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

TITLE OF THE INVENTION
MEDICAL DEVICE POSITIONING SYSTEM
APPLICANT:
Meril Corporation (I) Private Limited, an Indian company of the address Survey No. 135/139, Muktanand Marg, Bilakhia House, Pardi, Vapi, Valsad-396191 Gujarat, India.

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

FIELD OF DISCLOSURE
[1] The present disclosure relates to a medical device accessory. More particularly, the present disclosure relates to a medical device positioning system externally coupled to a catheter which assists in precise positioning of a distal end or distal portion of the catheter.
BACKGROUND OF DISCLOSURE
[2] A catheter is a thin, flexible tube-like medical device. Catheters come in various sizes, materials, and designs to suit their intended purposes. Some of the areas where catheterization is needed include, interventional cardiology and vascular system surgeries for placement of stents within the blood vessels in coronary artery diseases, peripheral artery diseases, and other vascular issues.
[3] The delivery of a stent using a delivery catheter is a minimally invasive procedure. It involves careful insertion and positioning of the catheter within a blood vessel, or duct to perform a range of medical procedures. Once the catheter is in the desired location, various medical procedures can be performed, including delivering stents, conducting measuring or imaging studies, ballooning etc.
[4] However, towards the very end phase of catheterization, precise positioning of the distal portion of a catheter with or without a medical device at an intended landing zone remains a significant challenge in clinical practices. For example, healthcare practitioners manually adjust the positioning of the stent at the intended landing zone, requiring them to move the distal portion of the catheter back-and-forth multiple times until the distal portion of the catheter with the stent is precisely positioned at the desired location for deployment of the stent. This demands physical efforts and controlled motor skills from the medical practitioner during the medical procedure. Additionally, the repeated back-forth movement of the catheter within the vasculature system can cause discomfort for the patient and more importantly, may result in damage to nearby tissue regions.
[5] Hence, there is a need to devise a system for precise positioning of the distal portion of a medical device like a catheter in a blood vessel.
SUMMARY
[6] Particular embodiments of the present disclosure are described herein below with reference to the accompanying drawings; however, it is to be understood that the disclosed embodiments are mere examples of the disclosure, which may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.
[7] The present disclosure relates to a medical device positioning system including a steering mechanism. The steering mechanism comprises a shaft, a control element, a curb and a slider. The shaft includes a shaft lumen extending from a proximal end to a distal end. The shaft lumen is configured to receive a catheter. The control element is disposed towards the proximal end of the shaft. The control element is rotatable in a clockwise direction or an anticlockwise direction. The curb is coupled to the distal end of the shaft. The curb includes at least one protrusion provided on an outer surface of the curb. The slider includes a slider passage and at least one slot. The slider passage is configured to receive the 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 the control element. The catheter is displaced at a millimeter scale upon movement of the shaft. The distance traversed by the curb within the slider defines the distance traversed by a distal portion of a catheter within the vasculature system.
BRIEF DESCRIPTION OF DRAWINGS
[8] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentality disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[9] Fig. 1a depicts a perspective cross-sectional view of a medical device positioning system 100 according to an embodiment of the present disclosure.
[10] Fig. 1b depicts an exploded side view of the system 100 according to an embodiment of the present disclosure.
[11] Fig. 1c depicts cross-sectional view of system 100 according to an embodiment of the present disclosure.
[12] Figs. 2 depicts a shaft 112 of the system 100 according to an embodiment of the present disclosure.
[13] Fig. 3a depicts a control element 114 of the system 100 according to an embodiment of the present disclosure.
[14] Fig. 3b depicts a cross-sectional view of the control element 114 of the system 100 according to an embodiment of the present disclosure.
[15] Fig. 4 depicts a gasket 115 of the system 100 according to an embodiment of the present disclosure.
[16] Fig. 5a depicts an isometric view of a curb 116 of the system 100 according to an embodiment of the present disclosure.
[17] Fig. 5b depicts a cross-sectional view of the curb 116 of the system 100 according to an embodiment of the present disclosure.
[18] Figs. 6a-6b depict an isometric view of a slider 118 of the system 100 according 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 to an appropriate catheter delivery system 130 in accordance with the present disclosure.
[22] Figs. 10-11 depict a schematic diagram of the system 100 when the catheter is positioned at an intended landing zone or desired location within the vasculature 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 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.
[24] 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.
[25] 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.
[26] Furthermore, the described includes, advantages, and characteristics of the embodiments may be combined in any suitable manner. One skilled in the relevant art will recognize that the embodiments may be practiced without one or more of the specific includes or advantages of a particular embodiment. In other instances, additional includes and advantages may be recognized in certain embodiments that may not be present in all embodiments. These includes and advantages of the embodiments will become more fully apparent from the following description and apportioned claims, or may be learned by the practice of embodiments as set forth hereinafter.
[27] This current disclosure pertains to a medical device positioning system (referred as system). The system may be used to position a medical device including, without limitation, a balloon, a stent, etc. in a body vasculature. In an exemplary embodiment, the system is used in interventional cardiology and/or vascular system surgery for placement of for example, a stent within a blood vessel/body vasculature to treat coronary artery disease, peripheral artery disease, or other vascular issues. In an embodiment, the system includes a steering mechanism that is used in conjunction with any suitable catheter. The system provides fine control over advancement or retraction of the distal portion of a catheter and helps in precise positioning of the catheter’s distal portion within the body vasculature, operating at a millimeter scale. This is significant as during the final phase of catheterization, a medical practitioner may be required to move the catheter in forward and backward directions one or more times to position the distal portion of catheter accurately using imaging techniques, e.g., fluoroscopy. The precise control provided by the system of the present disclosure helps in eliminating the forward and backward movement of the distal portion of catheter for positioning it accurately and achieve the same with minimum trials, possibly, a single go.
[28] The system of the present disclosure is mounted externally on a proximal portion of a catheter. In an embodiment, the translational movement of a catheter is achieved by a controlled rotational movement of a control element provided in the system. By rotating the control element, the distal portion of the catheter is displaced at a millimeter scale at the intended landing zone within a body vasculature. This precise control ensures, for example, the optimal positioning of a stent at the desired location or the intended landing zone. By mitigating the risk of misplacement, the system enhances overall procedural success, contributing to improved patient outcomes. Unlike the traditional method involving manual back-forth movement of the catheter, the device provides controlled positioning of the catheter’s distal portion, reducing the likelihood of repeated adjustments and minimizing the potential for damage to surrounding tissues thereby minimizing patient discomfort and the risk of complications associated. The ergonomic design of the system, including an encased steering mechanism within a compact handle, enhances usability and facilitates single-handed operation. The device overall improves practitioner comfort and contributes to procedural efficiency.
[29] Now referring to the figures, Fig. 1a illustrates an exemplary embodiment of a medical device positioning system 100 (hereinafter, system 100) used with a catheter during catheterization procedures. In an exemplary embodiment, the system 100 is ergonomically designed for easier operation.
[30] The system 100 has a proximal end 100a, a distal end 100b, a medial side 100c1, a lateral side 100c2 and a central portion 100c. In an embodiment, the system 100 is generally cuboidal in shape with a taper at the proximal end 100a and the distal end 100b, and a narrower profile in the central portion 100c. While the depicted embodiment includes tapers at sides and/or a narrower profile at the center, a person skilled in the art will appreciate that numerous variations to the shape of the handle can be made while practicing the inventive features of the present disclosure and the same are within the scope of the present disclosure.
[31] In an exemplary embodiment, as shown in Fig. 1a-1b, the system 100 includes a casing 110 and a steering mechanism 120. The steering mechanism 120 is an assembly of a plurality of components that are operationally coupled to each other, which is explained below. The steering mechanism 120 is seated in the casing 110. Further, a catheter is passed through the casing 110 and the steering mechanism 120, the movement of which is controlled by the steering mechanism 120. Further details of the casing 110 and the steering mechanism 120 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 an embodiment of the present disclosure. Fig. 1c depicts a cross-sectional view of the system/system 100 with a catheter 130. Each of the components, their interconnection 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 steering mechanism 120 and a portion of the catheter 130. The top case 110a and the bottom case 110b can 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 top case 110a and the bottom case 110b are made of polycarbonate.
[34] The top case 110a and the bottom case 110b may be provided with a suitable locking mechanism known in the art. In an exemplary embodiment, the top 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 110b together. In an embodiment, the press-fit elements include a plurality of protrusions 132a and plurality of holes 132b. Each of the plurality of protrusions 132a engages with a corresponding hole of the plurality of holes 132b and forms the press-fit lock.
[35] Further, the casing 110 includes a longitudinal groove. In the depicted embodiment, the longitudinal groove includes a proximal longitudinal groove 136a and a distal longitudinal groove 136b provided at the proximal end 100a and the distal end 100b of the system 100, respectively, and is configured to receive a catheter (e.g., the catheter 130).
[36] The casing 110 includes a first channel 134a next to the proximal longitudinal groove 136a. Further, the casing 110 includes a second channel 134b separated from the first channel 134a and provided towards the central portion 100c of the system 100. In an embodiment, the second channel 134b is of a stepped configuration. That is, the second channel 134b includes two diameters, a narrower diameter towards a proximal portion of the second channel 134b and a 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 of cavities. In an embodiment, the plurality of cavities includes a first cavity A provided distal to the first channel 134a and a second cavity B provided distal to the second channel 134b. The second cavity B includes at least one notch B1, as shown in Fig. 1a.
[38] In an exemplary embodiment, the steering mechanism 120 includes a shaft 112, a control element 114, a gasket 115, a curb 116 and a slider 118, as shown in Fig. 1b. The steering mechanism 120 enables the user to advance or retract a catheter (e.g., the catheter 130) while positioning the same within the vasculature system.
[39] The shaft 112 includes a hollow, nearly tubular body with a proximal end 112a 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 a backward direction. The exemplary length of the shaft 112 may be between 50 mm to 55 mm. In an embodiment, the length of the shaft 112 is 52 mm. The shaft 112 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., or combination thereof. In an exemplary embodiment, the shaft 112 is made of polycarbonate.
[40] The body of the shaft 112 may include multiple threaded portions. In an embodiment, the shaft 112 includes a proximal threaded portion 112a1 and a distal threaded portion 112b1 provided towards the proximal end 112a and the distal end 112b, respectively. The proximal threaded portion 112a1 is configured to engage with the control element 114, while the distal threaded portion 112b1 is configured to engage with the curb 116. The interaction between the proximal threaded portion 112a1 with the control element 114 helps in forward and backward movement of the shaft 112 upon rotation of the control element 114 in one direction and the other respectively. For example, rotation of the control element 114 in clockwise direction may move the shaft 112 forward while rotation of the control element 114 in anti-clockwise direction may move the shaft 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 and a second flat face (not shown) in the generally tubular body. In an exemplary embodiment, the generally tubular body extends from a lateral side 112e to a medial side 112f of the shaft 112. In an embodiment, the first flat face 112d and the second flat face are devoid of any threads. Thus, the proximal threaded portion 112a1 may be partially threaded, namely, the threaded and unthreaded portions are interspersed. This structure of the shaft 112 having the at least one flat surface helps in smooth sliding movement of the shaft 112 within the control element 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 the threads may extend throughout the portion 112a1. The proximal threaded portion 112a1 may have larger dimensions compared to the distal threaded portion 112b1. The dimensions include the diameter and length of the threaded portions. Further, the pitch of the two threaded portions may differ. The distal threaded portion 112b1 helps to lock the shaft 112 with the curb 116.
[42] Between the proximal threaded portion 112a1 and the distal threaded portion 112b1, a middle portion 112c is defined. In an exemplary embodiment, the middle portion 112c is unthreaded as shown in Fig. 2. While the depicted embodiment of the shaft 112 is unthreaded in the middle portion 112c, a person skilled in the art will appreciate that threads can be made on the middle portion 112c of the shaft 112 while practicing the inventive features of the present disclosure and the same are within the scope of the present disclosure. The diameter of the middle portion 112c may be less than or equal to the diameter of the distal threaded portion 112b1.
[43] The shaft 112 is disposed in the channel 134 of the casing 110, as shown in Fig. 1a-1b. In an embodiment, certain portions of the plurality of proximal threaded portion 112a1 of the shaft 112 are received within the first channel 134a and the middle portion 112c is received in a portion of the second channel 134b (i.e., with narrower diameter) of the casing 110.
[44] The shaft 112 includes a shaft lumen 112h, as shown in Fig. 2, extending from the proximal end 112a to the distal end 112b. The catheter 130 passes through the shaft lumen 112h of the shaft 112 (depicted in Fig. 2). The shaft 112 is configured to move linearly on application of a torque. Due to the movement of the shaft 112, the catheter 130 inside the shaft 112 moves due to frictional interaction between the catheter 130 and the shaft lumen 112h, resulting in a transverse movement or advancement of the catheter 130 as it progresses through the intricate vasculature system.
[45] Further, the shaft 112 includes one or more projections 112a2 at the proximal end 112a of the shaft 112. One or more projections 112a2 may be provided on a corresponding flat face (i.e., the first flat face 112d and the second flat face). In an exemplary embodiment, the shaft 112 includes a projection 112a2 on the first flat face 112d, as shown in Fig. 2. The projection 112a2 acts as a stopper and prevents further movement of the shaft 112 in a lumen 114b of the control element 114 once the projection 112a2 mates with a proximal end of the control element 114, while the control element 114 is being rotated.
[46] The control element 114 (Fig. 3a) is disposed on the proximal threaded portion 112a1 of the shaft 112. The cavity A of the casing 110 receives the control element 114, as shown in Fig. 1b. The control element 114 is capable of being rotated either in a clockwise direction or an anticlockwise direction by a user to maneuver a catheter (e.g., the catheter 130) within the vasculature system. The control element 114 may be of any suitable shape, such as, without limitation, cylindrical, spherical, cuboidal, hexagonal prism, etc. In an embodiment, the control element 114 has a cylindrical shape resembling a hollow rotating knob that is rotatable in both clockwise and anticlockwise directions.
[47] The control element 114 includes a top surface 114a and a lumen 114b, as shown in Fig. 3a. In an embodiment, the top surface 114a includes a plurality of grooves 114a1. The grooves 114a1 provide steady grip to the user. In an alternate embodiment, the grooves 114a1 may be absent. The lumen 114b of the control element 114 receives the shaft 112. In an embodiment, the lumen 114b of the control element 114 includes a plurality of threads 114b1 which mate with the corresponding threads of the proximal threaded portion 112a1 of the shaft 112, as shown in Fig. 3b.
[48] Further, the plurality of threads 114b1 in the lumen 114b of the control element 114 are for example, circular with which the partial threads of the proximal threaded portion 112a1 provided on the shaft 112 mate. Upon rotating the control element 114 either in the clockwise direction or the anticlockwise direction, the plurality of the threads 114b1 mates with the proximal threaded portion 112a1 of the shaft 112. The mating of the plurality of threads 114b1 with the proximal threaded portion 114b1 results in conversion of the rotational motion of the control element 114 into a linear motion of the shaft 112. As a result, the shaft 112 moves transversely either in the forward direction or in the backward direction. For example, rotating the control element 114 in the clockwise direction results in movement of the shaft 112 in the forward direction. Similarly, rotating the control element 114 in the backward direction results 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), thermoplastic polyurethane (TPU), thermoplastic rubber (TPR), polypropylene (PP), polycarbonate (PC), etc., or a combination thereof. In an exemplary embodiment, 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 outer surface 115e as shown in Fig. 4. In an embodiment, the gasket 115 is generally a hollow, tubular body defining a gasket passage 115c. The catheter 130 passes through the gasket passage 115c. The gasket 115 has a taper at the distal end 115b. The gasket passage 115c extends from the proximal end 115a and gradually tapers towards the distal end 115b. The taper at the distal end 115b creates a narrower profile of the gasket passage 115c at the distal end 115b than that at the proximal end115a. The dimension of the gasket passage 115c towards the proximal end 115a complements the dimension of the distal end 112b of the shaft 112, ensuring a complementary fit. The gasket 115 is configured to grip the distal 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 E-shape, etc.
[51] The exemplary length of the gasket 115 ranges from 3 mm to 8 mm. The gasket 115 may be made of any suitable compressible materials including, without limitation, natural rubber, nitrile rubber (NBR), ethylene propylene diene monomer (EPDM), polyurethane (AU), silicone (Q) etc., or combination thereof. In an exemplary embodiment, the gasket 115 is made of silicone. Due to compressible nature of the gasket 115, upon being twisted, the gasket 115 is configured to crimp and lock the catheter.
[52] The curb 116 includes an outer surface 116a, a proximal portion 116b and a distal portion 116c, as shown in Figs. 5a. The proximal portion 116b extends from a proximal end of the curb 116 and continues until a point from where the distal portion 116c starts, as shown in Fig. 5b. The distal portion 116c includes a distal tip 116c1. The distal portion 116c extends from the point where the proximal 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, the curb 116 is generally hollow and cylindrical in shape, defining a curb passage 116d with a taper at the distal tip 116c1. The curb passage 116d extends from the proximal portion 116b to the distal tip 116c1, as shown in Fig. 5b. In an embodiment, the curb passage 116d has a uniform diameter. Alternately, the curb passage 116d may be tapered. Tapering of the distal tip 116c1 results in narrowing the curb passage 116d towards the distal tip 116c1. That is, the curb passage 116d includes two diameters, a broader diameter towards the proximal portion 116b and a narrower diameter towards the distal tip 116c1, as shown in Fig. 5b.
[54] The curb passage 116d is configured to receive the distal threaded portion 112b1 of the shaft 112 and the gasket 115. The dimensions of the curb passage 116d complement the dimensions of the plurality of distal threaded portion 112b1 of the shaft 112. The dimensions towards the distal tip 116c1 of the curb passage 116d are complementary to the dimensions of the gasket passage 115c towards the distal end 115b of the gasket 115.
[55] The curb passage 116d may include a plurality of threads 116d1. In an embodiment, the plurality of threads 116d1 are provided in the proximal portion 116b of the curb passage 116d. The plurality of threads 116d1 mates with the corresponding threads of the distal threaded portion 112b1 of the shaft 112, as shown in Fig. 2, thereby locking the shaft 112 with the curb 116. The curb passage 116d towards the distal portion 116c receives the gasket 115, as shown in Fig 1b. The curb 116 prevents slippage of the gasket 115 from the distal end 112b of the shaft 112. Further, the curb 116 helps in twisting the gasket 115.The length of the curb 116 ranges from 10mm to 15mm. The curb 116 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 curb 116 is made of polycarbonate.
[56] The curb 116 includes at least one protrusion along the outer surface 116a. In an exemplary embodiment, the at least one protrusion includes a first protrusion 116f1 and a second protrusion 116f2, as shown in Fig. 5a. The at least one 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, the slider 118 is generally cylindrical in shape and is hollow from inside defining a slider 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 116a of 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 of the shaft 112. The slider 118 includes at least one slot. The at least one protrusion of the curb 116 is seated in the at least one slot of the slider 118. The at least one protrusion is configured to slide within the at least one slot of the slider 118. In an embodiment, the at least one slot includes a first slot 118c1 and a second slot 118c2. The first and second slot 118c1 and 118c2 extend from the distal portion 118b to at least a portion of the proximal portion 118a of the slider 118, as shown in Fig. 6a. The first protrusion 116f1 and second protrusion 116f2 of 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 118d may include at least one wing. In an embodiment, the cap 118d includes a first wing 118d1 and a second wing 118d2. The at least one wing provides grip for the user and enables the user to rotate the slider 118 in a clockwise or in anticlockwise 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 least one wing, the at least one tab 118e engages with the at least one notch B1 provided on the casing 110 (as shown in Fig. 6b) and is configured to lock the slider 118 within the second cavity B of the casing 110. Upon rotating the slider 118 in anticlockwise direction with the help of the at least one wing, the at least one tab 118e disengages from the at least one notch B1, resulting in unlocking the slider 118.
[61] The proximal portion 118a and the cap 118d of the slider 118 are disposed in a portion of the second channel 134b (i.e., with broader diameter) and the second cavity B of the casing 110, respectively. The length of the slider 118 ranges 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 is made of polycarbonate.
[62] Fig. 7 illustrates a flowchart of a method 700 for assembling the system 100, according to an embodiment of the present disclosure.
[63] The method 700 commences at step 702 in which the steering mechanism 120 of the system 100 is assembled. In an embodiment, the step 702 includes steps 702a – 702d.
[64] At step 702a, the control element 114 is disposed on the proximal threaded portion 112a of the shaft 112. As explained earlier, the plurality of threads 114b1 provided in the lumen 114b of the control element 114 mate with the corresponding threads of the proximal threaded portion 112a1 of the shaft 112.
[65] At step 702b, the gasket 115 is disposed in the curb 116. The gasket 115 is inserted in the curb passage 116d from the proximal portion 116b. As explained earlier, the dimensions of the curb passage 116d towards the distal portion 116c complement the dimensions of the outer surface 115e of the gasket 115. The gasket 115 resides within the curb passage 116d towards the distal portion 116c of the curb 116.
[66] At step 702c, the curb 116 is inserted into the slider 118. The slider 118 receives the curb 116 from the distal portion 118b. As explained earlier, the first protrusion 116f1 and the second protrusion 116f2 of the curb 116 are received within the first slot 118c1 and the second slot 118c2, respectively, of the slider 118. The protrusions 116f1 and 116f2 of the curb 116 are slidable within the respective slots of the slider 118.
[67] At step 702d, the distal threaded portion 112b1 of the shaft 112 is inserted 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 112b1 of the shaft 112. The curb passage 116d towards the proximal portion 116b of the curb 116, receives the distal threaded portion 112b1 of the shaft 112. As explained earlier, the plurality of threads 116d1 provided in the proximal portion 116b of curb passage 116d mate with the distal threaded portion 112b1 of shaft 112, thereby establishing the assembly of the steering mechanism 120.
[68] At step 704, the assembled steering mechanism 120 obtained from step 702d is encased within the casing 110. As explained earlier, the channel 134 provided in the casing 110 receives the shaft 112. The first channel 134a provided next to the proximal longitudinal groove 136a receives certain portions of the plurality of proximal threads 112a of the shaft 112. The second channel 134b with narrower diameter receives the middle portion 112c of the shaft 112, and the second channel 134b with broader diameter receives the slider 118. The first cavity A receives the control element 114, and a second cavity B receives the cap 118d of the slider 118, whereby the system 100 is assembled.
[69] Though the method 700 for assembling the system 100 is described herein with reference to Fig. 7, it should be understood that the steps outlined in the present disclosure are not limited to the sequence depicted. A person skilled in the art may interchange or rearrange the steps as deemed appropriate based on convenience without deviating the scope of invention.
[70] Fig. 8 illustrates a flowchart of an exemplary method 800 for operating the system 100 of the present disclosure.
[71] At step 802, the system 100 is mounted on a catheter 130 in close proximity with a handle of the catheter delivery system. The system 100 is attached to the catheter 130 of the catheter delivery system such that the system 100 is always outside a patient body when the catheter delivery system is in use. In one depicted embodiment, the proximal end 100a of the system 100 is provided in proximity to a distal end of the handle 160 of a catheter delivery system, as shown in Fig. 9. This arrangement facilitates a smooth operation during medical procedures, as medical practitioner can easily control the precise positioning of the distal portion of the catheter 130 from outside of the patient’s body. Furthermore, this provides safety and comfort of the patient, as the entirety of the system 100 remains external to the patient’s body throughout the procedure.
[72] In an initial position, as shown in Fig. 10, the distal end of the proximal threaded portion 112a1 of the shaft 112 is disposed within or aligned with the distal end of the control element 114. The gasket 115 is disposed within the curb 116. The distal end 112b of the shaft 112 is disposed inside the gasket 115 and the distal threaded portion 112b1 is in contact with the corresponding plurality of threads 116d1 of the curb 116. The curb 116 is positioned towards the proximal portion 118a of the slider 118 and the at least one protrusion 116f of the 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 the patient’s vasculature system and is advanced or navigated through the intricate pathways of the vasculature system using the appropriate catheter delivery system under an imaging system like fluoroscopy until a distal portion of the catheter is in close proximity to the intended landing zone. A medical practitioner can push an adequate length of catheter 130 inside a body vasculature 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 distal longitudinal groove 136b and finally exits the system 100 from the distal end 100b. In an exemplary embodiment, the distal portion of the catheter 130 includes a stent 170.
[75] At step 806, once the distal portion of the catheter 130 is around the intended landing zone or the desired location, say, within a few millimeters, the catheter 130 is locked with the gasket 115. For this, the slider 118 is rotated, for example, in a clockwise direction, facilitated by the at least one wing (the first wing 118d1 and/or the second wing 118d2). The slider 118 can be rotated till the at least one tab 118e of the slider 118 engages with the notch B1 of the cavity B provided in the casing 110. Once the two tab 118e and B1 come in contact, the slider 118 is locked inside the casing 110.
[76] Further, rotation of the slider 118 causes simultaneous rotation of the curb 116 in the corresponding direction, as the curb 116 is operatively coupled to the slider 118. The gasket 115, housed within the curb passage 116d, is configured to twist in response to the rotation of the curb 116. Due to this twist and as the gasket 115 is compressible, the gasket 115 firmly grips or locks the catheter 130 in place.
[77] At step 808, the control element 114 is rotated, for example, in the clockwise direction to advance the shaft 112, i.e., in the forward direction. As the control element 114 is rotated in the clockwise direction, the plurality of threads 114b1 provided within the lumen 114b of the control element 114 engages with the proximal threaded portion 112a1 of the shaft 112. This creates a frictional interaction between the shaft 112 and the control element 114. This frictional interaction is translated into a forward rotational motion of the shaft 112, as shown 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 the distal 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 body vasculature by a distance corresponding to the distance moved by the shaft 112 at step 810. The at least one protrusion (116f1 and 116f2) of the curb 116 slides forward 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 upon rotation of the control element 114 till the protrusion (116f1 and 116f2) of the curb 116 reaches the distal edge of the respective slot (118c1 and 118c2) of the slider 118. The distance traversed by the curb 116 within the slider 118 thus defines the distance traversed by the distal portion of the catheter 130 within the vasculature system.
[80] Once the distal portion of the catheter 130 is positioned in the intended landing zone, the catheter delivery system can be used to complete the medical procedure (e.g., treatment, delivery, etc.). After the completion of the procedure, the catheter 130 Is retracted from the vasculature system of the patient.
[81] The mechanism allows for incremental movement of the catheter 130, covering only a few millimeters during the final phase of the catheterization. In an exemplary embodiment, the system 100 is used to advance or retract the catheter 130 in a body vasculature by say, 27 mm to 32 mm. If the length of movement of the distal portion of the catheter 130 is to be increased or decreased, the length of the slot of the slider 118 can be changed. The system of the present invention enables a medical practitioner to adjust the position of the catheter 130 with precision at the desired location or the intended landing zone within the vasculature system. By providing such control over the catheter 130 advancement during the final phase, the system 100 minimizes the margin for error and allows for meticulous adjustment, ultimately enhancing the accuracy of the stent 170 placement. This helps in achieving optimal procedural outcomes, as it reduces the risk of misplacement and associated complications, thereby improving patient safety and treatment efficacy during the catheterization procedures.
[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 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 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 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) 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 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.