Fluorescent cervical cup for uterine manipulators

Abstract

The present patent of invention relates to the field of medicine and medical devices, and more specifically to an innovative fluorescent cervical cup for use in uterine manipulators during colpotomy surgical procedures. This improved device aims to increase the safety and efficacy of conventional or minimally invasive gynaecological procedures, including laparoscopic, robotic, and endoscopic surgery, particularly under conditions of limited visibility.

Description

[0001] Fluorescent Cervical Cup for Uterine Manipulators

[0002]

[0001] This invention patent falls within the field of medicine and medical devices, more specifically to an innovative fluorescent cervical cup used in uterine manipulators during colpotomy surgical procedures. This is an improved device that aims to enhance the safety and effectiveness of conventional or minimally invasive gynecological procedures, including laparoscopic, robotic and endoscopic surgeries, especially in conditions of limited visibility.

[0003]

[0002] The fluorescent cervical cup is a device designed for use in uterine manipulators during colpotomy procedures. The cup is made of biocompatible polymer, integrated with a fluorescent agent homogeneously distributed in the polymer matrix, which significantly improves visibility during surgery. The cervical cup can be entirely fluorescent, have only its distal portion fluorescent, or have fluorescent bands or areas at different wavelengths, facilitating the identification of specific parts of the cervical cup and optimizing surgical precision.This device is available in different sizes to adapt to various vaginal and cervical anatomies, as well as to different types of uterine manipulators. It is compatible with advanced imaging systems capable of performing fluorescence surgery and conventional or minimally invasive surgical techniques such as laparoscopies, robotics, or endoscopies.

[0004]

[0003] The invention aims to solve visibility problems during these procedures, especially in conditions of limited visualization, reducing the risk of complications and increasing the accuracy of the colpotomy.

[0005]

[0004] Currently, in clinical practice, colpotomy is a critical procedure during hysterectomy and other gynecological procedures, whether by conventional or minimally invasive surgery such as laparoscopy, robotics, or endoscopy. Precision during vaginal incision can be compromised by inadequate visibility of the cervix, especially under conditions of limited lighting. Conventional instruments do not offer adequate solutions to this challenge, which can result in damage to surrounding tissues and increased surgical time.

[0006]

[0005] US 2021 / 0275257 “Uterine manipulator including position sensor” refers to a uterine manipulator that includes a housing and a shaft extending distally from the housing. An end effector assembly is disposed on a distal end portion of the shaft. The end effector assembly includes a cervical cup and a uterine manipulation tip portion extending distally from the cervical cup. A position sensor is supported by the cervical cup. The position sensor is configured to identify a location within the cervical cup. However, this patient does not address improving visibility of the section site near the cervix through the integration of fluorescent properties into the cervical cup.

[0007]

[0006] WO2014007999 “Cup-shaped structure for colpotomy and intrauterine manipulator including the same” refers to a cup-shaped structure for engaging a patient’s cervix that includes a rim and includes a base that defines an opening through which one or more tubular limbs of a uterine manipulator can extend into the uterus. The cup-shaped structure is made of one or more of a polyphthalamide (PPA) material and a polyetheretherketone (PEEK) material. A uterine manipulator including a cup-shaped structure is also disclosed. However, it does not mention the use of fluorescent agents integrated into the cup material to improve visibility during surgical procedures.

[0008]

[0007] BR 112015022686-8 “Uterine Manipulator” refers to a uterine manipulator system comprising: a collar including a first platform connected to the inner surface of the collar; a stabilizer that includes a stabilizing ring adapted to couple the first platform and a shaft adapted to pass through the stabilizer; and the hollow tube of the collar with a bulbous tip. This patent does not solve the visibility problems associated with colpotomy, as it does not incorporate fluorescence into the cervical cup or any mechanism to improve visualization of the section site near the cervix.

[0009]

[0008] BR 1 12022025994-8 “Uterine Manipulator With Balloon Occluder” refers to a uterine manipulator device that includes: an elongated cannulated tube (5) having proximal and distal ends, a cervical cup positioned over the elongated cannulated tube with a superior distal portion of a first diameter and a proximal base portion of a second smaller diameter, and a balloon occluder assembly. The balloon occlusion assembly can be used independently or positioned proximally from the cervical cup on the elongated cannulated tube. Despite structural improvements, it does not address the issue of visibility through the use of fluorescent materials integrated into the cervical cup.

[0010]

[0009] As evidenced in previous patents, such as US 20210275257 A1 and US 1 1090082 B2, existing colpotomy systems face significant challenges related to this inadequate visibility. These devices generally use non-fluorescent components or only fluorescent labels, which limits their effectiveness in low-light environments. The present invention aims to overcome these limitations by offering a cervical cup with fluorescence integrated into the material, either fully or partially, such as in the distal fluorescent portion, providing a more comprehensive and effective solution to improve visibility during the surgical procedure.

[0010] Unlike the prior art, the object of the present patent presents peculiar characteristics and advantages:

[0011]

[0011] - Significantly improves visibility of the vaginal section area near the cervix during colpotomies, hysterectomies, and other gynecological procedures, reducing the risk of inadvertent injury to adjacent tissues.

[0012]

[0012] - The device can be configured to fluoresce completely or only in its distal portion, with markings at different wavelengths to facilitate the identification of specific parts of the cup during surgery, aiding in spatial orientation and precision of incisions.

[0013]

[0013] - Fluorescence can be passive, activated by specific light sources such as LEDs or lasers, or reactive, depending on the fluorescent agent used, offering flexibility according to the needs of the procedure and the availability of equipment.

[0014]

[0014] - The cup is made of biocompatible, durable polymer suitable for medical use, available in different sizes to accommodate various vaginal and cervical anatomies, and can be disposable or reusable after resterilization, offering a versatile and effective solution for gynecological procedures.

[0015]

[0015] The integration of fluorescence into the cervical cup material does not compromise its mechanical properties, ensuring durability and performance during clinical use.

[0016]

[0016] Figure 1 illustrates a side view of the fluorescent cervical cup, showing the basic structure of the device with the fluorescent structure.

[0017]

[0017] Figure 2 illustrates a cross-section showing the internal arrangement and fluorescence areas, highlighting the uniform distribution of the fluorescent agent in the polymeric matrix.

[0018] Figure 3 illustrates a top view of the cup, highlighting the markings at different wavelengths in the distal portion, which aid in identification and orientation during the procedure.

[0018]

[0019] Figure 4 illustrates a side view of 1 â Variant of the fluorescent cervical cup, showing the basic structure of the device with the fluorescent structure.

[0019]

[0020] Figure 5 illustrates a cross-section of 1 â variant showing the internal arrangement and areas of fluorescence.

[0020]

[0021] Figure 6 illustrates a top view of 1 â A variant of the cup highlighting the markings at different wavelengths in the distal portion.

[0021]

[0022] According to Figures 1 to 6, the present device consists of a main cup-shaped body, manufactured from biocompatible polymer integrated with a fluorescent agent, where the distal portion may have specific markings to aid in surgical guidance.

[0022]

[0023] The cervical cup can be manufactured entirely from a polymer impregnated with a fluorescent agent. The cup emits visible light under special LED or laser illumination, improving visibility of the cervix during colpotomy. The integration of the fluorescent agent during the extrusion or molding process ensures a homogeneous distribution and consistent effectiveness of the fluorescence.

[0023]

[0024] Alternatively, the cervical cup can be manufactured with only the distal portion coated with a fluorescent agent, or with markings at two or more different wavelengths to distinguish between the proximal and distal areas of the cup during the procedure. This allows for customization according to the specific needs of the procedure or the surgeon's preference.

[0024]

[0025] This device can be used in a wide range of gynecological procedures, not only in colpotomies, but also in hysterectomies, myomectomies, and other procedures where visibility of the cervix is ​​critical. Its compatibility with fluorescence imaging systems for conventional, laparoscopic, robotic, or endoscopic surgeries, and augmented reality platforms, enhances its application in conventional or minimally invasive surgeries, whether laparoscopic, robotic, or endoscopic.

[0025]

[0026] The fluorescent cervical cup for uterine manipulators described in this invention represents a significant improvement in the safety and effectiveness of colpotomy procedures. The addition of fluorescence, whether total or partial, and the use of different wavelengths provide superior visibility, essential for surgical precision. The use of biocompatible polymer in different sizes and the possibility of resterilization make this device a versatile solution for modern gynecological practice.

Claims

CLAIMS 1- “FLUORESCENT CERVICAL CUP FOR UTERINE MANIPULATORS”, characterized by comprising a cervical cup (1-6) manufactured from biocompatible polymer integrated with a passive fluorescent agent homogeneously distributed in the polymer matrix during the extrusion or molding or 3D printing process, resulting in a homogeneous distribution of the fluorescent agent throughout the cup structure. 2- “FLUORESCENT CERVICAL CUP FOR UTERINE MANIPULATORS”, according to claim 1, characterized by having an area or areas with different fluorescent wavelengths, where different passive fluorescent agents are added in distinct layers during the injection molding or 3D printing process, allowing the creation of zones with different fluorescent wavelengths within the same cervical cup. 3- “FLUORESCENT CERVICAL CUP FOR UTERINE MANIPULATORS”, according to claims 1 and 2, characterized by containing passive fluorescent nanoparticles encapsulated in microspheres and distributed within the polymeric matrix. 4- “FLUORESCENT CERVICAL CUP FOR UTERINE MANIPULATORS”, according to any of the preceding claims, characterized by using a double injection process, where an outer protective layer is molded over the inner layer containing the passive fluorescent agent. 5- “FLUORESCENT CERVICAL CUP FOR UTERINE MANIPULATORS”, according to claim 1, characterized by having the distribution of the passive fluorescent agent controlled through 3D printing technique, allowing the creation of customized fluorescence patterns for different surgical applications. 6- “FLUORESCENT CERVICAL CUP FOR UTERINE MANIPULATORS”, according to any of the preceding claims, characterized in that the proximal portion and the distal portion, or distal portions, are manufactured separately with different polymer compositions and passive fluorescent agent, and then joined together through thermal fusion or chemical adhesion to create a device with multispectral properties. 7- “FLUORESCENT CERVICAL CUP FOR UTERINE MANIPULATORS”, according to any of the preceding claims, provided as a surgical system characterized by a combination of the fluorescent cervical cup with a uterine manipulator equipped or not with position sensors, where the passive fluorescence of the cervical cup is used to automatically guide the orientation of the manipulator during colpotomy, integrating with surgical imaging and navigation systems. 8- “FLUORESCENT CERVICAL CUP FOR UTERINE MANIPULATORS”, according to any of the preceding claims, characterized by being compatible with imaging systems in conventional or minimally invasive surgeries such as laparoscopies, robotics and endoscopies or augmented reality, where the fluorescence emitted by the cervical cup is captured and processed by imaging software. 9- “FLUORESCENT CERVICAL CUP FOR UTERINE MANIPULATORS”, according to any of the preceding claims, characterized by having an anti-reflective coating on the outer surface, designed to eliminate light artifacts during the capture of fluorescent images in conventional or minimally invasive procedures such as laparoscopies, robotics, or endoscopies. 10- “FLUORESCENT CERVICAL CUP FOR UTERINE MANIPULATORS”, according to any of the preceding claims, characterized by being manufactured from a polymer containing antimicrobial additives, where the passive fluorescent agent also confers antimicrobial properties. 11- “FLUORESCENT CERVICAL CUP FOR UTERINE MANIPULATORS”, according to any of the preceding claims, characterized in that the base polymer is reinforced with carbon fibers or other high-strength material, allowing for a thinner and lighter device without compromising durability. 12- “FLUORESCENT CERVICAL CUP FOR UTERINE MANIPULATORS”, as defined in any of claims 1 to 11, characterized by being available in the form of a surgical kit, consisting of the fluorescent cervical cup, uterine manipulator, suitable light source for activating passive fluorescence and camera with filters to capture emitted light. 13- Method of manufacturing the “FLUORESCENT CERVICAL CUP FOR UTERINE MANIPULATORS”, as defined in any one of claims 1 to 11, characterized by integrating a fluorescent agent into the base polymer during the extrusion, molding or 3D printing process, resulting in a homogeneous distribution of the fluorescent agent throughout the cup structure.

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