Disposable colonoscopy examination kit with the ability to simultaneously wash the colon and insert a colonoscopy camera

Abstract

Disposable colonoscopy diagnostic examination kit with the ability to simultaneously wash the colon and insert a colonoscopy camera. Existing instruments, due to their material and geometric shape, cause complications and injuries to the patient, require anesthesia for the patient, and the instrument must be sterilized, and also do not have the ability to simultaneously wash and insert a colonoscopy camera.\nThe present design is a disposable contact kit made of unbreakable transparent plastic that includes a main tube with a three-way crossover. The head of the main tube is inserted into the patient's rectum with the help of a trailing almond-shaped piece soaked in lubricating gel, and then the speculum set with a parabolic opening shape soaked in lubricating gel is inserted into the rectum with a linear movement on the main tube, keeping the rectal opening open to the required size and locking it in place by releasing the cylinder lock. Then the almond-shaped piece is removed from the end of the main tube and the intestine is cleaned through the three-way connection of the main tube, which includes a thin tube for injecting disinfectants and washing agents and another tube for emptying intestinal waste. Finally, The colonoscopy camera guide hose is connected to the end of the main tube through a swivel joint, and the colonoscopy camera enters the colon by passing through this hose.

Description

Description of the invention Title of the invention Disposable colonoscopy examination kit with the ability to simultaneously wash the colon and insert a colonoscopy camera. Disposable colonoscopy examination kit with the ability to simultaneously wash the colon and insert the colonoscopy camera. Technical background of the relevant invention Medical field as a colonoscopy diagnostic examination kit, diagnosis of colon diseases (cancer, bleeding, rupture, etc.) Technical problem and stating the objectives of the invention The current rectal speculum used in medical centers is made of steel, which imposes high costs on medical centers and ultimately on patients in the preparation and maintenance of this device after each use. If the slightest mistake is made in the maintenance and disinfection instructions, it can cause the transmission and occurrence of diseases in clients. (Figure 1) Given the public's acceptance of disposable sanitary products, which has resulted from the increase in awareness of health, this issue has increased. In addition to ensuring hygiene in medical centers, this issue also accelerates the diagnosis and treatment of patients. This advantage will also prevent the spread of viral diseases. The disposable type of this device is produced, which is not used and welcomed due to its fragility, so it is proposed to produce this device with special materials and its biodegradable nature, which also helps to protect the environment. In the present design, the said device has been subjected to static and dynamic analysis, and based on the anatomy of the human body and the strength of the rectal muscles, stress-strain analysis has been applied based on the fracture theories of von Mises and Tresca, so that the part has the necessary resistance to pressure and muscle contractions, and its critical stress points are identified and reinforced. Therefore, based on the outputs of the loading analysis, the appropriate thickness, material, and geometric form have been selected for each part of the device (Figure 2). In Iran, the equipment used in the devices available in medical centers and doctors' offices is mostly imported. Due to the slow speed of colonoscopy procedures in medical centers and specialist doctors' offices, and the lengthy process of sterilizing equipment, patients spend a lot of time and money in these centers. The price of devices available on the market is high, preventing many medical centers and specialist doctors from using this equipment. Due to their geometric shape and sharp edges, existing equipment often causes severe pain in the patient and is sometimes prone to causing damage, tearing, and bleeding in the rectum and colon wall. Because the available equipment causes severe pain in the patient, in most cases, the use of this equipment during colonoscopy is accompanied by anesthesia for the patient.  Anesthesia requires initial patient preparation and then recovery, and is associated with risks for some patients (anesthesia is costly, stressful, time-consuming, and sometimes dangerous, with side effects). In some cases, it is observed that due to incomplete cleaning of the intestinal wall or bleeding, the colonoscopy procedure is not possible and the colonoscopy procedure has to be repeated at another time after repeated washing, as the existing equipment does not allow for simultaneous disinfection, washing, and performing the colonoscopy procedure. The cross-sectional shape of keeping the opening of the rectum and colon open in the use of existing instruments is such that it makes the muscles of the rectum and colon into an oval cross-section, which in addition to stretching the muscles on one side (large oval diameter) more than the other side (small oval diameter), does not allow sealing the outlet of the rectum in these instruments, and because in most cases, patients have bleeding and secretions in the colon, which leak out and cannot be controlled, and the exit of these materials is uncomfortable and disgusting for the operators and the patient themselves, and in some cases, if not followed properly, it can transmit the disease. (In the proposed instrument, the cross-sectional shape of the opening is circular, which can be applied continuously for different diameters depending on the need to keep the rectum open (using a speculum with a parabolic geometric shape), so in addition to the patient suffering little pain, it also completely seals the desired area.) A description of the state of the prior art and the history of developments related to the claimed invention. Colonoscopy means colonoscopy. It is an endoscopic examination of the colon and the lower part of the small intestine with a CCD camera or fiber optic camera mounted on a flexible tube, which is referred to below. The scope is inserted through the rectum for colonoscopy. (Figure 3) Common conditions for patients requiring colonoscopy include: gastrointestinal bleeding, unexplained changes in bowel habits, unexplained decrease in hematocrit (a sign of anemia), and suspected malignancy. Colonoscopy is also used to diagnose colon cancer, but it is more often used to diagnose inflammatory bowel disease. Also, patients with a family history of colon cancer are often screened for the first time in adolescence. For a colonoscopy to be performed properly, the colon must be clean and free of solids. Accordingly, according to existing techniques, the patient must follow a low-fiber diet or only clear liquids for one to three days. The day before the colonoscopy, the patient is given a laxative and plenty of fluids. Since the goal of the preparation is to clear the colon of solids, the patient should plan to spend the day in a comfortable environment with ready access to a restroom. In addition, the use of laxatives may also have side effects. Another method is to cleanse the colon using a solution of polyethylene glycol and electrolytes the day before the colonoscopy. Generally, this method involves a laxative in pill form and a bowel cleansing preparation of polyethylene glycol powder dissolved in water, which may have undesirable side effects. In the traditional method, the colonoscope is inserted into the colon and advanced along the colon using strong manual pressure that can damage, tear, or perforate the colon. Manual pressure also causes a lot of pain, which in some cases requires anesthesia. The use of anesthetic drugs requires additional recovery time after the treatment, which is very unpleasant for the patient anyway.Also, in the traditional method, the lack of bowel cleanliness in many cases causes incomplete and unsuccessful colonoscopy, which ultimately causes the patient to repeat all the unpleasant preparation steps and perform the screening a second time. In addition, the current process consumes more time to prepare the bowel and perform the colonoscopy. (Figure 4). Because the traditional method involves a long preparation process before the operation and is very painful and unpleasant during the operation, many patients refuse to undergo colonoscopy. This leads to the progression of the disease and ultimately serious and sometimes irreparable harm to patients. The difficulty and unpleasantness of the colonoscopy procedure in the traditional method disrupts the most vital parameter of treatment, which is timely and accurate diagnosis of the disease, and eliminates the time factor that is very important in the treatment of dangerous diseases. The need to use medical and therapeutic equipment in all parts of the country and access to all people, even in the most remote areas, is one of the requirements of a society's health system. Using a tool that can be used by all people and in all parts of the country is very important. In the field of diagnosing and screening colon diseases, the equipment that is the subject of this proposed project can make a significant contribution to this issue.Given that in remote and underserved areas, there are practically no shortage of people suffering from such diseases due to the difficult living conditions of these areas, and they are in dire need of such medical services. With the progress of societies in terms of health and considering the use of disposable medical equipment that has spread in all medical fields, this need was also felt. After the Covid-19 pandemic and many problems that have affected the whole world, paying attention to health and preventing the re-spread of such diseases has become the focus of attention of governments and health organizations around the world. Using disposable tools and minimizing the possibility of virus transmission can also be very effective in this regard. The present plan can also make a significant contribution to this and effectively solve part of the concerns of the health system in the country. Providing a solution to an existing technical problem along with an accurate, sufficient, and integrated description of the invention Accordingly, the present device design provides a method for performing colonoscopy along with bowel cleansing as a means of preparing the bowel for performing a diagnostic colonoscopy procedure. The first step is to insert the speculum: The present invention provides a rectal speculum for performing colonoscopy with colon cleansing. The speculum includes a main tube with a plain end for insertion into the patient's rectum and a threaded end with a cone for insertion of the colonoscope, an inlet tube for directing fluids into the main tube, an outlet tube for connection to a waste discharge hose that has a cap to close the end of the tube when not needed. (Figure 5) The inlet tube for disinfectant and rinsing fluids has a diameter smaller than the diameter of the main tube and preferably intersects the main tube at an angle to the end of the main tube. The disinfectant inlet tube and the waste discharge tube are preferably at an angle to the main axis of the main tube. (For ease of use), by closing the drain tube cap, a cam piece impregnated with a lubricating and disinfecting gel is inserted from the end of the main tube and by opening the rectal opening, it is possible to insert the head of the main tube into the rectum and advance the main tube and cam piece into the colon.Then, the speculum assembly, which includes the parabolic head, the stabilizing cylinder, and the sealing washers, is moved along the outer diameter of the main tube by releasing the stabilizing barb latch, and the parabolic head, impregnated with lubricating gel, gently opens the rectal opening to the required amount. The operator, by adjusting the amount of insertion of the main tube head and the amount of opening of the rectal opening, releases the stabilizing barb latch, and the assembly is fixed in its position. Figure 5-b and c). The next step is to wash and disinfect the inner lining of the colon: After inserting the speculum and the main tube and locking the set, the operator grabs this piece by the ring attached to the end of the cam piece and pulls it out. In most cases, the colon must be washed and disinfected again due to infection, bleeding, etc. Therefore, if necessary, the drain tube cap is opened and closed to the threaded end of the main tube. Disinfectants and detergents are injected into the main tube through a thin tube and then pumped into the colon. After the colon is full, it is sucked out and emptied through the drain tube, in which case waste materials such as blood, pus, and infection, etc. are also transferred. The washing cycle process continues until the desired final result is achieved. (Figure 5-d). After the colon washing and disinfection process is completed, the cap is closed to the end of the main tube and closed to the end of the drain tube by placing a sealing gasket, and the kit is ready to enter the next stage, which is the installation of the colonoscopy camera. It is worth noting that the parts of the colonoscopy kit are made of durable, clear plastic, allowing for better and more comfortable visibility for the operator. Step Three provides a system for performing colonoscopy with colon cleansing, which includes: Inserting the speculum: The speculum is inserted into the patient's rectum with a slight twist at a predetermined depth. After placing the speculum cap and releasing its stabilizing latch, the cam piece is removed from the speculum and after closing the threaded end inside the cone of the main tube, the bowel is washed and cleaned with repeated fill and empty cycles. Then the cap is opened from the end of the main tube and returned to its original position (the end of the discharge tube is closed using a sealing washer), the swivel joint is assembled to the end of the tube by a special nut. This joint is such that in addition to sealing, it allows for complete rotation and rotation, and the tail of the swivel ball can be installed with a colonoscopy camera hose. Inserting the colonoscopy camera: The colonoscopy camera enters the main tube through the guide hose and swivel joint and subsequently enters the large intestine. Before performing the colonoscopy, the colon is slowly filled with a moisturizing liquid to obtain a clearer and clearer view and also to keep the inner wall of the large intestine open and prevent its adhesion. It is performed by advancing the colonoscope to the cecum of the intestine and finally the camera is pulled out of the intestine and by removing the drain tube cap and closing it instead of the swivel joints at the end of the main tube, the fluids inside the large intestine are emptied through the drain tube, suction and the intestine. Then the colonoscopy instrument is pulled out from the large intestine and rectum and the colonoscopy diagnostic examination process is completed. (Figure 5 - E) Explanation of shapes, maps and diagrams Figure 1 - An example of a colonoscopy steel instrument Figure 2 - Example of a disposable colonoscopy instrument Figure 3 - General schematic of the colonoscopy process Figure 4 - Endoscopy camera equipment Figure 5- The main colonoscopy tube Figure 5-B: Dentinous part of the rectal kit stabilization tube Figure 5-C: Schematic of the speculum kit Figure 5-D: Exploded schematic of the speculum kit Figure 5-E: Colonoscopy kit The following diagrams show the different parts of the equipment: Figure 6 - Exploded view of the speculum kit Figure 7 - Speculum set The proposed colonoscopy tool is actually a combination of two two-stage tools in one tool, as follows: The first step is to insert the colonoscopy kit: In the first stage, the initial kit (Figure 6) is used in such a way that the tube (1) with its cap (5) closed is placed in the opening of the rectum and the elliptical piece (2) with the elliptical end impregnated with a lubricating and antiseptic gel passes through the main tube (1) and enters the rectum with pressure from its trailing ring (2). After the rectum is opened, the main tube (1), which has a diameter slightly larger than the elliptical piece, enters the rectum following the cam-shaped (oval) piece and advances to the required size inside the large intestine. The speculum assembly (Figure 7), which includes the speculum holding the rectum open (3), the speculum positioning cylinder (4), and the sealing washers (10), have already been placed and assembled on the main tube (1). The speculum cylinder has a barbed tongue that can be caught on the lower teeth (serrated ribs) of the main tube (1) and prevents the speculum from moving relative to the main tube (1). The sealing washers (10) are placed inside the internal grooves of the speculum cylinder and seal the inner wall surface of the speculum cylinder (4) relative to the outer wall of the main tube (1). This action prevents any internal secretions of the colon or disinfectants and detergents from escaping. By releasing the barb lock of the cylindrical speculum (4) and moving the set of speculum parts, which consists of a parabolic piece (3) impregnated with a lubricating and disinfecting gel, along with a cylindrical piece (4) and sealing washers (10) on the main tube (1), the operator opens the rectal opening further by guiding the parabolic piece (3). If the required defined amount and the length of the main tube (1) are reached, the speculum cylinder barb lock (4) is released and the set is fixed in its position. (Figure 8 shows a cutaway view of the speculum set and how the tool position fixing lock works.) Then, the operator uses the trailing ring of the cam piece (2) to guide it out of the intestine and rectum and pulls it inside the main tube (1). At this stage, the colonoscopy kit is inserted and we enter the second stage. Step 2: Disinfection and washing: In most cases, it is observed that the intestinal wall is not completely cleaned or due to bleeding and pus, etc., the intestine needs to be washed and disinfected again, so the cap (5) is opened from the end of the discharge tube and closed to the threaded end of the main tube (1). Disinfectant and washing materials are injected through a thin tube installed on the main tube (1) and pumped out through the discharge tube after the intestine is filled. The repetition of the washing process depends on the complete cleaning of the intestinal wall and is repeated as many times as necessary, if necessary. Figure 8 – Cutaway view of the speculum and how the locking barb works Step 3: Inserting the colonoscopy camera: After the disinfection and washing process is complete, it is time to insert the colonoscopy diagnostic examination camera. At this stage, the operator opens the end cap of the main tube and assembles the swivel joint assembly to the end of the main tube (1). The swivel joint assembly includes a conical part inside the sphere (6) that is inserted into the end of the main tube (1) and its conical part coincides with the inner conical part of the main tube (1) and seals it. Then, a trailing ball part (7) is placed inside the sphere of the part (6) and a hose (9) is connected to it. The cap (8) passes through the hose and assembles the ball part (7) and the cone part (6) on the end thread of the main tube (1). After assembly, in addition to complete sealing, the aforementioned assembly allows the ball (7) to rotate inside the cone (6) and creates a swivel joint. This joint allows the operator to rotate the colonoscopy camera more easily and creates different rotational-movement views. The intestine is kept open by injecting a special liquid, in addition to better image clarity, and the camera enters the large intestine through the hose, swivel joint, and the main tube, and the bowel examination is performed. A clear and precise statement of the advantages of the claimed invention over prior inventions. Considering the above, it was decided to design a disposable rectal speculum device that has the following features: The equipment used, depending on the type of operation and working conditions, has all the necessary provisions for patient comfort and better diagnostic performance. The present invention provides a device and method for performing a colonoscopy by cleaning and debriding the colon as a means of bowel preparation. From a hygienic point of view, since this equipment is disposable, it minimizes the possibility of disease transmission and does not cause any concerns for patients. Most of the parts of this instrument that are in direct contact with the patient are made of transparent plastic, so the operator has a better view of the patient's condition. In the manufacture of plastic parts in injection molds, care has been taken to ensure that all sharp corners and edges of the plastic parts in this product are smoothed and rounded to minimize the amount of damage and pain caused to the patient by the instrument during the colonoscopy procedure. (It is easier to polish and clean the edges of the plastic parts during the mold design and after the production process.) Because during the stage of inserting the colonoscopy kit, the head of the tube is equipped with a movable cam piece that is impregnated with a lubricating gel, it causes the least pressure and pain to the patient during the initial stage of inserting the kit (which in most existing equipment is accompanied by severe pain, bleeding, and rupture of the rectum and colon wall (sometimes the patient has to be anesthetized). In using this method, there is no longer a need for initial anesthesia for the patient. This means that the patient will incur less expense, experience less stress, and have fewer subsequent side effects. The colonoscopy procedure will also be faster (due to the elimination of the preparation stage for anesthesia and subsequent recovery). In previous methods, if the inner wall of the colon is contaminated for any reason (bleeding, incomplete cleaning, etc.), the colonoscopy procedure is stopped and postponed to the next time when the surface has been completely cleaned. This problem is solved in this tool. If cleaning is needed, the desired area can be quickly washed with disinfectants and detergents and the waste materials can be transferred outside without causing the slightest disruption to the process. The design of this equipment is such that (due to its special geometric shape and the use of a cam-shaped piece, etc.) the colonoscopy procedure (which is generally associated with pain and discomfort for the patient) will be performed with minimal discomfort and subsequent complications for the patient. The almond-shaped piece is impregnated with a lubricating gel, and due to its elliptical curved shape and viscosity, minimal pressure damage is caused to the intestinal wall, eliminating the possibility of rupture and bleeding of the rectum and intestinal wall. By using a swivel joint, it is possible to install a camera guide hose with 360-degree rotation. Because the equipment is disposable, the speed of the doctor and medical staff in this method is faster, and a larger number of patients can be seen than in the same time using existing equipment. The plastic used in this device is a durable plastic with standard medical grades. Description of at least one implementation method for implementing the invention We offer a rectal speculum kit for performing colonoscopy with bowel cleansing, which includes a rectal speculum with an inlet tube and an outlet tube that forms a cross-obstruction with a main tube. The speculum is designed to be movable along the main tube in a staggered manner, and for easier and less painful insertion of the speculum into the patient's rectum, it is designed as a parabolic geometric shape, the surface of which is impregnated with a lubricating and antiseptic gel. After the parabolic part of the speculum is placed in the patient's rectum to stabilize its position and prevent it from returning and exiting, a part of the lower wall of the main tube towards its plain end is toothed (comb gear). The locking barb that stabilizes the rectal speculum cylinder can be released in any desired position and the assembly is fixed on the main tube, which is used to clean and purify the large intestine, colonoscopy equipment for performing colonoscopy. After opening the cross-shaped tee cap of the main tube and closing this cap to the threaded end of the speculum, the operator connects the drain hose to the speculum drain tube. Disinfectants and detergents enter through the speculum injection tube and return fluids and waste are sucked and exited through the drain hose. The speculum is inserted into the patient's rectum with a slight twist at a predetermined depth. After inserting the speculum cap and releasing its stabilizing latch, the cam piece is removed from the speculum and after closing the threaded end inside the cone of the main tube, the bowel is washed and cleaned with repeated fill and empty cycles.Then the cap is removed from the end of the main tube and returned to its original location (the end of the discharge tube is closed using a sealing washer). The swivel joint is assembled to the end of the tube with a special nut. This joint is designed so that in addition to sealing, it can rotate and rotate completely. The swivel ball tail has the ability to install a colonoscopy camera hose. After the last pre-determined empty cycle, the cap is removed from the conical end of the speculum main tube and the colonoscopy is performed by slowly filling the colon with a moisturizing liquid and advancing the colonoscope to the cecum, and the colon is emptied. Explicit mention of the industrial application of the invention Colonoscopy diagnostic examination kit (diagnosis of colon and digestive system problems, including cancer, rectal ulcers and ruptures, etc.) with simultaneous washing of the intestinal wall for better results and ease of work.

Claims

Claims What is claimed: Claim 1) A disposable colonoscopy examination kit with the ability to simultaneously wash and disinfect the colon and guide a colonoscopy camera, including; a main tube with an inlet end for placement in the patient's rectum, and an outlet end that has a conical internal thread for positioning, stabilizing, and guiding the colonoscopy camera; such that the said kit enables simultaneous washing, disinfection, and colonoscopy examination. Claim 2) The kit according to claim 1, wherein the outlet pipe is connected to a waste discharge hose and has a flow control cap or valve. Claim 3) The kit according to claims 1 and 2, wherein the liquid inlet tube has a diameter smaller than the main tube and is designed for controlled conduction of the washing liquid and disinfectant. Claim 4) The kit according to any of the preceding claims, wherein the parabolic cap is designed to gradually open the rectal opening, thereby reducing pain and injury to the patient. Claim 5) The kit according to any one of the preceding claims, wherein the swivel joint allows free rotation of the hose or colonoscopy camera while maintaining a seal. Claim 6) A kit according to any one of the preceding claims, wherein the body and main components are made of transparent and resistant polymeric materials. Claim 7) The kit according to any one of the preceding claims, wherein part of the internal components comprises a cam piece impregnated with a lubricating and disinfecting gel. Claim 8) A kit according to any one of the preceding claims, which allows for cyclic colonic lavage by entering liquid from the inlet tube and discharging from the outlet tube. Claim 9) A kit according to any one of the preceding claims, wherein the components in contact with the rectal opening have a circular or parabolic cross-section to provide a proper seal and prevent leakage of fluids.

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