BHU INTRACAVITARY HIGH DOSE RATE (HDR) BRACHYTHERAPY APPLICATOR SET FOR TREATMENT OF GYNAECOLOGICAL CANCER

Abstract

The present invention discloses an advanced intracavitary applicator apparatus designed for high-dose rate (HDR) brachytherapy specifically targeting cervical cancer treatment. This innovative apparatus ensures optimal and precise placement of radioactive sources within the patient's anatomy, incorporating a semi-flexible intrauterine tandem and ovoid pairs. Key features include bladder and rectum retractors to minimize radiation exposure to surrounding organs, variable sizes of tandem/ovoids for accommodating a diverse patient population, and a secure plate fixation mechanism to prevent applicator rotation and uterine perforation. Additionally, the apparatus facilitates interstitial implants for effectively addressing larger and asymmetical tumors around the cervix. The applicator is fabricated using biocompatible materials through additive manufacturing techniques, ensuring compatibility with imaging modalities such as CT and MRI. Present invention aims to enhance treatment efficacy while prioritizing patient safety, offering a comprehensive solution for cervical cancer therapy through precise radiation delivery.

Specification

Description:FIELD OF THE INVENTION
The present invention relates to an intracavitary applicator apparatus. More specifically, it pertains to an applicator apparatus for high-dose rate (HDR) brachytherapy in the treatment of cervical cancer, facilitating optimal and precise source placement within the patient. The applicator apparatus features a rigid structure with flexibility in the intrauterine tandem and includes bladder/rectum retractors to reduce the dose to organs at risk (OARs).
BACKGROUND OF THE INVENTION
Intracavitary brachytherapy (ICBT) applicators are medical devices used to guide a radioactive source in and around the cervical region tumor to deliver a high radiation dose. The selection of a brachytherapy applicator to deliver an adequate dose to the tumor depends on the stage of cervical cancer and the patient's anatomy. Furthermore, the choice of the applicators is also based on the imaging modalities to be used for applicator reconstruction and treatment planning.
In the past five decades, commonly used intracavitary applicator shapes have included ovoids, rings, and cylinders with a central intrauterine tube. These shapes are designed to obtain a historically standard pear-shaped dose distribution, when the dose normalized to Point A as per Manchester System in intracavitary brachytherapy. Also, the tandem diameter of the intracavitary applicator depends on the size of the radioactive active source. For advanced-stage cervical cancer, a hybrid applicator, which combines intracavitary (IC) and the interstitial applicator is used to treat the disease in the region of the cervix, vagina, and lateral parametrium. Presently, various types of commercial applicators like Tandem-Ovoid, Tandem-Ring, Mold applicators, hybrid applicators, Static/Dynamic Intensity modulated brachytherapy (S/D-IMBT) applicators, and three-dimensional (3D) printed applicators, are used for the treatment of cervical cancer patients.
Initially, the applicators were made of rubber which was subsequently replaced with metal and plastic. The metallic applicators produce streak artifacts in CT images, and they are not MRI-compatible. Therefore, the selection of applicator material becomes important depending upon the imaging modalities (CT, MRI, and Ultrasound) used to visualize the applicator position relative to patient anatomy.
Therefore, the need of the hour is to have CT, MRI compatible applicators which can be easily accommodated inside the uterus and fornices. The 3D printing technology has enabled users to design BT applicators that are patient-tailored with fixed geometry applicators (Tandem-Ovoid, Tandem-Ring, and Tandem Cylinder) as an alternative to commercial applicators. In Tandem-Ovoid based ICBT Applicators, Ovoids are available in different diameters to fit them snugly in the fornices. An intrauterine tube (6) has variable lengths and angles according to the size of the uterus. There are many instances wherein it has been observed that the ovoid got displaced, and the rigid uterine tandem has perforated the uterus issues. Each of these applicators has their own set of advantages or disadvantages.
To overcome the drawbacks of the prior intracavitary applicator, the present invention provides a low cost intracavitary applicator apparatus with fixed ovoid and intrauterine tandem designs. In addition, a vaginal speculum is incorporated with the applicator to reduce the radiation dose to the organ at risk during treatment. Another factor in developing an in-house applicator system using a 3D printer is to reduce the cost of the applicator set and provide cost-effective treatment for destitute patients.
OBJECTIVES OF THE INVENTION
Accordingly, it is the primary object of the present invention to provide an improved high dose rate (HDR) brachytherapy intracavitary applicator apparatus for cervical cancer patients.
Another objective of the present invention is to provide an intracavitary applicator apparatus with variable sizes of semi-flexible intrauterine tandem and ovoid tandem pairs to accommodate a diverse range of patients.
Yet another objective of the present invention is to provide an organ retractor to protect and shield nearby organs from radiation exposure.
Still another objective of the present invention is to ensure the secure placement of the applicator in the uterus and preventing rotation within the body, while minimizing the risk of uterine perforation.
Additionally, the present invention aims to provide a facility of interstitial implants to effectively cover large tumor, and advance stages of cervical cancer.
SUMMARY OF THE INVENTION
This summary is provided to introduce a selection of concepts, in a simplified format, that are further described in the detailed description of the invention. This summary is neither intended to identify key or essential inventive concepts of the invention and nor is it intended for determining the scope of the invention. To further clarify advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof, which is illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail with the accompanying drawings.

Accordingly, the present invention relates to an intracavitary applicator apparatus for high dose rate (HDR) brachytherapy for the treatment of gynaecological cancer and the method of use thereof.
In a preferred embodiment, the intracavitary applicator apparatus for high dose rate brachytherapy system comprising a semi-flexible ovoid tandem pair consisting of a left ovoid tandem and a right ovoid tandem, an intrauterine rectangular tandem having a fixed cervical stopper at the front end, a vaginal speculum, and a vaginal cylinder with a fixation plate.
In an embodiment, the semi-flexible ovoid tandem pair and an intrauterine tandem are of variable sizes accommodating a diverse range of patients. The applicator comprising an ovoid tandem pair facilitating the interstitial implant tube, making it suitable for the treatment of advanced stage cancer. These applicators are precisely sized and shaped to ensure optimal placement within the patient for optimal results.
In another embodiment, the designed vaginal speculum of the brachytherapy applicator is inserted to dilate and view the cervix to facilitate the placement of intrauterine rectangular tandem, semi-flexible ovoid tandem pair. The vaginal speculum is an intricate part of the method of insertion of the applicator, and it acts as a retractor for organs at risk (OARs). The top and bottom surface of the vaginal speculum is used to retract the bladder and rectum respectively to minimize the radiation dose. The intrauterine tandem is a hollow rectangular structure comprising a intrauterine tube (6) used as a guide for the movement of HDR source. The semi-flexible ovoid tandem pair is inserted sequentially wherein the left ovoid tandem is inserted first followed by the placement of the right ovoid tandem, and interlocking of these three parts within the vaginal cavity to prevent the rotation and slippage. The hollow rectangular intrauterine tandem has a fixed cervical stopper at the front end ensuring that the intrauterine tandem does not go beyond the uterine canal and prevents the perforation of uterus at the end of fundus.
Yet in another embodiment the fixation plate is used after intracavitary applicators placement wherein a perennial cap is used to fasten the intracavitary applicator around the patient's waist during treatment and immobilize from any type of rotation or translation during treatment. The fixation plate maintains the geometry of the intrauterine tandem and ovoid tandems in the vaginal cavity while securing the retractors. It can also be modified for the additional placement of interstitial needles in further stages of applicator development.
Yet in another embodiment, the intracavitary applicator for HDR brachytherapy system is designed with CAD software and prototypes are fabricated using the applicator apparatus is fabricated using additive manufacturing by an HP MJF printer, it is a selective laser sintering method in which material is in the powder form. The material used is polyamide 12 which follows the biocompatibility standards of ISO.
BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWING
The drawings described herein are for illustrative purposes only of selective embodiments and not all possible implementations and are not intended to limit the scope of the present disclosure. The invention itself, however, both as to organize and method of operation, may best be understood by reference to the detailed description which follows taken in conjunction with the accompanying drawings in which:
Fig. 1 shows the HDR applicator full assembly for cervical carcinoma,wherein
Fig. 1a shows the Interstitial Implant ovoids.
Fig. 2 shows full assembly view of the applicator, wherein
Fig 2(a) shows perspective view of the applicator for accommodating the ovoid tandem pair and intrauterine rectangular tandem
Fig. 2(b) shows side view of the applicator
Fig. 2(c) shows back view of the applicator, representing the fixation plate.
Fig. 3(a) shows an Intrauterine (IU) tandem (10) for insertion in the uterus.
Fig. 3(b) shows isometric view of the Intrauterine tandem.
Fig. 4 illustrates left ovoid tandem, wherein
Fig. 4(a) illustrates side view of left ovoid tandem
Fig. 4(b) illustrates top view of left ovoid tandem
Fig. 4(c) illustrates perspective view of left ovoid tandem
Fig. 4(d) illustrates left ovoid with the interstitial implant needle fixation
Fig. 4(e) illustrates left ovoid tandem with the interstitial tube holding fixation component.
Fig. 5 illustrates left ovoid tandem, wherein
Fig. 5(a) shows side view of the right ovoid tandem of the intracavitary applicator
Fig. 5(b) illustrates top view of the right ovoid tandem of the intracavitary applicator
Fig. 5(c) illustrates isometric view of the intracavitary right ovoid tandem pair
Fig. 5(d) illustrates right ovoid with the interstitial implant needle fixation holes
Fig. 5(e) illustrates right ovoid tandem with the interstitial tube holding plastic fixation.
Fig. 6 illustrates Vaginal cylinder, wherein
Fig. 6(a) illustrates the isometric view of the vaginal cylinder
Fig. 6(b) illustrates the side view of the vaginal cylinder.
Fig. 7 illustrates the vaginal speculm and organ retractor, wherein
Fig. 7(a) illustrates the perspective view of the vaginal speculum assembly
Fig. 7(b) illustrates the side view of vaginal speculum.
Fig. 8 illustrates the fixation plate for the applicato, wherein
Fig. 8(a) illustrates the front view of fixation plate
Fig. 8(b) illustrates the side view of fixation plate.
Fig. 9 illustrates the placement of Intrauterine tube, left ovoid tandem, right ovoid tandem and cylinder, wherein
Fig. 9(a) represents the placement of left ovoid tandem on the Intrauterine tandem
Fig. 9(b) represents the placement of right ovoid tandem on the Intrauterine tandem after placement of left Ovoid tandem
Fig. 9(c) represents the placement of the vaginal cylinder for the fixation of all the tandem and ovoid.

Fig.10 represents view for ovoids with interstitial implant tube fixation component, wherein
Fig. 10(a) illustrates top and back side view of ovoid with interstitial implant tube.
Fig. 10(b) illustrates the component holding the guide tube for the insertion of interstitial implant tube.
DETAILED DESCRIPTION OF THE INVENTION
The present invention will now be described hereinafter with reference to the accompanying drawings in which a preferred embodiment of the invention is shown. This invention may, however, be embodied in many different forms and should not be construed as being limited to the embodiment set forth herein. Rather, the embodiment is provided so that this disclosure will be thorough, and will fully convey the scope of the invention to those skilled in the art.
Many aspects of the invention can be better understood with references made to the drawings below. The components in the drawings are not necessarily drawn to scale. Instead, emphasis is placed upon clearly illustrating the components of the present invention. Moreover, like reference numerals designate corresponding parts through the several views in the drawings. Before explaining at least one embodiment of the invention, it is to be understood that the embodiments of the invention are not limited in their application to the details of construction and to the arrangement of the components set forth in the following description or illustrated in the drawings. The embodiments of the invention are capable of being practiced and carried out in various ways. In addition, the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting.
The present invention discusses an intracavitary applicator apparatus (100) for high dose rate (HDR) brachytherapy system for the treatment of cervical cancer with optimal and precise placement within the patient.
Figure 1 illustrates the full assembly of an applicator apparatus (100), in accordance with the concept of the present disclosure. The intracavitary applicator apparatus (100) is for high dose rate (HDR) brachytherapy for the treatment of gynaecological cancer in the patient. The applicator apparatus (100) as disclosed in the present invention comprises an intrauterine tandem (10), a semi-flexible ovoid tandem pair (20,30), and also has provision for ovoid tandem pair with interstitial implant tube (20.1, 30.1) (fig 4d, 5d ) facility for the advanced stage tumor, a vaginal speculum (50) and a vaginal cylinder (40) with a fixation plate (60).
Figure 2(a, b and c) illustrates the perspective, side and back view of the applicator, accommodating the ovoid tandem pair and intrauterine rectangular tandem and a tightening screw (53) for speculum(50).
Figure 3(a and b) illustrates the intrauterine rectangular tandem (10), having an open end portion (7) facilitates the insertion of required radioactive source which delivers the radiation dose to the tumor. The intrauterine rectangular tandem (10) is a hollow rectangular tube having a cervical stopper (1) of 10 mm diameter at a fixed uterine length, and is placed at the front end of the rectangular tandem part of IU tube (10). The intrauterine tandem (10) has a rectangular cross-section of 6x6 mm in size and a tubular cross-section (6) beyond cervical stopper (1) with outer diameter of 4 mm at an angle of 15, 30, and 45 degrees (4) with a variable length of 40 mm, 50 mm, and 60 mm. The intrauterine rectangular tandem (10) is a hollow structure having a through passage of 2 mm diameter for the movement of HDR source, with an open end (7) for connection to transfer tubes and a closed end (2) covered with a fixed cap. The total length of the intrauterine rectangular tandem (10) is 300 mm, with the length of the tube (6), which is to be inserted in the uterus can be of variable uterine size ranging from 40-60 mm length. The intrauterine tube (6) is angled (4) at 15 degrees from the body's anatomical base. The intrauterine tandem (10) has indicated with a number (3) which is used as a safety feature during the insertion as well as treatment planning. The standard transfer tube for ICR applicators are made such that it is attached to the tandem having same number marking.
The semi-flexible ovoid tandem pair consists of a left ovoid tandem (20) and a right ovoid tandem (30) is inserted sequentially into the vagina, wherein the left ovoid tandem (20) is inserted first followed by the right ovoid tandem (30). Each ovoid tandem has a dimension of 20mm x 20mm x 30 mm (length x width x height).
Referring to figures 4a, 4b and 5a, 5b, left ovoid tandem (20) and right ovoid tandem (30) having dimensions of 20mm x 20mm x 30 mm (length x width x height). The length of the left ovoid tandem (20) and right ovoid tandem (30) is 20 mm and is marked as (22) and (32) respectively, the width is 20 mm and marked as (23) and (33) respectively, and the height is 30 mm and marked as (21) and (31) respectively. Further, the width marked (23) and (33) of the ovoid pairs (20, 30) varies according to the size of the vagina.
The markings on the ovoid tandem pairs (20,30) indicate the insertion sequence of the ovoids. The left ovoid tandem (20) is marked with one horizontal line (29) indicating one and the right ovoid tandem (30) marked with two horizontal line (37) indicating second. These markings also help in treatment planning.
The path of the HDR source within both ovoid tandem pair (20,30) is towards the adjacent surface of vaginal fornices to achieve optimal dose distribution, maintaining a center distance of 5 mm from the surface. Both ovoid tandem pair (20, 30) are geometrically designed with specific angles of 13 degrees from the top surface (25) (35) and the other at 10 degrees from the side surface (24) (34) of the axis of the tandem.
Referring to figures 4c and 5c, the ovoid tandem pair (20,30) features a ring structure, wherein the left ovoid tandem (20) has a guide ring (26) of diameter 11 mm and is placed at the top side of the ovoid face (27) having width of 5 mm. The guide ring (26) of diameter 11 mm is made to accommodate and fix at the cervical stopper (1). The space (28) below the guide ring (26) allows accommodation of the right ovoid tandem ring (39). The ring (39) is positioned below the first ring (26) and locked with the cervical stopper (1). The space (36) in the right ovoid tandem (30) is to accommodate the guide ring (26) and fix it inside the cavity to interlock in its place.
Referring to figures 4d and 5d, for the advanced stage tumor to cover a large volume, the ovoid tandem with the provision of interstitial needles is used. Referring to figure 4d, the left ovoid tandem with the provision of the interstitial needle is shown. The interstitial needles are inserted with the help of a guide tube, the guide tube is a hollow flexible nylon tube of 3mm outer diameter and a 2mm inner diameter, wherein the ends of the guide tube (guide tube is purchased from external vendor) are fitted in a fixation component (70).
Referring figures 4e and 5e, the fixation component (70) designed (shown in fig. 10 b) to be snap-fitted in the cutouts (20.1) (30.1) of the ovoid tandem. Each ovoid tandem has 3 interstitial holes placed at a distance of 7 mm from each other along the height of the ovoid. The fixation component holding guide tubes are fitted in ovoid (20.2, 30.2), to facilitate the insertion of plastic interstitial needles to reach the tumor at distal end.
As shown in figures 6a and 6b, the vaginal cylinder (40) having a diameter (41) of 24 mm has three rectangular cut out for accommodating the ovoid tandem pair (20, 30) and intrauterine rectangular tandem (10) which is used to immobilize the entire applicator apparatus and to prevent axis rotation of applicator. The cylinder (40) has an extension (43) which is a cutout supporting the intrauterine tandem(10). The extension (43) ends inside the space (38) of the ovoid. The vaginal cylinder (40) has multiple threads for fixing screws. The length of the cylinder head (42) is 50-70 mm. The length of extension (43) varies according to the size and the applicator ranging from 40 mm - 50 mm in length.
Referring to figures 7a and 7b, as illustrated, vaginal speculum (50) is an integral part of the apparatus, and is used to dilate the vaginal muscles for the visibility of the cervix and placement of intrauterine tandem. The size of the vaginal speculum (50) is made according to the size of the applicator apparatus. The speculum (50) has top surface (51) and bottom surface(52) for the retraction of organ bladder and rectum respectively, and securing position with the help of a screw (53). The speculum (50) is fixed to the vaginal cylinder (40) by a screw from the through holes (54). In this applicator apparatus it is tried to simplify the process of insertion and protect organs at risk by integrating the functionality of specum and retractors.
As shown in figures 8a and 8b, the fixation plate (60) is fitted over the vaginal cylinder (40) and locked with the help of screw (64). The fixation plate (60) has a cutout (62) for the placement of the vaginal cylinder (40) and it also has a C cutout (63), for placing the urinary catheter. The thickness of the fixation plate (60) is 5mm. After the placement of the fixation plate(60), the applicator (100) is tied to the patient body using a T-bandage with the cutouts (61) provided to hold and tie the T bandage to the patient and immobilise the applicator
Figures 9a, 9b, and 9c shows the placement of intrauterine tube, left ovoid tandem, right ovoid tandem, and cylinder, wherein the left ovoid tandem (20) is inserted first, followed by the right ovoid tandem (30), and subsequently the placement of vaginal cylinder (40) is done after all the parts are fitted to immobilize the entire applicator apparatus and to prevent axis rotation of applicator.
Figure 10a represents the top and back view of ovoid pairs (20,30) with interstitial fixation component fitted (20.2, 30.2) and fig. 10b shows the fixation component (70) for holding the guide tube (externally purchased tube) for the insertion of interstitial implant tube. The length of the fixation component at the end of guide tube is having length (70.1) of 10 mm, inner diameter (70.2) of 3 mm, and an outer diameter (70.3) of 5 mm. The component (70) is push fitted to the hollow guide tube of dimension 3 mm of outer diameter and 2 mm inner diameter to facilitate the implant needle insertion inside the guide tube. Once all the guide tubes are fixed the fixation component is snap fitted in the ovoid ends (20.2, 30.2) and remains snugly fitted providing the path for interstitial needle placement.
The applicator apparatus is fabricated using additive manufacturing by an HP MJF printer, it is a selective laser sintering method in which material is in the powder form. The material used is polyamide 12, which follows the biocompatibility standards of ISO.
A Method of performing intracavitary high dose rate brachytherapy applicator apparatus for the treatment of cervical cancer are as follows:
- The method begins with a comprehensive evaluation of the patient's medical history, cancer staging, and imaging studies (CT, MRI, or ultrasound) to determine the extent of the tumor and suitability for intracavitary HDR brachytherapy. The above evaluation procedure ensures the correct placement and use of an intracavitary high dose rate (HDR) brachytherapy applicator for effective treatment delivery. A consent is obtained from the patient, after discussing the procedure, potential risks, benefits, and alternatives. Following that the patient is placed under general or regional anaesthesia to ensure comfort and immobility during the applicator insertion procedure.
- A Foley catheter is inserted to ensure the patient has an empty bladder. Positioning the patient in the lithotomy position, clean and drape the perineal area using a sterile technique. The whole applicator apparatus assembly is placed in cidex solution for sterilization before patient use or sterilized with plasma sterilization.
- The vaginal speculum is inserted to view the cervical ostium (os). A uterine sound is used to measure the depth of the uterine cavity for the selection of appropriate size and type of intracavitary applicator. Also, the selection of ovoid size applicator is based on patient vagina space, depth of fornices. The central intrauterine tandem is gently inserted through the cervix into the uterine cavity, followed by positioning the semi-flexible ovoid tandem in the vaginal fornices to ensure good contact with the vaginal mucosa. The intrauterine tandem and ovoid tandem pair are secured in place using the vaginal cylinder. The vaginal speculum is part of the treatment as it functions as a rectal and bladder retractor. A fixation plate is used to hold the cylinder and speculum in place, ensuring that the entire applicator assembly is immobilized with a T bandage. In this setup, the whole applicator ensures fixed positioning during the CT scan and treatment of the patient.
- The procedure begins with inserting the metal vaginal speculum (50) to retract the rectal and bladder organs, followed by dilating the vagina to view the cervix. Subsequently, a uterine sound is used to measure the depth of the uterine cavity and the length of the uterus, allowing for the selection of the appropriate intrauterine tandem length. Following this, the intrauterine rectangular tandem (10) is inserted, with the left ovoid tandem (20) inserted first, followed by the right ovoid tandem (30).
- Once all the tandems are inserted and properly positioned, the vaginal cylinder (40) is then inserted, followed by the designed vaginal speculum (50). This vaginal cylinder is designed to secure the position of the intrauterine rectangular tandem. The vaginal speculum is fixed in place with the help of a screw over the vaginal cylinder (53).
Finally, fit the fixation plate (60) over the vaginal cylinder and lock it in position using a screw to secure the fixation plate. A T-shaped bandage made of cotton string is tied around the patient in the pelvic region and fixed by placing it through the holes of the fixation plate. The entire applicator assembly is immobilized with a T-shaped bandage, which fixes the ICBT applicator to the patient and prevents any rotational movement of the applicator within the cavity or around its axis.
ADVANTAGES OF THE INVENTION
• An advantage of the present invention is to provide an intracavitary applicator for HDR brachytherapy system which is safe, cost-effective, and compatible with Ultrasound, Computed Tomography (CT) and Magnetic Resonance Imaging (MRI) technologies.
• Another advantage of the present invention is to provide a high dose rate (HDR) brachytherapy for cervical cancer.
• Another advantage of the the present invention is that it facilitates optimal and precise source placement within the patient gynaecological cancer.
• The present invention provides an intracavitary applicator appartus having facility for interstitial implants to cover large tumor.

SPECIFIC EMBODIMENTS OF THE PRESENT DISCLOSURE:
The present disclosure relates to a intracavitary applicator apparatus (100) for high-dose rate brachytherapy, wherein the apparatus comprising:
a. a semi-flexible ovoid tandem pair consisting of a left ovoid tandem (20) and a right ovoid tandem (30);
b. a hollow intrauterine rectangular tandem (10) having a fixed cervical stopper (1) and an intrauterine tube (6) of variable length at front end;
c. a vaginal speculum (50); and
d. a vaginal cylinder (40) having a fixation plate (60),
wherein,
the left ovoid tandem (20) having a ring-like structure (26) at the top end is inserted first followed by the right ovoid tandem (30) having a guide ring-like structure (39);
the left ovoid tandem (20) ring-like structure (26) is suitable for being interlocked to the ring (39) of the right ovoid tandem (30) inside vaginal cavity for immobilization and covering the cavity area; and
each ovoid tandem pair having three interstitial holes placed centrally at a distance of 7 mm along the height of the ovoid for the placement of interstial needles in case of large tumors.
Such intracavitary applicator apparatus (100) is disclosed, wherein the semi-flexible ovoid tandem pair (20, 30) having length 20mm, width 20mm such that it varies according to the size of vagina covering 20 to 50 mm of the area and height 30 mm accommodating with a diverse range of patients, and wherein the ovoid tandem pair (20, 30) are at a specific angle of 13 degrees from top surface and the other at 10 degrees from the side surface of the axis of the tandem.
Such intracavitary applicator apparatus (100) is disclosed, wherein the ovoid tandem is suitable for insertion of interstitial needle with the help of a guide tube, wherein the guide tube is being fitted within a component that is fitted in cutouts of the left ovoid tandem (20).
Such intracavitary applicator apparatus (100) is disclosed, wherein the intrauterine rectangular tandem (10) has length of 300 mm, and has an open front end suitable for connecting to a transfer tube and a back end covered by a fixed cap.
Such intracavitary applicator apparatus (100) is disclosed, wherein the intrauterine tube (6) length is in the range of 40-60 mm and is adjustable and fixed using the cervical stopper (1) and wherein the intrauterine tube (6) guides the movement of HDR source.
Such intracavitary applicator apparatus (100) is disclosed, wherein the intrauterine tube (6) is angled at a range of 15, 30 and 45 degrees from the base of the body and the placement covers the large tumor size.
Such intracavitary applicator apparatus (100) is disclosed, wherein the vaginal speculum (50) is capable of being dilating the vaginal muscles, performing retraction of organs such that bladder and rectum and insertion of the ovoid tandem pair (20, 30) and the intrauterine tandem (10).
Such intracavitary applicator apparatus (100) is disclosed, wherein the vaginal cylinder (40) having an extension (43) comprising of three rectangular cutouts to accommodate the ovoid tandem pair (20, 30), and the intrauterine rectangular tandem (10).
Such intracavitary applicator apparatus (100) is disclosed, wherein the fixation plate (60) is fitted over the vaginal cylinder (40) and immobilizes the position with the help of a screw (64) and wherein the fixation plate has a C cutout (63) for placing the urinary catheter.
Such intracavitary applicator apparatus (100) is disclosed, wherein the applicator apparatus (100), after the placement of the fixation plate (60) is tied to the patient body using a T-bandage with the cutouts (61) provided to hold and tie the T bandage to the patient and immobilize the applicator.
List of reference numericals
100 Intracavitary applicator apparatus full assembly
1 Cervical stop
2 end point and cover of IU tube
3 marking on tube for identification
4 the angle of IU tube, varying angles (15°, 30°, 45°)
5 Total length of IU tandem
6 intrauterine tube(IU)
7 Represents a source path, its a through hole in IU tandem.
10 Intrauterine rectangular tandem
20 Left ovoid tandem
30 Right ovoid tandem
21 Height of ovoid (30 mm ) - fixed for all sets of ovoids
22 Length of ovoid (20 mm) - fixed for all sets of ovoids
23 width of ovoid (10 , 15, 20, 25 mm)
24 10 degree angle
25,35 13 degree angle
26 Guide and fixation ring
27 Width of the ring (5mm)
28 Cutout space below ring for fitting
29 Left ovoid tandem marked as one
26 Ovoid tandem guide ring
31 Height of ovoid (30 mm ) - fixed for all sets of ovoids
32 Length of ovoid (20 mm) - fixed for all sets of ovoids
33 width of ovoid (10 , 15, 20, 25 mm) - varies according to size of vagina
34 10 degree angle
36 Space of 5 mm from top surface to the guide ring
37 Right ovoid tandem marked as two
38 Cut out space below the ring
39 Ovoid tandem guide ring
40 Cylinder
41 Cylinder part holding tandems
42 Cylinder head part having threaded holes
43 Extension
50 Vaginal speculum
51 Top surface for Bladder retractor
52 Bottom surface for rectum retractor
53 Tightening screw for speculum
54 Through hole for screw
60 Fixation plate
61 T-bandage spacing
62 spacing in fixation plate to fit on vaginal cylinder
63 Urinary catheter space
64 Hole for screw placement
70 Fixation Component
, Claims:We claim:
1. An intracavitary applicator apparatus (100) for high-dose rate brachytherapy, wherein the apparatus comprising:
a. a semi-flexible ovoid tandem pair consisting of a left ovoid tandem (20) and a right ovoid tandem (30);
b. a hollow intrauterine rectangular tandem (10) having a fixed cervical stopper (1) and an intrauterine tube (6) of variable length at front end;
c. a vaginal speculum (50); and
d. a vaginal cylinder (40) having a fixation plate (60),
wherein,
the left ovoid tandem (20) having a ring-like structure (26) at the top end is inserted first, followed by the right ovoid tandem (30) having a guide ring-like structure (39);
the left ovoid tandem (20) having ring-like structure (26) is suitable for being interlocked to the ring (39) of the right ovoid tandem (30) inside vaginal cavity for immobilization and covering the cavity area; and
each ovoid tandem pair having three interstitial holes placed centrally at a distance of 7 mm along the height of the ovoid for the placement of interstial needles in case of large tumors.
2. The intracavitary applicator apparatus (100) as claimed in claim 1, wherein the semi-flexible ovoid tandem pair (20, 30) having length 20mm, width 20mm such that it varies according to the size of vagina covering 20 to 50 mm of the area and height 30 mm accommodating with a diverse range of patients, and wherein the ovoid tandem pair (20, 30) are at a specific angle of 13 degrees from top surface and the other at 10 degrees from the side surface of the axis of the tandem.

3. The intracavitary applicator apparatus (100) as claimed in claim 1, wherein the ovoid tandem is suitable for insertion of interstitial needle with the help of a guide tube, wherein the guide tube is being fitted within a component that is fitted in cutouts of the left ovoid tandem (20).

4. The intracavitary applicator apparatus (100) as claimed in claim 1, wherein the intrauterine rectangular tandem (10) has length of 300 mm, and has an open front end suitable for connecting to a transfer tube and a back end covered by a fixed cap.

5. The intracavitary applicator apparatus (100) as claimed in claim 1, wherein the intrauterine tube (6) length is in the range of 40-60 mm and is adjustable and fixed using the cervical stopper (1) and wherein the intrauterine tube (6) guides the movement of HDR source.

6. The intracavitary applicator apparatus (100) as claimed in claim 1, wherein the intrauterine tube (6) is angled at a range of 15, 30, and 45 degrees from the base of the body and the placement covers the large tumor size.

7. The intracavitary applicator apparatus (100) as claimed in claim 1, wherein the vaginal speculum (50) is capable of being dilating the vaginal muscles, performing retraction of organs such that bladder and rectum and insertion of the ovoid tandem pair (20, 30) and the intrauterine tandem (10).

8. The intracavitary applicator apparatus (100) as claimed in claim 1, wherein the vaginal cylinder (40) having an extension (43) comprising of three rectangular cutouts to accommodate the ovoid tandem pair (20, 30), and the intrauterine rectangular tandem (10).

9. The intracavitary applicator apparatus (100) as claimed in claim 1, wherein the fixation plate (60) is fitted over the vaginal cylinder (40) and immobilizes the position with the help of a screw (64) and wherein the fixation plate has a C cutout (63) for placing the urinary catheter.

10. The intracavitary applicator apparatus (100) as claimed in claim 1, wherein the applicator apparatus (100), after the placement of the fixation plate (60) is tied to the patient body using a T-bandage with the cutouts (61) provided to hold and tie the T bandage to the patient and immobilize the applicator.

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