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:
ACCESS DEVICE FOR A GUIDE WIRE

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

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

FIELD OF INVENTION
[1] The present disclosure relates to medical devices. More particularly, the present disclosure relates to an access device for a guide wire.
BACKGROUND OF INVENTION
[2] The basic, yet an important need, of any medical procedures that deal with the shrinkage of arterial passages due to the plaque buildup is the ability to navigate a guide wire through the affected area. Various medical interventions, such as stent implantation, balloon angioplasty, atherectomy procedures, etc., rely on the passage of a guide wire to successfully treat arterial blockages. However, one of the major challenges encountered in these procedures is the presence of occlusions, which prevents the smooth passage of the guide wire.
[3] Occlusions refer to complete or partial blockages within the arteries, caused by accumulation of plaque or other factors. When an occlusion occurs, it restricts blood flow and poses a significant obstacle to the successful completion of arterial interventions. Without a clear passage for the guide wire, physicians face difficulties in delivering stents, inflating balloons, or performing atherectomy procedures effectively using conventional devices.
[4] Chronic total occlusion (CTO) procedures can be challenging. Various techniques are employed in Chronic Total Occlusion (CTO) procedures, involving targeted collateral crossing, retrograde lesion crossing, and managing the subintimal space with balloon dilatation to connect antegrade and retrograde channels. However, achieving successful collateral crossing can be challenging due to factors like collateral selection and wire handling.
[5] Thus, there arises a need for a device that overcomes the problems associated with the conventional devices.
SUMMARY OF INVENTION
[6] Particular embodiments of the present disclosure are described herein below with reference to the accompanying drawings, however, it is to be understood that the disclosed embodiments are mere examples of the disclosure, which may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.
[7] The present disclosure relates to an access device for a guidewire. In an embodiment, the access device includes a rotating member. The rotating member includes internal threads disposed on an inner surface of the rotating member at least partially along a length of the rotating member from a distal end of the rotating member. The access device further includes a translating member operatively coupled to the rotating member and configured to linearly move in a distal direction in response to the rotating member rotating in a first direction. The translating member includes threads at least partially extending from a distal end of the translating member on an outer surface of the translating member and operationally coupled to the internal threads of the rotating member. The access device further includes a locking member operatively coupled to the rotating member and the translating member. In a first operational state, the locking member is configured to hold the guidewire and linearly move in the distal direction in response to the linear movement of the translating member in the distal direction, and rotate in the first direction in response to the rotating member rotating in the first direction to provide linear and rotational motion to the guidewire.
BRIEF DESCRIPTION OF DRAWINGS
[8] The summary above, as well as the following detailed description of illustrative embodiments, is better understood when read in conjunction with the apportioned drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentality disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.
[9] Fig. 1A depicts a perspective view of an access device 100 according to an embodiment of the present disclosure.
[10] Fig. 1B depicts a side view of the access device 100 according to an embodiment of the present disclosure.
[11] Fig. 2A depicts a perspective view of a distal end of a cylindrical enclosure 104 according to an embodiment of the present disclosure.
[12] Fig. 2B depicts a perspective view of a proximal end of the cylindrical enclosure 104 according to an embodiment of the present disclosure.
[13] Fig. 2C depicts an internal view of the cylindrical enclosure 104 according to an embodiment of the present disclosure.
[14] Fig. 2D depicts a side view of the cylindrical enclosure 104 according to an embodiment of the present disclosure.
[15] Fig. 3A depicts a perspective view of a handle assembly 106 according to an embodiment of the present disclosure.
[16] Fig. 3B depicts a side view of the handle assembly 106 according to an embodiment of the present disclosure.
[17] Fig. 3C depicts an internal view of the handle assembly 106 according to an embodiment of the present disclosure.
[18] Fig. 3D depicts a top view of the handle assembly 106 according to an embodiment of the present disclosure.
[19] Fig. 4 depicts different views of a grip 108 according to an embodiment of the present disclosure.
[20] Fig. 5A depicts a perspective view of a resilient member 110 according to an embodiment of the present disclosure.
[21] Fig. 5B depicts another perspective view of the resilient member 110 according to an embodiment of the present disclosure.
[22] Fig. 5C depicts a side view of the resilient member 110 according to an embodiment of the present disclosure.
[23] Fig. 6A depicts a perspective view of a rotating member 112 according to an embodiment of the present disclosure.
[24] Fig. 6B depicts a lateral view of the rotating member 112 according to an embodiment of the present disclosure.
[25] Fig. 6C depicts an internal view of the rotating member 112 according to an embodiment of the present disclosure.
[26] Fig. 7A depicts a perspective view of a translating member 114 according to an embodiment of the present disclosure.
[27] Fig. 7B depicts a front view of the translating member 114 according to an embodiment of the present disclosure.
[28] Fig. 7C depicts a lateral view of the translating member 114 according to an embodiment of the present disclosure.
[29] Fig. 7D depicts an internal view of the translating member 114 according to an embodiment of the present disclosure.
[30] Fig. 8A depicts a top view of a locking member 116 according to an embodiment of the present disclosure.
[31] Fig. 8B depicts a perspective view of the locking member 116 according to an embodiment of the present disclosure.
[32] Fig. 8C depicts an internal view of the locking member 116 according to an embodiment of the present disclosure.
[33] Fig. 8D depicts a side view of the locking member 116 according to an embodiment of the present disclosure.
[34] Fig. 9A depicts a perspective view of a translating pin 118 according to an embodiment of the present disclosure.
[35] Fig. 9B depicts a side view of the translating pin 118 according to an embodiment of the present disclosure.
[36] Fig. 10 depicts different views of a fastener 120 according to an embodiment of the present disclosure.
[37] Fig. 11A depicts a first operational state of the access device 100 when a user pulls the grip 108 towards a proximal direction according to an embodiment of the present disclosure.
[38] Fig. 11B depicts a second operational state of the access device 100 when the user releases the grip 108 according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF ACCOMPANYING DRAWINGS
[39] 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.
[40] 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.
[41] 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.
[42] 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.
[43] The present disclosure relates to an access device for a guide wire. In an embodiment, the access device includes a rotating member and a translating member coupled to the rotating member such that the rotational motion of the rotating member is converted to a translational (i.e., linear) motion of the translating member. In an embodiment, the access device includes a locking member coupled to the rotating member and the translating member. The translational motion of the translating member causes the locking member to grip the guidewire and impart a translational motion to the guidewire. Further, the rotational motion of the rotating member causes the locking member to rotate and impact a rotational motion to the guidewire. Thus, the access device provides the translational and rotational motion to the guidewire simultaneously. This combined motion allows for effective advancement of the guide wire across a lesion or obstruction.
[44] The rotational motion of the guidewire can be useful for navigating through tight spaces having lesions, obstructions or blockages. On the other hand, the linear motion of the guidewire allowing the guidewire to progress steadily through the vessel or anatomical structure. Thus, the access device enhances maneuverability of the guidewire and enables better control during medical procedures. It offers flexibility in navigating complex pathways and successfully traversing challenging lesions or blockages. The proposed access device can be utilized in several medical procedures such as stent implant, atherectomy, etc.
[45] Fig. 1A illustrates a perspective view of an access device 100 and Fig. 1B illustrates a side view of the access device 100, according to an embodiment of the present disclosure. The access device 100 is used to navigate a guidewire 102 through arterial passages. In an embodiment, the access device 100 includes a cylindrical enclosure 104, a handle assembly 106, a grip108, a resilient member 110, a rotating member 112, a translating member 114, a locking member 116, translating pins 118, and a fastener 120.
[46] The guide wire 102 has a proximal end 102a and a distal end 102b. The guidewire 102 passes through the access device 100. The guidewire 102 can be made of, without limitation, steel, nitinol or any other suitable material.
[47] Various views of the cylindrical enclosure 104 are illustrated in Figs. 2A – 2D, according to an embodiment. The cylindrical enclosure 104 has a proximal end 104a and a distal end 104b. The cylindrical enclosure 104 has a hollow, tubular structure defining a cavity 104c. The cylindrical enclosure 104 has an opening 104d at the proximal end 104a. The cylindrical enclosure 104 includes at least one slot 104e. The at least one slot 104e runs along a longitudinal axis of the cylindrical enclosure 104. In an embodiment, the cylindrical enclosure 104 includes two slots 104e provided on opposite sides of the cylindrical enclosure 104, i.e., the two slots 104e are 180 degrees apart. It should be appreciated though that more than two slots 104e may be provided on the cylindrical enclosure 104. The at least one slot 104e allow the translational movement of the translating pin 118 in forward (i.e., distal) and backward (i.e., proximal) direction. The distal end 104b of the cylindrical enclosure 104 has a conical shape. In an embodiment, the distal end 104b of the cylindrical enclosure 104 has a hole 104f for the passage for the guidewire 102. The cylindrical enclosure 104 may also include a groove 104g disposed circumferentially on the cylindrical enclosure 104 at the proximal end 104a.
[48] Figs. 3A – 3D illustrate different views of the handle assembly 106, according to an embodiment. The handle assembly 106 includes a tubular body 106a, first internal threads 106b1, second internal threads 106b2, a lumen 106c, at least one elongated pin 106d, and a forked portion 106e. The tubular body 106a of the handle assembly 106 has a proximal end 106a1 and a distal end 106a2. In an embodiment, the tubular body 106a is hollow and has a cylindrical shape. The distal end 106a2 of the tubular body 106a has the first internal threads 106b1 and the second internal threads 106b2 on an inner surface of the handle assembly 106 in close proximity to each other. The lumen 106c is extended between the proximal end 106a1 and a distal end 106a2 of the tubular body 106a. The lumen 106c provides the passage for the guidewire 102. The at least one elongated pin 106d is integrally coupled with an inner surface of the tubular body 106a at the distal end 106a2. The at least one elongated pin 106d extends outward in a distal direction from the distal end 106a2 of the tubular body 106a. In an embodiment, the at least one elongated pin 106d is integrally coupled with a supporting wall 106g of the handle assembly 106, disposed within the lumen 106c of the tubular body 106a. In an embodiment, the handle assembly 106 has two elongated pins 106d. The first internal threads 106b1 are coupled with the groove 104g of the cylindrical enclosure 104. The forked portion 106e of the handle assembly 106 has a proximal end 106e1 and a distal end 106e2. The forked portion 106e has an ergonomic shape so that the operator can hold the access device 100 easily. In an embodiment, the forked portion 106e has a generally triangular shape. A medial side of the forked portion 106e is coupled to a lateral side of the tubular body 106a. In an embodiment, the forked portion 106e and the tubular body 106a form an integral structure. The distal end 106e2 of the forked portion 106e includes two protrusions with each protrusion having at least one hole 106f. The two protrusions have a generally circular shape. The at least one hole 106f can be circular, elliptical, square, rectangular, etc. In an embodiment, the at least one hole 106f is circular. The handle assembly 106 is coupled to the grip 108 and the resilient member 110 at the at least one hole 106f. In an embodiment, the fastener 120 couples the handle assembly 106, the grip 108 and the resilient member 110 together.
[49] Fig. 4 shows different views of the grip 108, according to an embodiment. The grip 108 includes a top portion 108a, a bottom portion 108b, a proximal portion 108c and a distal portion 108d. In an embodiment, the top portion 108a of the grip 108 has a Y-shaped structure having two arms 108f with at least one-hole 108e on each arm 108f. The two arms 108f form a semicircular arc as shown. The semi-circular arc of top portion 108a of the grip 108 partially encircles the cylindrical enclosure 104 between the two slots 104e. Further, the top portion 108a of the grip 108 is coupled to the spiral groove 112d of rotating member 112 using the translational pins 118. The translational pins 118 pass through a respective hole 108e of the at least one hole 108e and extend into the spiral groove 112d of the rotating member 112 via the at least one slot 104e. In an embodiment, the bottom portion 108b has at least one hole 108g on either side of the bottom portion 108b. In an embodiment, the at least one hole 108g is aligned and concentric with the at least one hole 106f. In an embodiment, the bottom portion 108b is coupled to the at least one hole 106f of the forked portion 106e of the handle assembly 106 using the fastener 120. For example, the fastener 120 couples the at least one hole 108g of the bottom portion 108b, the at least one hole 106f of the handle assembly 106 and the resilient member 110 together. In an embodiment, the proximal portion 108c has a flat, continuous shape. The distal portion 108d of the grip 108 is designed to have an ergonomic shape to help an operator to hold and pull the grip 108 easily during the operation of the access device 100. In an embodiment, the distal portion 108d may include a plurality of semi-circular grooves.
[50] The resilient member 110 is operationally coupled to the forked portion 106e of the handle assembly 106 and the bottom portion 108b of the grip 108 via the at least one hole 106f and the at least one hole 108g, respectively. The resilient member 110 provides a resilient force, which helps in bringing the grip 108 back to an initial position. Thus, the resilient member 110 reduces manual force to be applied by the operator in operating the access device 100. In an embodiment, the resilient member 110 is a torsion spring. In an exemplary implementation depicted in Figs. 5A-5C, the resilient member 110 is a double torsion helical spring having two arms 110a and two coils 110b1 and 110b2.
[51] Different views of the rotating member 112 are shown in Figs. 6A-6C, according to an embodiment. The rotating member 112 has a proximal end 112a, distal end 112b, a lumen 112c, a spiral groove 112d, internal threads 112e, at least one guiding slot 112f and a notch 112g. The rotating member 112 is rotatably disposed within the cylindrical enclosure 104. The spiral groove 112d is provided on an outer surface of the rotating member 112. The top portion 108a of grip 108 and the rotating member 112 are coupled using the translating pins 118. The translating pins 118 extend through the at least one slot 104e of the cylindrical enclosure 104 and engage the spiral groove 112d. The translating pins 118 are configured to have a translational motion within the at least one slot 104e of the cylindrical enclosure 104 in response to the movement of the grip 108 by user. As the translating pins 118 engage the spiral groove 112d, the translational motion of the translational pins 118 is translated into a rotational motion of the rotating member 112. The rotating member 112 rotates within the cylindrical enclosure 104. The internal threads 112e and the at least one guiding slot 112f are disposed on the inner surface of the rotating member 112 at least partially along a length of the rotating member 112 from the distal end 112b. In an embodiment, the internal threads 112e and the at least one guiding slot 112f are disposed along the entire length of the rotating member 112. The at least one guiding slot 112f passes through the internal threads 112e structure. In an embodiment, the rotating member 112 includes two guiding slots 112f. In an embodiment, the internal threads 112e are coupled with the translating member 114 as shown in Fig. 7. The forward moment of the translating member 114 is restricted by a distal end of the guiding slots 112f. The at least one guiding slot 112f is coupled to the locking member 116 to provide a rotational motion to the locking member 116 and hence, to the guidewire 102 as explained later. The notch 112g is provided at the proximal end 112a of the rotating member 112. The notch 112g is coupled with the second internal threads 106b2 of the handle assembly 106, thereby coupling the rotating member 112 with the handle assembly 106.
[52] Figs. 7A-7D illustrate various views of the translating member 114 according to an embodiment. The translating member 114 is disposed within the lumen 112c of the rotating member 112. The translating member 114 includes a proximal end 114a, a distal end 114b, at least one elongated slot 114c, a lumen 114d, threads 114e and a cavity 114f. The translating member 114 is operatively coupled to the rotating member 112. In an embodiment, the proximal end 114a is co-axially coupled with proximal end 112a of the rotating member 112. The at least one elongated slot 114c extends from the proximal end 114a of the translating member 114 in a distal direction. In an embodiment, the translating member 114 has two elongated slots 114c. Each elongated slot 114c of the at least one elongated slot 114c of the translating member 114 receives a corresponding elongated pin 106d of the at least one elongated pin 106d of the handle assembly 106. The at least one elongated pin 106d disposed within the at least one elongated slot 114c restricts the rotational motion of the translating member 114. The lumen 114d provides the passage for the guidewire 102 and insertion of the locking member 116. The threads 114e are disposed on an outer surface of the translating member 114 and partially extend from the distal end 114b of the translating member 114 in a proximal direction. The threads 114e of the translating member 114 are operationally coupled to the internal threads 112e of the rotating member 112. When the rotating member 112 rotates, the coupling of the internal threads 112e of the rotating member 112 with the threads 114e of the translating member 114 will attempt to rotate the translating member 114. However, since the translating member 114 is restricted from rotating (due to the at least one elongated pin 106d disposed within the at least one elongated slot 114c), the translating member 114 moves linearly (i.e., in a translational motion) on the at least one elongated pin 106d. When the rotating member 112 rotates, the translating member 114 attempts to rotate along with it due to engagement of internal threads 112e of rotating member 112 and threads 114e of translating member 114. The rotational movement of the translating member 114 is restricted by the elongated pins 106d extruded from the supporting wall 106g of the handle assembly 106. The elongated pins 106d are inserted into the elongated slots 114c of the translating members 114 to help restrict the rotational motion therefore the translating member 114 is pulled forward (i.e., in a distal direction) and then pushed back (i.e., in a proximal direction) successively. Thus, the translating member 114 is configured to translate the rotational motion of the rotating member 112 into a linear (or translational) motion. The translating member 114 linearly moves in a distal direction and proximal direction in response to the rotating member (112) rotating in a first direction and a second direction respectively. In an embodiment, the first direction is anticlockwise and the second direction is clockwise. The cavity 114f is provided at the distal end 114b of the translating member 114. The cavity 114f is configured to hold at least a portion of the locking member 116.
[53] Various views of the locking member 116 are illustrated in Figs. 8A-8D, according to an embodiment. The locking member 116 includes a proximal end 116a, a distal end 116b, a plurality of jaws 116c, a lumen 116d and at least one stud 116e. The locking member 116 is operatively coupled to the rotating member 112 and the translating member 114. The locking member 116 is configured to allow or restrict the linear (or translational) motion of the translating member 114. The locking member 116 is configured to enable the rotational motion of the guidewire 102. The plurality of jaws 116c are provided at the proximal end 116a of the locking member 116. The plurality of jaws 116c are configured to reside within the cavity 114f of the translating member 114. In an embodiment, the locking member 116 has four jaws 116c. The plurality of jaws 116c are configured to hold the guidewire 102. In an embodiment, the plurality of jaws 116c are configured to move radially inwards to grab the guidewire 102 in response to the translating member 114 moving in the distal direction. Further, since the plurality of jaws 116c reside in the cavity 114f of the translating member 114. The plurality of jaws 116c are configured to have a linear motion (i.e., a translational motion) in response to the translational motion of the translating member 114. Consequently, the translational motion of the plurality of jaws 116c imparts translational motion to the guidewire 102. The lumen 116d allows the passage for the guidewire 102. The distal end 116b of the locking member 116 has at least one stud 116e. The at least one stud 116e is disposed on an outer surface of the locking member 116 towards the distal end 116b of the locking member 116. In an embodiment, the locking member 116 has two studs 116e. Further, the at least one stud 116e is aligned with the at least one guiding slot 112f. For example, each stud 116e of the at least one stud 116e aligns with a respective guiding slot 112f of the at least one guiding slot 112f. The number of the at least one stud 116e corresponds with the number of at least one guiding slot 112f. It should be appreciated that the locking member 116 may have more than two studs 116e suitably distributed across a circumference of the outer surface of the locking member 116 at the distal end 116b. The shape of the at least one stud 116e can be rectangular, triangular, semi-circular, etc. In an embodiment, the at least one stud 116e has a rectangular shape. The locking member 116 is configured to rotate when the rotating member 112 rotates in the first direction and the second direction. In an embodiment, when the rotating member 112 rotates, the at least one stud 116e is configured to rotate since the at least one stud 116e is disposed with the at least one guiding slot 112f. The rotation of the at least one stud 116e causes the locking member 116 to rotate, which in turn imparts a rotational motion to the guidewire 102. Thus, the rotating member 112 is configured to provide the rotational motion to the locking member 116 and the guidewire 102. Thus, the access device 100 provides both the translational and the rotational motion to the guidewire 102 simultaneously.
[54] Figs. 9A-9B illustrate various views of one translating pin 118 of the translating pins 118, according to an embodiment. The translating pin 118 has a first portion 118a, a second portion 118b, and a third portion 118c. The translating pin 118 couples the cylindrical enclosure 104, the grip 108 and the rotating member 112 together. The first portion 118a of the translating pin 118 engages the spiral groove 112d of the rotating member 112. The first portion 118a of the translating pin 118 is configured to slide within the spiral groove 112d of the rotating member 112 in response to the grip 108 being moved along the length of the at least one slot 104e by the user. The sliding of the first portion 118a of translating pin 118 within the spiral groove 112d of the rotating member 112 causes the rotating member 112 to rotate in the first direction or the second direction. The shape of the first portion 118a of translating pin 118 is suitably designed to enable the first portion 118a to slide within the spiral groove 112d. In an embodiment, the first portion 118a has a spherical shape. The third portion 118c of the translating pin 118 allows the operator to hold and/or rotate the translating pin 118 to couple the translating pin 118 with the grip 108 and the rotating member 112. In an embodiment, the third portion 118c has a disc shape. In an embodiment, an outer surface of the third portion 118c may have one or more features such as, without limitations, a plurality of protrusions, a plurality of grooves, a plurality of ridges, etc. for providing an easy grip for the operator. The second portion 118b is disposed between the first portion 118a and the third portion 118c. In an embodiment, the second portion 118b of the translating pin 118 has a cylindrical shape. The second portion (118b) of each translating pin (118) slides along a respective slot of the at least one slot (104e) in the proximal direction in response to the movement of the grip (108) in a proximal direction.
[55] The fastener 120 is operationally coupled to the at least one hole 106f at the distal end 106e2 of the forked portion 106e of the handle assembly 106 with the at least one hole 108g of the bottom portion 108b of the grip 108. The fastener 120 supports the resilient member 110 between the at least one hole 106f and the at least one hole 108g. In an embodiment shown in Fig. 10, the fastener 120 is a nut-bolt mechanism. The fastener 120 has a first coupling portion 120a and a second coupling portion 120b. In the depicted embodiment, the first coupling portion 120a is a bolt and the second coupling portion 120b is a nut. The first coupling portion 120a includes a head 120a2, a stem portion 120a6 having threads 120a10. In an embodiment, the head 120a2 of the first coupling portion 120a may include a plurality of projections 120a4 to provide a better grip for the user. In another embodiment, the head 120a2 may include features such as, without limitation, serrations, ridges, undulations, etc. for a better grip. In another embodiment, the head 120a2 of the first coupling portion 120a may not have any features. In an embodiment, the head 120a2 of the first coupling portion 120a is cylindrical, though it may have any other suitable shape. In an embodiment, the stem portion 120a6 is cylindrical. The second coupling portion 120b includes a cavity 120b2, threads 120b4. In an embodiment, the second coupling portion 120b may include features, such as, a plurality of projections 120b6 circumferentially disposed on an outer surface of the second coupling portion 120b. In an embodiment, the second coupling portion 120b is cylindrical. The shape and dimensions of the cavity 120b2 are designed such that the stem portion 120a6 of the first coupling portion 120a fits within the cavity 120b2. An internal surface of the cavity 120b2 has the threads 120b4. The threads 120b4 are complementary to the threads 120a10 of the first coupling portion 120a.
[56] Fig. 11A depicts a first operational state of the access device 100 when the user pulls the grip 108 in a proximal direction (a first operation state), according to an embodiment of the present disclosure. The guidewire 102 is inserted through the proximal end 100a of the access device 100 till the guidewire 102 comes out at the distal end 100b of the access device 100. Once the guidewire 102 is inserted, the grip 108 of the access device 100 is pulled by the user towards the proximal end 100a of the access device 100. This causes the grip 108 to move in the proximal direction along the length of the at least one slot 104e (i.e., from a distal end of the at least one slot 104e to a proximal end of the at least slot 104e). The movement of the grip 108 causes the first portion 118a of the translating pin 118 to slide within the spiral groove 112d of the rotating member 112 towards the proximal end 112a of the rotating member 112. The movement of the translating pins 118 over the spiral groove 112d results in an anti-clockwise (the first direction) rotational motion of the rotating member 112. The anti-clockwise rotational motion of the rotating member 112 is transferred to the translating member 114 through the coupling of the internal threads 112e of the rotating member 112 and threads 114e of the translating member 114. As the rotational motion of the translating member 114 is restricted, the rotational motion of the rotating member 112 causes the translating member 114 to move in the distal direction i.e., imparts a translational motion to the translating member 114 towards the distal end 112b of the rotating member 112. The translational movement of the translating member 114 causes the locking member 116 to be pushed radially inward. The distal end 114b of the translating member 114 exerts pressure on the plurality of jaws 116c of the locking member 116. The plurality of jaws 116c, in turn, securely grips the guidewire 102 and moves the guidewire 102 translationally in the distal direction due to the translational motion of the translating member 114. Further, the at least one stud 116e disposed within the at least one guiding slot 112f of the rotating member 112 causes the locking member 116 to rotate in response to the rotational motion of the rotating member 112 in the first direction. The rotational motion of the locking member 116 imparts a rotational motion to the guidewire 102 via the plurality of jaws 116c. Further, the resilient member 110 moves to a compressed state due to the pressure applied on the grip 108. Thus, both the translational and the rotational motion is provided simultaneously to the guidewire 102.
[57] Fig. 11B depicts a second operational state of the access device 100 for guidewire 102 when the user releases the grip 108 (a second operational state) according to an embodiment. When the user releases the grip 108, the resilient force of the resilient member 110 (in the compressed state) causes the grip 108 to move from the proximal end of the at least one slot 104e to the distal end of the at least one slot 104e and grip 108 moves in the distal direction to reach the initial position. As a result, the translating pins 118 move within the spiral groove 112d of the rotational member 112 toward the distal end 104b of the cylindrical enclosure 104. This results in rotation of rotating member 112 in second direction. In an embodiment, the second direction is a clockwise rotational motion. The rotational motion of the rotating member 112 in the second direction is transferred to the translating member 114 through the coupling of the internal threads 112e of the rotating member 112 and the threads 114e of the translating member 114. As the rotational motion of the translating member 114 is restricted, the rotational motion of the rotating member 112 causes the translating member 114 to move in the proximal direction, i.e., imparts a translational motion to the translating member 114. The translational movement of the translating member 114 causes the locking member 116 to be pushed radially outward. The pressure on the plurality of jaws 116c of the locking member 116 is released. The plurality of jaws 116c, in turn, releases the guidewire 102. As there is no grip on the guidewire 102, there is no linear or rotational motion of the guidewire 102 and the guidewire 102 maintains its position.
[58] Thus, the access device 100 enables controlled advancement of the guidewire 102 using both the linear and rotational motions, ensuring precise positioning of the guidewire 102 for the treatment of arterial lesions. Further, simultaneous liner and rotational motion of the guidewire 102 provided by the access device 100 allows the user to navigate the guidewire 102 even through areas where occlusions (partial or total) may be present. The grip 108 and the resilient member 110 allow for an easier operation of the access device 100 by the user as the user needs to apply minimal force on the grip 108 to advance the guidewire 102 as desired.
[59] 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. An access device (100) for a guidewire (102), the access device (100) comprising:
a. a rotating member (112) comprising:
i. internal threads (112e) disposed on an inner surface of the rotating member (112) at least partially along a length of the rotating member (112) from a distal end (112b) of the rotating member (112); and
b. a translating member (114) operatively coupled to the rotating member (112) and configured to linearly move in a distal direction in response to the rotating member (112) rotating in a first direction, the translating member (114) comprising:
i. threads (114e) at least partially extending from a distal end (114b) on an outer surface of the translating member (114) and operationally coupled to the internal threads (112e) of the rotating member (112); and
c. a locking member (116) operatively coupled to the rotating member (112) and the translating member (114) and, in a first operational state, the locking member (116) is configured to:
i. hold the guidewire (102) and linearly move in the distal direction in response to the linear movement of the translating member (114) in the distal direction; and
ii. rotate in the first direction in response to the rotating member (112) rotating in the first direction to provide linear and rotational motion to the guidewire (102).
2. The access device (100) as claimed in claim 1, wherein the rotating member (112) comprises at least one guiding slot (112f) disposed on the inner surface of the rotating member (112) at least partially along the length of the rotating member (112) from the distal end (112b) of the rotating member (112); and wherein the locking member (116) comprises:
a. a plurality of jaws (116c), provided at a proximal end (116a) of the locking member (116), and in the first operational state, the plurality of jaws (116c) is configured to move radially inward to hold the guidewire (102) and linearly move in the distal direction in response to the linear movement of the translating member (114) in the distal direction; and
b. at least one stud (116e), disposed on an outer surface of the locking member (116) towards a distal end (116b) of the locking member (116) and aligned with a respective guiding slot (112f) of the at least one guiding slot (112f) of the rotating member (112), and in the first operational state, configured to rotate in the first direction in response to the rotating member (112) rotating in the first direction.
3. The access device (100) as claimed in claim 1, wherein the access device (100) comprises:
a. translating pins (118) each translating pin (118) of the translating pins (118) comprises a first portion (118a) configured to engage with a spiral groove (112d) provided on an outer surface of the rotating member (112);
b. a grip (108), operatively coupled with the rotating member (112) via the translating pins (118);
c. wherein, in response to a movement of the grip (108) in a proximal direction, the first portion (118a) of each translating pin (118) is configured to slide within the spiral groove (112d) and the rotating member (112) is configured to rotate in the first direction in response to the sliding of the first portion (118a) of each translating pin (118) along the spiral groove (112d).
4. The access device (100) as claimed in claim 3, wherein the access device (100) comprises a cylindrical enclosure (104) comprising at least one slot (104e) provided on a surface of the cylindrical enclosure (104) along a longitudinal direction, wherein a second portion (118b) of each translating pin (118) slides along a respective slot of the at least one slot (104e) in the proximal direction in response to the movement of the grip (108) in a proximal direction, and wherein the rotating member (112) is disposed within the cylindrical enclosure (104).
5. The access device (100) as claimed in claim 4, wherein the cylindrical enclosure (104) comprises a groove (104g) disposed circumferentially on the cylindrical enclosure (104) at a proximal end (104a) of the cylindrical enclosure (104) and coupled with a first internal threads (106b1) of a handle assembly (106).
6. The access device (100) as claimed in claim 3, wherein the grip (108) comprises:
a. a top portion (108a) having two arms (108f) with at least one hole (108e) on each arm (108f), the top portion (108a) of the grip (108) is coupled to the spiral groove (112d) of the rotating member (112) using the translating pins (118), each translational pin (118) passing through a respective hole (108e) of the at least one-hole (108e) and extending into the spiral groove (112d) via the at least one slot (104e); and
b. a bottom portion (108b) having at least one hole (108g) on either side of the bottom portion (108b), wherein the at least one hole (108g) is coupled with at least one hole (106f) of a forked portion (106e) of a handle assembly (106) using a fastener (120).
7. The access device (100) as claimed in claim 3, wherein the access device (100) comprises a resilient member (110) coupled to a bottom portion (108b) of the grip (108) and, in a second operational state, configured to move the grip (108) in a distal direction to an initial position of the grip (108).
8. The access device (100) as claimed in claim 1, wherein the translating member (114) comprises at least one elongated slot (114c) extending inward from a proximal end (114a) of the translating member (114) and configured to receive a corresponding elongated pin (106d) of at least one elongated pin (106d), wherein the at least one elongated pin (106d) is configured to restrict a rotational motion of the translating member (114).
9. The access device (100) as claimed in claim 1, wherein the access device (100) comprises a handle assembly (106) comprising:
a. a tubular body (106a) having a proximal end (106a1) and a distal end (106a2) and a lumen (106c) extending therebetween, the tubular body (106a) including first internal threads (106b1) and second internal threads (106b2) on its inner surface and in close proximity to each other at the distal end (106a2); and
b. at least one elongated pin (106d) extending outwards from the distal end (106a2) and integrally coupled with a supporting wall (106g) of the handle assembly (106), disposed within the lumen(106c) of the tubular body (106a);
c. a forked portion (106e) having a proximal end (106e1) and a distal end (106e2) wherein the forked portion (106e) is coupled to a lateral side of the tubular body (106a) and the distal end (106e2) of the forked portion (106e) comprises two protrusions with each protrusion having at least one hole (106f), coupled with a bottom portion (108b) of a grip (108) and a resilient member (110) using a fastener (120).
10. The access device (100) as claimed in claim 1, wherein the rotating member (112) comprises a notch (112g) provided at a proximal end (112a) of the rotating member (112) and coupled with second internal threads (106b2) of the handle assembly (106).
11. The access device (100) as claimed in claim 1, wherein the translating member (114) is configured to linearly move in a proximal direction in response to the rotating member (112) rotating in a second direction.