WO2024057078A1

WO2024057078A1 - Urinary catheter with variable size

Info

Publication number: WO2024057078A1
Application number: PCT/IB2022/058796
Authority: WO
Inventors: Mohammad Sedigh HADJIAN JABER; Akram KAZEMI
Original assignee: Hadjian Jaber Mohammad Sedigh; Kazemi Akram
Priority date: 2022-09-17
Filing date: 2022-09-17
Publication date: 2024-03-21

Abstract

A catheter is designed that given its flexibility, can increase the diameter of the catheter throughout the urethra. This feature allows the user to first adjust the catheter to the thinnest diameter and insert it into the patient's urethra and then increase its diameter to achieve the desired result. This feature makes the patient feel less pain and lowers the possibility of damaging the urinary tract. This device can be used to relieve the obstructed urinary tract and drain the bladder at the same time. Indeed, thanks to its variable diameter this catheter has the opportunity to increase its size and over time it can adapt to the change in volume and the patient does not feel pain and the wall of the urethra will not expose to rupturing or bleeding.

Description

Urinary catheter with variable size

Technical Field

[0001] The technical field of this invention relates to the field of medicine and medical equipment for catheterization and draining the urinary tract.

Background Art

[0002] Patents related to the subject are as follows:

[0003] 1. In 1985, a patent entitled Variable diameter catheter with application number US4710181 A was registered by Clark R. Fuqua. This urinary catheter has a variable diameter so that it can pass through the urinary obstruction by lowering the diameter and causing the lowest damage to the urinary tract. In this invention, by making a double-layered catheter, when the urethra has stricture, the urinary catheter overlaps and its diameter becomes smaller, thus passing through the urethra.

[0004] According to the claim of the inventor of this invention, a flexible catheter can pass through any obstruction. But the main difference and advantage of this invention with the claimed invention is that the claimed catheter can have an increase in volume and hence can obviate the blockage.

[0005] 2. In 1986, a patent titled Balloon dilation catheter was registered with application number US5312430A. This invention includes a flexible catheter and a relatively strong apex and an oval sheath, which is inserted into the area of the urethra that is obstructed by the enlarged prostate, then the protrusion of this sheath causes the opening of urinary obstruction. The exact location of the balloon is the bladder neck and its sphincter.

[0006] The figure illustrates the tools required to direct observation of the inside of the urethra. Indeed, the inventor of this device, to be able to place the balloon exactly in the prostate obstruction, reaches the place of the prostate obstruction with the camera, then the balloon or the oval sheath is placed inside the duct and at the same time as the volume of this sheath increases, the blockage of the urethra and ureters, which is due to prostate enlargement, is obviated. [0007] This invention is considered one of the most similar inventions to the claimed one as it can increase the volume and seek to remove the urinary tract obstruction, but it has differences:

[0008] 1. This invention can drain the blockage in the prostate area in the urethra. This device removes urethral obstruction due to prostate enlargement. While the claimed invention can relieves any type of obstruction including stricture, stenosis, or atrophy throughout the urethra.

[0009] 2. Its balloon part can cause the urethra to rupture since if it is over-inflated, it may be more than the normal size of the patient's urethra and rupture the patient's urethra.

Technical Problem

[0010] The urinary catheter is often applied as one of the most common and essential medical and therapeutic equipment. Urinary catheters have different types, each used in specific situations. Firstly, the types of catheters that have been manufactured till now are described.

[0011] Types of urinary catheter:

[0012] 1. Condom catheter: This catheter is condom-shaped and can be utilized for several hours. This catheter is made for men who can urinate well and as they are unable to walk, they can stay in bed and use this catheter.

[0013] 2. Foley catheter: This catheter is classified into bi- and trifurcate types. In the bifurcate type, one duct is used to drain urine, and the other is connected to a balloon at the top of the catheter when the urinary catheter is inserted into the bladder, water is injected into it through a syringe and the balloon dilation prevents the catheter from leaving the bladder. In the trifurcate type, there is a third duct that enters the bladder and is used to inject water or serum into the bladder and is used to wash the bladder.

[0014] 3. Nelaton catheter:

[0015] This catheter is made of polyurethane, disposable, and cannot be utilized for a long time. This catheter is more durable than the Foley catheter, and sometimes Nelaton catheter is used to drain the urethra as the Foley catheter is easily bent and gets stuck in the urethra. This catheter is classified into bi- and trifurcate types.

[0016] 4. Coude catheter:

[0017] It is made of the materials same as the Nelaton catheters, and is specifically designed in a curved shape to maneuver around obstructions or blockages in the urethra and is usually used for people who suffer from urethral blockage and obstruction, including prostate enlargement in men, or urethra stenosis and stricture in women.

[0018] Urinary catheters, despite the difference in their materials and their multiple sizes, have many drawbacks that disrupt the patient's treatment process. Some of these drawbacks are as follows:

[0019] 1. Most patients who have been used to urethral catheterization always complained about the pain. Sometimes the pain caused by catheterization occurs due to the lack of experience of the therapist and sometimes because of obstruction or stricture of the urethra, the intensity of the pain makes the therapist unable to perform this task and the patient cannot tolerate it.

[0020] 2. Sometimes while patient catheterization, the urethra is damaged or ruptured because the therapist tries to pass the catheter through the urethra and because of stricture and obstruction, it leads to a bending of the catheter in the urethra and hence, rupture of the urethra.

[0021] 3. At times the therapist or doctor is not able to pass the catheter through the urethra, they are forced to utilize a smaller sized catheter and they have to try a smaller size each time to select the most miniature suitable catheter for the patient to pass it through the urethra, however, this has two significant drawbacks, firstly, it is not cost-effective, and secondly, a small-sized catheter (for example, a baby's catheter) cannot be left in the urethra of a 40-year-old person for many hours. The reason behind it is that the infant's catheter is not able to drain the urine of an adult and the urine is secreted from around the catheter.

[0022] 4. In patients with benign prostate enlargement, as well as other patients who are suffering from stenosis and stricture of the urethra and are unable to urinate, the therapist has to use high-risk methods such as emptying urine through Angiocath from the suprapubic area and draining the urine directly from the bladder, which suprapubic method increases the risk of infection in the patient.

[0023] The main objective of this invention is to facilitate catheterization such that any patient suffering from urinary tract obstruction or stricture for any reason can easily open their urethral stricture without pain and bleeding by a urinary catheter with variable size and catheterization can be performed easily in these patients.

Solution to Problem

[0024] To solve the aforementioned issues, a catheter is designed that given its flexibility, can increase the diameter of the catheter throughout the urethra. This feature allows the user to first adjust the catheter to the thinnest diameter and insert it into the patient's urethra and then increase its diameter to achieve the desired result.

[0025] This feature makes the patient feel less pain and lowers the possibility of damaging the urinary tract. This device can be used to relieve the obstructed urinary tract and drain the bladder at the same time.

[0026] Indeed, thanks to its variable diameter this catheter has the opportunity to increase its size and over time it can adapt to the change in volume and the patient does not feel pain and the wall of the urethra will not expose to rupturing or bleeding.

Advantageous Effects of Invention

[0027] 1. Preventing urethra rupture while catheterization by a novice and amateur therapist or when the urethra wall becomes sensitive.

[0028] 2. Minimizing the possibility of urethra infections after catheterization

[0029] 3. Catheterization with less pain for the patient

[0030] 4. Obviating the need for production and use of catheters in different sizes

[0031] 5. Adjustability of the thickness and the diameter of the catheters as desired

[0032] 6. Minimizing the possibility of using invasive methods to drain the bladder

[0033] 7. Obviating needs to use a guide or coude catheter

Brief Description of Drawings [0034] Fig 1 . Catheter with the smallest and largest diameter.

[0035] Fig2. Catheter insertion and placement in urethra.

[0036] Fig 3. Increasing catheter body and tip to obviate obstruction.

Description of Embodiments

[0037] Generally, the major components of this catheter are as follows:

[0038] The outer layer (104) consists of latex or other elastic material. This layer given its elasticity, allows the catheter to be adjusted in the thicker or thinner manner.

[0039] Two interwoven springs (101 b) wrapped around the catheter's central rod (105). These two springs have no contact with each other or to the central rod throughout the catheter and only at the tip of the catheter are connected to the main rod. On the other hand, the springs are connected to the spiral bevel gear (102a and 102b), and from inside the spiral bevel gear the main rod is connected to another gear (106), and as with the springs, it can rotate in the right or left direction.

[0040] the device controller adjusts the movement of the spiral bevel gear and the central rod gear and when the diameter of the catheter should be increased, the spiral bevel gear moves in one direction (for example, clockwise) and the central rod gear moves in the opposite one(counter-clockwise) to increase the diameter of the catheter. When the diameter should be reduced, the spiral bevel gear and the central rod gear are rotated in the reverse direction by the device controller. Whether the rotation of the springs to the right increases or decreases the diameter of the catheter depends on the direction of the spring’s rotation around the main rod. Technically, it does not matter from which side the springs have rotated around the central rod.

[0041] When the spiral bevel gear rotates in one direction in its axis in this catheter, it simultaneously moves backward or forwards in its spiral axis and simultaneously rotates the spring with it, given that the ends of the other springs are connected to the central rod, this rotation of the spiral bevel gear from one side increases the distance of the springs from each other and as a result, the diameter of the catheter increases and the length of the catheter decreases. When the spiral bevel gear rotates in the opposite direction, it causes the springs to get closer to each other, and as a result, the diameter of the catheter reduces, and the length of the catheter increases.

[0042] The springs density is higher at the tip of the catheter so that the springs are more intertwined in the end part of the tip of the spring and with more elasticity, and given the simultaneous rotation of the spiral bevel gear and also the rotation of the central rod in the opposite direction of the spiral bevel gear, the diameter of the catheter tip is increased more than the other parts and the catheter is fixed within the bladder.

[0043] There is an elastic spring inside this urinary catheter, which increases its diameter by rotating the spring in the opposite direction, reduces its diameter by rotating the spring in the direction, and relieves all types of urethra obstructions. Incorporated Conical Spiral Gears with COIL (301 ) and two intertwined springs make it possible to adjust the diameter of the catheter.

[0044] This catheter size is equivalent to catheter number 12, and its outer diameter (101 a) is 4 mm in the smallest state, and it can be used from the age of 6 years and above, and it can be considered the size of a catheter 26, whose outer diameter is 8.7 mm. To use this catheter, first, the catheter (1) is inserted easily into the urethra, after the catheter enters the bladder (2) spiral bevel gear (102a), the diameter of the spring (101 b) can be adjusted at the desired speed until it reaches the required value and the elasticity of the wall helps the catheter to increase in diameter to the size of the catheter 26.

[0045] The Digital Diameter Servo Controller (3) allows the user to command the device to adjust the diameter of the catheter by selecting the available positive, negative and reset buttons. This servo motor controller includes a manual or automatic device for starting and stopping the motor, selecting left or right rotation, selecting and adjusting the speed and direction of the motor, and also has overload protection.

[0046] This digital controller has 8 default modes, 8 stations or 8 pre-defined steps, of different sizes of standard urinary catheter diameters. [0047] Every time the positive or negative button is pressed, the spring diameter increases or decreases to one of 8 pre-programmed standard catheter sizes. In general, it includes 5 push buttons and a screen.

[0048] • Screen: it shows the status of the device whether it is on or off, the diameter of the catheter, the lock mode, the battery charge level.

[0049] • Button (+): for each press, the diameter of the spring increases by one step.

[0050] • Button (-): For each press, the diameter of the spring decreases by one step.

[0051] • Lock button: puts the diameter of the spring in a locked state so that the device does not go out of adjustment mode in case of pushing the positive and negative or reset buttons.

[0052] • Reset button: By pressing this button, the diameter of the catheter will slowly change to the starting point and the smallest diameter of the catheter.

[0053] • Power button: it is used to turn the device on and off.

[0054] A spring controller or digital diameter servo controller when entering the catheter into the bladder, allows the diameter of the spring to be increased or decreased at the desired speed until its diameter reaches the desired size. At the end of the treatment process, its diameter is slowly reduced to its original state, which is 4 mm in diameter, and it is removed from the patient's urethra.

[0055] Air balloon are not utilized in this catheter. To fix the catheter inside the bladder, a spindle-shaped part is embedded at the end of the catheter (103b) with a diameter of at least 6 mm, which provides more space, and also the spring material used makes the spring dilates more and creates a spindle-shaped part that acts like an air balloon and prevents the catheter from leaving the bladder and also prevents urine from leaking around the bladder.

[0056] The urine collected by the urinary catheter is drained into the urinary drainage bag through the two ways (302) created at the joint of the springs and the controller. In addition to the battery, a solar panel (303) located at the end supplies controller energy.

[0057] The major features of the claimed catheter with a variable size:

[0058] 1 . Catheter variable size: [0059] The claimed catheter, unlike other existing catheters, is made of two layers. The outer layer is illustrated in the figure below. This layer is made of latex and is very elastic. As the tip of the catheter increases in size (103b), the latex layer becomes at least 6 mm. normally, this spindle-shaped part is overlapping and its size is 4 mm (103a).

[0060] A spring is embedded inside the outer layer, so that the diameter of the spring is reduced (102a) or increased (102b) by the spring controller screw.

Examples

[0061] This invention, given its many applications in medicine and the disadvantages of previous catheters, can obviate many issues encountered in patients’ catheterization. This catheter is designed with a spring and a double-layer catheter can be produced. The function of this device is that the user puts the spring of the device in its thinnest position and after inserting the catheter into the patient's body, increases the thickness of the catheter to the required size.

Industrial Applicability

[0062] This device is applied after every prostate surgery and other urethra surgeries and different samplings.

Claims

[Claim 1 ] Urinary catheter with variable size which consists of the following parts a. a. outer latex layer b. b. Two interwoven elastic springs c. c. Central rod and gear d. d. Spiral bevel gear e. e. Urinary fluid outlet which two interwoven springs are wrapped around the central rod, and at the tip of the catheter, two springs are connected to the central rod, and on the other side, the springs are connected to the spiral bevel gear, and the central rod is passed from the spiral bevel gear to connect with another gear and it can rotate in the right or left direction like the springs, and all the springs are coated with a layer of latex.

[Claim 2] Urinary catheter where in claim 1 , when the spiral bevel gear rotates in one direction around its axis, it simultaneously moves backward or forwards in this spiral axis and simultaneously rotates the spring with it, given that the other ends of the springs are connected to the central rod this rotation from one side increases the distance of the springs from each other and as a result, the catheter diameter increases and the catheter length also decreases when the spiral gear rotates in the opposite direction it causes the springs to get closer to each other and hence, the diameter of the catheter reduces and the length of the catheter increases.

Urinary catheter where in claim 1 , the springs density is higher at the tip of the catheter so that the springs are more intertwined in the end part of the tip of the spring and with more elasticity, and given the simultaneous rotation of the spiral bevel gear and also the rotation of the central rod in the opposite direction of the spiral bevel gear, the diameter of the catheter tip is increased more than the other parts and the catheter is fixed within the bladder.