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

1. TITLE OF THE INVENTION:
STEERING SYSTEM FOR DELIVERY CATHETER

2. 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 the manner in which it is to be performed:

FIELD OF INVENTION
[1] The present disclosure relates to a catheter. More particularly, the present disclosure relates to a steering system for a delivery catheter.
BACKGROUND OF INVENTION
[2] Navigating through intricate anatomical structures and tortuous pathways to reach the desired location for catheter placement poses a significant challenge in medical procedures. A catheter is a thin, flexible tube-like medical device that is utilized in various sizes, materials, and designs to fulfill diverse medical purposes. Some common types of catheters include urinary catheters, central venous catheters, cardiac catheters, intravenous catheters and so on. Each type serves specific functions within the realm of medical intervention.
[3] The process of delivering a catheter is minimally invasive but demands precision and expertise. Inserting and positioning the catheter within a body cavity, blood vessel, or duct requires careful attention to detail. Once successfully placed, catheters facilitate a variety of medical procedures, including draining fluids, administering medications, conducting measurements or imaging studies, delivering nutrition, diagnosing conditions, and deploying stents, among others.
[4] Navigating through the intricate network of anatomical structures is challenging. Conventional devices necessitate physical exertion and precise motor skills from medical practitioners. For instance, rotating a knob continuously may be required to achieve the desired steering of a distal portion of the catheter so as to position the catheter at a desired location precisely. Additionally, to deflect the catheter in a specific direction, the practitioner might need to rotate the knob accordingly. For e.g., when shifting the catheter from one extreme position to another, the practitioner is required to first rotate the knob to neutralize the catheter’s position. After neutralizing, the practitioner then readjusts and rotates the knob further to deflect the catheter in a new direction. This sequential action of rotating the knob adds to the physical demand. Consequently, prolonged procedures may induce operator fatigue, potentially compromising the accuracy of the delivery of the catheter when such a manual approach is used. Particularly, in procedures requiring precise catheter placement, like cardiac catheterizations, manual methods can be significantly complex and may lead to fatal errors challenging the effectiveness of the procedure.
[5] Hence, there is a need for a steering system for a delivery catheter that overcomes the problems associated with the conventional devices.
SUMMARY OF THE INVENTION
[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 merely 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 invention relates to a catheter device (hereinafter, device). The device includes a steerable shaft having a proximal end and a distal end, and a steering mechanism. The steering mechanism configured to deflect a distal end of the steerable shaft in one of a plurality of steering directions.
[8] In an embodiment, the steering mechanism includes at least one control element assembly, a torque generating block and a cam assembly. The torque generating block is coupled to the at least one control element and the cam assembly. In an embodiment, the cam assembly includes a cam and at least one follower. The cam is coupled to the torque generating block. The at least one follower of the cam assembly are disposed in the cam. The at least one follower is coupled to the proximal end of the steerable shaft. The at least one control element assembly receives a trigger to deflect the distal end of the steerable shaft. Wherein, in response to the trigger received by the at least one control element assembly, the torque generating block is configured to generate a torque and rotate the cam in one of a clockwise or an anti-clockwise direction. In response to the rotation of the cam, the at least one follower is configured to deflect the distal end of the steerable shaft at a pre-defined angle in a corresponding direction.
BRIEF DESCRIPTION OF DRAWINGS
[9] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentality disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[10] Fig. 1a depicts a device 100, according to an embodiment of the present disclosure.
[11] Fig. 1b depicts a pull ring 122 coupled to at least one pull wire of the device 100, according to an embodiment of the present disclosure.
[12] Fig. 2a depicts a side view of a handle 140 of the device 100, according to an embodiment of the present disclosure.
[13] Figs. 2b-2c depict a first control element assembly 130 of a steering mechanism of the device 100, according to various embodiments of the present disclosure.
[14] Figs. 2d-2e depict a second control element assembly 132 of a steering mechanism of the device 100, according to various embodiments of the present disclosure.
[15] Figs. 3a-3b depict a torque generating block coupled to the at least one control element assembly, according to various embodiments of the present disclosure.
[16] Figs. 3c-3e depict top perspective views of the torque generating block at various positions, according to an embodiment of the present disclosure.
[17] Fig. 4 depicts an exploded side perspective view of a cam 200 coupled to a disc 170 of the torque generating assembly, according to an embodiment of the present disclosure.
[18] Fig. 5a depicts a side perspective view of a cam assembly provided within the handle 140 of the device 100, according to an embodiment of present disclosure.
[19] Fig. 5b depicts a perspective view of at least one follower, according to an embodiment of the present disclosure.
[20] Fig. 5c depicts a side perspective view of the cam assembly coupled to the at least one pull wires the device 100, according to an embodiment of the present disclosure.
[21] Fig. 5d depicts an exploded side perspective view of the cam assembly coupled to a tray assembly provided within the handle 140 of the device 100, according to an embodiment of present disclosure.
[22] Fig. 5e depicts a top perspective view of the cam assembly coupled to at least one base plate of the tray assembly, according to an embodiment of present disclosure.
[23] Fig. 5f depicts a bottom perspective view of the cam assembly coupled to at least one base plate of the tray assembly, according to an embodiment of present disclosure.
[24] Fig. 5g depicts a side perspective view of coupling between the cam assembly and the tray assembly, according to an embodiment of present disclosure.
[25] Figs. 6a-6b depict cross-sectional views of the handle 140 of the device 100, according to an embodiment of the present disclosure.
[26] Fig. 8 depicts a flowchart of a method 700 of operating the device 100, according to an embodiment of the present disclosure.
[27] Fig. 8 depicts a flowchart of a method 800 of operating the device 100, according to an embodiment of the present disclosure.
[28] Figs. 9a-9c depict an arrangement of various components of the handle 140 when a distal end 120b of a steerable shaft 120 is at a neutral position, according to an embodiment of the present disclosure.
[29] Figs. 10a-10c depict an arrangement of various components of the handle 140 when the distal end 120b of the steerable shaft 120 is at a 180-degree position on a right side, according to an embodiment of the present disclosure.
[30] Figs. 11a-11c depict an arrangement of various components of the handle 140 when the distal end 120b of the steerable shaft 120 is at a 180-degree position on the left side, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE DRAWINGS
[31] 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.
[32] 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.
[33] 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.
[34] 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.
[35] This current disclosure pertains to a steerable catheter device (or referred to as a device). The device may be used for cardiac catheterization, urinary catheterization, central venous catheterization, intravenous catheterization and more. A shaft of the device is introduced in the patient’s body and navigated through the vasculature to a target site for performing various medical procedures.
[36] In an embodiment, the device includes a handle having a steering mechanism for steering a distal end of a steerable shaft. The steerable shaft is coupled to the handle. With the help of the steering mechanism, the user can accurately control and maneuver the distal end of the steerable shaft. In an exemplary embodiment, the steering mechanism includes a plurality of control elements (hereinafter, the control element). With the help of the control elements, the user can deflect the distal end of the steerable shaft at various desired angles both in right or left direction. This improves the predictable positioning of the device while the user can perform other tasks in the medical procedure without requiring continuous readjustments of the steering mechanism to return to a neutral position while changing the direction.
[37] The handle also includes one or more steering indicators indicating at least one of angular rotation, direction of rotation, etc. This allows users to visually determine orientation of the steerable shaft, aiding medical professionals in accurately maneuvering the intricate vascular pathways in the patient’s body.
[38] The device is compact and easier to operate even with a single hand unlike conventional devices that require usage of both hands to rotate the handle for deflecting the distal end of the steerable shaft. The device ensures a consistent navigation of the steerable shaft through the intricate anatomical structures, challenging pathways during procedures due to single hand operation. It also enhances safety, precision, and ease of maneuvering within intricate anatomical structures, facilitating accurate and targeted interventions and eliminating fatigue related errors.
[39] Now referring to the figures, Fig. 1a illustrates an exemplary embodiment of a catheter device 100 (hereinafter, the device 100). In an exemplary embodiment, the device 100 includes a steerable shaft 120 and a handle 140.
[40] The steerable shaft 120 is a tubular structure having one or more lumens (not shown). The steerable shaft 120 has a proximal end 120a and a distal end 120b defining a length therebetween. The length of the steerable shaft 120 may range between 400 mm to 1200 mm. In an embodiment, the length of the steerable shaft 120 is 850 mm. The steerable shaft 120 may be made of material, such as, without limitation, polyether block amide (PEBA), nylon, polyurethane, polytetrafluoroethylene (PTFE), etc., or a combination thereof. In an embodiment, the steerable shaft 120 is made of PEBA.
[41] The proximal end 120a of the steerable shaft 120 is coupled to the handle 140. The handle 140 includes a proximal end 140a and a distal end 140b. The distal end 140b of the handle 140 is coupled to the proximal end 120a of the steerable shaft 120. The steerable shaft 120 may be coupled to the handle 140 using techniques, such as, without limitation, UV bonding, adhesive bonding. In an exemplary embodiment, the proximal end 120a of the steerable shaft 120 is coupled to the handle 140 using UV bonding technique.
[42] The handle 140 is ergonomically designed for easier operation. The handle 140 may have any suitable shape. In an embodiment, the handle 140 has a tubular body and is hollow from inside. The handle 140 may be made of one of a material including, but not limited to, polycarbonate, nylon, acrylonitrile butadiene styrene (ABS), polyethylene, polystyrene, polypropylene, polyether ether ketone, etc., or a combination thereof. In an embodiment, the handle 140 is made of polycarbonate. The handle 140 may have a predefined length ranging between 90 mm and 200 mm. In an embodiment, the length of the handle 140 is 100 mm.
[43] In an embodiment, the handle 140 includes tapering ends at the proximal end 140a and the distal end 140b. While the depicted embodiment includes tapers at both ends, 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.
[44] The handle 140 may include at least one hub. In an embodiment, the distal end 140b of the handle 140 is provided with a hub 260. The hub 260 may be a hollow, tubular structure. The hub 260 may include one or more vascular access valve 262 (for example, a hemostasis valve) provided at an outer surface of the hub 260 to maintain hemostasis and reduce the patient’s blood loss.
[45] The handle 140 includes a steering mechanism disposed within the tubular body. The steering mechanism is configured to deflect the steerable shaft 120 to one of a plurality of steering directions, which has been explained later.
[46] During catheterization, the distal end 120b of the steerable shaft 120 is introduced into the patient’s body first followed by the remaining portion of the steerable shaft 120 for performing a desired medical procedure. The distal end 120b of the steerable shaft 120 may be deflectable to one of plurality of steering direction, for example, a left steering direction or a right steering direction at a pre-defined angle with the help of the steering mechanism provided within the handle 140. For example, the steerable shaft 120 can be deflected in the right or left direction at an angle ranging between 60 degrees to 180 degrees. In an exemplary embodiment, the distal end 120b of the steerable shaft 120 is deflectable in one of the left or right direction at 180 degrees.
[47] The steerable shaft 120 includes a pull ring 122 and at least one pull wire coupled to the pull ring 122, as shown in Fig. 1b.
[48] The pull ring 122 is a small ring-like structure provided on the steerable shaft 120 at the distal end 120b. The pull ring 122 may be coupled to the inner surface of the steerable shaft 120 using techniques, such as, without limitation, adhesive bonding, UV bonding, etc. In an embodiment, the pull ring 122 is coupled to the steerable shaft 120 using adhesive bonding technique. The pull ring 122 may be made of platinum, iridium, tungsten, stainless steel, etc., or a combination thereof. In an embodiment, the pull ring 122 is made of platinum and iridium.
[49] The pull ring 122 is coupled to the at least one pull wire. The at least one pull wire is disposed at least partially within the steerable shaft 120. In an embodiment, the at least one pull wire includes a right pull wire 146a and a left pull wire 146b. The pull wire may include a predefined length. The predefined length of the pull wire may range between 450 mm and 1300 mm. In an embodiment, the length of each pull wire is 900 mm. The pull wire may be made of stainless steel, nitinol, etc. or a combination thereof. In an embodiment, the pull wire is made of stainless steel.
[50] Each pull wire includes a proximal end to a distal end. The distal ends of the pull wires are coupled to the pull ring 122. The pull wires may be coupled to the pull ring 122 using techniques, such as, without limitation, laser welding, spot welding, plasma welding, etc. In an embodiment, each pull wire is welded to the pull ring 122 using laser technique. In another embodiment, the pull ring 122 and the pull wires may form an integrated structure. The proximal ends of the pull wires extend out from the proximal end 120a of the steerable shaft 120 and are coupled to the steering mechanism of the handle 140, which has been explained later.
[51] With the help of the steering mechanism, the pull ring 122 and the pull wires are configured to deflect the distal end 120b of the steerable shaft 120 to one of the left or right steering directions, which has been explained later.
[52] The steering mechanism is pre-configured to deflect the distal end 120b of the steerable shaft 120 to one of the left or right steering directions. Specifically, the steering mechanism is pre-configured to create a tension in at least one of the pull wires. In response to the tension created by the steering mechanism, the pull wire is configured to pull the pull ring 122 in a corresponding direction. For example, the right pull wire 146a, upon being pulled by the steering mechanism, is configured to pull the pull ring 122 in the right direction, thereby deflecting the steerable shaft 120 in the right steering direction at the predefined angle. Similarly, the left pull wire 146b, upon being pulled by the steering mechanism, is configured to pull the pull ring 122 in the left direction, thereby deflecting the steerable shaft 120 in the left steering direction at the predefined angle.
[53] The steering mechanism includes various components for steering the distal end 120b of the steerable shaft 120 in one of the right or left steering directions. In an exemplary embodiment, the steering mechanism includes at least one control element assembly, a torque generating block and a cam assembly, which are described below.
[54] In an exemplary embodiment, the at least one control element assembly of the steering mechanism includes a first control element assembly 130 and a second control element assembly 132, as shown in Fig. 2a. In an embodiment, the first control element assembly 130 and the second control element assembly 132 are provided towards a distal end 120b of the handle 140. In an embodiment, the handle 140 includes two holes (not shown). Each hole is configured to receive a corresponding control element assembly. In an embodiment, the holes are provided opposite to each other and hence, the first control element assembly 130 and the second control element assembly 132 are placed opposite to each other.
[55] In an embodiment, one of the first control element assembly 130 or the second control element assembly 132 is configured to receive a trigger to deflect the distal end 120b of the steerable shaft 120 in the preconfigured steering direction. For example, in response to the trigger received by the first control element assembly 130, the steerable shaft 120 is pre-configured to deflect in the right steering direction. And, in response to the trigger received by the second control element assembly 132, the steerable shaft 120 is pre-configured to deflect in the left steering direction.
[56] Additionally, or optionally, the handle 140 includes a plurality of steering indicators and/or a plurality of pointers, as shown in Fig. 2a. The plurality of steering indicators and the plurality of pointers are configured to help the users press the appropriate control element assembly for deflecting the distal end 120b of the steerable shaft 120 in one of the left or right steering directions. The plurality of pointers and the plurality of steering indicators may be markers drawn or carved on the handle 140.
[57] In an exemplary embodiment, the plurality of steering indicators includes a neutral indicator 144a, a right steering indicator 144b and a left steering indicator 144c. Each steering indicator indicates the corresponding steering direction in which the distal end 120b of the steerable shaft 120 may be deflected. In an embodiment, the neutral indicator 144a indicates the neutral position of the distal end 120b of the steerable shaft 120. The right steering indicator 144b indicates 90 degrees steering angle of the distal end 120b of the steerable shaft 120 with respect to the neutral position in the right direction. The left steering indicator 144c indicates 90 degrees steering angle of the distal end 120b of the steerable shaft 120 with respect to the neutral position in the left direction.
[58] In an exemplary embodiment, the plurality of pointers includes a set of neutral pointers 144a1-144a2, a set of right pointers 144b1-144b2 and a set of left pointers 144c1-144c2. In the depicted embodiment, each set of the plurality of pointers are represented by drawings depicting the first control element assembly 130 and the second control element 132, respectively, however, it may have any other suitable shape, size and pattern. In an embodiment, the set of neutral pointers 144a1-144a2 are aligned with the neutral indicator 144a of the plurality of pointers. In an embodiment, the set of right pointers 144b1-144b2 and the set of left pointers 144c1-144c2 are aligned with the right indicator 114b and the left indicator 144c, respectively. The plurality of pointers indicates the pressed position and/or the unpressed position of the first control element assembly 130 and the second control element 132 corresponding to the respective steering directions.
[59] In situations where the user intends to deflect the distal end 120b of the steerable shaft 120, such as in the right or left direction, the user may refer to the corresponding steering indicator and/or the corresponding set of pointers during operation of the device 100. This helps the user to press the appropriate control element for movement of the distal end 120b of the steerable shaft 120 in the respective steering direction, thereby guiding the user during operation of the device 100. For example, the set of right pointers 144b1-144b2 and the right indicator 144b, together, indicate that the first control element assembly 130 is to be triggered to deflect the distal end 120b of the steerable shaft 120 in the right direction. Similarly, the set of left pointers 144c1-144c2 and the left indicator 144c, together, indicate that the second control element 142b is to be in the triggered to deflect the distal end 120b of the steerable shaft 120 in the left direction. The set of neutral pointers 144a1-144a2 and the neutral indicator 144a, together, indicate that the first control element 142a and the second control element 142b is configured to remain in unpressed position, when the distal end 120b of the steerable shaft 120 is in the neutral position.
[60] In an embodiment, Fig. 2b depicts the first control element assembly 130 in an inoperative position or in a position in the absence of a trigger. And, Fig. 2c depicts the first control element assembly 130 in a triggered position or in a position upon receiving the trigger.
[61] In an exemplary embodiment, the first control element assembly 130 includes a first control element 142a, a first casing 145a, a first connecting rod 150a and a first locking member A, as in Fig. 2b and 2c. Similarly, the second control element assembly 132 includes a second control element 142b, a second casing 145b, a second connecting rod 150b ad a second locking member B, as shown in Figs. 2d-2e. It should be appreciated that the structure, components, function and operation of the second control element assembly 132 are the same as that of the first control element assembly 130 and can be understood from the Figs. 2b and 2c of the first control element assembly 130. Therefore, they are not repeated here for the sake of brevity.
[62] The first control element 142a and the second control element 142b may have a predefined shape, such as, without limitation, cylindrical, cuboidal, cubical, etc. In an embodiment, both the first control element 142a and the second control element 142b have a cylindrical shape. The first control element 142a and the second control element 142b may be made of one of polycarbonate, acrylonitrile butadiene styrene (ABS), etc., or a combination thereof. In an embodiment, the first control element 142a and the second control element 142bare made of ABS.
[63] The first control element 142a is configured to receive a trigger from a user to deflect the distal end 120b of the steerable shaft 120 in its preconfigured direction. For example, the first control element 142a may be pre-configured to deflect the distal end in the right direction. According to an embodiment of the present disclosure, the first control element 142a is a push-button. In other words, the first control element 142a is pressed to provide a trigger to the steering mechanism to deflect the steerable shaft 120 in the right steering direction, as shown in Fig. 2c. Similarly, the second control element 142b is pressed to provide a trigger to the steering mechanisms to deflect the steerable shaft 120 in the left steering direction.
[64] It should be understood that though, the depicted embodiment of each control element of the respective control element assembly is a push-button, it should be appreciated that any other suitable mechanism may be used to provide a trigger to the steering mechanism.
[65] In an embodiment, the first control element 142a is coupled to a first casing 145a. The first casing 145a may be made of one of polycarbonate, acrylonitrile butadiene styrene (ABS), etc., or a combination thereof. In an embodiment, the first casing 145a and the second casing 145b are made of ABS. The first casing 145a may have a predefined shape, including, but not limited, cylindrical, cuboidal, cubical, etc. In an embodiment, the first casing 145a is cylindrical in shape. The first casing 145a is hollow from inside defining a first lumen (not shown) and an outer surface.
[66] In an embodiment, the outer surface of the first casing 145a is coupled to the handle 140. In an embodiment, the first casing 145a is disposed within the hole of the handle 140 using snap fit mechanism, though other suitable coupling mechanisms may be used. The first casing 145a is configured to remain stationary with respect to movement of the first control element 142a.
[67] A partial portion of the first control element 142a is seated within the first lumen of the first casing 145a. The first control element 142a and the first casing 145a may be separate components. With the depicted embodiment including the first control element and the first casing being separate components, a skilled person may still be able to perform the inventive feature of the present disclosure with the first control element and the first casing forming a respective integrated structure.
[68] In an embodiment, the first control element 142a of the first control assembly 130 is coupled to the first casing 145a using transition fit technique. In an embodiment, the first casing 145a facilitates in and out movement of the first control element 142a, in response to the trigger. In other words, the transition fit technique helps the first control element 142a to slightly move in and out of the first casing 145a, in response to the trigger received by the respective control element.
[69] For example, in the triggered position of the first control element assembly 130, the first control element 142a is configured to slightly move inside the first casing 145a, as shown in Fig. 2c. And, in the inoperative position of the first control element assembly 130, the first control element 142a is configured to slightly move out of the first casing 145a, as shown in Fig. 2b. Similarly, the second casing 145b facilitates in and out movement of the second control element 142b, in response to the trigger is received by the second control element assembly 132.
[70] It should be understood that though, the present disclosure describes transition fit technique for coupling the first control element to the first casing, it should be appreciated that any other suitable coupling techniques may be used without deviating the scope of the present disclosure, and the same are within the scope of the present invention.
[71] The first connecting rod 150a is coupled to the first control element assembly 130. Specifically, the first control element 142a is coupled to the first connecting rod 150a. In an embodiment, the first connecting rod 150a generally has a tubular structure. In an embodiment, the first connecting rod 150a includes between a first end 155a and a second end 155b. In an embodiment, the first end 155a of the first connecting rod 150a is coupled to the first control element 142a. The aforesaid coupling may be achieved using techniques, such as, without limitation, adhesive bonding, welding, brazing, soldering, etc., or a combination thereof. In an embodiment, the first connecting rod 150a is welded to the first control element 142a. Similarly, the second connecting rod 150b is coupled to the second control element 142b.
[72] In response to the trigger received by the first control element 142a, the first connecting rod 150a is pre-configured to move in the transverse direction. For example, in response to the trigger received by the first control element 142a, the first connecting rod 150a is pre-configured to move in the left direction. Similarly, in response to the trigger received by the second control element 142b, the second connecting rod 150b is pre-configured to move in the right direction.
[73] The second end 155b of the first connecting rod 150a helps in operatively coupling the first control element assembly 130 with the torque generating block, which has been explained later.
[74] The first connecting rod 150a may have a length and a diameter ranging between 10mm to 30mm, and 2 mm to 4mm, respectively. In an embodiment, the length and the diameter of the first connecting rod 150a is 20mm and 3mm, respectively. The first connecting rod 150a may be made of material, such as without, limitation, polycarbonate, nylon, acrylonitrile butadiene styrene (ABS), polyethylene, polystyrene, polypropylene, polyether ether ketone, etc., or combination thereof. In an embodiment, the first connecting rod 150a is made of polycarbonate. The first connecting rod 150a and the second connecting rod 150b may have the same or different length and diameter. In an embodiment, the first connecting rod 150a and the second connecting rod 150b have the same length and the same diameter.
[75] The first connecting rod 150a helps in coupling the first control element 142a with the first locking member A, which has been explained later. The first end 155a of the first connecting rod 150a includes at least one slot. In an embodiment, the first end 155a of the first connecting rod 150a includes a first slot 152a and a second slot 152b, as shown in Fig. 2b. Each slot of the first connecting rod 150a may have a suitable shape. In an embodiment, each slot is carved in an arc shape. The arc shape of each slot is configured to accommodate a partial portion of the first locking member A, thus helping in coupling the first connecting rod 150a with the first locking member A, which has been explained below. Similarly, in an embodiment, a first end 155c of the second connecting rod 150b includes at least one slot, namely, a third slot 152c and a fourth slot 152d.
[76] In an embodiment, the first locking member A includes at least one ball and at least one resilient element coupled to the at least one ball. In an embodiment, the first locking member A includes the first ball 156a and the second ball 156b, as shown in Figs. 2b-2c. In an embodiment, the at least one resilient element includes the first resilient element 154a and the second resilient element 154b, as shown in Figs. 2b-2c. Similarly, the second locking member B includes at least one ball (namely, a third ball 156c and a fourth ball 156d) and at least one resilient element (namely, a third resilient element 154c and a fourth resilient element 154d), as shown in Fig. 2d-2e.
[77] The first locking member A is disposed within the tubular body of the handle 140, as shown in Figs. 2b-2c. The first locking member A is inserted through the hole of the handle 140.
[78] Each ball may be made of any one of the materials including, but not limited to, stainless steel (SS), carbon steel, high-speed steel (HSS), etc., or a combination thereof. In an embodiment, each ball is made of stainless steel. In embodiment, each ball is having a sphere shape, though it may have any other shape. A diameter of each ball may range between 0.8 mm and 3mm. In an exemplary embodiment, each ball has equal dimension having 1.5mm diameter.
[79] In the inoperative position of the first control element assembly 130, each ball is disposed towards the second end of the first connecting rod 150a. A partial portion of each ball is in contact with the walls of the first connecting rod 150a, as shown in Fig. 2b. In an embodiment, in the triggered position of the first control element assembly 130, a partial portion of the first ball 156a and the second ball 156b are seated within the first slot 152a and the second slot 152b on the first connecting rod 150a, respectively, as shown in Fig. 2c. Similarly, in the triggered position of the second control element assembly 132, a partial portion of the third ball 156c and the fourth ball 156d are seated within the third slot 152c and the fourth slot 152d of the second connecting rod 150b, respectively, as shown in Fig. 2e.
[80] The spherical shape of each ball and the arc shape of the corresponding slot facilitate easy coupling and/or decoupling between the first locking member A and the first connecting rod 150a in the triggered and/or inoperative position of the first control element assembly 130. In an embodiment, the arc shape of each slot on the first connecting rod 150a provides more surface area for the corresponding balls of the first locking member A to engage.
[81] Each resilient element (the first resilient element 154a, the second resilient element 154b, the third resilient element 154c and the fourth resilient element 154d) are disposed on the corresponding ball (the first ball 156a, the second ball 156b, the third ball 156c and the fourth ball 156d). The first resilient element 154a and the second resilient element 154b may be made of any suitable material, such as without limitation, carbon steel, stainless steel. In an embodiment, the first resilient element 154a and the second resilient element 154b are made of carbon steel.
[82] According to an embodiment, the first resilient element 154a and the second resilient element 154b are compression springs. Each resilient element is configured to provide resilience to hold the corresponding control element assembly (the first control element assembly 130 and the second control element assembly 132) in the triggered position from the inoperative position, upon receiving the trigger.
[83] Together, the first ball 156a coupled with the first resilient element 154a and the second ball 156b coupled with the second resilient element 154b form the first locking member A. The first locking member A is configured to lock the first control element assembly 130 in the triggered position.
[84] During the inoperative position of the first control element assembly 130, in response to the of the first ball 156a and the second ball 156b with the wall of the first connecting rod 150a, each resilient element (the first resilient element 154a and the second resilient element 154b) is configured to experience a compression force, as shown in Fig. 2b. Similarly, each resilient element (the third resilient element 154c and the fourth resilient element 154d) of the second control element assembly 132 is configured to experience compression force, when the second control element 142b is in the inoperative position, as shown in Fig. 2d.
[85] In response to the transverse movement of the first connecting rod 150a upon receiving the trigger, the first ball 156a and the second ball 156b are configured to roll on the surface of the wall of the first connecting rod 150a and engage with the first slot 152a and the second slot 152b, respectively. In response to the interaction between the first ball 156a and the first slot 152a, and the second ball 156b and the second slot 152b, the first resilient element 154a and the second resilient element 154b are configured to provide resilience to the corresponding ball and hold the respective balls within the respective slots. This prevents movement/slippage of the first ball 156a and the second ball 156b from the respective slot, thereby locking the first control element assembly 130 in the triggered position. Similarly, each resilient element of the second control element (e.g., the third resilient element 154c and the fourth resilient element 154d) are configured to provide resilience to and hold the corresponding ball (the third ball 156c and the fourth ball 156d) within the respective slots of the second connecting rod 150b (the third slot 152c and the fourth slot 152d), respectively, thereby holding the second control element assembly 132 in the triggered position.
[86] The at least one control element assembly is operatively coupled to the torque generating block. Figs. 3a-3b depict the coupling between the at least one control element assembly and the torque generating block. The torque generating block is disposed within the hollow body of the handle 140.
[87] In an exemplary embodiment, the torque generating block includes a bar 160 and a disc 170. The bar 160 is operatively coupled to the first control element 142a and the second control element 142b. In an embodiment, the first connecting rod 150a and the second connecting rod 150b are coupled to the bar 160. Specifically, the second end 155b of the first connecting rod 150a and the second end 155d of the second connecting rod 150b are coupled to the bar 160.
[88] The first connecting rod 150a and the second connecting rod 150b are coupled perpendicularly to bar 160. In an embodiment, the first connecting rod 150a is coupled from one side (say, a first side) of the bar 160. And, the second connecting rod 150b is coupled to the bar 160 from a second side (side opposite to the first side) of the bar 160, as shown in Fig. 3b. The first connecting rod 150a and the second connecting rod 150b are coupled at a corresponding center point on the respective side of the bar 160. The first connecting rod 150a and the second connecting rod 150b may be coupled to the bar 160 using techniques, such as, without limitation, adhesive bonding, welding, brazing, soldering, etc. In an embodiment, the first connecting rod 150a and the second connecting rod 150b are welded to the bar 160. Thereby coupling the first control element 142a and the second control element 142b to the torque generating block.
[89] In response to the transverse motion of one of the first connecting rod 150a or the second connecting rod 150b, the bar 160 is configured to reciprocate the movement in the corresponding direction. For example, in response to the movement of the first connecting rod 150a moving in the left direction, the bar 160 is pre-configured to move in the corresponding direction. And in response to the movement of the second connecting rod 150b moving in the right direction, the bar 160 is pre-configured to move in the corresponding direction.
[90] The bar 160 may have a length range between 10mm and 25 mm. In an embodiment, the bar 160 has a length of 18mm. The bar 160 may be made of any suitable material, such as, without limitation, polycarbonate, nylon, acrylonitrile butadiene styrene (ABS), polyethylene, polystyrene, polypropylene, polyether ether ketone, etc., or a combination thereof. In an embodiment, the bar 160 is made of polycarbonate.
[91] In an embodiment, the bar 160 includes a first portion and a second portion. In an exemplary embodiment, the bar 160 includes a slot 162. In an embodiment, the slot 162 is provided towards the first portion of the bar 160. The slot 162 helps in coupling the bar 160 to the disc 170, which has been explained later. In an embodiment, the second portion of the bar 160 is solid.
[92] The bar 160 is operatively coupled to the disc 170. The disc 170 is generally circular in shape having a diameter and a thickness. The diameter and the thickness of the disc 170 may range between 10mm to 20mm and 2mm to 5mm, respectively. In an embodiment, the diameter and the thickness of the disc 170 is 15mm and 3mm, respectively. The disc 170 may be made of any suitable material, such as, without limitation, polycarbonate, nylon, acrylonitrile butadiene styrene (ABS), polyethylene, polystyrene, polypropylene, polyether ether ketone, etc., or a combination thereof. In an exemplary embodiment, the disc 170 is made of polycarbonate.
[93] The disc 170 includes a first face and a second face. In an embodiment, the disc 170 includes a pin 172, as shown in Figs. 3a-3b. The pin 172 is provided towards a periphery of the first face of the disc 170, as shown in Fig. 3a.
[94] The pin 172 is generally cylindrical in shape, though it may have any other suitable shape. The pin 172 may be made of material, such as, without limitation, acrylonitrile butadiene styrene, polycarbonate, polypropylene, etc. In an embodiment, the pin 172 is made of polycarbonate. In an embodiment, the pin 172 and the disc 170 are separate components. The pin 172 may be coupled to the first face of the disc 170 using techniques, such as, without limitation, UV bonding, adhesive bonding, laser welding etc. In an embodiment, the pin 172 is coupled to the disc 170 using adhesive bonding. In another embodiment, the pin 172 and the disc 170 form an integrated structure.
[95] The pin 172 is disposed within the slot 162 of the bar 160, thereby coupling the disc 170 to the bar 160. In an embodiment, the bar 160 is aligned at a central axis, say at A1, of the disc 170.
[96] In response to the transverse movement of the bar 160 in one of the left or right direction, the pin 172 is pre-configured to move within the slot 162 between a first point B1 and a second point B2. In response to the movement of the pin 172 within the slot 162, the disc 170 is configured to rotate in one of the clockwise or anticlockwise direction. The length of the slot 162 determines the maximum angle up to which the disc 170 can rotate. In response to the trigger provided to the at least one control element, the disc 170 is pre-configured to rotate in one of a clockwise direction or an anticlockwise direction.
[97] Exemplary depictions of the movement of the disc 170 due to the movement of the control element is demonstrated in Figs. 3c-3e. In absence of trigger (i.e., in the inoperative position of the first control element 142a and the second control element 142b), the pin 172 of the disc 170 is at the first point B1 in the slot 162 of the bar 160, as shown in Fig. 3c.
[98] In response to the first control element 142a being triggered, the first connecting rod 150a is pre-configured to push the bar 160 in the left direction, as shown in Fig. 3d. In response to the movement of the bar 160 in the left direction, the pin 172 of the disc 170 is configured to move within the slot 162 from the first point B1 to the second point B2. In response to the movement of the pin 172, the disc 170 is pre-configured to rotate in the anticlockwise direction.
[99] Similarly, in response to the second control element 142b being pressed, the second connecting rod 150b is pre-configured to push the bar 160 in the right direction, as shown in Fig. 3e. In response to the movement of the bar 160 in the right direction, the pin 172 of the disc 170 is configured to move within the slot 162 from the first point B1 to the second point B2. In response to the movement of the pin 172, the disc 170 is pre-configured to rotate in the clockwise direction.
[100] Fig. 4 depicts the coupling between the torque generating block and the cam assembly, according to an embodiment of the present disclosure. The cam assembly is coupled to the torque generating block, which has been explained later. In an exemplary embodiment, the cam assembly includes a proximal driveshaft 180a, a cam 200, a distal driveshaft 180b, and at least one follower.
[101] In an embodiment, the cam 200 generally has a cylindrical body. The cam 200 includes a proximal end 200a and a distal end 200b, defining a length. The length and a diameter of the cam 200 may range between 40mm and 60mm, and 10mm and 30mm, respectively. In an exemplary embodiment, the length and the diameter of the cam 200 is 50mm and 20 mm, respectively. The cam 200 may be made of material, such as, without limitation, acrylonitrile butadiene styrene, polycarbonate, polypropylene. In an embodiment, the cam 200 is made of polycarbonate.
[102] The cam 200 is operatively coupled to the disc 170 of the torque generating block, which has explained below. In response to the trigger received by the at least one control element assembly, the torque generating block is configured to generate a torque to rotate the cam 200 in one of the clockwise or an anticlockwise direction.
[103] In an embodiment, the distal end 200b of the cam 200 is coupled to the distal driveshaft 180b. The distal driveshaft 180b is generally tubular in shape. The distal driveshaft 180b includes a proximal end and a distal end. The distal driveshaft 180b includes a predefined length and a predefined diameter. The predefined length and the predefine diameter of the driveshaft may range between 30 mm and 80 mm, and 2 mm and 8 mm. The distal driveshaft 180b may be made of any suitable material, such as, without limitation, polycarbonate, acrylonitrile butadiene styrene (ABS), polyethylene, polystyrene, polypropylene, polyether ether ketone, etc., or a combination thereof. In an exemplary embodiment, the distal driveshaft 180b is made of polycarbonate.
[104] The distal driveshaft 180b helps in coupling the cam 200 with disc 170. In an exemplary embodiment, the proximal end of the distal driveshaft 180b is coupled to the cam 200. The distal end of the distal driveshaft 180b is coupled to the second face of the disc 170. Thus, the distal driveshaft 180b establishes the operative coupling between the torque generating block and the cam assembly.
[105] The distal driveshaft 180b may be coupled to the disc 170 and the cam 200 using techniques, such as, without limitation, adhesive bonding, welding, brazing, soldering., etc., or a combination thereof. In an embodiment, the distal driveshaft 180b is welded to the disc 170 and the cam 200.
[106] The distal driveshaft 180b is configured to transfer the rotational motion of the disc 170 to the cam 200 to rotate in the corresponding direction. In an embodiment, in response to the rotation of the disc 170 in one of the clockwise direction or the anticlockwise direction, the distal driveshaft 180b is pre-configured to rotate at its longitudinal axis. In response to the rotation of the distal driveshaft 180b, the cam 200 is pre-configured to rotate in the corresponding direction. Thus, in response to the rotation of the disc 170 in one of the clockwise direction or the anticlockwise direction, the cam 200 is pre-configured to rotate in the corresponding direction. For example, in response to the rotation of the disc 170 in the clockwise direction, the distal driveshaft 180b is pre-configured to rotate in the clockwise direction at its longitudinal axis. In response to the rotation of the distal driveshaft 180b in the clockwise direction, the cam 200 is pre-configured to rotate in clockwise direction. Thus, in response to the rotation of the disc 170 in the clockwise direction, the cam 200 is pre-configured to rotate in the clockwise direction.
[107] Similarly, in response to the rotation of the disc 170 in the anticlockwise direction, the distal driveshaft 180b is pre-configured to rotate in the anticlockwise direction at its longitudinal axis. In response to the rotation of the distal driveshaft 180b in the anticlockwise direction, the cam 200 is pre-configured to rotate in the anticlockwise direction. Thus, in response to the rotation of the disc 170 in the anticlockwise direction, the cam 200 is pre-configured to rotate in the anticlockwise direction.
[108] The proximal end 200a of the cam 200 is coupled to the proximal driveshaft 180a. The proximal driveshaft 180a generally has a tubular body. The proximal driveshaft 180a includes between a proximal end and a distal end.
[109] The proximal driveshaft 180a and the distal driveshaft 180b may have the same or different length. The total length of both the proximal driveshaft 180a and the distal driveshaft 180b may range between 60mm and 160 mm. In an embodiment, the total length of the proximal driveshaft 180a and the distal driveshaft 180b is 100mm. In an exemplary embodiment, the proximal driveshaft 180a and the distal driveshaft 180b has the same length. The proximal driveshaft 180a and the distal driveshaft 180b may have the same or different diameter. The diameter of the proximal driveshaft 180a and the distal driveshaft 180b may range between and 2mm and 8 mm. In an exemplary embodiment, the diameter of the proximal driveshaft 180a and the distal driveshaft 180b is 5 mm. The proximal driveshaft 180a and the distal driveshaft 180b may be made of the same or different materials. In an embodiment, the proximal driveshaft 180a and the distal driveshaft 180b are made of the same material.
[110] The distal end of the proximal driveshaft 180a is coupled to the proximal end 200a of the cam 200, using techniques, such as, without limitation, adhesive bonding, welding, brazing, soldering., etc., or a combination thereof. In an embodiment, the proximal driveshaft 180a is welded to the cam 200. In response to the rotation of the cam 200 in one of the clockwise direction or the anticlockwise direction, the proximal driveshaft 180a is configured to rotate at its longitudinal axis in the corresponding direction. For example, in response to the rotation of the disc 170 in the clockwise direction, the proximal driveshaft 180a is pre-configured to rotate in the clockwise direction. Similarly, in response to the rotation of the disc 170 in the anticlockwise direction, the proximal driveshaft 180a is pre-configured to rotate in the anticlockwise direction.
[111] In an embodiment, the proximal end of the proximal driveshaft 180a is operatively coupled to a T-connector 188. In the depicted embodiment, the T-connector 188 includes a body 188a, a first arm 188b and a second arm 188c.
[112] The body 188a generally has a tubular structure. The body 188a is hollow from inside defining a lumen. A proximal portion of the proximal driveshaft 180a is disposed within the lumen of the body 188a and is rotatable therein.
[113] The first arm 188b and the second arm 188c are coupled to the inner wall of the handle 140. The first and second arms (188b and 188c) are coupled to the handle 140 using techniques, including, but not limited to, UV bonding, adhesive bonding, etc. In an embodiment, the first arm 188b and the second arm 188c of the T-connector 188 are coupled to the handle 140 using adhesive bonding technique.
[114] The T-connector 188 is configured to provide stability and structural support to the proximal driveshaft 180a and the other operatively coupled components of the steering mechanism, thereby minimizing unwanted slippage of the components during the use of the device 100. The T-connector 188 may be made of any one material, including, without limitations, polycarbonate, acrylonitrile butadiene styrene (ABS), or a combination thereof. In an embodiment, the T-connector 188 is made of polycarbonate material.
[115] In an embodiment, the cam 200 includes at least one groove 202, as shown in Fig. 4. The at least one groove 202 may be carved on an outer surface of the cam 200, using techniques, such as, without limitation, laser cut, machining, etc. In an exemplary embodiment, the at least one groove 202 is carved on the outer surface of the cam 200 using machining technique.
[116] The at least one groove 202 may be carved in any suitable patterns. In an exemplary embodiment, the at least one groove 202 is a harmonic groove having sinusoidal or wave-like profile. In other words, the at least one groove 202 includes one or more alternating sections. As shown in Fig. 5a, the alternating sections of the groove 202 includes at least one peak region X and at least one trough region Y. In an embodiment, the at least one groove 202 includes one peak region X and one trough region Y provided at the proximal end 200a and the distal end 200b of the cam 200, respectively.
[117] It should be understood that though, the depicted embodiment includes at least one groove on the cam having one peak region and one trough region, it should be appreciated that the at least one groove may include more than one peak region and trough region.
[118] The at least one groove 202 is configured to receive the at least one follower. In response to the rotation of the cam 200 in one of the clockwise direction or anticlockwise direction, the at least one follower is configured to deflect the distal end 120b of the steerable shaft 120 at the predefined angle in one of the left or right direction, respectively, which has been explained later. The at least one groove 202 provides path for the at least one follower to move, thereby facilitating smooth and continuous motion of the at least one follower. In an embodiment, the at least one follower includes a first follower 206a and a second follower 206b, as shown in Fig. 5a.
[119] The first follower 206a and the second follower 206b may be made of material, such as, without limitation, polycarbonate, nylon, acrylonitrile butadiene styrene (ABS), polyethylene, polystyrene, polypropylene, polyether ether ketone, etc., or a combination thereof. The first follower 206a and the second follower 206b may be made of the same material or different material. In an embodiment, the first follower 206a and the second follower 206b are made of the same material. In an embodiment, the at least one tube is made of polycarbonate.
[120] In an embodiment, the at least one follower is T-shaped, though it may have any other suitable shape. Fig. 5b depict an exemplary embodiment of the first follower 206a. It should be appreciated that the structure, components, functions and operation of the second follower 206b are the same as that of the first follower 206a and can be understood from the Fig. 5b of the first follower 206a. Thus, they are not repeated for the sake of brevity.
[121] In the depicted embodiment, the first follower 206a includes a first vertical stem V1 and a first horizontal stem H1, as shown in Fig. 5b. The first vertical stem V1 and the first horizontal stem H1 of the first follower 206a may have a predefined structure, such as, without limitation, tubular, cuboidal, square, etc. In an embodiment, the first vertical stem V1 and the first horizontal stem H1 of the first follower 206a have tubular structure. The first vertical stem V1 is perpendicular to the first horizontal stem H1. The first vertical stem V1 is provided at a center point on the first horizontal stem H1 to form the T-shaped structure.
[122] The first vertical stem V1 and the first horizontal stem H1 of the first follower 206a may be separate components. The first vertical stem V1 and the first horizontal stem H1 of the first follower 206a may be coupled to each other using any suitable technique. In an embodiment, the first vertical stem V1 and the first horizontal stem H1 of the first follower 206a forms an integrated structure using molding technique. The integrated structure of the first vertical stem V1 and the first horizontal stem H1 may be formed using any other suitable techniques.
[123] The first vertical stem V1 and the first horizontal stem H1 of the first follower 206a may a corresponding predefined length. In the depicted embodiment, the length of the first vertical stem V1 is smaller than the first horizontal stem H1 of the first follower 206a. The first horizontal stem H1 and the second horizontal stem H2 of the first follower 206a and the second follower 206b, respectively, may have the same or different length. The length and a diameter of the first horizontal stem H1 and the second horizontal stem H2 may range between 100mm and 160 mm 2mm to 5mm, respectively. In an embodiment, the length and the diameter of the first horizontal stem H1 and the second horizontal stem H2 is 120 mm and 3mm, respectively. The first horizontal stem H1 and the second horizontal stem H2 of the first follower 206a and the second follower 206b, respectively, may have the same or different length. In an embodiment, the length of the first horizontal stem H1 and the second horizontal stem H2 are same.
[124] In an embodiment, the first vertical stem V1 of the first follower 206a is disposed within the groove 202 of the cam 200, as shown in Fig. 5a. Similarly, the second vertical stem V2 of the second follower 206b is disposed within the groove 202 of the cam 200, as shown in Fig. 5a.
[125] The first vertical stem V1 of the first follower 206a include a first surface S1, as shown in Fig 5b. The first surface S1 has polished surface. The polished surface of the first surface S1 facilitate a smooth interaction between the first vertical stem V1 and the groove 202 of the cam 200.
[126] Similarly, the second vertical stem V2 of the second follower 206b include a second surface (not shown), which is polished and facilitate a smooth interaction between the second vertical stem V2 and the groove 202 of the cam 200.
[127] In an embodiment, the first follower 206a and the second follower 206b are disposed opposite from each other within the at least one groove 202. The first vertical stem V1 and the second vertical stem V2 are disposed within the at least one groove 202 in such a way that the first horizontal stem H1 and the second horizontal stem H2 are aligned parallel to each other.
[128] In response to the rotation of the cam 200 in one of the clockwise direction or the anticlockwise direction, the first vertical stem V1 and the second vertical stem V2 are configured to follow the path provided by the groove 202 of the cam 200. The first vertical stem V1 and the second vertical stem V2 are configured to move between the peak region X and the trough region Y of the groove 202.
[129] For example, in response to rotation of the cam 200 in the clockwise direction, the first vertical stem V1 and the second vertical stem V2 move to the trough region Y and the peak region X, respectively. And, in response to rotation of the cam 200 in the anticlockwise direction, the first vertical stem V1 and the second vertical stem V2 move to the peak region X and the trough region Y, respectively.
[130] In response to the movement of the first vertical stem V1 and the second vertical stem V2 within the groove 202, the first horizontal stem H1 and the second horizontal stem H2 are pre-configured to move in the transverse direction. The first horizontal stem H1 and the second horizontal stem H2 are configured to move in a forward and a backward direction. The first horizontal stem H1 of the first follower 206a is pre-configured to move in the direction opposite to the direction of motion of the horizontal stem H2 of the second follower 206b. For example, in response to the rotation of the cam 200 in the clockwise direction, the first horizontal stem H1 is pre-configured to move in a backward direction and the second horizontal stem H2 is pre-configured to move in a forward direction simultaneously. And, in response to the rotation of the cam 200 in the anticlockwise direction, the first horizontal stem H1 is pre-configured to move in the forward direction and the second horizontal stem H2 is pre-configured to move in a backward direction simultaneously.
[131] The first follower 206a and the second follower 206b are coupled to the proximal end 120a of the steerable shaft 120. Specifically, in an embodiment, the at least one follower is coupled to a proximal end the at least one pull wire. The first horizontal stem H1 and the second horizontal stem H2 include a corresponding proximal end and a corresponding distal end. In an exemplary embodiment, the distal end of first horizontal stem H1 of the first follower 206a is coupled to the proximal end of the right pull wire 146a. And, the distal end of the second horizontal stem H2 of the second follower 206b is coupled to the proximal end of the left pull wire 146b, as shown in Fig. 5c.
[132] In response to the movement of the first horizontal stem H1 in the backward direction, the right pull wire 146a is configured to be pulled, thereby deflecting the steerable shaft 120 in the right direction. Similarly, in response to the movement of the second horizontal stem H2 in the backward direction, the left pull wire 146b is configured to be pulled, thereby deflecting the steerable shaft 120 in the left direction.
[133] In an embodiment, the cam assembly is mounted on a tray assembly. The tray assembly is configured to provide support and stability to the cam assembly while the device 100 is being operated. In an embodiment, the tray assembly includes at least one base plate and at least one curved plate coupled to the at least one base plate.
[134] In an exemplary embodiment, the at least one base plate includes a first base plate 212a and a second base plate 212b, as shown in Fig. 5d. The first base plate 212a and the second base plate 212b may have a predefined shape, such as, without limitation, cuboidal, hemisphere, etc. In an embodiment, the first base plate 212a and the second base plate 212b are cuboidal in shape. The first base plate 212a and the second base plate 212b may have a predefined length and a predefined thickness ranging between 40mm and 60 mm, and 2mm and 5mm, respectively. In an embodiment, the length and the thickness of the first base plate 212a and the second base plate 212b are 50 mm and 3 mm, respectively. The first base plate 212a and the second base plate 212b may be made of material, such as, without limitations, polycarbonate, nylon, acrylonitrile butadiene styrene (ABS), polyethylene, polystyrene, polypropylene, polyether ether ketone, etc., or a combination thereof. In an embodiment, the first base plate 212a and the second base plate 212b are made of polycarbonate.
[135] In an embodiment, the first follower 206a and the second follower 206b of the cam assembly are mounted on the first base plate 212a and the second base plate 212b of the tray assembly, respectively.
[136] In an embodiment, each base plate includes a corresponding inner surface and a corresponding outer surface. The inner surface of each base plate includes a corresponding at least one notch and a corresponding at least one channel.
[137] In an embodiment, the first inner surface of the first base plate 212a includes a first notch 214a, a first proximal channel 216a, a first distal channel 216b (as shown in Fig. 5e). And, the second inner surface of the second base plate 212b includes a second notch 214b, a second proximal channel 216c, a second distal channel 216d (as shown in Fig. 5f).
[138] The first notch 214a and the second notch 214b, as shown in Figs. 5e-5f, are formed using techniques, such as, without limitation, laser cut, machining, etc. In an embodiment, the first notch 214a and the second notch 214b are formed in the first base plate 212a and the second base plate 212b, respectively, using machining techniques.
[139] In an embodiment, the first notch 214a of the first base plate 212a and the second notch 214b of the second base plate 212b are configured to receive the first horizontal stem H1 of the first follower 206a and the second horizontal stem H2 of the second follower 206b, respectively. The first notch 214a and the second notch 214b are configured to provide a corresponding sliding surface for the first follower 206a and the second follower 206b, respectively.
[140] The first proximal channel 216a, the first distal channel 216b and the first base plate 212a may be separate components. And, the first proximal channel 216a and the first distal channel 216b may be coupled to the first base plate 212a using any suitable technique. Similarly, the second proximal channel 216c, the second distal channel 216d and the second base plate 212b may be separate components. In an exemplary embodiment, the first proximal channel 216a, the first distal channel 216b and the first base plate 212a form an integrated structure. In an embodiment, the first proximal channel 216a and the first distal channel 216b are formed on the first base plate 212a using machining technique, though other techniques such as, laser cut technique may be used. The second proximal channel 216c and the second distal channel 216d are formed on the second base plate 212b using the same technique. The first proximal channel 216a, the first distal channel 216b, the second proximal channel 216c and the second distal channel 216d may have a predefined length ranging between 5mm to 20mm. In an embodiment, the length of each channel is 10mm.
[141] The first proximal channel 216a, the first distal channel 216b, the second proximal channel 216c and the second distal channel 216d may have a predefined shape, such as, without limitation, cylinder, square, triangle, hexagonal, helical etc. In an embodiment, the first proximal channel 216a, the first distal channel 216b, the second proximal channel 216c and the second distal channel 216d are cylindrical in shape. The first proximal channel 216a, the first distal channel 216b, the second proximal channel 216c and the second distal channel 216d are hollow from inside defining a respective lumen.
[142] The lumen of the first proximal channel 216a and the lumen of the first distal channel 216b are configured to receive a proximal portion and a distal portion of the first follower 206a, respectively, in response to the rotation of the cam 200 in one of the clockwise or anticlockwise direction. The lumen of the second proximal channel 216c and the lumen of the second distal channel 216d are configured to receive a proximal portion of the second follower 206b, a distal portion of the first follower 206a, a proximal portion and a distal portion of the second follower 206b, respectively, in response to the rotation of the cam 200 in one of the clockwise or anticlockwise direction.
[143] For example, in response to rotation of the cam 200 in the clockwise direction, the lumen of the first proximal channel 216a is configured to receive a proximal portion of the first follower 206a. Simultaneously, the lumen of the second distal channel 216d is configured to receive a distal portion of the second follower 206b.
[144] In response to the rotation of the cam 200 in the anticlockwise direction, the lumen of the first distal channel 216b is configured to receive a distal portion of the first follower 206a. Simultaneously, the lumen of the second proximal channel 216c is configured to receive a proximal portion of the second follower 206b.
[145] In an embodiment, the first outer surface of the first base plate 212a includes a first protrusion 212c, as shown in Fig. 5f. The second outer surface of the second base plate 212b includes a second protrusion 212d, as shown in Fig. 5e.
[146] The first protrusion 212c and the second protrusion 212d may have a predefined shape, including, but not limited to, rectangle, square, triangle, polygon, etc. In an embodiment, the first protrusion 212c and the second protrusion 212d are rectangular in shape. The first protrusion 212c and the second protrusion 212d extends at least a partial length of the first base plate 212a and the second base plate 212b, respectively.
[147] The first protrusion 212c and the first base plate 212a may be separate components and can be coupled to each other using any suitable techniques. Similarly, the second protrusion 212d and the second base plate 212b may be separate components and can be coupled to each other. In an embodiment, the first protrusion 212c and the first base plate 212a form an integrated structure. The first protrusion 212c and the second protrusion 212d may be formed on the first base plate 212a and the second base plate 212b, respectively, using machining technique, though other techniques, such as, laser cut technique may be used.
[148] The at least one base plate is coupled to the at least one curve plate. In an embodiment, the at least one curved plate includes a first curved plate 222 and a second curved plate 224.
[149] In an exemplary embodiment, the first base plate 212a and the second base plate 212b are coupled to the first curved plate 222 and the second curved plate 224, respectively, as shown in Fig. 5g. The first protrusion 212c and the second protrusion 212d helps in coupling the first base plate 212a and the second base plate 212b to the respective curved plate.
[150] In an embodiment, each curved plate includes a corresponding flat surface and a corresponding curved surface. The first flat surface of the first curved plate 222 and the second flat surface of the second curved plate 224 include a first furrow and a second furrow, respectively, (not shown). The first furrow and the second furrow are configured to receive the first protrusion 212c of the first base plate 212a and the second protrusion 212d of the second base plate 212b, respectively.
[151] In an embodiment, the first protrusion 212c of the first base plate 212a and the second protrusion 212d of the second base plate 212b are fixedly disposed within the first furrow of the first curved plate 222 and the second furrow of the second curved plate 224, respectively. The first protrusion 212c and the second protrusion 212d may be coupled to the first furrow and the second furrow using techniques, such as, without limitation, adhesive bonding, laser welding, soldering, brazing, etc., or a combination thereof. In an embodiment, the first protrusion 212c and the second protrusion 212d are coupled to the first furrow and the second furrow, respectively, using adhesive bonding.
[152] The first curved surface of the first curved plate 222 and the second curved surface of the second curved plate 224 are coupled to the inner walls of the handle 140. In an embodiment, the first curved surface of the first curved plate 222 and the second curved surface of the second curved plate 224 are coupled to the inner walls of the handle 140 using techniques, such as, adhesive bonding, laser welding, soldering, brazing, etc., or a combination thereof. In an embodiment, the first curved surface of the first curved plate 222 and the second curved surface of the second curved plate 224 are coupled to the inner walls of the handle 140 using adhesive boding. This provides overall stability to the coupled steering mechanism within the handle 140.
[153] The arrangement of the various components of the steering mechanism, as described above are provided inside the handle 140 as shown in Figs. 6a-6b. The arrangement of the various components allows for a series of coordinated interactions of transverse motion and rotational motion. For example, an interaction between a desired control element and the corresponding connecting rod causes a transverse motion of the corresponding connecting rod and the bar 160. The bar 160 being operatively coupled to the disc 170, influences the disc 170 to rotate in both a clockwise direction and an anticlockwise direction. The proximal and distal driveshaft (180a and 180b) and the cam 200 being directly coupled to the disc 170 are configured to rotate in the corresponding direction. Consequently, the movement of the cam 200 directly influences the steering of the distal end 120b of the steerable shaft 120 due to the interaction of the at least one follower with the at least one groove 202 on the cam 200. The coordinated interactions result in accurate control over the manipulation of the at least one pull wire (that is coupled to the at least one follower) within the steerable shaft 120.
[154] Fig. 7 depicts a flowchart of a method 700 of assembling the device 100, according to an embodiment of the present disclosure. As mentioned earlier that, the device 100 includes the handle 140 with the steering mechanism and the steerable shaft 120. In an embodiment, at first, the steering mechanism is assembled, followed by the steps of coupling the steering mechanism with the handle 140 and last but not the least, operatively coupling the steering mechanism with the steerable shaft 120.
[155] The sequential steps disclosed herein the method 700 of assembling the steering mechanism are provided for illustrative purposes and are not intended to limit the scope of the present disclosure. The steps may be performed in a different order or concurrently, where applicable, without deviating the scope of the present disclosure.
[156] Firstly, the steering mechanism is assembled. As mentioned earlier, the steering mechanism includes the control element assemblies, the torque generating block, the cam assembly and the tray assembly.
[157] For initiating the assembly of the steering mechanism, each control element, the torque generating block the cam assembly and the tray assembly are assembled, individually, at step 702.
[158] At step 702a, the first control element assembly 130 and the second control element assembly 132 are assembled, individually. The first control element 142a of the first control element assembly 130 is coupled to the first casing 145a and the second control element 142b of the second control element assembly 132 is coupled to the second casing 145b. The coupling between the corresponding control element and the respective casing has been explained in the above paragraphs.
[159] The first control element 142a and the second control element 142b are coupled to the first connecting rod 150a and the second connecting rod 150b, respectively. The method of coupling has been explained above.
[160] At step 702b, the torque generating block is assembled. In an embodiment, the pin 172 of the disc 170 is disposed within the slot 162 of the bar 160, thus assembling the torque generating block.
[161] At step 702c, the cam assembly is assembled. In an embodiment, the proximal end 200a and the distal end 200b of the cam 200 are coupled to the proximal driveshaft 180a and the distal driveshaft 180b, respectively. The coupling has been explained earlier. The at least one follower (e.g., the first follower 206a and the second follower 206b) are disposed within the at least one groove 202 provided on the cam 200. The disposition of the first follower 206a and the second follower 206b within the groove 202 has been explained earlier.
[162] At step 702d, the tray assembly is assembled. In an embodiment, the first curved plate 222 and the second curved plate 224 are coupled to the first base plate 212a and the second base plate 212b, respectively. The coupling mechanism has been explained earlier.
[163] This completes the step 702 of assembling each control element assembly, the torque generating block, the cam assembly and the tray assembly, individually.
[164] At step 704, the control element assemblies, the torque generating block and the cam assembly are assembled together to form the steering mechanism.
[165] At step 704a, both the control element assemblies are operatively coupled to the torque generating block. In an embodiment, the first connecting rod 150a and the second connecting rod 150b are coupled to the bar 160, thus coupling each control element assemblies with the torque generating block. The coupling mechanisms have been mentioned earlier.
[166] At step 704b, the torque generating block is operatively coupled to the cam assembly. In an embodiment, the distal driveshaft 180b is coupled to the second face of the disc 170. The coupling mechanism has been discussed earlier.
[167] At step 704c, the cam assembly is assembled with the tray assembly. In an embodiment, the first follower 206a and the second follower 206b of the cam assembly are operatively coupled to the first base plate 212a and the second base plate 212b, respectively. Specifically, the proximal end and the distal end of the first horizontal stem H1 of the first follower 206a are disposed within an initial portion of the first proximal channel 216a and the first distal channel 216b of the first base plate 212a, respectively. Similarly, the proximal end and the distal end of the second horizontal stem H2 of the second follower 206b are disposed within an initial portion of the second proximal channel 216c and the second distal channel 216d, respectively. Thus, coupling the cam assembly with the tray assembly.
[168] This completes the step of assembling the control element assembly, the torque generating block, the cam assembly and the tray assembly together to form the steering mechanism.
[169] At step 706, the steering mechanism is coupled with the handle 140.
[170] At step 706a, each control element assembly are assembled with the handle 140. In an embodiment, the first casing 145a and the second casing 145b are coupled to the handle 140, which has been explained earlier.
[171] Further, the first locking member A and the second locking member B are disposed within the handle 140. The first locking member A and the second locking member B are operatively coupled to the first connecting rod 150a and the second connecting rod 150b, respectively. Thus, establishing the coupling between the first control element assembly 130, the second control element assembly 132 and the handle 140.
[172] At step 706b, the cam assembly is coupled to the handle 140. In an embodiment, the proximal driveshaft 180a is operatively coupled to the handle 140 via the T-connector 188, which has been explained earlier.
[173] At step 706c, the tray assembly is coupled to the handle 140. In an embodiment, the first curved plate 222 and the second curved plate 224 are coupled to the inner wall of the handle 140, which has been explained earlier.
[174] This completes the step 706 of assembling the steering mechanism with the handle 140.
[175] At step 708, the steering mechanism is coupled to the steerable shaft 120 of the device 100. In an embodiment, the at first follower 206a and the second follower 206b of the cam assembly are coupled to the right pull wire 146a and the left pull wire 146b, respectively. Thus, completing the assembly of the device 100, according to an embodiment of the present disclosure.
[176] Fig. 8 depicts a flowchart of a method 800 of operating the device 100, according to an embodiment of the present disclosure.
[177] The method 800 commences at step 802, where the user introduces the steerable shaft 120 into patient’s body. During the insertion, the distal end 120b of the steerable shaft 120 is in the neutral position.
[178] At step 802a, the first control element assembly 130 and the second control element assembly 132 are in inoperative position, as shown in Fig. 9a and Fig. 9b, respectively. In an embodiment, the first ball 156a and the second ball 156b are in contact with the walls of the first connecting rod 150a. The third ball 156c and the fourth ball 156d are in contact with the second connecting rod 150b. In other words, the first ball 156a, the second ball 156b, the third ball 156c and the fourth ball 156d are disengaged from the first slot 152a, the second slot 152b, the third slot 152c and the fourth slot 152d respectively provided on the corresponding connecting rod, as shown in Figs. 9a-9b. The surface of contact between each ball and the corresponding connecting rod is reduced. The reduced surface of contact increases the compression force acting upon the respective resilient element (i.e., the first resilient element 154a, the second resilient element 154b, the third resilient element 154c, the fourth resilient element 154d).
[179] At step 802b, the first and second connecting rods (150a and 150b) are stationary at its position. The bar 160 is disposed at the center axis A1 on the disc 170, as shown in Fig. 3c. The pin 172 of the disc 170 is disposed within the slot 162 of the bar 160 at the first point B1.
[180] At step 802c, the disc 170 and the cam 200 are stationary at their places. The first vertical stem V1 of the first follower 206a and the second vertical stem V2 of the second follower 206b are disposed opposite from each other at a middle point between the peak region X and the trough region Y of the groove 202, as shown in Fig. 8c.
[181] The proximal end and the distal end of the first horizontal stem H1 of the first follower 206a are disposed within an initial portion of the first proximal channel 216a and the first distal channel 216b of the first base plate 212a, respectively. Similarly, the proximal end and the distal end of the second horizontal stem H2 of the second follower 206b are disposed within an initial portion of the second proximal channel 216c and the second distal channel 216d, respectively.
[182] At step 802d, as the first horizontal stem H1 and the second horizontal stem H2 are stationary at their places, no tension or pulling force is experienced by the right pull wire 146a and the left pull wire 146b, respectively. As a result, the distal end 120b of the steerable shaft 120 is at the neutral position.
[183] At step 804, the user triggers a first desired control element assembly with the help of the plurality of steering indicators and the plurality of pointers.
[184] At step 804a, for example, if the user requires to deflect the distal end 120b of the steerable shaft 120 in the right direction, the user refers the set of right pointers 144b1-144b2 that are aligned with the right steering indicator 144b of the plurality of steering indicators and, as shown in Fig. 2a.
[185] As mentioned above, the set of right pointers 144b1-144b2 guides the user to trigger the first desired control element assembly (e.g., the first control element assembly 130) so as to deflect the distal end 120b of the steerable shaft 120 in the first desired steering direction (e.g., right steering direction). In other words, the user is guided to press the first control element 142a to deflect the distal end 120b of the steerable shaft 120 in the right direction by the pre-defined angle (i.e., 180 degrees), as shown in Fig. 10b. While, the second control element assembly 132 is in the inoperative position, as shown in Fig. 10a.
[186] In response to the pressing of the first control element 142a, the first connecting rod 150a is pre-configured to move in the left direction. The first slot 152a and the second slot 152b provided on the first connecting rod 150a are configured to engage with the first ball 156a and the second ball 156b, respectively, as shown in Fig. 10b. The increased contact surface between the first slot 152a and the second slot 152b on the first connecting rod 150a and the corresponding balls results in expansion of the first resilient element 154a and the second resilient element 154b. Expansion of the first resilient element 154a and the second resilient element 154b provides necessary resilience force for holding the first control element assembly 130 in the triggered position.
[187] The third and the fourth ball (156c and 156d) are disengaged from the corresponding third and fourth slot (152c and 152d) provided on the second connecting rod 150b, as shown in Fig. 10a. Thus, the second control element assembly 132 is configured to remain in the inoperative position when the distal end 120b of the steerable shaft 120 is to be deflected in the right direction.
[188] At step 804b, in response to the movement of the first connecting rod 150a, the bar 160 is pre-configured to move in the corresponding direction (i.e., towards the left direction), as show in Fig. 3d. In response to the movement of the bar 160 in the left direction, the pin 172 of the disc 170 is pre-configured to move within the slot 162 of the bar 160 from the first point B1 to the second point B2. In response to the movement of the pin 172 within the slot 162 of the bar 160, the disc 170 is pre-configured to rotate in the clockwise direction.
[189] At step 804c, as mentioned above, the length of the slot 162 of the bar 160 determines the extent of rotation of the disc 170. In an embodiment, the movement of the pin 172 within the slot 162 causes a half rotation of the disc 170. In response to the half rotation of the disc 170, the cam 200 is configured to rotate up to the same extent in the corresponding direction. The half rotation of the disc 170 in the clockwise direction is transferred to the cam 200 by distal driveshaft 180b.
[190] This movement translates the half rotation of the cam 200 into linear motion of the at least one follower. As the cam 200 undergoes half rotation in the clockwise direction, the at least one follower interacts and moves within the at least one groove 202, as shown in Fig. 9c. The first vertical stem V1 of the first follower 206a and the second vertical stem V2 of the second follower 206b are disposed at the trough region Y and the peak region X of the at least one groove 202, respectively.
[191] At step 804d, as the first vertical stem V1 of the first follower 206a is disposed at the trough region Y, the first horizontal stem H1 slides within the first notch 214a of the first base plate 212a and moves in a proximal direction (i.e., backward direction). The first proximal channel 216a receives at least a proximal portion of the first horizontal stem H1.
[192] Simultaneously, the second vertical stem V2 of the second follower 206b is disposed at the peak region X. The second horizontal stem H2 slides within the second notch 214b of the second base plate 212b and moves in a distal direction (i.e., in the forward direction). The second distal channel 216d receives at least a distal portion of the second horizontal stem H2.
[193] At step 804e, the movement of the first horizontal stem H1 in the proximal direction in the distal direction generates tension in the right pull wire 146a, resulting in the right pull wire 146a being pulled. This action causes the distal end 120b of the steerable shaft 120 to deflect in the first desired direction, which is the right direction. The movement of the second horizontal stem H2 in the distal direction prevents generation of tension in the left pull wire 146b.
[194] At step 806, the user triggers a second desired control element with the help of the plurality of steering indicators and the plurality of pointers so as to deflect the distal end 120b of the steerable shaft 120 in a second desired direction.
[195] At step 806a, for example, if the user requires to deflect the distal end 120b of the steerable shaft 120 in the left direction, the user refers the set of left pointers 144c1-144c2 that are aligned with the left steering indicator 144c of the plurality of steering indicators, as shown in Fig. 2a.
[196] As mentioned above, the set of left pointers 144c1-144c2 guides the user to trigger the second desired control element assembly (e.g., the second control element assembly 132) so as to deflect the distal end 120b of the steerable shaft 120 in the second desired steering direction (e.g., left steering direction). In other words, the user is guided to press the second control element 142b to deflect the distal end 120b of the steerable shaft 120 in the left direction by the pre-defined angle (i.e., 180 degrees), as shown in Fig. 11a. While, the first control element 142a are in the inoperative position, as shown in Fig. 10b.
[197] At step 806b, in response to the pressing of the second control element 142b, the second connecting rod 150b is pre-configured to move in the right direction. The third ball 156c and the fourth ball 156d are configured to engage with the third slot 152c and the fourth slot 152d provided on the second connecting rod 150b, respectively, as shown in Fig. 11a. The increased surface of contact between the at third and the fourth slot (152c and 152d) on the second connecting rod 150b and the corresponding ball results in expansion of the third resilient element 154c and the fourth resilient element 154d. Expansion of the third resilient element 154c and the fourth resilient element 154d provides necessary resilience force for holding the second control element 142b in triggered position.
[198] At step 806c, in response to the movement of the second connecting rod 150b, the bar 160 is pre-configured to move in the corresponding direction (i.e., towards the right direction), as shown in Fig. 3e. In response to the movement of the bar 160 in the right direction, the pin 172 of the disc 170 is pre-configured to move within the slot 162 of the bar 160 from the first point B1 to the second point B2. In response to the movement of the pin 172 within the slot 162 of the bar 160, the disc 170 is pre-configured to rotate in the anticlockwise direction.
[199] As mentioned above, the length of the slot 162 of the bar 160 determines the extent of rotation of the disc 170. In an embodiment, the movement of the pin 172 within the slot 162 causes a half rotation of the disc 170. In response to the half rotation of the disc 170, the cam 200 is configured to rotate up to the same extent in the corresponding direction. The half rotation of the disc 170 in the anticlockwise direction is transferred to the cam 200 by distal driveshaft 180b.
[200] At step 806d, this movement translates the half rotation of the cam 200 into linear motion of the at least one follower. As the cam 200 undergoes half rotation in the anticlockwise direction, the at least one follower interacts and moves within the at least one groove 202, as shown in Fig. 10c. The first vertical stem V1 of the first follower 206a and the second vertical stem V2 of the second follower 206b are disposed the peak region X and at the trough region Y of the at least one groove 202, respectively.
[201] As the first vertical stem V1 of the first follower 206a is disposed at the peak region X, the first horizontal stem H1 is configured to slide within the first notch 214a of the first base plate 212a and move in a distal direction (i.e., in the forward direction). The first distal channel 216b receives at least a distal portion of the first horizontal stem H1.
[202] Simultaneously, the second vertical stem V2 of the second follower 206b is disposed at the trough region Y, the second horizontal stem H2 is configured to slide within the second notch 214b of the second base plate 212b and move in the proximal direction (i.e., backward direction). The second proximal channel 216c receives at least a proximal portion of the second horizontal stem H2.
[203] At step 806e, the movement of the second horizontal stem H2 in the proximal direction generates tension in the left pull wire 146b, resulting in the left pull wire 146b being pulled. This action causes the distal end 120b of the steerable shaft 120 to deflect in the second desired direction, which is the left direction. The movement of the first horizontal stem H1 in the distal direction prevents generation of tension in the right pull wire 146a.
[204] 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 Claims:
1. A catheter device (100) comprising:
a) a steerable shaft (120) having a proximal end (120a) and a distal end (120b);
b) a steering mechanism configured to deflect the distal end (120b) of the steerable shaft (120) in one of a plurality of steering directions, the steering mechanism comprising:
i. at least one control element assembly (130, 132) for receiving a trigger to deflect the distal end (120b) of the steerable shaft (120);
ii. a torque generating block operatively coupled to the at least one control element assembly (130, 132); and
iii. a cam assembly coupled to the torque generating block, the cam assembly includes:
a. a cam (200) coupled to the torque generating block;
b. at least one follower (206a, 206b) disposed in the cam (200) and coupled to the proximal end (120a) of the steerable shaft (120);
wherein, in response to the trigger received by the at least one control element assembly (130, 132), the torque generating block is configured to generate a torque and rotate the cam (200) in one of a clockwise or an anti-clockwise direction, and
wherein, upon the rotation of the cam (200), the at least one follower (206a, 206b) is configured to deflect the distal end (120b) of the steerable shaft (120) at a pre-defined angle in a corresponding direction.
2. The catheter device (100) as claimed in claim 1, wherein the steerable shaft (120) includes:
a) a pull ring (122) provided at the distal end (120b) of the steerable shaft (120); and
b) at least one pull wire disposed at least partially within the steerable shaft (120), each pull wire (146a, 146b) of the at least one pull wire includes a distal end coupled to the pull ring (122) and a proximal end extending out from the proximal end (120a) of the steerable shaft (120); and
wherein, the each pull wire (146a, 146b) is proximally coupled to a corresponding follower (206a, 206b) of the at least one follower.
3. The catheter device (100) as claimed in claim 1, wherein each control element assembly (130,132) of the at least one control element assembly (130,132) includes:
a) a control element (142a, 142b) configured to receive the trigger to deflect the distal end 120b of the steerable shaft 120 in one of the plurality of steering directions.
4. The catheter device (100) as claimed in claim 1, wherein each control element assembly (130, 132) of the at least one control element assembly (130, 132) includes:
a) a casing (145a, 145b) to facilitate in and out movement of a control element (142a, 142b) of the control element assembly (130,132) in response to the trigger received by the control element (142a, 142b) of the control element assembly (130,132).
5. The catheter device (100) as claimed in claim 1, wherein each control element assembly (130,132) of the at least one control element assembly (130, 132) includes:
a) a connecting rod (150a, 150b) coupled to a control element (142a, 142b) of the control element assembly (130, 132), the connecting rod (150a, 150b) comprises:
i. at least one slot (152a, 152b, 152c and 152d) provided towards a first end,
b) a locking member (A, B) comprising:
i. at least one ball (156a, 156b, 156c and 156d);
ii. at least one resilient element, each resilient element (154a, 154b, 154c and 154d) being disposed on a corresponding ball of the at least one ball (156a, 156b, 156c and 156d);
c) wherein, in response to the trigger received by a control element assembly (130, 132), one slot (152a, 152b, 152c and 152d) of the at least one slot is configured to receive the corresponding ball (156a, 156b, 156c and 156d) of the at least one ball of the locking member (A, B); and
d) wherein, in response to the disposition of the ball (156a, 156b and 156c, 156d), a respective resilient element (154a, 154b, 154c, 154d) of the at least one resilient element is configured to hold the corresponding ball (156a, 156b, 156c, 156d) within the one slot (152a, 152b, 152c, 152d), thereby holding the control element assembly (130, 132) in the triggered position.
6. The catheter device (100) as claimed in claim 1, wherein the torque generating block includes:
a) a bar (160) coupled to the at least one control element assembly (130, 132) via a corresponding connecting rod (150a, 150b), the bar (160) includes a slot (162); and
b) a disc (170) comprising a pin (172) disposed within the slot (162) of the bar (160);
wherein, in response to the trigger received by the at least one control element assembly (130, 132), the bar (160) is configured to move translationally in one of a left or right direction,
wherein, in response to the translational movement of the bar (160), the pin (172) is configured to move within the slot (162) of the bar (160) between a first point (B1) and a second point (B2), and
wherein, in response to the movement of the pin (172) within the slot (162), the disc (170) is configured to rotate in one of the clockwise or anticlockwise direction.
7. The catheter device (100) as claimed in claim 1, wherein the cam assembly includes a distal driveshaft (180b) proximally coupled to a distal end (200b) of the cam (200) and distally coupled to the disc (170) of the torque generating block, thereby facilitating the coupling between the cam assembly and the torque generating block.
8. The catheter device (100) as claimed in claim 1, wherein the catheter device (100) includes a proximal driveshaft (180a) coupled to a proximal end (200a) of the cam (200).
9. The catheter device (100) as claimed in claim 8, wherein the catheter device (100) includes a T-connector (188) having;
a) a first arm 188b and a second arm 188c coupled to an inner wall of the handle (140); and
b) a body 188a having a lumen configured to receive a proximal portion of the proximal driveshaft (180a).
10. The catheter device (100) as claimed in claim 1, wherein the cam (200) includes at least one groove (202) carved on its outer surface configured to receive and provide a path for the at least one follower (206a, 206b) to move.
11. The catheter device (100) as claimed in claim 1, wherein the catheter device (100) includes at least one base plate (212a, 212b), each base plate (212a, 212b) comprises:
a) a protrusion (212c, 212d) provided on an outer surface of the base plate (212a, 212b)
b) at least one notch (214a, 214b) provided on an inner surface of the base plate (212a, 212b), the notch (214a, 214b) is configured to receive and provide a sliding surface to the follower (206a, 206b) of the at least one follower; and
c) at least one channel (216a, 216b, 216c and 216d) provided on the inner surface of the base plate (212a, 212b), each channel (216a, 216b, 216c and 216d) of the at least one channel is pre-configured to receive at least a portion of the follower (206a, 206b).
12. The catheter device (100) as claimed in claim 11, wherein the catheter device (100) includes at least one curved plate (222, 224), each curved plate (222, 224) includes
a) a flat surface coupled to the protrusion (212c, 212d) of the base plate (212a, 212b); and
b) a curved surface coupled to an inner wall of the handle (140).
13. The catheter device (100) as claimed in claim 1, wherein the catheter device (100) includes a plurality of steering indicators (144a, 144b, 144c) indicating the corresponding steering direction of the plurality of steering directions in which the distal end (120b) of the steerable shaft (120) is deflectable.
14. The catheter device (100) as claimed in claim 1, wherein the catheter device (100) includes a plurality of pointers (144a1-144a2, 144b1-144b2, 144c1-144c2) aligned with a respective steering indicator (144a, 144b, 144c) of the plurality of steering indicators, the plurality of pointers configured to guide the user to press the appropriate control element for deflection of the distal end (120b) of the steerable shaft (120) in the respective steering direction.