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

3. 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, different chambers of heart.
[3] The steerable catheter includes a control mechanism and a flexible catheter tube, whose distal part is inserted into the body. The movement of catheter tube inside the body is facilitated using the control mechanism at the proximal end of device.
[4] Conventionally, a manual control mechanism is used to control the deflection of catheter tube in anticlockwise direction and clockwise direction. For example, the user continuously rotates a knob in the required direction. When the user rotates the knob fully in the clockwise direction, a distal tip of the catheter tube will reach an extreme position on the right side. Now, if the user needs to move the distal tip of the catheter tube to an extreme position on the left side, the user needs to rotate the knob in anticlockwise direction until the distal tip of the catheter tube first reaches a neutral position and then continue rotating the knob in the anticlockwise direction until the distal tip of the catheter tube reaches the extreme position on the left side.
[5] The manual rotation is time consuming, and complex. Further, operating the conventional devices may either require one person to use both their hands or need more than one person. Thus, there arises a need for a catheter that overcomes the problems associated with the conventional catheters.
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. The catheter includes a catheter tube having a distal tip. A pull ring is disposed within the catheter tube towards a distal end of the catheter tube. The catheter also includes at least one pull wire having a distal end coupled to the pull ring. The catheter further includes a handle coupled to the catheter tube towards a proximal end of the catheter tube. At least one push button is provided on the handle and at least one sliding element is disposed within the handle. Each sliding element of the at least one sliding element is coupled to a proximal end of a corresponding pull wire of the at least one pull wire and operationally coupled to a corresponding push button of the at least one push button. In response to the corresponding push button being pressed, each sliding element is configured to pull the corresponding pull wire, thereby deflecting the distal tip of the catheter tube in a corresponding 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. 1a depicts an assembled view of a catheter 100 in accordance with an embodiment of the present disclosure.
[10] Fig. 1b depicts an expanded view of a proximal end of the catheter 100 in accordance with an embodiment of the present disclosure.
[11] Fig. 2 depicts a top cross-sectional view of a handle 130 of the catheter 100 in accordance with an embodiment of the present disclosure.
[12] Fig. 2a depicts an isometric view of a top casing 131a of the handle 130 in accordance with an embodiment of the present disclosure.
[13] Fig. 2b depicts an isometric view of a bottom casing 131b of the handle 130 in accordance with an embodiment of the present disclosure.
[14] Fig. 2c1 depicts a perspective view of a sliding element 147a in accordance with an embodiment of the present disclosure.
[15] Fig. 2c2 depicts a perspective view of a proximal portion of a pull wire 141a and a pull wire 141b in accordance with an embodiment of the present disclosure.
[16] Fig. 2c3 depicts a coupling of the pull wire 141a with a sliding element 147a in accordance with an embodiment of the present disclosure.
[17] Fig. 2c4 depicts an enlarged bottom perspective view showing the coupling of the pull wire 141a with the sliding element 147a in accordance with an embodiment of the present disclosure.
[18] Fig. 3a depicts an isometric view of a push button 133a of the catheter 100 in accordance with an embodiment of the present disclosure.
[19] Fig. 3b depicts a cross-sectional view of the push button 133a of the catheter 100 in accordance with an embodiment of the present disclosure.
[20] Fig. 4a depicts various components of a control mechanism when a distal tip 111 of a catheter tube 110 is in a neutral position in accordance with an embodiment of the present disclosure.
[21] Fig. 4b depicts various components of the control mechanism when the distal tip 111 of the catheter tube 110 is deflected by 90 degrees towards the right direction in accordance with an embodiment of the present disclosure.
[22] Fig. 4c depicts various components of the control mechanism when the distal tip 111 of the catheter tube 110 is deflected by 180 degrees towards the right direction in accordance with an embodiment of the present disclosure.
[23] Fig. 5a depicts a marker 145a in a first position in accordance with an embodiment of the present disclosure.
[24] Fig. 5b depicts the marker 145a in a second position in accordance with an embodiment of the present disclosure.
[25] Fig. 5c depicts the marker 145a in a third position in accordance with an embodiment of the present disclosure.
[26] Fig. 6 illustrates a flowchart of a method 600 for operating the catheter 100 during a medical procedure, in accordance with an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE DRAWINGS
[27] 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.
[28] 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.
[29] 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.
[30] 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.
[31] The present disclosure relates to a steerable catheter device (or a device). In an embodiment, the device includes a control mechanism to steer the catheter in both directions – to the left and to the right – by a desired angle. The control mechanism includes a combination of kinematically coupled elements for steering a catheter tube or an introducer sheath (hereinafter, referred to as a catheter tube) of the catheter. The control mechanism includes at least one push button to control the steering of the catheter tube in the desired direction. Unlike the conventional devices that need a user to manually rotate a knob bi-directionally, the proposed device provides several advantages. The use of the at least one push button enables the user to control the deflection of the catheter by a single-push action. The user can operate the device using only one hand. Therefore, the proposed device is easier to operate than a conventional device. The proposed devices also include a plurality of indicators indicating the position of a 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, thereby reducing human errors. In an embodiment, the control mechanism is enclosed within a handle of the device, reducing the size of the handle. This improves ergonomics and user comfort.
[32] Now referring to the figures, Fig. 1a shows an assembled view of a catheter 100 (or device 100) according to an embodiment. The catheter 100 may extend between a distal end 100a and a proximal end 100b, thus defining a length. The length of the catheter 100 ranges from 600 mm to 900 mm. In an exemplary embodiment, the length of the catheter 100 is 720 mm. The catheter 100 includes a catheter tube 110, a handle 130 and a hemostasis hub 150.
[33] The handle 130 is provided at the proximal end 100b of the catheter 100. The handle 130 encompasses a section of the catheter tube 110. The handle 130 is coupled to the catheter tube 110 towards a proximal end of the catheter tube 110. The catheter tube 110 extends through the handle 130 and a proximal end of the catheter tube 110 is coupled to a distal end of the hemostasis hub 150.
[34] The catheter tube 110 has a hollow, tubular structure and is made of a flexible material. 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 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. In an exemplary embodiment, the diameter of the catheter tube 110 is 3.77 mm.
[35] In an embodiment, the catheter tube 110 is inserted into the patient’s body 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 the pull ring (not shown) provided inside the catheter tube 110 at a 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 141a and 141b as depicted in figures later. In an embodiment, the pull ring and the at least one pull wire may be an integral component. The pull wires 141a and 141b further extend into the handle 130 of the device 100 as shown in Fig. 2. The pull wires 141a and 141b may be made of a material such as, without limitation stainless steel, nitinol, polymer etc. In an exemplary embodiment, the pull wires 141a and 141b are made from stainless steel.
[36] Fig. 1b depicts an enlarged view of a proximal end of the catheter 100 according to an embodiment. The proximal end of the catheter 100 includes the handle 130 and the hemostasis hub 150. The handle 130 includes a top casing 131a, a bottom casing 131b, and at least one push button. The top casing 131a and the bottom casing 131b are coupled to each other to form the handle 130 as shown in Fig. 1b using, for example, fasteners, adhesive, slide lock mechanism, male studs-groove coupling, etc.
[37] In an embodiment, the at least one push button includes a push button 133a and a push button 133b as shown in Figs. 1b and 2. The push button 133a and the push button 133b are used to control the deflection of a distal tip 111 (hereinafter the tip 111, as depicted in Fig. 1a) of the catheter tube 110. A user can deflect the tip 111 of catheter tube 110 to a desired position using the push button 133a and the push button 133b. In an example implementation, the push buttons 133a and 133b are identical. In an embodiment, the push button 133a is pressed to deflect the tip 111 of the catheter tube 110 in the right direction and the push button 133b is pressed to deflect the tip 111 of the catheter tube 110 in the left direction. The push buttons 133a and 133b are provided laterally on the handle 130. The detailed construction and working of the push buttons 133a and 133b are explained later.
[38] In an embodiment, the catheter 100 includes a plurality of indicators 135 (hereinafter, interchangeably referred to as indicators 135) which indicate a position of the tip 111 of the catheter tube 110. In the depicted embodiment, the catheter 100 includes six indicators 135a1-135a3 and 135b1-135b3 provided on a top surface of the top casing 131a. The indicators 135 are shown in detail in Figs 5a – 5c. The indicators 135a1 and 135b1 indicate a neutral position of the tip 111 of the catheter tube 110. The indicators 135a2 and 135b2 indicate a 90-degree position of the tip 111 of the catheter tube 110 in the right and the left direction, respectively. The indicators 135a3 and 135b3 indicate a 180-degree position of the tip 111 of the catheter tube 110 in the right and the left direction, respectively. Though only the indicators corresponding to 90-degree and 180-degree positions on the right and the left 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 right and left directions may be provided. The detailed working of each indicator is explained later.
[39] The hemostasis hub 150 includes a distal end and a proximal end. In an embodiment, the distal end of hemostasis hub 150 is coupled to the proximal end of the catheter tube 110. The hemostasis hub 150 helps in reducing the blood loss in the patient during the medical procedure.
[40] The hemostasis hub 150 has a tubular structure. The hemostasis hub 150 includes a tube 151 coupled laterally at a surface of hemostasis hub 150 and a 3-way stopcock 153 coupled at a proximal end of tube 151. The tube 151 may also serves as a medium to supply medicine or any infused agent during the medical procedure. The 3-way stopcock 153 can be used to operate the hemostasis hub 150 as and when needed.
[41] Fig. 2 is a top cross-sectional view of the handle 130 depicting various components of a control mechanism, according to an embodiment. The control mechanism is configured to deflect the tip 111 of the catheter tube 110. The control mechanism includes at least one sliding element and at least one resilient element. The at least one sliding element and the at least one resilient element are disposed within the handle 130. In an embodiment, the at least one sliding element includes sliding elements 147a and 147b. In an embodiment, the at least one resilient element includes resilient elements 149a and 149b. The control mechanism includes the at least one push button.
[42] In an embodiment, the top casing 131a includes a plurality of male studs 137a and the bottom casing 131b includes a plurality of grooves 137b. In an exemplary embodiment, the top casing 131a includes ten male studs 137a (as shown in Fig. 2a) and the bottom casing 131b includes ten grooves 137b (as shown in Fig. 2b). The shape and size of the plurality of male studs 137a and the plurality of grooves 137b correspond with each other. It should be appreciated that the number of the plurality of male studs 137a and the plurality of grooves 137b disclosed herein are exemplary and any other number of the plurality of male studs 137a and the plurality of grooves 137b can be used without deviating from the scope of the disclosure.
[43] Each groove 137b of the plurality of grooves 137b on the bottom casing 131b mates with the corresponding male stud 137a of the plurality of male studs 137a on the top casing 131a to couple the bottom casing 131b with the top casing 131a. Further, once the plurality of grooves 137b mate with the plurality of male studs 137a, the top casing 131a and the bottom casing 131b are coupled. The coupling of the top casing 131a and the bottom casing 131b forms a cavity to hold components of the control mechanism, and also forms a plurality of locking slots 139a and a plurality of locking slots 139b. The plurality of locking slots 139a and 139b are explained later.
[44] The top casing 131a include cutouts on each lateral side of the top casing 131a. Similarly, the bottom casing 131b also includes cutouts on each lateral side of the bottom casing 131b. When the top casing 131a couples with the bottom casing 131b, the respective cutouts form an opening to receive the push button 133a and the push button 133b.
[45] In an embodiment, each of the top casing 131a and the bottom casing 131b include a semi-circular groove provided centrally along the length of the top casing 131a and the bottom casing 131b. When the top casing 131a and the bottom casing 131b are coupled, the semi-circular grooves form a lumen to hold a proximal portion of the catheter tube 110. A diameter of the lumen corresponds to the diameter of the catheter tube 110. At least one guideway is provided laterally adjacent to the semi-circular grooves. The at least one sliding element is kinematically coupled with a respective guideway of the at least one guideway. In an embodiment, the at least one guideway includes guideways 143a and 143b (as shown in Figs. 2a – 2b).
[46] Each sliding element 147a and 147b is operationally coupled to a corresponding push button (in this case, the push buttons 133a and 133b, respectively) of the at least one push button. In response to the corresponding push button 133a or 133b being pressed, the corresponding sliding element 147a or 147b is configured to pull the corresponding pull wire 141a or 141b, thereby deflecting the tip 111 in a corresponding direction. According to an embodiment, each sliding element 141 and 147 are configured to move in a proximal direction in response to the corresponding push button 133a or 133b being pressed, thereby pulling the corresponding pull wire 141a or 141b. In an embodiment, the sliding elements 147a, 147b are configured to move in the proximal direction along a respective guideway (in this case, the guideways 143a, 143b, respectively) in response to the corresponding push button 133a or 133b being pressed. This is explained in detail later.
[47] In an embodiment, the sliding element 147a has a triangular shape. The sliding element 147a includes a plurality of slots 147a2, a projection 147a3 at a distal end of the sliding element 147a, and a hole 147a4 towards the distal end of sliding element 147a adjacent to a proximal end of the projection 147a3 (as shown in Fig. 2c1). Similarly, the sliding element 147b has a triangular shape, according to an embodiment. The sliding element 147b includes a plurality of slots, a projection 147b3 at a distal end of the sliding element 147b, and a hole towards the distal end of sliding element 147b adjacent to a proximal end of the projection 147b3. The structure and functions of the plurality of slots and the hole of the sliding element 147b are similar to the plurality of slots 147a2 and the hole 147a4.
[48] The sliding element 147a is kinematically coupled with the guideway 143a using, for example, a plurality of rollers 147a1. Each slot 147a2 of the plurality of slots 147a2 receive a corresponding roller 147a1 of the plurality of rollers 147a1. The plurality of slots 147a2 is rectangular with a circular hole (as shown in Fig. 2c1) in an embodiment, though the plurality of slots 147a2 may have any other suitable shape. In an embodiment, the plurality of rollers 147a1 includes four rollers 147a1. The plurality of rollers 147a1 facilitates the sliding element 147a to move forward and backward. The plurality of rollers 147a1 is coupled in the plurality of slots 147a2 of the sliding element 147a using a cylindrical pin. A corresponding hole may be provided in each of the plurality of slots 147a2 of the sliding element 147a and each of the plurality of rollers 147a1 to receive the respective cylindrical pin. Similarly, the sliding element 147b is kinematically coupled with the guideway 143b using, for example, a plurality of rollers 147b1 as depicted in Fig. 2. In an embodiment, the plurality of rollers 147b1 include four rollers 147b1. The plurality of rollers 147b1 facilitates the sliding element 147b to move forward and backward. The plurality of rollers 147b1 may be coupled to the plurality of slots of the sliding element 147b in a similar manner as explained earlier.
[49] A marker 145a is provided on the sliding element 147a, e.g., at a distal end of the projection 147a3 of the sliding element 147a and a marker 145b is provided on the sliding element 147b, e.g., at a distal end of the projection 147b3 of the sliding element 147b. The markers 145a and 145b together with the plurality of indicators 135 indicate a position of the tip 111 of the catheter tube 110. For example, an alignment of the marker 145a or the marker 145b with one of the plurality of indicators 135 indicates a corresponding position of the tip 111, as explained later.
[50] The pull wire 141a and the pull wire 141b exit from a respective slot provided on the catheter tube 110 towards the proximal end of the catheter tube 110 as shown in Fig. 2c2. A proximal end of the pull wire 141a after exiting from catheter tube 110 is coupled to the sliding element 147a. The pull wire 141a is coupled using technique, such as, without limitation, riveting technique, knotting, crimping, male female locking technique, clamping, hooking, welding, brazing, etc. In an embodiment, the proximal end of the pull wire 141a is crimped to the sliding element 147a via the hole 147a4 (as shown in Figs. 2c3 and 2c4). Similarly, a proximal end of the pull wire 141b after exiting from the catheter tube 110 is coupled to the sliding element 147b. The pull wire 141b is coupled using technique, such as, without limitation, riveting technique, knotting, crimping, male female locking technique, clamping, hooking, welding, brazing, etc. In an embodiment, the proximal end of the pull wire 141b is crimped to the sliding element 147b via the hole of the sliding element 147b.
[51] The sliding elements 147a and 147b may be made of a material such as, without limitation polycarbonate (PC), acrylonitrile butadiene styrene (ABS) etc. In an exemplary embodiment, the sliding elements 147a and 147b are made of acrylonitrile butadiene styrene (ABS). The plurality of rollers 147a1 and the plurality of rollers 147b1 may be made of a material, such as, without limitation, polycarbonate (PC), acrylonitrile butadiene styrene (ABS) etc. In an exemplary embodiment, the plurality of rollers 147a1 and the plurality of rollers 147b1 are made of acrylonitrile butadiene styrene (ABS).
[52] The resilient element 149a is disposed inside the cavity (formed by the coupling of the top casing 131a and the bottom casing 131b) between a proximal end of the sliding element 147a and a proximal end of the handle 130. A distal end of resilient element 149a is disposed adjacent to the proximal end of the sliding element 147a and a proximal end of the resilient element 149a is disposed adjacent to the proximal end of the handle 130. Similarly, the resilient element 149b is disposed inside the cavity (formed by the union of top casing 131a and bottom casing 131b) between a proximal end of the sliding element 147b and the proximal end of the handle 130. A distal end of resilient element 149b is disposed adjacent to the proximal end of the sliding element 147b and a proximal end of the resilient element 149b is disposed adjacent to the proximal end of the handle 130. The resilient elements 149a and 149b are compressed when the sliding elements 147a and 147b move backwards, respectively, in response to a corresponding push button of the push buttons 133a and 133b being pressed and are configured to provide a resilient force to move the sliding elements 147a and 147b in a distal direction to their original position, when the corresponding push button of the push buttons 133a and 133b is released. In an embodiment, the resilient elements 149a and 149b are compression springs.
[53] The resilient elements 149a and 149b may be made of a material such as, without imitation stainless steel (SS), cold rolled steel (CRS), hot rolled steel (HRS), mild steel (MS) etc. In an exemplary embodiment, the resilient elements 149a and 149b are made from stainless steel (SS).
[54] In an embodiment, the handle 130 includes a plurality of locking slots 139a and a plurality of locking slots 139b provided in the top casing 131a and in the bottom casing 131b. The plurality of locking slots 139a and 139b are used to lock the push buttons 133a and 133b, respectively, in a locking position of a plurality of locking positions. The plurality of locking positions corresponds to different steering positions of the tip 111. In an embodiment, the plurality of locking slots 139a include two locking slots 139a1 and 139a2 to restrict the push button 133a at two different locking positions as explained later. Similarly, the plurality of locking slots 139b includes two locking slots 139b1 and 139b2 to restrict the push button 133b at two different locking positions as explained later. The number of locking slots in the plurality of locking slots 139a and 139b may vary depending upon the requirements, e.g., in how many positions the tip 111 can be steered and locked.
[55] Figs. 3a and Fig. 3b show the push button 133a, according to an embodiment. As the push buttons 133a and 133b are identical, the components and functioning of the push button 133b can be understood using the Fig. 3a and Fig. 3b.
[56] The push button 133a includes an upper casing 133a1, a lower casing 133a2, a plurality of rollers (for example, rollers 133a3 and 133a4), an opening 133a6, and a locking mechanism. The locking mechanism is configured to lock the push button 133a in a locking position of a plurality of locking positions. In an embodiment, the locking mechanism of the push button 133a includes a slide lock 133a5, a resilient element 133a7 and an embossed groove 133a8. Similarly, the push button 133b includes an upper casing, a lower casing, a plurality of rollers, an opening and a locking mechanism configured to lock the push button 133b in a locking position of a plurality of locking positions of the push button 133b. In an embodiment, the locking mechanism of the push button 133b includes a slide lock, a resilient element and an embossed groove.
[57] In an embodiment, the upper casing 133a1 of the push button 133a is coupled to the lower casing 133a2 of the push button 133a using a snap fit mechanism to form a cavity to hold the rollers 133a3 and 133a4, the slide lock 133a5 and the resilient element 133a7. The opening 133a6 receives a distal portion of the slide lock 133a5. Similarly, the upper casing of the push button 133b is coupled to the lower casing of the push button 133b using a snap fit mechanism to form a cavity to hold the plurality of rollers, the slide lock and the resilient element of the push button 133b. The opening of the push button 133b receives a distal portion of the slide lock of the push button 133b. The upper casing 133a1 and the lower casing 133a2 includes the embossed groove 133a8. Similarly, the upper casing and the lower casing of the push button 133b includes the embossed groove of the push button 133b.
[58] The push button 133a is coupled to a lateral side of the sliding element 147a. Similarly, the push button 133b is coupled to a lateral side of the sliding element 147b.
[59] The rollers 133a3 and 133a4 are slidably coupled to the lateral side of the sliding element 147a and are configured to enable relative motion between the push button 133a and the sliding element 147a. The rollers 133a3 and 133a4 reduce the friction and provide a smooth contact between the rollers 133a3 and 133a4 and the lateral side of the sliding element 147a. The upper casing 133a1 and the lower casing 133a2 have a slot and the roller 133a3 is coupled with the upper casing 133a1 and the lower casing 133a2 using a cylindrical pin and a corresponding hole may be provided in each of the upper casing 133a1, the lower casing 133a2 and the roller 133a3 to receive the cylindrical pin. The roller 133a4 may be coupled with the upper casing 133a1 and the lower casing 133a2 in a similar manner. Similarly, the plurality of rollers of the push button 133b are slidably coupled to the sliding element 147b and is configured to enable a relative motion between the push button 133b and the sliding element 147b. The plurality of rollers of the push button 133b reduce the friction and provide a smooth contact between the plurality of rollers of the push button 133b and the lateral side of the sliding element 147b. The plurality of rollers of the push button 133b may be coupled to the upper casing and the lower casing of the push button 133b in a similar manner as described earlier.
[60] In an embodiment, the slide lock 133a5 includes a deep groove 133a9 on a lateral side of the slide lock 133a5. The slide lock 133a5 of the push button 133a is used to lock the push button 133a by engaging the slide lock 133a5 into a locking slot of the plurality of locking slots 139a. The push button 133a can be locked into any of the two slots 139a1 and 139a2. When either of the locking slots 139a1 or 139a2 receives the slide lock 133a5, the deep groove 133a9 on the slide lock 133a5 engages with the embossed groove 133a8. This results in a click sound and provides a tactile and audible feedback to the user. Similarly, the slide lock of the push button 133b includes a deep groove. The slide lock of the push button 133b is used to lock the push button 133b by engaging the slide lock of the push button 133b into a locking slot of the plurality of locking slots 139b. The push button 133b can be locked into any of the two slots 139b1 and 139b2. When either of the locking slots 139b1 or 139b2 receives the slide lock of the push button 133b, the deep groove on the slide lock of the push button 133b engages with the embossed groove of the push button 133b. This results in a click sound and provides a tactile and audible feedback to the user.
[61] In an embodiment, the resilient element 133a7 of the push button 133a is operatively coupled to the slide lock 133a5. The resilient element 133a7 is configured to apply necessary resilient force to hold the slide lock 133a5 in a locking position, i.e., to hold the push button 133a in the locking position. Similarly, the resilient element of the push button 133b is configured to apply necessary resilient force to hold the slide lock of the push button 133b in the locking position. In an embodiment, the resilient element 133a7 and the resilient element of the push button 133b are compression springs.
[62] The push button 133a can be unlocked using the slide lock 133a5. For example, the push button 133a can be unlocked by pushing the slide lock 133a5 towards the proximal end (against the force of the resilient element 133a7) of the push button 133a and then releasing the push button 133a, so that the push button 133a moves to the neutral position. A stopper (not shown) may be provided on each of the top casing 131a and the bottom casing 131b. The stopper, stops the push button 133a from popping out of the handle 130. The push button 133b can be unlocked in a similar manner. Another stopper (not shown) may be provided on each of the top casing 131a and the bottom casing 131b, which stops the push button 133b from popping out of the handle 130.
[63] A user can control the position of the sliding elements 147a and 147b and thereby, deflection of the tip 111 of the catheter tube 110 in a desired direction by pressing a corresponding push button of the push buttons 133a and 133b as explained later in detail. In an embodiment, the push button 133a is pressed to deflect the tip 111 of the catheter tube 110 in the right direction. After pressing the push button 133a, the push button 133a is then locked in one of plurality of locking slots 139a (in one of the locking slot 139a1 or the locking slot 139a2 in the depicted embodiment) by moving the slide lock 133a5 of the push button 133a in a distal direction. Once locked, the sliding element 147a stops and the tip 111 of the catheter tube 110 stays in the defined position. Then, the user releases the push button 133a. Similarly, the push button 133b is pressed to deflect the tip 111 of the catheter tube 110 in the left direction. After pressing the push button 133b, the push button 133b is then locked in one of the plurality of locking slots 139b (in one of the locking slot 139b1 or the locking slot 139b2 in the depicted embodiment) by moving the slide lock of the push button 133b in the distal direction. Once locked, the sliding element 147b stops and the tip 111 of the catheter tube 110 stays in the defined position. Then, the user releases the push button 133b.
[64] Fig. 4a shows components of the control mechanism in a first position, according to an embodiment. The first position may correspond to a neutral position of the tip 111. The marker 145a is aligned with indicator 135a1, which indicates that the tip 111 of the catheter tube 110 aligns with a central axis of catheter 100, i.e., is in the neutral position. The resilient element 149a remains in an uncompressed state. Similarly, the marker 145b is aligned with indicator 135b1, which indicates that the tip 111 of the catheter tube 110 aligns with the central axis of catheter 100, i.e., is in the neutral position. The resilient element 149b remains in uncompressed state. Thus, the tip 111 is in a neutral position. The positions of the markers 145a and 145b are illustrated in Fig. 5a according to an embodiment.
[65] Fig. 4b shows the components of the control mechanism in a second position, according to an embodiment. The second position may correspond to the tip 111 being in a 90-degree position on the right. When the user wants to deflect the tip 111 of the catheter tube 110 by 90 degrees in the right direction, the user presses the push button 133a. When the user presses the push button 133a, a pressure is applied on the sliding element 147a in a medial direction. This causes the sliding element 147a to move backwards as the plurality of rollers 147a1 coupled to the sliding element 147a slide along the guideway 143a backwards (i.e., in a proximal direction). As a result, the pull wire 141a coupled to the sliding element 147a is pulled. Consequently, the tip 111 of the catheter tube 110 is pulled in the right direction. Further, the marker 145a provided on the sliding element 147a too moves backward (i.e., in the proximal direction). Once the marker 145a aligns with indicator 135a2, which indicates that the tip 111 of the catheter tube 110 is deflected by 90 degrees in the right direction (as shown in Fig. 5b), the user may push the slide lock 133a5 forward. The locking slot 139a1 receives the distal portion of the slide lock 133a5 and locks the push button 133a. This locks the tip 111 of the catheter tube 110 in a 90-degree on the right side (the second position). Further, as the sliding element 147a moves backward, the resilient element 149a is pushed and reaches a partially compressed state. Thus, the control mechanism is said to be in the second position.
[66] Fig. 4c shows the components of the control mechanism in a third position, according to an embodiment. The third position may correspond to the tip 111 being in a 180-degree position on the right. When the user wants to deflect the tip 111 of the catheter tube 110 by 180 degrees in the right direction, the user presses the push button 133a. When the user presses the push button 133a, a pressure is applied on the sliding element 147a in a medial direction. This causes the sliding element 147a to move further backwards (in the proximal direction) as the plurality of rollers 147a1 coupled to the sliding element 147a slide along the guideway 143 backwards. As a result, the pull wire 141a coupled to the sliding element 147a, is pulled further. Consequently, the tip 111 of the catheter tube 110 is further pulled in the right direction. Further, the marker 145a too moves further backward. Once the marker 145a aligns with indicator 135a3, which indicates that the tip 111 of the catheter tube 110 is deflected by 180 degrees in the right direction (as shown in Fig. 5c), the user may push the slide lock 133a5 forward. The locking slot 139a2 receives the distal portion of the slide lock 133a5 and locks the push button 133a. This locks the tip 111 of the catheter tube 110 in a 180-degree on the right side (the third position). Further, as the sliding element 147a moves further backward, the resilient element 149a is pushed further and reaches a fully compressed state. Thus, the control mechanism is said to be in the third position.
[67] Similar steps can be performed using the push button 133b to deflect the tip 111 of the catheter tube 110 in the left direction.
[68] As shown in Figs. 5a – 5c, the markers 145a and 145b which can be seen from the top casing 131a of the handle 130 and their alignment with the plurality of indicators 135 provide the user a visual indication of the exact position of the tip 111 of the catheter tube 110. This enables the user to control steering of the tip 111 more accurately.
[69] Fig. 6 illustrates a flowchart of a method 600 for operating the device 100 during a medical procedure, according to an embodiment.
[70] At step 601, the user presses one push button of the push buttons 133a and 133b. The user selects the appropriate push button depending upon a desired direction (left or right) of the tip 111 of the catheter tube 110. In an embodiment, the user presses the push button 133a to deflect the tip 111 of the catheter tube 110 in the right direction or presses the push button 133b to deflect the tip 111 of the catheter tube 110 in the left direction.
[71] At step 603, the corresponding sliding element of the sliding elements 147a and 147b moves backward due to the downward force exerted by the push button as explained earlier. This causes the tip 111 of the catheter tube 110 to deflect in the desired direction. For example, when the push button 133a is pressed, the sliding element 147a moves backward and the pull wire 141a is pulled. This causes the tip 111 to deflect in the right direction. Similarly, when the push button 133b is pressed, the sliding element 147b moves backward and the pull wire 141b is pulled. This causes the tip 111 to deflect in the left direction.
[72] At step 605, the user may lock the corresponding push button (the push button 133a or the push button 133b) in a locking position once the distal tip 111 of the catheter tube 110 reaches the desired deflection. For example, when the distal tip 111 of the catheter tube 110 is deflected by 90 degrees in the right direction, the marker 145a aligns with the indicator 135a2, the user may lock the push button 133a by pushing forward the slide lock 133a5 in the locking slot 139a1. In another example, when the distal tip 111 of the catheter tube 110 is deflected by 180 degrees in the left direction, the marker 145b aligns with the indicator 135b3, the user may lock the push button 133b by pushing forward the slide lock of the push button 133b in the locking slot 139b2.
[73] At step 607, once the procedure is completed or when the user wants to steer the tip 111 in another direction, the user may unlock the push button (the push button 133a or the push button 133b) pressed at step 601, by pushing back the respective slide lock (the slide lock 133a5), as explained earlier. Then, the user may release the corresponding push button (the push button 133a or the push button 133b). As a result, the corresponding resilient element (the resilient element 149a or the resilient element 149b) applies the resilient force on the corresponding sliding element (the sliding element 147a or the sliding element 147b) and the corresponding sliding element moves in the distal direction. This applies a lateral force on the corresponding push button (the push button 133a or the push button 133b) bringing it back at a normal position so that the tip 111 comes back to the neutral position. Once the tip 111 is in the neutral position, the user can steer the tip 111 in the other direction by following similar steps as described herein.
[74] The proposed control mechanism allows the user to steer the distal tip of the catheter tube with a better control. The distal tip of the catheter tube can be easily steered by simply pressing a desired push button. The indicators on the catheter provide accurate visual feedback to the user about the position of the distal tip of the catheter tube, allowing the user to control the steering more accurately. While performing a procedure the user may lock or unlock the distal tip of the catheter tube in the desired position using a slide lock of the push button in a single push action. This improves the usability of the catheter. Further, the distal tip of the device can be brought to the neutral position easily through a resilient element action (e.g., a spring force of a compression spring). Moreover, unlike the conventional devices, which require the user to use both hands to operate such devices, the proposed device can be operated by the user using a single hand.
[75] 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) 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. at least one pull wire having a distal end coupled to the pull ring;
d. a handle (130) coupled to the catheter tube (110) towards a proximal end of the catheter tube (110);
e. at least one push button provided on the handle (130); and
f. at least one sliding element disposed within the handle (130), each sliding element (147a, 147b) of the at least one sliding element is coupled to a proximal end of a corresponding pull wire (141a, 141b) of the at least one pull wire and operationally coupled to a corresponding push button (133a, 133b) of the at least one push button, each sliding element (147a, 147b) is configured to pull the corresponding pull wire (141a, 141b), thereby deflecting the distal tip (111) in a corresponding direction.
2. The catheter (100) as claimed in claim 1, wherein the handle (130) comprises a top casing (131a) and a bottom casing (131b), which when coupled to the top casing (131a) forms the handle (130) defining a cavity.
3. The catheter (100) as claimed in claim 2, wherein each of the top casing (131a) and the bottom casing (131b) comprises a semi-circular groove provided centrally along a length of the top casing (131a) and the bottom casing (131b) and defining a lumen configured to hold a proximal portion of the catheter tube (110), when the top casing (131a) and the bottom casing (131b) are coupled.
4. The catheter (100) as claimed in claim 1, wherein each sliding element (147a, 147b) comprises a projection (147a3, 147b3) at a distal end of the sliding element (147a, 147b).
5. The catheter (100) as claimed in claim 1, wherein each sliding element (147a, 147b) is configured to move in a proximal direction in response to the corresponding push button (133a, 133b) being pressed, thereby pulling the corresponding pull wire (141a, 141b).
6. The catheter (100) as claimed in claim 1, wherein each sliding element (147a, 147b) is coupled with a corresponding plurality of rollers (147a1, 147b1), wherein the sliding element (147a, 147b) is configured to move in the proximal direction along a respective guideway (143a, 143b) in response to the corresponding push button (133a, 133b) being pressed.
7. The catheter (100) as claimed in claim 1, wherein each sliding element (147a, 147b) comprises a marker (145a, 145b), wherein an alignment of the marker (145a, 145b) with one of a plurality of indicators (135), provided on a top casing (131a) of the handle (130), indicates a corresponding position of the distal tip 111.
8. The catheter (100) as claimed in claim 1, wherein the catheter (100) comprises at least one resilient element disposed within the handle (130), each resilient element (149a, 149b) of the at least one resilient element is disposed between a proximal end of a corresponding sliding element (147a, 147b) of the at least one sliding element and a proximal end of the handle (130), and is configured to provide a resilient force to move the corresponding sliding element (147a, 147b) in a distal direction, when the corresponding push button (133a, 133b) is released.
9. The catheter (100) as claimed in claim 1, wherein each push button (133a, 133b) comprises:
a. a plurality of rollers (133a3, 133a4) slidably coupled to a lateral side of the respective sliding element (147a, 147b) and configured to enable a relative motion between the push button (133a, 133b) and the respective sliding element (147a, 147b); and
b. a locking mechanism configured to lock the push button (133a, 133b) in a locking position of a plurality of locking positions.
10. The catheter (100) as claimed in claim 9, wherein each push button (133a, 133b) comprises a upper casing (133a1) and a lower casing (133a2) coupled to the upper casing (133a1) and forming a cavity configured to hold the locking mechanism and the plurality of rollers (133a3, 133a4).
11. The catheter (100) as claimed in claim 9, wherein the locking mechanism of each push button (133a, 133b) comprises:
a. a slide lock (133a5) configured to be moved in a distal direction to lock the push button (133a, 133b) in the locking position of a plurality of locking positions; and
b. a resilient element (133a7) operatively coupled to the slide lock (133a5) and configured to apply a resilient force on the slide lock (133a5) to hold the push button (133a, 133b) in the locking position.
12. The catheter (100) as claimed in claim 11, wherein a distal portion of the slide lock (133a5) is configured to engage with a locking slot (139a1, 139a2, 139b1, 139b2) of a respective plurality of locking slots (139a, 139b) provided in the handle (130) to lock the push button (133a, 133b) in the locking position, wherein each locking slot (139a1, 139a2, 139b1, 139b2) corresponds to one locking position of the plurality of locking positions of the respective push button (133a, 133b).
13. The catheter (100) as claimed in claim 11, wherein each push button (133a, 133b) comprises an embossed groove (133a8) configured to engage with a corresponding deep groove (133a9) of the slide lock (133a5) when the push button (133a, 133b) is in the locking position.
14. The catheter (100) as claimed in claim 1, wherein the catheter (100) comprises a hemostasis hub (150) coupled to a proximal end of the catheter tube (110).
15. The catheter (100) as claimed in claim 1, wherein the pull ring and the at least one pull wire are an integral component.