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Applicator Device Assembly With Adjustable Features For Assisting Brachytherapy Treatment Of Gynaecological Cancers

Abstract: The present disclosure relates to an applicator device assembly with adjustable feature and optional attachments for assisting a brachytherapy treatment. The applicator device assists in performing a brachytherapy treatment, for treating vault/vaginal cancer patients. In particular, the applicator device is employed for targeting the tumor tissue developed in the vault/vaginal of the patient. The applicator device assembly as disclosed in the present disclosure, includes a cylindrical template [102], a threaded central platform [104], a first small ring [106] and a second bigger ring [108].

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Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
12 July 2021
Publication Number
09/2023
Publication Type
INA
Invention Field
BIO-MEDICAL ENGINEERING
Status
Email
patent@saikrishnaassociates.com
Parent Application

Applicants

GLOBAL HEALTH LIMITED
18, Block E, Defence Colony, New Delhi, Delhi 110024, India.

Inventors

1. Susovan Banerjee
H- 1564(SF), CR Park, New Delhi 110 019.
2. Venkatesan Kaliyaperumal
1076 (1st Floor), sector 38, Islampur Village, Gurugram, Haryana 122001
3. Tejinder Kataria
Brich Court 18, Nirvana Country, Sector 50, Gurugram, HARYANA 122018
4. Deepak Gupta
C 201 Rail Vihar, IRWO Westend Tower, sector 47, Gurugram, Haryana 122018

Specification

The present disclosure relates to the field of medical devices, in particular, to an applicator device assembly for assisting brachytherapy treatment in female genital tract cancers, more particularly for treating vault/vaginal cancer patients. BACKGROUND OF THE INVENTION
Radiotherapy is the treatment for recurrent vaginal vault cancers, and primary vaginal cancers. The first part of treatment is External beam Radiotherapy (with or without Concurrent Chemotherapy) followed by brachytherapy. Interstitial Image Guided Adaptive Brachytherapy (IGABT) in advanced gynaecological cancers is increasingly recognized as the new paradigm worldwide. The core of IGABT is assessment of tumour response during radiotherapy and adaptive tailoring of the brachytherapy boost according to the individual tumour response. Interstitial brachytherapy means placing hollow catheters/needles (through which the radioactive source can pass) within the tumour volume so that the tumors can get a very high conformal curative dose. The disease and normal structures can be contoured and a curable dose can be delivered. It is more important to use IGABT in cases where interstitial needles are used to treat the paravaginal or para cervical tissue, in tumours more than 0.5 cm thickness residual disease after external radiotherapy.
Depending on disease extent, a simple intracavitary/intravaginal application along with/without interstitial needles can be performed. Use of interstitial techniques in vault/vaginal cancer patients with residual disease after External beam radiotherapy (EBRT) gives rewarding results in terms of Local control of disease- and disease-free survival. The prime goal is to treat the residual disease in the vault/vagina delivering a curative dose and least dose to surrounding normal organs by use of interstitial needles to sculpt the dose of brachytherapy.
Various types of applicator devices are known in market, for performing

the IC+IS technique of brachytherapy treatment. One such applicator device is a Martinez perineal interstitial Template (MUPIT) type applicator device. This MUPIT type applicator device includes a multi-component plate-type template unit, and a tandem unit. The template unit is made up of multiple components, which are arranged together, and defines at least one central cylinder and a plurality of catheter routing holes. For performing the interstitial (IS) technique of brachytherapy treatment by the IGABT technique in post operative cancer cervix or cancer vagina treatment, the cylinder is inserted into the vagina of the patient while the bulky template abuts with an external perinium skin of the patient. Thereafter, the cylinder unit is installed and locked into the central hole of the template. Upon such positioning, a plurality of catheters (needles) are routed through the plurality of catheter routing holes of the template, to reach and pierce through the tumor tissue. The template unit is then assembled together with help of other accessories provided. After such positioning, the assembled template is stitched to the external skin of the vagina of the patient, for proper positioning. Thereafter, the radioactive source is exposed through the catheter needles to the tumor tissue, to perform tumor treatment thereon. Notably, the template of such MUPIT type applicator device is made up of multiple components, that are cumbersome to assembled together during the procedure/surgery. Although made of multiple components, its cylinder is fixed in length and cannot be customised according to individual patient's vaginal length. The divergent needles needs to be applied from perinium making them less accurate with increasing distance of disease at the vaginal vault. Furthermore, the plate-type template unit is stitched to the external skin and hangs outside of the vagina of the patient after performing the surgery, which is painful for the patient. The plurality of catheter routing holes in the template unit of such MUPIT type applicator device allows the catheter needles to be routed in a prefixed longitudinal direction and a lateral direction. The catheter needles used in the MUPIT applicator device are often obstructed by bones in

between due to their long path from the template to the target region of the tumor tissue in the cervix. Furthermore, the steel needles are not compatible to CT imaging or MRI imaging making identification of the disease difficult in the planning scan. Overall, it results in cumbersome and time consuming process, more chances of bleeding, increased pain for the patient limits its use in many centers.
Another type of the applicator device is Template Benidorm applicator. Besides having a bulky perineal template which is painful for the patient, it has lesser number of needle options which limits its reach to entirety of the tumor tissue in the cervix of the patient. Moreover, other types of applicator devices such as Venezia applicator and 3D printed customised templates incur higher costs of the treatment and unavailability of such applicator devices limit their use in many centers.
Accordingly, in light of the aforementioned problems, drawbacks and several other inherent shortcomings in the existing arts, there is a need to provide an improved robust applicator device, which requires relatively less effort and time for performing the brachytherapy treatment, while allowing for a greater reach to the tumor tissue developed in the vaginal vault of a patient. There is also a need felt to customise the length of the vaginal cylinder according to patient's size, and make the template/ applicator less bulky to meet patient's compliance and comfort. Further, there is a need to make the template/ applicator MRI (Magnatic resonace imaging) compatible for better treatment plans. OBJECTS OF THE PRESENT INVENTION
This section is provided to introduce certain aspects of the present disclosure in a simplified form that are further described below in the detailed description. This summary is not intended to identify the key features or the scope of the claimed subject matter.
In view of the shortcomings of the existing devices, there exists a need

for an applicator device for assisting brachytherapy treatment.
An object of the present disclosure is to provide an applicator device for cost effective treatment of vaginal/vault cancer.
Another object of the present disclosure is to provide an applicator device which is smaller in size and capable of being assembled according to the requirement.
Yet another object of the present disclosure is to provide an applicator device that reduces pain and bleeding during treatment of the patient.
Yet another object of the present disclosure is to provide an applicator device having more needle inserting options so that a predefined target area can be implanted with brachytherapy catheters/ needles with more accuracy.
The present disclosure also focuses on the need to make entry points of such catheters/needles nearer to the target that will make them more accurate. SUMMARY OF THE PRESENT INVENTION
An aspect of the present disclosure relates to an applicator device assembly (100) for brachytherapy treatment comprising: (a) a cylindrical template (102); (b) a threaded central platform (104); (c) a first ring (106); and (d) at least a second ring (108), wherein the threaded central platform (104) allows for adjusting the length of the device (100); and wherein the first ring (106) and at least the second ring (108) comprise at least a D-shaped aperture.
The present disclosure allows relatively better reach of the applicator device to the tumor tissue in a vaginal vault of a patient while performing the brachytherapy treatment which improves the overall result of the treatment. BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS
The present invention, both as to its organization and manner of operation, together with further objects and advantages, may best be understood by reference to the following description, taken in connection with the accompanying drawing. Other details of the present invention will be described in connection with the accompanying drawings, which are furnished

only by way of illustration and not in limitation of the invention:
Fig.l illustrates a block diagram of an Applicator device assembly [100] for assisting a brachytherapy treatment for treating gynecological cancers, in accordance with an embodiment of the present invention.
Fig.2 illustrates a perspective view of an applicator device with adjustable features for assisting a brachytherapy treatment for treating gynecological cancers, in accordance with an embodiment of the present disclosure.
Fig.3 illustrates a perspective view of an applicator device with adjustable features of Fig.l, in accordance with an embodiment of the present disclosure.
Fig 4a. illustrates a cross sectional view of a cylindrical template of an applicator device assembly with adjustable features, in accordance with an embodiment of the present disclosure.
Fig 4b. illustrates a cross sectional view of a first small ring of an applicator device assembly with adjustable features, in accordance with an embodiment of the present disclosure.
Fig 4c. illustrates a cross sectional view of a second bigger ring of an applicator device assembly with adjustable features, in accordance with an embodiment of the present disclosure.
Fig.5 illustrates a perspective view of a threaded central platform of an applicator device assembly with adjustable features, in accordance with an embodiment of the present disclosure.
It may be evident to skilled artisans that mechanical components in the figures are only illustrative, for simplicity and clarity, and has not necessarily been depicted to scale. DETAILED DESCRIPTION OF THE PRESENT INVENTION
Exemplary embodiments now will be described with reference to the accompanying drawings. The invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this invention will

be thorough and complete, and will fully convey its scope to those skilled in the art. The terminology used in the detailed description of the particular exemplary embodiments illustrated in the accompanying drawings is not intended to be limiting. In the drawings, like numbers refer to like elements.
The specification may refer to "an", "one" or "some" embodiment(s) in several locations. This does not necessarily imply that each such reference is to the same embodiment(s), or that the feature only applies to a single embodiment. Single features of different embodiments may also be combined to provide other embodiments.
As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless expressly stated otherwise. It will be further understood that the terms "includes", "comprises", "including" and/or "comprising" when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. It will be understood that when an element is referred to as being "connected" or "coupled" to another element, it can be directly connected or coupled to the other element or intervening elements may be present. Furthermore, "connected" or "coupled" as used herein may include connected or coupled. As used herein, the term "and/or" includes any and all combinations and arrangements of one or more of the associated listed items.
Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

In addition, all components described and depicted in the figures include the physical components required for the device assembly to function. Further, each component may comprise within itself one or more components, which are implicitly understood. These components may be operatively coupled to each other and may be configured to perform the function of the said device assembly. The components of the present disclosure may also be used in varying combinations (with or without using all of them) as per patient's requirement.
In the following description, for the purposes of explanation, numerous specific details have been set forth in order to provide a description of the invention. It will be apparent however, that the invention may be practiced without these specific details and features.
As used herein, an applicator device assembly refers to a device which assists in delivering a medicated product/dose into a bodily cavity while performing a brachytherapy treatment. Further the applicator device assembly is used for treating a tumor tissue developed inside the body of a patient.
The present invention provides an applicator device assembly with adjustable features for performing brachytherapy treatment. The applicator device assembly as disclosed in the present disclosure comprises a cylindrical template (102); a threaded central platform (104); a first ring (106); and at least a second ring (108), wherein the threaded central platform (104) allows for adjusting the length of the device (100); and wherein the first ring (106) and at least the second ring (108) comprise at least a D-shaped aperture.
The cylindrical template (102) provides for routing of the plurality of catheters (needles) therethrough to reach a target position in the tumor tissue in the vaginal vault and/or on the cervix of the patient. The aforementioned components of the present disclosure are arranged in such a way to provide a reference point to the plurality of catheters (needles) to reach the tumor tissue in the vaginal vault and/or on the cervix of the patient, the components also assist to maintain the shape of vagina for better dose distribution during the

treatment. Further, the components include specially structured spaces to allow the divergent catheters (needles) to pass easily and get connected with the radioactive source transferring tubes without kinking or folding of the catheters (needles) that may disrupt the radioactive source movement and hence the brachytherapy treatment. Furthermore, the plurality of catheters (needles) are capable of being provided with a radioactive source to treat the tumor tissue in the vaginal vault and/or on the cervix of the patient.
The cylindrical template (102) of the device of the present invention has a proximal first end portion and a distal second end portion, wherein the proximal first end portion is flat shaped and the distal second end portion is rounded. The proximal flat shaped first end portion has a centrally located threaded hole to couple the cylindrical template (102) with the threaded central platform (104).
The cylindrical template (102) of the device of the present invention comprises a plurality of a first set of enclosed channels parallel to each other extending along the length of the cylindrical template (102) from the proximal end to the distal end of the cylindrical template (102) arranged at the periphery of the cylindrical template (102) and the channel ends are open. In an embodiment, the first set of enclosed channels comprise at least 2 channels. In an embodiment, the 2 channels are located opposite each other. In another embodiment, the 2 channels are located near each other. In another embodiment, the first set of enclosed channels comprise 2-5, 2-10, 2-15, or 2-20 channels. In an embodiment, the first set of enclosed channels comprise any of 3, 4, 5, 6, 7, 8, 9, or 10 channels.
The cylindrical template (102) of the device of the present invention further comprises a plurality of a second set of channels extending from the proximal first end portion of the cylindrical template (102) to the surface of the cylindrical template (102), the channel ends are open and the lumen is at an angle relative to the length of the cylindrical template (102). In an embodiment, the first set of enclosed channels comprise at least 2 channels. In an

embodiment, the 2 channels are located opposite each other. In another embodiment, the 2 channels are located near each other. In another embodiment, the first set of enclosed channels comprise 2-5, 2-10, 2-15, or 2-20 channels. In an embodiment, the first set of enclosed channels comprise any of 3, 4, 5, 6, 7, 8, 9, or 10 channels.
The threaded central platform (104) of the device the present invention comprises an enclosed channel along the length of the threaded central platform (104) to accommodate a central threading needle, and one end of the channel is closed.
The diameter of the first ring (106) is smaller than that of at least the second ring (108), and wherein the first ring is located proximal to the first end portion of the cylindrical template (102). In an embodiment, the device comprises 2 second ring (108a, 108b). In a preferred embodiment, the device comprises a single second ring (108). In an embodiment, the diameter of the two second ring (108a, 108b) are identical. In another embodiment, the diameter of the two second ring (108a, 108b) are different, wherein the diameter of the second ring (108a, 108b) increases with distance away from the first ring (106).
The first ring (106) and at least a second ring (108) of the device of the present invention comprise a plurality of holes arranged in one or more concentric circles on the first ring (106) or the second right (108).
The cylindrical template (102), first ring (104) and at least a second ring (108) of the device of the present invention can be aligned to allow at least a catheter or needle to be supported by the device.
In a preferred embodiment, the cylindrical template (102), threaded central platform (104), first ring (106), and at least a second ring (108) are made of medical grade material.
The first ring (106) and at least a second ring (108) can travel along the length of the threaded central platform (104).
There is provided a use of the device (100) as substantially described

herein for use in treatment of vaginal cancers. EXAMPLES
Fig.l illustrates a block diagram of an applicator device assembly with adjustable feature, in accordance with the concepts of the present disclosure. The applicator device assembly assists in performing a brachytherapy treatment, for treating vault/vaginal cancer patients. In particular, the applicator device assembly is employed for targeting the tumor tissue developed in the vault/vaginal of the patient. The applicator device assembly as disclosed in the present disclosure, includes a cylindrical template [102], a threaded central platform [104], a first small ring [106] and a second bigger ring [108]. In FIG. 1, only one cylindrical template [102], one threaded central platform [104], one first small ring [106] and one second bigger ring [108] is shown, however the applicator device assembly [100] in other embodiments may comprise multiple such components or the device assembly may comprise any such numbers of said components, as may be required to implement such features of the present invention.
The Applicator device assembly [100] includes the cylindrical template [102]. The cylindrical template [102] has a first end portion and second end portion. The first end portion is flat shaped and the second end portion is rounded. The flat end portion has a threaded hole to couple/connect the cylindrical template [102] with the threaded central patform [104] hence allowing adjustment of the length according to patient's anatomy. The second end portion of the cylindrical templates includes a plurality of holes. Each of the plurality of holes has a diameter of 2 mm (accommodating at least 13 straight needles and atleast 8 oblique needles) at and around a central hole for passing a plurality of catheters (needles) [110, 116, 112, 114] in one or more directions for the target specific treatment of the patient. The cylindrical template [102] provides for routing of the plurality of catheters (needles) [110, 116, 112, 114] therethrough to reach a target position in the tumor tissue in the vault of the

vagina of the patient where a post surgery cancer cervix or endometrium patient has a cancerous growth in the left over stump/vault of the vagina that is otherwise difficult to cure by radiotherapy, while performing the brachytherapy treatment.
In an embodiment of the present disclosure, the cylindrical template [102] is made up of medical grade teflon. In another embodiment of the present disclosure, the cylindrical template [102] is made up of any other suitable material. Moreover, in near future a better medical grade material can be chosen as per description of any suitable manufacturer/ researcher. In a non limiting embodiment of the present disclosure, the cylindrical template [102] has a diameter of 3 cm.
The Applicator device assembly [100] includes the threaded central platform [104] connected with the cylindrical template [102]. The threaded central platform [104] provides an attachment to other three parts as/if necessary for the need of treatment and helps the assembly to function as a single device. It provides an inbuilt tunnel (central hole) for a catheter (needle) that is to be used for treatment along with other needles. In an embodiment of the present disclosure, the diameter of the inbuilt tunnel (central hole) is 2 mm. Further, the central platform [104] has a threaded end [504] (as shown in Fig.5). In an embodiment of the present disclosure the length of the threaded end of the central platform is 15 mm which is compatible with the threaded central hole of the cylindrical template [102] to make the physical connection/coupling between the threaded central platform [104] and the cylindrical template [102]. The option of threading gives a flexibility to adjust the length of the whole device as per need. In an embodiment of the present disclosure, the threaded central platform [104] is made up of medical grade teflon. In another embodiment of the present disclosure, the threaded central platform [104] is made up of any suitable material. Moreover, in near future a better medical grade material can be chosen as per description of any suitable manufacturer/

researcher.
The Applicator device [100] includes the first small ring [106] connected over the threaded central platform [104]. The first small ring [106] may be adjusted anywhere along the longitudinal axis of the threaded central platform [104], depending on length of the vagina of a patient. In an embodiment of the present disclosure, the first small ring [106] includes a plurality of supplementay holes, each having a diameter of 2.4 mm (13 holes) for allowing straight catheters (needles) [110, 116] to pass with ease. In another embodiment of the present disclosure, the diameter of the each of the plurality of holes may vary as per the requirement of the treatment. In yet another embodiment of the present disclosure, each of the plurality of holes is of the same diameter. In yet another embodiment of the present disclosure, the diameter of each of the holes is more than the diameter of the needles used for the treatment of the patient.
The first small ring [106] also includes a plurality of D-shaped apertures (as shown in Fig. 4b) for allowing the divergent needles [112, 114] to pass with ease which allows for a better reach of the applicator device assembly [100] to the tumor tissue in the female reproductive system particularly the vaginal vault of a patient while performing the brachytherapy treatment. This first small ring [106] thus helps to maintain the shape of vagina, it keeps the treating straight needles closer to vaginal mucoca helping in brachytherapy dose distribution in the vagina. It also allows the divergent needles [112, 114] to pass smoothly through its D aperture. In an embodiment of the present disclosure, the first small ring [106] is made up of medical grade teflon. In another embodiment of the present disclosure, the first small ring [106] is made up of any suitable material. Moreover, in near future a better medical grade material can be chosen as per description of any suitable manufacturer/ researcher.
The Applicator device assembly [100] includes the second bigger ring [108] connected over the central platform [104] (as shown in Fig.3). The second bigger ring [108] also referred as the bigger perineal ring. The diameter of the

second bigger ring [108] is relatively larger that the diameter of the first small ring [106]. The second bigger ring [108] may be adjusted anywhere along the longitudinal axis of the threaded central platform [104] with screws. In an embodiment of the present disclosure, the second bigger ring [108] includes a plurality of designated holes (as shown in Fig. 4c) has a diameter of 2 mm accommodating at least 16 straight needles which enables the applicator device assembly [100] to target the tumor tissues which are located even in the lower part of the vagina of a patient. In another embodiment of the present disclosure, the diameter of each of the plurality of holes may vary as per the requirement of the treatment.
The second bigger ring [108] further includes a plurality of central D-shaped large openings (as shown in Fig. 4c) for both the divergent [112, 114] and straight catheters (needles) [110, 116] of the cylindrical template [102] (as shown in Fig.4a) to pass unobstructed. Further, the second bigger ring [108] is designed in such a way that it can be tightly coupled with the threaded central platform [104]. In an embodiment of the present disclosure, the second bigger ring [108] is made up of medical grade teflon. In another embodiment of the present disclosure, the second bigger ring [108] is made up of any suitable material. Moreover, in near future a better medical grade material can be chosen as per description of any suitable manufacturer/ researcher.
Fig.2 illustrates a perspective view of an applicator device assembly with adjustable features, in accordance with an embodiment of the present disclosure. Fig. 2 illustrates a plurality of components associated with the Applicator Device assembly [100]. The plurality of components includes the cylindrical template [102], the threaded central platform [104], the first small ring [106] and the second bigger ring [108]. The plurality of components has already been described in detail in the Fig. 1 and therefore the Fig. 2 illustrates the perspective view of the components of the Applicator device assembly [100] to enable a person skilled in the art to apprehend the appearance of each of the

components. Further, the Fig. 2 illustrates the unassembled form of the Applicator device to get a better perspective of shape, size, and dimensions of the plurality of components used in the Applicator device [100]. Fig.3 illustrates a perspective view of an applicator device with adjustable features of Fig.l, in accordance with an embodiment of the present disclosure. Fig 4a illustrates a cross sectional view of a cylindrical template of an applicator device assembly with adjustable features, in accordance with an embodiment of the present disclosure. Fig 4b illustrates a cross sectional view of a first small ring of an applicator device assembly with adjustable features, in accordance with an embodiment of the present disclosure. Fig 4c illustrates a cross sectional view of a second bigger ring of an applicator device assembly with adjustable features, in accordance with an embodiment of the present disclosure. Fig.5 illustrates a perspective view of a threaded central platform of an applicator device assembly with adjustable features, in accordance with an embodiment of the present disclosure.
The present disclosure offers some technical advantages which are enumerated below for ease of understanding:
1. The present disclosure provides an applicator device which is smaller in size and capable of being assembled according to the need. The applicator device can be assembled in at least three different diameter sizes depending on diameter of vagina of the patient, for example: 3 cm, 3.5 cm, 4 cm and 5 cm.
2. The circular shape of the presently disclosed applicator device provides ease of use during treatment of the patient.
3. The plastic needles used by the presently disclosed applicator device results in less bleeding during treatment of the patient.
4. The divergent catheters (needles) used by the presently disclosed applicator device can go out easily from template enhancing the reach. Further, the divergent needles may be inserted closer to

target, giving better accuracy.
5. The perineal template of the presently disclosed applicator device provides a convenient and less painful treatment of the patient being circular in shape and less bulky.
6. The applicator length of the presently disclosed applicator device may be adjusted depending on length of the vagina.
7. The D shaped apertures in the rings presents an unique way to allow the needles already inserted for treating the vaginal vault to pass outside without folding or kinking.
8. The threaded central platform is also unique as it allows to adjust its length, bears a tunnel for the central treating needle and gives a simple platform to allow add on rings if required.
9. Needles can be inserted that can provide effective flexibility dose modulation, allow treatment of tumour diameters upto 8 cm to be treated.
10. With use of MR compatible screws it will be MRI compatible, hence such indigenous low cost template can allow developing country centres to practice a state of art technique for patients at a reasonable cost.
While the preferred embodiments of the present invention have been described hereinabove, it should be understood that various changes, adaptations, and modifications may be made therein without departing from the spirit of the invention. It will be obvious to a person skilled in the art that the present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive.

We claim:

1. An applicator device assembly (100) for brachytherapy treatment
comprising:
a. a cylindrical template (102);
b. a threaded central platform (104);
c. a first ring (106); and
d. at least a second ring (108),
wherein the threaded central platform (104) allows for adjusting the length of the device (100); and wherein the first ring (106) and at least the second ring (108) comprise at least a D-shaped aperture.
2. The device (100) as claimed in claim 1, wherein the cylindrical template (102) has a proximal first end portion and a distal second end portion, wherein the proximal first end portion is flat shaped and the distal second end portion is rounded.
3. The device (100) as claimed in claim 2, wherein the proximal flat shaped first end portion has a centrally located threaded hole to couple the cylindrical template (102) with the threaded central platform (104).
4. The device (100) as claimed in claim 1, wherein the cylindrical template (102) comprises a plurality of a first set of enclosed channels parallel to each other extending along the length of the cylindrical template (102) from the proximal end to the distal end of the cylindrical template (102) arranged at the periphery of the cylindrical template (102) and the channel ends are open.
5. The device (100) as claimed in claim 4, further comprising a plurality of a

second set of channels extending from the proximal first end portion of the cylindrical template (102) to the surface of the cylindrical template (102), the channel ends are open and the lumen is at an angle relative to the length of the cylindrical template (102).
6. The device (100) as claimed in claim 1, wherein said threaded central platform (104) comprises an enclosed channel along the length of the threaded central platform (104) to accommodate a central threading needle, and one end of the channel is closed.
7. The device (100) as claimed in claim 1, wherein the diameter of the first ring (106) is smaller than that of at least the second ring (108), and wherein the first ring is located proximal to the first end portion of the cylindrical template (102).
8. The device (100) as claimed in claim 1, wherein the diameter of a plurality of second ring (108) are identical; or the diameter of a plurality of second ring (108) are different, wherein the diameter of the second ring (108) increases with distance away from the first ring (106).
9. The device (100) as claimed in claim 1, wherein the first ring (106) and at least a second ring (108) comprise a plurality of holes arranged in one or more concentric circles on the first ring (106) or the second right (108).
10. The device (100) as claimed in claim 1, wherein the cylindrical template (102), first ring (104) and at least a second ring (108) can be aligned to allow at least a catheter or needle to be supported by the device (100).
11. The device (100) as claimed in claim 1, wherein the cylindrical template

(102), threaded central platform (104), first ring (106), and at least a second ring (108) are made of medical grade material.
12. The device (100) as claimed in claim 1, wherein the first ring (106) and at least a second ring (108) can travel along the length of the threaded central platform (104).

Documents

Application Documents

# Name Date
1 202111031184-STATEMENT OF UNDERTAKING (FORM 3) [12-07-2021(online)].pdf 2021-07-12
2 202111031184-PROVISIONAL SPECIFICATION [12-07-2021(online)].pdf 2021-07-12
3 202111031184-FORM 1 [12-07-2021(online)].pdf 2021-07-12
4 202111031184-FIGURE OF ABSTRACT [12-07-2021(online)].pdf 2021-07-12
5 202111031184-DRAWINGS [12-07-2021(online)].pdf 2021-07-12
6 202111031184-FORM-26 [12-10-2021(online)].pdf 2021-10-12
7 202111031184-GPA-201221.pdf 2021-12-27
8 202111031184-Correspondence-201221.pdf 2021-12-27
9 202111031184-Proof of Right [30-12-2021(online)].pdf 2021-12-30
10 202111031184-Others-070322.pdf 2022-03-08
11 202111031184-Correspondence-070322.pdf 2022-03-08
12 202111031184-ENDORSEMENT BY INVENTORS [27-06-2022(online)].pdf 2022-06-27
13 202111031184-DRAWING [27-06-2022(online)].pdf 2022-06-27
14 202111031184-COMPLETE SPECIFICATION [27-06-2022(online)].pdf 2022-06-27
15 202111031184-FORM 18 [22-09-2022(online)].pdf 2022-09-22
16 202111031184-FORM-26 [11-10-2022(online)].pdf 2022-10-11
17 202111031184-RELEVANT DOCUMENTS [12-10-2022(online)].pdf 2022-10-12
18 202111031184-POA [12-10-2022(online)].pdf 2022-10-12
19 202111031184-FORM 13 [12-10-2022(online)].pdf 2022-10-12
20 202111031184-GPA-151122.pdf 2022-11-18
21 202111031184-Correspondence-151122.pdf 2022-11-18
22 202111031184-FER.pdf 2023-04-13
23 202111031184-FER_SER_REPLY [12-10-2023(online)].pdf 2023-10-12
24 202111031184-US(14)-HearingNotice-(HearingDate-11-11-2025).pdf 2025-10-10
25 202111031184-Correspondence to notify the Controller [07-11-2025(online)].pdf 2025-11-07
26 202111031184-Written submissions and relevant documents [18-11-2025(online)].pdf 2025-11-18

Search Strategy

1 12apr2023_202111031184_searchE_12-04-2023.pdf
1 202111031184_SearchStrategyAmended_E_SS_202111031184 AE_28-07-2025.pdf
2 12apr2023_202111031184_searchE_12-04-2023.pdf