further, the generating of the at least one notification may be based on the status. Further, the at least one notification may include at least one operation information associated with the at least one operation. Further, the status corresponds to a degree of completion of the at least one operation, a halting of the at least one operation, etc. Further, the at least one operation may include a starting instance for the at least one operation, a terminating instance of the at least one operation, a halting instance for the at least one operation, etc.

In an embodiment, the device 100 may include a storage device 124 disposed within the housing 102. Further, the storage device 124 may be communicatively coupled with the processing device 112. Further, the storage device 124 may be configured for storing the at least one operation information.

In some embodiments, the device 100 may include a storage device 124 communicatively coupled with the processing device 112. Further, the storage device 124 may be configured for retrieving at least one schedule for the performing of the at least one operation. Further, the at least one schedule may include an instance for the performing of the at least one operation, a time interval for repeating the performing of the at least one operation, a number of instances during a day for the performing of the at least one operation, etc. Further, the processing device 112 may be configured for generating at least one command for the at least one pumping assembly 108 based on the at least one schedule. Further, the forcing of the at least one amount of the at least one fluid with the at least one force may be based on the at least one command.

Further, in an embodiment, the communication interface 114 may be configured for receiving at least one input from the at least one device. Further, the at least one input corresponds to an information associated with the instance for the performing of the at least one operation, the time interval for repeating the performing of the at least one operation, the number of instances during the day for the performing of the at least one operation, etc. Further, the processing device 112 may be configured for analyzing the at least one input. Further, the processing device 112 may be configured for generating the at least one schedule based on the analyzing of the at least one input. Further, the storage device 124 may be further configured for storing the at least one schedule.

Further, in some embodiments, the at least one pumping assembly 108 may include at least one pumping mechanism 116 and at least one actuator 118. Further, the least one pumping mechanism 116 may include a pump. Further, the at least one actuator may include a motor. Further, the motor may be electrically powered. Further, the at least one pumping mechanism 116 may be operatively coupled with the at least one fluid reservoir 104. Further, the at least one pumping mechanism 116 may be configured to be transitioned between a plurality of states for the forcing of the at least one amount of the at least one fluid with the at least one force. Further, the at least one actuator 118 may be operatively coupled with the at least one pumping mechanism 116. Further, the at least one actuator 118 may be configured for transitioning the at least one pumping mechanism 116 between the plurality of states. Further, the forcing of the at least one amount of the at least one fluid with the at least one force may be further based on the transitioning.

FIG. 2 is a schematic diagram of the device 100 connected to the human body 206 using the medical catheter 204 for allowing transferring of the at least one fluid to the human body 206, in accordance with some embodiments. Further, when a pump of the at least one pumping assembly 108 is on and the saline solution may be pushed through the medical catheter 204, the saline solution may only flow to the human body 206, and not to the waste collection unit 208 (such as a drainage reservoir).

FIG. 3 is a schematic diagram of the device 100 connected to the human body 206 using the medical catheter 204 for restricting transferring of the at least one fluid to the human body 206, in accordance with some embodiments. Further, when the pump is off, the saline solution may be not flowing to the human body 206, and the waste may be being drained from the human body 206 to the waste collection unit 208.

FIG. 4 is a schematic diagram of a device 400 for facilitating maintaining patency of medical catheters by means of a saline flush system, in accordance with some embodiments. Accordingly, the device 400 may include a wallet-sized housing 402 containing a microprocessor 404, a motorized pumping mechanism 406, a pressure sensor 408, a battery 410, and a saline cartridge 412. Further, the saline may be expelled by means of the motorized pumping mechanism 406 driven by a motor 416 through a tubing apparatus 414 containing a one-way valve that allows the saline to travel from the device 400 to the drainage catheter but does not allow for reflux of the saline into the device 400 or the catheter drainage bag or bulb. In addition, the tubing apparatus 414 may include the one-way valve to prevent the excursion of bodily fluids into the device 400.

Further, the injection of the saline from the device 400 into the drainage catheter may be optimized for a lumen of the drainage catheter. Further, the lumen may be of different sizes. Further, the lumen of the drainage catheter (or catheter) may be designed to achieve a sufficient velocity of the fluid through each of the side holes at the distal end of the catheter to keep these side holes free of debris and precipitations. For 8.5, 10, and 12 French-sized catheters, a recommended default volume of 10 mL of saline may be injected at a rate of 10 mL/second. For larger catheters, the injected volume and rate of saline may be modified. Further, parameters such as the frequency and volume of saline flushes desired may be programmed onto a LED screen 418 comprised in the device 400. Furthermore, a caliber of the catheter, its drainage location within the body, and the LED screen 418, in addition to which also provide feedback to at least one user regarding catheter flushing history and when a replacement of the saline cartridge 412 is necessary. In addition, the LED screen 418 may alert the at least one user when the pressure in the lumen of the drainage catheter is consistently high. Further, when the force of injection of fluid may be consistently insufficient to achieve a desired volume or velocity of flow through the catheter, the pressure sensor 408 within the device 400 may be triggered. Further, BluetoothTM and Wi-Fi capabilities send automated alerts to both a patient and an interventional radiology provider.

Further, the battery 410 may be configured to supply power to the device 400. Further, the battery 410 may include an AA standard or rechargeable battery. Further, the microprocessor 404 may include a CPU that controls the device 400. Further, the microprocessor 4044 may be used to program the device 400 and schedule intervals when the saline will get pushed through the catheter. Further, the LED screen 418 may be configured to display with a battery level indicator, scheduled intervals for pushing saline, pressure level in the catheter system with a warning, and a few other functions. Further, the motor 416 may be configured to trigger the pumping mechanism 406. Further, the pumping mechanism 406 may be used to push the saline through the saline cartridge 412. Further, the saline cartridge 412 holds the saline that may be pushed through the catheter, as shown in FIG. 2 and FIG. 3. Further, the catheter connects to the catheter in the patient’s body in an aseptic fashion via a traditional Luer lock system on the tubing apparatus’s 414 side. Further, the saline may only flow one way through the catheter connected to the patient’s body. Further, the device 400 may include buttons 420 which may be used by the patient to control the saline flush time intervals, clock on display, and other functions to be defined. Further, the pressure sensor 408 may be used to measure the pressure inside the catheter system. If the drainage catheter within the patient’s body is occluded, the pressure sensor 408 may detect elevated pressure and send a warning signal to the screen 418 notifying the patient to contact their doctor.

Further, the drainage catheters may be thin-walled tubes composed of either silicone, polyethylene, polyurethane, or other polymer blends, usually with a hydrophilic coating. The distal end of the catheter may include “side-holes” which maximize the ability of the catheter to drain fluids. Most drainage catheters also have a retention system composed of a “pigtail”- shaped distal end of the catheter and retention suture. Drainage catheters come in a variety of sizes, with 8.5, 10.2, and 12 French catheters being the most commonly utilized. Further, the drainage catheters are inserted percutaneously, or through the skin without the use of a large skin incision, under ultrasound, fluoroscopic, or computed tomography imaging guidance for a variety of drainage applications (renal, biliary, abscess). They may be inserted directly by means of a trocar or by the Seidinger technique which utilizes a needle and guidewire for access to the fluid collection of interest. Once inserted, the catheter may be typically attached to a gravity drainage bag/drainage bag or a suction bulb. The drainage bag or bulb/suction bulb may be detached in order for the patient to flush the drainage catheter with saline (unless an intervening 3-way stopcock is used between the catheter and bag/bulb).

Normally, when the saline is injected into a drainage catheter, the pressurized fluid bolus results in the clearance of the contents of the catheter into the draining fluid collection (such as an abscess cavity or the collecting system of the kidney). Once the injection is completed and the pressure within the draining fluid collection exceeds that of the catheter, the fluid may be expelled into the catheter and out of the body. Commonly, the drainage catheters may become partially or fully occluded as a result of the presence of debris within the fluid collection or crystalline deposit formation within the catheter. When this occurs, catheter exchange by the interventional radiology team is required to prevent organ failure or worsening of the patient’s condition.

Further, the pressure sensor 408 may detect when the fluid impedance within the catheter is elevated at the time of saline injection. In other words, the device 400 may detect when elevated pressure is required to maintain an optimal flow rate within the catheter during saline injections. If the increased impedance is detected, the patient may be alerted by the device 400 so that follow-up care can be arranged with their physician.

When elevated pressure (i.e., partial or complete occlusion) is present within the catheter, the microprocessor 404 may read the sensor 408 levels and display messages to the patient on a screen 418 (or the LED screen).

Further, the microprocessor 404 may also have BluetoothTM connectivity to communicate these alerts to the patient and the patient’s medical professional via a mobile application. Further, alerts to the patient include a notification when the catheter has been successfully flushed with saline, a notification when occlusion or partial occlusion is detected in the catheter, sensor pressure levels, a battery status of the pump, a notification when the saline cartridge 412 requires replacement, a notification of appointments with their Interventional Radiology Provider. Further, alerts to the patient’s medical professional include a notification that the catheter needs to be replaced due to occlusion or other faults, a type of catheter needed to be exchanged in the event of occlusion. Further, in some embodiments, the pumping mechanism 406 may include a piston rod and a disc, wherein a small plastic disc pushes the saline product through the catheter. Further, the motor 416 presses an actuator and then the saline is pushed through the connected catheter. This is similar to a hand pump.

Further, in some embodiments, the pumping mechanism 406 may include a saline- filled syringe (or syringe), wherein the syringe may be filled with saline and a user (such as IR or APP) or the patient may be pushing force forward (as shown in FIG. 4). Further, the motor 416 pushes the syringe releasing saline through the catheter.

Further, in some embodiments, the pumping mechanism 406 may include a peristaltic or roller pump. Further, a fluid may be contained in a flexible tube fitted inside a circular pump casing. Most peristaltic pumps work through rotary motion, though linear peristaltic pumps have also been made. Further, the rotor has a number of "wipers" or "rollers" attached to its external circumference, that compress the flexible tube as they rotate by. Further, a part of the flexible tube under compression may be closed, forcing the fluid to move through the tube.

Further, in some embodiments, the pumping mechanism 406 may include a water gun type air pressurized reservoir, wherein a pump may be used to push air into a partially water- filled reservoir. Further, the reservoir may be otherwise air-tight, but the reservoir may include one valve to let the incoming air in from the pump as well as a manually controlled valve operated by the user, commonly activated by pulling on a trigger. As more air is pumped in, the air in the reservoir is compressed, increasing in pressure; the water is under pressure by the now compressed air. Upon opening the valve (or a nozzle valve), the water may be pushed out through the nozzle valve as the pressurized air attempts to re-equilibrate with atmospheric pressure. This mechanism allows pumping energy to be stored and used as needed. As well, unlike the methods noted above, this air pressure system allows the production of a uniform, continuous stream of water.

FIG. 5 is a block diagram of a system 500 for maintaining patency of medical catheters by means of a saline flush system, in accordance with some embodiments. Accordingly, the system 500 may include a communication device 502, a processing device 504, and a storage device 506. Further, the communication device 502 may be communicatively coupled with the processing device 504 and the processing device 504 may be communicatively coupled with the storage device 506. Further, the communication device 502 may be communicatively coupled with a device 508 for maintaining the patency of the medical catheters by means of the saline flush system.

Further, the device 508 may include at least one pressure sensor configured for generating at least one pressure data based on detecting a pressure inside the catheter system. If the drainage catheter within the patient’s body is occluded, the pressure sensor may detect elevated pressure. Further, the pressure sensor may detect when the fluid impedance within the catheter is elevated at the time of saline injection. Further, the communication device 502 may be configured for receiving the at least one pressure sensor data from the at least one pressure sensor. Further, the processing device 504 may be configured for processing the at least one pressure sensor to determine a pressure inside the catheter. Further, the processing device 504 may be configured for comparing the pressure with a threshold pressure to generate an alert. Further, the communication device 502 may be configured for transmitting the alert to at least one of the device 508 and at least one user device. Further, the at least one user device may include at least one patient device associated with the patient and at least one healthcare device associated with a healthcare provider such as a doctor, the APPs, or the IR. Further, the at least one user device may include a smartphone, a tablet, a laptop, a mobile, and so on. Further, the alert may include a warning signal notifying the patient to contact their doctor. Further, the alert may notify when occlusion or partial occlusion is detected in the catheter. If an increased impedance is detected, the patient may be alerted by the device 508 so that follow-up care can be arranged with their physician. Further, the storage device 506 may be configured for storing the at least one pressure sensor data and the alert.

Further, in some embodiments, the device 508 may include at least one battery sensor configured for generating at least one battery data based on detecting a charge level associated with the battery. Further, the communication device 502 may be configured for receiving the at least one battery data from the at least one battery sensor. Further, the processing device 504 may be configured for processing the at least one battery data to determine a charge level associated the battery. Further, the processing device 504 may be configured for comparing the charge level with a threshold charge level to generate a battery alert. Further, the communication device 502 may be configured for transmitting the battery alert to at least one of the device 508 and at least one patient device. Further, in an instance, the threshold charge level may be 20%. Further, the battery alert may notify the at least one patient to recharge the battery of the device 508.

FIG. 6 is a schematic diagram of a device 600 for facilitating maintaining patency of a medical catheter, in accordance with some embodiments. Accordingly, the device 600 may include a housing 602, at least one fluid reservoir 604, at least one tube 606, at least one pumping assembly 608, at least one sensor 610, a processing device 612, and a communication interface 614.

Further, the at least one fluid reservoir 604 may be disposed within the housing 602. Further, the at least one fluid reservoir 604 may include at least one fluid. Further, the at least one tube 606 may be fluidly coupled with the at least one fluid reservoir 604. Further, the at least one tube 606 may include a first open end 620 and a second open end 622. Further, the first open end 620 may be fluidly coupled with an outlet of the at least one fluid reservoir 604. Further, the second open end 622 may be configured to be fluidly coupled with a hub of the medical catheter.

Further, the at least one pumping assembly 608 may be disposed within the housing 602. Further, the at least one pumping assembly 608 may be electrically powered. Further, the at least one pumping assembly 608 may be operatively coupled with the at least one fluid reservoir 604. Further, the at least one pumping assembly 608 may be configured for forcing at least one amount of the at least one fluid with at least one force from the at least one fluid reservoir 604 for moving the at least one amount of the at least one fluid to the medical catheter through the at least one tube 606 for performing at least one operation for the maintaining of the patency of the medical catheter.

Further, the at least one sensor 610 may be configured for generating at least one sensor data based on detecting at least one flow parameter of the at least the amount of the at least one fluid moving from the at least one fluid reservoir 604 to the medical catheter through the at least one tube 606.

Further, the processing device 612 may be disposed within the housing 602. Further, the processing device 612 may be communicatively coupled with the at least one sensor 610. Further, the processing device 612 may be configured for analyzing the at least one sensor data based on at least one criterion associated with the performing of the at least one operation. Further, the processing device 612 may be configured for determining a fluid movement characteristic associated with the moving of the at least one amount of the at least one fluid based on the analyzing. Further, the processing device 612 may be configured for comparing the fluid movement characteristic with an optimal fluid movement characteristic associated with the moving of the at least one amount of the at least one fluid for the performing of the at least one operation. Further, the processing device 612 may be configured for generating at least one notification based on the comparing.

Further, the communication interface 614 may be disposed within the housing 602. Further, the communication interface 614 may be communicatively coupled with the processing device 612. Further, the communication interface 614 may be configured for transmitting the at least one notification to at least one device.

Further, in some embodiments, the processing device 612 may be configured for determining a status of the at least one operation based on the analyzing of the at least one sensor data. Further, the generating of the at least one notification may be based on the status. Further, the at least one notification may include at least one operation information associated with the at least one operation.

Further, in some embodiments, the at least one fluid reservoir 604 may be at least one fluid cartridge. Further, the at least one fluid cartridge may be removably disposed in the housing 602. Further, the at least one tube 606 may be removably and fluidly coupled with the at least one fluid cartridge. Further, the at least one pumping assembly 608 may be removably and operatively coupled with the at least one fluid cartridge.

Further, in an embodiment, the processing device 612 may be configured for determining a first amount of the at least one fluid outflowed from the at least one fluid cartridge based on the analyzing. Further, the processing device 612 may be configured for determining a second amount of the at least one fluid remaining in the at least one fluid cartridge based on the determining of the first amount of the at least one fluid and at least cartridge information. Further, the processing device 612 may be configured for determining a requirement for replacing the at least one fluid cartridge based on the determining of the second amount of the at least one fluid remaining in the at least one fluid cartridge. Further, the generating of the at least one notification may be based on the determining of the requirement for the replacing of the at least one fluid cartridge.

FIG. 7 is a schematic diagram of a device 700 for facilitating maintaining patency of a medical catheter, in accordance with some embodiments. Accordingly, the device 700 may include a housing 702, at least one fluid reservoir 704, at least one tube 706, at least one pumping assembly 708, at least one sensor 710, a processing device 712, and a communication interface 714.

Further, the at least one fluid reservoir 704 may be disposed within the housing 702. Further, the at least one fluid reservoir 704 may include at least one fluid. Further, the at least one tube 706 may be fluidly coupled with the at least one fluid reservoir 704. Further, the at least one tube 706 may include a first open end 720 and a second open end 722. Further, the first open end 720 may be fluidly coupled with an outlet of the at least one fluid reservoir 704. Further, the second open end 722 may be configured to be fluidly coupled with a hub of the medical catheter.

Further, the at least one pumping assembly 708 may be disposed within the housing 702. Further, the at least one pumping assembly 708 may be electrically powered. Further, the at least one pumping assembly 708 may be operatively coupled with the at least one fluid reservoir 704. Further, the at least one pumping assembly 708 may be configured for forcing at least one amount of the at least one fluid with at least one force from the at least one fluid reservoir 704 for moving the at least one amount of the at least one fluid to the medical catheter through the at least one tube 706 for performing at least one operation for the maintaining of the patency of the medical catheter.

Further, the at least one sensor 710 may be configured for generating at least one sensor data based on detecting at least one flow parameter of the at least the amount of the at least one fluid moving from the at least one fluid reservoir 704 to the medical catheter through the at least one tube 706.

Further, the processing device 712 may be disposed within the housing 702. Further, the processing device 712 may be communicatively coupled with the at least one sensor 710. Further, the processing device 712 may be configured for analyzing the at least one sensor data based on at least one criterion associated with the performing of the at least one operation. Further, the processing device 712 may be configured for determining a required amount of the at least one fluid and a required force needed for the moving of the at least one fluid to the medical catheter through the at least one tube 706 for the performing of the at least one operation based on the analyzing of the at least one sensor data. Further, the at least one amount may include the required amount and the at least one force may include the required force. Further, the processing device 712 may be configured for generating at least one command for the at least one pumping assembly 708 based on the determining. Further, the processing device 712 may be communicatively coupled with the at least one pumping assembly 708. Further, the forcing of the at least one amount of the at least one fluid with the at least one force may include forcing the required amount of the at least one fluid with the required force based on the at least one command. Further, the processing device 712 may be configured for generating at least one notification based on the analyzing.

Further, the communication interface 714 may be disposed within the housing 702. Further, the communication interface 714 may be communicatively coupled with the processing device 712. Further, the communication interface 714 may be configured for transmitting the at least one notification to at least one device.

FIG. 8 is an illustration of an online platform 800 consistent with various embodiments of the present disclosure. By way of non-limiting example, the online platform 800 to facilitate maintaining patency of a medical catheter may be hosted on a centralized server 802, such as, for example, a cloud computing service. The centralized server 802 may communicate with other network entities, such as, for example, a mobile device 806 (such as a smartphone, a laptop, a tablet computer, etc.), other electronic devices 810 (such as desktop computers, server computers, etc.), databases 814, sensors 816, and a device 818 (such as the device 100, the device 600, the device 700, etc.) over a communication network 804, such as, but not limited to, the Internet. Further, users of the online platform 800 may include relevant parties such as, but not limited to, end-users, administrators, medical professionals, patients, caretakers, medical practitioners, service providers, service consumers, and so on. Accordingly, in some instances, electronic devices operated by the one or more relevant parties may be in communication with the platform.

A user 812, such as the one or more relevant parties, may access online platform 800 through a web based software application or browser. The web based software application may be embodied as, for example, but not be limited to, a website, a web application, a desktop application, and a mobile application compatible with a computing device 900.

With reference to FIG. 9, a system consistent with an embodiment of the disclosure may include a computing device or cloud service, such as computing device 900. In a basic configuration, computing device 900 may include at least one processing unit 902 and a system memory 904. Depending on the configuration and type of computing device, system memory 904 may comprise, but is not limited to, volatile (e.g. random-access memory (RAM)), non-volatile (e.g. read-only memory (ROM)), flash memory, or any combination. System memory 904 may include operating system 905, one or more programming modules 906, and may include a program data 907. Operating system 905, for example, may be suitable for controlling computing device 900’ s operation. In one embodiment, programming modules 906 may include image-processing modules. Furthermore, embodiments of the disclosure may be practiced in conjunction with a graphics library, other operating systems, or any other application program and is not limited to any particular application or system. This basic configuration is illustrated in FIG. 9 by those components within a dashed line 908.

Computing device 900 may have additional features or functionality. For example, computing device 900 may also include additional data storage devices (removable and/or non-removable) such as, for example, magnetic disks, optical disks, or tape. Such additional storage is illustrated in FIG. 9 by a removable storage 909 and a non-removable storage 910. Computer storage media may include volatile and non-volatile, removable and nonremovable media implemented in any method or technology for storage of information, such as computer-readable instructions, data structures, program modules, or other data. System memory 904, removable storage 909, and non-removable storage 910 are all computer storage media examples (i.e., memory storage.) Computer storage media may include, but is not limited to, RAM, ROM, electrically erasable read-only memory (EEPROM), flash memory or other memory technology, CD-ROM, digital versatile disks (DVD) or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store information and which can be accessed by computing device 900. Any such computer storage media may be part of device 900. Computing device 900 may also have input device(s) 912 such as a keyboard, a mouse, a pen, a sound input device, a touch input device, a location sensor, a camera, a biometric sensor, etc. Output device(s) 914 such as a display, speakers, a printer, etc. may also be included. The aforementioned devices are examples and others may be used.

Computing device 900 may also contain a communication connection 916 that may allow device 900 to communicate with other computing devices 918, such as over a network in a distributed computing environment, for example, an intranet or the Internet. Communication connection 916 is one example of communication media. Communication media may typically be embodied by computer readable instructions, data structures, program modules, or other data in a modulated data signal, such as a carrier wave or other transport mechanism, and includes any information delivery media. The term “modulated data signal” may describe a signal that has one or more characteristics set or changed in such a manner as to encode information in the signal. By way of example, and not limitation, communication media may include wired media such as a wired network or direct- wired connection, and wireless media such as acoustic, radio frequency (RF), infrared, and other wireless media. The term computer readable media as used herein may include both storage media and communication media.

As stated above, a number of program modules and data files may be stored in system memory 904, including operating system 905. While executing on processing unit 902, programming modules 906 (e.g., application 920 such as a media player) may perform processes including, for example, one or more stages of methods, algorithms, systems, applications, servers, databases as described above. The aforementioned process is an example, and processing unit 902 may perform other processes. Other programming modules that may be used in accordance with embodiments of the present disclosure may include machine learning applications.

Generally, consistent with embodiments of the disclosure, program modules may include routines, programs, components, data structures, and other types of structures that may perform particular tasks or that may implement particular abstract data types. Moreover, embodiments of the disclosure may be practiced with other computer system configurations, including hand-held devices, general purpose graphics processor-based systems, multiprocessor systems, microprocessor-based or programmable consumer electronics, application specific integrated circuit-based electronics, minicomputers, mainframe computers, and the like. Embodiments of the disclosure may also be practiced in distributed computing environments where tasks are performed by remote processing devices that are linked through a communications network. In a distributed computing environment, program modules may be located in both local and remote memory storage devices.

Furthermore, embodiments of the disclosure may be practiced in an electrical circuit comprising discrete electronic elements, packaged or integrated electronic chips containing logic gates, a circuit utilizing a microprocessor, or on a single chip containing electronic elements or microprocessors. Embodiments of the disclosure may also be practiced using other technologies capable of performing logical operations such as, for example, AND, OR, and NOT, including but not limited to mechanical, optical, fluidic, and quantum technologies. In addition, embodiments of the disclosure may be practiced within a general-purpose computer or in any other circuits or systems. Embodiments of the disclosure, for example, may be implemented as a computer process (method), a computing system, or as an article of manufacture, such as a computer program product or computer readable media. The computer program product may be a computer storage media readable by a computer system and encoding a computer program of instructions for executing a computer process. The computer program product may also be a propagated signal on a carrier readable by a computing system and encoding a computer program of instructions for executing a computer process. Accordingly, the present disclosure may be embodied in hardware and/or in software (including firmware, resident software, micro-code, etc.). In other words, embodiments of the present disclosure may take the form of a computer program product on a computer-usable or computer-readable storage medium having computer-usable or computer-readable program code embodied in the medium for use by or in connection with an instruction execution system. A computer-usable or computer- readable medium may be any medium that can contain, store, communicate, propagate, or transport the program for use by or in connection with the instruction execution system, apparatus, or device.

The computer-usable or computer-readable medium may be, for example but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, device, or propagation medium. More specific computer-readable medium examples (a non-exhaustive list), the computer-readable medium may include the following: an electrical connection having one or more wires, a portable computer diskette, a randomaccess memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), an optical fiber, and a portable compact disc read-only memory (CD-ROM). Note that the computer-usable or computer-readable medium could even be paper or another suitable medium upon which the program is printed, as the program can be electronically captured, via, for instance, optical scanning of the paper or other medium, then compiled, interpreted, or otherwise processed in a suitable manner, if necessary, and then stored in a computer memory.

Embodiments of the present disclosure, for example, are described above with reference to block diagrams and/or operational illustrations of methods, systems, and computer program products according to embodiments of the disclosure. The functions/acts noted in the blocks may occur out of the order as shown in any flowchart. For example, two blocks shown in succession may in fact be executed substantially concurrently or the blocks may sometimes be executed in the reverse order, depending upon the functionality/acts involved.

While certain embodiments of the disclosure have been described, other embodiments may exist. Furthermore, although embodiments of the present disclosure have been described as being associated with data stored in memory and other storage mediums, data can also be stored on or read from other types of computer-readable media, such as secondary storage devices, like hard disks, solid state storage (e.g., USB drive), or a CD-ROM, a carrier wave from the Internet, or other forms of RAM or ROM. Further, the disclosed methods’ stages may be modified in any manner, including by reordering stages and/or inserting or deleting stages, without departing from the disclosure.

According to some aspects, a method for automatically pumping saline into a percutaneous drainage catheter. Further, the method may include a saline flush system consisting of a motorized pump, tubing that pumps saline through a catheter tubing apparatus, a pressure-sensor apparatus required to maintain an optimal flow rate within the catheter during saline injections and to detect when there is increased impedance secondary to partial or complete obstruction of the catheter, and a control panel consisting of an LED display screen providing a user interface.

Further, according to some aspects, the flush system is contained within a housing.

Further, according to some aspects, the flush system comprises a saline cartridge and a pumping mechanism to move saline through a tubing and into a drainage catheter.

Further, according to some aspects, the tubing is connected to the saline cartridge within a flush apparatus with the drainage catheter.

Further, according to some aspects, the tubing is contiguous with and emptying into a waste bag.

Further, according to some aspects, the pressure sensor is configured to detect drainage catheter dysfunction and alert the patient.

Further, according to some aspects, the LED display screen is configured to allow for a selection of a plurality of different selectable drainage catheter types and injection rates and volumes.

Further, according to some aspects, the LED display screen is configured to allow the user to select one of a number of default injection parameters depending on catheter type and location within the body. Further, according to some aspects, the LED display screen provides visual notification of upcoming saline injections.

Further, according to some aspects, the LED display screen provides a notification of confirmation of a successful saline administration.

Further, according to some aspects, a second screen of the LED display provides for display of the occurrences of successful and failed injections, the number of days of injections, and the number and times of scheduled injections.

Further, according to some aspects, the method may include providing on the primary display the volume remaining within the saline cartridge.

Further, according to some aspects, the device is configured to send notifications to the patient's mobile via Bluetooth connectivity and an app on the mobile device. Alerts include notification when the catheter has been successfully flushed with saline, notification when occlusion or partial occlusion is detected in the catheter, sensor pressure levels, battery status of the pump, notification when the saline cartridge requires replacement and notification of appointments with their Interventional Radiology Provider.

Further, according to some aspects, the device is configured to send notifications to medical professionals via the patient’s mobile device app. These alerts include notification that the catheter needs to be replaced due to occlusion or other faults and a type of catheter needed to be exchanged in the event of occlusion.

Although the present disclosure has been explained in relation to its preferred embodiment, it is to be understood that many other possible modifications and variations can be made without departing from the spirit and scope of the disclosure.

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