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:
DEVICE TO CONTROL THE TORQUE OF WIRE-LIKE COMPONENT
2. APPLICANT:
Meril Corporation (I) Private Limited, an Indian company of the address Survey No. 135/139, Muktanand Marg, Bilakhia House, Pardi, Vapi, Valsad-396191 Gujarat, India.

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

 
FIELD OF INVENTION
[001] The present disclosure relates to the field of medical devices. More specifically, the present disclosure relates to a gripping and torque generating device used in medical applications.
BACKGROUND OF INVENTION
[002] In various medical procedures, particularly in interventional cardiology, neurology, and endovascular treatments, precise control and manipulation of wire-like components such as guidewires, catheters or delivery wires is important. The reason being that a wire-like component is used to navigate through one or more anatomical pathways for placement of a catheter, a stent, or an implant. A guidewire is a thin and flexible wire that navigates through one or more blood vessels or other anatomical pathways to guide catheters or other medical instruments to targeted locations. The ability to efficiently grip and apply controlled torque to a guidewire is essential for its precise maneuvering and placement. However, conventional devices that assist in generating torque for these procedures often require use of both hands, making the operation cumbersome and limiting the efficiency of the medical professional.
[003] Traditionally, a guidewire manipulation device utilizes a gripping mechanism that requires manual tightening or control of rotational movements using both hands. These devices often lead to prolonged procedures and fatigue for medical professionals. Furthermore, conventional devices do not allow for fine-tuned, single-handed control, making it difficult to maintain stability while adjusting a guidewire position. This limitation can lead to unintended movement, inaccurate positioning, and/or increased procedural time, all of which may impact the outcome of the procedure.
[004] Several conventional gripping and torque devices suffer from design inefficiencies that hinder precise control. In particular, these devices require continuous manual adjustments to maintain a firm grip on the guidewire, increasing the risk of slippage during critical phases of a procedure. Moreover, the reliance on rigid clamping mechanisms can lead to excessive pressure on the guidewire, potentially damaging the wire or compromising its flexibility.
[005] Therefore, there is a need for a torque device that overcomes the above limitations of existing torque devices.
SUMMARY OF INVENTION
[006] The present invention relates to a device to manipulate a guidewire. The device includes a housing and a locking assembly disposed in the housing. The locking assembly includes a first block, a second block and a shaft. The first block has a passage to pass the guidewire and a flow path engraved on a top surface of the first block. The second block is movably coupled to the first block. The second block includes an elongated portion with a hole configured to align with the passage of the first block and an actuator positioned towards a second end of the second block to enable manual operation for locking or unlocking the guidewire. The shaft includes an opening to pivotally couple the shaft with the second block, and a protrusion disposed in the flow path of the first block. In an unlocked configuration, the shaft is configured to move forward within the flow path and align the hole of the second block with the passage of the first block to allow passage of the guidewire through the first block and the second block. In a locked configuration, the shaft is configured to move backward within the flow path and misalign the hole with the passage, thereby securing the guidewire in a fixed position.
[007] The foregoing features and other features as well as the advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
BRIEF DESCRIPTION OF DRAWINGS
[008] 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 instrumentalities disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[009] Fig. 1A depicts a perspective view of an assembly of a guidewire 10 with a device 100, according to an embodiment of the present disclosure.
[0010] Fig. 1B depicts a cross-sectional view of the device 100, according to an embodiment of the present disclosure.
[0011] Fig. 1C depicts an exploded view of the device 100, according to an embodiment of the present disclosure.
[0012] Fig. 2A depicts a perspective view of a body 200 of the device 100, according to an embodiment of the present disclosure.
[0013] Fig. 2B depicts a rear view of a body 200 of the device 100, according to an embodiment of the present disclosure.
[0014] Fig. 3A depicts a side view of a knob 300 of the device 100, according to an embodiment of the present disclosure.
[0015] Fig. 3B depicts a perspective view of a knob 300 of the device 100, according to an embodiment of the present disclosure.
[0016] Fig. 3C depicts a perspective view of the device 100 and an axis of rotation of the knob 300, according to an embodiment of the present disclosure.
[0017] Figs. 4A and 4B depict respective exploded views of a locking assembly 400 of the device 100, according to an embodiment of the present disclosure.
[0018] Fig. 4C depicts an assembled view of the locking assembly 400 of the device 100, according to an embodiment of the present disclosure.
[0019] Figs. 5A- 5F depict various stages of torque being applied to the guidewire 10 using the device 100, according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[0020] 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.
[0021] 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.
[0022] 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.
[0023] 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.
[0024] The present disclosure relates to a device for manipulation of a wire-like component, with minimal effort, ensuring precise control of the wire-like component during its use in medical application. The wire-like component is controlled by manipulating a first end (or a portion thereof) of the wire-like component. In order to facilitate this manipulation, the device is coupled to the first end of the wire-like component. A medical professional manipulates the wire-like component by rotating or otherwise manipulating the device. In medical applications, the device is particularly useful in procedures such as interventional cardiology, neurology, endovascular treatments, orthopedic procedures, and minimally invasive surgeries or the like.
[0025] In an embodiment, the device includes a housing and a locking assembly. The housing includes a body and a knob. The body provides an ergonomic grip for ease of use. The knob is rotatably coupled to a shaft of the locking assembly, enabling transmission of torque to the wire-like component. The locking assembly of the device ensures firm grip, and allows to selectively lock or unlock a position of the wire-like component without disrupting the medical procedure. The locking assembly allows locking of the wire-like component at a desired position and restricts its longitudinal movement. Once in a locked configuration, the knob is rotated to apply torque to the wire-like component. When the locking assembly is in an unlocked configuration, the wire-like component is moved longitudinally relative to the device and towards a desired position. The device is configured to selectively apply torque and control longitudinal movement of the wire-like component.
[0026] The device has a compact design that provides comfortable and stable one-handed operation, reducing strain on a medical professional’s hand during a medical procedure. The knob, located at the top of the device, is a rotatable component that seamlessly transfers torque to a guidewire or a delivery wire (i.e., exemplary wire-like component). The position and design of the knob allow the medical professional to apply the required rotational force with minimal effort, providing fine-tuned control over the wire's movement. The ease of holding the device in a hand and rotating the knob with fingers, helps maintain consistent rotational control of the wire without the need for large, cumbersome movement(s). Due to this, the device ensures highly precise control of wire-like component in minimally invasive application(s), improving procedural efficiency and reducing the risk of errors.
[0027] Fig. 1A depicts a perspective view of a device 100, according to an embodiment of the present disclosure. Fig. 1B depicts a cross-sectional view of the device 100 Fig. 1C depicts an exploded view of the device 100. The device 100 is used for manipulation of a guidewire 10 in a medical procedure. The medical procedure may include minimally invasive procedures pertaining to interventional cardiology, neurology, endovascular treatments, orthopedic, minimally invasive surgeries or the like. The device 100 has a first end 100a and a second end 100b. The guidewire 10 passes through a channel provided in a center of the device 100, along a longitudinal axis.
[0028] Although, the device 100 of the present disclosure has been described in the context of manipulating a guidewire, it should be understood that the device 100 can also be used for other wire-like instruments such as a delivery wire, a catheter or the like and the same is within the scope of the teachings of the present disclosure.
[0029] The device 100 is selectively toggled between a locked configuration and an unlocked configuration by the medical professional. In the locked configuration, the guidewire 10 cannot move relative to the device 100, i.e., rotational and longitudinal movement of the guidewire 10 is arrested by the device 100. In the unlocked configuration, the guidewire 10 is allowed to move longitudinally and/or rotationally relative to the device 100, as required by the medical practitioner.
[0030] In an embodiment, the device 100 includes a housing and a locking assembly 400 disposed in the housing. The housing includes a body 200 and a knob 300 to hold and maneuver the device 100. The body 200 is disposed at the second end 100b of the device 100. The knob 300 is disposed at the first end 100a of the device 100. The locking assembly 400 is disposed at least partially within the knob 300. The locking assembly 400 includes a plurality of components that allow the medical professional to selectively toggle between the locked and unlocked configuration, thereby selectively locking the guidewire 10 at a pre-defined position relative to the device 100. Additionally or optionally, the locking assembly 400 is used to transfer torque to the guidewire 10.
[0031] The body 200 is used for holding and manoeuvring the device 100, thereby manoeuvring the guidewire 10. The body 200 has an ergonomic shape that at least partially fits in the medical professional’s hand. This allows the medical professional to comfortably operate the device 100 during the medical procedure.
[0032] Fig. 2A depicts a perspective view of the body 200, according to an embodiment of the present disclosure. Fig. 2B depicts a rear view of the body 200, as viewed from the second end 100b of the device 100. Corresponding to the first end 100a and second end 100b of the device 100, the body 200 has a first end 200a and a second end 200b. The body 200 may have a shape, such as, without limitation, cube, cuboidal, cylindrical, etc. In the depicted example, the shape of the body 200 is cylindrical. It is to be noted that the body 200 can be of any shape that is compact and allows a medical professional to firmly hold the device 100 and the same is within the scope of the teachings of the present disclosure.
[0033] The first end 200a is configured to at least partially receive the knob 300. The first end 200a of the body 200 is rotatably coupled to the knob 300. The body 200 is coupled to the knob 300 using at least one of snap-fit, press-fit, groove fit etc. In an example implementation, the first end 200a of the body 200 is coupled to the knob 300 using press-fit.
[0034] In an embodiment, the body 200 includes a grip 200c extending at least partially along its length. The grip 200c helps a medical professional to firmly hold the device 100. The body 200 includes a channel 200d axially extending from the first end 200a to the second end 200b. The channel 200d is configured to at least partially receive a length of the guidewire 10. The dimensions of the channel 200d are designed to allow longitudinal or rotational movement of the guidewire 10 relative to the device 100. In an embodiment, a diameter of the channel 200d at the second end 200b is relatively larger that a diameter of the channel 200d at the first end 200a. Alternately, the diameter of the channel 200d may be uniform across the entire length of the body 200. The guidewire 10 enters the channel 200d of the body 200 from the first end 200a and exits the device 100 from the second end 200b of the body 200, thus at least partially extending along the length of the body 200. The body 200 may be made of a material including, but not limited to, acrylonitrile butadiene styrene (ABS), polyether ether ketone (PEEK), photo polymer, etc. In an example implementation, the body 200 is made of ABS. The dimensions of the body 200 depend on the requirement(s) of the medical procedure, or on the preference of the medical professional.
[0035] The knob 300 is disposed at the first end 100a of the device 100. The knob 300 is configured to transfer the torque to the guidewire 10, as the medical practitioner selectively rotates the knob 300 in a clockwise or anti-clockwise direction relative to the body 200. The knob 300 may have a shape, such as, without limitation, circular, oval, cube, cuboidal, cylindrical, etc. In the depicted example, the shape of the knob 300 is substantially cylindrical. It is to be noted that the knob 300 can be of any shape that is compact and allows a medical professional to rotate the knob 300 relative to the body 200 and house the locking assembly 400, and the same is within the scope of the teachings of the present disclosure.
[0036] Fig. 3A depict a side view of the knob 300, according to an embodiment of the present disclosure. Fig. 3B depict a perspective view the knob 300. Corresponding to the first end 100a and second end 100b of the device 100, the knob 300 has a first end 300a and a second end 300b. In a depicted embodiment, the knob 300 includes a first disc 302, a second disc 304 and a neck 306 disposed therebetween. The first disc 302 is disposed towards the first end 300a. The second disc 304 is disposed towards the second end 300b. The neck 306 extends axially between the first disc 302 and the second disc 304. The knob 300 includes a lumen 300c extending from the first end 300a to the second end 300b. The lumen 300c extends along the entire length of the knob 300, i.e., the lumen 300c passes through the first disc 302, the second disc 304 and the neck 306. In an embodiment, the lumen 300c passes through the center of the first disc 302, the second disc 304 and the neck 306, along the longitudinal axis of the device 100. The lumen 300c is configured to at least partially receive the guidewire 10. The guidewire 10 enters the lumen 300c of the knob 300 from the first end 300a and exits the knob 300 from the second end 300b, thus at least partially extending along the length of the knob 300. The knob 300 may be made of a material including, but not limited to, acrylonitrile butadiene styrene (ABS), polyether ether ketone (PEEK), photo polymer, etc. In an example implementation, the knob 300 is made of ABS.
[0037] In an embodiment, an outer circumferential surface of the first disc 302 includes a plurality of ridges 302a. The ridges 302a facilitate a better grip for the medical professional and allows easier and controlled manipulation of the knob 300. It should be understood that the outer circumferential surface of the first disc 302 may have other features, such as grooves, undulations, or the like, instead of, or in addition to, the ridges, and the same is within the scope of the teachings of the present disclosure. In another embodiment, the outer circumferential surface of the first disc 302 is smooth. The first disc 302 houses the locking assembly 400.
[0038] The second disc 304 of the knob 300 is configured to couple the knob 300 to the body 200. The knob 300 is coupled to the body 200 using at least one of snap-fit, press-fit, groove-fit, etc. In an example implementation, the second disc 304 is disposed within the body 200 such that the first end 200a of the body 200 is disposed between the first disc 302 and the second disc 304. In an embodiment, the second disc 304 is rotatably disposed within the body 200. The second disc 304 rotates relative to the body 200 in response to the rotation of the first disc 302 of the knob 300. The rotation of the second disc 304 within the body 200 ensures smooth torque transfer to the guidewire 10 without the knob 300 being dislodged from the body 200. The dimensions of the knob 300 depends on the procedural requirement and/or the dimension of the body 200. In an embodiment, the diameter of the first disc 302 is more than the diameter of the channel 200d at the first end 200a. The diameter of the second disc 304 is more than the diameter of the channel 200d at the first end 200a. The diameter of the first disc 302 is more than the diameter of the second disc 304. The diameter of the neck 306 is less than or equal to the diameter of the channel at the first end 200a. The diameter of the neck 306 is less than the first disc 302 and the second disc 304.
[0039] Fig. 3C depicts a perspective view of the device 100 and an axis of rotation of the knob 300, according to an embodiment of the present disclosure. The knob 300 is configured to rotate along an axis A, allowing controlled torque transmission to the guidewire 10. The axis A may be at an angle with respect to the longitudinal axis of the device 100. In an exemplary embodiment, the axis A is perpendicular to the longitudinal axis of the device 100. The first disc 302 is capable of receiving a first rotational input and a second rotational input. In response to the first rotational input the first disc 302 rotates say, in a clockwise direction along the axis A. The clockwise rotation of the first disc 302 causes the second disc 304 to rotate in the same direction. As a result, torque is applied to the guidewire 10, causing it to rotate in the clockwise direction. This movement enables precise positioning and advancement of the guidewire 10 during medical applications.
[0040] In response to the second rotational input the first disc 302 rotates say, in a counterclockwise (or anti-clockwise) direction along the axis A. The counterclockwise rotation of the first disc 302 causes the second disc 304 to rotate in the same direction, thereby transferring torque to the guidewire 10, causing it to rotate in the counterclockwise direction. This movement allows for fine adjustments and/or controlled retraction of the guidewire 10 when repositioning is required. In an embodiment, the first rotational input and second rotational input correspond to the manual rotation of the knob 300 by the medical professional. By rotating the knob 300 in either the clockwise or counterclockwise direction, the medical professional can precisely maneuver and control the guidewire 10. The lumen 300c ensures that the guidewire 10 remains properly aligned while torque is applied.
[0041] Figs. 4A and 4B depict respective exploded views of the locking assembly 400, according to an embodiment of the present disclosure. The locking assembly 400 is disposed at least partially within the first disc 302 of the knob 300 and is configured to selectively toggle between the locked configuration and unlocked configuration of the device 100. In other words, the locking assembly 400 allows selectively locking and unlocking the guidewire 10 relative to the device 100. The locking assembly 400 has a first end 400a and a second end 400b. The first end 400a and the second end 400b are used as a reference to describe the respective ends of the plurality of components of the locking assembly 400. Each component of the locking assembly 400 has respective ends, the end towards the first end 400a is referred to as a first end of that component, similarly, the end towards the second end 400b is referred to as a second end of that component. The locking assembly 400 may include, without limitation, a first block 410, a shaft 420, a plurality of coupling element 430, a plurality of resilient members 440, a second block 450, etc.
[0042] The first block 410 is positioned towards the first end 400a of the locking assembly 400. In the depicted embodiment, the first block 410 has a first end, a second end, a top surface 410c and a bottom surface 410d. The first end and the second end of the first block 410 are respectively positioned towards the first end 400a and second end 400b of the locking assembly 400. The first block 410 is completely housed within the first disc 302 of the knob 300. The dimensions of the first block 410 may be chosen based upon the requirement(s) of the medical procedure. The length of the first block 410 may range between 2 mm and 6 mm. The width of the first block 410 may range between 2 mm and 5 mm. The height of the first block 410 may range between 1 mm and 3 mm. In an exemplary implementation, the length, the width and the height of the first block 410 are 4 mm, 3 mm, and 1.5 mm, respectively. The first block 410 may be made of a material including, without limitation, stainless steel, nitinol, titanium, cobalt chromium, acrylonitrile butadiene styrene (ABS), polyether ether ketone (PEEK), etc. In an example implementation, the first block 410 is made of stainless steel.
[0043] The first block 410 is moveably coupled to the second block 450. The first block 410 is moveably coupled to the second block 450 using at least one of a sliding fit, a groove and rail, a pivot or hinge, a spring-biased, a track and slot mechanism, etc. In an embodiment, the first block 410 includes a slot 412 extending from the first end to the second end. The slot 412 is configured to at least partially receive the second block 450. The dimensions of the slot 412 are designed to accommodate the second block 450. In the depicted embodiment, the slot 412 is disposed at the center of the first block 410. The first block 410 includes a first hole 414a in the top surface 410c, extending throughout a thickness of the top surface 410c, and a second hole 414b in the bottom surface 410d, extending throughout the thickness of the bottom surface 410d. The first block 410 has a passage to pass the guidewire 10. The first hole 414a of the first block 410 aligns with the second hole 414b to form the passage to allow at least a length of the guidewire 10 to extend across the first block 410. In other words, the passage includes the first hole 414a extending through the top surface 410c and the second hole 414b in the bottom surface 410d. The first hole 414a is configured to receive the guidewire 10 from the first end 300a of the knob 300, and the second hole 414b provides an exit for the guidewire 10 into the body 200 towards the second end 200b. The dimensions of the first hole 414a and the second hole 414b are designed to allow longitudinal and/or rotational movement of the guidewire 10 relative to the device 100.
[0044] The first block 410 includes a flow path 416 engraved in the top surface 410c. In an embodiment, the flow path 416 is provided at the center of top surface 410c. The flow path 416 is configured to provide a guided pathway for the movement of the shaft 420. The flow path 416 includes a plurality of forward end points and backward end points. In the depicted embodiment, the flow path 416 of the first block 410 includes an M-shaped engraving on the top surface 410c, provided for the movement of the shaft 420. Alternatively, the flow path 416 may have a zigzag shape, W-shape, wave-shape, curved or S-shape, stepped-shape, V-shape, A-shape, Z-shape, etc., engraving to facilitate controlled movement of the shaft 420 within the designated flow path 416. The flow path 416 may be open-looped or close-looped. In the depicted embodiment, the flow path 416 is close-looped. In a depicted embodiment, the flow path 416 has a plurality of edges, namely, A, B, C and D. The number of edges may vary depending upon the shape of the flow path 416. A few of the edges of the plurality of edges constitutes a forward end point and the remaining edges of the plurality of edges constitutes a backward end point. In the depicted embodiment, the edges B and D are forward end points. And, the edges A and C are backward end points.
[0045] The shaft 420 is operationally coupled to the flow path 416 of the locking assembly 400. The shaft 420 may have a pre-defined shape including, without limitation, bar, rod, tube, cylinder, etc. The shaft 420 is configured to move forward and backward within the flow path 416 relative to the first block 410. The shaft 420 includes an opening 420a and a protrusion 420b. The opening 420a is located towards the second end 400b of the locking assembly 400 and is used to pivotally couple the shaft 420 with the second block 450. The protrusion 420b is located towards the first end 400a of the locking assembly 400. The protrusion 420b is at a pre-defined distance from the opening 420a. The protrusion 420b is used to operationally couple the shaft 420 with the flow path 416. The protrusion 420b is disposed within the flow path 416 of the first block 410 such that the protrusion 420b moves along the shape of the flow path 416. The dimensions of the shaft 420 may vary based upon requirement(s) of the medical procedure. The length of the shaft 420 may range between 2 mm and 5 mm. The width of the shaft 420 may range between 0.2 mm and 0.5 mm. In an example implementation, the length, and the width of the shaft 420 are 3.5 mm, and 0.3 mm, respectively. The shaft 420 may be made of a material including, without limitation, stainless steel, nitinol, titanium, cobalt chromium, acrylonitrile butadiene styrene (ABS), polyether ether ketone (PEEK), etc. In an example implementation, the shaft 420 is made of stainless steel.
[0046] The first block 410 is moveably coupled to the second block 450. The coupling between the first block 410 and the second block 450 may be achieved through various mechanisms. In one embodiment, the first block 410 includes a plurality of cavities 418 towards the second end. The cavity 418 extends at least partially within the body 200 of the first block 410. The cavity 418 is configured to receive a corresponding coupling element 430. The plurality of coupling elements 430 is disposed towards the second end of the first block 410. The coupling elements 430 are configured to couple the first block 410 and the second block 450. The coupling element 430 may have a pre-defined shape including, without limitation, bar, rod, tube, cylinder, etc. Each of the plurality of coupling elements 430 includes a protruded end 430a. The protruded end 430a is at least partially disposed within the cavity 418 of the first block 410. The dimensions of the protruded end 430a may be chosen based on the dimensions of the cavity 418. In an embodiment, the diameter of the protruded end 430a is more than the diameter of the coupling element 430. The diameter of the protruded end 430a ranges from 0.5 mm to 1 mm. The diameter of the coupling element 430 ranges from 0.1 mm to 0.5 mm. In an example implementation, the diameter of the protruded end 430a and the coupling element 430 is 0.5 mm and 0.3 mm, respectively. The length of the coupling element 430 may range between 1 mm and 4 mm. In an example implementation, the length of the coupling element 430 is 2 mm. The coupling element 430 may be made of a material including, without limitation, stainless steel, nitinol, titanium, cobalt chromium, acrylonitrile butadiene styrene (ABS), polyether ether ketone (PEEK), etc. In an example implementation, the coupling element 430 is made of stainless steel.
[0047] In another embodiment, the coupling element 430 may be permanently coupled to the first block 410 without requiring a cavity 418. The coupling element 430 may be integrally formed with the first block 410 or attached using press-fitting, welding, adhesive bonding, or a mechanical fastener etc.
[0048] Additionally, or optionally, the resilient member 440 defines a cavity 440a. The cavity 440a is configured to receive the coupling elements 430, ensuring proper alignment and secure positioning within the locking assembly 400. The resilient member 440 is mounted on the coupling elements 430. The resilient member 440 is designed to provide controlled tension and resistance when engaging or disengaging the locking assembly 400 of the device 100. The plurality of resilient members 440 is configured to provide an opposing force when the second block 450 is moved forward towards the first block 410. In another embodiment, instead of a separate resilient member, the resilient member 440 may be integrated into the coupling element 430. In yet another embodiment, the coupling element 430 may include a flexible or elastic section that inherently provides the biasing force required for engaging and disengaging the locking assembly 400.
[0049] When the locking assembly 400 is activated, the resilient member 440 applies a biasing force, facilitating smooth movement of the shaft 420 and the second block 450 relative to the first block 410, thereby maintaining stability during manipulation of the guidewire 10. The elasticity of the resilient member 440 allows it to return to its original shape after compression, ensuring repeated and consistent performance. When the locking assembly 400 is engaged, the resilient member 440 compresses, allowing the shaft 420 to move within the flow path 416. When the locking assembly 400 is disengaged, the resilient member 440 self-expands, applying a restorative force to return the shaft 420 to move further within the flow path 416. This mechanism ensures precise locking and unlocking of the guidewire 10 relative to the device 100, improving the efficiency and accuracy of the device 100 during a medical procedure. In an embodiment, the resilient member 440 may be made of a medical-grade metal, including but not limited to stainless steel, nitinol, titanium, cobalt chromium, etc. In an embodiment, the resilient member 440 is a coil spring made of stainless steel.
[0050] In another embodiment, the resilient member 440 may be positioned between the first block 410 and the second block 450, rather than on the coupling elements 430. The resilient member 440may be affixed to at least one of the first block 410 or the second block 450 using mechanical fastening, welding, or adhesive bonding to provide controlled movement and stability. In some embodiments, an alternative biasing mechanism such as a leaf spring, torsion spring, elastomeric component, or magnetic repulsion system may replace the resilient member 440 to achieve the desired functionality.
[0051] While the depicted embodiments illustrate a specific arrangement of the plurality of cavities 418, coupling elements 430, and the resilient member 440, a person skilled in the art will appreciate that numerous variations can be implemented while maintaining the coupling and locking functionality of the first block 410 and the second block 450. These variations are within the scope of the teachings of the present disclosure.
[0052] The second block 450 is disposed towards the second end 400b of the locking assembly 400. The second block 450 is movably coupled to the first block 410, i.e., the second block 450 is configured to axially move at least partially within the slot 412 of the first block 410. In a depicted embodiment, the second block 450 has a first end and a second end. The second block 450 includes, without limitation, an elongated portion 452, a plate 454, an actuator 456, etc. The elongated portion 452 is positioned towards the first end and is configured to be at least partially disposed within the slot 412 of the first block 410. The elongated portion 452 is movably coupled to the first block 410 in such a way that the elongated portion 452 can move longitudinally/axially within the slot 412 of the first block 410. The elongated portion 452 includes a hole 452a disposed towards the first end and is configured to align with the passage of the first block 410. While toggling the device 100 from the locked configuration to the unlocked configuration, the shaft 420 is configured to move forward (i.e., towards the first end 400a) within the flow path 416 such that the hole 452a of the second block 450 aligns with the first hole 414a and the second hole 414b, i.e., the passage of the first block 410.
[0053] In the unlocked configuration of the device 100, the hole 452a of the second block 450 aligns with the passage of the first block 410, allowing the guidewire 10 to move freely relative to the device 100. In an unlocked configuration, the shaft 420 is configured to move forward (i.e., towards the first end 400a) within the flow path 416 and align the hole 452a of the second block 450 with the passage of the first block 410 to allow passage of the guidewire 10 through the first block 410 and the second block 450. In the locked configuration, the shaft 420 moves backward (i.e., towards the second end 400b) within the flow path 416. This movement causes the hole 452a of the second block 450 to misalign with the first hole 414a and the second hole 414b of the first block 410, thereby securing the guidewire 10 in a fixed position. In a locked configuration, the shaft 420 is configured to move backward within the flow path 416 and misalign the hole 452a with the passage, thereby securing the guidewire 10 in a fixed position. The shaft 420 is configured to toggle between the unlocked and the locked configuration. When the shaft 420 moves from a forward end point to a backward end point, it misaligns the hole 452a of the second block 450 with the passage of the first block 410, locking the guidewire 10. When the shaft 420 moves from a backward end point to a forward end point, it aligns the hole 452a with the passage, unlocking the guidewire 10. In the depicted embodiment, the edges B and D of the flow path 416 are forward end points. And, the edges A and C of the flow path 416 are backward end points.
[0054] The elongated portion 452 may have a pre-defined shape such as cylindrical, cuboidal, triangle, cone, etc. In an embodiment, the elongated portion 452 has a cuboidal shape. The width and height of the elongated portion 452 are determined based on the dimensions of the slot 412 of the first block 410. In an embodiment, the length of the elongated portion 452 is more than the length of the slot 412. The length of the elongated portion 452 may range between 3 mm and 8 mm. The width of the elongated portion 452 may range between 1 mm and 4 mm. The height of the elongated portion 452 may range between 0.5 mm and 2 mm. In an example implementation, the length, the width and the height of the elongated portion 452 are 5.5 mm, 1.5 mm, and 0.75 mm, respectively. The elongated portion 452 may be made of a material including, without limitation, stainless steel, nitinol, titanium, cobalt chromium, acrylonitrile butadiene styrene (ABS), polyether ether ketone (PEEK), etc. In an example implementation, the elongated portion 452 is made of stainless steel.
[0055] In one embodiment, the plate 454 is coupled to the elongated portion 452 towards the second end of the second block 450. The plate 454 may have a pre-defined shape such as cylindrical, cuboidal, square, rectangle, hexagon, pentagon, diamond, etc. In an embodiment, the plate 454 has a cuboidal shape. The plate 454 may include one or more curved edges. The plate 454 includes, without limitation, a plurality of apertures 454a, a fastener 454b and at least one groove 454c. The aperture 454a extends throughout the width of the plate 454. The apertures 454a are configured to movably receive the respective coupling element 430. The aperture 454a of the plate 454 facilitates the coupling of the second block 450 with the first block 410 via the plurality coupling elements 430. The number of apertures 454a is equal to the number of coupling elements 430. The aperture 454a of the second block 450 is configured to axially move along a length of the coupling element 430 depending upon the movement of the second block 450 either towards or away from the first block 410. The coupling between the aperture 454a and the coupling element 430 maintains the alignment of the first block 410 and the second block 450. The coupling between the aperture 454a and the coupling element 430 allows the resilient member 440 to at least partially abut the second block 450.
[0056] In an alternative embodiment, instead of using a separate plate 454, the elongated portion 452 may be designed with an integrated widened section incorporating the necessary coupling and locking features. This widened section may include built-in cavities or recesses to engage the coupling elements 430, eliminating the need for a separate plate. Alternatively, rather than having apertures 454a, the plate 454 may incorporate hooks, clamps, or projections that snap-fit into corresponding recesses in the first block 410, securing the second block 450 without requiring separate coupling elements 430.
[0057] The fastener 454b is disposed on a top edge of the plate 454. The fastener 454b is configured to be operationally coupled at least partially to the opening 420a of the shaft 420, thereby allowing the shaft 420 to at least partially pivot relative to the second block 450. The groove 454c is positioned towards the second end of the second block 450. The groove 454c is configured to receive the actuator 456 within the plate 454 of the second block 450, to enable the medical professional to toggle the device 100 using the actuator 456. The dimensions of the plate 454 are based on the dimensions of the slot 412 of the first block 410. In an embodiment, the cross-sectional area of the plate 454 is more than the cross-sectional area of the slot 412 in such a way that plate 454 is prevented to enter inside the slot 412. The length of the plate 454 may range between 0.5 mm and 2 mm. The width of the plate 454 may range between 1 mm and 5 mm. The height of the plate 454 may range between 1 mm and 3 mm. In an example implementation, the length, the width and the height of the plate 454 are 0.75 mm, 3 mm, and 1.5 mm, respectively. The plate 454 may be made of a material including, without limitation, stainless steel, nitinol, titanium, cobalt chromium, acrylonitrile butadiene styrene (ABS), polyether ether ketone (PEEK), etc. In an example implementation, the plate 454 is made of stainless steel.
[0058] In another embodiment, the fastener 454b may be replaced with a different coupling mechanism, such as a threaded connection or a press-fit mechanism between the plate 454 and the opening 420a of the shaft 420. Similarly, the groove 454c may be replaced or eliminated, with the actuator 456 being coupled to the second block 450 through a pivoting hinge mechanism, a sliding latch within a track formed in the second block 450, or an integrally formed flexible section designed to engage and disengage the locking assembly 400 when pressed.
[0059] The actuator 456 is positioned towards the second end of the second block 450 and is configured to enable a manual operation for locking or unlocking the guidewire 10. The actuator 456 has an elongated, cylindrical structure that is coupled to the plate 454. At least a length of the actuator 456 extends outside the first disc 302 of the knob 300, configured to allow the medical professional to manually operate the locking assembly 400 for locking and unlocking the guidewire 10 relative to the device 100. When the actuator 456 is pressed towards the knob 300, it moves the second block 450 inwards into the slot 412, i.e., towards the first block 410. Simultaneously, the shaft 420 is moved from a backward end point to the forward end point of the flow path 416. This movement aligns the hole 452a of the second block 450 with the first hole 414a and the second hole 414b of the first block 410, thereby, unlocking the guidewire 10. The actuator 456 has a bulged head 456a towards the second end. The bulged head 456a has an ergonomic design to provide the medical professional with a comfortable press button-like feature of the actuator 456 to manually engage and disengage the locking assembly 400. The first end is coupled to the groove 454c of the plate 454. In an embodiment, the fastener 454b helps to couple the actuator 456 to the groove 454c of the plate 454. The length of actuator 456 may range between 3 mm and 6 mm. The diameter of the actuator 456 may range between 0.5 mm and 2 mm. In an example implementation, the length, and the diameter of the actuator 456 are 4 mm, and 1 mm, respectively. The actuator 456 may be made of a material including, without limitation, stainless steel, nitinol, titanium, cobalt chromium, acrylonitrile butadiene styrene (ABS), polyether ether ketone (PEEK), etc. In an example implementation, the actuator 456 is made of stainless steel.
[0060] Additionally, in some embodiments, the actuator 456 may incorporate a built-in locking feature, such as a ratchet or cam mechanism, to ensure precise positioning and secure engagement without requiring a separate fastener 454b or groove 454c. While the depicted embodiments illustrate a specific arrangement of the plate 454, apertures 454a, fastener 454b, and groove 454c, a person skilled in the art will recognize that numerous alternative configurations can be implemented to achieve the same functional objectives. These variations fall within the scope of the teachings of the present disclosure.
[0061] Fig. 4C depicts an assembled view of the locking assembly 400, according to an embodiment of the present disclosure. An embodiment of the coupling between various components of the locking assembly 400 is now explained. The first block 410 is coupled to the second block 450 through the slot 412, allowing the elongated portion 452 of the second block 450 to be disposed within the slot 412. Upon pressing the actuator 456 by the medical professional, the hole 452a of the second block 450 aligns with the first hole 414a and the second hole 414b of the first block 410 in the unlocked configuration of the device 100, enabling the guidewire 10 to freely move relative to the device 100. In the locked configuration, the second block 450 is pushed forward (i.e., towards the second end 400b) by the resilient member 440, misaligning the hole 452a and the first hole 414a and the second hole 414b and securing the guidewire 10 in place (relative to the device 100).
[0062] The shaft 420 is pivotally coupled to the second block 450 via the opening 420a. The protrusion 420b of the shaft 420 is disposed within the flow path 416 of the first block 410, ensuring controlled engagement of the shaft 420 within the M-shaped engraving on the top surface 410c of the first block 410. The plurality of coupling elements 430 is positioned at the second end of the first block 410 and serves as a structural guide between the first block 410 and the second block 450. Each coupling element 430 has a protruded end 430a, which is at least partially disposed within the cavity 418 of the first block 410, preventing disengagement and ensuring structural stability. The resilient member 440 is coupled to the coupling elements 430, with its cavity 440a designed to receive the coupling elements 430. The plate 454 of the second block 450 is coupled to the elongated portion 452 and interacts with the coupling elements 430 via the aperture 454a. The fastener 454b on the plate 454 is coupled to the opening 420a of the shaft 420. The groove 454c on the plate 454 receives the actuator 456 and is coupled thereto with the help of the fastener 454b. The bulged head 456a of the actuator 456 extends outside the first disc 302 of the knob 300 to allow the medical professional to interact with the locking assembly 400.
[0063] An exemplary working of the device 100 is now explained. Figs. 5A- 5F depicts various stages of locking and unlocking the guidewire 10 using the device 100, according to an embodiment of the present disclosure. Initially, the lumen 300c of the knob 300 is in a locked configuration as shown in Fig. 5A. This is due to the misalignment of the first hole 414a and the second hole 414b of the first block 410 with the hole 452a of the second block 450. In the locked configuration of the device 100, the guidewire 10 is locked relative to the device 100.
[0064] To toggle the device 100 from the locked configuration to the unlocked configuration, the actuator 456 is pressed towards the knob 300, for example, by the medical professional. This causes the second block 450 to move towards the first block 410 and the shaft 420 to move within the flow path 416 from a backward end point to a forward end point. For example, the shaft 420 moves from the edge A (as shown in Fig. 5A) to the edge B (as shown in Fig. 5B) of the first block 410. As a result, the first hole 414a and the second hole 414b of the first block 410 align with the hole 452a of the second block 450. This creates a passage for the guidewire 10 to move relative to the device 100. If not already inserted, the guidewire 10 is inserted within the device 100, across the lumen 300c of the knob 300 and the channel 200d of the body 200.
[0065] As the pressure is released from the actuator 456, the resilient member 440 self-expands and pushes the second block 450 away from the first block 410. Simultaneously, the shaft 420 moves from a forward end point to a backward end point. For example, the shaft 420 moves from the edge B (as shown in Fig. 5B) to the edge C (as shown in Fig. 5C) in the flow path 416. As a result, the first hole 414a and the second hole 414b of the first block 410 misaligns with the hole 452a of the second block 450 to securing the guidewire 10 in place. This grips the guidewire 10 securely between the first block 410 and the second block 450, acquiring a locked configuration.
[0066] Once the device 100 is toggled to its locked configuration and the guidewire 10 is locked in place relative to the device 100, the knob 300 is rotated relative to the body 200. This rotation of the knob 300 transfers torque to the guidewire 10, enabling precise navigation and movement of the guidewire 10 through the anatomical pathway during a medical procedure as required. The locking assembly 400 ensures that the applied torque is directly transferred to the guidewire 10, allowing controlled positioning of the guidewire 10 without requiring full rotation of the device 100. In response to a clockwise rotation of the knob 300, the first disc 302 and the second disc 304 rotate in the same direction, applying clockwise torque to the guidewire 10. Similarly, in response to a counterclockwise rotation of the knob 300, the torque is reversed, allowing fine-tuned adjustments to the position of the guidewire 10.
[0067] After positioning the guidewire 10, the actuator 456 is pressed again to move the second block 450 towards the first block 410. Simultaneously, the shaft 420 moves from a backward end point to a forward end point. For example, the shaft 420 moves from edge C (as shown in Fig. 5C) to edge D (as shown in Fig. 5D) in the flow path 416 of the first block 410. As a result, the first hole 414a and the second hole 414b of the first block 410 aligns with the hole 452a of the second block 450.
[0068]
[0069] As the pressure is released from the actuator 456, the resilient member 440 self-expands and pushes the second block 450 away from the first block 410. Simultaneously, the shaft 420 moves from a forward end point to a backward end point. For example, the shaft 420 moves from the edge D (as shown in Fig. 5D) to the edge A (as shown in Fig. 5E) in the flow path 416. The resilient member 440 expands, assisting the shaft 420 in returning to its original position, as shown in Fig. 5F. Once the shaft 420 reaches edge A, the first hole 414a and the second hole 414b of the first block 410 misaligns with the hole 452a of the second block 450 to securing the guidewire 10 in place. The device 100 is now reset and ready for use repetitively in the procedure.
[0070] The proposed device presents several advantages over conventional torque and rotation devices used for guidewire manipulation. The device offers a single-handed operation, allowing medical professionals to precisely grip, rotate, and apply torque to the guidewire without requiring additional support, thereby enhancing procedural efficiency. The locking assembly, integrated within the knob, ensures a secure grip on the guidewire, preventing unintended slippage and enabling controlled manoeuvrability during medical procedures. Additionally, the device eliminates the need for full-body rotation, as torque can be applied solely by rotating the knob, making it highly suitable for delicate and precise movements in medical procedures. The adaptable design of the device allows it to accommodate various wire-like instruments, such as catheters, delivery wires, and guidewires, ensuring versatility across multiple medical applications. Overall, the device enhances precision, efficiency, and ease of use, addressing critical challenges such as uncontrolled torque transfer, guidewire slippage, and operator fatigue. By improving control and reducing procedural complexity, the device significantly enhances the safety and success rates of minimally invasive procedures compared to conventional torque devices.
[0071] 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 device (100) to manipulate a guidewire (10), comprising:
a. a housing; and
b. a locking assembly (400) disposed in the housing, the locking assembly (400) including:
i. a first block (410) having a passage to pass the guidewire (10) and a flow path (416) engraved in a top surface (410c) of the first block (410);
ii. a second block (450) movably coupled to the first block (410), the second block (450) including an elongated portion (452) having a hole (452a) configured to align with the passage of the first block (410) and an actuator (456) positioned towards a second end of the second block (450) configured to enable a manual operation for locking or unlocking the guidewire (10); and
iii. a shaft (420) including an opening (420a) to pivotally couple the shaft (420) with the second block (450), and a protrusion (420b) disposed in the flow path (416) of the first block (410);
wherein, in an unlocked configuration, the shaft (420) is configured to move forward within the flow path (416) and align the hole (452a) of the second block (450) with the passage of the first block (410) to allow passage of the guidewire (10) through the first block (410) and the second block (450);
wherein, in a locked configuration, the shaft (420) is configured to move backward within the flow path (416) and misalign the hole (452a) with the passage, thereby securing the guidewire (10) in a fixed position.
2. The device (100) as claimed in claim 1, wherein the first block (410) includes a slot (412) that extends from the first end to the second end.
3. The device (100) as claimed in claim 1, wherein the passage includes a first hole (414a) extending through the top surface (410c) and a second hole (414b) in a bottom surface (410d).
4. The device (100) as claimed in claim 1, wherein the second block (450) includes an elongated portion (452) positioned towards a first end and configured to be disposed within the slot (412) of the first block (410).
5. The device (100) as claimed in claim 1, wherein the locking assembly (400) includes a plurality of coupling elements (430) positioned towards the second end of the first block (410) and configured to couple the first block (410) and the second block (450).
6. The device (100) as claimed in claim 1, wherein the locking assembly (400) includes a plurality of resilient members (440) configured to provide an opposing force to forward movement of the second block (450).
7. The device (100) as claimed in claim 6, wherein the resilient member (440) is mounted on the coupling elements 430.
8. The device (100) as claimed in claim 1, wherein the flow path (416) engraved on the top surface (410c) includes one of a M-shape, zigzag- shape, W-shape, wave-shape, V-shape, A-shape, Z-shape.
9. The device (100) as claimed in claim 1, wherein the flow path (416) includes a plurality of forward end points and backward end points, wherein the shaft (420) upon movement from a backward end point to a forward end point, is configured to align the hole (452a) of the second block (450) with the passage of the first block (410), and wherein the shaft 420 upon movement from a forward end point to a backward end point, is configured to misalign the hole (452a) of the second block (450) with the passage of the first block (410).
10. The device (100) as claimed in claim 1, wherein the second block (450) includes a plate (454) coupled to an elongated portion (452) towards the second end of the second block (450).
11. The device (100) as claimed in claim 10, wherein the plate (454) comprises:
a. a plurality of apertures (454a) extending through the plate (454), each aperture (454a) is configured to receive a coupling element (430);
b. a fastener (454b) positioned on a top edge of the plate (454) and configured to couple to an opening (420a) of the shaft (420); and
c. a groove (454c) positioned towards a second end of the second block (450) and configured to receive the actuator (456) of the second block (450).
12. The device (100) as claimed in claim 1, wherein the first block (410) includes a plurality of cavities (418) towards the second end, configured to receive the corresponding coupling elements (430).
13. The device (100) as claimed in claim 1, wherein the housing comprising a body (200) and a knob (300) to hold and maneuver the device (100).