Description:FIELD OF THE INVENTION
The present invention relates to the field of medical science, and more particularly, the present invention relates to the Bladder assistance for radiotherapy [BART].
BACKGROUND FOR THE INVENTION:
The following discussion of the background to the invention is intended to facilitate an understanding of the present invention. However, it should be appreciated that the discussion is not an acknowledgment or admission that any of the material referred to was published, known, or part of the common general knowledge in any jurisdiction as of the priority date of the application. The details provided herein the background if belongs to any publication is taken only as a reference for describing the problems, in general terminologies or principles or both of science and technology in the associated prior art.
Urinary bladder is an anatomical structure located in the pelvis of the human body. Cancer of urinary bladder is affecting about 500,00 people every year. Treatment modality includes the use of radiotherapy among most patients. Radiotherapy to urinary bladder has many technical considerations. Its changing size based on filling, its proximity with other pelvic structure-like rectum, prostate [in males] and vagina, uterus [in females] poses challenges to plan and deliver radiotherapy [RT]. Attempt to deliver consistent and safe dose to the target part is leading to use of image guided radiotherapy, using empty bladder as target organ and using approximately equally filled bladder by advising fixing fluid intake before scheduled radiotherapy. All these methods are still inconsistent and IGRT is a technically advanced way requiring robust finance. Similar consideration of consistent bladder volume is desired for radiotherapy to prostate, cervix or other nearby structures.
Radiotehrapy to urinary bladder is required in malignancy of urinary bladder and other malignancies involving urinary bladder as extension of primary tumor. Radiotherapy to prostate or cervix also requires a consistent bladder volume. Delivering a fixed dose to the target volume of bladder requires bladder immobilization and consistent volume holding. Variation in bladder volume can lead to displacement of predesigned target volume, requiring re adjustment of field of RT. IGRT technique and daily contouring is being used to adjust the delivery area and volume for maintaining dose consistency, however IGRT is an expansive modality. The need to make a bladder consistent for a given volume has been attempted by making it empty before RT as well as arbitrary making it full with urine after a fixed volume of fluid intake.
Radiotherapy to urinary bladder and adjacent organ [prostate, cervix] requires a consistent volume of bladder and its possible separation from adjoining structures. These make radiotherapy safe and effective. While emptying urinary bladder before each delivery of radiotherapy fraction makes it consistent, it increases the vicinity of other pelvic organ to bladder, making it vulnerable for RT side effects. Standard practice if to use image guided radiotherapy [IGRT] with daily contouring for change in bladder shape. In centers with no IGRT or where affordability is an issue, other ways of making RT safe are by daily contouring and adopting either an empty bladder or an approximately consistently filled bladder by asking patient to drink fixed amount of fluid before RT sessions. These methods are arbitrary and rely more on pre-session contouring.
Bladder filling protocols- patients are asked to pass urine and the drink a fixed volume of water, assuming that after a time interval, equal amount of urine will be present in bladder, making it consistent. However, Braide et al. evaluated two bladders filling protocol and found none of them was giving consistent volume for RT.
Ultrasound scanning for bladder volume and biofeedback to decide for the fluid intake has been tried as well but failed to find a consistent volume of bladder. Although this biofeedback mechanism made a better bladder volume consistency as compared to control group with no biofeedback intervention, this is not suitable to decide RT planning.
Empty bladder protocol uses consistency of bladder volume by voiding just before RT. It has been done in carcinoma prostate cases and shown to be equally effective as of full bladder protocol. However, for urinary bladder, an empty bladder is less desired as it distort the target volume and increase risk of radiotherapy toxicity to nearby organs.
In light of the foregoing, there is a need for the Bladder assistance for radiotherapy [BART] that overcomes problems prevalent in the prior art.
OBJECTS OF THE INVENTION:
Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows.
The principal object of the present invention is to overcome the disadvantages of the prior art by providing the Bladder assistance for radiotherapy [BART] that is a simple urinary bladder catheter having a proximal inflatable bulb and three drainage port at base of bulb allowing a consistent volume filling up of bladder by bulb while urine is being drained out by drainage system at base of bulb.
An object of the present invention is to provide the Bladder assistance for radiotherapy [BART] that provides a simple and easy way to stabilize urinary bladder volume while radiotherapy is being done.
Another object of the present invention is to provide the Bladder assistance for radiotherapy [BART] that makes bladder full with consistent volume thus addressing issues of various RT preparations.
Other objects and advantages of the present disclosure will be more apparent from the following description, which is not intended to limit the scope of the present disclosure.
SUMMARY OF THE INVENTION:
The present invention provides Bladder assistance for radiotherapy [BART].
BART is a urinary bladder catheter which has a proximal inflatable bulb which expanded to a desired volume once fluid is pushed to it from distal end. This end is having a press valve making pushing fluid and removing it easy without leak. It has three openings at the base of an inflatable bulb which drains to a single channel at the distal end. These openings drain the urine from the urinary bladder. This device makes the urinary bladder- a) consistently filled with a pre-defined volume of water/ fluid and -b) drain all urine effectively thus making the bladder volume consistent. The distal end of urinary drainage system has attachment for collection bag.
This invention is a mechanical designed instrument that has therapeutic use of making urinary bladder a consistent volume bladder for RT. It has an intravesical part and an extra-vesicals part.
Intravesical part- It has two parts.
A] a inflatable bulb. It is a silicon based inflatable bulb attached to the proximal end of the catheter. It inflates by pushing fluid from the distal end, which has valve attached preventing leaks of fluid and allowing pushing fluid or taking it out by pressing it with syringe to do so.
B] three small openings are present at the base of an inflatable bulb which joins distally to make a single outgoing channel. IT has no valves, and it drains the vesicle urine.
Extravesical part - It has a silicon tube with a press- valve at the distal end. Another channel of draining urine is also embedded along with the outgoing tube. At the distal end, the drainage channel makes another tube, and it drains to the urinary drainage bag.

BRIEF DESCRIPTION OF DRAWINGS:
Reference will be made to embodiments of the invention, examples of which may be illustrated in accompanying figures. These figures are intended to be illustrative, not limiting. Although the invention is generally described in the context of these embodiments, it should be understood that it is not intended to limit the scope of the invention to these particular embodiments.
Figures 1, 2, and 3: show Bladder assistance for radiotherapy [BART].
DETAILED DESCRIPTION OF DRAWINGS:
While the present invention is described herein by way of example using embodiments and illustrative drawings, those skilled in the art will recognize that the invention is not limited to the embodiments of drawing or drawings described and are not intended to represent the scale of the various components. Further, some components that may form a part of the invention may not be illustrated in certain figures, for ease of illustration, and such omissions do not limit the embodiments outlined in any way. It should be understood that the drawings and the detailed description thereto are not intended to limit the invention to the particular form disclosed, but on the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the scope of the present invention as defined by the appended claim.
As used throughout this description, the word "may" is used in a permissive sense (i.e. meaning having the potential to), rather than the mandatory sense, (i.e. meaning must). Further, the words "a" or "an" mean "at least one” and the word “plurality” means “one or more” unless otherwise mentioned. Furthermore, the terminology and phraseology used herein are solely used for descriptive purposes and should not be construed as limiting in scope. Language such as "including," "comprising," "having," "containing," or "involving," and variations thereof, is intended to be broad and encompass the subject matter listed thereafter, equivalents, and additional subject matter not recited, and is not intended to exclude other additives, components, integers, or steps. Likewise, the term "comprising" is considered synonymous with the terms "including" or "containing" for applicable legal purposes. Any discussion of documents, acts, materials, devices, articles, and the like are included in the specification solely for the purpose of providing a context for the present invention. It is not suggested or represented that any or all these matters form part of the prior art base or were common general knowledge in the field relevant to the present invention.
In this disclosure, whenever a composition or an element or a group of elements is preceded with the transitional phrase “comprising”, it is understood that we also contemplate the same composition, element, or group of elements with transitional phrases “consisting of”, “consisting”, “selected from the group of consisting of, “including”, or “is” preceding the recitation of the composition, element or group of elements and vice versa.
The present invention is described hereinafter by various embodiments with reference to the accompanying drawing, wherein reference numerals used in the accompanying drawing correspond to the like elements throughout the description. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiment set forth herein. Rather, the embodiment is provided so that this disclosure will be thorough and complete and will fully convey the scope of the invention to those skilled in the art. In the following detailed description, numeric values and ranges are provided for various aspects of the implementations described. These values and ranges are to be treated as examples only and are not intended to limit the scope of the claims. In addition, several materials are identified as suitable for various facets of the implementations. These materials are to be treated as exemplary and are not intended to limit the scope of the invention.
The present invention provides Bladder assistance for radiotherapy [BART].
BART is a urinary bladder catheter which has a proximal inflatable bulb which expanded to a desired volume once fluid is pushed to it from distal end. This end is having a press valve making pushing fluid and removing it easy without leak. It has three openings at the base of an inflatable bulb which drains to a single channel at the distal end. These openings drain the urine from the urinary bladder. This device makes the urinary bladder- a) consistently filled with a pre-defined volume of water/ fluid and -b) drain all urine effectively thus making the bladder volume consistent. The distal end of urinary drainage system has attachment for collection bag.
This invention is a mechanical designed instrument that has therapeutic use of making urinary bladder a consistent volume bladder for RT. It has an intravesical part and an extra-vesicals part.
Intravesical part- It has two parts.
A] a inflatable bulb. It is a silicon based inflatable bulb attached to the proximal end of the catheter. It inflates by pushing fluid from the distal end, which has valve attached preventing leaks of fluid and allowing pushing fluid or taking it out by pressing it with syringe to do so.
B] three small openings are present at the base of an inflatable bulb which joins distally to make a single outgoing channel. IT has no valves, and it drains the vesicle urine.
Extravesical part - It has a silicon tube with a press- valve at the distal end. Another channel of draining urine is also embedded along with the outgoing tube. At the distal end, the drainage channel makes another tube, and it drains to the urinary drainage bag.
Proposed device has following advantages over existing methods for making urinary bladder volume consistent for RT
It is making a full bladder approach doable with fixed and consistent volume
It drains urine from the bladder which can cause volume fluctuations
It has very simple mechanism, easy to handle and not requiring extra training or caution in movement of patient.
It is cheap and can be produced at nominal cost.
Proposed Device is likely to have several advantages over existing devices.
Features
Nasser - Zelefsky Catheter
Empty Baldder Protocol
Bart Bladder Assistance for Radiotherapy
Size/portability
Small catheter
No device can be emptied by voiding or by intermittent catheterization
Small catheter, comparable size to other urinary catheters
Cost
Not disclosed

Expected to be at par with urinary catheter
Ease of placement
Need minimal training to fill two different ballons, one with fluid and the other with air

Minimal training similar to urinary catheter, only one bulb to inflate
Device principle
It works on float valve mechanism, allowing surplus volume to drain
Suture based; displacement risk high
It drains all urine thus allowing consistent fixed volume in bladder
Volume consistency
Consistent
Consistent
Consistent
Nearby organ risk
Minimal
More
Minimal

Differences from existing patented/ published devices - Nasser - Zelefsky catheter ?? it has two balloons; one is water filled which stay in bladder while the other is air filled which floats on the urine in bladder. Once a certain volume is reached, it will float high and allow drainage of extra volume outside by opening the valve. It requires gradual filling up of bladder initially to reach to threshold level of urine.
The disclosure has been described with reference to the accompanying embodiments herein and the various features and advantageous details thereof are explained with reference to the non-limiting embodiments in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein.
The foregoing description of the specific embodiments so fully revealed the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the scope of the embodiments as described herein.
, Claims:A bladder assistance device for radiotherapy (BART), the device comprising:
a urinary bladder catheter having a proximal inflatable bulb, wherein the bulb is configured to expand to a predetermined volume upon fluid introduction through a distal end;
a press valve at the distal end for enabling controlled fluid introduction and removal without leakage;
drainage ports located at a base of the inflatable bulb, the ports converging into a single drainage channel extending to the distal end; and
a drainage system connected to the distal end for urine collection.
The device as claimed in claim 1, wherein the proximal inflatable bulb is made of silicone material to ensure biocompatibility and durability.
The device as claimed in claim 1, wherein the press valve allows operation with a syringe for introducing or withdrawing fluid from the inflatable bulb.
The device as claimed in claim 1, wherein the drainage system comprises:
a flexible silicone tube forming the drainage channel; and
a connector at the distal end for attachment to a urinary drainage bag.
The device as claimed in claim 1, wherein the three drainage ports at the base of the inflatable bulb are positioned to ensure effective urine drainage from the bladder, minimizing residual volume.
A method for a bladder assistance device for radiotherapy, the method comprising:
inserting the catheter into the urinary bladder of a patient;
inflating the proximal bulb to a predefined volume using a fluid introduced through the press valve at the distal end;
maintaining consistent bladder volume during radiotherapy by ensuring continuous urine drainage through the drainage ports and channel; and
collecting the drained urine in a urinary drainage bag attached to the distal end.