FAQ

How to choose the right minimally invasive gynecological surgical instruments?

Medical Innovation Devices - Endoscope Industry Special

All India Institute of Ayurveda (AIIA) Medical Equipment Procurement Global Tender Document

April 6, 2022
Choosing the right minimally invasive gynecological surgical instruments requires comprehensive consideration of multiple factors, including the type of surgery, the technical parameters of the instrument, the ease of operation, and safety. The following are detailed suggestions:

Surgery type and instrument matching:

Hysteroscopic surgery: Choose the appropriate electrosurgical ring and electrode according to different surgical needs. For example, 26050 G, J and M electrosurgical rings are recommended for polypectomy; 26050 J, L and R electrosurgical rings are recommended for adhesion resection
.
Uterine septoplasty: 26050 J electrosurgical ring is recommended
.
Technical parameters:

Endoscope system: Choose an endoscope with an ultra-wide-angle field of view, such as the HOPKINS® ultra-wide-angle 6° endoscope, which is 20 cm long and has a LUER-Lock interface
.
Surgical electrodes: Electrodes that can adapt to plasma surgical systems, multiple electrodes are optional, and treatment blades of different lengths, thicknesses, curvatures, and energy levels are equipped according to different parts and symptoms.

Surgical instrument material: Choose medical stainless steel, pure metal instrument rods without electrical energy, working length ≥350 mm, diameter ≥3 mm

.
Convenience of operation:

Single-port laparoscopic surgery: Due to limited operating space, it is recommended to use instruments with curved straight and then curved shapes and straight and then curved shapes, and use joint linkage rod multi-degree-of-freedom instruments to enhance flexibility

.
Robot-assisted surgery: Using the da Vinci Si or Xi surgical platform system, a multi-channel port is placed through a 2.5cm single incision in the umbilicus, and then the surgical instruments and equipment are connected to the robot platform to give full play to its large degree of freedom and the function of internal wrist rotation

.
Safety and effectiveness:

Smokeless surgical electrodes: For example, the AutoLeep handle is convenient for plugging and unplugging surgical electrodes and Leep knife smokeless surgical electrodes, and has the characteristics of automatic excision of lesion tissue and controllable cone cutting range

. Biopsy forceps and other auxiliary tools: including biopsy forceps, electrosurgical or laser instruments and suture materials, etc., these tools can help perform more delicate operations and reduce tissue damage.

Special needs:

Uterine manipulator: In hysteroscopic surgery, choosing a suitable uterine manipulator can obtain good uterine manipulation and facilitate the exposure of the surgical operation site.

Cervical grasper and uterine grasper: According to the specific surgical needs, choose a uterine grasper with a LUER-Lock interface and blunt jaws, and a QUINONES brand uterine grasper with a fallopian tube inflation channel.

Other precautions:

Avoid high-pressure contact areas and sharp edges: Choose tools without high-pressure contact areas and sharp edges, and use trigger locks, ratchets and other functions to reduce continuous grip and squeezing force.

Indications and equipment requirements: Make sure that the selected instrument meets the surgical indications and consider the environmental conditions of the operating room, such as temperature, humidity, power supply and atmospheric pressure.

In short, when choosing minimally invasive gynecological surgical instruments, factors such as the type of surgery, technical parameters, ease of operation, safety and effectiveness should be fully evaluated, and comprehensive considerations should be made in combination with specific circumstances to ensure the success of the surgery and the patient's recovery.

How to choose the most appropriate electrosurgical ring and electrode according to different types of hysteroscopic surgery?

The selection of the most appropriate electrosurgical ring and electrode needs to be determined according to the specific type and goal of the hysteroscopic surgery. The following is a detailed guide to selecting electrosurgical rings and electrodes according to different types of hysteroscopic surgery:

Endometrial resection (TCRE):

Monopolar electrode: Suitable for high power output (70~100W), usually using a ring electrode for cutting operation

Bipolar electrode: Although less used in hysteroscopy, its advantage is that it does not require a loop electrode plate, and the electrothermal effect is relatively limited, which is suitable for delicate operations

Uterine myomectomy:

Monopolar electrode: Using an angled ring electrode, antegrade or transverse cutting can be performed, which is suitable for the removal of the anterior and posterior walls of the endometrium and myomas

Bipolar electrode: The roller barrel electrode has different specifications such as 2mm, 3mm, and 5mm in diameter, with a large contact area, suitable for removing larger fibroids.

Polypectomy:

Monopolar electrode: The needle electrode is suitable for cutting the endometrium and myometrium, and opening the window to remove intramural fibroids.

Bipolar electrode: Spherical electrode or twisted electrode can be used for coagulation and hemostasis of small blood vessels.

Transuterine adhesion release (TCRA):

Monopolar electrode: A ring electrode with adjustable cutting angle, suitable for removing uterine septum and intrauterine adhesions.

Bipolar electrode: The roller barrel electrode can effectively handle adhesion tissue due to its large contact area.

Removal of intrauterine foreign bodies:

Monopolar electrode: The needle electrode is suitable for cutting the endometrium and myometrium, and opening the window to remove intramural fibroids.

Bipolar electrode: The roller barrel electrode has different specifications such as 2mm, 3mm, and 5mm in diameter, with a large contact area, suitable for removing larger fibroids.

Vaporization:

Monopolar electrode: The vaporization electrode is grooved and uses a current power of 200W, which can vaporize the endometrium and small submucosal fibroids.

Bipolar electrode: There is no specific recommendation, but the bipolar circuit system is widely used in laparoscopy. Its advantage is that it does not require a loop electrode plate, but its electrothermal effect is relatively limited.

Other special uses:

Monopolar electrode: The horizontal semi-ring electrode is suitable for dividing large submucosal fibroids.

Bipolar electrode: The spring-shaped electrode is suitable for occasions where a deep coagulation effect is required.

In short, when choosing an electrosurgical ring and electrode, factors such as the type of surgery, the required power, the cutting depth, and the need for hemostasis should be considered comprehensively. For example, for surgeries that require delicate manipulation and deep coagulation, a bipolar electrode can be selected; while for surgeries that require rapid removal of a large amount of tissue, a monopolar electrode can be selected.

When using robot-assisted surgery, how to evaluate and select the most suitable surgical platform system?

When selecting and evaluating the most suitable robot-assisted surgical platform system, multiple factors need to be considered comprehensively, including technical features, operation mode, accuracy, cost-effectiveness and clinical application effect. The following is a detailed evaluation and selection method:

Technical features and functions:

Robotic arm design: Different robot systems use different robotic arm structures, such as serial mechanism, parallel mechanism, etc.

For example, the Stewart platform is known for its high rigidity and strong load-bearing capacity, which is suitable for high-precision surgery

Control system: Some systems provide multiple operation modes such as manual control mode, integrated planning software control mode and COBOT control mode

. These modes can be flexibly switched according to specific surgical needs to achieve the best surgical effect.

Accuracy and navigation system:

Vision system: High-quality 3D vision system can provide a clear surgical field of view, helping surgeons to position and operate more accurately

.
Navigation assistance: Advanced navigation system can track the relative position of the robot arm and the patient to ensure that the surgical instruments are accurately placed in the corresponding anatomical parts

. Indications and types of surgery:

Tumor size and location: Robot-assisted surgery is recommended for tumors with a diameter of less than 5 cm and intact capsule; for tumors with a diameter of more than 5 cm or that invade important blood vessels, careful selection is required based on the surgeon's experience.

Surgical specialty: Different robotic systems perform well in specific surgical areas. For example, the Da Vinci system is widely used in minimally invasive surgeries such as urology, obstetrics and gynecology, and cardiac surgery.

Economic benefits and clinical outcomes:

Cost-effectiveness analysis: Although the initial investment in robotic surgical systems is high, they improve surgical accuracy, shorten hospital stays, and reduce complications, thereby reducing long-term medical costs.

Clinical efficacy: A large number of studies have shown that the use of robotic systems for joint replacement surgery can achieve better prosthesis placement and angles, reduce collateral damage and complications.

Operational convenience and training needs:

User-friendliness: The ease of use and operation of the system are key factors. Some systems provide tactile feedback functions, allowing surgeons to better perceive the details during the operation.

Training and support: Choosing a robotic system with a complete training system and support services will help improve the doctor's operational proficiency and surgical success rate.

Real-time data processing and feedback:

Real-time trajectory generation: Some systems have the ability to generate trajectories in real time and can estimate controller parameters online, filter hand jitter, and reduce errors.

Data accumulation and analysis: By setting the robot arm operation safety zone and standardized operation procedures, a large amount of surgical data can be accumulated to provide support for subsequent data analysis and improvement.

What new or innovative surgical instruments have been developed for minimally invasive gynecological surgeries with special needs?

For minimally invasive gynecological surgeries with special needs, a variety of new or innovative surgical instruments have been developed in recent years to improve surgical effectiveness and safety. Here are some of the main innovative instruments:

CAMPO TROPHYscope® integrated hysteroscope: Designed for diagnosis, clinics, and emergency use, this device has an extremely small outer diameter (only 2.9 mm) and can be examined without dilating the cervical canal. Its stability, light-guiding performance, and dilation performance are optimized to ensure excellent image quality, and its unique additional sheath design makes operation easier and reduces the risk of endometrial damage.

Da Vinci Robotic System: Since its FDA approval in 2005, the Da Vinci robot has been widely used in the treatment of benign and malignant gynecological diseases. The system has 3D high-definition imaging, motion scaling, tremor filtering, and flexible arm inner wrist technologies, which effectively overcome the limitations of traditional laparoscopic surgery and open surgery.

TELELAO ALF-X Surgical Robotic System: The system was renamed Senhance in 2016. It has tactile feedback and can track the operator's eye movement to control the camera, making up for the shortcomings of the Da Vinci Robotic System. It has been verified in gynecological surgeries, including salpingo-oophorectomy, ovarian cystectomy, uterine myomectomy, etc.

New Gynecological Shaving System: Developed by KARL STORZ and the research team, it is introduced through the endoscopic straight working channel and can perform a variety of surgical operations such as polypectomy, uterine myomectomy, and endometrial resection. This technology significantly reduces cervical dilation, improves intraoperative observation, and uses saline solution instead of sorbitol/mannitol. It takes a short learning time and is easy to master.

Precision local suturing instruments: used in minimally invasive surgical procedures in various departments, can reinforce anastomosis and deal with bleeding problems. In addition, there is a restorable light weight loss surgery system, which is used in conjunction with an endoscope to adjust the gastric volume to achieve weight loss and improve safety.

Cold knife cutting technology: The innovation of this medical consumable lies in its closed stapler design and vaginal end hemostasis function, which can reduce complications caused by electrical energy equipment, protect patient health, and meet the needs of specimen removal.

How to ensure the safety and effectiveness of the instruments used in minimally invasive gynecological surgery?

In minimally invasive gynecological surgery, ensuring the safety and effectiveness of the instruments used requires comprehensive consideration and management from multiple aspects. The following are detailed measures:

R&D and design stage:

During the R&D process, professional knowledge in multiple fields such as polymer material science, ergonomics and clinical medicine should be combined to ensure the reliability and stability of surgical instruments.

The design and production of medical devices should take into account the nature of their intended use environment, appropriately reduce the risk of accidental entry of substances into the device, and minimize the risk of infection to users and other possible contacts.

Experimental verification:

Before new surgical instruments are put on the market, they must undergo a series of rigorous experimental verifications such as tissue experiments, animal experiments and clinical trials to ensure their stability and efficiency.

Standard specifications:

Follow the standards and specifications formulated by the state or industry, such as the relevant obstetrics and gynecology medical device standards managed by SAC/TC169. These standards specify the structural type, material requirements, test methods, inspection rules and packaging and transportation of the device, so as to ensure the safety and effectiveness of the medical device.

Pre-use inspection:

Before surgery, medical staff need to check whether the packaging of items such as diagnostic and treatment instruments is intact and undamaged and within the validity period, and implement hand hygiene and hand disinfection.

Operation training and supervision:

Surgical instruments should be used and maintained by professionally trained personnel. Nurses need to be familiar with the names, functions and correct operations of each system of the equipment, as well as the elimination of common minor faults, to ensure that the equipment is in good working condition.

Medical institutions should formulate relevant systems, regularly evaluate and assess the use of medical devices, and provide technical support and consulting services to ensure that the equipment is in good condition.

Postoperative maintenance and management:

Establish a quality and safety management team, implement a comprehensive quality management and improvement system, and promptly report the results of clinical use safety and risk management monitoring of medical devices.

Provide professional training for nursing staff to enable them to master the performance, operating principles and precautions of surgical instruments, so as to ensure that surgical instruments can be used professionally and in a standardized manner.

Special precautions:

When using laparoscopic equipment, pay attention to cutting off the power supply and setting it to zero, avoid using disposable surgical instruments, and conduct regular inspections and maintenance; adjust the power of the high-frequency current generator according to the tissue type, pay attention to hand-foot coordination, and avoid tissue damage.

In hysteroscopic surgery, appropriate cold instruments should be selected for mechanical operation to avoid the intervention of the electrical energy system to reduce the risk of complications.

How to evaluate and select instruments that are consistent with the surgical indications before performing minimally invasive gynecological surgery?

Before performing minimally invasive gynecological surgery, evaluating and selecting instruments that are consistent with the surgical indications requires comprehensive consideration of multiple factors. The following are detailed steps and precautions:

Clear indications and contraindications for surgery:

Understand the specific indications for surgery, such as suspected intra-abdominal bleeding, pelvic effusion or abscess, pelvic mass, etc.

Determine whether there are contraindications, such as severe pelvic adhesions, suspected adhesions between the intestinal tract and the posterior wall of the uterus, highly suspected malignant tumors, etc.

Choice of instruments:

Choose appropriate instruments according to the specific type of surgery. For example, the instruments required for colposcopy include bilobed vaginal speculum, vaginal side wall retractor, cotton swab, sponge holding forceps, long forceps (at least 20cm), cervical canal speculum, dissecting forceps, cervical canal curette, biopsy forceps, cervical polyp forceps and single-tooth holding hook, etc.

Laparoscopic surgery requires the preparation of special instruments such as color monitors, imaging instruments, cold light sources, power supplies, CO2 insufflators, cameras, fiberoptic light guides, high-frequency wires, multi-function electric knives, and ultrasonic knives

For single-port robotic surgery, single-port ports and corresponding robotic instruments need to be prepared, and extended instruments should be selected according to the patient's height

. Instrument specifications and models:

Choose instrument specifications and models that are suitable for surgical needs. For example, the HOLLY uterine manipulator is suitable for uteruses of different sizes, which can safely move adjacent organs and prevent complications.

Use mechanical pretreatment tools, such as simple cervical dilator, to reduce the risk of insertion failure during surgery.

Preoperative preparation:

Inform the operating room of the instruments used and ensure that all instruments are ready.

Assess the patient's comorbidities to ensure that they can tolerate the surgical operation.
Prepare necessary drugs and auxiliary equipment, such a Hormonal preparations are used for pretreatment of menopausal patients

Nursing cooperation:
Nurses need to be familiar with the purpose and operation of the equipment, confirm the position of the image monitor and foot switch, so that the operation can proceed smoothly
Pay attention to the changes in the patient's vital signs during the operation, and promptly detect and deal with possible complications

For more photos and details please contact me:
Company Name: Tonglu Wanhe Medical Instruments Co., Ltd.
Sales: Sue