CATHETERIZATION

FIELD OF THE INVENTION

[1] The present invention discloses an apparatus and method for the administration of topical anesthetic medicament to desensitize the urethral mucosal tissue prior to the catheterization. Particularly present invention divulges a syringe device(SD) consisting of a particulars terilized topical anesthetic medicament (TA) with exceptional anesthetic and antiseptic properties and a specially designed sterile applicator recognized as Urotip (UT) made of specialized thermoplastic elastomers (TPE) that supports the ease of administration of topical anesthetic gel into the urethral mucosal tissue for the most effective and effortless insertion of catheter to overcome the catheter related urinary bladder discomfort complications and further to minimize the additional procedures or use of antibiotics during intraurethral catheterization.

BACKGROUND OF THE INVENTION

[2] Intraurethral catheterization (IUC) is performed during general anesthesia, but it often leads to catheter-related bladder discomfort involving a burning sensation caused by irritation of the mucosa of the urinary tract and bladder due to the urinary catheter and is a conservative painful procedures while insertion of a Foley catheter through the urethra to the bladder for urinary drainage, for treating urinary retention, monitoring urinary output, and performing diagnostic studies. Moreover post operative catheter-related discomfort and pain at the time of catheter exchange and catheter traction results in inflammation, injury, trauma and ischemic necrosis to the mucosal tissue besides increased incidence of catheter- associated urinary tract infections.

[3] The first known urologic instruments were considered rather vicious when compared by today's standards. Catheters were used as early as 3,000 B.C. to relieve painful urinary retention. In those times, many materials were used to form a hollow catheter shape, including straw, rolled up palm leaves, hollow tops of onions, as well as, gold, silver, copper, brass, and lead upon the natural sources available. Malleable catheters were developed in the 11th century. In time, silver was used as the basis of catheters as it could be bent to any desired shape and was felt to have an antiseptic function. In 1930’s Dr. Frederick B Foley introduced the current interaction of modern day IUC which was made from latex rubber commonly referred as Foley catheter. Eventually the concept of closed sterile drainage system was introduced which reduced the risk of urinary tract infection (UTI) associated with lUC’s where the components includes a balloon retention catheter, pre-sealed connecting system that includes drainage bag.

[4] At present, the approach to intraurethral catheterization (IUC) remains the same today as it was in ancient times. It is the technique of passing a hollow, partially flexible tube through the urethra into the urinary bladder for the purposes of evading an obstructed urinary bladder or obtaining a sample of urine for analysis. Insertion of the catheter inside the urethra is specifically a difficult task as it is prone to trauma and pain. The important step while inserting the tip into the urethral meatus is to lubricate the tip of the catheter with a sterile lubricating gel, that help in smooth and painless insertion of the catheter into an orifice and also easier while removal of the catheter, further general process involves in advancing the catheter another 4 to 5 cm inside urethra until urine returns, then inflate the balloon with the sterile water and pull on the catheter gently to ensure that the balloon is in place, at this moment connect the catheter to the drainage bag for collection of urine. The balloon can then deflated when the catheter needs to be removed.

[5] In order to achieve a reduction in friction of medical devices such as catheters or probes or endoscopes with the skin or mucosa of the body found to be a remarkable chore in medical industry. Selection of right kind of subjective catheter and lubricant is essential so as to prevent skin irritations, pain and injuries due to the operative procedures or the catheterization. The utilization of erroneous catheter size, material and lubricants might worsen problems and result in reactions with the skin or mucosa of the interior and cause infections and health issues. However the use of impeccable catheter material and lubricants can minimize urethral trauma, risk of infection, and minimize pain and discomfort during the procedures, especially while using a lubricant containing local anesthetic.

[6] The biggest problem with the Foley catheter is with the tip of the catheter. The inability of insertion of catheter, and causation of tissue trauma during the insertion of catheter tip can cause amplitude damage to the lining of the bladder wall. This not only create a massive amount of pain and discomfort for the patient, but they also raise the risk of infections and even more life threatening ailments such as bladder cancer. Nevertheless, large variety of infections and traumas directly linked to catheterization which includes CAUTI (Catheter Associated Urinary Tract Infection), Cystitis, Bladder spasms, Urine blockages, Damage to the bladder wall through perforation and even penetration, Blood in the urine and patient distress levels etc. In conjunction with the major drawbacks of damaging effects associated with catheterization, the invasive nature and design of the traditional Foley catheter, is still a most widely used type of catheter as the users around the world have urbane to tolerate the discomfort, the pain and the constant infections caused by the catheter because the Foley catheter is the best choice of catheter for their situation. Hence a solution to the many problems caused by the discomforts of Foley catheter is to be resolved that can give relief to catheter users who have long awaited for a revolution in healthcare industry.

[7] An additional major drawbacks of the present procedure during IUC is when the gel is not properly instilled into the urethra or wiped off the catheter at the urethral introit us can cause non-anesthetic effect. Intraurethral topical anesthesia has been widely used and is effective in urological surgery but the incidence and treatment after other types of surgery in the post anesthesia care unit have been seldom reported. However despite of long tradition of local anesthesia in urology, there is scarcity of trials examining its effects on the pain of catheterization. To date there has been no effective pain reducing strategy for catheterization, except for symptomatic therapy that depends on analgesics to ease the patient’s anxiety.

[8] Catheters are made from various materials and coatings to improve their biocompatibility, ease of insertion and minimize infections. Nowadays the approach typically uses urethral catheters made of rubber, latex, polytetrafluoroethylene (Teflon), plastic (PVC) or silicone polymers. Latex, Teflon and rubber catheters were made by immersing the catheter into liquid latex to form a latex coating which causes allergy and irritationin most of the patients, while 100% silicone catheters are entirely free of latex with smooth surface and superiority in resistance, but were less flexible and rigid causing increased difficulty and uncomfortable during placement and following insertion. PVC based polymer catheters were less flexible but plasticizers such as DEHP (di (2- ethylhexyl) phthalamate) were major public health concerns that cause in vivo several problems. Ultimately, no single catheter material or type is best suitable for the patients suffering from urinary bladder complications across the board. This is because each person’s preferences, anatomies, and needs are different.

[9] Catheters are one of the most frequently used medical devices around the world, the primary key challenge is to develop innovative devices that facilitate the smooth insertion of catheter devising elasticity which also protect the mucosal layer of the urinary tract and reduce the risk of associated infections while diminishing the exploitation of incompatible, non-flexible and rigid catheter material which is a throbbing phase for most of the patients suffering since long period of time. Consequently to meet the rising demands of elevation in urinary tract complications in healthcare industry, the necessity to develop superlative catheters and allied devices for the procedure of catheterization in low cost, efficacy and superior quality is a key challenge.

[10] In general catheter lubricants comprising local anesthesia has been considered a widely accepted urological procedures for a standard practice of catheterization. Catheter lubricants are made of natural water-soluble jelly like substances applied on the outer surface of the catheter tip that helps in gentle process of insertion and removal of the catheter which subsequently reduce the risk of urethral trauma, discomfort and friction that in particular reduce infection, pain and mainly facilitates dilation of urethra. But the notable drawbacks with contemporary procedure is that, the gel may not properly instilled into the urethra or may wiped off the gel coating at the urethral introit us at the most and also the insufficient time allowed for consequential anesthetic effect results in distress, friction and non or inadequate local anesthetic effect at the site were reported. Aside urethra is a flattened convoluted tube with epithelial folds, making it prone to trauma on catheter insertion as the area contains a good blood and nerve supply. National guidelines of drugs recommends the usage of suitable lubricant from a single-use container while inserting urinary catheters to minimize the risk of infection and trauma to the urethra. With the various gels available with each containing different ingredients, it is still unclear whether an anesthetic or lubricating gel should be used.

[11] Historically, a 2% lidocaine anesthetic gel has been used in male catheterization but it was not until 1993 when de Courcy-Ireland (1993) identified it as a consideration for women. When lidocaine has been used in females, studies have shown varying success in comparison with lubricating gels (Chan et al, 2013). Muctar (1991) showed that use of a 2% anesthetic gel may reduce pain caused by involuntary movements in both male and female patients, while Chung et al (2007) later carried out a double-blinded experimental study, which showed that 2% lidocaine compared with lubricating gel reduced pain experience in females. These results were reproduced by Harmanli et al (2009). However, most of these studies identified limitations and some bias still.

[12] Patient develops multiple trauma or injuries to urethra if a lubricating or anesthetic gels when used in excessive amounts or over time due to the risk of increase in mucosal absorption that results in irritated and inflammable mucous membranes and other systemic side effects such as cardiac problems, hepatic problems, epilepsy etc., hence the gels must be applied in correct dosage to be effective without further complications.

[13] Thus, the present invention provides a solution to the underlying problems of the state of the art by providing a technical equipment or an apparatus which is feasible, eco-friendly, ergonomical, economical and industrially manageable device which is required for solving the aforementioned ensemble complications of IUC to replace the contemporary practice of catheterization employed for a long period of time. The innovative design comprises a syringe device consisting of a container that accommodates specified sterile topical anesthetic medicament, which connects with the sterile urotip applicator especially made of specialized thermoplastic elastomers to deliver the topical anesthetic medicament, which is a major advantage over the existing devices in the medical industry.

[14] The medical device incorporating a sterile urotip applicator composed of a specialized thermoplastic elastomers (TPE)know to be third generation rubber establishing technological revolution in rubber industry that combine many of the characteristics and properties of both vulcanized thermoset rubber and thermoplastic materials. Hence, they exhibits high elasticity of thermoset vulcanized rubber at room temperature and good processability of thermoplastic at high temperature. Because of the vulcanization is not required and the molding process is simple, the industrial production process of TPE is shortened by 25%, the energy consumption is saved by 25% to 40% and the efficiency is increased by 10 to 20 times compared with traditional thermoset vulcanized rubber, which can be called another technological revolution in the polymer industry. TPE can be processed and recycled for many times, saving the petroleum resources required for synthetic polymer materials and reducing environmental pollution.

[15] Thermoplastic elastomers (TPE) can be blended with various polymers such as polypropylene (PP), polyethylene (PE), polystyrene (PS). The blend shows excellent impact resistance, flexibility, and flexural properties. TPE has formed more than 30 varieties in 10 categories. The main varieties of TPE are thermoplastic styrene elastomer (SBC or TPS), thermoplastic polyolefin elastomer (TPO), thermoplastic polyurethane elastomer (TPU), thermoplastic polyester elastomer (TPEE), thermoplastic polyamide elastomer (TPAE), thermoplastic vulcanite (TPV), organo-fluorine elastomer (TPF), organic silicones, etc., covering almost all fields of synthetic rubber and synthetic resin. Most thermoplastic elastomers are co-polymers having rigid and flexible moieties in their back-bone. The synthesis of these elastomers achieved by the process of polymerization, results in a wide spectra of thermoplastic elastomers. There are imminent new varieties of TPE with specialized characteristics are under development to meet the needs of consumers inevitability to resist high temperature, high barrier properties, heat oil resistant and high insulating elastomers are industrialized. Medical device performance is largely dependent on the characteristics of the resins used. Medical-grade plastics can be engineered to have enhanced properties such as strength, flexibility, transparency, biocompatibility, and temperature and chemical resistance.

[16] The present invention discloses one of the specialized thermoplastic elastomers (TPE) which are chemically synthesized and blended by exhibiting high elasticity characteristic as vulcanized rubber at room temperature and good processibity property of thermoplastic at higher temperatures. Specialized TPE performed precisely at particular temperatures that results in producing a technologically advanced softerandmore flexible TPE material that provisions the significant molding of an anticipated applicator and these specialized TPE can be processed and recycled for many times saving petroleum resources required for the synthesis of polymer materials and reducing environmental pollution. Thus the present invention provides resolutions for the most of the contemporary difficulties allied in manufacturing of medical devices with TPE in the polymer industry.

[17] Prior art devices of this type have relied on different strategies of anesthetizing the site topically for intraurethral catheterization and others are discussed herein, In US Pat No. US6423038 illustrates a topical anesthetic device for intra uterine injection device is made of semi flexible silicon based elastomer material having an angle of curvature at the junction between hollow tube and injection device.

[18] The patent CN102805882A discloses soft tissue filler include hyalomitome acids that fix liquid in injected soft tissue filler several times, and fix liquid injects the diverse location of soft tissue filler at every turn.

[19] In US Pat No US20090131874device for application of lubricant, preferably in the form of gel, in an urethra so as to thereby facilitate the insertion of a medical instrument, such an urethral catheter or an endoscope, into the urethra, wherein the receptacle has the form of a dosing pipette, preferably a single dose pipette. ) being deformable, the lubricant from the lubricant-containing space can be squeezed out through the outlet opening of the sprout by compression of the gripping part with the fingers

[20] Patent no. W02019123004A1 ddiscloses a catheter comprising a catheter tube having a distal tip with a catheter tube distal opening to be inserted into a urethra of a female subject and a proximal tip having at least one catheter tube proximal opening; and a locator tip located proximal the distal tip of the catheter tube, wherein the locator tip is sized to remain outside a female urethra and configured to allow the catheter tube to pass there through.

[21] US Pat No US5671755A discloses A method for controlling unwanted discharge of urine, comprising the steps of: providing an applicator including an expandable body fixed thereto in a non-expanded condition; manipulating said applicator to insert said body into a urethra and to separate said applicator from said body, to permit said body to expand in the urethra; and withdrawing said body in its expanded condition from the urethra by pulling an appendage extending from said body and exteriorly of the urethra when discharge of urine is desired.

[22] Patent No WO1992007622A1 discloses an energy radiation applicator apparatus for treatment of benign hyperplasia, for connecting the applicator to a source of energy sufficient to elevate the temperature of tissue surrounding the applicator to a preselected temperature and for maintaining the preselected temperature during treatment; fluid receiving means surrounding the applicator so as to be positioned between the applicator and the tissue to be heated; and means for circulating cooling fluid through the fluid receiving means during heating of the tissue.

[23] However, none of the prior art has disclosed the method as proposed in the present invention. The present invention is exceptional as compared to the existing prior art as it describes the utilization of specialized thermoplastic elastomers which is a unique feature that gives highly flexible and elastic material for the safe, convenient and ease of administration of sterile urotip applicator into urethra with the help of syringe device containing of topical anesthetic medicament for the dissemination of drug during intrurethral catheterization, and this is a first kind of medical device in the healthcare facility to produce an urethral applicator feasible for the lubrication and anesthetization of urethra without the discomfort and distress during catheterization.

[24] Present invention primarily deliberates an establishment of an advanced customized technological design which isan effective, eco-friendly, convenient, and economically feasible device referred as ‘UROTIP’ to overcome the problem of discomfort and painful insertion procedure is particularly made of specific thermoplastic elastomers with improved characteristics to attain remarkable elasticity and flexibility for disseminating the topical anesthetic gel uniformly across the mucosal tissue of urethra to overcome the existing complications of IUC.

[25] Present invention also contemplates the limitations of current products in the market with respect to topical anesthetic gels in terms of sterility, dosage and delivery of the gel to desensitize the mucosal membranes of urethra prior to the insertion of a catheter. The specified topical anesthetic gel with improved properties, dosage and sterility lodging in the syringe container to transfer the gel through the sterile urotip applicator that mitigate the risks of urethral infection and reduce the need of additional procedure or use of antibiotic during catheterization.

SUMMARY OF THE INVENTION

[26] Present invention provides a topical anesthetic apparatus, a medical device for administration of a medicament prior to intraurethral catheterization. There are primarily three important components of the present device which includes a syringe device (SD), a sterile topical anesthetic medicament (TA) and a sterile urotip applicator (UT) situated between the proximal and distal end of the device for the delivery of the medicament.

[27] In an aspect of the present invention, a topical anesthetic device is an intricate device encompasses: (a) Syringe Device (SD) consisting of a hollow cylindrical container having an identifiable proximal end, distal end and sidewalls disposed between such ends providing inner surface to accommodate sterile medicament having a syringe opening at the distal end that firmly connects with the urotip applicator and a piston at the proximal end that is positioned to push and release pressure to deliver the medicament into the urotip applicator (b) a sterile Topical Anesthetic(TA) medicament in particular formulation with improved anesthetic and antiseptic properties accommodates the syringe container (c) sterile Uro tip Applicator (UT) positioned firmly at the distal end of the syringe device connecting to the syringe opening intimately that provides ideal grip to the urotip applicator to disseminate the medicament into the urethra such that the medicament reaches and desensitize the internal mucosal surface of the urethra prior to the insertion of catheter during catheterization.

[28] Conversely, industrializing the medical device is a diversified practice as it requires the skill and knowledge of various medical procedures and associated obstacles to assemble and construct a practical device that is beneficial and replaces the longstanding practice of routine medical method which is laborious, unhygienic, cost effective and antagonistic exercise in the medical industry since centuries designed for IUC. However the present invention solves the existing problem by manufacturing domicile comprehensive apparatus by designing the integral components of the device by simplifying and standardizing the traditional production process with specialized establishments.

[29] In an aspect of the present invention, the medical device comprising a sterile urotip applicator precisely made of specialized TPE are designed for maximum elasticity where blended with various polymers such as polypropylene, polyethylene, polystyrene but not polyurethane. Basically, a distinction is made between reactor-made TPEs (e.g. TPA, TPU, and TPC) and TPE compounds (e.g. TPS and TPV). The properties of reactor- made TPEs are implemented in one polymer. The properties of TPE blends result from mixing different polymers to form a so-called compound. The Blend shows an excellent control on resistance, elasticity and flexural or bendable properties. The TPE material has excellent processing characteristics and can be processed using a standard thermoplastic fabricating methods. There is a very less energy is used for production of these elastomers within short duration along with cost competence.

[30] The present invention utilizes the specialized TPE in combination of vulcanized rubbers with the processing properties of thermoplastics, delivering an innovative design by molding and producing an urotip applicator which exhibits typical and unique properties such as refined flexibility and elasticity, superior soft quality, excellent resistance to various medicaments over the existing range of products in the curative global market. The thermal and mechanical properties of the TPE formulations are designed effectively to produce a strong replacement for PVC and are fully recyclable, thus fulfil environmental requirements and are completely synthetic and latex free thereby minimizing allergy risks and considered as obligatory material indemnifying a standardized, toxicological, biological and customized substantial of polymer industry.

[31] In an aspect of the present invention, the manufacturing process of urotip applicator is characterised by the unique properties of the specialised thermoplastic elastomers which normally consists of two polymers, a polymer (thermoplastic in nature) that is frozen at particular temperature and a polymer (rubber) that is in molten state at a particular temperature of procedure. The raw materials used are proven level of biocompatibility, the rubber polymer has been selected from from a series of rubbers where representative grades have passed USP (United States Pharmacopeia) Class VI and polypropylene selected from medical grade USP Class VI category and paraffinic oil, a medicinal white oil complying with the EP (European Pharmacopeia) for liquid paraffin and USP 24 for mineral oils where components used in manufacturing process of medical device qualifies biocompatibility testing requirements such as, an intracutaneous irritation, subacute toxicity and implantation tests or effects of regulatory compliance.

[32] In general, the TPE frozen polymer forms bonds using physical cohesion forces. By heating, the frozen polymer is molten and a product can be shaped can therefore be processed and shaped in the same way as the thermoplastics. TPE is characterized by the fact that the material becomes fluid when heating and then is going back to a solid phase when cooling. Thereby rubber-like products can be manufactured by the use of plastic processing equipment. The main processes used for molding thermoplastic elastomers are Extrusion and Injection moulding other than Calendaring, Blow moulding and Melt calendaring. The general process involves melting temperature for most of TPE materials in a range from 160 to 240 °C and that temperature has to be reached before the material is passing the extruder head. The barrel has normally at least three temperature zones with separate temperature regulation. The temperature is increased with some 20 to 30 °C in each zone with the highest temperature at the end of the screw and in the extruder head. From the extruder head the product is going into a cooling bath where the molding temperatures generally range from 15 to 60 °C and will quickly be cold to room temperature with water, often after passing a calibration plate, and winded up. The material is injected into the mold when the pressure is in the range of 50 - 150 Pascal and the injection time is normally below 15 seconds for smaller moulding parts. Scraped products, i.e. with dimension faults, can be granulated and recirculated into the extruder.

[33] The present invention comprising of specialized TPE material has excellent processing characteristics and is processed using standard thermoplastic constructing methods including injection moulding and extrusion. The processing melting cylinder temperatures of injection moulding and extrusion are in the range of 180 to 220°C and 150 to 210°C respectively whereas the molding temperature recommendations are generally ranged between 25 to 45 °C. In the current invention an attempt was made by rapidly decreasing the molding temperatures and surprisingly at 18°C by providing the moldwith an adequate cooling channels to give temperature control, allowing heat to dissipate quickly and uniformly and ensuring short cycle times where the mold promulgated into significant flexible and high elasticity composite which is contrary to the existing knowledge.

[34] The other distinctive phases of the present invention while processing with the injection moulding includes the maintenance of injection pressures ranged from 200-1000 bar depending on the size and weight of the piece for smooth and uniform filling of the mold with an injection rate of 1 - 2 seconds. The optimum hold pressure is 40 - 60% of the injection pressure for determining the solidification point. The higher back pressures are maintained at 3- 5 bar for the color batches are used to ensure that no leakage occur in the mold after the shot. Open nozzle is suitable for processing with screw retraction and the screw made of standard polyolefin. The softer compounds generally give a lower output at increased backpressure. The frictional heat is lowest on the softer grades and increases substantially on harder grades. The absolute product is dried for 2 hours at 50°C while surface moisture forms due to the changes in temperatures and predrying is not necessary since they do not absorb moisture under normal storage conditions. [35] In an aspect of the present invention, the urotip device comprising specialized TPE’s alongside produce material advantages because of the cost and speed of manufacturing process, and TPEs are being specified as an alternative to thermoset rubber. It involves fewer process steps without the need for additional operations utilizing less energy, faster production and more cost efficient. TPE’s have lower specific gravity compared to alternative materials, hence can create numerous lighter weight parts by increasing the per gram production of the material.

[36] The surprising finding of the molding at more cooler temperature at 18°C is a key feature of the present invention that gives a more softer quality, highly flexible and elasticized product over the preexisting components and the process of manufacturing TPE’s at the preferred 18°C mold temperature supports in production of the device in preferred shape and consistency that causes less injury to the mucosal tissue of urethra and smooth ease of administration without pain or discomfort. Whereas the process of manufacturing silicon based catheters is very difficult and silicon catheters are not practicable with the skin or mucosa and continuous friction of the silicon material at urethral site may damage the bladder wall and may lead to cancer.

[37] In an aspect of the present invention, the medicament used in the syringe container is commonly an anesthetic agent in various percentages topically administered to mucous membranes of urethra and its rate and extent of absorption depending upon the concentration of total dose administered at the specific site of application and duration of exposure. Excessive dosage or short intervals between doses, can result increase in high plasma levels and serious adverse effects. The most common anesthetic agent used in the topical administration is Lidocaine HCL 2% gel. The safety and effectiveness of lidocaine depend on proper dosage, correct technique, and adequate precautions. The lowest dosage that results in effective anesthesia should be used. The dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance, and the technique of anesthesia. The incidence of adverse effects is directly proportional to the total dose of local anesthetic agent administered. Prior to catheterization, smaller volumes of 5 to 10 mL (100 to 200 mg) are usually adequate for lubrication.

[38] The present invention exclusively validates the dosage of the topical anesthetic medicament in sterile condition, where the combination of pharmaceutical composition containing lignocaine (A) in 2.5% and prilocaine (B) in 2.5% of weight portion with an addition of pH adjusting compositions and other combinations of formulations that resulted in an excellent anesthetics drug composition for desensitizing the urethral site within 3 to 5 minutes of time duration, and the dosage used is also in smaller volumes approximately 5 to 10 ml for adequate lubrication prior to catheterization. Thus the present invention solves the risks associated with the urethral infections by exploitation of disposable prefilled syringe device containing sterilized anesthetic gel and the delivery of the gel is progressed with an appropriate sterile disposable applicator that can be inserted directly into urethra to avoid the maximum risk of urethral tract infections and cross contamination while insertion of catheter into urethra, and also the doses are pre-determined that reduces the risk of instilling the higher dose and its adverse side effects.

[39] Thus, the present invention provides a solution to the underlying problem of the state of art by providing a standard medical device by developing an improved sterilized urotip applicator with specialized TPE that is attained at certain temperature by molding the TPE material into the production of highly flexible and substantial elasticity properties of device that solved numerous contemporary problems during catheterization. The flexibility and elasticity of the device is achieved surprisingly by rapid decreasing of the moulding temperature to 18 °C uniformly to get the fine elastic and flexible product that is significantly useful for the insertion and dissemination of particular topical anesthetic gel into urethra without any discomfort and distress and other side complications to the patients during catheterization.

[40] The present invention summarizes the advantages of the medical device sterile urotip applicator and precise topical anesthetic gel or medicament that recognizes and resolves the limitations of the existing products in healthcare facilities; by mitigating the risks of urethral infection and practice of high dosage by providing a readily available prefilled syringe with sterile gel or medicament with appropriate labelled dosage that reduces the need of additional procedure of antibiotic which is a major problem among the healthcare personnel to transfer the gel into a disposable syringe prior to catheter insertion and also resolves the problem of administration of over usage of drug. The present invention also resolves the major problem of delivery of the gel into the urethra by developing an appropriate sterile disposable applicator ‘urotip’ which is soft, flexible with high elasticity to deliver the gel or medicament having both antiseptic and lubricating properties that can be inserted directly into urethra without any discomfort and pain to the patient.

DETAILED DESCRIPTION OF PRESENT INVENTION

[41] It is to be understood that the present disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description. The present disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. Also it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting.

[42] The use of “including”, “comprising”, or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. The terms “a”, and “an” herein do not denote limitations of quantity, but rather denote the presence of at least one of the referenced item.

[43] The present disclosure is not to be limited in scope by the specific embodiments described herein, which are intended for the purposes of exemplification only. Functionally-equivalent products, devices, and methods are clearly within the scope of the disclosure, as described herein.

[44] Those skilled in the art will be aware that the present disclosure is subject to variations and modifications other than those specifically described. It is to be understood that the present disclosure includes all such variations and modifications. The disclosure also includes all such components, features, parts, and operations referred to or indicated in this specification, individually or collectively, any and all combinations of any or more of such steps or features.

[45] In an aspect of the present invention, thermoplastic elastomers are used across a wide range of industries. In addition to their ability to hold intricate designs and forms, these materials have unique attributes such as weathering and impact resistance that make them ideal for long-term industrial use.

[46] In general, manufacturers use processes, such as extrusion, injection molding, and thermoforming, to transform thermoplastics into finished goods. The general procedure including injection molding and extrusion for the production of thermoplastic elastomer molds involves blending base polymers with other materials or additives in order to achieve desired characteristics like durability, heat seal strength, high impact resistance, color, better flexibility, UV resistance, tensile strength and electrical conductivity whereas, Injection molding is one of the methods by which melted thermoplastics are formed into finished parts and products. During injection molding operations, manufacturers inject metal molds with the viscous liquid. The liquid fills the hollow shape of the mold and, after a sufficient cooling period, is ejected as a set plastic form and plastic extrusion is the process of transforming solid plastic into a shaped product. In contrast to injection molding, which is an intermittent discontinuous process, extrusion is a continuous manufacturing process. Typically, plastic is melted down and pressed into the desired shape and then cooled before experiencing other potential secondary extrusion sub-processes, such as blown, sheet or cast film, profile, pelletizing etc.

[47] In general, thermoplastic elastomers are melted (and re-melted) for subsequent processing operations. As these materials melt at higher temperatures and harden at cooler temperatures, they can be heated, formed, mixed with additives, and cooled into their final shape. Injection molding process is the most commonly used manufacturing process for the manufacture of plastic parts. It is so popular because of its ability to create a wide variety of items of differing sizes, shapes, and complexities. Injection molding is essentially a three-step process involving the following steps; Injection. Cooling and Ejection.

[48] Generally, the temperature of the melt can be anywhere between 200 to 300°C (392 to 572°F) and cools down to about 60°C ( 140°F) after being removed from the cavity (which absorbs most of the heat). The cooling time can take up to 60 percent of the entire cycle time. It ends when the molded part is hard enough to be ejected from the mold while leaving little or no residual plastic.

[49] Corresponding to the many industrial processes, temperature control is a critical consideration in injection molding and extrusion. Effective temperature control prevents quality issues such as shrinkage, warping and stresses developing in the material. The critical technical objective of the process is to find a balance among the temperature of the cooling fluid, the rate of mold cooling, and the quality of the final product.

[50] Many manufacturers use cooling tower water to cool the small channels within the mold with a temperature regulator attached to the injection-molding machine, regulating its temperature. While this technique is effective and incurs a lower operating cost, the mold will be prone to contamination. Cooling towers are openloop systems. By contrast, an industrial chiller can be used to regulate the temperature via closed-loop cooling, ensuring a higher degree of product purity.

[51] When plastics for the injection-molding process are being heated and mixed inside a machine, a specific temperature limit must be maintained as the temperature of the process will directly impact the quality of the final mixture. If the temperature is too low, the components may not mix properly. Alternately, when the temperature is too high, the mixture might become burned. Thus, there is typically an ideal point, or a prescribed temperature at which the process must be maintained.

[52] The temperature of the mold is another essential consideration that affects the quality of the injection-molded part. The best quality of the mold is obtained by a balance between heating the mixture sufficiently to create a homogeneous mixture and cooling it down at an ideal rate. Anything else would be undercooling or overcooling and affect the improper polymer flow which is a direct consequence issue in injection molding. When the mixture is not cooled sufficiently, it may not solidify completely before being ejected. This may leave residual plastic in the mold.

[53] Conversely, excessive cooling causes a lack of uniformity in the plastic material. This may cause further problems down the line such as shearing, cracking and cavities that do not fill up completely. Maintaining the mold temperature at a set temperature will yield the most optimum results. Close tolerance temperature control units can be used with industrial chiller systems to provide close temperature tolerances for process water. The close tolerance temperature control units come in varying flow variations and configurations and standard models have a pump and heat exchanger with a jacketed tank or a heat exchanger ensuring a stable injection-molding process without catastrophic freezing failures.

[54] For many years, thermoplastic manufacturers are working hard to develop unique highly engineered thermoplastic materials with specific standards and multiple applications and are using different processes for better working polymers to provide best possible thermoplastic solutions to the consumers. Amongst the thermoplastic establishments, below mentioned exemplified manufactures developed a high range of thermoplastic elastomers (TPE) for manufacturing of single-use syringe devices and other medical compounds by following a specific process individually for developing highly engineered thermoplastic molds.

EXAMPLE 1:

[55] Mediprene thermoplastic elastomers (TPE) were developed by Hexpol to provide a leak-proof plunger seal with the syringe barrel for single-use syringes by using a right TPE formulation which is the key to a safe and successful medical product. The material has excellent processing characteristics and processed using standard thermoplastic fabricating methods, including injection moulding and extrusion. All Mediprene TPE Syringe Plunger Series compounds fulfil a strict raw material selection policy and copolymer polypropylene has passed USP Class VI and meets the requirements in the EP Monograph 3.1.3 Polyolefin, however Mediprene grades are not suitable to use in any devices or materials intended for implantation in the human body.

[56] Mediprene, TPE processing combine the processability of a thermoplastic with the performance characteristics of thermoset rubber. The geometry, surface finish and processing method specified for the application, together with the type of material chosen, determine the final properties of the product. The mechanism involves fewer process steps, without the need for additional operations such as trimming which means less energy is used and production is faster and more costefficient. Mediprene TPEs have a lower specific gravity to create lighter-weight parts, and also produce more parts per kilogram of material. The Service Temperature Range from -50 to +125°C (unstressed material) and the processing temperatures involves Barrel Temperature as 180-220°C and 150-210°C in Injection Moulding and Extrusion process respectively, whereas the Mould Temperatures ranged from 20 - 50°C in both the processes which is an ideal temperature for obtaining the specified product.

EXAMPLE 2:

[57] Thermoplast TPE compounds especially developed by KRAIBURG provides the products with exceptional elasticity, thermoplastic processing, and flexibility, also tested according to ISO 10993-5 (Cytotoxicity). The processing methods include Extrusion and Injection Molding. The mechanical properties of medical compounds such as hardness, density, tensile strength, tear resistance are tested according to described medical basic approvals: USP Class VI (chapter 88), USP 661 (in vitro), ISO 10993-4 (Haemolysis, indirect in human blood), ISO 10993-10 (Intracutaneous Irritation) and ISO 10993-11 (Acute Systemic Toxicity). However, there are no changes in formulation or process (except of necessary adjustments e.g. due to new regulations).

[58] Thermoplast TPE, manufacturing guidelines includes injection moulding and extrusion processes that involves definite phases throughout the procedure were specified such as, cylinder temperatures ranged from 180-220°C and 160-200°C respectively, Hot runner temperatures are 200-250°C (390 - 480 °F), Injection pressure 200 - 1000 bar (2900 - 14504 psi), Injection rate of 1-2 seconds. The hold pressure for determining the solidification point, starting with 40 % - 60 % of the required injection pressure. Back pressure of 20 - 100 bar; Mold temperature range from 25 - 40 °C (77 - 104 °F), if surface moisture forms as a result of changes in temperature, the material should be dried for 2 - 4 hours at 60 - 80 °C (140° F) that intended to provide custom-engineered thermoplastic materials or molds.

ADVANTAGES OF THE PRESENT INVENTION:

[59] The present invention is a key challenge in the medical industry by developing a specialized TPE with improved characteristics and properties to enhance the TPE processing by blending the base polymers with other material and additives molded at particular temperatures and pressures in order to get an improved TPE material with an exceptional flexible and elastic properties to obtain an enormously softer product useful for solving the underlying problem in the healthcare industry by producing an upgraded sterile urotip applicator that solved numerous contemporary problems during catheterization that is significantly useful for the insertion and dissemination of topical anesthetic gel into urethra without causing injury, distress and discomfort because of the production of softer liable product obtained by specialized TPE.

[60] The specialized TPE with desirable properties were obtained surprisingly with certain changes in the reference guidelines obtained by the above exemplified manufacturers by altering the grades of processing methods of injection molding and extrusion. In particular to the injection moulding process, the general recommendations for molding temperature of Thermoplast TPE was 25 - 45°C and Mediprene was 20-50°C, In contrary to the existing knowledge and general processing molding temperature range (15-60°C), the present invention surprisingly found a superior quality product with improved flexibility, elasticity and softness which is achieved merely by reducing the mold temperature to 18°C in cold runner mould with back pressure of 3 to 5 bar and by pre-drying the mold at 50°C for 2 hours to obtain a liable product with proper consistency and shape. The product also accomplished with mechanical properties of medical compounds such as hardness, density, tensile strength and tear resistance.

[61] The present invention is a new finding in the medical industry in the field of intra urethral topical anesthetic devices with improved characteristics and biocompatibility. The medical apparatus with superior softer quality with sterility of the urotip applicator and topical anesthetic gel is an innovative mechanism in healthcare system that resolves the underlying problem since ages while disseminating the topical anesthetic gel into urethra during catheterization that governs numerous impediments and sufferings by the patients.

[62] The present invention exclusively validates the dosage of the topical anaesthetic medicament in sterile condition, where the combination of pharmaceutical composition containing lignocaine (A) in 2.5% and prilocaine (B) in 2.5% of weight portion with an addition of pH adjusting compositions and other combinations of formulations that resulted in an excellent anaesthetics drug composition for desensitizing the urethral site within 3 to 5 minutes of time duration, and the dosage used is also in smaller volumes approximately 5 to 10 ml for adequate lubrication prior to catheterization.

[63] The present invention, an augmented medical device with sterile urotip applicator through specialized TPE with sterile specified topical anesthetic gel readily considered into clinical trials and construct discovered as healthier and upgraded medical device with conceded results in clinical studies.

EVALUATION OF “VIRCHOW’S MEDICAL DEVICE” WITH MARKETED DEVICES

[64] The present invented medical device sterile urotip applicator with specialized TPE is evaluated and compared with the manufacturing processes of indicated marketed TPE mold process in terms of Cylinder Temperatures, Mold Temperature, Back Pressure, Pre-Drying Temperature and Time through injection molding method and the differentiation is tabulated as below: