Medical device positioning system

Abstract

TITLE OF INVENTION: MEDICAL DEVICE POSITIONING SYSTEM The present disclosure relates to a medical device positioning system (100) including a steering mechanism. The steering mechanism (120) comprises a shaft (112) that further includes a shaft lumen (112h), a control element (114), a curb (116) and a slider (118). The shaft lumen (112h) is configured to receive a catheter. The control element (114) is rotatable in a clockwise or an anticlockwise direction. The slider (118) includes a slider passage (118f) and at least one slot (118c1, 118c2). The slider passage (118f) is configured to receive the curb (116) and allow the curb (116) to slide in response to the movement of the shaft (112). The shaft (112) is configured to move in a transverse direction upon rotation of the control element (114). The catheter is displaced at a millimeter scale upon movement of the shaft (112). The distance traversed by the curb (116) within the slider (118) defines the distance traversed by a distal portion of a catheter within the vasculature system. Fig. 1b

Description

FIELD OF DISCLOSURE[1] The present disclosure relates to a medical device accessory. Moreparticularly, the present disclosure relates to a medical device positioning systemexternally coupled to a catheter which assists in precise positioning of a distalend or distal portion of the catheter.BACKGROUND OF DISCLOSURE[2] A catheter is a thin, flexible tube-like medical device. Catheters come invarious sizes, materials, and designs to suit their intended purposes. Some of theareas where catheterization is needed include, interventional cardiology andvascular system surgeries for placement of stents within the blood vessels incoronary artery diseases, peripheral artery diseases, and other vascular issues.[3] The delivery of a stent using a delivery catheter is a minimally invasiveprocedure. It involves careful insertion and positioning of the catheter within ablood vessel, or duct to perform a range of medical procedures. Once thecatheter is in the desired location, various medical procedures can be performed,including delivering stents, conducting measuring or imaging studies, ballooningetc.[4] However, towards the very end phase of catheterization, precisepositioning of the distal portion of a catheter with or without a medical device atan intended landing zone remains a significant challenge in clinical practices. Forexample, healthcare practitioners manually adjust the positioning of the stent atthe intended landing zone, requiring them to move the distal portion of thecatheter back-and-forth multiple times until the distal portion of the catheterwith the stent is precisely positioned at the desired location for deployment ofthe stent. This demands physical efforts and controlled motor skills from themedical practitioner during the medical procedure. Additionally, the repeatedback-forth movement of the catheter within the vasculature system can causediscomfort for the patient and more importantly, may result in damage tonearby tissue regions.[5] Hence, there is a need to devise a system for precise positioning of thedistal portion of a medical device like a catheter in a blood vessel.SUMMARY[6] Particular embodiments of the present disclosure are described hereinbelow with reference to the accompanying drawings; however, it is to beunderstood that the disclosed embodiments are mere examples of thedisclosure, which may be embodied in various forms. Well-known functions orconstructions are not described in detail to avoid obscuring the presentdisclosure in unnecessary detail. Therefore, specific structural and functionaldetails disclosed herein are not to be interpreted as limiting, but merely as abasis for the claims and as a representative basis for teaching one skilled in theart to variously employ the present disclosure in virtually any appropriatelydetailed structure.[7] The present disclosure relates to a medical device positioning systemincluding a steering mechanism. The steering mechanism comprises a shaft, acontrol element, a curb and a slider. The shaft includes a shaft lumen extendingfrom a proximal end to a distal end. The shaft lumen is configured to receive acatheter. The control element is disposed towards the proximal end of the shaft.The control element is rotatable in a clockwise direction or an anticlockwisedirection. The curb is coupled to the distal end of the shaft. The curb includes atleast one protrusion provided on an outer surface of the curb. The slider includesa slider passage and at least one slot. The slider passage is configured to receivethe curb and allow the curb to slide in response to the movement of the shaft.The at least one slot are configured to receive respective protrusion of the curb.The shaft is configured to move in a transverse direction upon rotation of thecontrol element. The catheter is displaced at a millimeter scale upon movementof the shaft. The distance traversed by the curb within the slider defines thedistance traversed by a distal portion of a catheter within the vasculaturesystem.BRIEF DESCRIPTION OF DRAWINGS[8] The summary above, as well as the following detailed description ofillustrative embodiments, is better understood when read in conjunction withthe 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 disclosedherein. Moreover, those in the art will understand that the drawings are not toscale.[9] Fig. 1a depicts a perspective cross-sectional view of a medical devicepositioning system 100 according to an embodiment of the present disclosure.

[10] Fig. 1b depicts an exploded side view of the system 100 according to anembodiment of the present disclosure.

[11] Fig. 1c depicts cross-sectional view of system 100 according to anembodiment of the present disclosure.

[12] Figs. 2 depicts a shaft 112 of the system 100 according to an embodimentof the present disclosure.

[13] Fig. 3a depicts a control element 114 of the system 100 according to anembodiment of the present disclosure.

[14] Fig. 3b depicts a cross-sectional view of the control element 114 of thesystem 100 according to an embodiment of the present disclosure.

[15] Fig. 4 depicts a gasket 115 of the system 100 according to an embodimentof the present disclosure.

[16] Fig. 5a depicts an isometric view of a curb 116 of the system 100 accordingto an embodiment of the present disclosure.

[17] Fig. 5b depicts a cross-sectional view of the curb 116 of the system 100according to an embodiment of the present disclosure.

[18] Figs. 6a-6b depict an isometric view of a slider 118 of the system 100according to an embodiment of the present disclosure.

[19] Fig. 7 depicts a flowchart of a method 700 for assembling the system 100,according to an embodiment of the present disclosure.

[20] Fig. 8 depicts a flowchart of a method 800 for operating the system 100,according to an embodiment of the present disclosure.

[21] Fig. 9 depicts one embodiment of the system 100 operatively coupled toan appropriate catheter delivery system 130 in accordance with the presentdisclosure.

[22] Figs. 10-11 depict a schematic diagram of the system 100 when thecatheter is positioned at an intended landing zone or desired location within thevasculature system, according to an embodiment of the present disclosure.DETAILED DESCRIPTION OF THE DRAWINGS

[23] Prior to describing the invention in detail, definitions of certain words orphrases used throughout this patent document will be defined: the terms"include" and "comprise", as well as derivatives thereof, mean inclusion withoutlimitation; 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 toor 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 patentdocument, and those of ordinary skill in the art will understand that suchdefinitions apply in many, if not most, instances to prior as well as future uses ofsuch defined words and phrases.

[24] Reference throughout this specification to "one embodiment," "anembodiment," or similar language means that a particular feature, structure, orcharacteristic described in connection with the embodiment is included in atleast one embodiment. Thus, appearances of the phrases "in one embodiment,""in an embodiment," and similar language throughout this specification may, butdo not necessarily, all refer to the same embodiment, but mean "one or morebut not all embodiments" unless expressly specified otherwise. The terms"including," "comprising," "having," and variations thereof mean "including butnot limited to" unless expressly specified otherwise. An enumerated listing ofitems does not imply that any or all of the items are mutually exclusive and / ormutually inclusive, unless expressly specified otherwise. The terms "a," "an,"and "the" also refer to "one or more" unless expressly specified otherwise.

[25] Although the operations of exemplary embodiments of the disclosedmethod may be described in a particular, sequential order for convenientpresentation, it should be understood that the disclosed embodiments canencompass an order of operations other than the particular, sequential orderdisclosed. For example, operations described sequentially may in some cases berearranged or performed concurrently. Further, descriptions and disclosuresprovided in association with one particular embodiment are not limited to thatembodiment, and may be applied to any embodiment disclosed herein.Moreover, for the sake of simplicity, the attached figures may not show thevarious ways in which the disclosed system, method, and apparatus can be usedin combination with other systems, methods, and apparatuses.

[26] Furthermore, the described includes, advantages, and characteristics ofthe embodiments may be combined in any suitable manner. One skilled in therelevant art will recognize that the embodiments may be practiced without oneor more of the specific includes or advantages of a particular embodiment. Inother instances, additional includes and advantages may be recognized in certainembodiments that may not be present in all embodiments. These includes andadvantages of the embodiments will become more fully apparent from thefollowing description and apportioned claims, or may be learned by the practiceof embodiments as set forth hereinafter.

[27] This current disclosure pertains to a medical device positioning system(referred as system). The system may be used to position a medical deviceincluding, without limitation, a balloon, a stent, etc. in a body vasculature. In anexemplary embodiment, the system is used in interventional cardiology and / orvascular system surgery for placement of for example, a stent within a bloodvessel / body vasculature to treat coronary artery disease, peripheral arterydisease, or other vascular issues. In an embodiment, the system includes asteering mechanism that is used in conjunction with any suitable catheter. Thesystem provides fine control over advancement or retraction of the distal portionof a catheter and helps in precise positioning of the catheter's distal portionwithin the body vasculature, operating at a millimeter scale. This is significant asduring the final phase of catheterization, a medical practitioner may be requiredto move the catheter in forward and backward directions one or more times toposition the distal portion of catheter accurately using imaging techniques, e.g.,fluoroscopy. The precise control provided by the system of the presentdisclosure helps in eliminating the forward and backward movement of the distalportion of catheter for positioning it accurately and achieve the same withminimum trials, possibly, a single go.

[28] The system of the present disclosure is mounted externally on a proximalportion of a catheter. In an embodiment, the translational movement of acatheter is achieved by a controlled rotational movement of a control elementprovided in the system. By rotating the control element, the distal portion of thecatheter is displaced at a millimeter scale at the intended landing zone within abody vasculature. This precise control ensures, for example, the optimalpositioning of a stent at the desired location or the intended landing zone. Bymitigating the risk of misplacement, the system enhances overall proceduralsuccess, contributing to improved patient outcomes. Unlike the traditionalmethod involving manual back-forth movement of the catheter, the deviceprovides controlled positioning of the catheter's distal portion, reducing thelikelihood of repeated adjustments and minimizing the potential for damage tosurrounding tissues thereby minimizing patient discomfort and the risk ofcomplications associated. The ergonomic design of the system, including anencased steering mechanism within a compact handle, enhances usability andfacilitates single-handed operation. The device overall improves practitionercomfort and contributes to procedural efficiency.

[29] Now referring to the figures, Fig. 1a illustrates an exemplary embodimentof a medical device positioning system 100 (hereinafter, system 100) used with acatheter during catheterization procedures. In an exemplary embodiment, thesystem 100 is ergonomically designed for easier operation.

[30] The system 100 has a proximal end 100a, a distal end 100b, a medial side100c1, a lateral side 100c2 and a central portion 100c. In an embodiment, thesystem 100 is generally cuboidal in shape with a taper at the proximal end 100aand the distal end 100b, and a narrower profile in the central portion 100c.While the depicted embodiment includes tapers at sides and / or a narrowerprofile at the center, a person skilled in the art will appreciate that numerousvariations to the shape of the handle can be made while practicing the inventivefeatures of the present disclosure and the same are within the scope of thepresent disclosure.

[31] In an exemplary embodiment, as shown in Fig. 1a-1b, the system 100includes a casing 110 and a steering mechanism 120. The steering mechanism120 is an assembly of a plurality of components that are operationally coupled toeach other, which is explained below. The steering mechanism 120 is seated inthe casing 110. Further, a catheter is passed through the casing 110 and thesteering mechanism 120, the movement of which is controlled by the steeringmechanism 120. Further details of the casing 110 and the steering mechanism120 are described in the context of various diagrams below.

[32] Fig. 1b depicts an exploded view of the assembly of various components(casing 110 and steering mechanism 120) of the system 100 according to anembodiment of the present disclosure. Fig. 1c depicts a cross-sectional view ofthe system / system 100 with a catheter 130. Each of the components, theirinterconnection and their operation are described in detail below.

[33] The casing 110 is an assembly of a top case 110a and a bottom case 110b,as shown in Fig. 1b. The casing 110 encases various components of the steeringmechanism 120 and a portion of the catheter 130. The top case 110a and thebottom case 110b can be made of materials including, without limitation, highdensity polyethylene (HDPE), polyoxymethylene (POM), thermoplasticpolyurethane (TPU), thermoplastic rubber (TPR), polypropylene (PP),polycarbonate (PC), etc. In an exemplary embodiment, the top case 110a and thebottom case 110b are made of polycarbonate.

[34] The top case 110a and the bottom case 110b may be provided with asuitable locking mechanism known in the art. In an exemplary embodiment, thetop case 110a and the bottom case 110b are provided with press-fit elements,which when pressed, secure the top case 110a and the bottom case 110btogether. In an embodiment, the press-fit elements include a plurality ofprotrusions 132a and plurality of holes 132b. Each of the plurality of protrusions132a engages with a corresponding hole of the plurality of holes 132b and formsthe press-fit lock.

[35] Further, the casing 110 includes a longitudinal groove. In the depictedembodiment, the longitudinal groove includes a proximal longitudinal groove136a and a distal longitudinal groove 136b provided at the proximal end 100aand the distal end 100b of the system 100, respectively, and is configured toreceive a catheter (e.g., the catheter 130).

[36] The casing 110 includes a first channel 134a next to the proximallongitudinal groove 136a. Further, the casing 110 includes a second channel 134bseparated from the first channel 134a and provided towards the central portion100c of the system 100. In an embodiment, the second channel 134b is of astepped configuration. That is, the second channel 134b includes two diameters,a narrower diameter towards a proximal portion of the second channel 134b anda broader diameter towards a distal portion of the second channel 134b.

[37] Each of the top case 110a and the bottom case 110b include a plurality ofcavities. In an embodiment, the plurality of cavities includes a first cavity Aprovided distal to the first channel 134a and a second cavity B provided distal tothe second channel 134b. The second cavity B includes at least one notch B1, asshown in Fig. 1a.

[38] In an exemplary embodiment, the steering mechanism 120 includes ashaft 112, a control element 114, a gasket 115, a curb 116 and a slider 118, asshown in Fig. 1b. The steering mechanism 120 enables the user to advance orretract a catheter (e.g., the catheter 130) while positioning the same within thevasculature system.

[39] The shaft 112 includes a hollow, nearly tubular body with a proximal end112a and a distal end 112b (shown in Fig. 2), defining a length therebetween.The shaft 112 is configured to move transversely both in a forward and abackward direction. The exemplary length of the shaft 112 may be between 50mm to 55 mm. In an embodiment, the length of the shaft 112 is 52 mm. Theshaft 112 may be made of materials including, without limitation, high-densitypolyethylene (HDPE), polyoxymethylene (POM), thermoplastic Polyurethane(TPU), thermoplastic rubber (TPR), polypropylene (PP), polycarbonate (PC), etc.,or combination thereof. In an exemplary embodiment, the shaft 112 is made ofpolycarbonate.

[40] The body of the shaft 112 may include multiple threaded portions. In anembodiment, the shaft 112 includes a proximal threaded portion 112a1 and adistal threaded portion 112b1 provided towards the proximal end 112a and thedistal end 112b, respectively. The proximal threaded portion 112a1 is configuredto engage with the control element 114, while the distal threaded portion 112b1is configured to engage with the curb 116. The interaction between the proximalthreaded portion 112a1 with the control element 114 helps in forward andbackward movement of the shaft 112 upon rotation of the control element 114in one direction and the other respectively. For example, rotation of the controlelement 114 in clockwise direction may move the shaft 112 forward whilerotation of the control element 114 in anti-clockwise direction may move theshaft 112 backward.

[41] The proximal threaded portion 112a1 may include at least one flat surface.In an embodiment, the at least one flat surface includes a first flat face 112d anda second flat face (not shown) in the generally tubular body. In an exemplaryembodiment, the generally tubular body extends from a lateral side 112e to amedial side 112f of the shaft 112. In an embodiment, the first flat face 112d andthe second flat face are devoid of any threads. Thus, the proximal threadedportion 112a1 may be partially threaded, namely, the threaded and unthreadedportions are interspersed. This structure of the shaft 112 having the at least oneflat surface helps in smooth sliding movement of the shaft 112 within the controlelement 114. Though the present disclosure includes a shaft with two flat faces,it should be appreciated that the shaft may / may not include any flat face and thethreads may extend throughout the portion 112a1. The proximal threadedportion 112a1 may have larger dimensions compared to the distal threadedportion 112b1. The dimensions include the diameter and length of the threadedportions. Further, the pitch of the two threaded portions may differ. The distalthreaded portion 112b1 helps to lock the shaft 112 with the curb 116.

[42] Between the proximal threaded portion 112a1 and the distal threadedportion 112b1, a middle portion 112c is defined. In an exemplary embodiment,the middle portion 112c is unthreaded as shown in Fig. 2. While the depictedembodiment of the shaft 112 is unthreaded in the middle portion 112c, a personskilled in the art will appreciate that threads can be made on the middle portion112c of the shaft 112 while practicing the inventive features of the presentdisclosure and the same are within the scope of the present disclosure. Thediameter of the middle portion 112c may be less than or equal to the diameterof the distal threaded portion 112b1.

[43] The shaft 112 is disposed in the channel 134 of the casing 110, as shown inFig. 1a-1b. In an embodiment, certain portions of the plurality of proximalthreaded portion 112a1 of the shaft 112 are received within the first channel134a and the middle portion 112c is received in a portion of the second channel134b (i.e., with narrower diameter) of the casing 110.

[44] The shaft 112 includes a shaft lumen 112h, as shown in Fig. 2, extendingfrom the proximal end 112a to the distal end 112b. The catheter 130 passesthrough the shaft lumen 112h of the shaft 112 (depicted in Fig. 2). The shaft 112is configured to move linearly on application of a torque. Due to the movementof the shaft 112, the catheter 130 inside the shaft 112 moves due to frictionalinteraction between the catheter 130 and the shaft lumen 112h, resulting in atransverse movement or advancement of the catheter 130 as it progressesthrough the intricate vasculature system.

[45] Further, the shaft 112 includes one or more projections 112a2 at theproximal end 112a of the shaft 112. One or more projections 112a2 may beprovided on a corresponding flat face (i.e., the first flat face 112d and the secondflat face). In an exemplary embodiment, the shaft 112 includes a projection112a2 on the first flat face 112d, as shown in Fig. 2. The projection 112a2 acts asa stopper and prevents further movement of the shaft 112 in a lumen 114b ofthe control element 114 once the projection 112a2 mates with a proximal end ofthe control element 114, while the control element 114 is being rotated.

[46] The control element 114 (Fig. 3a) is disposed on the proximal threadedportion 112a1 of the shaft 112. The cavity A of the casing 110 receives thecontrol element 114, as shown in Fig. 1b. The control element 114 is capable ofbeing rotated either in a clockwise direction or an anticlockwise direction by auser to maneuver a catheter (e.g., the catheter 130) within the vasculaturesystem. The control element 114 may be of any suitable shape, such as, withoutlimitation, cylindrical, spherical, cuboidal, hexagonal prism, etc. In anembodiment, the control element 114 has a cylindrical shape resembling ahollow rotating knob that is rotatable in both clockwise and anticlockwisedirections.

[47] The control element 114 includes a top surface 114a and a lumen 114b, asshown in Fig. 3a. In an embodiment, the top surface 114a includes a plurality ofgrooves 114a1. The grooves 114a1 provide steady grip to the user. In analternate embodiment, the grooves 114a1 may be absent. The lumen 114b ofthe control element 114 receives the shaft 112. In an embodiment, the lumen114b of the control element 114 includes a plurality of threads 114b1 whichmate with the corresponding threads of the proximal threaded portion 112a1 ofthe shaft 112, as shown in Fig. 3b.

[48] Further, the plurality of threads 114b1 in the lumen 114b of the controlelement 114 are for example, circular with which the partial threads of theproximal threaded portion 112a1 provided on the shaft 112 mate. Upon rotatingthe control element 114 either in the clockwise direction or the anticlockwisedirection, the plurality of the threads 114b1 mates with the proximal threadedportion 112a1 of the shaft 112. The mating of the plurality of threads 114b1 withthe proximal threaded portion 114b1 results in conversion of the rotationalmotion of the control element 114 into a linear motion of the shaft 112. As aresult, the shaft 112 moves transversely either in the forward direction or in thebackward direction. For example, rotating the control element 114 in theclockwise direction results in movement of the shaft 112 in the forwarddirection. Similarly, rotating the control element 114 in the backward directionresults in movement of the shaft 112 in the backward direction.

[49] Exemplary length of the control element 114 ranges from 15mm to 20mm.The control element 114 may be made of materials including, without limitation,high-density polyethylene (HDPE), polyoxymethylene (POM), thermoplasticpolyurethane (TPU), thermoplastic rubber (TPR), polypropylene (PP),polycarbonate (PC), etc., or a combination thereof. In an exemplaryembodiment, the control element 114 is made of polycarbonate.

[50] The gasket 115 (Fig. 4) is disposed at the distal end 112b of the shaft 112.The gasket 115 includes a proximal end115a, a distal end 115b, and an outersurface 115e as shown in Fig. 4. In an embodiment, the gasket 115 is generally ahollow, tubular body defining a gasket passage 115c. The catheter 130 passesthrough the gasket passage 115c. The gasket 115 has a taper at the distal end115b. The gasket passage 115c extends from the proximal end 115a andgradually tapers towards the distal end 115b. The taper at the distal end 115bcreates a narrower profile of the gasket passage 115c at the distal end 115b thanthat at the proximal end115a. The dimension of the gasket passage 115c towardsthe proximal end 115a complements the dimension of the distal end 112b of theshaft 112, ensuring a complementary fit. The gasket 115 is configured to grip thedistal end 112b of the shaft 112. The gasket 115 may be of any suitable shape,such as, without limitation, hollow truncated cone, tubular shape, silicone Eshape, etc.

[51] The exemplary length of the gasket 115 ranges from 3 mm to 8 mm. Thegasket 115 may be made of any suitable compressible materials including,without limitation, natural rubber, nitrile rubber (NBR), ethylene propylene dienemonomer (EPDM), polyurethane (AU), silicone (Q) etc., or combination thereof.In an exemplary embodiment, the gasket 115 is made of silicone. Due tocompressible nature of the gasket 115, upon being twisted, the gasket 115 isconfigured to crimp and lock the catheter.

[52] The curb 116 includes an outer surface 116a, a proximal portion 116b anda distal portion 116c, as shown in Figs. 5a. The proximal portion 116b extendsfrom a proximal end of the curb 116 and continues until a point from where thedistal portion 116c starts, as shown in Fig. 5b. The distal portion 116c includes adistal tip 116c1. The distal portion 116c extends from the point where theproximal portion 116b ends to the distal tip 116c1.

[53] The curb 116 may be of any suitable shape, such as, without limitation,tubular, cuboidal, cube, conical, pentagonal prism, etc. In an embodiment, thecurb 116 is generally hollow and cylindrical in shape, defining a curb passage116d with a taper at the distal tip 116c1. The curb passage 116d extends fromthe proximal portion 116b to the distal tip 116c1, as shown in Fig. 5b. In anembodiment, the curb passage 116d has a uniform diameter. Alternately, thecurb passage 116d may be tapered. Tapering of the distal tip 116c1 results innarrowing the curb passage 116d towards the distal tip 116c1. That is, the curbpassage 116d includes two diameters, a broader diameter towards the proximalportion 116b and a narrower diameter towards the distal tip 116c1, as shown inFig. 5b.

[54] The curb passage 116d is configured to receive the distal threaded portion112b1 of the shaft 112 and the gasket 115. The dimensions of the curb passage116d complement the dimensions of the plurality of distal threaded portion112b1 of the shaft 112. The dimensions towards the distal tip 116c1 of the curbpassage 116d are complementary to the dimensions of the gasket passage 115ctowards the distal end 115b of the gasket 115.

[55] The curb passage 116d may include a plurality of threads 116d1. In anembodiment, the plurality of threads 116d1 are provided in the proximal portion116b of the curb passage 116d. The plurality of threads 116d1 mates with thecorresponding threads of the distal threaded portion 112b1 of the shaft 112, asshown in Fig. 2, thereby locking the shaft 112 with the curb 116. The curbpassage 116d towards the distal portion 116c receives the gasket 115, as shownin Fig 1b. The curb 116 prevents slippage of the gasket 115 from the distal end112b of the shaft 112. Further, the curb 116 helps in twisting the gasket 115.Thelength of the curb 116 ranges from 10mm to 15mm. The curb 116 may be madeof materials including, without limitation, high-density polyethylene (HDPE),polyoxymethylene (POM), thermoplastic Polyurethane (TPU), thermoplasticrubber (TPR), polypropylene (PP), polycarbonate (PC), etc. In an exemplaryembodiment, the curb 116 is made of polycarbonate.

[56] The curb 116 includes at least one protrusion along the outer surface116a. In an exemplary embodiment, the at least one protrusion includes a firstprotrusion 116f1 and a second protrusion 116f2, as shown in Fig. 5a. The at leastone protrusion is configured to slide within the slider 118.

[57] The slider 118 includes a proximal portion 118a and a distal portion 118b.The slider 118 may be of any suitable shape, such as, without limitation,cylindrical, cube, cuboidal, conical, pentagonal prism, etc. In an embodiment, theslider 118 is generally cylindrical in shape and is hollow from inside defining aslider passage 118f. The slider passage 118f is configured to receive the curb 116,as the dimensions of the slider passage 118f complement the outer surface 116aof the curb 116.

[58] The slider 118 is operatively coupled to the curb 116, as shown in Fig. 1b.and provides a passage for the curb 116 to slide in response to the movement ofthe shaft 112. The slider 118 includes at least one slot. The at least oneprotrusion of the curb 116 is seated in the at least one slot of the slider 118. Theat least one protrusion is configured to slide within the at least one slot of theslider 118. In an embodiment, the at least one slot includes a first slot 118c1 anda second slot 118c2. The first and second slot 118c1 and 118c2 extend from thedistal portion 118b to at least a portion of the proximal portion 118a of the slider118, as shown in Fig. 6a. The first protrusion 116f1 and second protrusion 116f2of the curb 116 are seated in the first slot and second slot 118c1 and 118c2,respectively, thereby operatively coupling the slider 118 with the curb 116.

[59] The distal portion 118b of the slider 118 includes a cap 118d. The cap 118dmay include at least one wing. In an embodiment, the cap 118d includes a firstwing 118d1 and a second wing 118d2. The at least one wing provides grip for theuser and enables the user to rotate the slider 118 in a clockwise or inanticlockwise direction.

[60] In an exemplary embodiment, the cap 118d includes at least one tab 118e.Upon rotating the slider 118 in a clockwise direction with the help of the at leastone wing, the at least one tab 118e engages with the at least one notch B1provided on the casing 110 (as shown in Fig. 6b) and is configured to lock theslider 118 within the second cavity B of the casing 110. Upon rotating the slider118 in anticlockwise direction with the help of the at least one wing, the at leastone tab 118e disengages from the at least one notch B1, resulting in unlockingthe slider 118.

[61] The proximal portion 118a and the cap 118d of the slider 118 are disposedin a portion of the second channel 134b (i.e., with broader diameter) and thesecond cavity B of the casing 110, respectively. The length of the slider 118ranges from 27mm to 32mm. The slider 118 may be made of materials including,without limitation, high-density polyethylene (HDPE), polyoxymethylene (POM),thermoplastic Polyurethane (TPU), thermoplastic rubber (TPR), polypropylene(PP), polycarbonate (PC), etc. In an exemplary embodiment, the slider 118 ismade of polycarbonate.

[62] Fig. 7 illustrates a flowchart of a method 700 for assembling the system100, according to an embodiment of the present disclosure.

[63] The method 700 commences at step 702 in which the steering mechanism120 of the system 100 is assembled. In an embodiment, the step 702 includessteps 702a - 702d.

[64] At step 702a, the control element 114 is disposed on the proximalthreaded portion 112a of the shaft 112. As explained earlier, the plurality ofthreads 114b1 provided in the lumen 114b of the control element 114 mate withthe corresponding threads of the proximal threaded portion 112a1 of the shaft112.

[65] At step 702b, the gasket 115 is disposed in the curb 116. The gasket 115 isinserted in the curb passage 116d from the proximal portion 116b. As explainedearlier, the dimensions of the curb passage 116d towards the distal portion 116ccomplement the dimensions of the outer surface 115e of the gasket 115. Thegasket 115 resides within the curb passage 116d towards the distal portion 116cof the curb 116.

[66] At step 702c, the curb 116 is inserted into the slider 118. The slider 118receives the curb 116 from the distal portion 118b. As explained earlier, the firstprotrusion 116f1 and the second protrusion 116f2 of the curb 116 are receivedwithin the first slot 118c1 and the second slot 118c2, respectively, of the slider118. The protrusions 116f1 and 116f2 of the curb 116 are slidable within therespective slots of the slider 118.

[67] At step 702d, the distal threaded portion 112b1 of the shaft 112 isinserted into the gasket 115 which is disposed within the curb 116. Specifically,the gasket 115 receives the distal end 112b of the distal threaded portion 112b1of the shaft 112. The curb passage 116d towards the proximal portion 116b ofthe curb 116, receives the distal threaded portion 112b1 of the shaft 112. Asexplained earlier, the plurality of threads 116d1 provided in the proximal portion116b of curb passage 116d mate with the distal threaded portion 112b1 of shaft112, thereby establishing the assembly of the steering mechanism 120.

[68] At step 704, the assembled steering mechanism 120 obtained from step702d is encased within the casing 110. As explained earlier, the channel 134provided in the casing 110 receives the shaft 112. The first channel 134aprovided next to the proximal longitudinal groove 136a receives certain portionsof the plurality of proximal threads 112a of the shaft 112. The second channel134b with narrower diameter receives the middle portion 112c of the shaft 112,and the second channel 134b with broader diameter receives the slider 118. Thefirst cavity A receives the control element 114, and a second cavity B receives thecap 118d of the slider 118, whereby the system 100 is assembled.

[69] Though the method 700 for assembling the system 100 is described hereinwith reference to Fig. 7, it should be understood that the steps outlined in thepresent disclosure are not limited to the sequence depicted. A person skilled inthe art may interchange or rearrange the steps as deemed appropriate based onconvenience without deviating the scope of invention.

[70] Fig. 8 illustrates a flowchart of an exemplary method 800 for operating thesystem 100 of the present disclosure.

[71] At step 802, the system 100 is mounted on a catheter 130 in closeproximity with a handle of the catheter delivery system. The system 100 isattached to the catheter 130 of the catheter delivery system such that thesystem 100 is always outside a patient body when the catheter delivery system isin use. In one depicted embodiment, the proximal end 100a of the system 100 isprovided in proximity to a distal end of the handle 160 of a catheter deliverysystem, as shown in Fig. 9. This arrangement facilitates a smooth operationduring medical procedures, as medical practitioner can easily control the precisepositioning of the distal portion of the catheter 130 from outside of the patient'sbody. Furthermore, this provides safety and comfort of the patient, as theentirety of the system 100 remains external to the patient's body throughout theprocedure.

[72] In an initial position, as shown in Fig. 10, the distal end of the proximalthreaded portion 112a1 of the shaft 112 is disposed within or aligned with thedistal end of the control element 114. The gasket 115 is disposed within the curb116. The distal end 112b of the shaft 112 is disposed inside the gasket 115 andthe distal threaded portion 112b1 is in contact with the corresponding pluralityof threads 116d1 of the curb 116. The curb 116 is positioned towards theproximal portion 118a of the slider 118 and the at least one protrusion 116f ofthe curb 116 is seated in the at least one slot 118c of the slider 118.

[73] At step 804, the distal portion of the catheter 130 is inserted into thepatient's vasculature system and is advanced or navigated through the intricatepathways of the vasculature system using the appropriate catheter deliverysystem under an imaging system like fluoroscopy until a distal portion of thecatheter is in close proximity to the intended landing zone. A medicalpractitioner can push an adequate length of catheter 130 inside a bodyvasculature as needed to perform a medical procedure.

[74] The catheter 130 passes through the proximal longitudinal groove 136a,the shaft lumen 112h, the curb passage 116d, the gasket passage 115c, the distallongitudinal groove 136b and finally exits the system 100 from the distal end100b. In an exemplary embodiment, the distal portion of the catheter 130includes a stent 170.

[75] At step 806, once the distal portion of the catheter 130 is around theintended landing zone or the desired location, say, within a few millimeters, thecatheter 130 is locked with the gasket 115. For this, the slider 118 is rotated, forexample, in a clockwise direction, facilitated by the at least one wing (the firstwing 118d1 and / or the second wing 118d2). The slider 118 can be rotated till theat least one tab 118e of the slider 118 engages with the notch B1 of the cavity Bprovided in the casing 110. Once the two tab 118e and B1 come in contact, theslider 118 is locked inside the casing 110.

[76] Further, rotation of the slider 118 causes simultaneous rotation of thecurb 116 in the corresponding direction, as the curb 116 is operatively coupled tothe slider 118. The gasket 115, housed within the curb passage 116d, isconfigured to twist in response to the rotation of the curb 116. Due to this twistand as the gasket 115 is compressible, the gasket 115 firmly grips or locks thecatheter 130 in place.

[77] At step 808, the control element 114 is rotated, for example, in theclockwise direction to advance the shaft 112, i.e., in the forward direction. As thecontrol element 114 is rotated in the clockwise direction, the plurality of threads114b1 provided within the lumen 114b of the control element 114 engages withthe proximal threaded portion 112a1 of the shaft 112. This creates a frictionalinteraction between the shaft 112 and the control element 114. This frictionalinteraction is translated into a forward rotational motion of the shaft 112, asshown in Fig. 11. The shaft 112 is thus pushed forward.

[78] Along with the shaft 112, the curb 116 and the gasket 115 coupled to thedistal threaded portion 112b1 of the shaft 112 are also pushed forward. Further,the catheter 130 locked with the gasket 115 is also advanced in the bodyvasculature by a distance corresponding to the distance moved by the shaft 112at step 810. The at least one protrusion (116f1 and 116f2) of the curb 116 slidesforward within the at least one slot (118c1 and 118c2) of the slider 118.

[79] The shaft 112, curb 116 and the gasket 115 can be moved forward uponrotation of the control element 114 till the protrusion (116f1 and 116f2) of thecurb 116 reaches the distal edge of the respective slot (118c1 and 118c2) of theslider 118. The distance traversed by the curb 116 within the slider 118 thusdefines the distance traversed by the distal portion of the catheter 130 withinthe vasculature system.

[80] Once the distal portion of the catheter 130 is positioned in the intendedlanding zone, the catheter delivery system can be used to complete the medicalprocedure (e.g., treatment, delivery, etc.). After the completion of theprocedure, the catheter 130 Is retracted from the vasculature system of thepatient.

[81] The mechanism allows for incremental movement of the catheter 130,covering only a few millimeters during the final phase of the catheterization. Inan exemplary embodiment, the system 100 is used to advance or retract thecatheter 130 in a body vasculature by say, 27 mm to 32 mm. If the length ofmovement of the distal portion of the catheter 130 is to be increased ordecreased, the length of the slot of the slider 118 can be changed. The system ofthe present invention enables a medical practitioner to adjust the position of thecatheter 130 with precision at the desired location or the intended landing zonewithin the vasculature system. By providing such control over the catheter 130advancement during the final phase, the system 100 minimizes the margin forerror and allows for meticulous adjustment, ultimately enhancing the accuracy ofthe stent 170 placement. This helps in achieving optimal procedural outcomes,as it reduces the risk of misplacement and associated complications, therebyimproving patient safety and treatment efficacy during the catheterizationprocedures.

[82] The scope of the invention is only limited by the appended patent claims.More generally, those skilled in the art will readily appreciate that allparameters, dimensions, materials, and configurations described herein aremeant to be exemplary and that the actual parameters, dimensions, materials,and / or configurations will depend upon the specific application or applicationsfor which the teachings of the present invention is / are used.

Claims

1. A medical device positioning system (100) including a steering mechanism, the steering mechanism (120) comprising; a. a shaft (112) having a proximal end (112a), a distal end (112b) and a 5 shaft lumen (112h) extending therebetween and configured to receive a catheter; b. a control element (114) disposed towards the proximal end (112a) of the shaft (112), configured to rotate in a clockwise direction or an anticlockwise direction; c. a curb (116) coupled to the distal end (112b) of the shaft (112) and includes at least one protrusion (116f1, 166f2) provided on an outer surface (116a) of the curb (116); and d. a slider (118) having: i. a slider passage (118f) configured to receive the curb (116) 15 and allow the curb (116) to slide in response to the movement of the shaft (112); and ii. at least one slot (118c1 and 118c2) configured to receive respective protrusion (116f1, 116f2) of the curb 116; wherein, the shaft (112) is configured to move in a transverse direction upon rotation of the control element (114); wherein a distal portion of the catheter is displaced at a millimeter scale upon movement of the shaft (112); and wherein, distance traversed by the curb (116) within the slider (118) defines the distance traversed by a distal portion of a catheter within the vasculature system.2.The medical device positioning system (100) as claimed in claim 1, wherein the shaft (112) includes a proximal threaded portion (112a1) configured to engage with the control element (114).3.The medical device positioning system (100) as claimed in claim 2, wherein the control element (114) includes a lumen (114b) having a plurality of threads (114b1) configured to mate with the proximal threaded portion (112a1).4.The medical device positioning system (100) as claimed in claim 2, wherein the proximal threaded portion (112a1) of the shaft (112) may include at least one flat surface (112d).5.The medical device positioning system (100) as claimed in claim 1 and 4, wherein the proximal end (112a) of the shaft (112) includes one or more projections (112a2) provided on the at least one flat surface (112d), configured to limit movement of the shaft (112) in a lumen (114b) of the control element (114).6.The medical device positioning system (100) as claimed in claim 1, wherein the shaft (112) includes a distal threaded portion (112b1) configured to engage with the curb (116).7.The medical device positioning system (100) as claimed in claims 2 and 6, wherein dimensions of the proximal threaded portion (112a1) are larger than dimensions of the distal threaded portion (112b1).8.The medical device positioning system (100) as claimed in claim 1, wherein the curb (116) having a curb passage (116d), includes: a. a proximal portion (116b) provided with a plurality of threads (116d1) to mate with a distal threaded portion (112b1) of the shaft (112), and b.a distal portion (116c) configured to receive a gasket (115).9.The medical device positioning system (100) as claimed in claim 1, wherein the slider (118) includes a cap (118d) provided towards a distal portion (118b) of the slider (118) having: a. at least one wing (118d1 and 118d2) to rotate the slider (118) in one 5 of a clockwise direction or an anti-clockwise direction; and b. at least one tab (118e) configured to lock the slider (118) within a casing (110) upon rotation of the slider (118).10.The medical device positioning system (100) as claimed in claim 1, wherein the steering mechanism includes a gasket (115) to be seated in the curb (116) and configured to receive the distal end (112b) of the shaft (112).11.The medical device positioning system (100) as claimed in claim 10, wherein the gasket (115) is configured to twist upon rotation of the slider (118) and lock the catheter (130).12.The medical device positioning system (100) as claimed in claim 10, wherein the gasket (115) is made of a compressible material.13.The medical device positioning system (100) as claimed in claim 12, wherein the gasket (115) is made of one of natural rubber, nitrile rubber (NBR), ethylene propylene diene monomer (EPDM), polyurethane (AU), silicone (Q), or combinations thereof.14.The medical device positioning system (100) as claimed in claim 1, wherein at least one of the shaft (112), the control element (114), the slider (118) are made of one of high-density polyethylene (HDPE), polyoxymethylene (POM), thermoplastic Polyurethane (TPU), thermoplastic rubber (TPR), polypropylene (PP), polycarbonate (PC), or combinations thereof.