WO2015187113A1

WO2015187113A1 - Balloon unit serving as a valve found inside reservoir catheter

Info

Publication number: WO2015187113A1
Application number: PCT/TR2015/000252
Authority: WO
Inventors: Ceren GENC; Hasan KARABAY
Original assignee: Astra Medikal Tibbi Aletler Ith Ihr Tic Ltd Şti; KARAKUS, Kerim; KARAKUS, Fatih
Priority date: 2014-06-04
Filing date: 2015-06-04
Publication date: 2015-12-10

Abstract

The application comprises a catheter with a balloon unit serving as a valve providing the discharge of fluid inside the bladder by deflating and preventing the discharge of the fluid inside the bladder by inflating the balloon. The balloon (1) is connected to the probe system by an air duct (2). Said air duct (2) has an opening (2. a) at the end of the air duct (2) where the fluid passes for inflating the balloon (1).

Description

BALLOON UNIT SERVING AS A VALVE FOUND INSIDE RESERVOIR

CATETHER

DESCRIPTION

TECHNICAL FIELD

The invention is a product design addressing to medical industry and covering the patients that must carry out urine discharge temporarily with a problem of urinary incontinence and disorders with urinary incontinence in the urology field of medical science.

FORMER TECHNIQUE

Today, various types of products have been developed according to the disease types/patient pertaining the urinary discharge in the lower urinary systems in the field of urinary incontinence. However, some part of these products remain very primitive compared to today's technology and some of them cause infection, complications and diseases and some of them force the patient to severe surgeries. The common part of all of them is they reduce the quality of life of the patient. Nowadays, if we are t list the products according to the disease types used in the current market related to the urination of a patient:

- Probe-catheter for the patients undergoing surgery and the patients receiving treatment as inpatient and outpatient in hospitals,

- Depending on the complications and trauma, plug catheter for the paralyzed, unable to use urination system bedridden or disabled patients,

- Sphinx and mesh prosthesis for urinary incontinence developing depending on aging.

It is the group of patients treated in inpatient or outpatient in health care providers, hospitals, etc. termed and indefinitely admitting to the institutions and discharged. Before the admission, surgery, during and after the surgery probe and catheter are attached by subjecting the relevant patients to catheterization. Infection seen in use of probe is 30% of all hospital infections and 80-95% is associated with urinary catheter.

The risk of bacteriuria for everyday use of the probe is approximately 3-7%. In 10- 25% of patients with bacteriuria USI develops and in 3% of them bacteremia, serious and life-threatening complications develop. UTIs are the most important unwanted consequences of the use of the probe. Other than that, noninfectious problems, nonbacterial urethritis, urethral strictures and mechanical trauma are considered to be among these problems. The second group of patients; plug catheter is used in patients with spina bifida, multiple sclerosis, spinal cord injury, spinal tumors, intervertebral disc herniation, cases causing neurogenic bladder, such as diabetic neuropathy, after urinary diversions, obstructive uropathy, hypotonic bladder, cases of bladder dysfunction as detrusor-sphincter discoordination and / or voiding dysfunction. The most common unwanted side effects seen with these patients are urinary tract infections (UTI).

Urethral bleeding is a finding that can be seen particularly in new patients and it may form due to false passage. Urethral strictures and meatal stenosis in the long term may develop.

The third group of patients; is the group of diseases with urinary incontinence which was especially due to inability to generate the necessary compression of the sphincter muscle bundles, depending on the prostate surgery in aging men, especially in women and occurs when patients with urinary incontinence is connected. These patients are attached sfinter prosthesis as invasive surgery. During the attachment of the prosthesis a number Sfint complications occur. These are: · Urethral (urinating channel in the penis) can be traumatic and the probe may need to stay longer (0-2%)

^• Bleeding may take place in the surgery site (1-5%) 5· Infection may develop (1-3%) and it may proceed to the placed prosthesis. The treatment is with antibiotics at the beginning. If not succeeded the prosthesis may need to be removed (infection developed 5-15%)

^• Narrowing can take place in urinary tract and may require additional surgical treatment. ιο· Urinary incontinence may continue (7-14%).

• Prosthesis may not work (12%)

A product auto controlled subject of invention with a balloon inside similar to reservoir-balloon catheter used in the lower urinary system has not previously been produced and its differences from the existing products include;

15 · Eliminating the risk of infection since the product has no part other than urethra,

^• Not causing any injury or bruising in the discharge system for it will be replaced every 30 days,

• Patient being able to attach the product himself without requiring a technical intervention and providing patient self-control

20 · Patients continuing their social life and upgrading their quality of life without the need for treatments repeated 4-10 times of a day, carrying bags of medical materials with them constantly,

^• Decrease of material and spiritual loads of caregivers and nurses either in hospitals or at home

25 · Being low in price although "better" compared to the current products. Because of that causing much lower costs to both the government and the user,

Far from being an alternative to the product of the invention subject, it has the design to take place of all the products category mentioned above, reduce costs and will have a much easier use.

30 EXPLANATION OF THE INVENTION Explanation of the Figures

Figure-1 : General view of the catheter

Figure-2: View of the balloon in deflated form

Figure-3: View of the balloon in inflated form

Figure-4: The position of the inflated balloon within the bladder Figure-5: The position of the deflated balloon within the assembly mechanism

Figure-6: The position of the fluid inside the balder in balloon inflated status

Figure-7: The position of the fluid inside the balder in balloon deflated status

Explanation of the Reference Numbers

1- Balloon

2- Air duct

2.a- Hole

3- Manecothead

4- Bladder

5- Pushing rod

6- Labyrinth channel

Balloon (1 ) as seen in Figure-4 is connected to the probe system with air duct (2). As details seen in Figure.2 it expands by inflating with the fluid coming from the hole (2. a) at the end of the air duct (2) and it closes the volume it is present as in figure-6. Since the gases occupy the volume of the environment they are in and transmit the pressure equally to each point it provides the advantage for the balloon (1 ) wrapped in inflated form, applying the same force to every point in the site it contacts and to work stable and regular and obtain a homogenous impermeability.

As seen in Figure-4 the balloon (1)while wrapping the outer volume in inflating position since the material around it is a flexible (elastic) material it also forces the wall it occupies and expands a bit. Due to this expansion while the effect of impermeability reaches to higher dimensions the labyrinth channel (6) (external part) of catheter touching the body also prevents the urine from escaping out of catheter by expanding a bit. (Figure-6)

The flexibility of the balloon (1 )and shaping easily becomes suitable to the system.

The balloon (1) is within the probe and in case it is inflated it blocks the bladder opening and urinary tract and prevents the proceeding of the fluid in the volume it occupies. The balloon (1 ) prevents the discharge of the urine found in the opening of the balder by inflating within the probe. Afterwards it provides the discharge of the fluid inside the balder (4) by deflating (Figure-7)

As seen in Figure-1 catheteris placed into the bladder (4)with the help of a pushing rod (5) and nesting is created inside by pulling back with manecothead (3). The fluid is given to the balloon (1 ) after pulling the nesting created and the pushing rod (5)and the balloon is (1 )allowed to inflate (Figure-3). The inflated balloon (1 )serves to prevent the fluid inside the bladder (4) (Figure-6). When the balloon (1 )is lowered (figure-2) it helps the fluid inside the balder (4)to go out (figure-7).

DETAILED EXPLANATION OF THE INVENTION The invention is a balloon unit serving as a valve providing the discharge of the fluid inside the balder by deflating and preventing the discharge of the fluid inside the balder by inflating found basically inside the catheter. The connection of the balloon (1 ) to the probe system is provided with the air duct (2).

The said air duct (2) has a hole (2. a) found at the end of the air duct (2) where the fluid passes inflating the balloon (1 ).

While the balloon (1) wraps the outer volume in inflating position at the same time it expands by forcing also the wall it occupies. This flexibility of the balloon (1) and to be easily shapes is provided by its form of elastic material product.

The invention also has a labyrinth channel found in the outer part of catheter touching the body preventing the escape of the urine from the outside of catheter and expanding as a result of forcing the wall it occupies by the expansion of the balloon (1 ).

The preferred application of the balloon unit serving as a valve found inside the reservoir catheter of the subject of invention has been told and the invention is actually as it is mentioned in the claims.

Claims

1 - The invention is a balloon unit serving as a valve providing the discharge of the fluid inside the bladder by inflating found inside the catheterand its property is; to be characterized by being provided with the balloon (1 ) connected to the probe system with the air duct (2).

2- The inventionis according to the claim 1 and its property is; to be characterized by being provided with the hole (2. a) found at the end of the air duct (2) providing the passage of the fluid inflating the balloon (1 ).

3- The inventionis according to the claim 1 , its property is; to be characterized with an elastic material balloon (1) providing the easy shaping and flexibility and expansion by forcing the wall it occupies at the same time while wrapping the outer volume in inflating position.

4- The invention is according to the claim 1 , its property is; to be characterized with labyrinth channel (6) found in the outer part of catheter touching the body preventing the escape of the urine outside of catheter and expanding as a result of forcing the wall it occupies with the balloon (l )expanding.