WO2021260461A1

WO2021260461A1 - A diagnostic tool for grading stenosis in upper airway

Info

Publication number: WO2021260461A1
Application number: PCT/IB2021/054690
Authority: WO
Inventors: Alekya B; Bhushan V; V S N Sitaram GUPTA; Arjun B S; Kevin ABHISHEK; S Siddesh SHENOY; Sanjay Rao; Hardik J. PANDYA; Mayur BHUVA
Original assignee: Indian Institute Of Science
Priority date: 2020-06-26
Filing date: 2021-05-28
Publication date: 2021-12-30

Abstract

The present disclosure pertains to a sensor integrated diagnostic tool for management of pathological airway in paediatric population. The tool (200) can be used for characterizing the tracheal obstruction, such as stenosis, of varying grades and anomaly types. The tool (200) is a combination of an array of flow sensors (206) and an unfurling actuator (222) with radial arms that houses tactile sensors (208) at the tip of the arm. The flow sensor array (206) yields airflow patterns across various segments of the tracheobronchial tree and the unfurling actuator (222) measures patency with tactile sensors 208 capable of distinguishing between malacic and healthy tissue. The unfurler has radial arms that remain coiled inside the cylindrical casing at the distal tip (204). Upon actuation, the arms uncoil radially outward. The movement of the radial arms causes the tactile sensors (208) to contact the tracheal walls and gives a measure of the tracheal diameter.

Description

A DIAGNOSTIC TOOL FOR GRADING STENOSIS IN UPPER AIRWAY

TECHNICAL FIELD

[0001] The present disclosure relates to the field of diagnostic tools, and more particularly, the present invention relates to a handheld diagnostic tool for grading stenosis.

BACKGROUND

[0002] Background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.

[0003] Airway obstruction is any blockage in the air way that conveys inhaled air from nose and mouth to lungs. The one of the most common causes of the airway obstruction is stenosis, which is an abnormal narrowing of a tubular organ or blood vessel, and can occur anywhere in the body. If the narrowed tube organ is in a part of body (e.g. upper airway) that may contribute to the airway obstruction. The respiratory tract of a body is divided into the upper airways and lower airways. The upper airways or upper respiratory tract includes nose and nasal passages, paranasal sinuses, the pharynx, and the portion of larynx above vocal folds (cords). Airway obstruction is one of the common problems in the infants and newly born which need an immediate attention.

[0004] The small airway geometry caused by stenosis may cause various health issues with time. Some of the health issues include congenital tracheal stenosis, tracheomalacia, tracheal agenesis, and atresia. Lung and airway disorders such as pneumonia and congenital anomalies are one of the major causes for infant mortality in India. Common symptoms of chronic upper airway include recurrent stridor, chronic cough, cyanotic episodes, feeding difficulties, recurrent aspiration, and pneumonia. Severity of airway symptoms generally corresponds with the degree of airway obstruction and diligent monitoring is required to determine an appropriate management strategy.

[0005] FIGs. 1A, IB, 1C illustrates the conventional tools that are being used for measuring the upper airway stenosis include endotracheal tubes (FIG. 1A), kirschner wire measuring sticks2 (FIG. IB), and bronchoscope (FIG. 1C). However, there conventional tools have certain limitations to their usage. The endotracheal tube needs to be interchanged multiple times in order to provide an approximate estimation of the degree of stenosis, which can even worsen the swelling of tissues. The measuring sticks need to be swapped until the right fit is determined. Also, optical distortion the bronchoscope can affect the measurements of the stenosis which can lead to give false estimation of stenosis.

[0006] There is, therefore, a requirement in the art for a means to precisely and efficiently diagnose upper airway stenosis.

OBJECTS OF THE PRESENT DISCLOSURE

[0007] Some of the objects of the present disclosure, which at least one embodiment herein satisfies are as listed herein below.

[0008] It is an object of the present disclosure to provide for a diagnostic tool that can enable its administration even in severely constricted airway.

[0009] It is an object of the present disclosure to provide for a diagnostic tool that is a portable, hand-held device which makes its deployment easier both in a clinical and non- clinical setting.

[0010] It is an object of the present disclosure to provide for a diagnostic tool that does not demand significant computation requirement.

[0011] It is an object of the present disclosure to provide for a diagnostic tool that heralds a new vertical of hand-held diagnostic tool with a potential to accelerate diagnosis time and implement management strategies efficiently, thereby minimizing trauma to the subject.

[0012] It is an object of the present disclosure to provide for a diagnostic tool that is effective, safe and patient-centric.

[0013] It is an object of the present disclosure to provide for a diagnostic tool that enables quick decision making in emergency intubation both in a clinical and non-clinical setting.

[0014] It is an object of the present disclosure to provide for a diagnostic tool that enables for advancing beyond narrow geometries.

[0015] It is an object of the present disclosure to provide for a diagnostic tool that can extend its usage both for children and adult population seeking medical treatment for chronic airway disease.

[0016] It is an object of the present disclosure to provide for a diagnostic tool that does not demand for a sophisticated clinical setting, and can extend its application not just for conventional hospital setting but also emergency intubation in an un-controlled setting.

[0017] It is an object of the present disclosure to provide for a diagnostic tool that can assist surgeons in decision making and efficient management strategies. Current techniques to assess tracheal obstruction are subjective and dependent greatly on the experience and skill of the surgeon. The proposed tool provides a quantitative measure of localised tissue stiffness and locates stenosis, -an ability that will significantly improve diagnosis and thereby treatment outcomes.

SUMMARY

[0018] The present disclosure relates to the field of diagnostic tools, and more particularly, the present invention relates to a handheld diagnostic tool for grading stenosis. [0019] In an aspect, the present disclosure provides for a diagnostic tool for monitoring stenosis of an airway. The diagnostic tool may include a hollow tube casing having a proximal end and a distal end, an actuator unit that may include an unfurler placed at the distal end, and the unfurler may include one or more radial arms that radially expand to measure patency of the airway. The diagnostic tool may further include one or more tactile sensors placed facing radially outwards at a tip of one or more radial arms of the unfurler to measure tissue stiffness and a control and feedback unit operatively coupled to the one or more tactile sensors, the control and feedback unit located at the proximal end configured to: receive, from the one or more sensors, a first set of signals corresponding to tissue stiffness, receive, from the one or more radial arms of the unfurler, a second set of signals corresponding to the patency of the airway; and based on the received first and second set of signals, determine the state of a tissue of the airway.

[0020] In an embodiment, the tube casing may be used to cover a plurality of tool components.

[0021] In an embodiment, the one or more radial arms may be configured to move radially inward and outward and the one or more radial arms may measure any or a combination of inner diameter of duct, body orifice, cylindrical channels and cylindrical bodies.

[0022] In an embodiment, a handle may be configured at the proximal end for holding the diagnostic tool.

[0023] In an embodiment, the tube casing may further include an outer channel, a flexible printed circuit board (PCB), and a spring wire.

[0024] In an embodiment, the spring wire may be connected to the actuator unit to provide torque control between the proximal end and the distal end of the diagnostic tool, wherein the outer channel may be fastened rigidly to the handle. [0025] In an embodiment, the spring wire may be attached to one or more encoders within the handle and may enable application of torque to rotate the spring wire.

[0026] In an embodiment, an array of flow sensors may be located in a plurality of slits in the tube casing towards the distal end, the array of flow sensors may measure air velocity at a plurality of segments of a tracheobronchial tree of the airway.

[0027] In an embodiment, the array of flow sensors may include a plurality of micro heaters mounted on the flexible PCB to air velocity at a plurality of segments of a tracheobronchial tree of the airway.

[0028] In an embodiment, an end cap may be attached to the distal end of the tube casing to restrict undesired outward movement of the one or more radial arms and the spring wire- arm assembly.

BRIEF DESCRIPTION OF DRAWINGS

[0029] The accompanying drawings are included to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification. The drawings illustrate exemplary embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure. The diagrams are for illustration only, which thus is not a limitation of the present disclosure.

[0030] FIGs. 1A, IB, and 1C illustrate conventional diagnostic tools used for measurement of stenosis.

[0031] FIG. 2 illustrates an exemplary representation of proposed diagnostic tool, in accordance with an embodiment of the present disclosure.

[0032] FIG. 3 illustrates an exemplary representation of elaborated view of proposed diagnostic tool, in accordance with an embodiment of the present disclosure.

[0033] FIG. 4 illustrates an exemplary representation of schematic and exploded view of the proposed tool with details on end effector for patency measurement, in accordance with an embodiment of the present disclosure.

[0034] FIG. 5 illustrates an exemplary representation of schematic diagram representing intubation of the proposed tool to demonstrate its tactile sensing capability, in accordance with an embodiment of the present disclosure.

[0035] FIG. 6 illustrates an exemplary representation of schematic and exploded view of the proposed tool indicating the location of flow sensors and the flexible PCB, in accordance with an embodiment of the present disclosure. [0036] FIG. 7 illustrates an exemplary representation of flexible PCB design and mounting of flow sensors in the proposed diagnostic tool, in accordance with an embodiment of the present disclosure.

[0037] FIG. 8 illustrates an exemplary representation of proposed process flow for fabricating microheater, and tactile sensor used in the proposed diagnostic tool, in accordance with an embodiment of the present disclosure.

[0038] FIG. 9 illustrates fluid flow simulation in stenosed trachea and the response of microheaters on the probe is plotted, in accordance with an embodiment of the present disclosure.

[0039] FIG. 10 illustrates test bench and tracheal holder shown in the figure is used to validate the tool dimensions and perform characterization experiments, in accordance with an embodiment of the present disclosure.

DETAILED DESCRIPTION

[0040] The following is a detailed description of embodiments of the disclosure depicted in the accompanying drawings. The embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.

[0041] If the specification states a component or feature “may”, “can”, “could”, or

“might” be included or have a characteristic, that particular component or feature is not required to be included or have the characteristic.

[0042] As used in the description herein and throughout the claims that follow, the meaning of “a,” “an,” and “the” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of “in” includes “in” and “on” unless the context clearly dictates otherwise.

[0043] Exemplary embodiments will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplary embodiments are shown. These exemplary embodiments are provided only for illustrative purposes and so that this disclosure will be thorough and complete and will fully convey the scope of the invention to those of ordinary skill in the art. The invention disclosed may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Various modifications will be readily apparent to persons skilled in the art. The general principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the invention. Moreover, all statements herein reciting embodiments of the invention, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents as well as equivalents developed in the future (i.e., any elements developed that perform the same function, regardless of structure). Also, the terminology and phraseology used is for the purpose of describing exemplary embodiments and should not be considered limiting. Thus, the present invention is to be accorded the widest scope encompassing numerous alternatives, modifications, and equivalents consistent with the principles and features disclosed. For purpose of clarity, details relating to technical material that is known in the technical fields related to the invention have not been described in detail so as not to unnecessarily obscure the present invention.

[0044] The use of any and all examples, or exemplary language (e.g., “such as”) provided with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non - claimed element essential to the practice of the invention.

[0045] The present disclosure relates to the field of diagnostic tools, and more particularly the present invention relates to a diagnostic tool for grading stenosis.

[0046] FIG. 2 illustrates an exemplary representation of proposed diagnostic tool, in accordance with an embodiment of the present disclosure.

[0047] FIG. 3 illustrates an exemplary representation of elaborated view of proposed diagnostic tool, in accordance with an embodiment of the present disclosure.

[0048] As illustrated, the proposed diagnostic tool 200 can include a proximal end

202 and a distal end 204. The proximal end and the distal end of the too can be operatively coupled with a tube casing, which can be used to cover the entire tool components. The tube casing can be hollow and made of but not limited to silicone, nylon, polyurethane, latex/ silicon rubber, polyethylene terephthalate,polyvinylidene fluoride, fluorinated ethylene propylene, polyolefins such as high density polyethylene and low density polyethylene or other thermoplastic elastomers. The proximal end 202 of the tool 200 can serve the user/clinician/medical practitioner with control and feedback information. The distal end 204 of the tool 200 can include an actuator unit having an actuator mechanism with an unfurler210, which can be a radially expanding mechanism referred placed at the distal end 204 to measure a diameter of the stenosis. The sensors 208 can be housed on the tip of the radial arms of the unfurling actuator (also can be referred as an actuating mechanism), to measure tissue stiffness, and sensors 208 can be but not limited to tactile sensors 208. The tactile sensors 208 used can be based on MEMS technology involving boron doped piezoresistive silicon diaphragm structure or any other principles and can be substituted with capacitive/piezoelectric/optical/pressure or force sensors. The techniques used for fabricating these sensors can be thick film, thin film and Microelectromechanical systems based. The unfurler actuator 222 can include plurality of radial arms which can be configured to move radially inward and outward. The radial arms can be fabricated using materials like fibre glass, stiff metallic material having innate properties like rolling without compromising on stiffness, steel, stainless steel, spring steel, nitinol based shape memory alloy tendon wires or helical springs, plastics like TPU (thermoplastic polyurethane), PETG and PLA. The radial arms can be used to measure patency of the airway, however the tool can be used to measure inner diameter of duct/ body orifice/ cylindrical channels and / or cylindrical bodies. The tool 200 can be advanced into the trachea, just like conventional endotracheal guide wire, through mouth, larynx and into the windpipe. The tactile sensors 208 can be used to measure stiffness of the tissues and can indent normally (at 90 degree) to the target tissue surface. The tool 200 can include a handle at the proximal end, which is to be used for holding the tool 200.

[0049] FIG. 4 illustrates an exemplary representation of schematic and exploded view of the proposed tool with details on end effector for patency measurement, in accordance with an embodiment of the present disclosure.

[0050] FIG. 5 illustrates an exemplary representation of schematic diagram representing intubation of the proposed tool to demonstrate its tactile sensing capability, in accordance with an embodiment of the present disclosure.

[0051] FIG. 6 illustrates an exemplary representation of schematic and exploded view of the proposed tool indicating the location of flow sensors and the flexible PCB, in accordance with an embodiment of the present disclosure.

[0052] As illustrated in FIGs 4, 5, and 6, in an embodiment, the tube casing 212 can include an outer channel 218, a flexible printed circuit board (PCB) 228, and a spring wire 216 inside the hollow tube casing 212. A torque control between proximal end 202and the actuator mechanism 222 at distal end 204 can be achieved using the spring wire 216 (can also be referred as spring steel coil), and the spring wire can be replaced using torsion springs wires of varying length and diameter depending on purpose. The outer channel 218 can be made of but not limited to polyimide, other durable polymer can also be used for making the outer channel 218. The spring wire 216 can be made of steel. The outer channel 218 can be fastened rigidly to the handle casing at the proximal end 202. The spring wire 216 can be attached to a motorized encoder 220 or alternatively a manual knob with an analogue encoder 220 housed within the handle casing. The encoders220 can enable the application of torque and thus rotation of the spring wire 216 can be achieved. The tool 200 can include an array of flow sensors 206, to measure air velocity at various segments of the tracheobronchial tree. The flow sensors can be exposed through slits in the tube casing 212. At the distal end 204, the outer channel 218 is attached to the cylindrical casing having slits 226 for the radial arm. The number of slits in the tube casing can be equal to number of radial arms of the actuator mechanism 222.

[0053] In an embodiment, micro-heaters 230 can be mounted on the flexible PCB 228 to determine velocity of the air across various segments of the tracheobronchial tree. Metals such as Pt, Au, Ni, Ag,Cu,W , as well as polysilicon can be used for fabricating the micro heaters 230. The micro-heaters 230 can include temperature sensors 232 that can be but not limited to a resistance temperature detectors (RTDs) made of platinum, nickel, gold, copper or any suitable metals or alloys. According to Bernoulli’s principle, reduction in cross section area in the fluid conduit causes pressure drop at the site of constriction and a surge in air velocity is seen. Leveraging this phenomenon, thermal flow sensors 206 that can be configured to be operates at constant temperature with a closed loop feedback control. The mechanism is such that, the thermal flow sensor 206 close to the site of constriction can experience a higher thermal exchange with the fast flowing air (airstream has higher velocity) and as the sensor 206 is configured to maintain its temperature constant, the feedback circuit can drive more current in order to maintain the temperature constant. Thus, the additional current pumped can be used to calculate rate of thermal exchange between the micro-heater 230 and the incoming air flow. Velocity at the location can be used to calculate power consumed by the flexible PCB 228. In this way, the velocity profiles at various segments of the tracheal region can be used to locate stenosis.

[0054] In an embodiment, actuating the radial arms can be based on an unfurling mechanism. The spring wire 216 can be attached with a sufficiently flexible radial arm that can be extended out radially when the spring wire is turned. Tactile sensor 208 can be mounted on the radial arms such that the tactile sensors 208 face outside radially. Upon actuation/rotation the radial arms can move in radially outward direction such that contact can be made between the tactile sensors 208 and tissue wall. At the handle, the encoder 220 reading can be proportional to radial distance travelled by the radial arms, thus can detect orifice diameter. An end cap 224 can be attached to the distal end 204 of the tool casing 200 to restrict undesired outward movement of the radial arm or the spring wire-arm assembly. [0055] In an embodiment, the tactile sensors 208 mounted on the radial arms facing radially outward indents on the tissue wall to determine the tissue state (healthy or malacic). Both congenital and acquired forms of stenosis can be observed to alter tissue mechanical properties. Studies have shown inflammation of the tracheal tissue severely reduces the cross- section area and thus increasing the chance of collapse. In a set of cases, disintegration of the cartilage is found to reduce the mechanical strength of the tissue (malacic). Thus, integration of tactile sensors 208 on the radial arms can facilitate tissue stiffness measurement. Once the tool 200 is advanced into the tracheobronchial tree (as illustrated in FIG. 5), the grip/torque can be released gradually due to which the unfurler can start to uncoil and the probe with force sensor can start moving radially outward. Upon contact with the tissue wall the first spike in output of tactile sensor can be detected as initial contact. Upon further release the radial travel can give two outputs, the distance uncoiled, and the force being exerted. Suitable comparison can be made for that of normal and malacic tissue and can be used to arrive at a conclusion on parameters such as malacic segment length, orifice diameter across any segment of the upper airway.

[0056] FIG. 7 illustrates an exemplary representation of flexible PCB design and mounting of flow sensors in the proposed diagnostic tool, in accordance with an embodiment of the present disclosure.

[0057] FIG. 8 illustrates an exemplary representation of proposed process flow for fabricating microheater, and tactile sensor used in the proposed diagnostic tool, in accordance with an embodiment of the present disclosure.

[0058] As illustrated in FIGs 7 and 8, in an embodiment, the flexible PCB 228 can include different sensors, contact and pads. Further, different fabrication steps that can be carried out in order to fabricate the sensors. The fabrication steps can include but without limiting to lithography, etching, passivation, ion implantation, and metallization.

[0059] FIG. 9 illustrates fluid flow simulation in stenosed trachea and the response of microheaters on the probe is plotted, in accordance with an embodiment of the present disclosure.

[0060] In an embodiment, as illustrated in FIG.9, results shows that the airflow rate close to the stenosis section is higher compared to the healthy section due to the constriction of airflow. This increased airflow rate can be measured or sensed by the flow sensor 206. The flow patterns illustrate that the voltage sensed is proportional to the flow rate which directly corresponds to the degree of constriction. Also, the tactile sensors 208 mounted on the radial arms indicate a higher change in voltage for a malacic tissue compared to a healthy one.

[0061] FIG. 10 illustrates test bench and tracheal holder shown in the figure is used to validate the tool dimensions and perform characterization experiments, in accordance with an embodiment of the present disclosure. The FIG. 10 shows the experimental setup, and different tools that were used in conducting the experiment.

[0062] The tool is primarily designed for paediatric population, however the scope is not limited to a specific age group. The tool can extend its usage both for children and adult population seeking medical treatment for chronic airway disease. The tool does not demand for a sophisticated clinical setting, and can extend its application not just for conventional hospital setting but also emergency intubation in an un-controlled setting. Tool administration into the airway is similar to that of a convention airway guide wire (Bougie) and hence does not require specialized training. Its utility can be extended irrespective of a clinician’s area of expertise. By understanding the alteration in tissue mechanical property, the mechanism of airway collapse can be better understood. The trauma and complications associated with long duration intubation can be better understood.

[0063] Knowledge on localized airflow profile across various segments of tracheobronchial tree can provide fundamental understanding of the chronic airway anomalies and hence, can assist surgeons in decision making and efficient management strategies. Current techniques to assess tracheal obstruction are subjective and dependent greatly on the experience and skill of the surgeon. The proposed tool provides a quantitative measure of tracheal dimensions and elasticity-an ability that will significantly improve diagnosis and thereby treatment outcomes. The multifunctional, sensor integrated airway management tool will be a first-of-its-kind diagnostic tool developed for monitoring paediatrics with chronic airway obstruction. The airflow patterns generated by the tool can locate the site of obstruction even in challenging airways. The tactile sensors can provide an understanding on the mechanical property of the tissue and thus the percentage reduction can represent tissue stiffness that precipitates to collapse can be better understood.

[0064] The small dimensions of the tool can enable its administration even in severely constricted airway. The tool is a portable, hand-held device which makes its deployment easier both in a clinical and non-clinical setting. The usage of tool does not demand significant computation requirement. The invention heralds a new vertical of hand-held diagnostic tool with a potential to accelerate diagnosis time and implement management strategies efficiently, thereby minimizing trauma to the subject. The tool design has been carefully crafted to make it effective, safe and patient-centric. The tool can enable quick decision making in emergency intubation both in a clinical and non-clinical setting. The tool’s flexibility can make it easier for advancing beyond narrow geometries. The right size of endotracheal tube has so far been a crude estimate practise, however with the help of the tool, right cuff size of the endotracheal tube can be chosen. Patency/diameter of any body- orifice can be obtained using this mechanism.

ADVANTAGES OF THE PRESENT DISCLOSURE

[0065] The present disclosure provides for a diagnostic tool that can enable its administration even in severely constricted airway.

[0066] The present disclosure provides for a diagnostic tool that is a portable, hand held device which makes its deployment easier both in a clinical and non-clinical setting. [0067] The present disclosure provides for a diagnostic tool that does not demand significant computation requirement.

[0068] The present disclosure provides for a diagnostic tool that heralds a new vertical of hand-held diagnostic tool with a potential to accelerate diagnosis time and implement management strategies efficiently, thereby minimizing trauma to the subject. [0069] The present disclosure provides for a diagnostic tool that is effective, safe and patient-centric.

[0070] The present disclosure provides for a diagnostic tool that enables quick decision making in emergency intubation both in a clinical and non-clinical setting.

[0071] The present disclosure provides for a diagnostic tool that enables for advancing beyond narrow geometries.

[0072] The present disclosure provides for a diagnostic tool that can extend its usage both for children and adult population seeking medical treatment for chronic airway disease. [0073] The present disclosure provides for a diagnostic tool that does not demand for a sophisticated clinical setting, and can extend its application not just for conventional hospital setting but also emergency intubation in an un-controlled setting.

[0074] The present disclosure provides for a diagnostic tool that can assist surgeons in decision making and efficient management strategies. Current techniques to assess tracheal obstruction are subjective and dependent greatly on the experience and skill of the surgeon. The proposed tool provides a quantitative measure of tracheal dimensions and elasticity-an ability that will significantly improve diagnosis and thereby treatment outcomes.

Claims

We Claim:

1. A diagnostic tool for monitoring stenosis of an airway, said diagnostic tool comprising: a hollow tube casing, said tube casing having a proximal end and a distal end; an actuator unit comprising an unfurler, said unfurler placed at the distal end, wherein said unfurler comprises one or more radial arms, the one or more radial arms radially expand to measure patency of the airway; one or more tactile sensors, said one or more tactile sensors placed facing radially outwards at a tip of one or more radial arms of the unfurler, said one or more tactile sensors measure tissue stiffness; a control and feedback unit operatively coupled to the one or more tactile sensors, said control and feedback unit located at the proximal end, wherein the control and feedback unit is configured to: receive, from the one or more sensors, a first set of signals corresponding to tissue stiffness; receive, from the one or more radial arms of the unfurler, a second set of signals corresponding to the patency of the airway; and based on the received first and second set of signals, determine the state of a tissue of the airway.

2. The diagnostic tool as claimed in claim 1, wherein the tube casing is used to cover a plurality of tool components.

3. The diagnostic tool as claimed in claim 1, wherein the one or more radial arms are configured to move radially inward and outward.

4. The diagnostic tool as claimed in claim 1, wherein the one or more radial arms measure any or a combination of inner diameter of duct, body orifice, cylindrical channels and cylindrical bodies.

5. The diagnostic tool as claimed in claim 1, wherein a handle is configured at the proximal end for holding the diagnostic tool.

6. The diagnostic tool as claimed in claim 1, wherein the tube casing further comprises an outer channel, a flexible printed circuit board (PCB), and a spring wire, wherein the spring wire is connected to the actuator unit to provide torque control between the proximal end and the distal end of the diagnostic tool, wherein the outer channel is fastened rigidly to the handle.

The diagnostic tool as claimed in claim 1, wherein the spring wire is attached to one or more encoders within the handle, wherein the one or more encoders enables application of torque to rotate the spring wire.

8. The diagnostic tool as claimed in claim 1, wherein an array of flow sensors are located in a plurality of slits in the tube casing towards the distal end, said array of flow sensors measure air velocity at a plurality of segments of a tracheobronchial tree of the airway.

9. The diagnostic tool as claimed in claim 1, the array of flow sensors comprise a plurality of micro-heaters mounted on the flexible PCB to air velocity at a plurality of segments of a tracheobronchial tree of the airway.

10. The diagnostic tool as claimed in claim 1, wherein an end cap is attached to the distal end of the tube casing to restrict undesired outward movement of the one or more radial arms and the spring wire-arm assembly.