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: PACING GUIDEWIRE

2. APPLICANT:
Meril Life Sciences Pvt. Ltd., an Indian company of Survey No. 135/139 Bilakhia House, Muktanand Marg, Chala, Vapi-Gujarat 396191, India.

The following specification particularly describes the invention and the manner in which it is to be performed:

FIELD OF INVENTION
[001] The present disclosure relates to a guidewire. More specifically, the present disclosure relates to a guidewire having a pacing mechanism.
BACKGROUND OF INVENTION
[002] Guidewire is one of the essential components in any percutaneous medical procedure. For example, transcatheter aortic valve implantation/replacement (TAVI/TAVR) procedure is practiced to percutaneously advanced an implant to the site of treatment (usually within the heart) and deploy the implant therein. TAVI/TAVR procedures are practiced by cardiac interventionalists to repair/replace a stenosed native aortic valve.
[003] Before commencing the TAVI/TAVR procedure, a guidewire is first advanced percutaneously to the treatment site. Only after the guidewire is parked at the treatment site, the delivery system along with the implant is advanced over the guidewire to the treatment site.
[004] Moreover, the guidewire is also used to conduct electrical pulse/signal to the treatment site. Usually, the electrical pulse/signal is conducted to control the pacing of the heart during the TAVI/TAVR procedure.
[005] However, when a conventional guidewire is pushed inside the vasculature to advance the guidewire to the treatment site, the guidewire tends to undesirably slip around. Even after the conventional guidewire is parked at the treatment site, the surrounding compressive forces from the pumping action of the heart makes it unstable, thereby causing difficulties for the cardiac interventionalist to complete the TAVI/TAVR procedure with confidence.
[006] Furthermore, for the pacing mechanism, the conventional guidewires are provided with two or more coiled conductors of different diameters. The coiled conductors having different diameters imparts uneven physical properties such as, flexibility, deformability, kink resistance, etc. Due to said uneven physical properties, especially at a distal portion of the conventional guidewire, there is an increased risk of ventricular perforation and cardiac effusion.
[007] Hence, there arises a need for a new guidewire which overcomes the challenges associated with the conventional guidewires.
SUMMARY OF INVENTION
[008] The present disclosure relates to a guidewire including at least one elongate member and at least one coiled member. The elongate member includes a proximal portion disposed towards a proximal end of the elongate member. The proximal portion is coated with one or more layers of coating. The elongate member includes a distal portion disposed towards a distal end of the elongate member. The distal portion include a plurality of sections having a uniform profile and/or a tapered profile. At least a part of the distal portion includes a curved configuration. The coiled member is wrapped around at least a portion of the distal portion of the elongate member and intermittently coated with at least one layer of coating. The curved configuration of the distal portion is defined by a length ‘L’, a height ‘H’, and a curve ratio between the height ‘H’ and length ‘L’ ranging from 1 to 1.2.
[009] The foregoing features and other features as well as the advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
BRIEF DESCRIPTION OF DRAWINGS
[0010] 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 instrumentalities disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[0011] Fig. 1 depicts a guidewire 100 in accordance with one or more embodiment of the present disclosure.
[0012] Fig. 1a depicts an elongate member 110 of the guidewire 100 in accordance with one or more embodiment of the present disclosure.
[0013] Fig. 1b depicts a distal portion 110b1 of the elongate member 110 wrapped inside a coiled member 130 of the guidewire 100 in accordance with one or more embodiment of the present disclosure.
[0014] Fig. 2 depicts the guidewire 100 with an uncoated region ‘uc’ spaced away from the proximal end 110a in accordance with one or more embodiment of the present disclosure.
[0015] Fig. 3 depicts a curved configuration of the distal portion 110b1 of the guidewire 100 in accordance with one or more embodiment of the present disclosure.
[0016] Fig. 3a depicts another curved configuration of the distal portion 110b1 of the guidewire 100 in accordance with one or more embodiment of the present disclosure.
[0017] Fig. 3b depicts another curved configuration of the distal portion 110b1 of the guidewire 100 in accordance with one or more embodiment of the present disclosure.
[0018] Fig. 3c depicts another curved configuration of the distal portion 110b1 of the guidewire 100 in accordance with one or more embodiment of the present disclosure.
[0019] Fig. 3d depicts another curved configuration of the distal portion 110b1 of the guidewire 100 in accordance with one or more embodiment of the present disclosure.
[0020] Fig. 4 depicts a method 200 to manufacture the guidewire 100 in accordance with one or more embodiment of the present disclosure.
DETAILED DESCRIPTION OF ACCOMPANYING DRAWINGS
[0021] 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.
[0022] 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.
[0023] 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.
[0024] Furthermore, the described features, 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 features or advantages of a particular embodiment. In other instances, additional features and advantages may be recognized in certain embodiments that may not be present in all embodiments. These features 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.
[0025] The present disclosure discloses a guidewire. The guidewire is used in percutaneous medical procedures, for example transcatheter aortic valve implantation/replacement (TAVI/TAVR) procedures, etc. Furthermore, the guidewire is used to control the pacing of the heart (or other organ, as required) during the percutaneous medical procedures.
[0026] The guidewire of the present disclosure is a great tool for interventionalist, as it can be easily maneuvered through the tortuous vasculature and is less likely to become blocked or kinked due to its unique shape. This makes it easier for interventionalist to perform the procedure accurately and efficiently. The guidewire also reduces the need for manual manipulation of the catheter, which can reduce the risk of complications during the interventional procedures.
[0027] Further, the distal end of the guidewire of the present disclosure is provided with enough flexibility, deformability and softness to minimize the risk of ventricular perforation and cardiac effusion. The guidewire also helps with stability once the guidewire is parked at the treatment site.
[0028] Fig. 1 depicts an exemplary guidewire 100 of the present disclosure. The guidewire 100 includes at least one elongate member 110, at least one coiled member 130, one or more jackets 150, etc.
[0029] Fig. 1a depicts the elongate member 110 of the guidewire 100. The elongate member 110 extends between a proximal end 110a and a distal end 110b of the elongate member 110. The distal end 110b of the elongate member 110 is inserted within the vasculature to advance the guidewire 100 to a treatment site. The elongate member 110 is made of a material selected from stainless steel (S.S.), nitinol, etc. In an exemplary embodiment, the elongate member 110 is made of stainless steel. The elongate member 110 may include a length ranging from 260 mm to 300 mm. The elongate member 110 may have a pre-defined cross-sectional shape selected from circular, square, rectangular, flat, etc. In an exemplary embodiment, the elongate member 110 has a circular cross-section.
[0030] The elongate member 110 may include a proximal portion 110a1 disposed towards the proximal end 110a of the elongate member 110. The proximal portion 110a1 may have a length ranging from 2420 mm to 2820 mm. The proximal portion 110a1 may include a uniform diameter ranging from 0.86 mm to 0.90 mm. In an exemplary embodiment, the length and diameter of the proximal portion 110a1 of the elongate member 110 is 2580 mm and 0.89 mm respectively.
[0031] The proximal portion 110a1 of the elongate member 110 may be coated with one or more layers of coating. The one or more layers of coating may be selected from polytetrafluoroethylene (PTFE), hydrophilic, silicon, etc. In an exemplary embodiment, the proximal portion 110a1 is coated with one layer of PTFE. The coating helps to reduce friction and enables ease of insertion.
[0032] Additionally or optionally, the proximal portion 110a1 of the elongate member 110 may be provided with one or more uncoated regions ‘uc’. In an exemplary embodiment, the uncoated region ‘uc’ may be provided as is while manufacturing the guidewire 100. In an alternate embodiment, the uncoated region ‘uc’ may be provided with a “peel-away” coating that is removed by the user if required at the time of performing a percutaneous procedure.
[0033] The uncoated region ‘uc’ may have a length ranging from 10 mm to 20 mm. In an exemplary embodiment, the length of the uncoated region ‘uc’ is 10 mm. The uncoated region ‘uc’ enables the user to connect the elongate member 110 to at least one terminal of either of a positive terminal or a negative terminal of a direct current (DC) source. Thus, the uncoated region ‘uc’ helps the user to transmit electrical pulse/signal through the guidewire 100. In an exemplary embodiment, the uncoated region ‘uc’ is electrically connected to the negative terminal of a battery and the positive terminal of the battery is electrically connected to the patient’s body. Further, the uncoated region ‘uc’ helps the user to feel excellent tactile feedback when the guidewire 100 is advanced through the vasculature to the treatment site.
[0034] In an exemplary embodiment, as shown in Fig. 1, the uncoated region ‘uc’ is disposed at the proximal end 110a of the elongate member 110.
[0035] In an alternate exemplary embodiment, as shown in Fig. 2, the uncoated region ‘uc’ is spaced away from the proximal end 110a of the elongate member 110.
[0036] Referring back to Fig. 1a, the elongate member 110 may include a distal portion 110b1 disposed towards the distal end 110b of the elongate member 110. The distal portion 110b1 may have a length ranging from 140 mm to 180 mm. In an exemplary embodiment, the length of the distal portion 110b1 is 170 mm.
[0037] The distal portion 110b1 may include a plurality of sections 111. In an exemplary embodiment, as shown in Fig. 1a, the distal portion 110b1 of the elongate member 110 include a first section 111a, a second section 111b, a third section 111c and a fourth section 111d. The sections 111 may have uniform profile/diameter and/or tapered profile/diameter.
[0038] The first section 111a is disposed adjacent to the proximal portion 110a1 of the elongate member 110. The first section 111a may have a length ranging from 60 mm to 100 mm. In an exemplary embodiment, the length of the first section 111a is 90 mm. In an exemplary embodiment, the first section 111a tapers towards the distal end 110b. The first section 111a may have a maximum diameter ranging from 0.86 mm to 0.90 mm. The first section 111a may have a minimum diameter ranging from 0.30 mm to 0.35 mm. In an exemplary embodiment, the maximum and minimum diameter of the first section 111a is 0.87 mm and 0.33 mm respectively. The first section 111a helps to provide pushability to the guidewire 100.
[0039] The second section 111b is disposed adjacent to the first section 111a of the elongate member 110. The second section 111b may have a length ranging from 30 mm to 40mm. In an exemplary embodiment, the second section 111b includes a uniform diameter. The diameter of the second section 111b ranges from 0.30 mm to 0.35 mm. In an exemplary embodiment, the length and diameter of the second section 111b is 35 mm and 0.33 mm respectively. The second section 111b provides support to the guidewire 100.
[0040] The third section 111c is disposed adjacent to the second section 111b of the elongate member 110. The third section 111c may have a length ranging from 20 mm to 30 mm. In an exemplary embodiment, the length of the third section 111c is 25 mm. In an exemplary embodiment, the third section 111c tapers towards the distal end 110b. The third section 111c may have a maximum diameter ranging from 0.30 mm to 0.35 mm. The third section 111c may have a minimum diameter ranging from 0.15 mm to 0.20 mm. In an exemplary embodiment, the maximum and minimum diameter of the third section 111c is 0.33 mm and 0.18 mm respectively. The third section 111c behaves as a transition section and provides flexibility to the guidewire 100.
[0041] The fourth section 111d is disposed at the distal end 110b, adjacent to the third section 111c of the elongate member 110. The fourth section 111d may have a length ranging from 15 mm to 25 mm. In an exemplary embodiment, the fourth section 111d includes a uniform diameter. The diameter of the fourth section 111d ranges from 0.15 mm to 0.20 mm. In an exemplary embodiment, the length and diameter of the fourth section 111d is 20 mm and 0.18 mm respectively. The fourth section 111d helps to behaves as a shaping section and provides flexibility to the guidewire 100.
[0042] As shown in Fig. 1, the distal portion 110b1 may at least partially enclosed/wrapped by the coiled member 130. In an exemplary embodiment, as shown in Fig. 1, the second, third and fourth section 111b, 111c, 111d are completely enclosed by the coiled member 130 and the first section 111a is partially enclosed by the coiled member 130. After the coiled member 130 is wrapped around the elongate member 110, the outer diameter of the coiled member 130 ranges from 0.87 mm to 0.92 mm. In an exemplary embodiment, the coiled member 130 has a uniform outer diameter of 0.89 mm.
[0043] The coiled member 130 may be relatively more flexible than the elongate member 110 which helps to set flexibility, torqueability and crossability of the guidewire 100. The said difference in flexibility helps to provide more tactile feedback to the operator of the guidewire 100.
[0044] The coiled member 130 may include at least one cable wrapped around in a pre-defined pitch. The cable may include a pre-defined cross-sectional shape including but not limited to circular, flat, etc. In an exemplary embodiment, the cable has a circular cross section. The cable may include a diameter ranging from 0.12 mm to 0.17 mm. In an exemplary embodiment, the diameter of the cable is 0.15 mm. In an exemplary embodiment, the pitch of the coiled member 130 is substantially same as the diameter of the cable.
[0045] The cable may be made of a material including but not limited to stainless steel, nitinol, platinum, titanium, tungsten, etc. In an exemplary embodiment, the cable of the coiled member 130 is made from stainless steel. The material of the cable may optionally be pre-shaped.
[0046] An enlarged view of the coiled member 130 wrapped around the elongate member 110 is depicted in Fig. 1b. The coiled member 130 may be intermittently coated with at least one layer of coating selected from PTFE, ethylene tetrafluoroethylene (ETFE) and Hydrophilic, etc. In an exemplary embodiment, the layer of coating provided on the coiled member 130 is PTFE. The layer of coating disposed over the coiled member 130 provides easy low-friction movement and manipulation of the guidewire 100 through the vasculature and also function as electrical insulation.
[0047] In an exemplary embodiment, as shown in Fig. 1b, the coiled member 130 includes four coated regions ‘c’. The remaining of the coiled member 130 is left uncoated. The uncoated regions of the coiled member 130 helps to conduct the electrical pulse/signal transmitted from the uncoated region ‘uc’ of the elongate member 110 (as described above), thus helping in pacing of the treatment (or surrounding) site.
[0048] The ends of the cable of the coiled member 130 may be coupled to the elongate member 110, via soldering, plasma welding, laser welding, epoxy, etc.
[0049] In an exemplary embodiment, as shown in Figs. 1 and 1b, the end of the cable (disposed towards the proximal end 110a) is coupled to the first section 111a via a jacket 150.
[0050] The jacket 150 may be made of a material including but not limited to stainless steel (S.S.), platinum, copper, etc. In an exemplary embodiment, the jacket 150 is made of stainless steel. The jacket 150 may have a pre-defied shaped including but not limited to conical, cylindrical, parabolic, dome, etc. In an exemplary embodiment, the jacket 150 is conical shaped. The jacket 150 helps to clamp the coiled member 130 over the elongate member 110.
[0051] In an exemplary embodiment, as shown in Fig. 1b, the end of the cable (disposed towards the distal end 110b) is coupled to the distal end 110b of the elongate member 110 via a dome shaped weld 170. The dome shaped weld 170 disposed at the distal end 110b helps in fracture reduction as well as provides easy cross blockage with less pain.
[0052] Additionally or optionally, similar to the distal end 110b of the elongate member 110, the proximal end 110a of the elongate member 110 is provided with the dome shaped weld 170. The dome shaped weld 170 disposed at the proximal end 110a provides protection from injury during usage of the guidewire 100.
[0053] As shown in Fig. 3, at least a part of the distal portion 110b1 of the guidewire 100 includes a curved configuration, i.e., the distal portion 110b1 may form a spiral-like structure. The curved configuration of the distal portion 110b1 is defined by a length ‘L’, a height ‘H’ and a pitch ‘P’ as shown in Fig. 3. The length ‘L’ of the curved configuration ranges from 20 mm to 49 mm. The height ‘H’ of the curved configuration ranges from 23 mm to 50 mm. The pitch ‘P’ of the curved configuration ranges from 6 mm to 12 mm. In an exemplary embodiment, the length ‘L’, height ‘H’ and pitch ‘P’ of the curved configuration are partially influenced by a diameter of the distal portion 110b1.
[0054] The height ‘H’ of the curved configuration may either be same as the length ‘L’ or more than the length ‘L’ by 3mm or less. In other words, the height ‘H’ of the curved configuration is equal to length ‘L’ + (0mm to 3mm). In an exemplary embodiment, the said relation between the height ‘H’ and length “L’ of the curved configuration of the distal portion 110b1 helps to park the guidewire 100 in the left ventricle (LV) and grip the LV wall while it provides central alignment for the transcatheter procedures like transcatheter aortic valve implantation (TAVI) and transcatheter aortic valve repair (TAVR).
[0055] A curve ratio between the height ‘H’ and length ‘L’ of the curved configuration ranges from 1 to 1.2. The said range of curve ration helps to park the guidewire 100 in the left ventricle (LV) and grip the LV wall while it provides central alignment for the transcatheter procedures like transcatheter aortic valve implantation (TAVI) and transcatheter aortic valve repair (TAVR).
[0056] In an exemplary embodiment, as shown in Fig. 3a, the length, height and pitch of the curved configuration of the distal portion 110b1 is 20 mm, 23 mm and 6 mm respectively.
[0057] In an exemplary embodiment, as shown in Fig. 3b, the length, height and pitch of the curved configuration of the distal portion 110b1 is 25 mm, 27 mm and 8 mm respectively.
[0058] In an exemplary embodiment, as shown in Fig. 3c, the length, height and pitch of the curved configuration of the distal portion 110b1 is 29 mm, 32 mm and 6 mm respectively.
[0059] In an exemplary embodiment, as shown in Fig. 3d, the length, height and pitch of the curved configuration of the distal portion 110b1 is 35 mm, 36 mm and 12 mm respectively.
[0060] In an exemplary embodiment, not shown, the length, height and pitch of the curved configuration of the distal portion 110b1 is 42 mm, 42 mm and 15 mm respectively.
[0061] In an exemplary embodiment, not shown, the length, height and pitch of the curved configuration of the distal portion 110b1 is 49 mm, 50 mm and 18 mm respectively.
[0062] The above-described embodiments of the guidewire 100 is selected by a medical practitioner based at least on patient’s heart size and the dimension of the LV curve wall.
[0063] Fig. 4 depicts an exemplary method 200 to manufacture the guidewire 100 of the present disclosure. The method commences at step 201 by obtaining a pre-defined length of the elongate member 110. In an exemplary embodiment, the elongate member 110 is PTFE coated.
[0064] At step 203, the distal portion 110b1 of the elongate member 110 is subjected to a grinding process to obtain the plurality of sections 111.
[0065] At step 205, at least a part of the distal portion 110b1 of the elongate member 110 is shaped to the curved configuration using pre-defined molds (not shown). In an exemplary embodiment, to shape the distal portion 110b1 of the elongate member 110, the mold along with the distal portion 110b1 of the elongate member 110 is kept at a pre-defined temperature of 500 °C to 700 °C for 30 minutes.
[0066] At step 207, the elongate member 110 is quenched by rapid cooling the distal portion 110b1 of the elongate member 110. In an exemplary embodiment, the distal portion 110b1 of the elongate member 110 is put in chilled water for rapid cooling.
[0067] At step 209, the elongate member 110 is subjected to a cleaning technique. In an exemplary embodiment, the elongate member 110 is cleaned using an ultrasonic cleaning process.
[0068] At step 211, the end of the cable (disposed towards the proximal end 110a) of the coiled member 130 is coupled to the first section 111a of the elongate member 110. In an exemplary embodiment, the cable is coupled to the elongate member 110 via a laser welding technique.
[0069] At step 213, the end of the cable (disposed towards the distal end 110b) of the coiled member 130 is coupled to the distal end 110b of the elongate member 110 via a dome shaped weld 170. In an exemplary embodiment, the dome shaped weld 170 is formed by plasma welding technique.
[0070] At step 215, the jacket 150 is inserted over the elongate member 110 from the proximal end 110a and crimped over the coupling between the end of the cable (disposed towards the proximal end 110a) of the coiled member 130 and the first section 111a of the elongate member 110. In an exemplary embodiment, the jacket 150 is crimped using a crimping device (not shown).
[0071] The guidewire 100 will now be explained with the help of the following examples:
[0072] Example 1 (Prior art): Conventional guidewire
[0073] A ventricular tachycardia procedure was performed using a conventional unipolar guidewire. A femoral puncture was created to advance and position the distal end portion of the unipolar guidewire on a wall of the right ventricle (RV). The proximal end portion of the unipolar guidewire was connected to a first pole of an external pulse generator using an alligator clamp. A second opposite pole of the external pulse generator was electrically connected to a large surface skin electrode placed at a left thigh of the patient.
[0074] During the above procedure, for pacing purpose, the electrodes were parked at the RV. And, to reach the target, access was gained through a second femoral artery, which took more time and made the process more complicated and time-consuming.
[0075] Example 2 (Present invention): Percutaneous procedure with guidewire 100 and observations
[0076] The guidewire 100 was advanced through a catheter under fluoroscopic guidance. The distal end 110b of the guidewire 100 provided enough flexibility, deformability, and softness to minimize the risk of ventricular perforation and cardiac effusion. The guidewire 100 also helped with stability once the guidewire 100 was parked inside the LV of the heart. The guidewire 100 maintained its position while a balloon catheter was advanced over the guidewire 100.
[0077] The guidewire 100 was used to control the pacing of the heart during the procedure. The positive terminal of the pulse generator was connected to the patient’s body. And the negative terminal was connected with the guidewire’s 100 uncoated region ‘uc’ at the proximal portion 110a1 of the elongate member 110. The pacing was provided via the guidewire 100 after the artery was blocked using the inflated balloon of the balloon catheter.
[0078] During the placement, the distal end 110b of the outer curvature of the guidewire 100 made direct contact with the LV wall tissue, which equally distributed the current on the LV wall and maintained the heartbeat at a lower current supply.
[0079] 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 guidewire (100) comprising:
a. at least one elongate member (110) extending between a proximal end (110a) and a distal end (110b), the elongate member (110) including:
i. a proximal portion (110a1) disposed towards the proximal end (110a) of the elongate member (110), the proximal portion (110a1) coated with one or more layers of coating;
ii. a distal portion (110b1) disposed towards the distal end (110b) of the elongate member (110), the distal portion (110b1) include a plurality of sections (111) having a uniform profile and/or a tapered profile, at least a part of the distal portion (110b1) includes a curved configuration;
b. at least one coiled member (130) wrapped around at least a portion of the distal portion (110b1) of the elongate member (110), and intermittently coated with at least one layer of coating;
wherein the curved configuration of the distal portion (110b1) is defined by a length ‘L’, a height ‘H’, and a curve ratio between the height ‘H’ and length ‘L’ ranging from 1 to 1.2.
2. The guidewire (100) as claimed in claim 1, wherein the one or more layers of coating over the elongate member (110) is selected from polytetrafluoroethylene (PTFE), hydrophilic, and silicon.
3. The guidewire (100) as claimed in claim 1, wherein the proximal portion (110a1) of the elongate member (110) is provided with one or more uncoated regions ‘uc’.
4. The guidewire (100) as claimed in claim 1, wherein the plurality of sections (111) include:
a. a first section 111a disposed adjacent to the proximal portion (110a1) of the elongate member (110) and tapers towards the distal end (110b);
b. a second section 111b disposed adjacent to a first section (111a) of the elongate member (110) and includes a uniform diameter;
c. a third section (111c) disposed adjacent to a second section (111b) of the elongate member (110) and tapers towards the distal end (110b); and
d. a fourth section 111d is disposed at the distal end (110b) and includes a uniform diameter.
5. The guidewire (100) as claimed in claim 1, wherein a second section (111b), a third section (111c), and a fourth section (111d) are completely enclosed by the coiled member (130) and the first section (111a) is partially enclosed by the coiled member (130).
6. The guidewire (100) as claimed in claim 1, wherein the coiled member (130) includes at least one cable wrapped around in a pre-defined pitch that is substantially same as a diameter of the cable.
7. The guidewire (100) as claimed in claim 1, wherein the at least one layer of coating over the coiled member (130) is selected from polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), and hydrophilic.
8. The guidewire (100) as claimed in claim 1, wherein the coiled member (130) includes four coated regions ‘c’.
9. The guidewire (100) as claimed in claim 1, wherein an end of a cable of the coiled member (130) disposed towards the proximal end (110a) is coupled to a first section (111a) of the elongate member (110) via a jacket (150).
10. The guidewire (100) as claimed in claim 1, wherein an end of the cable of the coiled member (130) disposed towards the distal end (110b) is coupled to the distal end (110b) of the elongate member (110) via a dome shaped weld (170).
11. The guidewire (100) as claimed in claim 1, wherein the proximal end (110a) of the elongate member (110) is provided with a dome shaped weld (170).
12. The guidewire (100) as claimed in claim 1, wherein the length ‘L’ of the curved configuration ranges from 20 mm to 49 mm.
13. The guidewire (100) as claimed in claim 1, wherein the height ‘H’ ranges from 23 mm to 50 mm.
14. The guidewire (100) as claimed in claim 1, wherein the curved configuration of the distal portion (110b1) is defined by a pitch ‘P’ ranging from 6 mm to 12 mm.
15. The guidewire (100) as claimed in claim 1, wherein the height ‘H’ of the curved configuration is either same as the length ‘L’ or more than the length ‘L’ by 3mm or less.