Mictional dysfunction controller

Abstract

The present invention comprises a mictional dysfunction controller formed by a cylindrical body made from medical-grade hydrophilic silicone and having 3 discs (D1, D2 and D3), of which two discs have a protuberance in the centre, namely a fixed proximal disc (D1) coupled to the bladder neck and thus promoting the occlusion thereof, and a sliding distal disc (D3) fitted to the female external meatus and providing the complete occlusion of the urethra, thus promoting continence, wherein the disc (D2) is coupled to the disc (D1), thus guaranteeing a perfect fit for any patient, wherein an opening and closing mechanism is provided on the distal end, which makes it possible to empty the bladder when desired, and wherein the controller is made in several sizes, the calibre of which is in the range of 06 to 26 FR, which ensures a perfect fit for the widest range of anatomies and pathologies, including babies, adults, the elderly and wheelchair users.

Description

[0001] MICTIONAL DYSFUNCTION CONTROLLER FIELD OF APPLICATION

[0002]

[0001] This descriptive report concerns the invention patent of a unique MICTIONAL DYSFUNCTION CONTROLLER for patients with various micturition dysfunctions, used in patients of both sexes, with an innovative design and featuring important technological and functional improvements, according to the most modern engineering and medical concepts and in accordance with the required standards and specifications, featuring its own characteristics and fundamental requirements of novelty and inventive activity, resulting in a series of real and extraordinary technical, practical and economic advantages.

[0003] BACKGROUND OF THE PRESENT INVENTION

[0004]

[0002] As is known to those skilled in the art, intermittent catheterization is the main measure used for this purpose and has the main drawback of needing to be performed several times during the day, in addition to the amount of material required for this purpose.

[0005]

[0003] Currently, permanent or intermittent bladder catheterization and the use of diapers have been viable alternatives for patients who present with bladder emptying disorders, whether due to permanent loss of urine, or deficient or absent emptying.

[0006]

[0004] INTERMITTENT BLADDER CATHETERIZATION (CIL - Clean Intermittent Catheterization) is the main measure used for this purpose, requiring the use of several CIL catheters to perform bladder emptying (urine disposal) several times a day. This procedure is not normally performed by the patient himself, given the need for skill and manual dexterity and the use of other products to perform it. Therefore, according to the protocol of the Permanent Commission for Health Care Protocols of SES-DF - CPPAS, we list below some prerequisites for its use: Patient training to perform it daily every 4 hours; Manual dexterity, to avoid complications such as: "urethral stricture, ongoing UTI, urethral trauma, etc.."; Adequate space for the passage of the catheter.For example: "catheterization should be performed in bed, the user can spread the material beside her or use a support table"; Urethral catheter (CIL) - the gauge should be defined in the medical and / or nursing report; Lidocaine jelly 2% 30g, to lubricate the urethra and aid the passage of the catheter; Non-sterile hydrophilic gauzes for local hygiene; Procedure gloves.

[0007]

[0005] PERMANENT BLADDER CATHETERIZATION is performed using a Foley catheter - which has an inflatable balloon that is connected to an external collection bag (usually attached to the patient's leg) and emptied at varying intervals. Although it adequately empties the bladder, its characteristics such as: size, material from which it is usually made and the inconvenience of the existence of an inflatable balloon that bothers the patient, mean that it is not used as a permanent form in the situations described.

[0008]

[0006] “PERMANENT, REMOVABLE AND SELF-SUPPORTING URETHRAL CATHETER”, which also uses adjustable discs. However, its design does not allow for perfect adaptation to all patients, since the anatomical features of each patient vary greatly, and the product cannot be firmly fixed to all types of bladder necks, thus not guaranteeing its perfect functioning. This is not the case with the present patent, as it was designed to serve all types of patients with their most varied anatomical possibilities.

[0009]

[0007] When we talk about social benefits, it's important to highlight that the use of urinary catheters can significantly improve patients' quality of life. Choosing the right catheter can make all the difference in this regard, as maintaining the catheter is what guarantees the benefits of treatment. Therefore, preventing patients from discontinuing their use is crucial, especially to prevent worsening of their clinical condition.

[0010]

[0008] In this sense, some inventors designed the products that are the subject of the patent documents indicated below, but did not pay attention to the details mentioned above.

[0011]

[0009] Patent document BR 10 2014 021737 1 , published on April 7, 2015, provides for a permanent, removable, and self-supporting urethral catheter that is innovative in that it can be adjusted to the patient's anatomy. The catheter in question is indicated by the numerical reference and has a tubular body with two discs, one proximal (fixed) and the other distal (mobile); the distal end of the tubular body of the catheter has holes that communicate with a longitudinal channel that crosses the tubular body. The catheter has a connector that can be closed with a corresponding cap. This catheter also differs from our invention, as it cannot fully meet the needs of patients with the most diverse voiding dysfunctions.

[0012]

[0010] The benefits of our patent consist of the development of a product that will modify the treatment of various urinary disorders and promote a better quality of life for affected patients. It promotes, for example, the control of nocturnal enuresis (bedwetting during sleep), dysuria (painful urination), pollakiuria (increased urinary frequency), and can prevent some cases of kidney failure, avoiding irreversible situations that often culminate in hemodialysis and transplantation. Other examples include urinary hesitancy (difficulty initiating urinary flow), overflow incontinence (involuntary loss of urine due to a full bladder), and overactive bladder (increased urinary frequency and urgency).It also allows the patient to retain urine or empty the bladder in a similar way to the natural way, simply by activating the opening and closing mechanism, located at the distal end of the product, thus promoting a significant reduction in possible kidney complications, allowing patients to return to a full routine without limitations.

[0013]

[0011] It will provide an improvement in all physical indicators (urinary tract infections) and quality of life, in addition to significantly interfering in the cost of treatment. It also promotes the reduction, and possible elimination, of diapers and the interruption of the use of barrier creams, definitively eliminating intermittent bladder catheterization (CIC) and permanent bladder catheterization.

[0014]

[0012] Analyzing the documents cited above and known from the state of the art, as can be observed, none fully presents the construction characteristics and treatment of pathologies that other devices will not bring, as described previously, of the MICTIONAL DYSFUNCTION CONTROLLER, object of the present patent, thus addressing the various urinary dysfunctions and promoting a better quality of life for the affected patients.

[0015]

[0013] The VOIDING DYSFUNCTION CONTROLLER will be used by patients of both sexes, thus obtaining an integrated product with real possibilities of economical industrialization, minimizing costs, assembly time and labor expenses, in addition to a precise assembly effect, with better results and a high standard of safety and financial savings for patients.

[0016]

[0014] The development of a probe for bladder catheterization for patients with urinary dysfunctions is important, given that, currently, permanent or intermittent bladder catheterization and the use of diapers are viable alternatives for patients who present with bladder emptying and emptying control disorders, whether due to permanent loss of urine, or deficient or absent emptying.

[0017]

[0015] Urinary incontinence and retention in patients of all ages poses a challenging problem for the medical community, especially in cases where surgically implantable devices are not applicable, whether due to comorbidities such as diabetes, severe neurological injury, younger age, or elderly individuals with these anomalies. Difficulty with self-catheterization in children and the elderly, especially females, causes the bladder to be inadequately emptied. Consequently, damage to the urinary tract occurs, leading to kidney failure, leading to irreversible situations that often culminate in hemodialysis and transplantation.

[0018]

[0016] The main benefit of this patent is that it is anatomical, allowing it to be installed on the patient, and can even be used alone or in conjunction with other associated devices, and can be connected (optionally) to a collection bag only at the time of bladder emptying. It serves patients of both sexes and all ages, and treats other pathologies in addition to urinary incontinence and retention as already mentioned above, thus tending to reestablish normality in the act of urination of these patients, being effective for the various urinary dysfunctions and promoting a better quality of life for the affected patients.

[0019]

[0017] In this context, the aforementioned patent becomes quite innovative and beneficial to society, given that it makes it possible to considerably improve the quality of life of patients, as it avoids the use of disposable diapers and the need for intermittent catheterization several times a day, providing security to restore a proper sexual routine, as well as significant budget savings. Furthermore, because the invention has the power to perform adequate emptying, the incidence of urinary infections in these patients is very low, a factor that essentially suspends the use of medications (antibiotics), a factor that prevents the emergence of new clinical problems, as well as ensuring greater longevity for these patients.

[0020]

[0018] Therefore, the voiding dysfunction controller that is the subject of this patent eliminates the daily introduction of several catheters into the urethra, occurring only once a month, the user does not feel pain during the procedure, there is no creation of stenosis in the urethra, it does not cause recurrence of urinary infections, there is no dependence on third parties on a daily basis, there is no limitation of freedom, there is no discomfort, it allows for low costs, there is no need to use gloves, diapers, gases, saline solution, antibiotics, etc., there is no need to use a Foley catheter, there is no need to use an external bag on the patient's leg, there is no need to empty several times a day, there is no urine leakage, there is no need for several daily changes, there is no clothing limitation, there is no sensation of heat, it does not cause allergies, it provides a better quality of life and control of urinary flow by the patient himself, it reduces possible kidney complications, it returns patients to a full and unlimited routine, it provides an improvement in all physical indicators, it eliminates intermittent bladder catheterization, it eliminates permanent bladder catheterization and it does not cause interference in the sexual act.

[0021]

[0019] Therefore, one of the objectives of the present patent is to provide an invention with a cylindrical body made of MEDICAL GRADE HYDROPHILIC SILICONE having 3 discs (D1, D2 and D3 in the attached figure), of which 02 discs have a protuberance in the center, a fixed proximal disc (element D1 in the attached figure), which will be coupled to the bladder neck, thus promoting its occlusion; and a sliding distal disc (element D3 in the attached figure) which, adjusted to the female external meatus, provides complete occlusion of the urethra, promoting continence. Disc D2 will be coupled to disc D1, thus ensuring its perfect accommodation to any patient. At the distal end there is an opening and closing mechanism that allows emptying of the bladder when desired.

[0022]

[0020] Another objective of this patent is achieved, as the product will be manufactured in various sizes, with its caliber ranging from 06 to 26 FR, a fact that ensures perfect adaptation to the most diverse anatomies and pathologies, including serving children, adults, the elderly and wheelchair users; promoting a better quality of life for affected patients, since the control of urinary flow returns to a similar to natural, in addition to the other benefits previously mentioned, such as a significant reduction in possible renal complications, returning patients to a full and unrestricted routine. Ultimately, providing an improvement in all physical indicators (Example: urinary tract infections and others) and an improved quality of life. In addition, it significantly impacts the cost of treatment, with the reduction - and possible elimination - of diapers and discontinuation of the use of barrier creams and relief tubes.

[0021] The device that is the subject of this patent aims to serve all patients, both male and female, with illnesses that cause urinary dysfunction, whether incontinence or retention, as well as the most diverse urinary dysfunctions and promote a better quality of life for affected patients.

[0023] BRIEF DESCRIPTION OF THE FIGURES

[0024]

[0022] To complement this description, in order to obtain a better understanding of the characteristics of this patent, and in accordance with a preferred practical implementation thereof, the description is accompanied, in annex, by a set of drawings, where, in an exemplary, although not limitative manner, the following is represented: Figure 1 represents an elevation view of the device.

[0025] Figure 2 shows a view of the device disks.

[0026] DETAILED DESCRIPTION OF THE INVENTION

[0027]

[0023] According to the figures mentioned above, and in their details, the MICTIONAL DYSFUNCTION CONTROLLER object of the present patent consists of a cylindrical body made of MEDICAL GRADE HYDROPHILIC SILICONE and having 3 discs (D1, D2 and D3 of the attached figure), of which, 02 discs with a protuberance in the center, being a fixed proximal disc (element D1 in the attached figure), which will be coupled to the bladder neck, thus promoting its occlusion; and a sliding distal disc (element D3 in the attached figure) which, adjusted to the female external meatus, provides complete occlusion of the urethra, promoting continence. Disc D2 will be coupled to disc D1, thus ensuring its perfect accommodation to any patient. At the distal end there is an opening and closing mechanism that allows emptying of the bladder when desired.

[0024] This patent will be manufactured in various sizes, with its caliber ranging from 06 to 26 FR, which guarantees perfect adaptation to the most diverse anatomies and pathologies, including children, adults, the elderly and wheelchair users.

[0028]

[0025] There is no knowledge of a MICTIONAL DYSFUNCTION CONTROLLER in patients of both sexes that combines all the constructive and functional characteristics reported above, and that directly or indirectly, mainly with the efficiency proposed by the object of the present patent.

[0029]

[0026] Having described and illustrated the present invention, it is to be understood that it may undergo numerous modifications and variations in its form of embodiment, provided that such modifications and variations do not depart from the spirit and scope of the invention, as defined in the claims table.

Claims

CLAIMS 1 - MICTIONAL DYSFUNCTION CONTROLLER characterized by the fact that it is made up of a cylindrical body made of MEDICAL GRADE HYDROPHILIC SILICONE and has 3 discs (D1, D2 and D3) of which, two discs with a protuberance in the center, being a fixed proximal disc (D1), which will be attached to the bladder neck, thus promoting its occlusion; and a sliding distal disc (D3), adjusted to the female external meatus, provides complete occlusion of the urethra, promoting continence, and the disc (D2) will be attached to the disc (D1), thus ensuring its perfect accommodation to any patient, so that at the distal end an opening and closing mechanism is provided that allows emptying of the bladder when desired. 2 - MICTIONAL DYSFUNCTION CONTROLLER according to claim 1, characterized by the fact that it is made in different sizes, with its caliber ranging from 06 to 26 FR, which guarantees perfect adaptation to the most diverse anatomies and pathologies, including serving children, adults, the elderly and wheelchair users.

Images