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 DELIVERY 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 delivery catheter. More particularly, the present disclosure relates to a steerable delivery catheter.
BACKGROUND OF INVENTION
[2] A catheter is a thin, flexible tube-like medical device. Catheters come in various sizes, materials, and designs to suit their intended purposes. Some common types of catheters include urinary catheters, central venous catheters, cardiac catheters, intravenous catheters and so on.
[3] The delivery of a catheter is a minimally invasive procedure. It involves careful insertion and positioning of the catheter within a body cavity, blood vessel, or duct to perform a range of medical procedures. Once the catheter is in the desired location, various medical procedures can be performed, including draining fluids, administering medications or treatments, conducting measuring or imaging studies, delivering nutrition, diagnosing potential abnormalities or conditions, delivering stents, etc.
[4] However, it can be challenging to navigate through intricate anatomical structures, tortuous pathways and reach the desired location.
[5] Conventional devices require physical effort and controlled motor skills from a medical practitioner. For example, the medical practitioner may have to rotate a knob continuously to achieve a desired steering of the catheter. Further, when the catheter needs to be deflected from an extreme position in one direction to an extreme position in the other direction, the medical practitioner may first have to rotate the knob continuously to bring the catheter to a neutral position and then again rotate the knob continuously to obtain the desired steering. Consequently, prolonged procedures can lead to operator fatigue, potentially affecting the quality of catheter delivery when such a manual approach is used. Also, procedures that requires precise catheter delivery, such as cardiac catheterizations, can be particularly complex when performed manually.
[6] Hence, there is a need of catheter delivery device that overcomes the problems associated with the conventional devices.
SUMMARY OF INVENTION
[7] Particular embodiments of the present disclosure are described herein below with reference to the accompanying drawings; however, it is to be understood that the disclosed embodiments are mere examples of the disclosure, which may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.
[8] The present disclosure relates to a catheter device. In an embodiment, the catheter device includes a shaft, a pull ring, at least one pull wire and a handle. The shaft has a proximal end, a distal end and a tip at the distal end. The pull ring is provided within the shaft at the distal end of the shaft. The at least one pull wire is disposed at least partially within the shaft. Each pull wire of the at least one pull wire has a distal end coupled to the pull ring and a proximal end extending out from the shaft towards the proximal end of the shaft. The handle, coupled to the proximal end of the shaft, includes a steering mechanism configured to steer the tip to a plurality of steering positions. The steering mechanism includes a control element rotatable in a clockwise direction and an anti-clockwise direction and at least one resilient element operatively coupled to the control element. Each resilient element is coupled to the proximal end of a corresponding pull wire. In response to the control element being rotated in one of the clockwise direction or the anticlockwise direction, a corresponding resilient element of the at least one resilient element is configured to pull the corresponding pull wire, thereby steering the tip in a corresponding direction.
BRIEF DESCRIPTION OF DRAWINGS
[9] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentality disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[10] Fig. 1 depicts a device 100 according to an embodiment of the present disclosure.
[11] Fig. 2 depicts an exploded side view of a handle 120 of the device 100 according to an embodiment of the present disclosure.
[12] Fig. 2a depicts a top view of the handle 120 of the device 100 according to an embodiment of the present disclosure.
[13] Fig. 2b depicts an exploded top view perspective view of the handle 120 of the device 100 according to an embodiment of the present disclosure.
[14] Fig. 2c depicts a coupling of at least one pull wire with at least one resilient element125 according to an embodiment of the present disclosure.
[15] Fig. 2d depicts an exploded bottom perspective view of the handle 120 of device 100 according to an embodiment of present disclosure.
[16] Fig. 3a depicts a bottom isometric view of the locking member 126 according to an embodiment.
[17] Fig. 3b depicts a top isometric view of the locking member 126 according to an embodiment.
[18] Fig. 3c depicts a bottom view of the locking member 126 according to an embodiment.
[19] Fig. 4 depicts a flowchart of a method 400 of operating the device 100 according to an embodiment of the present disclosure.
[20] Figs. 5a1 – 5a3 depict various components of the device 100 when a distal tip 110c of the shaft 110 is at a neutral position according to an embodiment of the present disclosure.
[21] Figs. 5b1 – 5b3 depict various components of the device 100 when the distal tip 110c of the shaft 110 is at a 90-degree position on a left side according to an embodiment of the present disclosure.
[22] Figs. 5c1 – 5c3 depict various components of the device 100 when the distal tip 110c of the shaft 110 is at a 180-degree position on the left side according to an embodiment of the present disclosure.
[23] Figs. 5d1 – 5d4 depict various components of the device 100 in an unlock position, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE DRAWINGS
[24] 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.
[25] 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.
[26] 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.
[27] Furthermore, the described includes, advantages, and characteristics of the embodiments may be combined in any suitable manner. One skilled in the relevant art will recognize that the embodiments may be practiced without one or more of the specific includes or advantages of a particular embodiment. In other instances, additional includes and advantages may be recognized in certain embodiments that may not be present in all embodiments. These includes and advantages of the embodiments will become more fully apparent from the following description and apportioned claims, or may be learned by the practice of embodiments as set forth hereinafter.
[28] This current disclosure pertains to a steerable catheter device (or referred to as device). The device may be used for cardiac catheterization, urinary catheterization, central venous catheterization, intravenous catheterization and more. A shaft of the device is introduced in the patient’s body and navigated through the vasculature to a target site for performing various medical procedures.
[29] In an embodiment, the device includes a handle having a steering mechanism for steering a shaft coupled to the handle. With the help of the proposed steering mechanism, the user can accurately control and maneuver the shaft. In an exemplary embodiment, the steering mechanism includes a control element (such as a push button with a rotating knob). With the help of the control element, the user can steer the shaft at various desired angles for example right angle, straight angle etc. both in clockwise and anti-clockwise direction. The steering mechanism also includes a locking member coupled to the control element. The locking member locks the control element once the user has rotated the control element to a desired position. This improves the predictability of the device and the user can perform other tasks in the medical procedure without having to worry about a change in the direction of the shaft.
[30] The handle also includes steering indicators indicating angles, directions etc. This allows users to visually determine the accurate position and orientation of the shaft, aiding medical professionals in accurately assessing the procedure's progress.
[31] Further, the steering mechanism includes a resilient element which enables the user to bring the shaft to the neutral position quickly via a return spring mechanism.
[32] As the steering mechanism is encased in the handle, the device is compact and easier to operate even with a single hand. Thus, the proposed device presents several advantages of the conventional devices. The proposed device ensures a consistent navigation of the shaft through the intricate anatomical structures, challenging pathways during procedures. It also enhances safety, precision, and ease of maneuvering within intricate anatomical structures, facilitating accurate and targeted interventions.
[33] Now referring to the figures, Fig. 1 illustrates an exemplary embodiment of a catheter device 100 (hereinafter, device 100). The device 100 may include plurality of components operationally coupled to each other. In an exemplary embodiment, as shown in Fig. 1, the device 100 includes a shaft 110, a handle 120 and a hub 130.
[34] The shaft 110 is a long, tubular structure having one or more lumens. The shaft 110 has a proximal end 110a and a distal end 110b. The proximal end 110a of the shaft 110 is coupled to the handle 120. The handle 120 includes a steering mechanism to steer the shaft 110, which has been explained later. The shaft 110 includes a distal tip 110c (hereinafter, tip 110c) at the distal end 110b. During catheterization, the distal end 110b of the shaft 110 is introduced into the human body for performing a desired medical procedure. The shaft 110 can be made of any suitable material such as, without limitation, Polytetrafluoroethylene (PTFE), Polyether block amide (PEBA), Nylon, etc. In an embodiment, the shaft 110 is made of PEBA.
[35] The device 100 includes a pull ring (not shown) and at least one pull wire. The pull ring is a small ring like structure provided within the shaft 110 at the distal end 110b of the shaft 110. The at least one pull wire is disposed at least partially within the shaft 110. Each pull wire of the at least one pull wire has a distal end coupled to the pull ring and a proximal end extending out from the shaft 110 towards the proximal end 110a of the shaft 110. To deflect the tip 110c of the shaft 110 in a desired direction, a corresponding pull wire of the at least one pull wire is pulled using a steering mechanism, which in turn pulls the pull ring, causing the tip 110c of the shaft 110 getting deflected in the desired direction (which will be explained later).
[36] The handle 120 has a proximal end 120a and a distal end 120b. The distal end 120b of the handle 120 is coupled to the proximal end 110a of the shaft 110. The handle 120 is ergonomically designed for easier operation. In an embodiment, the handle 120 is generally rectangular in shape with a taper at the distal end 120b. In an embodiment, the handle 120 includes a steering mechanism and a locking mechanism. The handle 120 encloses various components of the steering mechanism and the locking mechanism, which are explained later.
[37] The hub 130 has a proximal end 130a and a distal end 130b. The distal end 130b of the hub 130 is coupled to the proximal end 110a of the shaft 110. The hub 130 may be provided with a three-way valve 130c (as depicted in Figs.2c-2d) at the proximal end 130a. The hub 130 includes a valve at the distal end 130b to maintain the hemostasis to reduce the patient’s blood loss.
[38] Figs. 2 – 2d depict various components of the device 100 disposed within the handle 120 according to an embodiment of the present disclosure. The steering mechanism includes a control element 122, at least one resilient element 125, according to an embodiment.
[39] The steering mechanism is configured to steer the tip 110c at the distal end 110b of the shaft 110 to a plurality of steering positions, for example, right angle, straight angle, acute angle, obtuse angle etc. in both clockwise and anti-clockwise direction. In an embodiment, the tip 110c is steered at the steering angles (for example, right angle, straight angle) in the clockwise and anti-clockwise directions.
[40] Fig. 2 depicts an exploded view of the handle 120 of the device 100 according to an embodiment of the present disclosure. The handle 120 includes a casing 121. The casing 121 includes a top case 121a and a bottom case 121b. The casing 121 encases various components of the steering mechanism and the locking mechanism, which has been explained in the later parts. The top case 121a and the bottom case 121b can be made of materials including, without limitation, polycarbonate, Acrylonitrile Butadiene Styrene (ABS), etc. In an exemplary embodiment, the top case 121a and the bottom case 121b are made of ABS. The top case 121a and the bottom case 121b are coupled together using, for example, a press-fit mechanism via corresponding slots 121a1 and 121b1 provided on the top case 121a and the bottom case 121b, respectively, to form the handle 120.
[41] A top surface of the top case 121a may include a plurality of steering indicators 121c1-121c6 (collectively referred to as the steering indicators 121c) configured to indicate the plurality of steering positions and a neutral position of the tip 110c, shown in Fig. 2a. Each of the plurality of steering indicators 121c1-121c6 indicates a corresponding direction and steering angle of the tip 110c of the shaft 110. The control element 122 is provided with at least one pointer 122a1. In an exemplary embodiment, the at least one pointer 122a1 includes a first pointer A and a second pointer B, shown in Fig. 2a. The at least one pointer 122a1 may be any marker that visually indicates the position of the control element 122to the user. In the depicted embodiment, the at least one pointer 122a1 is in the form of a black triangle pointing towards the periphery of the control element 122, however, it may have any other suitable shape, size and pattern (e.g., blue arrows). Together, the steering indicators 121c and the at least one pointer 122a1 provide visual cues that allow the users to accurately determine the position and orientation of the tip 110c of the shaft 110, which has been explained later.
[42] In an embodiment, the steering indicator 121c1 indicates a neutral position of the tip 110c. The steering indicators 121c2 and 121c3 indicate a 90 degrees steering angle and 180 degrees steering angle of the tip 110c in an anticlockwise direction (or left direction), respectively. Similarly, the steering indicators 121c5 and 121c6 indicate a 90 degrees steering angle and 180 degrees steering angle of the tip 110c in a clockwise direction (or right direction), respectively. Further, the steering indicator 112c4 indicates an unlock position. It should be understood that though the depicted embodiment, shows the steering indicators 121c corresponding to 90-degree and 180-degree steering angles on the left and right directions, it should be appreciated any number of desired indicators may be provided, e.g., 60-degree, 120-degree and 180-degree on the left and right directions.
[43] Referring to Fig. 2b, the top case 121a of the handle 120 has a hole ¬¬¬121d on the top surface. The hole 121d receives the control element 122. In an embodiment, the control element 122 is a push button having rotating knob and is rotatable in both clockwise and anticlockwise directions. The control element 122 has a generally cylindrical shape and may include a top surface 122a and a bottom surface 122b.
[44] The top surface 122a includes a deep groove and a grip 122a’ provided within the deep groove. The grip 122a’ is configured to enable the user to rotate the control element 122 during the operation of the device 100. The user holds the grip 122a’ and rotates the control element 122 in a clockwise or anticlockwise direction by turning the grip 122a’ appropriately. To steer the tip 110c of the shaft 110 in a desired direction, the user holds the grip 122a’ and rotates the control element 122 in a clockwise or anticlockwise direction by turning the grip 122a’ appropriately. Consequently, the tip 110c is steered in the right or left direction, respectively. The user may rotate the control element 122 until one of the at least one pointer 122a1 is aligned with a desired steering indicator of the plurality of steering indictors 121c. For example, to steer the tip 110c in 90-degree position or 180- degree position on a left side, the control element 122 is moved in the anticlockwise direction until the pointer A is aligned with the steering indicator 121c2 or 121c3, respectively. Similarly, to steer the tip 110c in 90- degree position or 180- degree position on a right side, the control element 122 is moved in the clockwise direction until the pointer B is aligned with the steering indicator 121c5 or 121c6, respectively.
[45] In an embodiment, the at least one resilient element 125 is operatively coupled to the control element 122. In an embodiment, the steering mechanism includes at least one support member 123 extending downward from the bottom surface 122b of the control element 122 and positioned towards the distal end 120b of the handle 120, as shown in the Fig. 2b and Fig. 2d. The at least one support member 123 engages a corresponding resilient element of the least one resilient element 125, which has been explained later. The user holds the grip 122a’ of the control element 122 and rotates it in the desired direction, resulting in the movement of the at least one support member 123 in the direction of the movement. In response to the rotation of the control element 122 in one of the clockwise and anticlockwise direction, a corresponding support member of the at least one support member 123 is configured to induce tension in the corresponding resilient element, thereby steering the tip 110c in a corresponding direction, which has been explained later.
[46] In an exemplary embodiment, the at least one support member 123 includes a first support member 123a and a second support member 123b. In an exemplary embodiment, the at least one resilient element 125 includes a first resilient element 125a and a second resilient element 125b. The first support member 123a is engaged with the first resilient element 125a and the second support member 123b is engaged with the second resilient element 125b. The at least one resilient element 125 provides tension and resilience, which ensures that the control element 122 stays in place at the selected steering indicator 121c (explained later). According to an embodiment, the at least one resilient element 125 is spiral torsion spring.
[47] Fig. 2c depicts a coupling of the at least one pull wire with the at least one resilient element 125 according to an embodiment. Each pull wire of the at least one pull wire is coupled to the corresponding resilient element of the at least one resilient element 125 using, for example, riveting, knotting, crimping, male female locking technique, clamping, hooking, welding, brazing, soldering, etc. In an embodiment, at least one pull wire includes a first pull wire 140a and a second pull wire 140b. In an embodiment, the first pull wire 140a is coupled to the first resilient element 125a and the second pull wire 140b is coupled to the second resilient element 125b using crimping.
[48] Rotating the control element 122 results in the rotation of the at least one support member 123. In response to the rotation of the control element 122 in the clockwise or anticlockwise direction, tension is induced in a corresponding resilient element of the at least one resilient element 125, which is configured to pull a corresponding pull wire of the at least one pull wire, thereby steering the tip 110c in that direction. For example, in response to the control element 122 rotated anticlockwise, tension is induced in the first resilient element 125a, which pulls the first pull wire 140a, thereby steering the tip 110c in the anticlockwise direction (i.e., the left direction). Similarly, in response to the control element 122 rotated clockwise, tension is induced in the second resilient element 125b, which pulls the second pull wire 140b, thereby steering the tip 110c in the clockwise direction (i.e., the right direction). The steering angle by which the tip 110c is steered depends upon how much the control element 122 is rotated. Thus, the steering of the shaft 110 is regulated and controlled. This is further explained in conjunction with Figs. 4 and 5a1 – 5d4.
[49] Referring to Fig. 2d a support column 122b1, positioned centrally, extends vertically downwards from the bottom surface 122b of the control element 122. According to an embodiment, the support column 122b1 has a cylindrical shape. A resilient member 124 is disposed around the support column 122b1. The support column 122b1 provides support to the resilient member 124. The resilient member 124 helps in returning the control element 122 (and hence, the tip 110c to a neutral position) quickly as is explained later. According to an embodiment, the resilient member 124 is a helical spring. In response to the control element 122 being rotated to a desired position and locked, the resilient member 124 experiences a compression force and moves to a compressed state. In response to the control element 122 being rotated to an unlocked position, the resilient member 124 is configured to apply a resilient force on the control element 122 in a direction opposite to the direction of rotation of the control element 122 to the unlock position, thereby bringing the control element 122 to a neutral position. For example, when the control element 122 is rotated in the anticlockwise direction to the unlock position, the resilient member 124 applies the resilient force in the clockwise direction and when the control element 122 is rotated in the clockwise direction to the unlock position, the resilient member 124 applies the resilient force in the anticlockwise direction. Further, the at least one support member 123 also rotates along the rotation of the control element 122. This action releases the tension experienced by the corresponding resilient element (125a or 125b) depending upon the direction of the rotation of the control element 122. As a result, the corresponding pull wire and hence, the tip 110c returns to neutral position. The resilient force thus applied by the corresponding element (125a or 125b) also helps the control element 122 to return to the neutral position. The user does not have to apply a lot of force to move the control element 122 to the neutral position. This enhances the operability of the device 100 and also reduces time during the medical procedure. This has been explained further in conjunction with Figs. 5d1 – 5d4.
[50] Referring again to Fig. 2b, the bottom case 121b includes a first cylindrical body 121b2 having an axial hole. The first cylindrical body 121b2 receives the proximal end 110a of the shaft 110. Further, the bottom case 121b includes a hole 121b3 at the distal end 120b of the handle 120 and a hole 121b7 (as shown in Fig. 2d) at the proximal end 120a of the handle 120. The proximal end 110a of the shaft 110 passes through the hole 121b3 and the hole 121b7 to couple with the distal end 130b of the hub 130. The bottom case 121b also includes a second cylindrical body 121b4 sitting vertically over the first cylindrical body 121b2. The second cylindrical body 121b4 has a hole 121b5, which receives one end of the support column 122b1 of the control element 122. The bottom case 121b also includes a hole 121b6 on a top surface of the bottom case 121b to receive various components of the steering mechanism as shown.
[51] In an embodiment, the locking mechanism includes a locking member 126. Fig. 3a depicts a bottom isometric view, Fig. 3b depicts a top isometric view and Fig. 3c depicts a bottom view of the locking member 126 according to an embodiment. The locking member 126 is disposed within the top case 121a. In an embodiment, the locking member 126 is coupled to an inner surface of the top case 121a. In another embodiment, the locking member 126 forms an integral structure with the top case 121a.
[52] In an embodiment, the locking member 126 has a ring shape. The top case 121a may include a corresponding groove (not shown) to receive the locking member 126. The locking member 126 is configured to lock the control element 122 in the plurality of steering position. This ensures that the tip 110c remains in the deflected position. This improves the usability of the device 100 during the medical procedure since the user can perform other required tasks without causing any deviation in the achieved steering of the tip 110c.
[53] The locking member 126 is operatively coupled to the control element 122. In an embodiment, the control element 122 includes at least one protrusion 127 along its outer surface. In an exemplary embodiment, the control element 122 includes a first protrusion 127a and a second protrusion 127b (as shown in Fig. 2b). In an exemplary embodiment, the at least one pointer 122a1 may be any marker that visually indicates the position of the first and second protrusions 127a and 127b to the user.
[54] In an exemplary embodiment, the locking member 126 includes a ridge 126a disposed axially on an inner surface of the locking member 126, a plurality of projections extending downwards from the ridge 126a and a plurality of notches 126b provided on the ridge 126a. In an embodiment, the plurality of notches 126b includes notches 126b1-126b5 and the plurality of projections include projections 126c1, 126c2, 126c3, 126c4 (herein after referred as ‘126c1-126c4’).
[55] The plurality of projections 126c1 – 126c4 enable the user to lock the control element 122 at the plurality of steering positions. The plurality of projections 126c1-126c4 are configured to engage the at least one protrusion 127 of the control element 122. In an embodiment, each projection of the plurality of the projections 126c1-126c4 corresponds to a steering position of the plurality of steering positions. In response to the control element 122 being rotated to one steering position of the plurality of steering positions, a corresponding projection of the plurality of projections 126c1 – 126c4 engages with a corresponding protrusion (127a or 127b) of the at least one protrusion 127 of the control element 122. For example, the projections 126c2 and 126c3 correspond to 90-degree and 180-degree steering positions in the left direction, respectively and engage the first protrusion 127a when the control element 122 is rotated in the anticlockwise direction to these steering positions. Similarly, the projections 126c1 and 126c4 correspond to 90-degree and 180-degree steering positions in the right direction, respectively and engage the second protrusion 127b when the control element 122 is rotated in the clockwise direction to these steering positions. Further, the ridge 126a is configured to restrict an upward movement of the at least one protrusion 127 of the control element 122, thereby locking the control element 122 at the steering position.
[56] In an embodiment, the plurality of notches 126b includes a first set of notches and a second set of notches. In an embodiment, the first set of notches includes a first notch 126b1 and a second notch 126b2, and the second set of notches includes a third notch 126b3, a fourth notch 126b4 and a fifth notch 126b5. During the operation of the device 100, each notch of the first set of notches is configured to receive a corresponding protrusion of the at least one protrusion 127 when the control element 122 is in a neutral position. For example, the second notch 126b2 receives the first protrusion 127a and the first notch 126b1 receives the second protrusion 127b. As the first and the second protrusions 127a-127b are in the second notch 126b2 and the first notch 126b1, the control element 122 remains locked at the neutral position.
[57] Further, each notch of the second set of notches is configured to provide a passage to a corresponding protrusion of the at least one protrusion 127 to move upwards, in response to the control element 122 being rotated to the unlock position, thereby unlocking the control element 122 and returning the control element 122 to the neutral position. For example, the fourth notch 126b4 and the third notch 126b3 provide the passage to the first protrusion 127a and the second protrusion 127b, respectively, when the control element 122 is rotated to the unlock position in the clockwise direction. Similarly, the third notch 126b3 and the fifth notch 126b5 provide the passage to the first protrusion 127a and the second protrusion 127b, respectively, when the control element 122 is rotated to the unlock position in the anticlockwise direction. The operation of the locking mechanism has been explained in detail in conjunction with Fig. 4 and Figs. 5a1 – 5d4. The number of plurality of notches 126b depends upon the number of at least one protrusion 127 on the control element 122. The number of projections 126c1 – 126c4 depicted herein are merely exemplary and any number of similar projections can be provided depending upon the number of the plurality of steering positions that the tip 110c can be steered to using the steering mechanism.
[58] Fig. 4 depicts a flowchart of a method 400 of operating the device 100 according to an embodiment of the present disclosure.
[59] The method 400 commences at step 401 where the tip 110c is at a neutral position illustrated in Figs. 5a1 – 5a3. The pointers A and B align with the steering indicators 121c1 (as shown in Fig. 5a1). The first protrusions 127a and the second protrusion 127b on the control element 122 are engaged with the second notch 126b2 and the first notch 126b1 of the locking member 126, respectively (as shown in Fig. 5a3). There is no tension in the first and the second spiral torsion springs 125a – 125b. The first and the second pull wires 140a – 140b and hence, the tip 110c are at the neutral position (as shown in Fig. 5a2).
[60] At step 402, the user holds the grip 122a’ and rotates the control element 122 towards a first desired steering indicator to achieve a first steering position of the plurality of steering positions. Before rotating the control element 122, the user may need to gently press the control element 122 downward. When the user presses the control element 122 down, the first and the second protrusions 127a and 127b come out of the second notch 126b2 and first notch 126b1, respectively, thereby unlocking the control element 122. Further, the resilient member 124 experiences a compressive force. This action allows the user to rotate the control element 122 in a desired direction, either clockwise or anticlockwise, towards a desired steering indicator from the steering indicator 121c on the top case 121a of the handle 120 as needed. In the depicted embodiment, the control element 122 is rotated in the anticlockwise direction and the pointer A is aligned with the steering indicator 121c2 (the first desired steering indicator) indicating that the tip 110c is to be steered towards left by 90 degrees – the first steering position – (as shown in Fig. 5b1). Rotating the control element 122 in the anticlockwise direction induces tension in the first resilient element 125a since the first support member 123a is engaged with the first resilient element 125a. Due to the tension in the first resilient element 125a, the first pull wire 140a is pulled. This, in turn, steers the tip 110c towards the left by 90 degrees (as shown in Fig. 5b2).
[61] As the control element 122 rotates towards the steering indicator 121c2 (the first desired steering indicator), the first and second protrusions 127a and 127b on the control element 122 also move inside the ridge 126a in the same direction. When the pointer A aligns with the steering indicator 121c2, the first protrusion 127a engages with the projection 126c2 of the locking member 126 and a ‘click’ sound is produced. Further, the second protrusion 127b of the control element 122 stays close by the second notch 126b2 of the locking member 126 (as shown in Fig. 5b3).
[62] At step 403, the user releases the control element 122 upon the ‘click’ sound. Due to the resilient force exerted by the resilient member 124, the control element 122 moves upwards. The first and the second protrusions 127a – 127b contact the ridge 126a. The ridge 126a restricts any further upward movement of the first and the second protrusions 127a – 127b. Consequently, the control element 122 is prevented from moving further up. Thus, the locking member 126 locks the control element 122 at the first steering position and the tip 110c remains steered at the 90 degrees to the left.
[63] At step 404, in order to steer the tip 110c further, the user holds the grip 122a’ and gently rotates the control element 122 towards a second desired steering indicator to achieve a second steering position of the plurality of steering positions. In the depicted embodiment, the control element 122 is rotated in the anticlockwise direction and the pointer A is aligned with the steering indicator 121c3 (the second desired steering indicator) indicating that the tip 110c is to be steered towards left by 180 degrees – the second steering position – (as shown in Fig. 5c1). As the user rotates the control element 122 further in the anticlockwise direction, the resilient member 124 experiences a compressive force. Rotating the control element 122 in the anticlockwise direction induces tension in the first resilient element 125a since the first support member 123a is engaged with to the first resilient element 125a. Due to the tension in the first resilient element 125a, the first pull wire 140a is pulled. This, in turn, steers the tip 110c further towards the left by 180 degrees (as shown in Fig. 5c2).
[64] As the control element 122 rotates towards the steering indicator 121c3 (the second desired steering indicator), the first and second protrusions 127a and 127b on the control element 122 also move inside the ridge 126a in the same direction. When the pointer A aligns with the steering indicator 121c3, the first protrusion 127a also engages with the projection 126c3 of the locking member 126 and a ‘click’ sound is produced. Further, the second protrusion 127b of the control element 122 stays close by the fifth notch 126b5 of the locking member 126 (as shown in Fig. 5c3).
[65] At step 405, the user releases the control element 122 upon the ‘click’ sound. Due to the resilient force exerted by the resilient member 124, the control element 122 moves upwards. The first and the second protrusions 127a – 127b contact the ridge 126a. The ridge 126a restricts any further upward movement of the first and the second protrusions 127a-127b. Consequently, the control element 122 is prevented from moving further up. Thus, the locking member 126 locks the control element 122 at the second steering position and the tip 110c remains steered at the 180 degrees to the left.
[66] At step 406, the user gently rotates the control element 122 and the at least one pointer 122a1 aligns with the unlock steering indicator 121c4 (or the unlock position) when the user wants to bring the tip 110c to the neutral position. The resilient member 124 experiences rotational compressive force due to the rotation of the control element 122 as well as longitudinal compressive force due to pressing the control element 122. When the first protrusion 127a aligns with the unlock steering indicator 121c4 (as shown in Fig. 5d3), the first protrusion 127a aligns with the third notch 126b3 and the second protrusion 127b aligns with the fifth notch 126b5 (as shown in Fig. 5d4).
[67] At step 407, the user releases the control element 122. The resilient member 124 applies the rotational resilient force on the control element 122 in the opposite direction as well as applies longitudinal resilient force in the upward direction. The third notch 126b3 and the fifth notch126b5 allow passage to the first and second protrusions 127a-127b, respectively. As a result, the control element 122 moves upwards and in the clockwise direction. Consequently, the first support member 123a too moves in the same direction, thereby releasing the tension in the first resilient element 125a and the resilient force of the first resilient element 125a too is applied on the control element 122. As a result, the control element 122 reaches the neutral position and the pointers A and B align with the steering indicators 121c1. Consequently, the tip 110c also moves to the neutral position. Thus, through the spring action of the resilient member 124 and the first resilient element 125a, the user is able to steer the tip 110c to the neutral position quickly without further action or force from the user. This improves the usability of the device 100. It also reduces the overall procedure time especially when the user needs to steer the tip 110c from an extreme position in one direction (for example, 180 degrees in the left) to an extreme position in the other direction (for example, 180 degrees in the right). Unlike the conventional systems where the user has to continuously rotate a control element 122, e.g., a knob, to bring a conventional catheter’s tip from the extreme position on the left to the neutral position and then continuously rotate the knob further to the extreme position on the right, the device 100 enables the user to bring the tip 110c to the neutral position quickly without having to rotate the knob continuously.
[68] Though the method 400 has been explained with respect to the user steering the tip 110c in the left direction, the control element 122 may be operated in a similar manner to steer the tip 110c in the right direction.
[69] The scope of the invention is only limited by the appended patent claims. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used. , C , Claims:We claim
1. A catheter device (100) comprising:
a. a shaft (110) having a proximal end (110a), a distal end (110b) and a tip (110c) at the distal end (110b);
b. a pull ring provided within the shaft (110) at the distal end (110b) of the shaft (110);
c. at least one pull wire disposed at least partially within the shaft (110), each pull wire (140a, 140b) of the at least one pull wire has a distal end coupled to the pull ring and a proximal end extending out from the shaft (110) towards the proximal end (110a) of the shaft (110);
d. a handle (120), coupled to the proximal end (110a) of the shaft (110), comprising a steering mechanism configured to steer the tip (110c) to a plurality of steering positions, the steering mechanism comprising:
i. a control element (122) rotatable in a clockwise direction and an anti-clockwise direction;
ii. at least one resilient element (125) operatively coupled to the control element (122), each resilient element (125a, 125b) is coupled to the proximal end of a corresponding pull wire (140a, 140b);
iii. wherein, in response to the control element (122) being rotated in one of the clockwise direction or the anticlockwise direction, a corresponding resilient element (125a, 125b) of the at least one resilient element (125) is configured to pull the corresponding pull wire (140a, 140b), thereby steering the tip (110c) in a corresponding direction.
2. The catheter device (100) as claimed in claim 1, wherein the catheter device (100) comprises a locking member (126) operatively coupled to the control element (122) and configured to lock the control element (122) in the plurality of steering positions, the locking member (126) comprising:
a. ridge (126a) disposed axially on an inner surface of the locking member (126); and
b. a plurality of projections (126c1 – 126c4) extending downward from the ridge (126a) and configured to engage at least one protrusion (127) of the control element (122), each projection (126c1 – 126c4) of the plurality of projections (126c1 – 126c4) corresponds to a steering position of the plurality of steering positions;
c. wherein, in response to the control element (122) being rotated to one steering position of the plurality of steering positions, a corresponding projection (126c1 – 126c4) of the plurality of projections (126c1 – 126c4) engages with a corresponding protrusion (127a, 127b) of the at least one protrusion (127) of the control element (122) and the ridge (126a) is configured to restrict an upward movement of the at least one protrusion (127) of the control element (122), thereby locking the control element (122) at the steering position.
3. The catheter device (100) as claimed in claim 2, wherein the locking member (126) comprises a plurality of notches (126b) provided on the ridge (126a), the plurality of notches (126b) comprising:
a. A first set of notches (126b1, 126b2), each notch (126b1, 126b2) of the first set of notches is configured to receive a corresponding protrusion (127a, 127b) of the at least one protrusion (127) when the control element (122) is in a neutral position; and
b. A second set of notches (126b3 – 126b5), each notch (126b3 – 126b5) of the second set of notches is configured to provide a passage to a corresponding protrusion (127a, 127b) of the at least one protrusion (127) to move upward, in response to the control element (122) being rotated to an unlock position, thereby unlocking the control element (122).
4. The catheter device (100) as claimed in claim 3, wherein:
a. the at least one protrusion (127) of the control element (122) comprises a first protrusion (127a) and a second protrusion (127b);
b. the first set of notches comprises a first notch (126b1) and a second notch (126b2) configured to receive the second protrusion (127b) and the first protrusion (127a), respectively, when the control element (122) is in the neutral position; and
c. the second set of notches comprises a third notch (126b3), a fourth notch (126b4) and a fifth notch (126b5);
d. wherein the third notch (126b3) and the fifth notch (126b5) are configured to engage the first protrusion (127a) and the second protrusion (127b) respectively, in response to the control element (122) being rotated to the unlock position in the anticlockwise direction and wherein the fourth notch (126b4) and the third notch (126b3) are configured to engage the first protrusion (127a) and the second protrusion (127b) respectively, in response to the control element (122) being rotated to the unlock position in the clockwise direction.
5. The catheter device (100) as claimed in claim 2, wherein the locking member (126) is disposed within a top case (121a) of the handle (120) and coupled to an inner surface of the top case (121a).
6. The catheter device (100) as claimed in claim 5, wherein the locking member (126) forms an integral structure with the top case (121a).
7. The catheter device (100) as claimed in claim 1, wherein the at least one resilient element (125a, 125b) comprises:
a. a first resilient element (125a) coupled to a proximal end of a first pull wire (140a) of the at least one pull wire and configured to pull the first pull wire (140a) in response to the control element (122) being rotated in the anticlockwise direction, thereby steering the tip (110c) in a first direction; and
b. a second resilient element (125b) coupled to a proximal end of a second pull wire (140b) of the at least one pull wire and configured to pull the second pull wire (140b) in response to the control element (122) being rotated in the anticlockwise direction, thereby steering the tip (110c) in a second direction.
8. The catheter device (100) as claimed in claim 1, wherein the handle (120) comprises a plurality of steering indicators (121c) provided on a top surface of a top case (121a) of the handle (120) configured to indicate the plurality of steering positions and a neutral position of the tip (110c).
9. The catheter device (100) as claimed in claim 8, wherein the control element (122) comprises at least one pointer (122a1), wherein alignment of a pointer (A, B) of the at least one pointer (122a1) with one of the plurality of steering indicators (121c) visually indicates a corresponding steering position of the plurality of steering positions to a user.
10. The catheter device (100) as claimed in claim 1, wherein the control element (122) comprises a grip (122a’) provided on a top surface 122a of the control element (122) configured to enable the user to rotate the control element (122).
11. The catheter device (100) as claimed in claim 1, wherein a resilient member (124) is disposed around a support column (122b1) extending vertically downwards from a bottom surface (122b) of the control element (122), wherein, in response to the control element (122) being rotated to an unlock position, the resilient member (124) is configured to apply a resilient force on the control element (122) in a direction opposite to a direction of rotation of the control element (122) to the unlock position, thereby bringing the control element (122) to a neutral position.
12. The catheter device (100) as claimed in claim 1, wherein the catheter device (100) comprises a hub (130) having a distal end (130b) coupled to the proximal end (110a) or the shaft (110).
13. The catheter device (100) as claimed in claim 1, wherein the handle (120) comprises a top case (121a) and a bottom case (121b) coupled to form the handle (120).
14. The catheter device (100) as claimed in claim 1, wherein the handle (120) comprises a top case (121a) having a hole (121d) configured to receive the control element (122).
15. The catheter device (100) as claimed in claim 1, wherein the control element (122) comprises at least one support member 123 extending downward from a bottom surface (122b) of the control element (122) and positioned towards a distal end (120b) of the handle (120), each support member (123a, 123b) is configured to engage a corresponding resilient element (125a, 125b) of the at least one resilient element (125) and, in response to the rotation of the control element (122) in one of the clockwise or anticlockwise direction, a corresponding support member (123a, 123b) is configured to induce tension in the corresponding resilient element (125a, 125b).
16. The catheter device (100) as claimed in claim 1, wherein the handle (120) comprises a bottom case (121b) comprising:
a. a first cylindrical body (121b2) having an axial hole;
b. a hole (121b3) at a distal end (120b) of the handle (120);
c. a hole (121b7) at a proximal end (120a) of the handle (120), wherein the axial hole of the first cylindrical body (121b2), the hole (121b3) and the hole (121b7) at the proximal end (120a) of the handle (120) are configured to provide a passage to the shaft (110); and
d. a second cylindrical body (121b4) having a hole (121b5) configured to receive one end of a support column (122b1) of the control element (122).