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:
STEERABLE CATHETER

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

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

FIELD OF INVENTION
[1] The present disclosure relates to a medical device. More particularly, the present disclosure relates to a steerable catheter.
BACKGROUND OF INVENTION
[2] A steerable catheter is a medical device used in minimally invasive procedures to understand the condition of any organ of body or treat the ailing organs. The steerable catheter is inserted into the body to navigate through the blood vessels, for example, to different chambers of heart.
[3] The steerable catheter includes a control mechanism and a flexible catheter, whose distal part is inserted into the body. The movement of the steerable catheter inside the body is facilitated using a control mechanism at the proximal end of such a device.
[4] Conventionally, to control the deflection of steerable catheter in anticlockwise direction and clockwise direction, the manual rotation method is used for steering. In this technique, the user is required to continuously rotate the knob in the required direction until the desired deflection is reached.
[5] The manual rotation is time consuming, complex and needs more than one person to operate it in many cases. Thus, there arises a need for a device that overcomes the problems associated with the conventional devices.
SUMMARY OF 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 mere examples of the disclosure, which may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.
[7] The present disclosure relates to a catheter. In an embodiment, the catheter includes a catheter tube, a pull ring, pull wires and a steering mechanism. The catheter tube has a distal tip. The pull ring is disposed within the catheter tube towards a distal end of the catheter tube. The pull wires are coupled to the pull ring. The steering mechanism is coupled to a proximal end of each pull wire and is configured to steer the distal tip in a plurality of positions. The steering mechanism includes a pinion and racks coupled to the pinion. The racks are configured to move linearly in response to the rotation of the pinion. Each rack is coupled to a corresponding pull wire of the pull wires. In response to the rotation of the pinion in a clockwise direction, one rack of the racks is configured to move in a backward direction and pull the corresponding pull wire, thereby deflecting the distal tip in a right direction. In response to the rotation of the pinion in an anticlockwise direction, other rack of the racks is configured to move in a backward direction and pull the corresponding pull wire, thereby deflecting the distal tip in a left direction.
BRIEF DESCRIPTION OF DRAWINGS
[8] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentality disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[9] Fig. 1 depicts an assembled view of a device 100, in accordance with an embodiment of the present disclosure.
[10] Fig. 1a depicts a cross sectional view of a proximal portion of the device 100, in accordance with an embodiment of the present disclosure.
[11] Fig. 1b depicts an exploded view of the proximal portion of the device 100, in accordance with an embodiment of the present disclosure.
[12] Fig. 1c depicts an exploded view of the steering mechanism of the device 100, in accordance with an embodiment of the present disclosure.
[13] Fig. 1d depicts a top cross-sectional view of the proximal portion of the device 100, in accordance with an embodiment of the present disclosure.
[14] Fig. 2 depicts a schematic circuit diagram of a motor 123, in accordance with an embodiment of the present disclosure.
[15] Fig. 3a depicts a rack and pinion mechanism in a first position, in accordance with an embodiment of the present disclosure.
[16] Fig. 3b depicts the rack and pinion mechanism in a second position, in accordance with an embodiment of the present disclosure.
[17] Fig. 3c depicts the rack and pinion mechanism in a third position, in accordance with an embodiment of the present disclosure.
[18] Fig. 3d depicts a top view of the device 100, in accordance with an embodiment of the present disclosure.
[19] Fig. 4 illustrates a flowchart of a method 400 for operating the device 100 during a medical procedure, in accordance with an embodiment of the present disclosure.
[20] Fig. 5a depicts an assembled view of a device 300, in accordance with an embodiment of the present disclosure.
[21] Fig. 5b depicts a cross sectional view of a proximal portion of the device 300, in accordance with an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[22] Prior to describing the disclosure 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.
[23] 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.
[24] 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.
[25] 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.
[26] The present disclosure proposes devices having a steering mechanism driven by at least one motor for steering the catheter or an introducer sheath (hereinafter, referred to as a catheter). The steering mechanism can be controlled using at least one control element that controls power to the at least one motor. Unlike the conventional devices that need a user to manually rotate a knob bi-directionally, the proposed devices provide several advantages. The use of the at least one control element (e.g., push buttons) enables the user to control the deflection of the catheter by a single-push action. Therefore, the proposed devices are easier to operate than the conventional devices. Due to the motor-driven steering mechanism and faster action, the deflection of the catheter can be achieved more quickly, thereby, reducing the time required for the medical procedure. It also improves the maneuverability. The proposed devices also include a plurality of indicators indicating the position of the distal tip of the catheter. This provides immediate feedback to the user and is, therefore, able to control the deflection more precisely, consistently and accurately, reducing human errors. In an embodiment, the steering mechanism is enclosed within a handle of the device, reducing the size of the handle. This improves ergonomics and user comfort.
[27] In an embodiment, the steering mechanism includes a rack and pinion mechanism including a pinion and two racks coupled to the pinion. The rack and pinion mechanism is driven by a motor. The motor is powered by a battery pack. When the pinion rotates the racks move linearly in opposite directions creating a tension in pull wires coupled to the racks, thereby deflecting the distal tip of the catheter. The steering mechanism also includes at least one control element. In an embodiment, the at least one control element includes two push buttons. In another embodiment, the at least one control element includes a two-way switch. The user can control the deflection (including the direction and degree) by operating the at least one control element appropriately.
[28] Now referring to the figures, Fig. 1 shows an assembled view of a device 100 (or catheter 100) according to an embodiment. The device 100 has a proximal end 100a and a distal end 100b. In an exemplary embodiment, the device 100 includes a catheter tube 110, a steering mechanism disposed within a handle 121 and hemostasis hub 170.
[29] The catheter tube 110 has a hollow, tubular structure and is made of a flexible material. The catheter tube 110 has a proximal end and a distal end. The catheter tube 110 includes a distal tip 111 (interchangeably referred to as a tip 111) at the distal end of the catheter tube 110. The catheter tube 110 may be made of a material such as, without limitation, polytetrafluoroethylene (PTFE), polyether-block-amide (PEBAX), nylon, etc. In an exemplary embodiment, the catheter tube 110 is made of polyether-block-amide (PEBAX). The catheter tube 110 may have a diameter of at least 0.33 mm. In an embodiment, the diameter of the catheter tube 110 may range from 0.33 mm to 10 mm.
[30] In an embodiment, the distal tip 111 of the catheter tube 110 is inserted into the patient’s body and navigated through the patient’s vasculature to a target site where a medical procedure is to be performed. The catheter tube 110 when inserted into the patient’s body needs to be moved to reach the target site. The catheter tube 110 includes a pull ring (not shown) provided inside the catheter tube 110 at the distal end of the catheter tube 110. At least one pull wire is disposed within the catheter tube 110 and a distal end of the at least one pull wire is coupled to the pull ring. In an embodiment, the at least one pull wire includes pull wires 147a and 147b. In an embodiment, the pull ring and the at least one pull wire may be an integral component. The pull wires 147a and 147b further extend into the handle 121 of the device 100 as shown in Fig. 1d. The pull wires 147a and 147b may be made of a material such as, without limitation, stainless steel, nitinol, polymer, etc. In an exemplary embodiment, the pull wires 147a and 147b are made from stainless steel.
[31] The handle 121 is provided at the proximal end 100a of the catheter 100. The handle 121 encompasses a section of the catheter tube 110. The handle 121 is coupled to the catheter tube 110 towards the proximal end of the catheter tube 110. The catheter tube 110 extends through the handle 121 and the proximal end of the catheter tube 110 is coupled to a distal end of the hemostasis hub 170.
[32] The handle 121 may be of ergonomic shape for easy handling. The handle 121 may have any suitable shape. In an exemplary embodiment, the handle 121 is shaped in the shape of a gun including a top section 121a and a bottom section 121b making an angle with the top section 121a as shown in Fig. 1. The top section 121a and the bottom section 121b are generally cylindrical. In an embodiment, the top section 121a includes a depression as shown in Fig. 1. The handle 121 includes slots 121a1 and 121a2. The slots 121a1 and 121a2 are longitudinal. In an embodiment, the slots 121a1 and 121a2 are provided on a top surface of the depression of the top section 121a. The bottom section 121b of the handle 121 includes at least one hole (not shown) and a grip 121b1 (shown in Fig. 1a). The grip 121b1 allows the user to hold the device 100. Each of the at least one hole receives a corresponding switch element of the at least one switch element. According to an embodiment, the handle 121 includes a right part and a left part coupled to form the handle 121. The right part and the left part can be coupled using any suitable coupling mechanism.
[33] The handle 121 may be made of a material including, without limitation, polycarbonate (PC), acrylonitrile butadiene styrene (ABS), polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC), polycarbonate etc. In an exemplary embodiment, the handle 121 is made of acrylonitrile butadiene styrene (ABS).
[34] The hemostasis hub 170 includes a distal end and a proximal end. In an embodiment, the distal end of hemostasis hub 170 is coupled to the proximal end of the catheter tube 110. The hemostasis hub 170 helps in reducing the blood loss in the patient during the medical procedure. The hemostasis hub 170 may include other functions also such as, inserting dilators, inserting other catheters, etc.
[35] The hemostasis hub 170 has a tubular structure. The hemostasis hub 170 includes a tube 171 coupled laterally at a surface of hemostasis hub 170 and a 3-way stopcock 173 coupled at a proximal end of tube 171. The tube 171 may also serves as a medium to supply medicine or any infused agent during the medical procedure. The 3-way stopcock 173 can be used to operate the hemostasis hub 170 as and when needed.
[36] Fig. 1a and Fig. 1b depict a cross-sectional view and an exploded view of a proximal portion of the catheter 100 according to an embodiment. Fig. 1c depicts an exploded view of the steering mechanism, according to an embodiment. As shown, the steering mechanism includes a motor 123, a pinion 125, racks 127 and 129 (depicted in Fig. 1c), a support sheath 131, at least one control element and a battery pack 150. The at least one control element is electrically coupled to the motor 123 and is operable to cause the motor 123 to rotate in the clockwise direction and an anti-clockwise direction In an embodiment, the at least one control element includes a first push button 141 (hereinafter, referred to as the push button 141) and a second push button 143 (hereinafter, referred to as the push button 143). The disposal of the steering mechanism within the handle 121 makes the device 100 compact and easier to operate. The steering mechanism is coupled to a proximal end of each pull wire 147a, 147b and configured to deflect the distal tip 111 in a plurality of positions.
[37] In an embodiment, the motor 123 is an electrically powered gear motor. The motor 123 includes a shaft 123a, a positive terminal 123b and a negative terminal 123c. The shaft 123a of the motor 123 is used to provide motion to the pinion 125, which further drives the racks 127 and 129. The motor 123 includes a gear train mechanism, which decreases the speed by decreasing the rotation per minute (RPM) and maintains adequate torque for pulling the pull wires 147a and 147b during the operation of the device 100. The motor 123 is electrically coupled to the battery pack 150.
[38] The motor 123 is electrically coupled to the push buttons 141 and 143, and the battery pack 150 as explained later. The shaft 123a of the motor 123 is coupled to the pinion 125.
[39] In an example implementation, the motor 123 is rectangular in size. The motor 123 may have power rating ranging from 3.5 V to 6 V. In an exemplary embodiment, the motor 123 has power rating of 3.7 V.
[40] In an embodiment, the pinion 125 includes an axial groove and a plurality of teeth on its periphery. The pinion 125 is operatively coupled to the shaft 123a. The pinion 125 can be coupled to the shaft 123a using various techniques, such as, UV bonding, adhesive bonding, heat bonding, solvent bonding, etc. In an exemplary embodiment, the pinion 125 is coupled to the shaft 123a using UV bonding. The pinion 125 is operatively coupled with the racks 127 and 129. The racks 127 and 129 together with the pinion 125 form a rack and pinion mechanism. As the shaft 123a of motor 123 rotates, the pinion 125 rotates, which further transfers motion to the two racks 127 and 129. The racks 127 and 129 are configured to move linearly in response to the rotation of the pinion 125.
[41] The pinion 125 may be made of any suitable material such as, without limitation, stainless steel, carbon steel, bronze, alloy steel, aluminum, polymers, etc. In an example implementation, the pinion 125 is made of Polyoxymethylene polymer. In an embodiment, the pinion 125 has a cylindrical shape, though the pinion 125 may have any other suitable shape. The pinion 125 may have a diameter ranging from 7 mm to 15 mm. In an example implementation, diameter of the pinion 125 is 10 mm.
[42] The racks 127 and 129 translate the circular motion of the pinion 125 into a linear motion. In an embodiment, the rack 127 includes a plurality of teeth on its medial side along the length of the rack 127. Similarly, the rack 129 includes a plurality of teeth on its medial side along the length of the rack 129. The plurality of teeth of the racks 127 and 129 engage with the plurality of teeth of the pinion 125 during the operation of the device 100. In an embodiment, the top section 121a includes a longitudinal channel (not shown) in each of the right and left part of the handle 121 receiving the rack 129 and the rack 127, respectively.
[43] Further, the racks 127 and 129 includes markers 127a and 129a, respectively (as shown in Fig. 1c). The markers 127a and 129a include a dome shape structure having a tip. The marker 127a is provided at the distal end on a top surface of the rack 127. In an embodiment, the marker 127a and the rack 127 form an integral structure, though it is possible that the marker 127a and the rack 127 are separate components coupled together using a suitable technique. Similarly, the marker 129a is provided at the distal end on a top surface of the rack 129. In an embodiment, the marker 129a and the rack 129 form an integral structure, though it is possible that the marker 129a and the rack 129 are separate components coupled together using a suitable technique. Alignment of the markers 127a and 129a with an indicator of the plurality of indicators indicates a position of a distal tip 111 of the catheter tube 110 during the operation of the device 100 and provides the user with a visual feedback. This helps the user to operate the device 100 more accurately. The markers 127a and 129acan be made of a material such as, without limitation, stainless steel, carbon steel, bronze, alloy steel, aluminum, polymers, etc. In an embodiment, the markers 127a and 129aare made of polyoxymethylene polymer.
[44] As the shaft 123a of motor 123 rotates, the pinion 125 rotates. The rotational motion of the pinion 125 is converted to a linear motion of the racks 127 and 129 via the rack and pinion mechanism. The racks 127 and 129 move back and forth in a longitudinal direction. The linear motion of the racks 127 and 129 can be controlled by controlling the rotation of the pinion 125 with respect to the racks 127 and 129.
[45] In an embodiment, the stoppers 121c are provided within the handle 121 to restrict movement of the racks 127 and 129 beyond a pre-defined limit if the user accidently presses the push buttons 141 and 143 longer than required. The stoppers 121c are provided towards a distal end of the top section 121a as depicted in Fig. 1a.
[46] The device 100 includes the pull wires 147a and 147b (as shown in Figs. 1c-1d). The proximal end of pull wires 147a and 147b are coupled to the markers 127a and 129a of the racks 127 and 129 respectively, using any suitable coupling mechanism, such as, knotting, bonding, welding, etc. In an exemplary embodiment, a proximal end of the pull wire 147a is bonded to the marker 127a and a proximal end of the pull wire 147b is bonded to the marker 129a. The rack and pinion mechanism drives the pull wires 147a and 147b. The pull wires 147a and 147b facilitate the movement or deflection of the tip 111 of the catheter tube 110. A distal end of the pull wire 147a and a distal end of the pull wire 147b are coupled to the pull ring. The markers 127a and 129a behave as a fixing unit for the pull wires 147a and 147b and transfer tensile force on the pull ring through pull wires 147a and 147b for the deflection of the tip 111. Further, the markers 127a and 129a help a medical practitioner to determine a position of the tip 111 of the catheter tube 110 easily during the operation of the device 100.
[47] The racks 127 and 129 may be made of any suitable material such as, without limitation, stainless steel, carbon steel, bronze, alloy steel, aluminum, polymers, etc. The racks 127 and 129 may have a shape such as, cube, cuboid, polygonal prism, cylindrical, etc. In an example implementation, the racks 127 and 129 are made of polyoxymethylene polymer and are cuboidal in shape. The racks 127 and 129 may have a length, width and height ranging from 50 mm to 100 mm, 8 mm to 15 mm and 5 mm to 10 mm, respectively. In an example implementation, the length, width and height of the racks 127 and 129 are 85 mm, 11 mm and 8 mm, respectively.
[48] The support sheath 131 is configured to support the racks 127 and 129 and provide stability to the rack and pinion mechanism. In an embodiment, the support sheath 131 is mounted on the racks 127 and 129. The support sheath 131 includes locks 131a and 131b on each lateral side of the support sheath 131, respectively. The locks 131a and 131b protrude from a bottom surface of the support sheath 131 and extend longitudinally. In an embodiment, the locks 131a and 131b are semi-cylindrical. The racks 127 and 129 include longitudinal grooves (not shown) provided on the top surface of the racks 127 and 129 and extend from respective a proximal end to distal end of the racks 127 and 129. The grooves have a shape corresponding to the locks 131a and 131b. The lock 131a is slidably disposed within the groove on the rack 127. Similarly, the lock 131b is slidably disposed within the groove on the rack 129.
[49] The support sheath 131 also includes longitudinal slots 131c and 131d. In an embodiment, the slots 131c and 131d are disposed parallel to the locks 131a and 131b. The slots 131c and 131d align with the slots 121a1 and 121a2 on the handle 121. The slots 131c and 131d receive the markers 127a and 129a, respectively (as depicted in Figs. 1b-1c) such that the markers 127a and 129a are configured to slide within the corresponding slot of the slots 131c and 131d during the operation of the device 100. The width of the slots 131c and 131d correspond to the width of the markers 127a and 129a.
[50] The support sheath 131 may be made of any suitable material such as, without limitation, stainless steel, aluminum, polycarbonate, acrylonitrile butadiene styrene (ABS), etc. The support sheath 131 may have a shape such as a cuboid, cube, etc. In an example implementation, the support sheath 131 is made of ABS and is cuboidal in shape. The support sheath 131 may have a length, width and height ranging from 70 mm to 250 mm, 20 mm to 50 mm and 3 mm to 8 mm. In an example implementation, the length, width and height of the support sheath 131 are 170 mm, 35 mm and 5 mm.
[51] In an embodiment, the push buttons 141 and 143 are disposed on the handle 121 of the device 100. The handle 121 includes two holes to receive the push buttons 141 and 143. In an embodiment, the bottom section 121b includes the holes on a distal side of the bottom section 121b.
[52] The push buttons 141 and 143 control positions of the racks 127 and 129 and thereby control the deflection of the distal tip 111 of the catheter tube 110. The push buttons 141 and 143 are electrically coupled to the motor 123 and the battery pack 150.
[53] A user can control the position of the racks 127 and 129 and thereby, deflection of the distal tip 111 of the catheter tube 110 in a desired direction by pressing a corresponding push button of the push buttons 141 and 143 explained later in detail. In an embodiment, the push button 141 is pressed to deflect the distal tip 111 of the catheter tube 110 in the right direction and the push button 143 is pressed to deflect the distal tip 111 of the catheter tube 110 in the left direction. When the user releases the corresponding push button of the push buttons 141 and 143, the motor 123 stops and the catheter tube 110 stays in the defined position. In an example implementation, the push buttons 141 and 143 are identical. The push button 141 includes two terminals 141a and 141b. Similarly, the push button 143 also includes two terminals 143a and 143b. The push buttons 141 and 143 may have any suitable shape. In an embodiment, the push buttons 141 and 143 are generally cylindrical with a hemispherical cap on top.
[54] The battery pack 150 includes one or more batteries to provide power to the motor 123. In an embodiment, the battery pack 150 includes a first battery 151 (hereinafter referred to as the battery 151) and a second battery 153 (hereinafter referred to as the battery 153). The batteries 151 and 153 may have a suitable voltage capacity to drive the motor 123. In an embodiment, the batteries 151 and 153 are 9 V batteries. The battery pack 150 is electrically coupled to the motor 123 and the push buttons 141 and 143 as explained in conjunction with Fig. 2. In an example implementation, the batteries 151 and 153 are identical. The battery 151 includes a positive terminal 151a and a negative terminal 151b. Similarly, the battery 153 also includes a positive terminal 153a and a negative terminal 153b. Further, the battery pack 150 includes two snap-fit connectors 151c and 153c coupled to the batteries 151 and 153, respectively. The connecting wires 145 (connecting wires 145a, 145b, 145c, 145d, 145e, 145f are collectively referred to as connecting wires 145) are coupled to the snap-fit connectors 151c and 153c for coupling the batteries 151 and 153 with the motor 123 and the push buttons 141 and 143.
[55] Fig. 2 shows a schematic of electrical coupling between the motor 123, the batteries 151 and 153, and the push buttons 141 and 143, according to an embodiment. In an example implementation, the terminal 141a of the push button 141 is connected to the negative terminal 151b of the battery 151 through the connecting wire 145a and the terminal 141b of the push button 141 is connected with the negative terminal 123c of the motor 123 through the connecting wire 145b. Similarly, the terminal 143a of push button 143 is connected to the negative terminal 153b of the battery 153 through the connecting wire 145c and the terminal 143b of the push button 143 is connected with the positive terminal 123b of the motor 123 through the connecting wire 145d. The positive terminal 151a of the battery 151 is connected to the positive terminal 123b of the motor 123 through the connecting wire 145e. Similarly, the positive terminal 153a of the battery 153 is connected to the negative terminal 123c of the motor 123 through the connecting wire 145f.
[56] As the batteries 151 and 153 are connected with the motor 123 with opposite polarity, the motor 123 and thereby, the pinion 125 is able to rotate in a first direction (e.g., clockwise) and a second direction, (e.g., anti-clockwise) as explained. In response to the push button 141 and the push button 143 being pressed, the motor 123 rotates in the first direction or the second direction, respectively. In an example implementation, when the push button 141 is pressed, the circuit connecting the battery 151 with the motor 123 is complete and the motor 123 rotates in the clockwise direction. Further, when the push button 141 is released, this circuit is disconnected, thereby removing power from the motor 123 and the motor 123 stops. Similarly, when the push button 143 is pressed, the circuit connecting the battery 153 with the motor 123 is complete and the motor 123 rotates in the anticlockwise direction. Further, when the push button 143 is released, this circuit is disconnected, thereby removing power from the motor 123 and the motor 123 stops.
[57] In an exemplary embodiment, the handle 121 of the device 100 includes a plurality of indicators which indicate a position of the distal tip 111 of the catheter tube 110 during the operation of the device 100 and provides the user with a visual feedback. The plurality of indicators are disposed along the length of the slots 121a1 and 121a2 on the top surface of the top section 121a of the handle 121. In the depicted embodiment, plurality of indicators includes six indicators 161a-161b, 162a-162b and 163a-163b (as depicted in Fig. 3d). The indicators 161a and 161b indicate a neutral position of the distal tip 111 of the catheter tube 110. The indicators 162a and 162b indicate a 90-degree position of the distal tip 111 of the catheter tube 110 in the left and the right direction, respectively. The indicators 163a and 163b indicate a 180-degree position of the distal tip 111 of the catheter tube 110 in the left and the right direction, respectively. Though only the indicators corresponding to 90-degree and 180-degree positions on the left and the right direction are shown, it should be apparent that any number of desired indicators may be provided based upon the requirements. For example, the indicators corresponding to 30-degree, 60-degree, 90-degree, 120-degree, 150-degree and 180-degree positions on the left and right directions may be provided.
[58] Fig. 3a shows a first position of the racks 127 and 129. As shown, the marker 129a is aligned with the indicator 161a and the marker 127a is aligned with the indicator 161b, which indicates that the distal tip 111 of the catheter tube 110 is in the neutral position. The tips of the markers 127a and 129a are visible to the user in the slots 121a1 and 121a2, respectively.
[59] Fig. 3b shows a second position of the racks 127 and 129 after the push button 141 is pressed by the user. As explained earlier, when the push button 141 is pressed, the motor 123 rotates in the clockwise direction. This results in the clockwise rotation of the pinion 125. Through the rack and pinion mechanism, when the pinion 125 rotates in the clockwise direction, the rack 129 moves in forward direction and the rack 127 moves in backward direction. Consequently, the marker 129a moves in forward direction and the marker 127a moves in backward direction . As a result, the pull wire 147a coupled to the rack 127 is pulled, thereby deflecting the distal tip 111 in the right direction. As shown, in the second position, the marker 127a aligns with the indicator 162b, thereby indicating that the distal tip 111 of the catheter tube 110 has moved (or deflected) by 90 degrees to the right direction. In an embodiment, the marker 129a moves beyond the slot 121a2 and its tip is not visible to the user when the distal tip 111 is in the second position as depicted in Fig. 3d.
[60] Fig. 3c shows a third position of the racks 127 and 129 after the push button 143 is pressed by the user. As explained earlier, when the push button 143 is pressed, the motor 123 rotates in the anti-clockwise direction. This results in the anti-clockwise rotation of the pinion 125. Through the rack and pinion mechanism, when the pinion 125 rotates in the anti-clockwise direction, the rack 127 moves in forward direction and the rack 129 moves in backward direction. Consequently, the marker 127a moves in forward direction and the marker 129a moves in backward direction. As a result, the pull wire 147b coupled to the rack 129 is pulled, thereby deflecting the distal tip 111 in the left direction. As shown, in the third position, the marker 129a aligns with the indicator 162a, thereby indicating that the distal tip 111 of the catheter tube 110 has moved (or deflected) by 90 degrees to the left direction. In an embodiment, the marker 127a moves beyond the slot 121a1 and its tip is not visible to the user when the distal tip 111 is in the third position.
[61] Though the positions of the racks 127 and 129 are illustrated only for 90-degree deflection on the left and the right directions, the positions for the racks 127 and 129 for other deflection positions would be readily apparent.
[62] Fig. 4 illustrates a flowchart of a method 400 for operating the device 100 during a medical procedure, according to an embodiment.
[63] At step 401, the user presses one push button of the push buttons 141 and 143. The user selects the appropriate push button depending upon a desired direction (left or right) of the distal tip 111 of the catheter tube 110. In an embodiment, the user presses the push button 141 to deflect the distal tip 111 of the catheter tube 110 in the right direction or presses the push button 143 to deflect the distal tip 111 of the catheter tube 110 in the left direction.
[64] At step 403, the motor 123 receives the power from a corresponding battery of the batteries 151 and 153. As described earlier, the motor 123 receives the power from the battery 151 when the push button 141 is pressed and from the battery 153 when the push button 143 is pressed, as described earlier.
[65] At step 405, the shaft 123a of the motor 123 rotates. The shaft 123a will rotate either clockwise or anti-clockwise as per the connection of motor 123 with the corresponding battery. In an embodiment, when the motor 123 receives power from the battery 151, the shaft 123a rotates in the clockwise direction and when the motor 123 receives the power from the battery 153, the shaft 123a rotates in the anticlockwise direction.
[66] At step 407, the pinion 125 starts rotating in the rotational direction of the shaft 123a. Thus, the pinion 125 rotates in the clockwise direction when the shaft 123a rotates in the clockwise direction and in the anticlockwise direction when the shaft 123a rotates in the anticlockwise direction.
[67] At step 409, the racks 127 and 129 start moving linearly. The racks 127 and 129 move in opposite direction. The motion of the racks 127 and 129 depends upon the rotation of the pinion 125. For example, when the pinion 125 rotates in the clockwise direction the rack 127 moves backward and the rack 129 moves forward (as shown in Fig. 3b). Similarly, when the pinion 125 rotates in the anticlockwise direction, the rack 127 moves forward and the rack 129 moves backward (as shown in Fig. 3c). Since the racks 127 and 129 move in opposite direction, the pull wires 147a and 147b coupled to the racks 127 and 129, respectively, also move in the opposite direction. This causes the distal tip 111 of the catheter tube 110 to deflect in a direction depending upon the movement of the racks 127 and 129. For example, when the rack 127 moves forward (and the rack 129 moves backward), the distal tip 111 of the catheter tube 110 deflects towards the left direction. Similarly, when the rack 127 moves backward (and the rack 129 moves forward), the distal tip 111 of the catheter tube 110 deflects towards the right direction. Further, the markers 127a and 129a also move in the direction of the racks 127 and 129, respectively.
[68] At step 411, the user releases the corresponding push button of the push buttons 141 and 143 once the distal tip 111 of the catheter tube 110 reaches the desired deflection. For example, considering that the user wants to deflect the distal tip 111 of the catheter tube 110 by 90 degrees in the right direction and has accordingly pressed the push button 141 at step 401, the user releases the push button 141 once the marker 127a aligns with the indicator 162b. In another example, considering that the user wants to deflect the distal tip 111 of the catheter tube 110 by 180 degrees in the left direction and has accordingly pressed the push button 143 at step 401, the user releases the push button 143 once the marker 129a aligns with the indicator 163a. Once the user releases the push button 143, the power to the motor 123 is disconnected and the motor 123 stops. Consequently, the rotation of the pinion 125 and the movement of the racks 127 and 129 also stops. As a result, the distal tip 111 of the catheter tube 110 remains in the deflected position.
[69] Though it is described that the user releases the corresponding push button once one of the markers 127a and 129a align with a desired indicator of the indicators 161a – 161b, 162a-162b and 163a-163b the user may release the corresponding push button even when the markers 127a, 129a are not aligned with the desired indicator based upon the requirement. For example, the user may release the push button 141 when the marker 127a is at a position between the indicators 162b and 163b Thus, a more granular control of the deflection of the distal tip 111 of the catheter 100 can be obtained.
[70] Fig. 5a shows an assembled view of a device 300 (or catheter 300) according to an embodiment. Fig. 5b show a cross sectional view of a proximal portion of the device 300 according to an embodiment. In the depicted embodiment, the at least one control element of the device 300 includes a switch 341 instead of the two push buttons 141 and 143. Other components of the device 300 are structurally and functionally similar to the corresponding components of the device 100, and hence, are not explained in detail for brevity. In an embodiment, the switch 341 is a two-way switch. The switch 341 includes two pairs of terminals (not shown) and is electrically coupled to the motor 123 and the batteries 151 and 153 in a schematically similar manner as depicted in Fig. 2 such that the motor 123 is capable of rotating in both the clockwise and anti-clockwise directions. The switch 341 includes a button configurable to be in one of three positions – a first position, a second position and a third position. In the third position, the connection between the motor 123 and the batteries 151 and 153 is disconnected and hence, the motor 123 stops. In an embodiment, the user presses the button of the switch 341 upward (i.e., the first position) to deflect the distal tip 111 of the catheter tube 110 in the right direction or presses the switch 341 downward (i.e., the second position) to deflect the distal tip 111 of the catheter tube 110 in the left direction. When the button of the switch 341 is in the first position or the second position, the operation of the device 300 (including the rotation of the motor 123, the movement of the pinion 125, the racks 127 and 129, the corresponding deflection of the pull wires 147a and 147b, the movement of the markers 127a and 129a, etc.) is similar to when the push buttons 141 and 143 are pressed, respectively and hence, the operation of the device 300 is not explained in detail for brevity.
[71] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. , Claims:WE CLAIM
1. A catheter (100, 300) comprising:
a. a catheter tube (110) having a distal tip (111);
b. a pull ring disposed within the catheter tube (110) towards a distal end of the catheter tube (110);
c. pull wires (147a, 147b) coupled to the pull ring;
d. a steering mechanism coupled to a proximal end of each pull wire (147a, 147b) and configured to deflect the distal tip (111) in a plurality of positions; the steering mechanism comprising:
i. a pinion (125); and
ii. racks (127, 129) coupled to the pinion (125) and configured to move linearly in response to the rotation of the pinion (125); each rack (127, 129) is coupled to a corresponding pull wire (147a, 147b) of the pull wires (147a, 147b);
iii. wherein, in response to the rotation of the pinion (125) in a clockwise direction, one rack (127) of the racks (127, 129) is configured to move in a backward direction and pull the corresponding pull wire (147a, 147b), thereby deflecting the distal tip (111) in a right direction.
iv. wherein, in response to the rotation of the pinion (125) in an anticlockwise direction, other rack (129) of the racks (127, 129) is configured to move in a backward direction and pull the corresponding pull wire (147a, 147b), thereby deflecting the distal tip (111) in a left direction.
2. The catheter (100, 300) as claimed in claim 1, wherein the steering mechanism comprises a motor (123) having a shaft (123a) coupled to the pinion (125), wherein the pinion (125) is configured to rotate in response to the rotation of the motor (123).
3. The catheter (100, 300) as claimed in claim 2, wherein the steering mechanism comprises at least one control element electrically coupled to the motor (123) and operable to cause the motor (123) to rotate in the clockwise direction and the anticlockwise direction.
4. The catheter (100) as claimed in claim 3, wherein the at least one control element comprises:
a. a first push button (141) configurable to be pressed and in response to being pressed, the motor (123) rotates in the clockwise direction; and
b. a second push button (143) configurable to be pressed and in response to being pressed, the motor (123) rotates in the anticlockwise direction.
5. The catheter (300) as claimed in claim 3, wherein the at least one control element comprises a switch (341) configurable to be at least in a first position and a second position; wherein, in response to the switch (341) being in the first position, the motor (123) rotates in the clockwise direction and, in response to the switch (341) being in the second position, the motor (123) rotates in the anticlockwise direction.
6. The catheter (100, 300) as claimed in claim 3, wherein the at least one control element couples the motor (123) to a first battery (151) and a second battery (153) in opposite polarity, wherein in response to coupling the motor (123) with the first battery (151), the motor (123) rotates in the clockwise direction and in response to coupling the motor (123) with the second battery (153), the motor (123) rotates in the anti-clockwise direction.
7. The catheter (100, 300) as claimed in claim 3, wherein the steering mechanism is disposed within a handle (121).
8. The catheter (100, 300) as claimed in claim 1, wherein each rack (127, 129) comprises a plurality of teeth on a medial side along a length of the rack (127, 129) and the pinion (125) comprises a plurality of teeth on a periphery of the pinion (125), wherein the plurality of teeth of the racks (127, 129) are configured to engage the plurality of teeth of the pinion (125).
9. The catheter (100, 300) as claimed in claim 1, wherein a support sheath (131), coupled to the racks (127, 129), is provided to support the racks (127, 129).
10. The catheter (100, 300) as claimed in claim 1, wherein each rack (127, 129) is coupled to a respective marker (127a, 129a), each marker (127a, 129a) being coupled to a proximal end of a respective pull wire (147a, 147b) of the pull wires (147a, 147b), wherein alignment of the marker (127a, 129a) with one of a plurality of indicators (161a-161b, 162a-162b, 163a-163b), provided on a handle (121), indicates a corresponding position of the plurality of positions of the distal tip (111).