A spark plug for Sentinel lymph node detection.

Abstract

The invention relates to an injection dilator that enables the injection of dye into the cervix uteri to facilitate the identification of the sentinel lymph node in gynecological oncological surgeries, particularly in surgeries for endometrial and cervical cancer.

Description

1 TARIFF A spark plug for Sentinel lymph node detection. Technical Area The invention has implications for gynecological oncological surgeries, particularly in the treatment of endometrial and cervical cancer. In surgeries, an incision is made in the cervix uteri to enable the identification of the sentinel lymph node. It relates to a spark plug that enables paint injection. State of the Art Sentinel lymph node staining system detects cancer cells initially from the primary tumor. It is a surgical mapping method used to locate the lymph node that has been affected. The method involves placing blue dye (methylene blue, isosulfan blue) or radioactive 10 around the tumor. the discoloration or marking of the first lymph node by injecting a substance This helps prevent unnecessary lymph node removal. Currently, sentinel lymph node staging is used in the surgical staging of malignancies originating from the cervix uteri. The tumor node (SLN) mapping method is widely used. In this method, the tumor To identify the sentinel lymph node that receives the first lymphatic drainage from the region, 15 dyes or fluorescent substances are injected into the cervix uteri at specific anatomical points. Marker substances are injected. After the injection, dye or The marker substance travels along the lymphatic channels and reaches the sentinel lymph node. and during surgery, this node is visualized with the help of imaging systems This allows for the identification of unnecessarily enlarged lymph nodes. Preventing dissections, reducing surgical morbidity, and accurate staging. This is the goal. The procedure of injecting dye into the cervix (uterine cavity) is usually performed using thin injection needles or these This is carried out using various injection devices developed for this purpose. 25 The injection must be administered at the correct depth, in the appropriate anatomical location, and in a controlled amount. Its applicability is of great importance in terms of successful sentinel lymph node labeling. This is important. However, in current practices, the injection depth needs to be standardized. inability to perform the procedure, failure to maintain needle stability during application, paint leakage. various factors such as its occurrence and the fact that the process depends significantly on user experience 30 2 Technical difficulties may be encountered. Typically, disposable, fixed materials are used for this process. Needle syringes of varying lengths (e.g., 25G spinal needles) are used, and each quadrant... (12, 3, 6, 9 o'clock positions) separate injections are administered. The procedure is performed using a handheld device. It is performed with a syringe. Therefore, injecting dye into the cervix (uterine cavity) is safer. 5 that make it controlled, repeatable and easy to implement for the user The development of fuel injection spark plugs is of great importance. As a result of research conducted on this subject, the code US20030187319A1 was encountered. The relevant code... The document describes the initial stages of tumor cells entering the lymphatic vessels from the primary source of the tumor. a method used to identify sentinel lymph nodes, which are the lymph nodes that have been reached. It relates to the sentinel lymph node detection device and a related detection method. However, 10 Current techniques for injecting dye into the cervix—how, at what depth, how many points, what... Adjustable needle depth for determining the amount and stability of the injection, dose equalization. or does not offer a mechanical spark plug solution fixed to the cervical os. In conclusion, due to the negative aspects described above and the current solutions being the subject of discussion... Due to its shortcomings, an improvement in the relevant technical field is necessary. 15 It has been made. Purpose of the Invention The invention was created by drawing inspiration from existing situations and overcoming the aforementioned drawbacks. It aims to solve the problem. The main purpose of the invention is to enable the detection of the sentinel lymph node in the cervix 20 The goal is to develop an injection plug that enables the injection of dye into the uterus. The other purpose of the invention is to provide an adjustable needle output compared to existing fixed-needle syringes. Our goal is to offer an injection plug that can adapt to different anatomies. Another aim of the invention is to create a reusable, cost-effective product in the long run. The goal is to offer an injection plug that reduces medical waste. 25 Another aim of the invention is to achieve more consistent, reliable and stable fixation and dosage control. The goal is to obtain reproducible sentinel lymph node staining results. The invention is intended to fulfill the purposes described above, in the field of gynecological oncology. In surgeries, the sentinel lymph node is located in the cervix uteri. It is an injection spark plug that enables paint injection, and its feature is; 30 3  A body placed in the cervical os,  Moving inside the body, the injection depth is determined in each quadrant. enabling precise adjustment and including the following: adjustable needle unit 5 (Mounted inside the body, rotating or push-pull) a mechanism that allows the length of outward extension to be adjusted telescopic tube and The telescopic tube at least at two different injection depths that ensures it is fixed and creates stopping points. 10-stage locking mechanism It includes. The structural and characteristic features and all the advantages of the invention are given in the figures below. This becomes clearer thanks to the detailed explanation written with references to these figures. This will be understood as such, and therefore the evaluation will also take these forms and detailed explanations into account. This should be done taking this into consideration. 15 Figures that will help understand the invention. Figure 1 shows general and detailed views of the injection spark plug, which is the subject of this invention. Explanation of Part References 1. Body 2. Telescopic tube 20 3-stage locking mechanism 4. Motion stopper 5. Lateral needle exit 6. Needle sheath 7. Flow path 25 8. Telescopic depth sheath 9. Case body 4 Detailed Description of the Invention This detailed explanation describes the preferred type of injection spark plug that is the subject of this invention. Their structures are explained solely to facilitate a better understanding of the subject. The injection bougie, the subject of this invention, whose appearance is given in Figure 1, is used by the surgeon to insert a single bougie into the cervix. From a stable access point, four 5-inch rollers apply paint at adjustable depth and in even amounts. It has been developed to allow for easy application to the dial, in its most basic form; A spark plug (port) body placed in the cervical os, an adjustable length wire coming from the spark plug. from a needle unit, an injection mechanism and a dosage control system It consists of. The spark plug body (1) mentioned here is made of silicone or medical grade plastic. It is manufactured. The outer part is conical or round, designed to fit into the cervical os. 10 It is designed to include a needle channel and a needle locking mechanism inside. Additionally, the dilator can be attached to soft tissues or a vacuum device that can be temporarily secured to the cervix. It may have an assisted gripper. The injection spark plug that is the subject of this invention has an adjustable needle unit, The unit in question allows for precise adjustment of the injection depth at each quadrant. 15 It provides and includes a telescopic tube (2) and a stepped locking mechanism (3). The telescopic tube is located inside the body and can be rotated or pushed-pull. Its mechanism allows you to adjust the amount (length) of its extension. Calibration markings are found corresponding to millimeter or dial (surface / deep) measurements. The telescopic tube (2) surrounds the needle hub and reduces the amount of needle tip exposed by 20 an outer body that limits the needle sheath (6) and the inner body to which the needle is attached. It operates on the principle of sliding movement within it. Telescopic structure, depth It provides the linear movement required for the change. The aforementioned stepped lock The mechanism (3) is to fix the telescopic tube (2) at two different points. It provides and creates millimeter-precise stopping points. 25-step The locking mechanism (3) ensures that the tube is locked at its maximum length, preventing the needle tip from being locked. It allows very little to be exposed, and thus the aforementioned surface adjustment is achieved. It happens. With the release of the lock in the stepped locking mechanism (3), the telescopic tube By allowing it to shorten, the needle tip is extended further outwards. Thus... The aforementioned deep adjustment is achieved, and the second key point here is to set this position to 30. It fixes it in place. The subject of the invention is a standard injector attached to the proximal (outer) end of a spark plug. It has a Luer lock connector to which it can be attached. Alternatively, there is an internal reservoir and It may be a piston mechanism. The system, in each injection cycle (for each dial) a dosage that allows the delivery of a pre-set, fixed volume of dye (e.g., 0.5 mL). It includes limiter (volumetric control) or clear markings on the injector. The invention describes a standard medical injection plug designed to ensure volumetric accuracy. It uses an injector. The desired amount of paint is determined by the retraction of the injector piston. This is determined by the distance. This eliminates the need for any external measuring device. without, precisely using the volume scale on the injector body. It is adjustable. It ensures even paint distribution to each quadrant during application. To ensure this, a mechanical stroke limits the movement of the injector piston. There is a limiter. This limiter ensures that the piston only rotates 10 seconds per turn for each dial. It allows movement within a defined, fixed distance. This is achieved with the help of an injector. The total volume captured is distributed into equal portions across each quadrant. The preferred and targeted volume range with this invention is suitable for precision applications. These are low volumes, between 0.1 ml and 2 ml, depending on the syringe size used. (1 ml, 2 ml, 5 ml, etc.), this range can be adjusted flexibly. The system is especially suitable for 15 Offering high reproducibility at sub-milliliter (microinjection) levels It has been optimized. In short, volume equalization between dials is achieved through "total volume equalization with the help of an injector". "Calibration of volume" and "mechanical stroke restrictor for each dispensing step" This is achieved through a combination of principles such as "stabilization". This method is complex. A simple, reliable, and repeatable volume 20 without the need for electronic systems. It offers control. The invention describes a spark plug designed for long-lasting and highly durable refilling. It has been designed with usability in mind, and accordingly, the materials used are predominantly... Surgical techniques are used on titanium and moving parts that are subject to critical mechanical wear. Grade 25 stainless steel has been chosen. The subject of this invention is an injection dilator that allows controlled injection into different quadrants of the cervix uteri. There is a lateral needle exit (5) to allow injection. Lateral Needle exit (5), relative to the longitudinal axis of the spark plug body (1) of the injection needle will protrude laterally, preferably at an angle of approximately 90° It is structured in this way. Thus, the spark plug body (1) is placed in the cervical os and stable 30 While held in position, the injection needle is directed into the targeted quadrant of the cervical tissue. Guidance is provided. 6 When not in use, the needle is kept in a protected position inside the needle sheath (6); When injection is to be given, the telescopic tube (2) and the telescopic depth sleeve (8) with relative movement of the needle tip out of the lateral needle exit (5) in a controlled amount The needle is inserted into the cervical tissue using a telescopic tube. This is determined by the combined operation of (2) and the stepped locking mechanism (3). Thus, 5 The depth the needle tip will reach inside the tissue is predetermined by the user. It can be selected and locked in the selected position. Lateral needle exit (5), basic position of the spark plug body (1) within the cervical os It is structured in such a way that it can be directed to different cervical quadrants while being protected. This For this purpose, the body and / or needle carrier section rotates 10 degrees around its longitudinal axis. It has a rotatable structure. In the preferred configuration, the rotary mechanism in question, mechanical stop and / or click points defined at approximately 90° intervals It has. Thanks to this, the lateral needle exit (5) is located at the 12, 3, 6 and 9 o'clock positions of the cervix uteri. They can be directed to their corresponding dials in sequence. At each position Temporarily fixing the mechanism prevents the needle from being undesirable during injection. It prevents rotation and ensures the injection is directed to the targeted anatomical region. It ensures its implementation. Thanks to this configuration of the lateral needle exit (5), the device can be placed in the cervical os. The inserted portion must be completely removed and reinserted for each injection. 20 different quadrants can be displayed from the same location without needing to be repositioned. Injections can be administered. Thus, standardization of injection points and needles... Stability and repeatability of the application are increased. The operating principle of the injection spark plug, which is the subject of this invention, is as follows: The use of the inventory spark plug primarily involves the body of the spark plug. (1) by placing the device in the cervical os, the device will be in a stable position relative to the cervix 25 This is ensured. The conical or rounded outer structure of the body is compatible with the cervical os. It provides; in preferred configurations, the device is secured with the help of additional fastening elements. Its location can be maintained throughout the application process. The dye or marker to be used before injection is placed in a standard syringe. is being withdrawn and the connection located at the proximal end of the injector device in question is 30 It is connected to the region. The dye in the injector flows through the device (7) It is transmitted to the injection needle via this route. 7 Next, the desired injection depth is determined. The user, By moving the telescopic tube (2) inside the body (1), the needle tip is lateral to the needle. It adjusts the amount that will come out of the outlet (5). The telescopic tube (2) has a step lock. from the different fixing points on the mechanism (3) By positioning the injection site, a superficial or deep injection position is selected. At the selected position, 5 The mechanism locks, preventing the needle from advancing beyond the predetermined depth during injection. or its backward movement is prevented. After depth adjustment is complete, the lateral needle exit (5) is brought to the first target dial, preferably The needle tip is directed towards the 12 o'clock position. The needle tip is removed from the needle sheath by a specified amount (6) It is extracted and advanced into the cervical tissue, and by moving the injector plunger, 10 A predetermined amount of dye is applied to the cervical tissue. Delivering an equal amount of paint to each quadrant increases the stroke distance of the injector piston. This is provided by means of the limiting motion stopper (4). The motion stopper (4), the piston advances a predetermined distance in each injection cycle by allowing the total paint volume to be controlled and repeatable between quadrants 15 It ensures that it is distributed in this way. After the first injection is completed, the needle is withdrawn from the cervical tissue safely. The mechanism is positioned and rotated approximately 90°. Lateral needle exit with fixation at the next mechanical stop and / or click point. (5) is directed to the next cervical quadrant, preferably at 3 o'clock. Same 20 The injection procedure is repeated in this quadrant. Subsequently, the rotating mechanism is moved again in approximately 90° increments. Lateral needle exit (5) corresponds to the cervical positions at 6 and 9 o'clock respectively. The needle is guided to the dials. At each position, the needle reaches a predetermined depth. It is advanced into the cervical tissue and, thanks to the motion stopper (4), to the predetermined 25 Paint is applied in a volumetric manner. In this way, the device maintains its basic position when placed in the cervical os, thus protecting the cervix uterine. Sequential, controlled, and repeatable injections can be administered to different quadrants. Position of the telescopic tube (2) for superficial and deep injections as needed. Different injection depths can be selected by changing the settings. 30 8 After all planned injections are completed, the needle is completely covered with a needle sheath (6) It is withdrawn and secured. The injector is detached from the device. The injection plug is then removed from the cervical os in a controlled manner. It is reusable. after the device has undergone appropriate sterilization procedures in the facilities It is possible to reuse it. 5 Thus, the injection spark plug that is the subject of this invention features stable placement in the cervix and adjustable design. injection depth, lateral needle exit, controlled guidance to different cervical quadrants. and by providing mechanical dose limiting features together, sentinel lymph node Standardized, controlled cervical dye injections performed for mapping purposes. It ensures that it is performed in a repeatable manner. 10

Claims

9 REQUESTS 1. Detection of sentinel lymph node in gynecological oncological surgeries. a method that involves injecting dye into the cervix uterine to provide It is an injection spark plug, and its characteristics are:  A trunk placed in the cervical os (1), 5  Moving inside the body (1), injection in each quadrant It allows for precise adjustment of its depth and includes the following: including adjustable needle unit That part that fits inside the spark plug, rotated or pushed-pull. a 10 with an adjustable outward extension length thanks to its mechanism telescopic tube (2) and The telescopic tube (2) at least at two different injection depths that ensures it is fixed and creates stopping points. Step locking mechanism (3) It includes. 15 2. A spark plug conforming to claim 1, characterized by its ability to distribute equally across each quadrant. the distance the injector piston moves, which determines the amount of paint delivered. It includes a limiting motion stopper (4).

3. An injection plug conforming to Claim 1, characterized by its ability to deliver the needle to the specified depth. A lateral needle exit that allows the needle to exit laterally from the cervical tissue (5) 20 It includes.

4. An injection plug conforming to Claim 1, characterized by the fact that no needle is used. It includes a needle sheath (6) which allows it to be placed in a protected position in case of injury.

5. An injection plug conforming to claim 3, characterized by its relative movement to the needle. 25 that allows the tip to exit the lateral needle exit (5) in a controlled amount It includes a telescopic depth sleeve (8).

6. A dilator suitable for request 3, with the following feature: cervix uterine at 12:

30. A lateral bearing that can be oriented to its quadrants corresponding to directions 6 and 9 respectively. It includes needle exit (5).

7. An injection dilator conforming to Claim 1, featuring titanium and / or surgical 30 It contains an injection spark plug manufactured from high-grade stainless steel. 35

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