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

1. TITLE OF THE INVENTION:
GUIDEWIRE CONTROL DEVICE
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 medical device. More particularly, the present disclosure relates to a guidewire control device.
BACKGROUND OF INVENTION
[2] Atherosclerosis is a condition where fats, cholesterol and other substances build up in the blood vessel’s walls. This buildup is also called plaque. The plaque can cause blood vessels to narrow, reducing or blocking blood flow through such vessels. The plaque may also burst, leading to a blood clot. If untreated, atherosclerosis leads to severe consequences such as, tissue damage, organ damage and may even a heart attack/stroke.
[3] Various minimally invasive medical interventions, such as stent implantation, balloon angioplasty, atherectomy procedures, etc., are available to treat the blockages in blood vessels and restore the blood flow. Such procedures rely on the passage of a guidewire through blood vessels to a target site and deliver subsequent devices such as, angioplasty balloons, stents, thrombectomy device, atherectomy devices and the like using the guidewire to remove the blockages. However, medical practitioners often encounter difficulty in reaching the target site, especially when navigating the guidewire via complex pathways such as crossing old lesions and fresh blockages. Therefore, a precise control of the guidewire is important in such procedures.
[4] A few guidewire control devices are currently available. Some conventional guidewire control devices impart a longitudinal back-and-forth motion to a guidewire so that the guidewire is able to move forward. However, performance of such devices severely degrades when navigating the guidewire through the hard lesions. Since the guidewire only has a longitudinal motion, a distal tip simply presses against a hard lesion, thereby increasing chances of deformation or damage to a distal tip of the guidewire.
[5] It is, therefore, desirable for the guidewire to have a rotational motion so that the guidewire works in a drill-like fashion. Some conventional devices impart a rotational motion (i.e., torque) to a guidewire. To give the rotational motion to the guidewire, these conventional devices have mechanical actuators that are manually operated, i.e., a medical practitioner needs to manually manipulate these mechanical actuators (e.g., press a lever, or pull a grip of a handle). However, the conventional devices suffer from many drawbacks. Due to manual operation, such devices are prone to human errors. For example, if a medical practitioner applies a lesser force than required, the guidewire may not penetrate a hard lesion. On the other hand, applying an excessive force may damage the guidewire and/or a vessel. Thus, the accuracy of the operation depends upon the medical practitioner’s skill and it is difficult to have a precise control on the guidewire motion. Further, typically a higher force is needed to operate the mechanical actuators, which may lead to fatigue for the medical practitioner. In addition, these devices require the medical practitioner to use multiple fingers, typically four fingers, to hold and operate the mechanical actuator. Therefore, the conventional devices are cumbersome to use.
[6] Thus, there arises a need for a device that overcomes the problems associated with the conventional devices.
SUMMARY OF INVENTION
[7] Particular embodiments of the present disclosure are described herein below with reference to the accompanying drawings, however, it is to be understood that the disclosed embodiments are mere examples of the disclosure, which may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.
[8] The present disclosure relates to a device for controlling a guidewire. In an embodiment, the device includes a motor, a bevel gear assembly and a shaft. The motor is configured to rotate in a pre-defined direction. The bevel gear assembly includes a driving gear coupled to the motor and configured to rotate in response to the rotation of the motor. The bevel gear assembly further includes a proximal driven gear and a distal driven gear coupled to the driving gear. Each of the driving gear, the proximal driven gear and the distal driven gear includes a gear wheel, a toothed portion and a non-toothed portion alternately arranged on the gear wheel. The shaft is rotatably coupled to the proximal driven gear and the distal driven gear. The shaft includes an aperture configured to receive a guidewire. In response to the toothed portion of the driving gear engaging with the toothed portion of the proximal driven gear, the proximal driven gear is configured to rotate in a first direction. In response to the toothed portion of the driving gear engaging with the toothed portion of the distal driven gear, the distal driven gear is configured to rotate in a second direction opposite to the first direction. In a single rotation of the driving gear, the toothed portion of the driving gear alternately engages with the toothed portion of the proximal driven gear and the toothed portion of the distal driven gear, causing the shaft and the guidewire to alternately rotate in the first direction and the second 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. 1 depicts a section view of a device 100, according to an embodiment of the present disclosure.
[11] Fig. 2 depicts an exploded view of the device 100, according to an embodiment of the present disclosure.
[12] Fig. 3 depicts a perspective view of the device 100, according to an embodiment of the present disclosure.
[13] Fig. 4 depicts a cross-sectional view of the device 100, according to an embodiment of the present disclosure.
[14] Fig. 5a depicts a perspective of a left casing 111, according to an embodiment of the present disclosure.
[15] Fig. 5b depicts a side view of a right casing 113, according to an embodiment of the present disclosure.
[16] Fig. 6 depicts a perspective view of a motor 120, according to an embodiment of the present disclosure.
[17] Fig. 7a depicts a top view of a driving gear 141, according to an embodiment of the present disclosure.
[18] Fig. 7b depicts a side view of the driving gear 141, according to an embodiment of the present disclosure.
[19] Fig. 7c depicts a bottom perspective view of the driving gear 141, according to an embodiment of the present disclosure.
[20] Fig. 8a depicts a perspective view of a shaft 160 coupled with a proximal driven gear 143 and a distal driven gear 145, according to an embodiment of the present disclosure.
[21] Fig. 8b depicts another perspective view of the shaft 160, according to the embodiment of the present disclosure.
[22] Fig. 9a depicts a perspective view of a locking nut 170, according to an embodiment of the present disclosure.
[23] Fig. 9b depicts a perspective view of a locking ring 180, according to an embodiment of the present disclosure.
[24] Fig. 10a depicts a configuration of the device 100 imparting an anticlockwise rotational motion to a guidewire 10 coupled to the device 100, according to an embodiment of the present disclosure.
[25] Fig. 10b depicts a configuration of the device 100 imparting a clockwise rotational motion to the guidewire 10, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOPANYING DRAWINGS
[26] 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.
[27] 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.
[28] 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.
[29] Furthermore, the described features, advantages, and characteristics of the embodiments may be combined in any suitable manner. One skilled in the relevant art will recognize that the embodiments may be practiced without one or more of the specific features or advantages of a particular embodiment. In other instances, additional features and advantages may be recognized in certain embodiments that may not be present in all embodiments. These features and advantages of the embodiments will become more fully apparent from the following description and apportioned claims, or may be learned by the practice of embodiments as set forth hereinafter.
[30] The present disclosure relates to a device for controlling a guidewire. The device may be used in various medical procedures, for example, stent implantation, balloon angioplasty, atherectomy procedures or any other procedure involving navigation of a guidewire through a patient’s vasculature. The device helps in navigating a guidewire to a target site with high precision and accuracy. The proposed device rotates the guidewire alternately in clockwise and anti-clockwise directions. In other words, the device imparts a drill-like motion to the guidewire, breaking up hardened blood tissue, and creating a smooth path and sufficient space for navigation, while preventing damage to surrounding tissues. The device is electrically controlled through a switching element. This results in elimination of human errors and provides enhanced rotational control when navigating through the coronary and periphery vasculature. As the device is capable of being controlled using one finger, the device is easy to operate and causes less fatigue in the user.
[31] Now, referring to figures, Fig. 1 and Fig. 2 depict a sectional view and an exploded view, respectively, of a device 100 for controlling a guidewire, according to an embodiment of a present disclosure. Fig. 3 and Fig. 4 show a perspective view and a cross-sectional view, respectively, of the device 100. The device 100 is used to navigate the guidewire through vasculature of a patient during various medical procedures, such as, angioplasty, percutaneous coronary intervention (PCI), thrombolysis etc. In an embodiment, the device 100 rotates the guidewire in a clockwise and anti-clockwise direction alternately, similar to a drilling motion, which facilitates in breaking hardened blood tissues or hard lesions and creating a smooth path for navigating the guidewire. The device 100 may be used for controlling any type of a guidewire, including, without limitation, hydrophilic guidewires, steerable guidewires, stiff guidewires or the like. The guidewire may be made of a biocompatible material, such as, without limitation, stainless steel, nitinol, platinum, etc.
[32] The device 100 has a proximal end 100a and a distal end 100b. In an embodiment, the device 100 includes a handle 110, a motor 120, a power source 130, a bevel gear assembly, a switching element 150, a shaft 160, and a locking assembly. In an embodiment, the bevel gear assembly includes a driving gear 141, a proximal driven gear 143, a distal driven gear 145. Further, in an embodiment, the locking assembly includes a locking nut 170, and a locking ring 180. Various components of the device 100 work in synchronization to provide alternate clockwise and anti-clockwise rotational motion to the guidewire as explained later.
[33] The handle 110 allows the medical practitioner to hold and operate the device 100. The handle 110 encloses a space and houses various components of the device 100. The handle 110 may be made of a material including, without limitation, High density polyethylene (HDPE), Polyoxymethylene (POM), thermoplastic polyurethane (TPU), thermoplastic rubber (TPR), polypropylene (PP), polycarbonate (PC), etc. In an exemplary embodiment, the handle 110 is made of medical grade polycarbonate. The handle 110 is designed to have an ergonomic shape for the comfort of the medical practitioner. The handle 110 includes a tubular portion 110a and a gripping portion 110b (shown in Fig. 3). The tubular portion 110a is provided towards a top end of the handle 110 and defines a space to hold various components of the device 100. The gripping portion 110b is provided towards a bottom end of the handle 110 and may be solid having slots to hold respective components of the device 100. The medical practitioner may grip the gripping portion 110b to hold the device 100. In an embodiment, the tubular portion 110a may be generally cylindrical and the gripping portion 110b may have a quadrilateral shape such that the handle 110 may resemble the shape of a gun. It should be understood though that the tubular portion 110a and the gripping portion 110b may have any other shape. The handle 110 includes a left casing 111 and a right casing 113 coupled to form the handle 110. Figs. 5a and 5b depict the left casing 111 and the right casing 113 according to an embodiment. The left casing 111 and the right casing 113 may be mirror images of each other. The left casing 111 includes a top portion 111a and a bottom portion 111b. The top portion 111a is semi-circular and the bottom portion 111b is quadrilateral in shape. Similarly, the right casing 113 includes a top portion 113a and a bottom portion 113b. The top portion 113a is semi-circular and the bottom portion 113b is quadrilateral in shape. The top portion 111a of the left casing 111 when coupled with the top portion 113a of the right casing 113 forms the tubular portion 110a of the handle 110. The bottom portion 111b of the left casing 111 when coupled with the bottom portion 113b of the right casing 113 forms the gripping portion 110b of the handle 110 which is rectangular in shape. The left casing 111 and the right casing 113 may be coupled using any known technique, for example, a snap-fit mechanism, fasteners, etc. In an example implementation, protrusions 111c may be provided in the left casing 111 and corresponding holes 113c may be provided in the right casing 113 (or vice versa) forming a snap-fit lock. It should be noted that the dimensions of the protrusions 111c and the holes 113c are complementary with each other. In an embodiment, the protrusions 111c and the holes 113c are cylindrical, though they may have any other shape. The handle 110 may include a proximal groove 115a, a distal groove 115b, a proximal opening 115c, a distal opening 115d, a first slot 115e, a second slot 115f and an opening 115g as shown in Figs. 3 and 4, and the left casing 111 and the right casing 113 may have corresponding cut-outs to forms aforesaid features of the handle 110. The proximal groove 115a and the distal groove 115b are provided in the tubular portion 110a towards a proximal and a distal end, respectively, of the handle 110. The proximal opening 115c and the distal opening 115d are provided in the tubular portion 110a at the proximal and distal end, respectively, of the handle 110. The first slot 115e and the second slot 115f are provided in the gripping portion 110b. The proximal opening 115c and the distal opening 115d provide a passage for the shaft 160. The opening 115g receives the switching element 150.
[34] Fig. 6 depicts an exemplary motor 120. The motor 120 may be disposed in the gripping portion 110b of the handle 110, for example, inside the second slot 115f of the handle 110. The motor 120 may be an AC motor or a DC motor. In an embodiment, the motor 120 is a DC motor. In an example implementation, the motor 120 is a DC gear motor having a gearbox for reducing rotational speed and increasing output torque of the motor 120. The motor 120 drives the rotation of the driving gear 141 (explained later). The motor 120 includes a motor shaft 121. The motor shaft 121 may have a pre-defined cross-sectional shape, such as, circular, D-shaped, oval, square, etc. In an example implementation, the motor shaft 121 has a D-shaped cross-section. The motor shaft 121 rotates in response to the rotational motion of the motor 120. The motor 120 and the motor shaft 121 are configured to rotate in a pre-defined direction (e.g., clockwise or anti-clockwise direction) based upon requirements. In an embodiment, the motor 120 and the motor shaft 121 may be oriented vertically.
[35] The power source 130 is coupled to the motor 120 and provides power to the motor 120. The power source 130 may be disposed in the gripping portion 110b of the handle 110, for example, inside the first slot 115e of the handle 110. The power source 130 may have a pre-defined shape, for example, rectangular. In an embodiment, the power source 130 is a DC-power source and includes one or more batteries. The batteries may be of any type including, but not limited to, lithium-ion, lead-nickel, nickel cadmium, zinc-air, nickel metal hydride, zinc-manganese dioxide, etc. In an exemplary embodiment, the power source 130 includes a zinc-manganese dioxide battery.
[36] The device 100 includes a switching element 150 is coupled to the motor 120 and the power source 130 using suitable wires/cables. The switching element 150 connects/disconnects power supply (provided by the power source 130 to/from the motor 120 upon activation/deactivation of the switching element 150. The switching element 150 is capable of receiving a first actuation input and a second actuation input. In response to receiving the first actuation input, the switching element 150 is configured to couple (or connect) the power source 130 to the motor 120, causing the motor 120 to rotate in the pre-defined direction. In response to receiving the second actuation input, the switching element 150 is configured to decouple (or disconnect) the power source 130 from the motor 120, causing the motor 120 to stop rotating. The switching element 150 may reside in the opening 115g provided in the gripping portion 110b towards a distal side end of the gripping portion 110b. This allows the medical practitioner to operate the switching element 150 easily. The switching element 150 may have any desired shape, for example, cylindrical as shown in Fig. 2. The first and second actuation inputs depend upon the switching element 150. In an embodiment, the switching element 150 is a push-button switch as shown in Fig. 2. In this case, the first and second actuation inputs correspond to pressing and releasing the switching element 150, respectively. In this embodiment, the switching element 150 may be connected to the motor 120 and the power source 130 such that when the switching element 150 is pressed, the circuit between the power source 130 and the motor 120 is closed, providing power to the motor 120 for rotation. When the switching element 150 is released, the circuit between the power source 130 and the motor 120 is opened, disconnecting the power from the motor 120, causing the motor 120 to stop. In another embodiment, the switching element 150 may be a two-way switch, a rocker switch, a toggle switch, a slide switch, a dip switch, a micro switch or the like.
[37] Figs. 7a – 7c illustrate the driving gear 141 according to an embodiment. The driving gear 141 may be disposed inside the tubular portion 110a of the handle 110. The driving gear 141 is coupled to the motor shaft 121 of the motor 120 and is configured to rotate in response to the rotation of the motor shaft 121 of the motor 120. The rotational direction of the driving gear 141 is the same as the rotational direction of the motor shaft 121. The driving gear 141 has a top end 141f and a bottom end 141g. The driving gear 141 includes a gear shaft 141e provided at the bottom end 141g and a gear wheel 141a provided at the top end 141f. The gear wheel 141a may be conical or frustum-shaped, though the gear wheel 141a may have any other shape. The driving gear 141 includes a toothed portion 141b and a non-toothed portion 141c provided on a top surface of the gear wheel 141a for a partial circumference of the gear wheel 141a. The toothed portion 141b and the non-toothed portion 141c are arranged alternatingly (or alternately). The toothed portion 141b includes a plurality of teeth 141b1 (hereinafter the teeth 141b1). The teeth 141b1 may be triangular, square, rectangular, spiral, helical, etc. In an example implementation, the teeth 141b1 are triangular in shape. Providing the teeth 141b1 for only a partial circumference of the gear wheel 141a helps the guidewire to rotate in the clockwise and anti-clockwise direction alternately as described later. The gear shaft 141e may be cylindrical. The gear shaft 141e is coupled with the motor shaft 121 of the motor 120. In an embodiment, the gear shaft 141e includes a hole 141d provided centrally. The hole 141d is configured to receive and couple with the motor shaft 121 using any known technique, such as, without limitation, threaded mechanism, screw mechanism, press-fit mechanism, adhesive bonding mechanism, pinning mechanism, and coupling mechanism, etc. In an example implementation, the gear shaft 141e is coupled with the motor shaft 121 using press-fit mechanism. The cross-sectional dimensions and shape of the hole 141d may correspond to the cross-sectional shape and dimensions of the motor shaft 121.
[38] The proximal driven gear 143 and the distal driven gear 145 are coupled to the driving gear 141. Fig. 8a depicts the proximal driven gear 143 according to an embodiment. The proximal driven gear 143 is situated proximal to the driving gear 141. The proximal driven gear 143 may be disposed inside the tubular portion 110a of the handle 110. The proximal driven gear 143 includes a gear wheel 143a. The gear wheel 143a may have conical or frustum shape, where the diameter of the gear wheel 143a reduces from a proximal end of the proximal driven gear 143 to a distal end of the proximal driven gear 143. The gear wheel 143a has a toothed portion 143b and a non-toothed portion 143c provided on a distal surface of the gear wheel 143a for a partial circumference of the gear wheel 143a. The toothed portion 143b and the non-toothed portion 143c are arranged alternatingly (or alternately). The toothed portion 143b includes a plurality of teeth 143b1 (hereinafter the teeth 143b1). The teeth 143b1 may be triangular, square, rectangular, spiral, helical, etc. In an example implementation, the teeth 143b1 are triangular in shape. The teeth 143b1 are configured to engage with the teeth 141b1 of the driving gear 141. In an embodiment, the proximal driven gear 143 includes a hole (not shown) provided centrally.
[39] The distal driven gear 145 (as shown in Fig. 8a) is situated distal to the driving gear 141. The distal driven gear 145 may be disposed inside the tubular portion 110a of the handle 110. The distal driven gear 145 includes a gear wheel 145a. The gear wheel 145a may have conical or frustum shape, where the diameter of the gear wheel 145a reduces from a proximal end of the distal driven gear 145 to a distal end of the distal driven gear 145. The gear wheel 145a has a toothed portion 145b and a non-toothed portion 145c provided on a proximal surface of the gear wheel 145a for a partial circumference of the gear wheel 145a. The toothed portion 145b and the non-toothed portion 145c are arranged alternatingly (or alternately). The toothed portion 145b includes a plurality of teeth 145b1 (hereinafter the teeth 145b1). The teeth 145b1 may be triangular, square, rectangular, spiral, helical, etc. In an example implementation, the teeth 145b1 are triangular in shape. The teeth 145b1 are configured to engage with the teeth 141b1 of the driving gear 141. In an embodiment, the distal driven gear 145 includes a hole (not shown) provided centrally.
[40] In an embodiment, the toothed potion 143b of the proximal driven gear 143 and the toothed portion 145b of the distal driven gear 145 face each other. Similarly, the non-toothed portion 143c of the proximal driven gear 143 and the non-toothed portion 145c of the distal driven gear 145 face each other. The toothed portions 141b, 143b, 145b are provided on a pre-defined percentage of a circumference of the respective gear wheel 141a, 143a, 145a. In an embodiment, the pre-defined percentage may range between 20% - 50%. Preferably, the pre-defined percentage may range between 40% - 50%. In an example implementation, the pre-defined percentage is 50% as depicted in Figs. 7a – 7c and Fig. 8a. In other words, the toothed portions 141b, 143b, 145b are provided on 50% of the circumference of the respective gear wheels 141a, 143a, 145a, and the non-toothed portions 141c, 143c, 145c are provided on 50% circumference of the respective gear wheels 141a, 143a, 145a. This causes the guidewire to alternately rotate in clockwise and anticlockwise direction for half a rotation each of the motor 120 (explained later). The depicted embodiment, utilizes the entire rotation of the motor 120 and is therefore, more power efficient and provides optimal drill-like motion to the guidewire, which improves the overall performance of the device 100. In an embodiment, the tooth portions 141b, 143b, 145b includes a single toothed segment and the non-toothed portions 141c, 143c, 145c includes a single non-toothed segment as shown in Figs. 7a – 7c and Fig. 8a. However, this should not be considered as limiting.
[41] The driving gear 141, the proximal driven gear 143 and the distal driven gear 145 may be made of a material, such as, without limitation, high-density polyethylene (HDPE), polyoxymethylene (POM), thermoplastic polyurethane (TPU), thermoplastic rubber (TPR), polypropylene (PP), polycarbonate (PC), etc. In an example implementation, the driving gear 141, the proximal driven gear 143 and the distal driven gear 145 are made of polycarbonate (PC). The driving gear 141, the proximal driven gear 143 and the distal driven gear 145, and respective teeth (141b1, 143b1 and 145b1) may be dimensioned based upon requirements. In an embodiment, the proximal driven gear 143 and the distal driven gear 145 may be identical. This helps in providing consistent and symmetric rotational motion in clockwise and anti-clockwise direction to the guidewire. It should be noted that the structure and dimensions of the driving gear 141, the proximal driven gear 143, and the distal driven gear 145 may or may not be same.
[42] In an embodiment, the driving gear 141, the proximal driven gear 143 and the distal driven gear 145 are coupled with each other to form the bevel gear assembly. The rotational axis of the proximal driven gear 143 and the distal driven gear 145 make a pre-defined angle with the rotational axis of the driving gear 141. In an embodiment, the proximal driven gear 143 and the distal driven gear 145 are positioned in such a way that their rotational axes are perpendicular to the rotational axis of the driving gear 141. The driving gear 141, the proximal driven gear 143, and the distal driven gear 145 are designed and coupled in a manner to achieve the desired rotation of the guidewire as explained later. In an embodiment, the toothed portion 141b, the toothed portion 143b and toothed portion 145b are designed such that when the toothed portion 141b of the driving gear 141 engages with the toothed portion 143b of the proximal driven gear 143 (i.e., when one or more of the teeth 141b1, 143b1 engage with each other), the non-toothed portion 141c of the driving gear 141 aligns with the toothed portion 145b of the distal driven gear 145. Similarly, when the toothed portion 141b engages with the toothed portion 145b of the distal driven gear 145 (i.e., when one or more of the teeth 141b1, 145b1 engage with each other), the non-toothed portion 141c of the driving gear 141 aligns with the toothed portion 143b of the proximal driven gear 143. Thus, at a time, the driving gear 141 engages with only one of the proximal driven gear 143 or the distal driven gear 145. During one rotation of the driving gear 141, Further, the toothed portion 141b of the driving gear 141 engages with the toothed portion 143b of the proximal driven gear 143 for a first part of the rotation. In response to the toothed portion 141b of the driving gear 141 engaging with the toothed portion 143b of the proximal driven gear 143, the proximal driven gear 143 is configured to rotate in a first direction. The rotation of the proximal driven gear 143 causes the distal driven gear 145 to rotate in the first direction. In an embodiment, the first direction is the same as the pre-defined direction of rotation of the motor 120 and the driving gear 141. In another embodiment, the first direction may be opposite to the pre-defined direction. Further, the toothed portion 141b engages with the toothed portion 145b for a second part of the rotation of the driving gear 141. In response to the toothed portion 141b of the driving gear 141 engaging with the toothed portion 145b of the distal driven gear 145, the distal driven gear 145 is configured to rotate in a second direction, which is opposite to the first direction. The rotation of the distal driven gear 145 causes the proximal driven gear 143 to rotate in the second direction. Thus, the toothed portion 141b of the driving gear 141 alternately engages with the toothed portion 143b of the proximal driven gear 143 and the toothed portion 145b of the distal driven gear 145 in a single rotation of the driving gear 141, causing the proximal driven gear 143 and the distal driven gear 145 to rotate in opposite directions alternately in a single rotation of the driving gear 141. The values of the first part and the second part depend upon the pre-defined percentage of the circumference on which the toothed portions 141b, 143b and 145b are provided. For instance, in an exemplary configuration where the toothed portions (141b, 143b, and 145b) are provided on half circumference of respective gear wheels (141a, 143a and 145a), the first part and the second part are equal to half, and the proximal driven gear 143 and the distal driven gear 145 rotate in one direction (say, anticlockwise) for half a rotation of the driving gear 141, and rotate in the opposite direction (say, clockwise) for the other half of the rotation of the driving gear 141.
[43] Fig. 8a depicts an exemplary shaft 160. The shaft 160 has a proximal end 160a and a distal end 160b. The shaft 160 may be disposed such that the proximal end 160a extends out of the proximal opening 115c of the handle 110 in a proximal direction and the distal end 160b extends out of the distal opening 115d of the handle 110 in a distal direction. The shaft 160 has an elongated, tubular structure. In an embodiment, the shaft 160 is cylindrical, though the shaft 160 may have any other shape. The shaft 160 includes an aperture 160c extending longitudinally from the proximal end 160a to the distal end 160b of the shaft 160. The aperture 160c is configured to receive the guidewire. The guidewire is configured to rotate in response to the rotation of the shaft 160. In other words, the rotation of the shaft 160 causes the guidewire to rotate. The diameter of the aperture 160c correspond to the diameter of the guidewire. The shaft 160 is rotatably coupled to the proximal driven gear 143 and the distal driven gear 145. In an embodiment, the shaft 160 passes through the hole provided in each of the proximal driven gear 143 and the distal driven gear 145. The shaft 160 is rotatably coupled to the proximal driven gear 143 and the distal driven gear 145 such that the shaft 160 is configured to rotate in response to the rotation of either of the proximal driven gear 143 or the distal driven gear 145. Since the proximal driven gear 143 and the distal driven gear 145 rotate alternately in the first direction (e.g., clockwise) and the second direction (e.g., anti-clockwise) in a single rotation of the driving gear 141, the shaft 160 also rotates in the first and the second direction alternately, causing the guidewire too to rotate in the first and second direction alternately in one rotation of the driving gear 141, thereby having a drill-like motion. In other word, the alternating engagement of the toothed portion 141b of the driving gear 141 with the toothed portions 143b, 145b of the proximal driven gear 143 and the distal driven gear 145, respectively, in a single rotation of the driving gear 141, causes the shaft 160 and the guidewire to rotate alternately in the first and second directions. The shaft 160 may be coupled to the proximal driven gear 143 and the distal driven gear 145 at the respective hole using a technique, such as, threaded mechanism, press-fit mechanism, adhesive bonding mechanism, pinning mechanism, coupling mechanism and the like. The proximal driven gear 143 and the distal driven gear 145 are coupled with the shaft 160 at a pre-defined distance therebetween.
[44] In an embodiment, a proximal holder 161 and a distal holder 163 may be provided to hold the shaft 160 while allowing the rotation of the shaft 160. The proximal holder 161 and the distal holder 163 provide support to the shaft 160. The proximal holder 161 and a distal holder 163 may be disposed towards the proximal end 160a and the distal end 160b of the shaft 160, respectively. The proximal holder 161 and the distal holder 163 may be circular in shape. Each of the proximal holder 161 and the distal holder 163 includes a hole (not shown) provided centrally, through which the shaft 160 is passed. The proximal holder 161 and the distal holder 163 reside within the proximal groove 115a and the distal groove 115b of the handle 110, respectively. The proximal groove 115a and the distal groove 115b are complementary to the shape and dimensions of the proximal holder 161 and the distal holder 163, respectively. The proximal holder 161 and the distal holder 163 may be made of a material, such as, without limitation, high density polyethylene (HDPE), polyoxymethylene (POM), thermoplastic polyurethane (TPU), thermoplastic rubber (TPR), polypropylene (PP), polycarbonate (PC), etc. In an example implementation, the proximal holder 161 and the distal holder 163 are made of medical grade polycarbonate (PC).
[45] In an embodiment, an extended portion 160f is provided at the distal end 160b of the shaft 160. The extended portion 160f is used to couple the shaft 160 with the locking assembly. The outer surface of extended portion 160f may be smooth, threaded or partially threaded. In an embodiment, the extended portion 160f is threaded and has threads 160e provided on an outer surface of the extended portion 160f. The extended portion 160f is coupled to the locking nut 170. The extended portion 160f has a tubular structure and includes a cavity 160d (shown in Fig. 4 and Fig. 8b). The cavity 160d extends from a distal end of the extended portion 160f towards a proximal end of the extended portion 160f for at least a partial length of the extended portion 160f. In an example implementation, the cavity 160d extends for the entire length of the extended portion 160f. The cavity 160d is coaxial with the aperture 160c of the shaft 160. The cavity 160d extends to a distal end of the aperture 160c. The cavity 160d is configured to receive the locking ring 180 and has a diameter corresponding to an outer diameter of the locking ring 180. The diameter of the cavity 160d is larger than the diameter of the aperture 160c.
[46] The shaft 160 may be made of a material, such as, without limitation, high-density polyethylene (HDPE), polyoxymethylene (POM), thermoplastic polyurethane (TPU), thermoplastic rubber (TPR), polypropylene (PP), polycarbonate (PC), etc. In an example implementation, the shaft 160 is made of medical grade polycarbonate (PC). The shaft 160 may be dimensioned based upon requirements.
[47] The locking assembly is configured to lock the guidewire. The locking assembly is coupled to the shaft 160 and the guidewire. In the depicted embodiment, the locking assembly includes the locking nut 170 and the locking ring 180. It should not be considered as limiting and other locking assemblies for locking the guidewire are also within the scope of the present disclosure. Examples of such assemblies include, without limitation, a torque device, a slide-lock mechanism, a twist-lock mechanism, a spring-loaded gripper, a rotary knob lock or the like.
[48] The locking nut 170 and the locking ring 180 are coupled with each other and are also coupled with the shaft 160. Fig. 9a depicts an exemplary locking nut 170, according to an embodiment. The locking nut 170 has a proximal end 170a and a distal end 170b. The locking nut 170 may be generally cylindrical, though the locking nut 170 may have any other shape. Optionally, the locking nut 170 may have a tapered profile at the distal end 170b, with the diameter of the locking nut 170 reducing towards the distal end 170b such that the locking nut 170 defines a conical structure. The locking nut 170 includes an opening 170c provided at the proximal end 170a and extending towards the distal end 170b for at least partial length of the locking nut 170. In an example implementation, the opening 170c extends for a partial length of the locking nut 170. The opening 170c is configured to receive the extended portion 160f of the shaft 160. The inner surface of the opening 170c includes inner threads 171. The inner threads 171 are configured to engage with the threads 160e of the extended portion 160f of the shaft 160. The inner threads 171 are complementary to the threads 160e of the extended portion 160f of the shaft 160. Though in the depicted embodiment, the locking nut 170 is coupled to the shaft 160 via a threaded coupling, it should be understood that the locking nut 170 and the shaft 160 may be coupled via any other techniques, e.g., snap-fit, tapered-fit, etc. An extension 173 is provided centrally within the opening 170c of the locking nut 170 and extends longitudinally towards the proximal end 170a of the locking nut 170. When the locking nut 170 is coupled to the shaft 160, for example, via the threaded coupling with the extended portion 160f, the extension 173 is disposed inside the cavity 160d of the shaft 160. The extension 173 helps in locking the guidewire as explained later. The locking nut 170 includes a hole 173b provided centrally and extending from a proximal face 173a of the extension 173 to the distal end 170b of the locking nut 170. The hole 173b is configured to receive the guidewire and has dimensions corresponding to the dimensions of the guidewire. Optionally, an outer surface of the locking nut 170 may include serrations 175 or any other features, such as, grooves, undulations, etc., which help in gripping the locking nut 170 more securely. The locking nut 170 may be made of a material, such as, without limitation, high-density polyethylene (HDPE), polyoxymethylene (POM), thermoplastic polyurethane (TPU), thermoplastic rubber (TPR), polypropylene (PP), polycarbonate (PC), etc. In an embodiment, the locking nut 170 is made of medical grade polycarbonate (PC).
[49] Fig. 9b depicts an exemplary locking ring 180. The locking ring 180 has a proximal end 180a and a distal end 180b. The locking ring 180 may be made of a compressible material including, without limitation, natural rubber, nitrile rubber (NBR), ethylene propylene diene monomer (EPDM), polyurethane (PU), silicone (Q), etc. In an exemplary embodiment, the locking ring 180 is made of silicone. The locking ring 180 is disposed inside the cavity 160d of the extended portion 160f of the shaft 160 such that the proximal end 180a of the locking ring 180 aligns with the proximal end of the cavity 160d (as shown in Fig. 4). In an embodiment, the locking ring 180 may be cylindrical, though the locking ring 180 may have any other shape. The locking ring 180 includes a hole 181 extending from the distal end 180b to the proximal end 180a of the locking ring 180. The hole 181 is configured to receive the guidewire. The diameter of the hole 181 corresponds to the diameter of the guidewire. The hole 181 of the locking ring 180 and the hole 173b of the locking nut 170 align with the aperture 160c of the shaft 160. The locking ring 180 may have a tapered portion 182 at the proximal end 180a. The tapered profile is provided for efficient locking with the guidewire.
[50] The locking nut 170 and the locking ring 180 work in sync to lock the guidewire disposed within the device 100 as follows. The inner threads 171 are aligned with the threads 160e and the locking nut 170 is rotated to engage the inner threads 171 with the threads 160e. The rotation of the locking nut 170 causes the extension 173 to move in a proximal direction and the proximal face 173a of the extension 173 mates with a distal face 183 of the locking ring 180. When the locking nut 170 is rotated further in the same direction, (or when the locking nut 170 is coupled to the extended portion 160f of the shaft 160) the extension 173 pushes the locking ring 180 in the proximal direction. As a result, the locking ring 180 is compressed and the hole 181 too is radially compressed, causing the locking ring 180 to grip the guidewire securely, thereby locking the guidewire. This prevents any unwanted movement of the guidewire during the operation of the device 100.
[51] An embodiment of the operation of the device 100 is now explained with reference to Figs. 10a – 10b. A guidewire, such as a guidewire 10, is inserted into the device 100. For example, a distal end of the guidewire 10 may be inserted from the proximal end 100a into the aperture 160c of the shaft 160 and pushed through the aperture 160c, the hole 181 of the locking ring 180 and the hole 173b of the locking nut 170 until the distal end of the guidewire 10 exits from the distal end 170b of the locking nut 170. In another example, a proximal end of the guidewire 10 may be inserted from the distal end 100b into the hole 173b of the locking nut 170 and pushed through the hole 173b, the hole 181 of the locking ring 180 and the aperture 160c of the shaft 160 until the proximal end of the guidewire 10 exits from the proximal end 160a of the shaft 160. The locking nut 170 may then be tightened on the extended portion 160f by rotating the locking nut 170, thereby locking the guidewire 10 as explained earlier. The guidewire 10 may be chosen based upon needs of the medical procedure.
[52] Once the guidewire 10 is locked, a medical practitioner presses the switching element 150, connecting the power from the power source 130 to the motor 120 and the motor 120 starts rotating in the pre-defined direction, say, in the clockwise direction. Since, the motor shaft 121 is coupled with the gear shaft 141e of the driving gear 141, the driving gear 141 also starts rotating in the clockwise direction. As explained earlier, in a single rotation of the driving gear 141, the toothed portion 141b of the driving gear 141 alternately engages with the toothed portion 143b of the proximal driven gear 143 and the toothed portion 145b of the distal driven gear 145. In the depicted embodiment, the toothed portion 141b of the driving gear 141 is coupled (or engaged) with the toothed portion 145b of the distal driven gear 145 (illustrated in Fig. 10a) for half cycle of each rotation of the driving gear 141. As a result, the distal driven gear 145 rotates in the anticlockwise direction, causing the shaft 160 and the guidewire 10 to rotate in the anticlockwise direction as shown in Fig. 10a. Similarly, the toothed portion 141b of the driving gear 141 is coupled (or engaged) with the toothed portion 143b of the proximal driven gear 143 (illustrated in Fig. 10b) for the other half cycle of each rotation of the driving gear 141 and the proximal driven gear 143 rotates in the clockwise direction, causing the shaft 160 and the guidewire 10 to rotate in the clockwise direction as shown in Fig. 10b. Thus, the guidewire 10 alternately rotates in the clockwise and anticlockwise direction. Thus, the device 100 imparts a drilling motion to the guidewire 10, thereby creating space for navigation of the guidewire 10. The medical practitioner may keep the switching element 150 pressed to continue providing the drill-like motion to the guidewire 10. When the switching element 150 is released, the switching element 150 disconnects the power from the motor 120, causing the motor 120 to stop rotating. As a result, the driving gear 141 too stops rotating and no rotational motion is imparted to the guidewire 10. By pressing or releasing the switching element 150 as desired, the medical practitioner is able to control the rotation of the guidewire 10 based upon procedural requirements.
[53] The present disclosure offers several advantages over conventional devices. The device enables controlled movement of the guidewire using the drilling motion, ensuring precise positioning and navigation of the guidewire for the treatment of vessel blockages. Due to the drilling motion imparted by the proposed device, a guidewire creates more space when navigating through legions or blockages. This minimizes the damage to the guidewire and also improves the crossability of the guidewire. The device is electrically controlled and therefore, unlike a conventional device having a mechanical control mechanism, the device provides accurate control and eliminates human errors when navigating through the coronary and peripheral vasculature, improving precision. In addition, the device can be easily operated by the medical practitioner with a single finger, thereby minimizing any discomfort/fatigue and associated errors. Moreover, the device also enables enhanced rotational speed control as the switching element directly controls the power from the power source to the motor. Overall, the device exhibits improved performance when accessing distal anatomy, navigating tortuous vessels, crossing old lesions, and/or working through fresh blockages as compared to conventional devices.
[54] 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. , C , Claims:WE CLAIM
1. A device (100) for controlling a guidewire, the device (100) comprising:
a. a motor (120) configured to rotate in a pre-defined direction;
b. a bevel gear assembly comprising:
i. a driving gear (141) coupled to the motor (120) and configured to rotate in response to the rotation of the motor (120);
ii. a proximal driven gear (143) coupled to the driving gear (141); and
iii. a distal driven gear (145) coupled to the driving gear (141);
wherein each of the driving gear (141), the proximal driven gear (143) and the distal driven gear (145) comprises: a gear wheel (141a, 143a, 145a), a toothed portion (141b, 143b, 145b) and a non-toothed portion (141c, 143c, 145c) alternately arranged on the gear wheel (141a, 143a, 145a); and
c. a shaft (160) rotatably coupled to the proximal driven gear (143) and the distal driven gear (145), the shaft (160) comprising an aperture (160c) configured to receive a guidewire;
d. wherein in response to the toothed portion (141b) of the driving gear (141) engaging with the toothed portion (143b) of the proximal driven gear (143), the proximal driven gear (143) is configured to rotate in a first direction;
e. wherein in response to the toothed portion (141b) of the driving gear (141) engaging with the toothed portion (145b) of the distal driven gear (145), the distal driven gear (145) is configured to rotate in a second direction opposite to the first direction;
f. wherein, in a single rotation of the driving gear (141), the toothed portion (141b) of the driving gear (141) alternately engages with the toothed portion (143b) of the proximal driven gear (143) and the toothed portion (145b) of the distal driven gear (145), causing the shaft (160) and the guidewire to alternately rotate in the first direction and the second direction.
2. The device (100) as claimed in claim 1, wherein the toothed portions (141b, 143b, 145b) are provided on a pre-defined percentage of a circumference of the respective gear wheel (141a, 143a, 145a), wherein the pre-defined percentage ranges between 20% and 50%.
3. The device (100) as claimed in claim 1, wherein the toothed portions (141b, 143b, 145b) are provided on a pre-defined percentage of a circumference of the respective gear wheel (141a, 143a, 145a), wherein the pre-defined percentage ranges between 40% - 50%.
4. The device (100) as claimed in claim 1, wherein the toothed portions (141b, 143b, 145b) are provided on a pre-defined percentage of a circumference of the respective gear wheel (141a, 143a, 145a), wherein the pre-defined percentage is 50%.
5. The device (100) as claimed in claim 1, wherein the device (100) comprises a locking assembly coupled to the shaft (160) and the guidewire, the locking assembly configured to lock the guidewire.
6. The device (100) as claimed in claim 5, wherein the locking assembly comprises:
a. a locking nut (170) comprising:
i. an opening (170c) extending from a proximal end (170a) of the locking nut (170) toward a distal end (170b) of the locking nut (170), the opening (170c) configured to receive an extended portion (160f) of the shaft (160);
ii. an extension (173) provided within the opening (170c) and extending towards the proximal end (170a) of the locking nut (170); and
iii. a hole (173b) provided centrally in the locking nut (170) and extending from a proximal face (173a) of the extension (173) to the distal end (170b) of the locking nut (170); and
b. a locking ring (180) disposed inside a cavity (160d) of the extended portion (160f) of the shaft (160) and comprising a hole (181) extending between a proximal end (180a) and a distal end (180b) of the locking ring (180);
c. wherein the hole (173b) of the locking nut (170) and the hole (181) of the locking ring (180) are aligned with the aperture (160c) of the shaft (160) and are configured to receive the guidewire;
d. wherein when the locking nut (170) is coupled to the extended portion (160f) of the shaft (160), the extension (173) is configured to push the locking ring (180) in a proximal direction, causing the hole (181) of the locking ring (180) to radially compress, thereby locking the guidewire.
7. The device (100) as claimed in claim 6, wherein the opening (170c) of the locking nut (170) comprises inner threads (171) configured to engage with threads (160e) provided on an outer surface of the extended portion (160f) of the shaft (160).
8. The device (100) as claimed in claim 1, wherein the device (100) comprises a switching element (150) coupled to the motor (120) and capable of receiving a first actuation input, the switching element (150) configured to cause the motor (120) to rotate in the pre-defined direction in response to receiving the first actuation input.
9. The device (100) as claimed in claim 1, wherein the device (100) comprises a power source (130) configured to provide power to the motor (120).
10. The device (100) as claimed in claim 1, wherein the toothed portion (141b, 143b, 145b) comprises a single toothed segment and the non-toothed portion (141c, 143c, 145c) comprises a single non-toothed segment.
11. The device (100) as claimed in claim 1, wherein the driving gear (141) comprises a gear shaft (141e) coupled to a motor shaft (121) of the motor (120).
12. The device (100) as claimed in claim 1, wherein the motor (120) is a DC gear motor.
13. The device (100) as claimed in claim 1, wherein the device (100) includes a proximal holder (161) and a distal holder (163) coupled to the shaft (160) and configured to support the shaft (160), wherein the proximal holder (161) and the distal holder (163) reside within a proximal groove (115a) and a distal groove (115b), respectively, provided in a handle (110).