Description:FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(Section 10 and Rule 13)

1. TITLE OF THE INVENTION:
INTRAVASCULAR LITHOTRIPSY DEVICE

2. APPLICANT:
Name : Meril Medical Innovations Private Limited
Nationality : Indian
Address : Survey No 1574 (Old No 135/139), Bilakhia House, Muktanand Marg, Chala, Vapi, Valsad, Gujarat, 396191 India.

3. PREAMBLE TO THE DESCRIPTION
The following specification particularly describes the invention and the manner in which it is to be performed:
 
FIELD OF INVENTION
[1] The present disclosure relates to a medical device. More particularly, the present disclosure relates to an intravascular lithotripsy device.
BACKGROUND OF INVENTION
[2] Intravascular Lithotripsy (IVL) is a medical procedure designed to treat calcified plaque in arteries, often in patients with coronary artery disease. The IVL procedure involves the use of a catheter that delivers sonic waves to break down the hardened calcium deposits in the vessel walls. Once the plaque is fragmented, the vessel can be dilated to restore blood flow and maintain the opening. IVL is particularly useful for effective fragmentation of rigid plaques in the vessel and vessel dilation.
[3] During the IVL procedure, an inflatable balloon catheter is inflated at the site of the calcified plaque. As the sonic waves are delivered to break down the calcium deposits, the blood flow through the affected artery is temporarily reduced or stopped. The blood flow is temporarily reduced or stopped till the time the procedure is being performed, generally lasting only as long as it takes to fragment the plaque and allow for safe dilation. The purpose of reducing blood flow is to prevent any fragmented plaque from dislodging and potentially causing downstream blockages.
[4] While the reduction in blood flow is necessary for the success of IVL, it can lead to specific complications, if not carefully managed. For example, the temporary reduction or stoppage of blood flow during the IVL procedure can result in ischemia. This condition occurs when tissues downstream of the obstruction do not receive enough oxygen and nutrients, potentially leading to tissue dysfunction. While this is usually a short-term effect, it can be problematic if blood flow is not restored promptly.
[5] Further, if the blood flow is excessively reduced or there are delays in restoring it after the IVL procedure, there is a risk of tissue damage. Prolonged periods of reduced blood flow can compromise the health of surrounding tissues, especially in critical areas like the heart or the brain, where oxygen and nutrients are essential for proper function.
[6] Hence, there is a need to develop an intravascular lithotripsy device that maintains blood flow throughout the procedure and overcomes the aforementioned problems.
SUMMARY OF INVENTION
[7] Particular embodiments of the present disclosure are described herein below with reference to the accompanying drawings; however, it is to be understood that the disclosed embodiments are mere examples of the disclosure, which may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.
[8] The present disclosure relates to a device that allows a continuous flow of a body fluid within a vessel during a lithotripsy procedure. In an embodiment, the device includes a first tube and a second tube. In an embodiment, the first tube includes a first hole. The first hole is provided towards a proximal end of the first tube. The second tube is partially disposed within a first lumen of the first tube. A proximal end of the second tube is coupled to the first tube towards the proximal end of the first tube. A distal end of the second tube protrudes from a distal end of the first tube. In an embodiment, an aperture is provided on the second tube towards the proximal end of the second tube. The aperture is aligned with the first hole of the first tube. In an embodiment, the device includes an inflatable balloon provided towards a distal end of the device, and coupled to the first tube and the second tube. The second tube is configured to provide a passage to a body fluid to enter the second tube from its distal end and to discharge from the aperture, while the inflatable balloon is expanded during a lithotripsy procedure.
BRIEF DESCRIPTION OF DRAWINGS
[9] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentality disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[10] Fig. 1a depicts perspective views of a device 100, according to an embodiment of the present disclosure.
[11] Fig. 1b depicts an enlarged view of a distal portion of the device 100, according to an embodiment of the present disclosure.
[12] Fig. 2 depicts a perspective view of a first tube 200, according to an embodiment of the present disclosure.
[13] Fig. 3a depict perspective view of a second tube 300, according to an embodiment of the present disclosure.
[14] Fig. 3b depicts a sectional view of the device 100, according to an embodiment of the present disclosure.
[15] Fig. 4a depicts a sectional view showing a third tube 400 coupled to the first tube 200, according to an embodiment of the present disclosure.
[16] Fig. 4b depicts coupling between at least one emitter 330 and a power source 700, according to an embodiment of the present disclosure.
[17] Fig. 5 depicts the device 100 disposed within a blood vessel 1000, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[18] Prior to describing the invention in detail, definitions of certain words or phrases used throughout this patent document will be defined: the terms "include" and "comprise", as well as derivatives thereof, mean inclusion without limitation; the term "or" is inclusive, meaning and/or; the phrases "coupled with" and "associated therewith", as well as derivatives thereof, may mean to include, be included within, interconnect with, contain, be contained within, connect to or with, couple to or with, be communicable with, cooperate with, interleave, juxtapose, be proximate to, be bound to or with, have a property of, or the like. Definitions of certain words and phrases are provided throughout this patent document, and those of ordinary skill in the art will understand that such definitions apply in many, if not most, instances to prior as well as future uses of such defined words and phrases.
[19] Reference throughout this specification to “one embodiment,” “an embodiment,” or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in one embodiment,” “in an embodiment,” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment, but mean “one or more but not all embodiments” unless expressly specified otherwise. The terms “including,” “comprising,” “having,” and variations thereof mean “including but not limited to” unless expressly specified otherwise. An enumerated listing of items does not imply that any or all of the items are mutually exclusive and/or mutually inclusive, unless expressly specified otherwise. The terms “a,” “an,” and “the” also refer to “one or more” unless expressly specified otherwise.
[20] Although the operations of exemplary embodiments of the disclosed method may be described in a particular, sequential order for convenient presentation, it should be understood that the disclosed embodiments can encompass an order of operations other than the particular, sequential order disclosed. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Further, descriptions and disclosures provided in association with one particular embodiment are not limited to that embodiment, and may be applied to any embodiment disclosed herein. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed system, method, and apparatus can be used in combination with other systems, methods, and apparatuses.
[21] Furthermore, the described includes, advantages, and characteristics of the embodiments may be combined in any suitable manner. One skilled in the relevant art will recognize that the embodiments may be practiced without one or more of the specific includes or advantages of a particular embodiment. In other instances, additional includes and advantages may be recognized in certain embodiments that may not be present in all embodiments. These includes and advantages of the embodiments will become more fully apparent from the following description and apportioned claims, or may be learned by the practice of embodiments as set forth hereinafter.
[22] The current disclosure pertains to a device for an intravascular lithotripsy (IVL) procedure (hereinafter, the procedure).
[23] Unlike a conventional IVL device, which temporarily obstructs blood flow during the procedure, the device of the present disclosure enables continuous blood circulation during the procedure. In an embodiment, the device includes a first tube and a second tube. A distal end of the second tube protrudes from a distal end of the first tube.
[24] In an embodiment, the device includes an inflatable balloon provided at a distal end of the device and coupled to the first tube and the second tube. The device includes at least one emitter provided on a portion of the second tube disposed inside the inflatable balloon. The inflatable balloon is expanded during the lithotripsy procedure. The at least one electrode is configured to generate acoustic pressure waves (or sonic waves) that help in creating microfractures in the calcified plaque. The inflatable balloon provides mechanical stability and helps in uniform energy distribution.
[25] In an embodiment, the second tube includes an aperture towards a proximal end. The second tube is configured to provide a passage for a body fluid (e.g., blood), while the inflatable balloon is expanded during the lithotripsy procedure, thereby, allowing continuous blood flow during the procedure. The body fluid enters the second tube from the distal end of the second tube and is discharged back into the blood vessel via the aperture of the second tube. By maintaining perfusion, the device significantly reduces the risk of ischemia and tissue damage, ensuring better patient safety and procedural outcomes. Thus, the device helps in treating calcified plaques without compromising blood supply to downstream tissues.
[26] Now referring to figures, Fig. 1a illustrates an intravascular lithotripsy (IVL) device 100 (hereinafter, device 100). The device 100 helps in treating calcified plaques without compromising blood supply to downstream tissues. The device 100 includes a proximal end 100a and a distal end 100b. The device 100 includes an inflatable balloon 500 disposed towards the distal end 100b of the device 100, as shown in Fig. 1b. The device 100 includes at least one emitter disposed within the inflatable balloon 500. The at least one emitter is configured to generate sonic waves. The sonic waves propagate through the inflatable balloon 500 and help in creating microfractures in the calcified plaque. The inflatable balloon 500 provides mechanical stability and helps in uniform energy distribution.
[27] In an embodiment, the device 100 includes a first tube 200 and a second tube 300. The first tube 200 extends from the proximal end 100a towards the distal end 100b of the device 100. An exemplary first tube 200 is shown in Fig. 2. The first tube 200 includes a proximal end 200a and a distal end 200b, thereby defining a length. The dimensions of the first tube 200 are chosen according to procedural requirements. In an embodiment, the length of the first tube 200 may range between 370 mm and 385 mm. In an embodiment, the length of the first tube 200 is 375 mm. An outer diameter of the first tube 200 may range between 1.17 mm and 1.20 mm. In an embodiment, the outer diameter of the first tube 200 is 1.18 mm. In an embodiment, the first tube 200 is made of a biocompatible material, for example, Nylon 11, though it may be made of any other suitable biocompatible material.
[28] The first tube 200 includes at least two holes. The at least two holes are provided towards the proximal end 200a. In an embodiment, the first tube 200 includes a first hole 220 and a second hole 240. The first hole 220 and the second hole 240 are provided on an outer surface of the first tube 200. The first hole 220 is provided towards the proximal end 200a of the first tube 200. The second hole 240 is provided between the first hole 220 and the proximal end 200a of the first tube 200. In other words, the second hole 240 is located proximal to the first hole 220. The second hole 240 is configured to receive a guidewire via a hub (not shown).
[29] The first hole 220 and the second hole 240 may be formed on the first tube 200 using techniques, such as, without limitation, laser cut, trim and slit, etc. In an embodiment, the first hole 220 and the second hole 240 are formed on the first tube 200 using trim and slit technique. The first hole 220 and the second hole 240 may have the same or different shape, including, but not limited to, circular, rectangular, square, oval, elliptical, polygonal, triangular, etc. In an embodiment, the shape of first hole 220 and the second hole 240 are circular. The first hole 220 and the second hole 240 may have the same or different predefined diameter. In an embodiment, the first hole 220 and the second hole 240 have the same diameter ranging 0.35 mm and 0.37 mm. In an embodiment, the diameter of the first hole 220 and the second hole 240 are 0.36 mm.
[30] The first tube 200 generally has a tubular structure and is hollow from inside, thereby defining a first lumen 210 (as shown in Fig. 3b). The first lumen 210 of the first tube 200 is configured to receive a portion of the second tube 300. In other words, the second tube 300 is partially disposed within the first tube 200. In an embodiment, approximately 30% of the length of the second tube 300 is disposed within the first tube 200. The first hole 220 and the second hole 240 extend into the first lumen 210. An outer diameter of the second tube 300 is selected such that it is equal to or less than the diameter of the first lumen 210 of the first tube 200. The diameter of the first lumen 210 may range between 1.45 mm and 1.48 mm. In an embodiment, the diameter of the first lumen 210 is 1.46 mm.
[31] The second tube 300 has a proximal end 300a and a distal end 300b, as shown in Fig. 3a, thereby defining a length. The dimensions of the second tube 300 are chosen based upon the procedural requirements. In an embodiment, the length of the second tube 300 may range between 345 mm and 355 mm. In an embodiment, the length of the second tube 300 is 350 mm. In an embodiment, the second tube 300 is made of high viscosity polyamide, though the second tube 300 may be made of any other suitable biocompatible material.
[32] In an embodiment, the second tube 300 extends between the second hole 240 of the first tube 200 and the distal end 100b of the device 100, as shown in Fig. 3b. The distal end 300b of the second tube 300 protrudes out from the distal end 200b of the first tube 200. The distal end 300b of the second tube 300 aligns with the distal end 100b of the device 100.
[33] The proximal end 300a of the second tube 300 is coupled to the first tube 200 towards the proximal end 200a of the first tube 200. In an embodiment, the proximal end 300a of the second tube 300 is coupled to the second hole 240 of the first tube 200. The proximal end 300a of the second tube 300 may be coupled to the second hole 240 of the first tube 200 using, techniques, such as, without limitation, thermal bonding, adhesive bonding, etc. In an embodiment, the proximal end 300a of the second tube 300 is coupled to the second hole 240 of the first tube 200 using thermal bonding.
[34] The second tube 300 is generally tubular in structure and is hollow from inside, thereby defining a second lumen 300d. The second lumen 300d extends between the proximal end 300a and the distal end 300b. The second lumen 300d is configured to receive the guidewire from the proximal end 300a of the second tube 300. In an embodiment, the second tube 300 includes an aperture 310 provided towards the proximal end 300a of the second tube 300. The aperture 310 is provided on an outer surface of the second tube 300 and extends to the second lumen 300d. The aperture 310 of the second tube 300 aligns with the first hole 220 of the first tube 200.
[35] The second lumen 300d of the second tube 300 is configured to provide a passage to a body fluid (e.g., blood) to enter the second tube 300 from its distal end 300b and to discharge from the aperture 310, while the inflatable balloon 500 is expanded during the lithotripsy procedure. This allows a continuous blood flow in the vessel during the lithotripsy procedure. By maintaining perfusion, the device 100 significantly reduces the risk of ischemia and tissue damage, ensuring better patient safety and procedural outcomes. Thus, the device 100 helps in treating calcified plaques without compromising blood supply to downstream tissues.
[36] The aperture 310 may be formed on the second tube 300 using techniques, such as, without limitation, laser cut, trim and slit technique, etc. In an embodiment, the aperture 310 is formed on the second tube 300 using trim and slit technique. The aperture 310 has a predefined shape, including, but not limited to, circular, rectangular, square, oval, elliptical, polygonal, triangular, etc. In an embodiment, the shape of the aperture 310 is circular. In an embodiment, the aperture 310 has the same diameter as the first hole 220. The aperture 310 may have a predefined diameter ranging 0.35 mm and 0.37 mm. In an embodiment, the diameter of the aperture 310 is 0.36 mm.
[37] The inflatable balloon 500 is provided towards the distal end 100b of the device 100. The inflatable balloon 500 is disposed between the distal ends (200b and 300b) of the first tube 200 and second tube 300. The inflatable balloon 500 includes a proximal end 500a and a distal end 500b.
[38] The proximal end 500a of the inflatable balloon 500 is coupled to the distal end 200b of the first tube 200. The proximal end 500a of the inflatable balloon 500 may be coupled to the distal end 200b of the first tube 200 using techniques, such as, without limitation, thermal bonding, adhesive bonding. In an embodiment, the proximal end 500a of the inflatable balloon 500 is coupled to the distal end 200b of the first tube 200 using thermal bonding.
[39] In an embodiment, the distal end 500b of the inflatable balloon 500 is coupled to the outer surface of the second tube 300 towards the distal end 300b of the second tube 300 such that a portion 300c of the second tube 300, towards the distal end 300b, is disposed within the balloon 500, as depicted in Fig. 3b. In an embodiment, the distal end 500b of the inflatable balloon 500 is coupled to the outer surface of the second tube 300 using the same techniques that is used for coupling the proximal end 500a of the inflatable balloon 500 and the distal end 200b of the first tube 200.
[40] The outer surface of the second tube 300 is provided with at least one marker. The device 100 includes at least one marker provided on the portion 300c of the second tube 300. In an embodiment, the portion 300c of the second tube 300 is provided with two markers, namely, a proximal marker 320a and a distal marker 320b. The proximal marker 320a and the distal marker 320b have a predefined gap therebetween. The proximal end 500a and the distal end 500b of the inflatable balloon 500 align with the proximal marker 320a and the distal marker 320b, respectively. The at least one marker may be radiopaque markers such as, without limitation, platinum, gold, tungsten, or platinum-iridium alloy (Pt-Ir), etc. The at least one marker helps in aligning the inflatable balloon 500 at the target site using any imaging guidance.
[41] The inflatable balloon 500 is inflated at the target site with the help of an inflation fluid. The inflation fluid is introduced into the inflatable balloon 500 through the first lumen 210 of the first tube 200. The first lumen 210 of the first tube 200 provides a passage for an inflation fluid from the proximal end 200a of the first tube 200 into the inflatable balloon 500.
[42] In an embodiment, the device 100 includes a third tube 400, as shown in Fig. 4a. The third tube 400 includes a proximal end 400a and a distal end 400b. The third tube 400 is generally tubular in structure and is hollow from inside, thus defining a third lumen 400c. In an embodiment, the distal end 400b of the third tube 400 is beveled, though the distal end 400b may be unbeveled in another embodiment. In an embodiment, the third tube 400 is a hypo tube. The third tube 400 facilitates navigation of the device 100 through the tortuous pathways of the vessel. In an embodiment, the third tube 400 is made of medical grade-stainless steel 304 (SS304), though it may be made of any other suitable material.
[43] In an embodiment, a proximal portion towards the proximal end 200a of the first tube 200 is disposed within the third lumen 400c and is coupled to the third tube 400 (as shown in Fig. 4a). The third lumen 400c extends between the proximal end 400a and the distal end 400b of the third tube 400. In an embodiment, approximately 20%-40% length of the first tube 200 is disposed within the third tube 400. In an embodiment, the distal end 400b of the third tube 400 is coupled to the proximal end 200a of the first tube 200. The distal end 400b of the third tube 400 may be coupled to the proximal end 200a of the first tube 200 using techniques, such as, without limitation, thermal bonding, adhesive bonding. In an embodiment, the distal end 400b of the third tube 400 is coupled to the proximal end 200a of the first tube 200 using thermal bonding. An outer diameter of the first tube 200 is selected such that it is equal to or less than a diameter of the third lumen 400c. The diameter of the third lumen 400c may range between 0.82 mm and 0.88 mm. In an embodiment, the diameter of the third lumen 400c is 0.85 mm.
[44] The third lumen 400c of the third tube 400 is configured to provide passage for the inflation fluid from an inflation fluid reservoir into the inflatable balloon 500 via the first lumen 210 of the first tube 200 to inflate the inflatable balloon 500. The proximal end of the third tube 400 is coupled to the inflation fluid reservoir via a port (not shown).
[45] A length of the third tube 400 may range between 1248 mm and 1252 mm. In an embodiment, the length of the third tube 400 is 1250 mm. In an embodiment, the third tube 400 is made of medical grade stainless steel 304, though it may be made of any other suitable biocompatible material.
[46] The device 100 includes at least one emitter 330 (hereinafter, emitter 330) and at least one insulator 332 (hereinafter, insulator 332). In an embodiment, the portion 300c of the second tube 300 includes two emitters 330 and two insulators 332. The emitters 330 and the insulators 332 are provided on the outer surface of the portion 300c of the second tube 300.
[47] The emitters 330 and the insulators 332 are provided between the markers 320. Each insulator 332 is provided beneath a respective emitter 330 of at least one emitter 330. Each emitter 330 is mounted on the respective insulator 332. The emitters 330 help in decalcifying the calcified portion in the vasculature. The emitters 330 operate at a predefined frequency of sonic waves. The predefined frequency may range between 0.9Hz and 1.0Hz.
[48] The emitters 330 are electrically coupled to a power source 700 using at least one connecting wire 600 (hereinafter, connecting wire 600), as shown in Figs. 4a-4b. In an embodiment, the connecting wire 600 extend between the emitters 330 and the power source 700 provided at the proximal end 100a of the device 100. The connecting wire 600 are disposed within the first lumen 210 of the first tube 200 and the third lumen 400c of the third tube 400. The connecting wire 600 is configured to electrically couple the at least one emitter 330 with the power source 700. In an embodiment, the emitters 330 act as transducers. The emitters 330 are configured to generate controlled acoustic pressure waves upon receiving an electric current from the power source 700. The at least one emitter 330 is configured to generate sonic waves at a predefined frequency upon receiving electric power from the power source 700. This initiates the lithotripsy procedure, producing circumferential sonic waves that travel through the soft tissues but specifically break hard calcified structure. The insulators 332 are configured to isolate the emitters 330 from the second tube 300, ensuring controlled energy delivery while preventing unintended conduction throughout the second tube 300.
[49] During the procedure, a surgeon may insert the distal end 100b of the device 100 into the patient’s body. The inflatable balloon 500 of the device 100 is in a deflated state during the insertion of the distal end 100b of the device 100. The device 100 is advanced through the vessel towards a target region. The inflatable balloon 500 remains deflated at this stage. The inflatable balloon 500 is placed at the target region with the help of the at least one marker. The at least one marker helps in aligning the inflatable balloon 500 at the target site using any imaging guidance. Once the inflatable balloon 500 is positioned at the target site, the inflation fluid is introduced in the inflatable balloon 500 via the third lumen 400c of the third tube 400 and the first lumen 210 of the first tube 200 to inflate/expand the inflatable balloon 500.
[50] Thereafter, an electric power is supplied to the emitters 330 from the power source 700. Upon receiving the electrical power, the emitters 330 generating circumferential shockwaves, thus initiating the lithotripsy procedure. These waves propagate through soft tissues while precisely targeting and breaking hard calcified structures in the vessel. While the decalcification procedure is carried out, the blood from the vessel enters into the second lumen 300d of the second tube 300 and oozes out of the aperture 310 and the first hole 220 (as shown in Fig. 5), thereby, allowing continuous blood flow within the vessel throughout the procedure.
[51] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. , Claims:WE CLAIM
1. A device (100) for allowing a continuous flow of a body fluid within a vessel during a lithotripsy procedure, the device (100) comprising:
a. a first tube (200) comprising a first hole (220) towards a proximal end (200a) of the first tube (200),
b. a second tube (300) partially disposed within a first lumen (210) of the first tube (200) and comprising:
i. a proximal end (300a) coupled to the first tube (200) towards the proximal end (200a) of the first tube (200);
ii. a distal end (300b) protruding from a distal end (200b) of the first tube (200); and
iii. an aperture (310) provided towards the proximal end (300a) of the second tube (300) and aligned with the first hole (220) of the first tube (200); and
c. an inflatable balloon (500) provided towards a distal end (100b) of the device (100) and coupled to the first tube (200) and the second tube (300);
wherein, the second tube (300) is configured to provide a passage to a body fluid to enter the second tube (300) from the distal end (300b) of the second tube (300) and to discharge from the aperture (310), while the inflatable balloon (500) is expanded during a lithotripsy procedure.
2. The device (100) as claimed in claim 1, wherein the first tube (200) includes a second hole (240) provided between the first hole (220) and the proximal end (200a) of the first tube (200), wherein the proximal end (300a) of the second tube (300) is coupled to the second hole (240).
3. The device (100) as claimed in claim 1, wherein the device (100) includes at least one emitter (330) provided on a portion (300c) of the second tube (300) disposed inside the inflatable balloon (500), the at least one emitter (330) is electrically coupled to a power source (700) and is configured to generate sonic waves at a predefined frequency upon receiving electric power from the power source (700).
4. The device (100) as claimed in claim 3, wherein at least one connecting wire (600) is disposed within the first lumen (210) of the first tube (200) and is configured to electrically couple the at least one emitter (330) with the power source (700).
5. The device (100) as claimed in claim 3, wherein the device (100) includes at least one insulator (332) provided on the portion (300c) of the second tube (300) and each insulator (332) is provided beneath a respective emitter (330) of at least one emitter (330), the at least one insulator (332) is configured to isolate the at least one emitter (330) from the second tube (300).
6. The device (100) as claimed in claim 1, wherein the inflatable balloon (500) includes:
a. a proximal end (500a) coupled to the distal end (200a) of the first tube (200), and;
b. a distal end (500b) coupled to an outer surface of the second tube (300) towards the distal end (300b) of the second tube (300),
wherein the first lumen (210) of the first tube (200) provides a passage for an inflation fluid from the proximal end (200a) of the first tube (200) into the inflatable balloon (500).
7. The device (100) as claimed in claim 1, wherein the device (100) includes a third tube (400) comprising:
a. a proximal end (400a);
b. a distal end (400b) coupled to the proximal end (200a) of the first tube (200) and;
c. a third lumen (400c) extending between the proximal end (400a) and the distal end (400b) of the third tube (400) and configured to provide a passage for an inflation fluid into the inflatable balloon (500) via the first tube (200),
d. wherein a proximal portion of the first tube (200) is disposed within the third lumen (400c).
8. The device (100) as claimed in claim 1, wherein the device (100) includes at least one marker provided on the portion (300c) of the second tube (300).
9. The device (100) as claimed in claim 8, wherein the device (100) includes a proximal marker (320a) and a distal marker (320b) aligned with a proximal end (500a) and a distal end (500b) of the inflatable balloon (500), respectively.